[Federal Register Volume 89, Number 150 (Monday, August 5, 2024)]
[Proposed Rules]
[Pages 63498-63811]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-14975]
[[Page 63497]]
Vol. 89
Monday,
No. 150
August 5, 2024
Part II
Department of Health and Human Services
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45 CFR Parts 170, 171, and 172
Health Data, Technology, and Interoperability: Patient Engagement,
Information Sharing, and Public Health Interoperability; Proposed Rule
Federal Register / Vol. 89 , No. 150 / Monday, August 5, 2024 /
Proposed Rules
[[Page 63498]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
45 CFR Parts 170, 171, and 172
RIN 0955-AA06
Health Data, Technology, and Interoperability: Patient
Engagement, Information Sharing, and Public Health Interoperability
AGENCY: Office of the National Coordinator for Health Information
Technology (ONC), Department of Health and Human Services (HHS).
ACTION: Proposed rule.
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SUMMARY: This proposed rule seeks to advance interoperability, improve
transparency, and support the access, exchange, and use of electronic
health information through proposals for: standards adoption; adoption
of certification criteria to advance public health data exchange;
expanded uses of certified application programming interfaces, such as
for electronic prior authorization, patient access, care management,
and care coordination; and information sharing under the information
blocking regulations. It proposes to establish a new baseline version
of the United States Core Data for Interoperability. The proposed rule
would update the ONC Health IT Certification Program to enhance
interoperability and optimize certification processes to reduce burden
and costs. The proposed rule would also implement certain provisions
related to the Trusted Exchange Framework and Common Agreement (TEFCA),
which would support the reliability, privacy, security, and trust
within TEFCA.
DATES: To be assured consideration, written or electronic comments must
be received at one of the addresses provided below, no later than 5
p.m. Eastern Time on October 4, 2024.
ADDRESSES: You may submit comments, identified by RIN 0955-AA06, by any
of the following methods (please do not submit duplicate comments).
Because of staff and resource limitations, we cannot accept comments by
facsimile (FAX) transmission.
Federal eRulemaking Portal: Follow the instructions for
submitting comments. Attachments should be in Microsoft Word, Microsoft
Excel, or Adobe PDF; however, we prefer Microsoft Word. http://www.regulations.gov.
Regular, Express, or Overnight Mail: Department of Health
and Human Services, Office of the National Coordinator for Health
Information Technology, Attention: Health Data, Technology, and
Interoperability: Patient Engagement, Information Sharing, and Public
Health Interoperability Proposed Rule, Mary E. Switzer Building, Mail
Stop: 7033A, 330 C Street SW, Washington, DC 20201. Please submit one
original and two copies.
Hand Delivery or Courier: Office of the National
Coordinator for Health Information Technology, Attention: Health Data,
Technology, and Interoperability: Patient Engagement, Information
Sharing, and Public Health Interoperability Proposed Rule, Mary E.
Switzer Building, Mail Stop: 7033A, 330 C Street SW, Washington, DC
20201. Please submit one original and two copies. (Because access to
the interior of the Mary E. Switzer Building is not readily available
to persons without Federal government identification, commenters are
encouraged to leave their comments in the mail drop slots located in
the main lobby of the building.)
Inspection of Public Comments: All comments received before the
close of the comment period will be available for public inspection,
including any personally identifiable or confidential business
information that is included in a comment. Please do not include
anything in your comment submission that you do not wish to share with
the general public. Such information includes, but is not limited to,
the following: a person's social security number; date of birth;
driver's license number; state identification number or foreign country
equivalent; passport number; financial account number; credit or debit
card number; any personal health information; or any business
information that could be considered proprietary. We will post all
comments that are received before the close of the comment period at
http://www.regulations.gov.
Docket: For access to the docket to read background documents,
comments received, or the plain-language summary of the proposed rule
of not more than 100 words in length required by the Providing
Accountability Through Transparency Act of 2023, go to http://www.regulations.gov or the Department of Health and Human Services,
Office of the National Coordinator for Health Information Technology,
Mary E. Switzer Building, Mail Stop: 7033A, 330 C Street SW,
Washington, DC 20201 (call ahead to the contact listed below to arrange
for inspection).
FOR FURTHER INFORMATION CONTACT: Michael Lipinski, Office of Policy,
Office of the National Coordinator for Health Information Technology,
202-690-7151.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Executive Summary
A. Purpose of Regulatory Action
B. Summary of Major Provisions
1. ONC Health IT Certification Program Updates
a. New and Revised Standards and Certification Criteria
i. The United States Core Data for Interoperability Version 4
(USCDI v4)
ii. SMART App Launch 2.2
iii. User-Access Brands and Endpoints
iv. Standards for Encryption and Decryption of Electronic Health
Information
v. Minimum Standards Code Sets Updates
vi. New Imaging Requirements for Health IT Modules
vii. Revised Clinical Information Reconciliation and
Incorporation Criterion
viii. Revised Electronic Prescribing Certification Criterion
ix. New Real-Time Prescription Benefit Criterion
x. Electronic Health Information (EHI) Export--Single Patient
EHI Export Exemption
xi. Revised End-User Device Encryption Criterion
xii. Revised Criterion for Encrypt Authentication Credentials
xiii. Health IT Modules Supporting Public Health Data Exchange
xiv. Bulk Data Enhancements
xv. New Requirements to Support Dynamic Client Registration
Protocol in the Program
xvi. New Certification Criteria for Modular API Capabilities
xvii. Multi-factor Authentication Criterion
xviii. Revised Computerized Provider Order Entry--Laboratory
Criterion
xix. Revised Standardized API for Patient and Population
Services Criterion to Align with Modular API Capabilities
xx. Patient, Provider, and Payer APIs
2. Conditions and Maintenance of Certification Requirements--
Insights and Attestations
a. Insights Condition and Maintenance of Certification
Requirements
b. Attestations Condition and Maintenance of Certification
Requirements
3. Administrative Updates
4. Correction--Privacy and Security Certification Framework
5. Information Blocking Enhancements
6. Trusted Exchange Framework and Common AgreementTM
C. Severability
D. Costs and Benefits
II. Background
A. Statutory Basis
1. Standards, Implementation Specifications, and Certification
Criteria
2. ONC Health IT Certification Program Rules
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B. Regulatory History
III. ONC Health IT Certification Program Updates
A. Standards and Implementations Specifications
1. National Technology Transfer and Advancement Act
2. Compliance with Adopted Standards and Implementation
Specifications
3. ``Reasonably Available'' to Interested Parties
B. New and Revised Standards and Certification Criteria
1. The United States Core Data for Interoperability Version 4
(USCDI v4)
a. Background and USCDI v4 Update
b. Certification Criteria that Reference USCDI
2. SMART App Launch 2.2
3. User-Access Brands and Endpoints
4. Standards for Encryption and Decryption of Electronic Health
Information
a. Background
b. Proposal
5. Minimum Standards Code Sets Updates
6. New Imaging Requirements for Health IT Modules
7. Revised Clinical Information Reconciliation and Incorporation
Criterion
8. Revised Electronic Prescribing Certification Criterion
a. Electronic Prescribing Standard
b. Proposed Transactions c. Additional Proposals
9. New Real-Time Prescription Benefit Criterion
a. Background
b. Revision to the Base EHR Definition and Health IT Module
Dependent Criteria Requirements
c. Real-Time Prescription Benefit Standard
d. Sending and Receiving Real-Time Prescription Benefit
Information
e. Additional Topics
10. Electronic Health Information (EHI) Export--Single Patient
EHI Export Exemption
a. Background
b. Proposal for EHI Export
c. Proposal for Associated Assurances Requirements for Single
Patient EHI Export Exemption
11. Revised End-User Device Encryption Criterion
a. Background
b. Proposal
12. Revised Criterion for Encrypt Authentication Credentials
a. Background
b. Proposal
13. Health IT Modules Supporting Public Health Data Exchange
a. Background
b. Regulatory History
c. Proposal Overview
d. Revised Certification Criteria for Health IT Modules
Supporting Public Health Data Exchange
e. New Certification Criteria for Health IT Modules Supporting
Public Health Data Exchange
f. New Standardized API for Public Health Data Exchange
14. Bulk Data Enhancements
a. Background
b. Proposal
15. New Requirements to Support Dynamic Client Registration
Protocol in the Program
a. Background to Dynamic Client Registration
b. Adoption of HL7 UDAP Security IG v1
c. Revision of Standardized API for Patient and Population
Services to Support Dynamic Client Registration
d. Removal of Reference to OpenID Connect Core Specification
e. API Conditions and Maintenance Updates to Support Dynamic
Client Registration
16. New Certification Criteria for Modular API Capabilities
a. Proposal Background
b. Modular API Capabilities Certification Criteria
17. Multi-Factor Authentication Criterion
a. Background
b. Proposal
18. Revised Computerized Provider Order Entry--Laboratory
Criterion
19. Revised Standardized API for Patient and Population Services
Criterion to Align with Modular API Capabilities
a. Proposed Revisions for Registration
b. Proposed Revisions for Patient and User Access
c. Proposed Revisions for System Access
d. Other Restructured Requirements
e. Proposed Requirements for System Read and Search API,
Subscriptions, and Workflow Triggers for Decision Support
Interventions
20. Patient, Provider, and Payer APIs
a. Background on CMS Interoperability Rulemaking
b. Proposal Overview
c. Proposed Certification Criteria
d. Revision and Addition of API Condition and Maintenance of
Certification Requirements
e. Revisions to Real World Testing Requirements
f. Addition of Criteria to the Base EHR Definition
C. Conditions and Maintenance of Certification Requirements--
Insights and Attestations
1. Insights Condition and Maintenance of Certification
Requirements
a. Background
b. Process for Reporting Updates
c. Minimum Reporting Qualifications
d. Measure Updates
2. Attestations Condition and Maintenance of Certification
Requirements
D. Administrative Updates
1. Program Correspondence
2. ONC-Authorized Certification Bodies (ACB) Surveillance of
Certain Maintenance of Certification Requirements
a. Background and Proposal Summary
b. Updates to Principles of Proper Conduct for Maintenance of
Certification Requirements
c. Updates to Surveillance for Maintenance of Certification
Requirements
3. Updates to Principles of Proper Conduct for API Discovery
Details
4. New ONC-ACB Principles of Proper Conduct for Notice of
Program Withdrawal
5. Updates to ONC Direct Review Procedures
a. Health IT Developers' Response to Notices of Non-conformity
and Corrective Action Plan Requirements
b. Suspension, Termination, and Appeals
c. Appeals
6. Certification Ban
7. Updates Pursuant to 2014 Edition Removal
a. Removal of ``Complete EHR'' References
b. Removal of ``EHR Modules'' References
8. Definition of Serious Risk to Public Health or Safety
9. Removal of Time-limited Criteria
10. Privacy and Security Framework Incorporation of DSI
Criterion
E. Correction--Privacy and Security Certification Framework
IV. Information Blocking Enhancements
A. Defined Terms
1. Health Care Provider
2. Health Information Technology or Health IT
3. ``Interfere With'' or ``Interference''
a. Application of ``Interference'' to TEFCA\TM\ Requirements
B. Exceptions
1. Privacy Exception
a. Privacy Exception--Definition of Individual
b. Privacy Sub-exception--Interfering with Individual Access
Based on Unreviewable Grounds
c. Privacy Sub-exception--Individual's Request Not to Share EHI
2. Infeasibility Exception
a. Segmentation Condition Modifications
b. Third Party Seeking Modification Use Condition Modifications
c. Responding to Requests Condition Modifications
3. Protecting Care Access Exception
a. Background and Purpose
b. Threshold Condition and Structure of Exception
c. Patient Protection Condition
d. Care Access Condition
e. Clarifying Provisions: Presumption and Definition of ``Legal
Action''
4. Requestor Preferences Exception
5. Exceptions That Involve Practices Related to Actors'
Participation in The Trusted Exchange Framework and Common
Agreement\TM\ (TEFCA\TM\)
a. Definitions
b. TEFCATM Manner Exception
V. Trusted Exchange Framework and Common Agreement\TM\
A. Subpart A--General Provisions
B. Subpart B--Qualifications for Designation
C. Subpart C--QHIN\TM\ Onboarding and Designation Processes
D. Subpart D--Suspension
E. Subpart E--Termination
F. Subpart F--Review of RCE[supreg] or ONC Decisions
G. Subpart G--QHINTM Attestation for the Adoption of
the Trusted Exchange Framework and Common AgreementTM
VI. Incorporation by Reference
VII. Response to Comments
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VIII. Collection of Information Requirements
A. Qualified Health Information Networks\TM\
B. ONC-ACBs
IX. Regulatory Impact Analysis
A. Statement of Need
B. Alternatives Considered
C. Overall Impact
1. Executive Orders 12866 and 13563--Regulatory Planning and
Review Analysis
a. Costs and Benefits
b. Accounting Statement and Table
D. Regulatory Flexibility Act
E. Executive Order 13132--Federalism
F. Unfunded Mandates Reform Act of 1995
Regulation Text
I. Executive Summary
A. Purpose of Regulatory Action
The Secretary of Health and Human Services has delegated
responsibilities to the Office of the National Coordinator for Health
Information Technology (ONC) for the implementation of certain
provisions in Title IV of the 21st Century Cures Act (Pub. L. 114-255,
Dec. 13, 2016) (Cures Act) that are designed to: advance
interoperability; support the access, exchange, and use of electronic
health information (EHI); and identify reasonable and necessary
activities that do not constitute information blocking.\1\ ONC is
responsible for implementation of certain provisions of the Health
Information Technology for Economic and Clinical Health Act (Pub. L.
111-5, Feb. 17. 2009) (HITECH Act) including: requirements that the
National Coordinator perform duties consistent with the development of
a nationwide health information technology infrastructure that allows
for the electronic use and exchange of information and that promotes a
more effective marketplace, greater competition, and increased consumer
choice, among other goals; and requirements to keep or recognize a
program or programs for the voluntary certification of health
information technology. This proposed rule seeks to fulfill statutory
requirements; provide transparency; advance equity, innovation, and
interoperability; and support the access to, and exchange and use of,
EHI. Transparency regarding healthcare information and activities--as
well as the interoperability and electronic exchange of health
information--are all in the best interest of the patient and are
central to the efforts of the Department of Health and Human Services
to enhance and protect the health and well-being of all Americans.
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\1\ Reasonable and necessary activities that do not constitute
information blocking, also known as information blocking exceptions,
are identified in 45 CFR part 171 subparts B, C and D. ONC's
official website, HealthIT.gov, offers a variety of resources on the
topic of Information Blocking, including fact sheets, recorded
webinars, and frequently asked questions. To learn more, please
visit: https://www.healthit.gov/topic/information-blocking/.
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In addition to addressing the HITECH Act's and Cures Act's
requirements described above and advancing interoperability, the
proposed rule aligns with and supports Executive Orders (E.O.) 13994,
13985, 14036, and 14058. The President issued E.O. 13994 on January 21,
2021, to ensure a data-driven response to COVID-19 and future high-
consequence public health threats. The Cures Act and the information
blocking provisions in the 21st Century Cures Act: Interoperability,
Information Blocking, and the ONC Health IT Certification Program (85
FR 25642) (ONC Cures Act Final Rule) have enabled critical steps to
making data available across the healthcare system. The proposed rule
proposes to adopt certification criteria to advance interoperability
and support public health reporting and exchange. Because we recognize
the need for greater interoperability of public health technology and
access to more actionable data by public health authorities (PHA) and
their partners, the proposed rule lays out a multi-pronged approach
that takes advantage of, and builds upon, the various previous efforts
to advance public health reporting, including advancements in
HL7[supreg] Fast Healthcare Interoperability Resources-based
(FHIR[supreg]) solutions and evolving standards related to public
health interoperability. We have proposed this approach to allow for
systems to mature and advance in an aligned fashion, reduce the need
for manual workarounds and intervention, and lead to wider adoption of
advanced standards-based capabilities.
The proposed adoption of the United States Core Data for
Interoperability Standard Version 4 (USCDI v4) would promote the
establishment and use of interoperable data sets of EHI for
interoperable health data exchange. As discussed in section III.B.1,
USCDI v4 would facilitate the collection, access and exchange of data
for use in public health and emergency response (e.g., the COVID-19
pandemic) by capturing and promoting the sharing of key data elements
related to public health. The proposal to adopt a new certification
criterion for standardized FHIR-based application programming
interfaces (APIs) for public health reporting, as discussed in section
III.B.13.f, reflects ONC's continued efforts to develop and standardize
APIs and facilitate exchange of public health data between health care
providers and public health agencies, to securely access EHI through
the broader adoption of standardized APIs.\2\ \3\As discussed in
section III.B, adopting USCDI v4 and the proposals in Sec.
170.315(g)(20) are intended to facilitate core public health missions
including detecting and monitoring, investigating and responding,
informing and disseminating, and being response-ready. We also expect
our proposed changes to improve patient access to more complete,
standardized, immunization information stored in certified health IT
products.
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\2\ ONC. (2022, October 18). API Resource Guide. ONC Health IT
Certification Program API Resource Guide. Retrieved March 16, 2023,
from https://onc-healthit.github.io/api-resource-guide/.
\3\ Section 4002 of the 21st Century Cures Act (Cures Act)
established a condition of certification that requires health IT
developers to publish application programming interfaces (APIs) that
allow ``health information from such technology to be accessed,
exchanged, and used without special effort through the use of [APIs]
or successor technology or standards, as provided for under
applicable law.'' The Cures Act's API Condition of Certification
requirement also states that a developer must, through an API,
``provide access to all data elements of a patient's electronic
health record to the extent permissible under applicable privacy
laws.'' The API Conditions and Maintenance of Certification
requirements and certification criteria are identified in 45 CFR
part 170.
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We are committed to advancing health equity, and this proposed rule
is consistent with E.O. 13985 of January 20, 2021, Advancing Racial
Equity and Support for Underserved Communities Through the Federal
Government.\4\ Section 1 of E.O. 13985 states that ``the Federal
Government should pursue a comprehensive approach to advancing equity
for all, including people of color and others who have been
historically underserved, marginalized, and adversely affected by
persistent poverty and inequality.'' Section 1 of E.O. 13985 also
states that because ``advancing equity requires a systematic approach
to embedding fairness in decision-making processes, executive
departments and agencies must recognize and work to redress inequities
in any policies and programs that serve as barriers to equal
opportunity.'' We believe USCDI v4 and proposals in Sec. 170.315(f)
and Sec. 170.315(g)(20) would not only support identifying and
responding to public health threats, but also support advancing equity.
As noted above, we propose to modify current certification
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criteria in Sec. 170.315(f) and adopt new criteria in Sec. 170.315(f)
for Health IT Modules supporting public health data exchange that would
help increase the data shared between health care providers,
laboratories, and PHAs, and would increase interoperability among the
different systems in place at each entity. Our proposed changes focus
on providing more complete patient-level information for contact
tracing and further case investigation, patient outreach, direct care,
and other clinical and public health activities. For example, some of
the proposed standards would require the exchange of available patient
demographic information, including race, ethnicity, sex, and contact
information; and may allow PHAs to get more complete data when
providers and laboratories have these data elements and can
appropriately fill the fields. Additionally, if finalized as proposed,
the adoption of USCDI v4 would update the USCDI standard to include new
data elements under the Health Status Assessments, Medications,
Allergies and Intolerances, Goals and Preferences, Encounter
Information, Vital Signs, and Laboratory data classes, and a new data
class, Facility Information, as discussed in section III.B.1 of this
proposed rule. Expanding the data elements included in USCDI would
increase the amount and type of data available to be used and exchanged
through certified health IT. Our proposed standards update for public
health and USCDI v4 could help capture more accurate and complete
patient characteristics that are reflective of patient diversity and
could potentially help data users address disparities in health
outcomes for all patients, including those who may be marginalized and
underrepresented. This could also support data users' abilities to
identify, assess, and analyze gaps in care, which could in turn be used
to inform and address the quality of healthcare through interventions
and strategies. This could lead to better patient care, experiences,
and health outcomes.
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\4\ United States, Executive Office of the President [Joseph
Biden]. Executive Order 13985: Advancing Racial Equity and Support
for Underserved Communities Through the Federal Government. Jan 20,
2021. 86 FR 7009 through 7013, https://www.federalregister.gov/documents/2021/01/25/2021-01753/advancing-racial-equity-and-support-for-underserved-communities-through-the-federal-government.
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As discussed in section III.B.1, the proposal to adopt USCDI v4
also supports the concept of ``health equity by design,'' where health
equity considerations are identified and incorporated from the
beginning and throughout the technology design, build, and
implementation processes, and health equity strategies, tactics, and
patterns are guiding principles for developers, enforced by technical
architecture, and built into the technology at every layer. With every
successive USCDI version supported by certified health IT, the
capabilities and workflows included will help support equity and
efforts to reduce disparities.
President Biden's E.O. 14036, Promoting Competition in the American
Economy,\5\ issued on July 9, 2021, established a whole-of-government
effort to promote competition in the American economy and reaffirmed
the policy stated in E.O. 13725 of April 15, 2016 (Steps to Increase
Competition and Better Inform Consumers and Workers to Support
Continued Growth of the American Economy).\6\ This proposed rule would
foster competition by advancing foundational standards for certified
API technology, which enable--through applications (apps) and without
special effort--improved legally permissible sharing of EHI among
clinicians, patients, researchers, and others. As described throughout
the proposed rule, competition would be advanced through these improved
API standards that can help individuals connect to their information
and can help health care providers involved in the patient's care to
securely access information. For example, these standards are designed
to foster an ecosystem of new applications that can connect through the
API technology to provide patients with improved electronic access to
EHI and more choices in their health care providers. This is similar to
how APIs have impacted other sectors of the economy, such as travel,
banking, and commerce.
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\5\ United States, Executive Office of the President [Joseph
Biden]. Executive Order 14036: Promoting Competition in the American
Economy. Jul 9, 2021. 86 FR 36987 through36999, https://www.federalregister.gov/documents/2021/07/14/2021-15069/promoting-competition-in-the-american-economy.
\6\ Federal Register: Steps to Increase Competition and Better
Inform Consumers and Workers to Support Continued Growth of the
American Economy.
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Further, as described in section IV of this proposed rule, we
propose enhancements to support information sharing under the
information blocking regulations and promote innovation and
competition, while ensuring patients' privacy and access to care remain
protected. As we have noted, addressing information blocking is
critical for promoting innovation and competition in health IT and for
the delivery of healthcare services to individuals, as discussed in
both the ONC Cures Act Proposed (84 FR 7508) and Final (85 FR 25790
through 25791) Rules, and reiterated in the Health Data, Technology,
and Interoperability: Certification Program Updates, Algorithm
Transparency, and Information Sharing (HTI-1) Final Rule (89 FR 1192).
Specifically, we described how the information blocking provisions
provide a comprehensive response to the issues identified by empirical
and economic research that suggested that information blocking may
weaken competition, encourage consolidation, and create barriers to
entry for developers of new and innovative applications and
technologies that enable more effective uses of EHI to improve
population health and the patient experience.\7\ We explained that the
information blocking provision of the Public Health Service Act (PHSA)
itself expressly addresses practices that impede innovation and
advancements in EHI access, exchange, and use, including care delivery
enabled by health IT (89 FR 1195, citing section 3022(a)(2) of the
PHSA). Actors subject to the information blocking provisions may, among
other practices, attempt to exploit their control over interoperability
elements to create barriers to entry for competing technologies and
services that offer greater value for health IT customers and users,
provide new or improved capabilities, and enable more robust access,
exchange, and use of EHI (85 FR 25820).\8\ Information blocking may
also harm competition not just in health IT markets, but also in
markets for healthcare services (85 FR 25820). In the ONC Cures Act
Final Rule, we described practices that dominant market providers may
leverage and use to control access and use of their technology,
resulting in technical dependence and possibly leading to barriers to
entry by would-be competitors, as well as making some market providers
vulnerable to acquisition or inducement into arrangements that enhance
the market power of incumbent providers to the detriment of consumers
and purchasers
[[Page 63502]]
of healthcare services (85 FR 25820). The implementation of the new
information blocking provisions proposed and discussed in section IV of
this proposed rule would continue to promote innovation and support the
lawful access, exchange, and use of EHI, while strengthening support
for individuals' privacy and EHI sharing preferences.
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\7\ See, e.g., Martin Gaynor, Farzad Mostashari, and Paul B.
Ginsberg, Making Health Care Markets Work: Competition Policy for
Health Care, 16-17 (Apr. 2017), available at http://heinz.cmu.edu/news/news-detail/index.aspx?nid=3930; Diego A. Martinez et al., A
Strategic Gaming Model For Health Information Exchange Markets,
Health Care Mgmt. Science (Sept. 2016). (``[S]ome healthcare
provider entities may be interfering with HIE across disparate and
unaffiliated providers to gain market advantage.'') Niam Yaraghi, A
Sustainable Business Model for Health Information Exchange
Platforms: The Solution to Interoperability in Healthcare IT (2015),
available at http://www.brookings.edu/research/papers/2015/01/30-sustainable-business-model-health-information-exchange-yaraghi;
Thomas C. Tsai Ashish K. Jha, Hospital Consolidation, Competition,
and Quality: Is Bigger Necessarily Better? 312 J. AM. MED. ASSOC.
29, 29 (2014).
\8\ See also Martin Gaynor, Farzad Mostashari, and Paul B.
Ginsberg, Making Health Care Markets Work: Competition Policy for
Health Care, 16-17 (Apr. 2017), available at http://heinz.cmu.edu/news/news-detail/index.aspx?nid=3930.
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Lastly, in support of E.O. 14058, Transforming Federal Customer
Experience and Service Delivery to Rebuild Trust in Government, issued
on December 16, 2021, we are committed to advancing the equitable and
effective delivery of services with a focus on the experience of
individuals, health IT developers, and health care providers.\9\ The
proposed rule supports the Department of Health and Human Services'
agency-wide approach to electronic prior authorization that meets the
Department's interoperability and burden reduction goals, such as
reducing documentation requirements associated with completing prior
authorization requests for payers.\10\ Proposed certification criteria
would make available certified health IT that can enable payers
contracting with the Federal government, such as Medicare Advantage
plans, to meet Centers for Medicare & Medicaid Services (CMS)
requirements for sharing information. Additionally, improving the
equitable access, exchange, and use of EHI would help enable patient-
centric care, which is expected to improve equity in health outcomes.
This proposed rule further recognizes patient feedback and preferences
in their care and how patients and their representatives may want to
monitor and share EHI with relevant health care providers and entities.
The health IT certification provisions of the proposed rule aim to
reduce the burden associated with prior authorization processes, which
can ensure that patients receive the care they need in a timely manner,
lower administrative cost, and reduce the complexity of obtaining a
prior authorization for health care providers and patients.
Collectively, these provisions of the proposed rule help advance the
equitable and effective delivery of services with a focus on the
experience of individuals, health IT developers, and health care
providers.
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\9\ United States, Executive Office of the President [Joseph
Biden]. Executive Order 14058: Transforming Federal Customer
Experience and Service Delivery To Rebuild Trust in Government. Dec
13, 2021. 86 FR 71357 through71366, https://www.federalregister.gov/documents/2021/12/16/2021-27380/transforming-federal-customer-experience-and-service-delivery-to-rebuild-trust-in-government.
\10\ Strategy on Reducing Regulatory and Administrative Burden
Relating to the Use of Health IT and EHRs (Burden Reduction Report),
February 2020, pages 26-28, https://www.healthit.gov/sites/default/files/page/2020-02/BurdenReport_0.pdf.
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We also strive to further advance Federal agency coordination. ONC
works with CMS to ensure that our certification criteria and standards
support and complement CMS programs that reference ONC regulations,
such as the Medicare Promoting Interoperability Program and the
Promoting Interoperability performance category of the Merit-based
Incentive Payment System (MIPS). In addition, a final rule titled
``Medicare and Medicaid Programs; Patient Protection and Affordable
Care Act; Advancing Interoperability and Improving Prior Authorization
Processes for Medicare Advantage Organizations, Medicaid Managed Care
Plans, State Medicaid Agencies, Children's Health Insurance Program
(CHIP) Agencies and CHIP Managed Care Entities, Issuers of Qualified
Health Plans on the Federally-Facilitated Exchanges, Merit-Based
Incentive Payment System (MIPS) Eligible Clinicians, and Eligible
Hospitals and Critical Access Hospitals in the Medicare Promoting
Interoperability Program'' (CMS Interoperability and Prior
Authorization final rule, 89 FR 8758) appeared in the Federal Register
on February 8, 2024, and included requirements for certain payers
regulated by CMS to establish APIs that can facilitate electronic prior
authorization processes by 2027 (89 FR 8919). CMS also finalized
electronic prior authorization measures for eligible clinicians who
participate in the Promoting Interoperability performance category of
the MIPS; and eligible hospitals and critical access hospitals that
participate in the Medicare Promoting Interoperability Program,
beginning in the CY 2027 performance period and the EHR reporting
period in CY 2027, respectively (89 FR 8760). In this proposed rule, we
propose to adopt standards and establish certification criteria to
facilitate electronic prior authorization using certified health IT,
which providers can use to complete the required actions under the
finalized measures. Lastly, we are committed to our continued,
collaborative work with the Centers for Disease Control and Prevention
(CDC) on improving public health data systems. The proposed updates to
the ONC Health IT Certification Program's public health criteria and
complementary public health criteria for PHA systems would support
CDC's Data Modernization Initiative and Public Health Data
Strategy.\11\ We believe these approaches would increase efficiency for
delivery of services and programs, reduce confusion for participants in
these programs, and better serve the public interest.
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\11\ Public_Health_Data_Strategy-final-P.pdf (cdc.gov).
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While this rulemaking does not propose to require entities to adopt
any specific standards to ensure that their information and
communication technology (ICT), including software, applications,
websites, and electronic documents, is accessible for people with
disabilities, entities covered by this rule may also be subject to
applicable requirements of Federal nondiscrimination laws. For example,
Section 504 of the Rehabilitation Act of 1973 (Section 504) prohibits
recipients of Federal financial assistance from discriminating on the
basis of disability by excluding people with disabilities from
participation in, denying them the benefits of, or subjecting them to
discrimination in their programs or activities. 29 U.S.C. 794. Section
1557 of the Patient Protection and Affordable Care Act (Section 1557)
prohibits certain health programs and activities, including those
receiving Federal financial assistance from HHS, from discriminating on
the basis of race, color, national origin, sex, age, or disability by
excluding them from participation in, denying them the benefits of, or
subjecting them to discrimination in their health programs or
activities. 42 U.S.C. 18116(a). Newly issued Section 504 regulations
require recipients to ensure that web content and mobile apps that a
recipient provides or makes available, directly or through contractual,
licensing, or other arrangements, be readily accessible to and usable
by individuals with disabilities, with some exceptions. See 89 FR 40066
and 45 CFR Secs. 84.82-.89(a). The rule requires technical
accessibility standards that must be met on May 11, 2026, for entities
with fifteen or more employees and May 10, 2027, for entities with
fewer than fifteen employees unless the recipient can demonstrate that
compliance with this section would result in a fundamental alteration
in the nature of a program or activity or in undue financial and
administrative burdens or unless an exception applies. 45 CFR Sec.
84.84(b); 84.85. Title III of the Americans with Disabilities Act (ADA)
prohibits discrimination on the basis of disability in the full and
equal enjoyment of places of public accommodation. 42 U.S.C. 12182.
Title II of the ADA prohibits state and local government
[[Page 63503]]
entities from discriminating on the basis of disability by excluding
people with disabilities from participation in, denying them the
benefits of, or subjecting them to discrimination in their services,
programs, or activities. 42 U.S.C. 12132. On April 24, 2024, the
Department of Justice published regulations establishing specific
requirements, including the adoption of specific technical standards,
for making accessible the services, programs, and activities offered by
State and local government entities through the web and mobile
applications. 89 FR 31320. More generally, these statutes and their
implementing regulations apply to programs, services and activities
implemented through or with information and communications technology
(ICT). In addition, the Section 1557 implementing regulation addresses
ICT specifically, providing that covered entities, including health
programs and activities that receive Federal financial assistance from
HHS, shall ensure that their health programs or activities provided
through ICT are accessible to individuals with disabilities, unless
doing so would result in undue financial and administrative burdens or
a fundamental alteration in the nature of the health programs or
activities. 89 FR 37522 (May 6, 2024) (45 CFR 92.204).
B. Summary of Major Provisions
1. ONC Health IT Certification Program Updates
a. New and Revised Standards and Certification Criteria
i. The United States Core Data for Interoperability Version 4 (USCDI
v4)
The USCDI standard in Sec. 170.213 is a baseline set of data that
can be commonly exchanged across care settings for a wide range of
uses. Certain certification criteria in the ONC Health IT Certification
Program (Program) currently require the use of one of the versions of
the USCDI standard by in Sec. 170.213. We propose to update the USCDI
standard in Sec. 170.213 by adding USCDI v4 and by establishing an
expiration date of January 1, 2028, for USCDI v3 for purposes of the
Program. We propose to add USCDI v4 in Sec. 170.213(c) and incorporate
it by reference in Sec. 170.299. We propose that up to and including
December 31, 2027, a Health IT Module certified to certification
criteria referencing Sec. 170.213 may use either version of the
standard. We propose that by January 1, 2028, a health IT developer of
a Health IT Module certified to certification criteria referencing
Sec. 170.213 must update its Health IT Module to USCDI v4 and provide
the updated version to their customers in order to maintain
certification of that Health IT Module. We propose that any Health IT
Modules seeking certification to certification criteria referencing
Sec. 170.213 on or after January 1, 2028, would need to be capable of
exchanging the data elements that the USCDI v4 comprises.
ii. SMART App Launch 2.2
As discussed in section III.B.2, we propose to adopt the
HL7[supreg] FHIR[supreg] SMART Application Launch Framework
Implementation Guide release 2.2.0 (SMART v2.2 Guide) in Sec.
170.215(c)(3). We propose that the adoption of the SMART v2 Guide in
Sec. 170.215(c)(2) expires on January 1, 2028. We propose that a
Health IT Module certified to criteria referencing the implementation
specifications in Sec. 170.215(c) may use the SMART v1, SMART v2, or
SMART v2.2 guides for the time period up to and including December 31,
2025. Then, by January 1, 2026, when the adoption of SMART v1 expires,
a health IT developer of a Health IT Module certified to certification
criteria referencing the implementation specifications in Sec.
170.215(c) must update its Health IT Module to either the SMART v2 or
SMART v2.2 Guides and provide the updated version to its customers in
order to maintain certification of that Health IT Module. Then, by
January 1, 2028, when the adoption of the SMART v2 Guide expires, a
health IT developer of a Health IT Module certified to certification
criteria referencing the implementation specifications in Sec.
170.215(c) must update its Health IT Module to the SMART v2.2 Guide and
provide the updated version to its customers in order to maintain
certification of that Health IT Module. On and after January 1, 2028,
we propose that any Health IT Modules seeking certification to
certification criteria referencing the implementation specifications in
Sec. 170.215(c), would need to be capable of supporting SMART v2.2
Guide functionality.
iii. User-Access Brands and Endpoints
We propose to adopt the User-access Brands and Endpoints (Brands)
specification for our service base URL publication requirements, as
explained in section III.B.3. This applies to our current service base
URL publication requirements in Sec. 170.404(b)(2), where we propose
to reorganize the criterion's paragraphs in a way that places existing
service base URL requirements into Sec. 170.404(b)(2)(i) and (ii) and
adds the new Brands requirement in Sec. 170.404(b)(2)(iii). We propose
in our updated Sec. 170.404(b)(2)(iii) to require that, by January 1,
2028, service base URLs and related API Information Source details,
including each organization's name, location, and facility identifier,
must be published in an aggregate vendor-consolidated ``FHIR Bundle''
according to the Brands specification. Additionally, in our proposal to
revise Sec. 170.404(b)(3) where we propose new requirements for the
publication of API discovery details for payer network information,
including service base URLs and API Information Source details, we
propose to adopt Brands specification.
iv. Standards for Encryption and Decryption of Electronic Health
Information
As discussed in section III.B.4, we propose to adopt the updated
version of Annex A of the Federal Information Processing Standards
(FIPS) 140-2 (Draft, October 12, 2021) in Sec. 170.210(a)(3) and
incorporate it by reference in Sec. 170.299. We propose to add an
expiration date of January 1, 2026, to the FIPS 140-2 (October 8, 2014)
version of the standard presently adopted in Sec. 170.210(a)(2). We
also propose to remove the standard found in Sec. 170.210(f), which is
no longer referenced in any active certification criteria. Revising
Sec. 170.210(a) by adding an expiration date in Sec. 170.210(a)(2)
and a new version of the FIPS standard in Sec. 170.210(a)(3) would
impact three certification criteria that currently reference the
standard in Sec. 170.210(a)(2), including Sec. 170.315(d)(7) ``end-
user device encryption;'' (d)(9) ``trusted connection;'' and (d)(12)
``encrypt authentication credentials.'' Note that we also propose to
change the names of the certification criteria in Sec. 170.315(d)(7)
and (d)(12) to ``health IT encryption'' and ``protect stored
authentication credentials'' respectively, as discussed in sections
III.B.11 and III.B.12 of this preamble.
v. Minimum Standards Code Sets Updates
Early in ONC's standards and certification rulemakings, we
established a policy of adopting newer versions of ``minimum
standards'' code sets that update frequently (e.g., 77 FR 54170 and 80
FR 62612). Adopting newer versions of these code sets enables improved
interoperability and implementation of health IT with minimal
additional burden. If adopted, newer versions of these minimum
standards code sets would serve as the baseline for certification, and
[[Page 63504]]
developers of certified health IT would be able to use newer versions
of these adopted standards on a voluntary basis. Because these code
sets are updated frequently, we will consider whether it may be more
appropriate to adopt a version of a minimum standards code set issued
after publication of this proposed rule, but before publication of a
final rule. In section III.B.5, we discuss our proposals to adopt newer
versions of the following minimum standards code sets:
Sec. 170.207(a)--Problems
Sec. 170.207(c)--Laboratory tests
Sec. 170.207(d)--Medications
Sec. 170.207(e)--Immunizations
Sec. 170.207(f)--Race and Ethnicity
Sec. 170.207(n)--Sex
Sec. 170.207(o)--Sexual orientation and gender information
Sec. 170.207(p)--Social, psychological, and behavioral data
vi. New Imaging Requirements for Health IT Modules
We propose, as explained in section III.B.6, to revise the
certification criteria adopted in Sec. 170.315(b)(1), (e)(1), (g)(9),
and (g)(10) to include new certification requirements to support
access, exchange, and use of diagnostic images via imaging links.
However, we are not proposing a specific standard associated with the
support of this functionality, and we note that this requirement can be
met with a context-sensitive link to an external application which
provides access to images and their associated narrative. We believe
that this proposal, if finalized as proposed, will promote more
consistent access to images for providers and patients. We propose that
by January 1, 2028, a health IT developer of a Health IT Module
certified to the certification criteria related to ``transitions of
care'' in Sec. 170.315(b)(1), ``view, download, and transmit'' in
Sec. 170.315(e)(1), ``application access--all data request,'' in Sec.
170.315(g)(9), and ``standardized API for patient and population
services,'' in Sec. 170.315(g)(10) must update their Health IT Module
and provide the updated version to their customers to maintain
certification of that Health IT Module.
vii. Revised Clinical Information Reconciliation and Incorporation
Criterion
We propose, as described in section III.B.7, a primary proposal and
an alternative proposal for revising the ``clinical information
reconciliation and incorporation'' certification criterion in Sec.
170.315(b)(2) to expand the number and types of data elements that
Health IT Modules certified to this criterion would be required to
reconcile and incorporate. Our primary proposal would require Health IT
Modules certified to Sec. 170.315(b)(2) to be capable of reconciling
and incorporating all USCDI data elements according to at least one of
the versions of the USCDI standard specified in Sec. 170.213. Our
alternative proposal would require Health IT Modules to reconcile and
incorporate data elements from six additional USCDI data classes beyond
the existing three data classes required as part of the current
certification criterion's functionality. We also propose new functional
requirements to enable user-driven automatic reconciliation and
incorporation. We propose that by January 1, 2028, a health IT
developer of a Health IT Module certified to the criterion in Sec.
170.315(b)(2) must update their Health IT Module and provide the
updated version to their customers in order to maintain certification
of that Health IT Module. We also propose that any Health IT Modules
seeking certification for the criterion in Sec. 170.315(b)(2) on or
after January 1, 2028, would need to be capable of supporting this
functionality.
viii. Revised Electronic Prescribing Certification Criterion
We propose to incorporate the National Council for Prescription
Drug Programs (NCPDP) SCRIPT standard \12\ version 2023011 in an
updated version of the electronic prescribing certification criterion
in Sec. 170.315(b)(3)(ii). Under this proposal, as described in
section III.B.8 of this proposed rule, health IT developers may
maintain health IT certification conformance with the current version
of the criterion using NCPDP SCRIPT standard version 2017071 for the
time period up to and including December 31, 2027. We propose that by
January 1, 2028, a health IT developer of a Health IT Module certified
to the criterion in Sec. 170.315(b)(3) must update the Health IT
Module to use the NCPDP SCRIPT standard version 2023011 and provide
that update to their customers in order to maintain certification of
the Health IT Module. We propose that any Health IT Modules for which a
health IT developer seeks certification to the criterion in Sec.
170.315(b)(3) on or after January 1, 2028, would need to be able to
perform the required prescription-related electronic transaction in
accordance with the NCPDP SCRIPT standard version 2023011. We also
propose a series of updates to the transactions included in Sec.
170.315(b)(3)(ii) including removing transactions currently identified
as optional for the certification criterion.
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\12\ See https://standards.ncpdp.org/.
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ix. New Real-Time Prescription Benefit Criterion
Real-time prescription benefit tools empower providers and their
patients to compare the patient-specific cost of a drug to the cost of
a suitable alternative, compare prescription costs at different
pharmacies, view information about out-of-pocket costs, and learn
whether prior authorization for a specific drug is required. In order
to implement section 119(b)(3) of the Consolidated Appropriations Act,
2021 (Pub. L. 116-260), as discussed in section III.B.9, we propose to
establish a real-time prescription benefit certification criterion in
Sec. 170.315(b)(4) based on the National Council for Prescription Drug
Programs (NCPDP) Real-Time Prescription Benefit (RTPB) standard version
13. We also propose to include this certification criterion in the Base
EHR definition in Sec. 170.102.
x. Electronic Health Information (EHI) Export--Single Patient EHI
Export Exemption
As explained in section III.B.10, we propose to exempt Health IT
Modules that act primarily as intermediaries between systems and,
through integration, function without any direct human interaction from
the requirement in Sec. 170.315(b)(10)(i)(B) to provide functionality
without subsequent developer assistance to operate. We propose that
this exemption proposed in Sec. 170.315(b)(10)(i)(F) would be
available if the developer of such a Health IT Module receives fewer
than ten requests in the immediately preceding calendar year for a
single patient EHI export. Relatedly, we propose in Sec.
170.402(b)(2)(iii) that developers of certified health IT with Health
IT Modules certified to Sec. 170.315(b)(10) that claim the exemption
proposed in Sec. 170.315(b)(10)(i)(F) would need to report the number
of requests for single patient EHI export on an annual basis to their
ONC-Authorized Certification Bodies (ACBs) by March 1 of each calendar
year beginning in 2028.
xi. Revised End-User Device Encryption Criterion
As discussed in section III.B.11, we propose to revise Sec.
170.315(d)(7) to include a new requirement that Health IT Modules
certified to this criterion encrypt EHI stored server-side on and after
January 1, 2026. To include this new requirement, we propose
reorganizing the certification criterion's paragraphs in a way that
places existing
[[Page 63505]]
end-user device encryption requirements into Sec. 170.315(d)(7)(i) and
(d)(7)(ii) and adds the new server encryption requirement in Sec.
170.315(d)(7)(iii). Then, we propose placing the applicable proposed
encryption standard and default settings requirements to both the end-
user device and server encryption requirements into Sec.
170.315(d)(7)(iii) and (iv) respectively. We also propose to require
that personally identifiable information must be encrypted in Health IT
Modules certified to this revised certification criterion. Finally, we
propose to change Sec. 170.315(d)(7) by renaming it to ``health IT
encryption,'' to better describe the end-user and proposed server-side
requirements together.
xii. Revised Criterion for Encrypt Authentication Credentials
As explained in section III.B.12, we propose to revise the
``encrypt authentication credentials'' certification criterion in Sec.
170.315(d)(12). We propose to revise the certification criterion by
expiring our current ``yes'' or ``no'' attestation requirement and
replacing it with a new requirement that Health IT Modules that store
authentication credentials protect the confidentiality and integrity of
its stored authentication credentials according to the Federal
Information Processing Standards (FIPS) 140-2 (October 12, 2021)
industry standard. We also propose to change the name of this
certification criterion to ``protect stored authentication
credentials,'' to better describe how we propose to revise the
criterion.
xiii. Health IT Modules Supporting Public Health Data Exchange
Public health promotes and protects the health of all people and
their communities. To accomplish this mission, public health
authorities (PHAs) rely in part on public health information exchange,
including data from healthcare facilities and providers, laboratories,
schools, social and community service providers, and other data
partners to acquire the information they need. However, PHAs often do
not have access to--or, often, the ability to share--the data required
to optimally address public health needs (emergent or otherwise) due to
the lack of common standards utilized in the reported data, variable
reporting requirements, limited interoperability of systems, or
inadequate public health data infrastructure and technology.
Considering the need for greater interoperability of public health
technology and access to more actionable data by PHAs and their
partners,\13\ as discussed in section III.B.13, we propose: to revise
the Program's current certification criteria related to public health
in Sec. 170.315(f), including referencing newer versions of respective
exchange and vocabulary standards in the current Sec. 170.315(f)
certification criteria (Sec. 170.315(f)(1)-(f)(7)); proposing two
additional certification criteria for birth reporting (Sec.
170.315(f)(8)) and bi-directional exchange with a prescription drug
monitoring program (PDMP) (Sec. 170.315(f)(9)); proposing new
certification criteria for Health IT Modules supporting public health
data exchange in Sec. 170.315(f)(21)-(25), (28) and (29); and,
proposing a new certification criterion for a standardized
FHIR[supreg]-based API for public health data exchange in Sec.
170.315(g)(20). The new certification criterion in Sec. 170.315(g)(20)
would support ongoing and future development of public health FHIR IGs
leveraging a core set of existing, modular, and extensible capabilities
and standards. The standards referenced in the proposed Sec.
170.315(g)(20) certification criterion support FHIR capabilities such
as API-based event notifications (i.e., FHIR Subscriptions), SMART App
Launch, Bulk Data Export, and requirements for authorization and
authentication, drawing on the Program's requirements for Health IT
Modules certified to Sec. 170.315(g)(10).
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\13\ https://www.gao.gov/products/gao-22-106175.
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xiv. Bulk Data Enhancements
We propose, as discussed in section III.B.14, to adopt the
HL7[supreg] FHIR[supreg] Bulk Data Access v2.0.0: STU 2 implementation
specification (Bulk v2 IG) in Sec. 170.215(d)(2). We also propose to
require, in many of our proposed certification criteria that reference
Sec. 170.215(d)(2), server support for the ``group export'' operation
and a ``_type'' query parameter for performance improvement. We believe
this proposal would better support interoperability with Health IT
Modules certified to support FHIR Bulk Data Access and better enable
performant exporting of complete sets of FHIR resources for pre-defined
cohorts of patients. This would raise the floor from our current Bulk
v1 IG requirements for certification, where we require support for the
group export operation but do not require support for any of the
optional query parameters in the IG. We believe that these new
certification requirements, based on additional implementer
clarifications included in the Bulk v2 IG, would provide meaningful
improvements in the performance of Bulk APIs. Additionally, we welcome
comment on the issues hindering the effective exchange of population
data using Bulk FHIR APIs and additional steps ONC can take to help
address those issues.
xv. New Requirements To Support Dynamic Client Registration Protocol in
the Program
We propose, as explained in section III.B.15, to add requirements
in the Program to support dynamic client registration and subsequent
authentication and authorization for dynamically registered apps for
patient-facing, user-facing, and system confidential applications. This
includes adding requirements to the following in the Program:
Sec. 170.315(g)(10) certification criterion
Sec. 170.315(g)(20), (30), and (32)-(35) proposed
certification criteria
Sec. 170.315(j)(2), (5), (8), (11) proposed certification
criteria
API Conditions and Maintenance of Certification requirements
in Sec. 170.404
We propose to adopt the HL7[supreg] Unified Data Access Profiles
(UDAPTM) Security for Scalable Registration, Authentication,
and Authorization Implementation Guide Release 1.0.0 implementation
guide (UDAP Security IG v1), and we propose to require several specific
sections of it to support requirements in the Program criteria listed
above. This proposal would facilitate timelier patient, provider, and
system access to health information using applications by providing a
more uniform, standardized, and automated application registration
pathway.
xvi. New Certification Criteria for Modular API Capabilities
We propose, as discussed in section III.B.16, to add a new category
of certification criteria to Sec. 170.315 titled ``modular API
capabilities'' in Sec. 170.315(j). Several proposals across this
proposed rulemaking would establish capabilities necessary to support
standardized APIs across clinical, public health, administrative, and
other use cases. We propose that the certification criteria in Sec.
170.315(j) would represent API capabilities that are standards-based,
including through new standards, such as HL7[supreg] Clinical Decision
Support (CDS) Hooks, SMART Health Cards, and HL7 FHIR[supreg]
Subscriptions, as well as standards and functionalities historically
referenced in Sec. 170.315(g)(10). These modular API capabilities
would be referenced and incorporated into Health IT Modules to support
standardized APIs for clinical use cases in Sec. 170.315(g)(10),
public
[[Page 63506]]
health use cases in Sec. 170.315(g)(20), and health insurance and
coverage use cases in Sec. 170.315(g)(30)-(36), as well as other
future use cases across the health IT landscape.
xvii. Multi-Factor Authentication Criterion
As explained in section III.B.17, we propose to revise the ``multi-
factor authentication'' (MFA) certification criterion in Sec.
170.315(d)(13) and accordingly update the privacy and security (P&S)
certification framework in Sec. 170.550(h). The proposed update would
revise our MFA certification criterion by replacing our current ``yes''
or ``no'' attestation requirement with a specific requirement to
support multi-factor authentication and configuration for three
certification criteria on and after January 1, 2028. We propose to
apply the updated MFA requirements by revising each of the
certification criteria in Sec. 170.315(b)(3), (e)(1), (g)(10), and
(g)(30) to require that a Health IT Module certified to these criteria
also be certified to Sec. 170.315(d)(13)(ii) on and after January 1,
2028. Given our proposal to embed Sec. 170.315(d)(13) references into
each applicable certification criterion, Sec. 170.315(d)(13) does not
need to be referenced again in Sec. 170.550(h)(3), therefore, we
propose to expire all the references to Sec. 170.315(d)(13) in Sec.
170.550(h)(3) by December 31, 2027. We believe these updates would
match industry best practices for information security, particularly
for important authentication use cases in certified health IT.
xviii. Revised Computerized Provider Order Entry--Laboratory Criterion
We propose, as discussed in section III.B.18, to update the
``computerized provider order entry--laboratory'' certification
criterion in Sec. 170.315(a)(2) to require enabling a user to create
and transmit laboratory orders electronically according to the standard
proposed in Sec. 170.205(g)(2), the HL7[supreg] Laboratory Order
Interface (LOI) Implementation Guide (IG). We further propose to update
Sec. 170.315(a)(2) to require technology to receive and validate
laboratory results according to the standard proposed in Sec.
170.205(g)(3), the HL7[supreg] Laboratory Results Interface (LRI) IG.
Ensuring that systems creating laboratory orders can transmit orders
and receive associated results and values electronically, according to
national standards, would create more complete patient information
available to clinicians throughout the laboratory workflow. We propose
that by January 1, 2028, a health IT developer of a Health IT Module
certified to the criterion in Sec. 170.315(a)(2) must update its
Health IT Module and provide the updated version to its customers in
order to maintain certification of that Health IT Module. We propose
that any Health IT Modules seeking certification for the criterion in
Sec. 170.315(a)(2) on or after January 1, 2028, would need to be
capable of supporting this functionality.
xix. Revised Standardized API for Patient and Population Services
Criterion To Align With Modular API Capabilities
As discussed in section III.B.19, we propose to revise the
certification criterion in Sec. 170.315(g)(10) to reorganize
requirements to improve clarity and align with new proposals in this
rule, including proposed:
restructuring of existing requirements to reference the
``modular API capabilities'' certification criteria proposed in Sec.
170.315(j)
support for dynamic registration and subsequent authentication
and authorization of patient-facing, user-facing, and system
confidential apps
support for multi-factor authentication for patient-facing
authentication according to requirements proposed in Sec.
170.315(d)(13)(ii)
support for imaging links in data response requirements
support for a read and search API for system apps
support for ``_type'' query parameter for Bulk FHIR API
support for the issuance of verifiable health records as
specified by the requirements proposed in Sec. 170.315(j)(22)
support for subscriptions as a server according to the
requirements specified in proposed Sec. 170.315(j)(23)
support for workflow triggers for decision support
interventions according to the requirements specified in proposed Sec.
170.315(j)(20)
support for authorization revocation for users (e.g.,
clinicians)
moving of the API documentation requirements in Sec.
170.315(g)(10) to the API Conditions and Maintenance of Certification
requirements in Sec. 170.404
We propose that by January 1, 2028, a health IT developer of a
Health IT Module certified to the criterion in Sec. 170.315(g)(10)
must update its Health IT Module and provide the updated version to its
customers in order to maintain certification of that Health IT Module.
We propose that any Health IT Modules seeking certification for the
criterion in Sec. 170.315(g)(10) on or after January 1, 2028, would be
to the updated version of the certification criterion.
xx. Patient, Provider, and Payer APIs
The combined exchange of clinical and administrative data among
healthcare payers, patients, and providers is a complex challenge that
can prevent participants in the healthcare system from gaining insights
into the full picture of an individual's care. In order to realize the
benefits of a more unified stream of clinical and administrative data,
patients and health care providers must be able to more efficiently
access and exchange EHI with the entities that steward this
information, especially healthcare payers. In the CMS Interoperability
and Patient Access Final Rule (85 FR 25510), which appeared in the
Federal Register on May 1, 2020, and the CMS Interoperability and Prior
Authorization Final Rule (89 FR 8758), which appeared in the Federal
Register on February 8, 2024, CMS finalized policies for certain
healthcare payers that it regulates \14\ to facilitate patient access
to clinical and administrative data held by payers; availability of
information about provider networks; exchange of information between
payers when beneficiaries patients change coverage; provider access to
data held by payers; and electronic prior authorization.
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\14\ The ``impacted payers'' under the CMS Interoperability and
Patient Access Final Rule (85 FR 25510) and the CMS Interoperability
and Prior Authorization Final Rule (89 FR 8758) are Medicare
Advantage (MA) organizations, state Medicaid fee-for-service (FFS)
programs, state Children's Health Insurance Program (CHIP) FFS
programs, Medicaid managed care plans, CHIP managed care entities,
and Qualified Health Plan (QHP) issuers on the Federally-facilitated
Exchanges (FFEs).
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As explained in section III.B.20, we propose a set of certification
criteria in Sec. 170.315(g)(30) through (36) that aim to complement
and advance the policies that CMS has developed to increase patient,
provider, and payer access to information. Health IT developers,
including those that support payers, would be able to ensure that
Health IT Modules certified to these proposed criteria, when used to
satisfy the CMS requirements, have been tested for conformance with
widely available industry standards designed to support
interoperability for each use case. We propose to adopt a set of
HL7[supreg] FHIR[supreg] IGs in Sec. 170.215 to support these
certification criteria, and to incorporate these specifications by
reference in Sec. 170.299.
[[Page 63507]]
2. Conditions and Maintenance of Certification Requirements--Insights
and Attestations
a. Insights Condition and Maintenance of Certification Requirements
As discussed in section III.C.1, we propose to update the Insights
Condition by requiring health IT developers to include health care
provider identifiers, for providers included in the data submitted in
response for the measures specified in Sec. 170.407, to allow us to
better interpret the results of the data received. We also propose
updates to the overall process for reporting and newer versions of
certified health IT for responses submitted under the Insights
Condition in Sec. 170.407(b).
We also propose to update two measures under the Insights
Condition. We propose to revise the ``individuals' access to electronic
health information through certified health IT'' measure in Sec.
170.407(a)(3)(i) to include both individuals and individuals'
authorized representatives accessing their EHI. Additionally, we
propose to revise the name of the measure in Sec. 170.407(a)(3)(ii) to
``C-CDA reconciliation and incorporation through certified health IT''
and propose to require developers to submit responses on specific data
classes and elements from C-CDA documents reconciled and incorporated
both through manual and automated processes in Sec.
170.407(a)(3)(ii)(E). We also intend to make various technical updates
to the measure specification sheets accompanying the Insights
Condition, including the clarification of certain definitions and
terms, as well as adding new metrics.
b. Attestations Condition and Maintenance of Certification Requirements
As discussed in section III.C.2, we propose to revise the
Attestations Condition and Maintenance of Certification requirements by
adding the requirement in Sec. 170.406(a)(2) that a health IT
developer, as a Condition of Certification, attest to compliance with
Sec. 170.402(b)(4), if the health IT developer certified a Health IT
Module(s) to the ``decision support interventions'' certification
criteria in Sec. 170.315(b)(11).
3. Administrative Updates
As discussed in section III.D.1, we propose to revise the Program
correspondence provision (Sec. 170.505) to explicitly specify when
applicants for ONC-Authorized Testing Laboratory (ATL) status,
applicants for ONC-ACB status, ONC-ACBs, ONC-ATLs, health IT developers
or any other party to a proceeding under subpart E of 45 CFR part 170
will be considered to have received correspondence or other written
communication from ONC or the National Coordinator.
As discussed in section III.D.2, we propose to expand ONC-ACBs
responsibilities under Sec. 170.556 for conducting surveillance of
developers' satisfaction of certain Maintenance of Certification
requirements under the Program. We also propose new and revised
principles of proper conduct (PoPCs) in Sec. 170.523 to support the
proposed expanded surveillance responsibilities. Specifically, an ONC-
ACB would be required to monitor Program-participating developers'
satisfaction of specific requirements applicable to the developers
under subpart D of 45 CFR part 170, report results of these
surveillance activities to ONC, and engage with developers where
applicable to encourage corrective action for identified non-
conformities. A new proposed PoPC in Sec. 170.523(x), pursuant to a
new proposed requirement in Sec. 170.556(d)(7)(ii), would require ONC-
ACBs to report to ONC when a developer fails to establish or to
successfully complete an appropriate corrective action plan (CAP) for a
Maintenance of Certification non-conformity identified by an ONC-ACB.
To increase efficiency for developers' documentation of their CAPs,
and ONC-ACBs' review and monitoring of these plans, we propose in Sec.
170.556(d)(3) to tailor the minimum required CAP elements based on the
non-conformities addressed by the CAP. For example, certain CAP
elements designed for non-conformities with certification criteria in
45 CFR subpart C would not be required by regulation in a CAP specific
to a developer having missed a deadline in subpart D, such as for
submission of real world testing documents (Sec. 170.405) or
submission of attestations (Sec. 170.406).
As discussed in section III.D.3, we propose a requirement in Sec.
170.523(m)(6) for ONC-ACBs, beginning January 1, 2027, to obtain a
regular reporting of API discovery details, including service base URLs
and related organization details, that are required by Sec.
170.404(b)(2) and (b)(3). In section III.D.4, we propose a new PoPC for
ONC-ACBs in Sec. 170.523(y) requiring an ONC-ACB to give the National
Coordinator sufficient notice of its intent to withdraw its
authorization under the Program.
In section III.D.5, we discuss our proposal to update the ONC
direct review regulatory framework in 45 CFR 170.580 to align with the
proposed enhancements to the ONC-ACBs' role in surveillance of Program-
participating developers' satisfaction of certain Maintenance of
Certification requirements. To enhance efficiency for developers and
ONC, we propose to revise direct review CAP regulatory requirements to
add flexibility to tailor the minimum elements the developer must
address in such a plan for a non-conformity substantiated through an
ONC direct review. We also propose procedural revisions to Sec.
170.581, suspension and termination of certification procedures in
Sec. 170.580(d) and (f), and hearing officer and appeals provisions in
Sec. 170.580(g)(5) and (7)(ii), to clarify that certain ``ONC''
decisions are in fact made by the National Coordinator, and explicitly
provide for the Secretary to choose to exercise direct oversight of
certain National Coordinator and hearing officer decisions before the
decisions become final. We also propose to revise wording throughout 45
CFR 170.580 and 45 CFR 170.581 to clarify that certain determinations
are made by the National Coordinator (who is appointed by the
Secretary) rather than more generally by or within the Office of the
National Coordinator (the organizational unit headed by the National
Coordinator).
As discussed in section III.D.6, we propose to update paragraphs
(a) and (b) of the certification ban provisions in Sec. 170.581 to
explicitly provide for the Secretary to review, at the Secretary's
discretion, the National Coordinator's determination to impose a
certification ban before the ban becomes effective. In section III.D.7,
we propose to remove the ``Complete EHR'' and ``EHR Module'' terms from
certain sections within subpart E of 45 CFR part 170.
As discussed in section III.D.8, we propose to codify a definition
of serious risk to public health or safety for purposes of Program
regulations in 45 CFR part 170. This definition would enhance
understanding among developers and users of certified health IT of the
types of conditions, events, or phenomena that would constitute a
dangerous non-conformity to Program requirements if caused (or
contributed to) by a product certified under the Program, even if the
Health IT Modules within such product continued to pass lab testing
procedures, in-the-field surveillance testing, or both with respect to
the technical standards and certification criteria adopted in subparts
B and C of part 170. As discussed in section III.D.9, we propose to
remove Sec. 170.550(m) ``time-limited certification and certification
status for certain 2015 Edition certification criteria'' and to
[[Page 63508]]
remove certification criteria with time-limited certification and
certification status, including Sec. 170.315(a)(10), (a)(13), (b)(6),
(e)(2), and (g)(8). Additionally, as discussed in section III.D.9, we
propose to revise Sec. 170.315(b)(7) and (b)(8) to remove Sec.
170.315(b)(7)(ii) and (b)(8)(i)(B), which were time-limited provisions
(now expired) that permitted health IT to demonstrate security tagging
of Consolidated-Clinical Document Architecture (C-CDA) documents at the
document level. In section III.D.10, we propose to revise Sec.
170.550(h), the Privacy and Security Certification Framework
requirements by adding the certification criterion ``decision support
interventions'' in Sec. 170.315(b)(11) to the list of certification
criteria in Sec. 170.550(h)(3)(ii).
4. Correction--Privacy and Security Certification Framework
We propose to make a correction to the Privacy and Security
Certification Framework in Sec. 170.550(h), as discussed in section
III.E. We revised Sec. 170.550(h) in the ONC Cures Act Final Rule but
intended for Sec. 170.550(h)(4) to remain unchanged. However, when we
drafted the amendatory instructions, we erroneously included the
instruction to revise all of paragraph (h) (85 FR 25952). Therefore,
when the Code of Federal Regulations was updated, Sec. 170.550(h)(4)
was removed. We now propose to add the Sec. 170.550(h)(4) that existed
prior to the ONC Cures Act Final Rule being finalized.
5. Information Blocking Enhancements
In this rule, we propose revisions to defined terms for purposes of
the information blocking regulations, which appear in 45 CFR 171.102.
We propose to revise three existing exceptions in subpart B of 45 CFR
part 171 and solicit comment on potential revisions to one exception in
subpart D. We propose two new exceptions, one in each in subparts B and
C of part 171. We propose to codify in Sec. 171.401 definitions of
certain terms relevant to the Trusted Exchange Framework and Common
Agreement\TM\ (TEFCA\TM\) and in Sec. 171.104 descriptions of certain
practices that constitute interference with the access, exchange, and
use of electronic health information (EHI).
As discussed in section IV.A.1, we propose to amend the definition
of ``health care provider,'' codified in 45 CFR 171.10,2 so that it is
explicitly clear that it references 42 U.S.C. 300jj(3) and that for
purposes of this definition the terms ``laboratory'' and ``pharmacist''
have the meanings established for these terms in 42 U.S.C. 300jj(10)
and (12), respectively. In IV.A.2, we propose that for purposes of the
information blocking regulations in 45 CFR part 171 both ``health
information technology'' and its shorter form, ``health IT,'' have the
same meaning as ``health information technology'' in 42 U.S.C.
300jj(5).
For purposes of the information blocking definition (Sec.
171.103), the term ``interfere with or interference'' is currently
defined in Sec. 171.102. Informed by the concerns and questions that
interested parties have brought to our attention, we propose in section
IV.A.3 to add a section (Sec. 171.104) to the information blocking
regulations that would codify certain practices (acts and omissions)
that constitute interferences for purposes of the information blocking
definition (codified in Sec. 171.103). The proposed codified practices
are not an exhaustive list; additional practices not described in the
proposed Sec. 171.104 that are likely to interfere with, prevent, or
materially discourage access, exchange, or use of EHI may also be
considered to rise to the level of an interference. The proposed
codification of these specific practices is intended to provide actors,
and those who seek to engage in EHI access, exchange, or use with
actors, certainty that these specific practices constitute
interference. The codification of these practices may also help
regulated entities and other interested parties to consider the
likelihood that any practice an actor might contemplate or engage in
may also meet the definition of ``interference'' and ``interfere with''
(as defined in Sec. 171.102) for purposes of the information blocking
regulations (45 CFR part 171).
For purposes of the information blocking Privacy Exception, the
term ``individual'' is defined in Sec. 171.202(a)(2). As currently
worded, this text includes cross-references to incorrect citations
within Sec. 171.202(a)(2). The text also includes one unnecessary
cross-reference citation within Sec. 171.202(a)(2). We do not propose
to change the substance of the definition, but in section IV.B.1.a, we
propose technical corrections to the cross-reference citations within
Sec. 171.202(a)(2)(iii), (iv), and (v).
In section IV.B.1.b, to clearly establish coverage of the Sec.
171.202(d) sub-exception for all actors' practices under the same
requirements, we propose to change the name of the sub-exception to:
``interfering with individual access based on unreviewable grounds.''
This proposed change to the header text is intended to express the
expansion of its availability to actors who are not Health Insurance
Portability and Accountability Act of 1996 (HIPAA) covered entities or
business associates (as defined in 45 CFR 160.103). As explained in
section IV.B.1.c, we propose to slightly modify the header of Sec.
171.202(e) for ease of reference to ``Individual's request not to share
EHI.'' More importantly, we propose to revise the Sec. 171.202(e) sub-
exception to remove the existing limitation that allows the exception
to be used only for individual-requested restrictions on EHI sharing
that are permitted by other applicable law. The proposal would extend
the availability of the Sec. 171.202(e) sub-exception to an actor's
practice of applying restrictions the individual has requested on the
access, exchange, or use of an individual's EHI even when the actor may
have concern that another law applicable to some or all of the actor's
operations could compel the actor to provide access, exchange, or use
of EHI contrary to the individual's expressed wishes.
We propose, as discussed in section IV.B.2, revisions to three
conditions of the Infeasibility Exception (45 CFR 171.204).
Specifically, we propose to modify the Sec. 171.204(a)(2) segmentation
condition to enhance clarity and certainty, and to provide for its
application to additional specific situations. We propose to revise the
condition to specifically cross-reference additional information
blocking exceptions under which an actor may choose to withhold EHI
that the actor could, under applicable law, make available.
We propose to modify the Sec. 171.204(a)(3) third party seeking
modification use condition by changing the words ``health care
provider'' to ``covered entity as defined in 45 CFR 160.103'' in the
exclusion from applicability of this condition. We also propose in
Sec. 171.204(a)(3)(ii) to extend the exclusion from applicability of
the third party seeking modification use condition requests for
modification use from health care providers, as defined in Sec.
171.102 and who are not covered entities, requesting such use from
actors whose activities would make them a business associate of that
same health care provider if the healthcare provider (actor) was
covered by HIPAA.
We propose to modify the Sec. 171.204(b) responding to requests
condition by establishing different timeframes for sending written
responses to the requestor based on the Sec. 171.204(a) condition
under which fulfilling the requested access, exchange, or use of EHI is
infeasible. The proposed revision would retain the requirement that
actors communicate to requestors ``in writing the reason(s) why the
request is infeasible'' that we
[[Page 63509]]
finalized in the ONC Cures Act Final Rule. We discuss these proposals
further in sections IV.B.2.a through c of this proposed rule.
In section IV.B.3, we propose a new Protecting Care Access
Exception that would, under specified conditions (see sections IV.B.3.b
through d and the draft regulatory text of proposed Sec. 171.206),
apply to acts or omissions likely to interfere with access, exchange,
or use of particular EHI that an actor believes could create a risk of
exposing patients, care providers, and other persons who assist in
access or delivery of health care to potential administrative, civil,
or criminal investigations or other actions on certain bases. A summary
of these bases follows below in this section. (Please see section
IV.B.3 of this proposed rule for detailed discussion.)
The proposed Protecting Care Access Exception (Sec. 171.206) would
be a new exception in addition to the other information blocking
exceptions. The proposed new exception is designed to create certainty
for actors that certain practices for which no other exception would
apply will not be considered ``information blocking'' under the
information blocking statute (PHSA section 3022) and regulations (45
CFR part 171). Like any existing or proposed information blocking
exception in 45 CFR part 171, the proposed Protecting Care Access
Exception (Sec. 171.206) is not intended to override any provision of
another law that is independently applicable to the actor.
The practices that the proposed Protecting Care Access Exception
(Sec. 171.206) would except from the information blocking definition
would be those implemented based on the actor's good faith belief that
sharing EHI indicating that any person(s) sought, received, provided,
or facilitated the provision or receipt of reproductive health care
that was lawful under the circumstances in which it was provided could
result in a risk of potential exposure to legal action for those
persons and that the risk could be reduced by practices likely to
interfere with particular access, exchange, or use of specific EHI. For
purposes of the Protecting Care Access Exception, we propose to rely on
the same definition of ``reproductive health care'' (which can be found
in 45 CFR 160.103) that is used for purposes of the HIPAA regulations.
In addition, we discuss in section IV.B.3.b how we would interpret
whether care is ``lawful under the circumstances in which it is
provided.''
To satisfy the proposed new Protecting Care Access (Sec. 171.206)
Exception, an actor's practice would need to satisfy the threshold
condition (Sec. 171.206(a)), and at least one of the other two
conditions in the exception: the patient protection condition (Sec.
171.206(b)) or the care access condition (Sec. 171.206(c)). The
combination of conditions required to satisfy the proposed new
Protecting Care Access Exception and the definition of ``legal action''
(in Sec. 171.206(d)) for purposes of the exception would, together,
ensure that the exception would not apply to an actor's attempts to
shield any person from legal action based on allegations that health
care items or services the person provided are substandard.
These provisions together would also ensure that the exception
focuses on the specific situation where an actor limits the sharing of
EHI because the actor believes it could result in a risk of potentially
exposing the patient or another person to an investigation or other
civil, criminal, or administrative action based on the mere fact that
the person sought, obtained, provided, or facilitated reproductive
health care that was lawful under the circumstances in which it was
provided. For instance, the exception would not apply to an actor's
attempt to interfere with EHI sharing in order to reduce a patient's or
other person's risk of exposure to a criminal investigation or charges
not related to the act of seeking, obtaining, providing, or
facilitating reproductive health care. For example, the act of not
sharing information because of the risk of a criminal investigation
related to operating a vehicle while intoxicated or committing fraud
would not be covered under this exception.
The Protecting Care Access Exception's threshold condition (Sec.
171.206(a)), proposed in section IV.B.3.b, includes requirements that
the practice be: undertaken based on the actor's belief as specified in
Sec. 171.206(a)(1), no broader than necessary as specified in Sec.
171.206(a)(2), and be implemented consistent with a written
organizational policy or case-by-case determination contemporaneously
documented in writing as specified in Sec. 171.206(a)(3). Meeting the
threshold condition would be necessary, but not alone sufficient, for
an actor's practice to be covered by the proposed Protecting Care
Access (Sec. 171.206) exception. To satisfy the exception, any actor's
practice likely to interfere with access, exchange, or use of EHI would
also need to satisfy at least one of the other two conditions (in
paragraphs (b) and (c)) of the proposed exception.
In section IV.B.3.c, we propose a patient protection condition
(Sec. 171.206(b)), that can be met by practices implemented by the
actor for the purpose of reducing a risk of potential legal action that
the actor believes a patient could otherwise face because the EHI shows
or invites a reasonable inference that the patient has or has done any
of the following (see proposed Sec. 171.206(b)(1)):
(i) obtained reproductive health care that was lawful under the
circumstances in which it was provided;
(ii) Inquired about or expressed an interest in seeking
reproductive health care; or
(iii) Particular demographic characteristics or any health
condition(s) or history for which reproductive health care is often
sought, obtained, or medically indicated.
The proposed patient protection condition would specify (Sec.
171.206(b)(2)) that to meet the condition the actor's practice must be
subject to nullification by explicit request or directive from the
patient. We also clarify (in proposed Sec. 171.206(b)(3)) that for
purposes of the patient protection condition's other paragraphs that
``patient'' means the natural person who is the subject of the EHI or
another natural person referenced in, or identifiable from, the EHI as
having sought or received reproductive health care.\15\
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\15\ The definition of ``person'' for purposes of 45 CFR part
171 is codified in Sec. 171.102 and is, by cross-reference to 45
CFR 160.103, the same definition used for purposes of the HIPAA
Privacy Rule (45 CFR part 160 and subpart E of 45 CFR part 164). The
Sec. 160.103 definition of ``person'' clarifies the meaning of
``natural person'' within it. We use ``natural person'' in this
proposed rule with that same meaning.
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In section IV.B.3.d, we propose a care access condition (Sec.
171.206(c)) that can be met by practices an actor might choose to
implement for the purpose of reducing a risk of potential exposure to
legal action for licensed health care professionals, other health care
providers, or persons involved in providing or in facilitating the
provision or receipt of reproductive health care that is lawful under
the circumstances in which such health care is provided. We request
comment on multiple, potentially non-exclusive, alternative proposals
for additional requirements under the care access condition that would
function to restrict the exception's coverage of practices that
interfere with access, exchange, or use in scenarios that also
implicate the HIPAA Privacy Rule's individual right of access
provisions (45 CFR 164.524). In order to satisfy this proposed
condition, if finalized, the practice would need to meet the
requirements finalized in Sec. 171.206(c).
We propose clarifying provisions in Sec. 171.206(d) (discussed in
section
[[Page 63510]]
IV.B.3.b of this proposed rule) and Sec. 171.206(e) (discussed in
section IV.B.3.e of this proposed rule). Proposed Sec. 171.206(d)
would clarify when reproductive health care sought, obtained, provided,
or facilitated by someone other than the actor will be presumed to have
been lawful for purposes of assessing whether an actor's practice meets
the exception's patient protection or care access condition. In Sec.
171.206(e) we propose to define ``legal action'' for purposes of Sec.
171.206. We propose in section IV.B.4, a new information blocking
exception: ``Requestor Preferences'' in 45 CFR 171.304. This exception
would stand separate from and independent of other exceptions and would
apply where an actor honors or adheres to a requestor's preference(s)
expressed or confirmed in writing for: (1) limitations on the amount of
EHI made available to the requestor; (2) the conditions under which EHI
is made available to the requestor; and (3) when EHI is made available
to the requestor for access, exchange, or use. The exception would
offer an actor certainty that, so long as the actor's practices meet
the conditions of the exception, the actor can honor or adhere to a
requestor's preferences related to these specific preferences without
concern that the actor may be engaging in ``information blocking'' as
defined in 45 CFR 171.103.
We propose to add a new definitions section in Sec. 171.401 for
certain terms used in Subpart D, which we propose to align with the
definitions used in the proposed 45 CFR 172. We seek comment on some
aspects of the TEFCA Manner Exception in 45 CFR 171.403, including the
limitation on its use for requests made via a FHIR API and the
application of the Fees and Licensing Exceptions to practices that
satisfy the exception.
6. Trusted Exchange Framework and Common Agreement\TM\
Section 3001(c)(9) of PHSA, as added by the 21st Century Cures Act
(Pub. L. 114-255, Dec. 13, 2016) (Cures Act), calls for the development
or support of a ``trusted exchange framework, including a common
agreement among health information networks nationally.'' On January
19, 2022, ONC published in the Federal Register the Notice of
Publication of the Trusted Exchange Framework and Common Agreement (87
FR 2800), in which ONC published the Trusted Exchange Framework (TEF):
Principles for Trusted Exchange and the Common Agreement for Nationwide
Health Information Interoperability Version 1. ONC published in the
Federal Register a notice titled Trusted Exchange Framework and Common
Agreement Version 1.1 on November 7, 2023 (88 FR 76773), in which ONC
published the Common Agreement for Nationwide Health Information
Interoperability Version 1.1 (November 2023), and published version 2.0
implementing the latest industry standards among other changes on May
1, 2024 (89 FR 35107). Section 3001(c)(9)(A) of the PHSA states that
the overall goal for TEFCA\TM\ is to ensure full network-to-network
exchange of health information. ONC intends to accomplish this by
establishing a floor for interoperability under TEFCA across the
country. The Common Agreement \16\ is authorized by section
3001(c)(9)(B)(i) of the statute, which addresses: baseline legal and
technical requirements for the Common Agreement, organizational and
operational policies to enable exchange, minimum conditions for
exchange, and a process for filing and adjudicating noncompliance with
its terms. The Common Agreement addresses all of these to enable users
in different health information networks (HINs) to securely share
information with each other--all under commonly agreed-to expectations
and terms. The Trusted Exchange Framework,\17\ authorized under the
same provision of the PHSA, describes a common set of principles for
policies and practices to facilitate data-sharing.
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\16\ Common Agreement for Nationwide Health Information
Interoperability, Version 1.1 (November 2023), available at Federal
Register:: Trusted Exchange Framework and Common Agreement Version
1.1.
\17\ The Trusted Exchange Framework (TEF): Principles for
Trusted Exchange (January 2022), available at https://www.healthit.gov/sites/default/files/page/2022-01/Trusted_Exchange_Framework_0122.pdf.
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The Recognized Coordinating Entity[supreg] (RCE\TM\) is an ONC
contractor that is charged with helping ONC to develop, operationalize,
and update the Common Agreement, as well as assist ONC in stewarding
the Qualified Health Information Network\TM\ (QHIN\TM\) Technical
Framework (QTF),\18\ which provides the technical specifications for
how QHINs connect to one another. The RCE also helps ONC to oversee
QHIN-facilitated network operations and QHIN compliance with the Common
Agreement.
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\18\ Qualified Health Information Network (QHIN) Technical
Framework, Version 1.0 (January 2022), available at https://rce.sequoiaproject.org/wp-content/uploads/2022/01/QTF_0122.pdf.
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As explained in the proposed part 172 of subchapter D of title 45
of the Code of Federal Regulations, by standardizing health information
exchange across many different networks, TEFCA will help to ensure full
network-to-network exchange of health information. Doing so will
simplify exchange by significantly reducing the number of connections
(e.g., portals) that individuals, health care providers, and other
interested parties need to make to get the health information they
seek. It does so by creating baseline governance, legal, and technical
requirements that will enable secure information sharing across
different networks nationwide, including: a common method for
authenticating trusted network participants, a common set of rules for
trusted exchange, organizational and operational policies to enable the
exchange of health information among networks, and a process for filing
and adjudicating noncompliance with the terms of the Common Agreement.
As explained in proposed part 172, we believe that TEFCA will help
lower the cost and expand the nationwide availability of secure health
information exchange capabilities. The availability of TEFCA-based
services, such as electronic address directories and patient record
location, will also help scale health information exchange nationwide
and usher in new support for FHIR API usage and adoption. FHIR API
usage and adoption has become a centerpiece of the interoperability
initiatives of ONC and other U.S. government agencies such as CDC,\19\
CMS,\20\ Health Resources and Services Administration (HRSA),\21\ and
the Veteran's Administration (VA).\22\
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\19\ See CDC, Public Health Informatics Office (PHIO), https://www.cdc.gov/csels/phio/it_takes_practice.html.
\20\ See CMS, Policies and Technology for Interoperability and
Burden Reduction, https://www.cms.gov/policies-and-technology-interoperability-and-burden-reduction.
\21\ See HRSA, Uniform Data System (UDS) Modernization
Initiative, https://bphc.hrsa.gov/data-reporting/uds-training-and-technical-assistance/uniform-data-system-uds-modernization-initiative.
\22\ See VA, VA Technical Reference Model v 23.12, https://www.oit.va.gov/Services/TRM/StandardPage.aspx?tid=8233.
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In section V of this proposed rule, we propose to implement certain
provisions related to TEFCA in order to provide greater process
transparency and further implement section 3001(c)(9) of the PHSA, as
added by the Cures Act. We propose to add a new part, part 172, to
subchapter D of title 45 of the Code of Federal Regulations to
implement certain provisions related to the TEFCA. These proposed
provisions would establish the processes associated with the
qualifications necessary for an entity to receive and maintain
Designation (as we propose to define that term in Sec. 172.102) as a
QHIN capable of trusted exchange under the Common
[[Page 63511]]
Agreement. The proposals would also establish the procedures governing
Onboarding (as we propose to define that term in Sec. 172.102) of
QHINs and Designation of QHINs, suspension, termination, and
administrative appeals to ONC, as described in the sections below. We
believe establishing these provisions in regulation would support
reliability, privacy, security, and trust within TEFCA, which would
further TEFCA's ultimate success.
In subpart A, we propose the statutory basis, purpose, and scope of
the TEFCA provisions in part 172; the applicability of the TEFCA
provisions in part 172; and relevant definitions. In subpart B, we
propose requirements related to the qualifications needed to be
Designated, as proposed to be defined in Sec. 172.102. In subpart C,
we describe the proposed QHIN Onboarding and Designation processes. In
subpart D, we propose RCE and QHIN suspension rights, notice
requirements for suspension, and the requirements related to the effect
of suspension. In subpart E, we propose RCE and QHIN termination
rights, notice requirements for termination, and requirements related
to the effect of termination. In subpart F, we propose to establish
QHIN appeal rights and the process for filing an appeal to ONC. These
appeal rights would ensure that a QHIN, or Applicant QHIN, that (1)
disagrees with certain RCE determinations or (2) believes an action or
inaction by a QHIN or the RCE could threaten TEFCA's integrity will
have recourse to appeal such determination, action, or inaction to ONC.
In subpart G, we propose requirements related to QHIN attestation
for the Adoption of TEFCA. This subpart implements section
3001(c)(9)(D) of the PHSA. Section 3001(c)(9)(D)(i) requires the
publication on ONC's website of those HINs that have adopted the Common
Agreement and are capable of trusted exchange pursuant to the Common
Agreement. Section 3001(c)(9)(D)(ii) requires HHS to establish, through
notice and comment rulemaking, a process for HINs that voluntarily
elect to adopt TEFCA to attest to such adoption.
C. Severability
It is our intent that if any provision of this rule were, if or
when finalized, held to be invalid or unenforceable facially, or as
applied to any person, plaintiff, or stayed pending further judicial or
agency action, such provision shall be severable from other provisions
of this rule, and from rules and regulations currently in effect, and
not affect the remainder of this rule. It is also our intent that,
unless such provision shall be held to be utterly invalid or
unenforceable, it be construed to give the provision maximum effect
permitted by law including in the application of the provision to other
persons not similarly situated or to other, dissimilar circumstances
from those where the provision may be held to be invalid or
unenforceable.
In this rule, we propose provisions that are intended to and will
operate independently of each other, even if multiple of them serve the
same or similar general purpose(s) or policy goal(s). Where a provision
is necessarily dependent on another, the context generally makes that
clear (such as by cross-reference to a particular standard,
requirement, condition, or pre-requisite). Where a provision that is
dependent on one that is stayed or held invalid or unenforceable (as
described in the preceding paragraph) is included in a subparagraph,
paragraph, or section within part 170, 171, or 172 of 45 CFR, we intend
that other provisions of such subparagraph(s), paragraph(s), or
section(s) that operate independently of said provision would remain in
effect.
To ensure our intent for severability of provisions is clear in the
CFR, we propose to add to existing Sec. 170.101 and Sec. 171.101, and
to include in the proposed new Sec. 172.101 a paragraph stating our
intent that if any provision is held to be invalid or unenforceable it
shall be construed to give maximum effect to the provision permitted by
law, unless such holding shall be one of utter invalidity or
unenforceability, in which case the provision shall be severable from
this part and shall not affect the remainder thereof or the application
of the provision to other persons not similarly situated or to other
dissimilar circumstances.
D. Costs and Benefits
Executive Orders 12866 and 13563 direct agencies to assess all
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety effects, distributive impacts, and equity). Executive
Order 14094 entitled ``Modernizing Regulatory Review'' (hereinafter,
the Modernizing E.O.) amends section 3(f) of Executive Order 12866
(Regulatory Planning and Review). The amended section 3(f) of Executive
Order 12866 defines a ``significant regulatory action'' as an action
that is likely to result in a rule that may: (1) have an annual effect
on the economy of $200 million or more (adjusted every 3 years by the
Administrator of the Office of Information and Regulatory Affairs
(OIRA) for changes in gross domestic product); or adversely affect in a
material way the economy, a sector of the economy, productivity,
competition, jobs, the environment, public health or safety, or State,
local, territorial, or Tribal governments or communities; (2) create a
serious inconsistency or otherwise interfere with an action taken or
planned by another agency; (3) materially alter the budgetary impacts
of entitlement grants, user fees, or loan programs or the rights and
obligations of recipients thereof; or (4) raise legal or policy issues
for which centralized review would meaningfully further the President's
priorities or the principles set forth in this Executive Order, as
specifically authorized in a timely manner by the Administrator of OIRA
in each case. OMB has determined that this proposed rule is a
significant regulatory action, as the potential economic impacts
associated with this proposed rule could be greater than $200 million
per year. Accordingly, we have prepared a Regulatory Impact Analysis
(RIA) that, to the best of our ability, presents the costs and benefits
of this proposed rule. We have estimated the potential monetary costs
and benefits of this proposed rule for the health IT community,
including costs and benefits as they relate to health IT developers,
health care providers, patients, and the Federal Government (i.e.,
ONC), and have broken those costs and benefits out by section. In
accordance with E.O. 12866, we have included the RIA summary table as
Table 82.
We note that we have rounded all estimates to the nearest dollar
and that all estimates are expressed in 2022 dollars as it is the most
recent data available to address all cost and benefit estimates
consistently. The wages used to derive the cost estimates are from the
May 2022 National Occupational Employment and Wage Estimates reported
by the U.S. Bureau of Labor Statistics.\23\ We also note that estimates
presented in sections titled ``Employee Assumptions and Hourly Wage,''
``Quantifying the Estimated Number of Health IT Developers and
Products,'' and ``Number of End Users that Might Be Impacted by ONC's
Proposed Regulations'' are used throughout this RIA.
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\23\ May 2022 National Occupational Employment and Wage
Estimates, United States. U.S. Bureau of Labor Statistics. https://www.bls.gov/oes/current/oes_nat.htm.
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We estimate that the total annual cost for this proposed rule for
the first year
[[Page 63512]]
after it is finalized (including one-time costs), based on the cost
estimates outlined above and throughout this RIA, would result in
$431.1 million. The total undiscounted perpetual cost over a 10-year
period for this proposed rule (starting in year two), based on the cost
estimates outlined above, would result in $398.1 million. We estimate
the total costs to health IT developers to be $829.2 million.
We estimate the total annual benefit across all entities for this
proposed rule beginning in Year 3, when the associated policies are
required to be implemented and expected benefits to be realized, would
be on average $22.2 million. We estimate the total benefits across all
entities to be $177.6 million. We estimate the total undiscounted
perpetual annual net benefit for this proposed rule (starting in year
three), based on the estimates outlined above, would result in a net
benefit of $75.4 million.
II. Background
A. Statutory Basis
The Health Information Technology for Economic and Clinical Health
Act (HITECH Act), Title XIII of Division A and Title IV of Division B
of the American Recovery and Reinvestment Act of 2009 (Pub. L. 111-5),
was enacted on February 17, 2009. The HITECH Act amended the Public
Health Service Act (PHSA) and created ``Title XXX--Health Information
Technology and Quality'' (Title XXX) to improve healthcare quality,
safety, and efficiency through the promotion of health IT and EHI
exchange.
The 21st Century Cures Act (Pub. L. 114-255) (Cures Act) was
enacted on December 13, 2016, to accelerate the discovery, development,
and delivery of 21st century cures, and for other purposes. The Cures
Act, through Title IV--Delivery, amended the HITECH Act by modifying or
adding certain provisions to the PHSA relating to health IT.
Section 119 of Title I, Division CC of the Consolidated
Appropriations Act, 2021, Public Law 116-260 (CAA), enacted on December
27, 2020, requires sponsors of prescription drug plans to implement one
or more real-time benefit tools (RTBTs) that meet the requirements
described in the statute, after the Secretary has adopted a standard
for RTBTs and at a time determined appropriate by the Secretary. For
purposes of the requirement to implement a real-time benefit tool in
section 1860D-4(o)(1) of the Social Security Act, described above, the
CAA provides that one of the requirements for an RTBT is that it can
integrate with electronic prescribing and EHR systems of prescribing
healthcare professionals for the transmission of formulary and benefit
information in real time to such professionals. The statute requires
incorporation of RTBTs within both the Medicare Part D prescription
drug program and the ONC Health IT Certification Program (Program).
Specifically, the law amends the definition of a ``qualified electronic
health record'' (qualified EHR) in section 3000(13) of the PHSA to
require that a qualified EHR must include (or be capable of including)
an RTBT.
1. Standards, Implementation Specifications, and Certification Criteria
The HITECH Act established two Federal advisory committees, the
Health IT Policy Committee (HITPC) and the Health IT Standards
Committee (HITSC). Each was responsible for advising the National
Coordinator for Health Information Technology (National Coordinator) on
different aspects of standards, implementation specifications, and
certification criteria.
Section 4003(e) of the Cures Act amended sections 3002 and 3003 of
the PHSA by replacing, in an amended section 3002, the HITPC and HITSC
with one committee named the Health Information Technology Advisory
Committee (Health IT Advisory Committee or HITAC). Section 3002(a) of
the PHSA, as added by the Cures Act, establishes that the HITAC
recommends to the National Coordinator policies and standards,
implementation specifications, and certification criteria, relating to
the implementation of a health information technology infrastructure,
nationally and locally, that advances the electronic access, exchange,
and use of health information. Further described in section 3002(b)(1)
of the PHSA, this includes recommending to the National Coordinator a
policy framework to advance interoperable health information technology
infrastructure, updating recommendations to the policy framework, and
making new recommendations, as appropriate. Section 3002(b)(2)(A) of
the PHSA specifies that in general, the HITAC shall recommend to the
National Coordinator for purposes of adoption under section 3004,
standards, implementation specifications, and certification criteria
and an order of priority for the development, harmonization, and
recognition of such standards, specifications, and certification
criteria. Like the process previously required of the former HITPC and
HITSC, section 3002(b)(5) of the PHSA requires the HITAC to develop a
schedule, updated annually, for the assessment of policy
recommendations, which the Secretary publishes in the Federal Register.
Section 3004 of the PHSA establishes a process for the adoption of
health IT standards, implementation specifications, and certification
criteria and authorizes the Secretary to adopt such standards,
implementation specifications, and certification criteria. As specified
in section 3004(a)(1), the Secretary is required, in consultation with
representatives of other relevant Federal agencies, to jointly review
standards, implementation specifications, and certification criteria
endorsed by the National Coordinator under section 3001(c) and
subsequently determine whether to propose the adoption of such
standards, implementation specifications, or certification criteria.
Section 3004(a)(3) requires the Secretary to publish all such
determinations in the Federal Register.
Section 3004(b)(3) of the PHSA, titled, Subsequent Standards
Activity, provides that the Secretary shall adopt additional standards,
implementation specifications, and certification criteria as necessary
and consistent with the schedule published by the HITAC. We consider
this provision in the broader context of the HITECH Act and Cures Act
to grant the Secretary the authority and discretion to adopt standards,
implementation specifications, and certification criteria that have
been recommended by the HITAC and endorsed by the National Coordinator,
as well as other appropriate and necessary health IT standards,
implementation specifications, and certification criteria.
2. ONC Health IT Certification Program Rules
Section 3001(c)(5) of the PHSA provides the National Coordinator
with the authority to establish a certification program or programs for
the voluntary certification of health IT. Section 3001(c)(5)(A)
specifies that the National Coordinator, in consultation with the
Director of the National Institute of Standards and Technology (NIST),
shall keep or recognize a program or programs for the voluntary
certification of health IT that is in compliance with applicable
certification criteria adopted under section 3004 of the PHSA. The
certification program(s) must also include, as appropriate, testing of
the technology in accordance with section 13201(b) of the HITECH Act.
Section 13201(b) of the HITECH Act requires that, with respect to the
development of
[[Page 63513]]
standards and implementation specifications, the Director of NIST shall
support the establishment of a conformance testing infrastructure,
including the development of technical test beds. Section 13201(b) also
indicates that the development of this conformance testing
infrastructure may include a program to accredit independent, non-
Federal laboratories to perform testing.
Section 4003(b) of the Cures Act added section 3001(c)(9)(B)(i) to
the PHSA, which requires the National Coordinator ``to convene
appropriate public and private stakeholders'' with the goal of
developing or supporting a Trusted Exchange Framework and a Common
Agreement (collectively, ``TEFCA'') for the purpose of ensuring full
network-to-network exchange of health information. Section
3001(c)(9)(B) outlines provisions related to the establishment of a
Trusted Exchange Framework for trust policies and practices and a
Common Agreement for exchange between health information networks
(HINs)--including provisions for the National Coordinator, in
collaboration with the NIST, to provide technical assistance on
implementation and pilot testing of TEFCA. Section 3001(c)(9)(C)
requires the National Coordinator to publish TEFCA on its website and
in the Federal Register. Section 3001(c)(9)(D)(i) requires the National
Coordinator to publish a list of HINs that have adopted TEFCA. Section
3001(c)(9)(D)(ii) requires the Secretary to establish a process for
HINs to attest that they have adopted TEFCA.
Section 4002(a) of the Cures Act amended section 3001(c)(5) of the
PHSA by adding section 3001(c)(5)(D), which requires the Secretary,
through notice and comment rulemaking, to require conditions of
certification and maintenance of certification for the Program.
Specifically, the health IT developers or entities with technology
certified under the Program must, in order to maintain such
certification status, adhere to certain conditions and maintenance of
certification requirements concerning information blocking; assurances
regarding appropriate exchange, access, and use of electronic health
information; communications regarding health IT; application
programming interfaces (APIs); real world testing; attestations
regarding certain conditions and maintenance of certification
requirements; and submission of reporting criteria under the EHR
Reporting Program in accordance with section 3009A(b) of the PHSA.
B. Regulatory History
The Secretary issued an interim final rule with request for
comments on January 13, 2010, ``Health Information Technology: Initial
Set of Standards, Implementation Specifications, and Certification
Criteria for Electronic Health Record Technology'' (75 FR 2014), which
adopted an initial set of standards, implementation specifications, and
certification criteria. On March 10, 2010, the Secretary issued a
proposed rule, ``Proposed Establishment of Certification Programs for
Health Information Technology'' (75 FR 11328), that proposed both
temporary and permanent certification programs for the purposes of
testing and certifying health IT. A final rule establishing the
temporary certification program was published on June 24, 2010,
``Establishment of the Temporary Certification Program for Health
Information Technology'' (75 FR 36158), and a final rule establishing
the permanent certification program was published on January 7, 2011,
``Establishment of the Permanent Certification Program for Health
Information Technology'' (76 FR 1262).
We have engaged in multiple rulemakings to update standards,
implementation specifications, certification criteria, and the Program,
a history of which can be found in the October 16, 2015 final rule
``2015 Edition Health Information (Health IT) Certification Criteria,
2015 Edition Base Electronic Health Record (EHR) Definition, and ONC
Health IT Certification Program Modifications'' (80 FR 62602) (2015
Edition Final Rule). The history can be found at 80 FR 62606. A final
rule making corrections and clarifications was published for the 2015
Edition Final Rule on December 11, 2015 (80 FR 76868), to correct
preamble and regulatory text errors and clarify requirements of the
Common Clinical Data Set (CCDS), the 2015 Edition privacy and security
certification framework, and the mandatory disclosures for health IT
developers.
The 2015 Edition Final Rule established a new edition of
certification criteria (``2015 Edition health IT certification
criteria'' or ``2015 Edition'') and a new 2015 Edition Base EHR
definition. The 2015 Edition established the minimum capabilities and
specified the related minimum standards and implementation
specifications that Certified EHR Technology (CEHRT) would need to
include to support the achievement of ``meaningful use'' by eligible
clinicians, eligible hospitals, and critical access hospitals under the
Medicare and Medicaid EHR Incentive Programs (EHR Incentive Programs)
(now referred to as the Promoting Interoperability Programs and the
Promoting Interoperability performance category under MIPS) when the
2015 Edition is required for use under these and other programs
referencing the CEHRT definition. The final rule also adopted a
proposal to change the Program's name to the ``ONC Health IT
Certification Program'' from the ONC HIT Certification Program,
modified the Program to make it more accessible to other types of
health IT beyond EHR technology and for health IT that supports care
and practice settings beyond the ambulatory and inpatient settings, and
adopted new and revised Principles of Proper Conduct (PoPC) for ONC-
ACBs.
After issuing a proposed rule on March 2, 2016, ``ONC Health IT
Certification Program: Enhanced Oversight and Accountability'' (81 FR
11056), we published a final rule by the same title (81 FR 72404) (EOA
Final Rule) on October 19, 2016. The EOA Final Rule finalized
modifications and new requirements under the Program, including
provisions related to our role in the Program. The final rule created a
regulatory framework for our direct review of health IT certified under
the Program, including, when necessary, requiring the correction of
non-conformities found in health IT certified under the Program and
suspending and terminating certifications issued to Complete EHRs and
Health IT Modules. The final rule also set forth processes for us to
authorize and oversee accredited testing laboratories under the
Program. In addition, it included provisions for expanded public
availability of certified health IT surveillance results.
On March 4, 2019, the Secretary published a proposed rule titled,
``21st Century Cures Act: Interoperability, Information Blocking, and
the ONC Health IT Certification Program'' (84 FR 7424) (ONC Cures Act
Proposed Rule). The proposed rule proposed to implement certain
provisions of the Cures Act that would advance interoperability and
support the access, exchange, and use of electronic health information.
We also requested comment in the ONC Cures Act Proposed Rule (84 FR
7467) as to whether certain health IT developers should be required to
participate in TEFCA as a means of providing assurances to their
customers and ONC that they are not taking actions that constitute
information blocking or any other action that may inhibit the
appropriate exchange, access, and use of EHI, with the goal of
developing or
[[Page 63514]]
supporting TEFCA for the purpose of ensuring full network-to-network
exchange of health information.
On May 1, 2020, a final rule was published titled, ``21st Century
Cures Act: Interoperability, Information Blocking, and the ONC Health
IT Certification Program'' (85 FR 25642) (ONC Cures Act Final Rule).
The final rule implemented certain provisions of the Cures Act,
including Conditions and Maintenance of Certification requirements for
health IT developers, the voluntary certification of health IT for use
by pediatric health providers, and reasonable and necessary activities
that do not constitute information blocking. The final rule also
implemented certain parts of the Cures Act to support patients' access
to their EHI, and the implementation of information blocking policies
that support patient electronic access. Additionally, the final rule
modified the 2015 Edition health IT certification criteria and Program
in other ways to advance interoperability, enhance health IT
certification, and reduce burden and costs, as well as improving
patient and health care provider access to EHI and promoting
competition. On November 4, 2020, the Secretary published an interim
final rule with comment period titled, ``Information Blocking and the
ONC Health IT Certification Program: Extension of Compliance Dates and
Timeframes in Response to the COVID-19 Public Health Emergency'' (85 FR
70064) (Cures Act Interim Final Rule). The interim final rule extended
certain compliance dates and timeframes adopted in the ONC Cures Act
Final Rule to offer the healthcare system additional flexibilities in
furnishing services to combat the COVID-19 pandemic, including
extending the applicability date for information blocking provisions to
April 5, 2021.
On April 18, 2023, the Secretary published a proposed rule titled,
``Health Data, Technology, and Interoperability: Certification Program
Updates, Algorithm Transparency, and Information Sharing'' (88 FR
23746) (HTI-1 Proposed Rule). The HTI-1 Proposed Rule proposed to
implement the Electronic Health Record (EHR) Reporting Program
provision of the Cures Act by establishing new Conditions and
Maintenance of Certification requirements for health IT developers
under the Program. The HTI-1 Proposed Rule also proposed to make
several updates to certification criteria and implementation
specifications recognized by the Program, including revised
certification criterion for: ``clinical decision support'' (CDS),
``patient demographics and observations'', and ``electronic case
reporting.'' The HTI-1 Proposed Rule also proposed to establish a new
baseline version of the United States Core Data for Interoperability
(USCDI). Additionally, the HTI-1 Proposed Rule proposed enhancements to
support information sharing under the information blocking regulations.
On January 9, 2024, the Secretary issued the ``Health Data,
Technology, and Interoperability: Certification Program Updates,
Algorithm Transparency, and Information Sharing'' final rule (HTI-1
Final Rule), which implemented the EHR Reporting Program provision of
the 21st Century Cures Act and established new Conditions and
Maintenance of Certification requirements for health IT developers
under the Program (89 FR 1192). The HTI-1 Final Rule also made several
updates to certification criteria and standards recognized by the
Program. The Program updates included revised certification criteria
for ``decision support interventions,'' ``patient demographics and
observations,'' and ``electronic case reporting,'' as well as adopted a
new baseline version of the USCDI standard, USCDI Version 3.
Additionally, the HTI-1 Final Rule provided enhancements to support
information sharing under the information blocking regulations. Through
these provisions, we sought to advance interoperability, improve
algorithm transparency, and support the access, exchange, and use of
EHI. The HTI-1 Final Rule also updated numerous technical standards in
the Program in additional ways to advance interoperability, enhance
health IT certification, and reduce burden and costs for health IT
developers and users of health IT.
On November 15, 2023, the Secretary issued a proposed rule titled,
``Medicare Program; Contract Year 2025 Policy and Technical Changes to
the Medicare Advantage Program, Medicare Prescription Drug Benefit
Program, Medicare Cost Plan Program, and Programs of All-Inclusive Care
for the Elderly; Health Information Technology Standards and
Implementation Specifications'' (88 FR 78476). This proposed rule
proposed to adopt the National Council for Prescription Drug Programs
(NCPDP) Real-Time Prescription Benefit standard version 13.
On June 17, 2024, the Secretary issued the Part D and Health IT
Standards final rule (89 FR 51238 through 51265). This final rule
adopted the NCPDP Real-Time Prescription Benefit standard version 13 in
45 CFR 170.205(c)(1) and to incorporate this standard by reference in
45 CFR 170.299. In this final rule, CMS also adopted requirements for
Part D sponsors to use the standard in in 45 CFR 170.205(c)(1) when
implementing an RTBT.
III. ONC Health IT Certification Program Updates
A. Standards and Implementations Specifications
1. National Technology Transfer and Advancement Act
The National Technology Transfer and Advancement Act (NTTAA) of
1995 (15 U.S.C. 3701 et seq.) and the Office of Management and Budget
(OMB) Circular A-119 \24\ require the use of, wherever practical,
technical standards that are developed or adopted by voluntary
consensus standards bodies to carry out policy objectives or
activities, with certain exceptions. The NTTAA and OMB Circular A-119
provide exceptions to electing only standards developed or adopted by
voluntary consensus bodies, namely when doing so would be inconsistent
with applicable law or otherwise impractical. Agencies have the
discretion to decline the use of existing voluntary consensus standards
if it is determined that such standards are inconsistent with
applicable law or otherwise impractical, and instead use a government-
unique standard or other standard. In addition to the consideration of
voluntary consensus standards, the OMB Circular A-119 recognizes the
contributions of standardization activities that take place outside of
the voluntary consensus standards process. Therefore, in instances
where use of voluntary consensus standards would be inconsistent with
applicable law or otherwise impracticable, other standards should be
considered that: meet the agency's regulatory, procurement or program
needs; deliver favorable technical and economic outcomes; and are
widely utilized in the marketplace. In this proposed rule, we use
voluntary consensus standards except for:
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\24\ https://www.whitehouse.gov/wp-content/uploads/2020/07/revised_circular_a-119_as_of_1_22.pdf.
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The USCDI v4 standard. We propose to adopt USCDI v4 in
Sec. 170.213. This standard is a hybrid of government policy (i.e.,
determining which data to include in the USCDI) and voluntary consensus
standards (i.e., the vocabulary and code set standards attributed to
USCDI data elements);
The Federal Information Processing Standard (140-2)
related to the
[[Page 63515]]
protection of electronic health information adopted in Sec. 170.210;
The CMS standards for QRDA I and III respectively adopted
in Sec. 170.205(h)(2) and (k)(3).
We are not aware of any voluntary consensus standards that could
serve as an alternative for the purposes we describe in further detail
throughout this proposed rule, including for establishing a baseline
set of data that can be commonly exchanged across care settings for a
wide range of uses. We refer readers to section III.B.1 of this
preamble for a discussion of the USCDI.
2. Compliance With Adopted Standards and Implementation Specifications
In accordance with Office of the Federal Register regulations
related to ``incorporation by reference,'' 1 CFR part 51, which we
follow when we adopt proposed standards and implementation
specifications in any subsequent final rule, the entire standard or
implementation specification document is deemed published in the
Federal Register when incorporated by reference therein with the
approval of the Director of the Federal Register. Once published,
compliance with the standard and implementation specification includes
the entire document unless we specify otherwise. For example, if we
adopted the SMART Application Launch Framework Implementation Guide
Release 2.2 (SMART v2.2) proposed in this proposed rule (see section
III.B.2), health IT certified to certification criteria referencing
this IG would need to demonstrate compliance with all mandatory
elements and requirements of the IG. If an element of the IG is
optional or permissive in any way, it would remain that way for testing
and certification unless we specified otherwise in regulation. In such
cases, the regulatory text would supersede the permissiveness of the
IG.
3. ``Reasonably Available'' to Interested Parties
The Office of the Federal Register has established requirements for
materials (e.g., standards and implementation specifications) that
agencies propose to incorporate by reference in the Code of Federal
Regulations (79 FR 66267: 1 CFR 51.5(a)). To comply with these
requirements, in section VI (``Incorporation by Reference'') of this
preamble, we provide summaries of, and uniform resource locators (URLs)
to, the standards and implementation specifications we propose to adopt
and subsequently incorporate by reference in the Code of Federal
Regulations. To note, we also provide relevant information about these
standards and implementation specifications throughout the relevant
sections of the proposed rule.
B. New and Revised Standards and Certification Criteria
1. The United States Core Data for Interoperability Version 4 (USCDI
v4)
a. Background and USCDI v4 Update
The United States Core Data for Interoperability (USCDI) is a
standardized set of health data classes and data elements for the
sharing of electronic health information.\25\ We established USCDI as a
standard in the ONC Cures Act Final Rule (85 FR 25670), adopting USCDI
Version 1 (USCDI v1) in Sec. 170.213 and incorporating it by reference
in Sec. 170.299.\26\ In a final rule titled ``Health Data, Technology,
and Interoperability: Certification Program Updates, Algorithm
Transparency, and Information Sharing'' (HTI-1 Final Rule) and
published on January 9, 2024, we adopted USCDI Version 3 (USCDI v3) in
Sec. 170.213 and incorporated it by reference in Sec. 170.299 (89 FR
1210 through 1223).
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\25\ https://www.healthit.gov/isa/united-states-core-data-interoperability-uscdi.
\26\ https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-D/part-170#p-170.213.
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The USCDI standard in Sec. 170.213 is a baseline set of data that
can be commonly exchanged across care settings for a wide range of
uses. Certain certification criteria in Sec. 170.315 currently require
the use of one of the versions of the USCDI standard in Sec. 170.213.
USCDI is also referenced by HHS programs and used by the healthcare
community to align interoperability requirements and national
priorities for health IT across industry initiatives. For the overall
structure and organization of USCDI, including data classes and data
elements, please see www.healthIT.gov/USCDI.
As described in the ONC Cures Act Final Rule, we use a predictable,
transparent, and collaborative process to expand the USCDI standard,
including providing the opportunity for public comment (85 FR 25670).
Additionally, as described in the ONC Cures Act Final Rule, health IT
developers can use the Standards Version Advancement Process (SVAP) to
voluntarily implement and use the most recent National Coordinator-
approved version of USCDI without waiting for ONC to require that newer
version via rulemaking (85 FR 25669). ONC uses a public comment process
to identify newer versions of standards for approval by the National
Coordinator as part of SVAP.\27\ USCDI v3 was available for voluntary
implementation through SVAP as of September 2023.
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\27\ https://www.healthit.gov/isa/standards-version-advancement-process.
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Based on feedback ONC received through the ONC New Data Element and
Class submission system, ONC identified a set of data elements and data
classes for a draft version of USCDI v4, which was released in January
2023. The draft version of USCDI v4 included 20 new data elements and
one new data class as well as updates to minimum standard code set
versions. ONC then finalized and released USCDI v4 in July 2023.
We propose to update the USCDI standard in Sec. 170.213 by adding
USCDI v4. We propose that for purposes of the Program, the adoption of
USCDI v3 expires on January 1, 2028. We propose to add USCDI v4 in
Sec. 170.213(c) and incorporate it by reference in Sec. 170.299. We
propose that as of January 1, 2028, any Health IT Modules seeking
certification to criteria referencing Sec. 170.213 would need to be
capable of exchanging the data elements that the USCDI v4 comprises.
The additional data elements in USCDI v4 reflect many of the
recommendations expressed by the Health IT Advisory Committee in their
report to the National Coordinator.\28\ As finalized in the HTI-1 Final
Rule, beginning on January 1, 2026, only USCDI v3 will be available in
Sec. 170.213 as the USCDI standard for use by developers of certified
health IT (89 FR 1215). This proposed rule would advance the USCDI
standard to USCDI v4, continuing ONC's commitment to a transparent and
predictable schedule for health IT developers with respect to updates
to the USCDI's regulatory baseline. If finalized, this proposal would
provide significant clarity and certainty to health IT developers who
would have substantial time to update certified health IT to support
USCDI v4.
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\28\ https://www.healthit.gov/sites/default/files/page/2023-05/2023-04-12_IS_WG_USCDI_v4_Transmittal_Letter_508.pdf.
---------------------------------------------------------------------------
For certification to a criterion in Sec. 170.315 that references
the USCDI standard adopted in Sec. 170.213, we propose that a Health
IT Module must use at least one of the versions of the USCDI standard
that is (1) adopted in Sec. 170.213 or approved by SVAP at the time
the Health IT Module seeks certification and (2) not expired at the
time of use. When a Health IT Module certified to a criterion in Sec.
170.315 that references the USCDI standard adopted in Sec. 170.213 is
using a version with an
[[Page 63516]]
upcoming expiration date or is using an interim version approved by
SVAP, we propose that the health IT developer must update the Module to
either a new version of the standard adopted in Sec. 170.213 or a
subsequent version approved by SVAP prior to the expiration date or
dates defined in order to maintain certification of that Health IT
Module as described in Sec. 170.315. Consistent with the health IT
developer must provide the updated Health IT Module to their customers
by the expiration date or dates defined in order to maintain
certification of that Health IT Module as described in Sec. 170.315.
We describe these proposals further in section III.B.1.b below.
b. Certification Criteria That Reference USCDI
The USCDI standard is currently cross-referenced in certain
certification criteria (see Sec. 170.213). A Health IT Module can be
certified to any of these criteria by ensuring that it complies with
any unexpired version of the USCDI included in Sec. 170.213 or a
version of the USCDI standard that is approved through SVAP at the time
the Health IT Module seeks certification. The certification criteria
that currently cross-reference to USCDI via Sec. 170.213 are as
follows:
``Care coordination--Transitions of care--Create'' (Sec.
170.315(b)(1)(iii)(A)(1) and (2));
``Care coordination--Clinical information reconciliation
and incorporation--Reconciliation'' (Sec. 170.315(b)(2)(iii)(D)(1)-
(3));
``Decision support interventions--Decision support
configuration'' (Sec. 170.315(b)(11)(ii)(A) and (B), and (iv)(A)(5)-
(13)));
``Patient engagement--View, download, and transmit to 3rd
party--View'' (Sec. 170.315(e)(1)(i)(A)(1) and (2), and (iii));
``Transmission to public health agencies--electronic case
reporting'' (Sec. 170.315(f)(5)(i)(C)(2)(i));
``Design and performance--Consolidated CDA creation
performance'' (Sec. 170.315(g)(6)(i)(A) and (B));
``Design and performance--Application access--all data
request--Functional requirements'' (Sec. 170.315(g)(9)(i)(A)(1) and
(2)); and
``Design and performance--Standardized API for patient and
population services--Data response'' (Sec. 170.315(g)(10)(i)(A) and
(B)).
We propose that up to and including December 31, 2027, a Health IT
Module certified to criteria referencing Sec. 170.213 may use either
USCDI v3 or USCDI v4. We propose that by January 1, 2028, a health IT
developer of a Health IT Module certified to criteria referencing Sec.
170.213 must update to USCDI v4 and provide the updated version to
their customers in order to maintain certification of that Health IT
Module. We also note that if these proposals are finalized, for any
time before January 1, 2026, USCDI v1 could still be used to meet the
applicable certification criteria as well (see 89 FR 1211 through
1223).
Further, we propose that Health IT Modules certified to
certification criteria that reference Sec. 170.213 would need to
update their Health IT Modules to accommodate USCDI v4 data elements
using the FHIR[supreg] US Core Implementation Guide Version 7.0.0
proposed in Sec. 170.215(b)(1)(iii) and the HL7 CDA R2 Implementation
Guide: Consolidated CDA Templates for Clinical Notes, Edition 3--US
Realm, proposed in Sec. 170.205(a)(1). We also propose that adoption
of the standards in Sec. 170.205(a)(6) and Sec. 170.215(b)(1)(ii)
expire on January 1, 2028. As stated in the HTI-1 Final Rule, our
intent would be to adopt the version of these standards necessary for
developers of certified health IT to have appropriate implementation
guidance to meet the certification criteria that reference USCDI v4,
and these updated implementation guides best align with and support
effective implementation of USCDI v4. Based on public comments on HTI-1
and prior rulemakings, we believe that the health IT industry,
healthcare standards developers, and health care providers expect and
support ONC making such determinations so that the adopted version of
standards are the most up-to-date available and are feasible for real-
world implementation (see 89 FR 1215).
2. SMART App Launch 2.2
In the ONC HTI-1 Final Rule, we adopted the HL7[supreg]
FHIR[supreg] SMART Application Launch Framework Implementation Guide
Release 2.0.0 (SMART v2 Guide), a profile of the OAuth 2.0
specification, in Sec. 170.215(c)(2) (89 FR 1291 through 1295). Public
comments received during the HTI-1 rulemaking process indicated near
universal support for the adoption of the SMART v2 Guide, with the
caveat that several of these commenters suggested we adopt the newest
balloted version of the SMART App Launch IG, which at the time of the
HTI-1 public comment period was version 2.1. We declined to adopt the
newest balloted version of the SMART App Launch IG in the HTI-1 Final
Rule, noting that the SMART v2 Guide had ``already been an established
part of the Program via SVAP and rigorously tested . . .'' (89 FR
1292). However, we also noted that ``[w]e will consider potential ways
the SMART v2.1 IG could be included in the Program in the future . .
.'' (89 FR 1292).
We note that current ONC policy as established in the ONC Cures Act
Final Rule (85 FR 25741) and reiterated in the HTI-1 Final Rule (89 FR
1293) is that as part of supporting the SMART App Launch ``permission-
patient'' capability, Health IT Modules presented for testing and
certification must include the ability for patients to authorize an
application to receive their EHI based on FHIR resource-level scopes.
Furthermore, we finalized in the HTI-1 Final Rule (89 FR 1294) that as
part of supporting the SMART App Launch ``permission-v2'' capability
Health IT Modules must support certain sub-resource scopes for the
Condition and Observation resources. Specifically, we established
minimal conformance requirements at the category level for the
Condition and Observation resources using specifications and guidance
from the SMART v2 Guide and FHIR US Core 6.1.0 implementation guides to
ensure that Health IT Modules required to support the SMART v2 Guide
are capable of supporting the finer-grained resource constraints
capability without being overly prescriptive in setting expectations
for how the Health IT Module implements such capabilities.
In this proposed rule, we clarify the existing Program requirements
to support patient authorization using SMART App Launch capabilities.
Specifically, we clarify that if both the ``permission-patient'' and
``permission-v2'' capabilities are required in support of patient
authorization for certification to a criterion in the Program, then a
Health IT Module must support the following:
Support for the ability for patients to authorize an
application to receive their EHI based on individual FHIR resource-
level and individual sub-resource-level scopes.
Support for the ability for patients to authorize an
application to receive their EHI based on individual sub-resource-level
scopes when corresponding resource-level scopes are requested.
These requirements enable patients to have the ability to authorize
access to their EHI at a more granular level in alignment with required
SMART App Launch authorization capabilities. The capabilities enabled
by these requirements empower patients with authorization ability at
the individual sub-resource level, and the ability to provide granular
authorization at the
[[Page 63517]]
individual sub-resource level even if the authorization request from
the app is made at the resource level. We note that both the
``permission-patient'' and ``permission-v2'' capabilities are required
as part of the ``Permissions'' subsection of the SMART App Launch IGs
proposed in Sec. 170.215(c)(2) and Sec. 170.215(c)(3). We propose
``Permissions'' in Sec. 170.315(j)(9), which is cross-referenced in
Sec. 170.315(g)(10) and Sec. 170.315(g)(30) in this proposed rule. We
anticipate that future certification criteria will also include
``permission-patient'' and ``permission-v2'' support requirements to
support of patient authorization and we intend for this clarification
to support patient authorization of individual sub-resource level
scopes to also apply.
Specific guidance and requirements regarding the implementation of
resource and sub-resource scopes are included in the US Core 7.0.0
implementation guide. We clarify for the purposes of certification
under the Program, support for the US Core IG includes supporting all
SMART App Launch scope requirements included in the US Core IG,
including requirements to support resource and sub-resource scopes.
We note throughout this rule we propose revisions to existing API
certification criteria and propose new API certification criteria
wherein specificity in the requirements regarding the properties of
applications is important. To provide a consistent and industry
standard definition of app types referenced in Program API
certification criteria, we clarify that ``confidential app,'' ``public
app,'' and ``native app'' as referenced in this rule and in Program API
requirements refers to ``confidential client,'' ``public client,'' and
``native application'' respectively as defined in internet Engineering
Task Force (IETF) Request for Comments (RFC) 6749 ``The OAuth 2.0
Authorization Framework.'' \29\
---------------------------------------------------------------------------
\29\ IETF RFC 6749 ``The OAuth 2.0 Authorization Framework''
available here: https://datatracker.ietf.org/doc/rfc6749/.
---------------------------------------------------------------------------
The SMART Application Launch Framework Implementation Guide,
Release 2.2 (SMART v2.2 Guide), published at the end of April 2024, is
the most recent version available at the time of this proposed rule.
The SMART v2.2 Guide includes features that iterate on the features of
the SMART v2 Guide, including the enhancements from the SMART v2.1
Guide and the latest industry consensus updates.
Notable enhancements in the SMART v2.2 Guide include a more
detailed and standardized ``fhirContext'' parameter, including the
ability for servers to include optional ``roles'' for offering a
detailed description of included resource references in the
``fhirContext'' parameter; updates to the ``fhirUser'' context
parameter to allow the use of the ``PractitionerRole'' resource for
representing the current user authorizing the launch; and clarification
regarding the ``exp'' field in the token introspection response,
ensuring consistency between the ``exp'' field in the token
introspection response and the ``expires_in'' interval in the original
access token response. Additionally, to eliminate ambiguity in URL
resolution, the SMART v2.2 Guide mandates the use of absolute URLs in
the Well-Known configuration file, disallowing relative URLs. The SMART
v2.2 Guide also introduces a new Cross-Origin Resource Sharing (CORS)
security requirement applicable to servers supporting purely browser-
based apps. Finally, an important new addition to the SMART v2.2 Guide
is the User-Access Brands and Endpoints (Brands) specification, which
allows API providers to publish Brands associated with their FHIR
Endpoints to enable apps to collect and present these Brands to users
(e.g., patients).
Overall, these enhancements to the SMART v2.2 Guide improve
standardization and provide clarity to help support consistent
implementation and improve interoperability. We welcome comment on our
assessment of these SMART v2.2 Guide changes.
Based on HTI-1 public comment feedback and to make use of the new
Brands specification in the Program, we propose to adopt the SMART v2.2
Guide in Sec. 170.215(c)(3) and incorporate it by reference as a
subparagraph in Sec. 170.299. Additionally, we propose that the
adoption of the SMART v2 Guide in Sec. 170.215(c)(2) would expire on
January 1, 2028. If we finalize these proposals, developers of
certified health IT with Health IT Modules certified to criteria
referencing the implementation specifications in Sec. 170.215(c) may
use the SMART v1, SMART v2, or SMART v2.2 Guides for the time period up
to and including December 31, 2025. Then by January 1, 2026, when the
adoption of SMART v1 expires, developers of certified health IT with
Health IT Modules certified to criteria referencing the implementation
specifications in Sec. 170.215(c) must update to the SMART v2 or SMART
v2.2 Guides and provide the updated version to their customers in order
to maintain certification of that Health IT Module. Finally, by January
1, 2028, when the adoption of the SMART v2 Guide expires, developers of
certified health IT with Health IT Modules certified to criteria
referencing the implementation specifications in Sec. 170.215(c) must
update to the SMART v2.2 Guide and provide the updated health IT module
to their customers in order to maintain certification of that Health IT
Module. We propose that any Health IT Modules seeking certification to
criteria referencing the implementation specifications in Sec.
170.215(c) on or after January 1, 2028, would need to be capable of
supporting the SMART v2.2 Guide.
Our proposal to require health IT developers participating in the
program to update and provide to customers Health IT Modules updated to
according to the timelines for the implementation specifications in
Sec. 170.215(c) includes all certification criteria that reference the
implementation specifications in Sec. 170.215(c) directly, or via
reference to our proposed modular API capabilities certification
criteria in Sec. 170.315(j)(6), (j)(7), (j)(8), (j)(9), and (j)(10)
that also reference the implementation specifications in Sec.
170.215(c). In this proposed rule these certification criteria are:
Sec. 170.315(g)(10), (g)(20), (g)(30), (g)(32), (g)(33), (g)(34), and
(g)(35). We note that Sec. 170.315(g)(20), (g)(30), (g)(32), (g)(33),
(g)(34), and (g)(35) are new Program certification criteria proposed in
this rule and the only currently finalized certification criterion in
the Program that includes a reference to Sec. 170.215(c) is Sec.
170.315(g)(10).
To reference the SMART Guide across these proposed new and revised
certification criteria, we propose to move the SMART Guide component
references (e.g., specific capabilities and sections) out of the
subparagraphs in Sec. 170.215(c), so that only entire SMART Guide
references are listed under Sec. 170.215(c). This will enable the
SMART Guides to be referenced across Program certification criteria,
whilst also enabling references to specific SMART Guide components
tailored to the requirements of a specific certification criterion. For
example, the proposed Sec. 170.315(j)(9) certification criterion as
proposed in the section titled ``New Certification Criteria for Modular
API Capabilities'' would reference Sec. 170.215(c) along with a list
of applicable SMART Guide components tailored specifically to describe
SMART Guide requirements for patient authorization for standalone apps.
We note that later versions of the SMART Guide may be finalized by
the time of our final rule. During the time between our proposed rule
and our final rule, the FHIR community may, for example, issue
technical corrections in a SMART v2.2.x Guide or release a
[[Page 63518]]
newer SMART v2.x Guide minor release. We intend to evaluate and
potentially adopt in the final rule the most recent available version
of the SMART Guide that aligns with the SMART v2.2 Guide changes
outlined in this proposed rule. We encourage interested parties to
monitor the SMART App Launch IG directory of published versions
(https://hl7.org/fhir/smart-app-launch/history.html) for all IG
iterations, technical corrections, and releases. We welcome comment on
this proposal.
3. User-Access Brands and Endpoints
In the ONC HTI-1 Final Rule, we finalized requirements in Sec.
170.404(b)(2) for Certified API Developers to publish certain service
base URLs and related organization (i.e., API Information Source)
details in a standardized FHIR[supreg] format (89 FR 1285 through
1290). Public comments received during the HTI-1 rulemaking process
indicated strong support for the ``continued development and
standardization of publication formats for FHIR `service base URLs' ''
(89 FR 1286). Many of these commenters suggested we adopt a FHIR
implementation guide, with a particular emphasis on the Patient-access
Brands (PAB) specification. We declined to adopt PAB or any other FHIR
implementation guides for Sec. 170.404(b)(2) at the time, and instead
finalized more generalized base FHIR requirements to best ensure
compatibility with the emerging industry FHIR implementation guides.
Given the particular interest in the PAB specification we noted in HTI-
1 that ``[w]e will consider the Patient-access Brands specification for
adoption in future rulemaking as it develops'' (89 FR 1288).
Currently, the PAB specification, now referred to as ``User-access
Brands and Endpoints,'' (and referred to as Brands herein) is set for
publication as a sub-specification in the SMART v2.2 Guide. The Brands
specification ``defines FHIR profiles for Endpoint, Organization and
Bundle resources that help users connect their apps to health data
providers.'' \30\ It provides guidelines for API providers to publish
Brands associated with their FHIR endpoints that apps can collect and
present to users. Each Brand can include information like organization
name, location, identifiers, patient portal details, FHIR API
Endpoints, and more. These Brands are assembled in FHIR ``Bundle''
format, and these Bundles can made available in two ways: by FHIR
servers including a link in their SMART ``.well-known/smart-
configuration'' \31\ metadata file, or through vendor-consolidated
Brand Bundles that are openly published.
---------------------------------------------------------------------------
\30\ https://hl7.org/fhir/smart-app-launch/STU2.2/brands.html.
\31\ https://hl7.org/fhir/smart-app-launch/STU2.2/brands.html#metadata-in-well-knownsmart-configuration.
---------------------------------------------------------------------------
We propose to update our current maintenance of certification (MoC)
requirements in Sec. 170.404(b)(2) that reference FHIR resources and
elements directly and adopt Brands in Sec. 170.404(b)(2)(iii) as a
replacement. Specifically, we propose to reorganize the regulation text
paragraphs in a way that places existing service base URL requirements
into Sec. 170.404(b)(2)(ii) that expire on December 31, 2027. We
propose in our updated Sec. 170.404(b)(2)(iii) to require that, by
January 1, 2028, service base URLs and related API Information Source
details, including each organization's name, location, and facility
identifier, must be published in an aggregate vendor-consolidated
``FHIR Bundle'' according to the Brands specification. Additionally, we
propose to move our existing publication terms and quarterly review and
update requirements, that we have currently finalized in Sec.
170.404(b)(2) and (b)(2)(iii)(B), to subparagraphs under Sec.
170.404(b)(2)(i) that apply broadly to other sub-paragraphs under Sec.
170.404(b)(2), including our new proposed Brands requirements in Sec.
170.404(b)(2)(iii). Finally, we propose that a health IT developer may
meet the proposed revised MoC requirements by satisfying the new
conformance requirements proposed in Sec. 170.404(b)(2)(i), (iii), and
(iv) in lieu of Sec. 170.404(b)(2)(i) and (ii) prior to December 31,
2027.
We believe that our proposed changes to Sec. 170.404(b)(2)
logically build on our existing MoC requirements in Sec. 170.404(b)(2)
because the Brands specification uses profiles of the same base FHIR
resources (i.e., ``Endpoint,'' ``Organization,'' and ``Bundle'') we
have finalized in Sec. 170.404(b)(2). Requiring the use of the more
standardized FHIR profiles in Brands that are designed specifically for
the endpoint publication use case reduces inconsistent and varied
implementations leading to increased interoperability. We also believe
that our proposed changes to Sec. 170.404(b)(2) align with much of the
public feedback we received during the HTI-1 rulemaking process where
the Brands precursor PAB specification was cited numerous times (89 FR
1286 through 1289). We welcome comment on this proposal to reference
Brands for publication of service base URLs and related organization
details in Sec. 170.404(b)(2).
Additionally, in our revised Sec. 170.404(b)(3) where we propose
new requirements for the publication of API discovery details for payer
network information, including service base URLs and API Information
source details, we propose to adopt Brands specification. Please see
section III.B.20.d for further details on proposed Sec. 170.404
updates.
We note that the Brands specification is a sub-specification in the
SMART v2.2 Guide and we anticipate that subsequent versions of Brands
will be included in subsequent versions of the SMART Guide. We also
note that our proposed January 1, 2028 date for the SMART v2.2 Guide to
be the minimum version in Sec. 170.215(c) (see section III.B.2 for our
proposal to adopt the SMART v.2.2 Guide in Sec. 170.215(c)) matches
the date that health IT developers subject to the requirements in Sec.
170.404(b)(2) must support Brands for publication of API discovery
details for patient access.
As we noted in section III.B.2, later versions of the SMART Guide
may be finalized by the time of our final rule. This includes changes
to the Brands specification, or potential corrections if identified,
and we intend to evaluate and potentially adopt in the final rule the
most recent available version of the SMART Guide if doing so would best
support interoperability and effective program implementation. We
encourage interested parties to monitor the SMART App Launch IG
directory of published versions (https://hl7.org/fhir/smart-app-launch/history.html) for all IG iterations, technical corrections, and
releases. We welcome comment on this proposal.
4. Standards for Encryption and Decryption of Electronic Health
Information
a. Background
In the 2015 Edition Final Rule, ONC adopted the October 8, 2014,
version of Annex A: Approved Security Functions for Federal Information
Processing Standards (FIPS) Publication 140-2. This October 8, 2014,
version was the most recent version published by the National Institute
of Standards and Technology (NIST) when the 2015 Edition Final Rule
published (80 FR 62707).
b. Proposal
Since finalizing the October 8, 2014, version of Annex A: Approved
Security Functions for FIPS Publication 140-2 standard in the 2015
Edition Final Rule,
[[Page 63519]]
encryption techniques and security best practices have continued to
advance, and NIST has published several updated versions of Annex A:
Approved Security Functions for FIPS Publication 140-2.\32\ The most
recent version of Annex A for FIPS Publication 140-2 is Draft, October
12, 2021. We propose to adopt the Draft, October 12, 2021, version of
Annex A for FIPS Publication 140-2 in Sec. 170.210(a)(3) and
incorporate it by reference as a subparagraph in Sec. 170.299. We also
propose that the adoption of the FIPS 140-2 October 8, 2014, version in
Sec. 170.210(a)(2) expire on January 1, 2026. We note that the FIPS
140-2 October 8, 2014, version was inadvertently removed from Sec.
170.299, therefore we propose to incorporate by reference the standard
in Sec. 170.299(m)(3). We welcome comment on these proposals.
---------------------------------------------------------------------------
\32\ See pages 4-6 of the October 12, 2021 version of Annex A
for a revision history of the standard. Available at: https://csrc.nist.gov/csrc/media/publications/fips/140/2/final/documents/fips1402annexa.pdf.
---------------------------------------------------------------------------
We note that revising Sec. 170.210(a) would implicate three
certification criteria that reference standards in Sec. 170.210(a):
Sec. 170.315(d)(7) End-user device encryption, which we
propose to revise and rename as ``Health IT encryption'' elsewhere in
this preamble;
Sec. 170.315(d)(9) Trusted connection; and
Sec. 170.315(d)(12) Encrypt authentication credentials,
which we propose to further revise and rename as ``Protect stored
authentication credentials'' elsewhere in this preamble.
Given the cross reference to Sec. 170.210(a)(2) in these
certification criteria, we propose to revise each certification
criterion in Sec. 170.315(d)(7), (d)(9), and (d)(12) to replace
``standard'' with ``at least one version of the standard'' and ``Sec.
170.210(a)(2)'' with ``Sec. 170.210(a)'' where appropriate in each
certification criterion. At revised Sec. 170.315(d)(7)(iv) we propose
to revise both ``standard'' and ``Sec. 170.210(a)(2)'' in this manner.
In Sec. 170.315(d)(9)(i) and (ii); and at revised Sec.
170.315(d)(12)(i)(A), we also propose to revise ``standard'' and
``Sec. 170.210(a)(2)'' in this manner. As noted, we describe our
remaining proposed revisions to Sec. 170.315(d)(7) and Sec.
170.315(d)(12) elsewhere in this preamble at III.B.11 and III.B.12 and
we invite readers to review those sections.
Additionally, we propose to remove the standard found in Sec.
170.210(f) that is no longer referenced in any active certification
criteria. We welcome comments on our proposals.
Finally, we solicit comment on the transition to the next FIPS
standard, FIPS 140-3, that is currently underway.\33\ We are monitoring
development in this area, and we welcome comment on FIPS 140-3 and any
potential impacts to our Program requirements. We note that Annex A for
FIPS 140-2 is compatible with current FIPS 140-3 guidance as an
``Approved Security Function,'' and we intend to re-evaluate the latest
FIPS 140-3 guidance at the time of the final rule to ensure continued
capability with FIPS 140-3.\34\ We recognize the potential for changes
in FIPS 140-2 and 140-3 by the time of our final rule. Therefore, we
intend to consider and potentially finalize the most recent Approved
Security Functions that align with current FIPS guidance at the time
and that are compatible with the Annex A for FIPS 140-2 update we are
proposing in this proposed rule. We welcome comment on this proposal.
---------------------------------------------------------------------------
\33\ See FIPS 140-3 Transition Effort page--https://csrc.nist.gov/projects/fips-140-3-transition-effort.
\34\ The ``10. Approved Security Functions'' requirements in
FIPS 140-3 (March 22, 2019 version) state that ``Approved security
functions include those that are . . . adopted in a FIPS and
specified either in an appendix to the FIPS or in a document
referenced by the FIPS.'' The October 12, 2021 draft version of
Annex A for FIPS 140-2 meets that criterion to contain ``Approved
Security Functions'' according to FIPS 140-3. See https://csrc.nist.gov/pubs/fips/140-3/final.
---------------------------------------------------------------------------
5. Minimum Standards Code Sets Updates
We established a policy in the 2015 Edition Final Rule for minimum
standards code sets that update frequently (80 FR 62612). In the final
rule entitled ``Health Information Technology: Standards,
Implementation Specifications, and Certification Criteria for
Electronic Health Record Technology, 2014 Edition; Revisions to the
Permanent Certification Program for Health Information Technology'' (77
FR 54163) we discussed the benefits of adopting newer versions of
minimum standards code sets, including the improved interoperability
and implementation of health IT with minimal additional burden (77 FR
54170). As we stated in the HTI-1 Final Rule, when determining whether
to propose newer versions of minimum standards code sets, we consider
the impact on interoperability and whether a newer version would
require substantive effort for developers of certified health IT to
implement (89 FR 1224). If adopted, newer versions of minimum standards
code sets would serve as the baseline for certification and developers
of certified health IT would be able to use newer versions of these
adopted standards on a voluntary basis. We reiterate that while minimum
standard code sets update frequently, perhaps several times in a single
year, these updates are confined to concepts within the code system,
not substantive changes to the standards themselves.
For certification to a criterion in Sec. 170.315 that references
the standard adopted in Sec. 170.207, we propose that a Health IT
Module must use at least one of the versions of the standard that is
(1) adopted in Sec. 170.207 or approved by SVAP at the time the Health
IT Module seeks certification and (2) not expired at the time of use.
We also propose that when a Health IT Module certified to a criterion
in Sec. 170.315 that references the standard adopted in Sec. 170.207
is using a version with an upcoming expiration date or is using an
interim version approved by SVAP, the health IT developer must update
the Module to either a new version of the standard adopted in Sec.
170.207, or a subsequent version approved by SVAP, prior to the
expiration date or dates defined in order to maintain certification of
that Health IT Module as described in Sec. 170.207. In addition, the
health IT developer must provide the updated Health IT Module to their
customers by the expiration date or dates defined in Sec. 170.207 in
order to maintain certification of that Health IT Module as described
in Sec. 170.315.
Sec. 170.207(a)--Problems
We propose to revise Sec. 170.207(a)(2), which is currently
reserved, to reference SNOMED CT[supreg], U.S. Edition, September 2023
Release and incorporate it by reference in Sec. 170.299. We also
propose that the adoption of the standard in Sec. 170.207(a)(1),
SNOMED CT, U.S. Edition, March 2022 Release, would expire on January 1,
2028, and that the adoption of the standard in Sec. 170.207(a)(4),
IHTSDO SNOMED CT, U.S. Edition, September 2015 Release, would expire on
January 1, 2026.
Sec. 170.207(c)--Laboratory tests
We propose to revise Sec. 170.207(c)(2) to reference Logical
Observation Identifiers Names and Codes (LOINC[supreg]) Database
version 2.76, a universal code system for identifying laboratory and
clinical observations produced by the Regenstrief Institute, Inc. and
incorporate it by reference in Sec. 170.299. We also propose that the
adoption of the standard in Sec. 170.207(c)(1), LOINC Database Version
2.72, would expire on January 1, 2028, and that the adoption of the
standard in Sec. 170.207(c)(3), LOINC Database version 2.52, would
expire on January 1, 2026.
Sec. 170.207(d)--Medications
We propose to revise the citations in Sec. 170.207(d) to improve
organization of
[[Page 63520]]
this section. Specifically, we propose to revise Sec. 170.207(d)(1) to
list standards for clinical drugs and to reference multiple releases of
RxNorm, a standardized nomenclature for clinical drugs produced by the
United States National Library of Medicine. We propose in Sec.
170.207(d)(1)(ii) to reference RxNorm, December 4, 2023 Full Monthly
Release and incorporate it by reference in Sec. 170.299. We propose to
move the standard adopted in Sec. 170.207(d)(1), RxNorm, July 5, 2022
Release, to Sec. 170.207(d)(1)(i), and that the adoption of this
standard would expire on January 1, 2028. We propose to move the
standard adopted in Sec. 170.207(d)(3), RxNorm, September 8, 2015
Release, to Sec. 170.207(d)(1)(iii) and that the adoption of this
standard would expire on January 1, 2026. Finally, we propose to move
National Drug Codes, currently included via cross-reference in Sec.
170.207(d)(4), to Sec. 170.207(d)(2). We note that Sec. 170.207(d)(2)
is currently reserved. We also propose to reserve Sec. 170.207(d)(3)
and remove Sec. 170.207(d)(4).
Sec. 170.207(e)--Immunizations
We propose to reference in Sec. 170.207(e)(5) the CDC National
Center of Immunization and Respiratory Diseases (NCIRD) Code Set
(CVX)--Vaccines Administered, updates through September 29, 2023, and
incorporate it by reference in Sec. 170.299. We also propose to
reference in Sec. 170.207(e)(6) the National Drug Code (NDC)--Vaccine
NDC Linker, updates through November 6, 2023, and incorporate it by
reference in Sec. 170.299. We propose that adoption of the standards
in Sec. 170.207(e)(1), the HL7[supreg] Standard Code Set CVX--Vaccines
Administered, dated through June 15, 2022, and Sec. 170.207 (e)(2),
NDC--Vaccine NDC Linker, dated July 19, 2022, would expire on January
1, 2028. We also propose that adoption of the standards in Sec.
170.207(e)(3), HL7 Standard Code Set CVX--Vaccines Administered,
updates through August 17, 2015, and Sec. 170.207(e)(4), NDC--Vaccine
NDC Linker, updates through August 17, 2015, would expire on January 1,
2026.
Sec. 170.207(f)--Race and Ethnicity
We propose to revise Sec. 170.207(f)(1) to include recent updates
to the U.S. Office of Management and Budget's Statistical Policy
Directive No. 15: Standards for Maintaining, Collecting, and Presenting
Federal Data on Race and Ethnicity (SPD 15). In Sec. 170.207(f)(1)(i)
we propose to include The Office of Management and Budget Standards for
Maintaining, Collecting, and Presenting Federal Data on Race and
Ethnicity, Statistical Policy Directive No. 15, as revised, October 30,
1997 with an expiration date of January 1, 2026 for adoption of that
standard. In Sec. 170.207(f)(1)(ii) we propose to include the U.S.
Office of Management and Budget's Statistical Policy Directive No. 15:
Standards for Maintaining, Collecting, and Presenting Federal Data on
Race and Ethnicity (SPD 15), as revised, March 29, 2024.
We propose to revise Sec. 170.207(f)(2) to include CDC Race and
Ethnicity Code Set standards. In Sec. 170.207(f)(2)(i) we propose to
include CDC Race and Ethnicity Code Set Version 1.0 (March 2000) with
an expiration of January 1, 2026, for adoption of that standard. In
Sec. 170.207(f)(2)(ii) we propose to include CDC Race and Ethnicity
Code Set Version 1.2 (July 08, 2021) and incorporate it by reference in
Sec. 170.299. We propose to remove and reserve Sec. 170.207(f)(3).
Sec. 170.207(m)--Numerical references
We propose that adoption of the standard in Sec. 170.207(m)(1),
The Unified Code of Units of Measure, Revision 1.9, would expire on
January 1, 2026.
Sec. 170.207(n)--Sex
We propose that adoption of the standard in Sec. 170.207(n)(1),
HL7 Version 3 Standard, Value Sets for AdministrativeGender and
NullFlavor, would expire on January 1, 2026. We propose to revise Sec.
170.207(n)(2) to reference use of at least one of the versions of
SNOMED CT U.S. Edition specified in Sec. 170.207(a). We also propose
to revise Sec. 170.207(n)(3) to reference use of at least one of the
versions of LOINC specified in Sec. 170.207(c).
Sec. 170.207(o)--Sexual orientation and gender information
We propose to revise Sec. 170.207(o)(1)-(3) to reference use of at
least one of the versions of SNOMED CT U.S. Edition specified in Sec.
170.207(a) instead of Sec. 170.207(a)(4). We also propose to revise
Sec. 170.207(o)(4) to reference use of at least one of the versions of
LOINC specified in Sec. 170.207(c).
Sec. 170.207(p)--Social, psychological, and behavioral data
We propose to revise Sec. 170.207(p)(1) through (8) to reference
use of at least one of the versions of LOINC specified in Sec.
170.207(c).
We propose to revise Sec. 170.207(p)(4), (5), (6), (7), and (8) to
reference use of at least one of the versions of the standard specified
in Sec. 170.207(m).
Sec. 170.207(r)--Provider type
We propose that adoption of the standard in Sec. 170.207(r)(1)
would expire on January 1, 2026.
Sec. 170.207(s)--Patient insurance
We propose that adoption of the standard in Sec. 170.207(s)(1),
Public Health Data Standards Consortium Source of Payment Typology Code
Set Version 5.0 (October 2011), would expire on January 1, 2026.
In addition to updating the minimum standards code sets listed
above, we propose to update the certification criteria that reference
those minimum standards. These certification criteria include
Sec. Sec. 170.315(a)(12), 170.315(b)(1)(iii)(B)(2) and (G)(3),
170.315(c)(4)(iii)(C), (E), (G), (H), and (I), 170.315(f)(1)(i)(B)-(C),
170.315(f)(3)(ii) and (f)(4)(ii).
6. New Imaging Requirements for Health IT Modules
Diagnostic images are critical to supporting care in a variety of
healthcare settings. Clinicians routinely use diagnostic images to
support patient care and patients can better facilitate and coordinate
care when they have access to their own images. Diagnostic images are
often stored in systems external to an EHR, such as picture archiving
and communication systems (PACS), vendor neutral archives (VNA), or
other imaging platforms. While radiologists, ophthalmologists,
dermatologists, pathologists, and other imaging specialists generally
have direct access to full diagnostic quality images on these systems,
access to both diagnostic quality and lesser quality images for
referring providers can be inconsistent, depending on how broadly the
hospitals or provider practice deploys access to their imaging
infrastructure.
While certain images may be exchanged electronically in an
automated manner, patients are often provided their diagnostic quality
images on physical media (e.g., compact disc read-only memory (CD-ROM))
to physically transport to their next clinical visit. Some PACS and VNA
systems provide access to images through a web-based viewer, but those
web-based viewers are often not accessible outside of the hospital or
practice's immediate network.
In the Health Information Technology: Standards, Implementation
Specifications, and Certification Criteria for Electronic Health Record
Technology, 2014 Edition; Revisions to the Permanent Certification
Program for Health Information Technology (2014 Edition Final Rule),
ONC adopted an ``Image Results'' certification criterion to
[[Page 63521]]
support the CMS EHR Incentive Program requirement, also known as the
Meaningful Use or ``MU Stage 2 Objective'' requirement, that required
eligible clinicians, eligible hospitals, and critical access hospitals
to have access to imaging results and information through Certified EHR
Technology (77 FR 54172).\35\ The certification criterion required a
Health IT Module to indicate the availability of a patient's images and
narrative interpretations and enable access to those images and
narrative interpretations. ONC stated that the requirements of this
certification criterion could be met via the capability to directly
link to images stored in the EHR system or providing a context-
sensitive link to an external application which provides access to
images and their associated narrative. We also stated in the 2014
Edition Final Rule that the use of the Digital Imaging and
Communications in Medicine (DICOM) standard (or any other imaging
standards) was unnecessary to meet the functional requirement expressed
in the imaging results certification criterion (77 FR 54173). Instead,
we reiterated our understanding stated in the 2014 Edition Proposed
Rule that the adoption of standards was unnecessary to enable users to
electronically access images and their narrative interpretations, as
required by this certification criterion (77 FR 13838).
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\35\ For more discussion regarding ONC's support of the CMS EHR
Incentive Program, Stage 2 Meaningful Use, please see: https://www.cms.gov/newsroom/fact-sheets/cms-proposes-definition-stage-2-meaningful-use-certified-electronic-health-records-ehr-technology.
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In the 2015 Edition Proposed Rule, ONC proposed to maintain the
``Imaging Results'' certification criterion (80 FR 16822) and while
some commenters supported this proposal, ONC ultimately removed the
``Imaging Results'' certification criterion in the 2015 Edition Final
Rule because the associated CMS EHR Incentive Programs objective (now
referred to as Promoting Interoperability objectives) was removed and
no longer required technological support (80 FR 62683). Instead, we
finalized a certification criterion related to imaging in Sec.
170.315(a)(3) ``Computerized provider order entry--diagnostic
imaging,'' which is currently available for certification in the
Program and requires that a Health IT Module enable a user to record,
change, and access diagnostic imaging orders.
We acknowledge there are certain use cases and circumstances where
image access via physical media may be more appropriate than network
access (e.g., locations without adequate network capabilities).
However, we believe the prevalence of CD-ROMs and other physical media
to share diagnostic quality images across healthcare settings indicates
a lack of interoperability and access to imaging results that
represents a continued burden for patients and clinicians. The
widespread use of CD-ROMs and other physical media to share diagnostic
quality images persists despite the adoption of PACS and VNA systems,
the implementation of web-based viewers for diagnostic imaging, and the
emergence of electronic standards and profiles meant to facilitate
medical image access and exchange. For instance, the DICOM standard
establishes a service-based process for web-based medical imaging,
DICOMwebTM. The Integrating the Healthcare Enterprise (IHE)
XCPD, XCA, and XCA-I profiles support electronic transactions that can
be used to facilitate medical imaging access. While these standards and
others currently exist, there is not yet a clear consensus or full
adoption of these pathways in health IT.
ONC believes that promoting access to and the exchange of images
via Program requirements may encourage more widespread adoption and
integration of these already existing pathways and reduce burdens
caused by physical media exchange. Therefore, we propose to revise
three certification criteria by adding new provisions to include
support of a link to diagnostic imaging: ``transitions of care'' in
Sec. 170.315(b)(1); ``application access--all data request'' in Sec.
170.315(g)(9); and ``standardized API for patient and population
services'' in Sec. 170.315(g)(10). We describe in subsequent
paragraphs the criterion-specific details of the proposals to require
support for imaging links in the Program. We believe that support for
imaging links in these certification criteria will promote the
availability of electronic image access for patients and providers. To
enable a consistent understanding of ``imaging link'' across
certification criteria requirements in the Program, we propose to
define ``imaging link'' in Sec. 170.102 to be ``technical details
which enable the electronic viewing or retrieval of one or more images
over a network.'' The proposed definition of ``imaging link'' is
intended to be sufficiently broad to include the technical details used
by the protocols and technologies implemented by industry to view and
retrieve images. We also note that there is no specific standard
associated with the support of this link, and that the functionality of
this requirement can be met with a context-sensitive link to an
external application which provides access to images and their
associated narrative. The DICOMweb standard (e.g., DICOM PS3.18 2023d--
Web Services) \36\ is likely to be among the standards widely used by
hospitals and providers to support imaging links, but the Health IT
Module certified to these certification criteria is not required to
support a specific standard. We also clarify that although this
proposal does not include specific security standards, we expect the
appropriate authentication and authorization processes to be supported
to prevent unauthorized access via the imaging links required in this
proposal. For example, health IT developers may consider SMART Health
Links as one possible standard by which to generate secure links to
patient images.
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\36\ https://dicom.nema.org/medical/dicom/2023d/ 2023d/.
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We propose to revise the Sec. 170.315(b)(1) ``Transitions of
care'' certification criterion to support imaging links by adding
imaging links to the data required to be supported in the ``Create''
functionality in Sec. 170.315(b)(1)(iii) by adding a new paragraph in
Sec. 170.315(b)(1)(iii)(H). The ``Create'' functionality in Sec.
170.315(b)(1)(iii) specifies the requirement to enable a user to create
a transition of care/referral summary formatted in accordance with the
standard specified in Sec. 170.205(a)(3), (4), and (5) using the
Continuity of Care Document, Referral Note, and (inpatient setting
only) Discharge Summary document templates including at a minimum the
data described under Sec. 170.315(b)(1)(iii)(A)--(G). We propose
specifically to add a paragraph in Sec. 170.315(b)(1)(iii)(H) to
indicate on and after January 1, 2028 imaging links are a part of the
minimum ``Create'' requirements in Sec. 170.315(b)(1)(iii).
We propose to revise the Sec. 170.315(g)(9) ``Application access--
all data request'' certification criterion to support imaging links by
adding imaging links to the data required to be supported in responses
to requests for patient data in a summary record formatted according to
the data response requirements at paragraphs in Sec.
170.315(g)(9)(i)(A)(1) and (2). Specifically, we propose to add a
paragraph Sec. 170.315(g)(9)(i)(A)(3)(v) that indicates on and after
January 1, 2028 imaging links are required to be supported as part of
the data response requirements in Sec. 170.315(g)(9)(i)(A)(1) and (2).
We also propose to revise the data response requirements in paragraphs
Sec. 170.315(g)(9)(i)(A)(1) and (2) to reference the data requirements
proposed in Sec. 170.315(g)(9)(i)(A)(3)(v).
[[Page 63522]]
We propose to revise the Sec. 170.315(g)(10) ``Standardized API
for patient and population services'' certification criterion to
support imaging links by adding imaging links to the data required to
be supported for data response for patients and users and for data
response for systems. Specifically, we propose to add imaging links as
data required to be supported on and after January 1, 2028 in data
response for patients and users consistent with FHIR and US Core
requirements at the paragraph proposed in Sec.
170.315(g)(10)(ii)(B)(1). Additionally, we propose to add imaging links
as data required to be supported on and after January 1, 2028 in data
response for systems consistent with FHIR and US Core requirements
proposed in Sec. 170.315(g)(10)(iii)(B)(1), and the Bulk FHIR API data
response for systems in accordance with FHIR, US Core, and Bulk Data
Access, including the ``_type'' query parameter, requirements proposed
in Sec. 170.315(g)(10)(iii)(B)(2) and Sec.
170.315(g)(10)(iii)(B)(2)(ii).
We also propose to revise the ``view, download, and transmit to 3rd
party'' certification criterion in Sec. 170.315(e)(1) to add
functional support for viewing and download of diagnostic quality and
lower quality images as well as inclusion of an imaging link to those
diagnostic images in either a downloaded or transmitted Continuity of
Care Document (CCD). We propose that Health IT Modules support this
functionality on and after January 1, 2028. Specifically, we propose to
add both diagnostic quality images and reduced quality images to the
data that must be supported for viewing by patients (and their
authorized representatives) according to paragraph (e)(1)(i)(A) by
including support for diagnostic quality images and reduced quality
images at the proposed paragraph (e)(1)(i)(A)(8). Furthermore, we
propose to include imaging links in the requirements in Sec.
170.315(e)(1)(i)(B)(2)(i) and (ii) specifying the data required to be
included at a minimum in ambulatory summaries and inpatient summaries
respectively be downloadable in accordance with the requirements
specified at paragraph (e)(1)(i)(B)(2), which details the download
requirements for ambulatory summaries and inpatient summaries
downloaded according to the standard specified in Sec. 170.205(a)(4)
through (6) following the CCD document template. Finally, we propose
that patients (and their authorized representatives) must be able to
use technology to download both diagnostic quality and reduced quality
images at the proposed Sec. 170.315(e)(1)(i)(B)(4). Like broad
requirements proposed in Sec. 170.315(e)(1)(i)(A)(8), we propose that
Health IT Modules certified to Sec. 170.315(e)(1) support these
specific scenarios on and after January 1, 2028. Again, there is no
standard specified for either the images or the imaging links in the
proposed requirements, though we anticipate that DICOM and the DICOMweb
standard (such a--DICOM PS3.18 2023d--Web Services) are likely to be
among standards widely used by hospitals and providers to support
images and imaging links respectively.
We believe it is important to support the ability to view and
download both diagnostic and lower quality images. While it is critical
for patients to have access to diagnostic imaging, lower quality images
are also important and, for example, a patient may decide that it is
useful to have the lower quality images for quick reference. This
revised certification criterion requires that both types of imaging be
supported for viewing and for direct downloading by patients.
The view and download requirements of this certification criterion
could be met via the capability to directly link to images stored in
the Health IT Module or providing a context-sensitive connection to an
external application which provides access to images and their
associated narrative. In either case, however, the view and download
functionalities must be accessible to the patient through the same
internet-based technology as the other functionalities of Sec.
170.315(e)(1). Electronic exchange of the image itself does not need to
be included as part of the Sec. 170.315(e)(1)(C) ``Transmit to third
party'' functionality. However, similar to the proposals for the other
certification criteria discussed above, an imaging link to the images
accessible to the patient must be provided.
We propose that on and after January 1, 2028, a Health IT Module
seeking certification to any of the certification criteria in Sec.
170.315(b)(1), (e)(1), (g)(9), and (10), must meet the proposed
requirements for imaging links. We note that health IT developers are
also required to meet the Assurances Condition of Certification
maintenance requirement in Sec. 170.402(b)(3) that any health IT
developer with a Health IT Module certified to these certification
criteria would need to update their Health IT Modules and provide the
updated version to their customers, including the most recently adopted
capabilities and standards included in the revised certification
criteria order to maintain certification of that Health IT Module. We
welcome comments on these proposals.
7. Revised Clinical Information Reconciliation and Incorporation
Criterion
We propose to revise the ``Clinical information reconciliation and
incorporation'' (CIRI) certification criterion in Sec. 170.315(b)(2).
These proposed revisions are intended to expand our existing CIRI
certification requirements to additional data elements and promote new
capabilities that would benefit providers by reducing the burden of
reconciliation and incorporation in clinical workflows.
Our requirements for CIRI in the Program were first established in
the ``Health Information Technology: Initial Set of Standards,
Implementation Specifications, and Certification Criteria for
Electronic Health Record Technology'' Jan. 13, 2010, interim final rule
to enable a user to electronically compare two or more medication lists
(75 FR 2014). We subsequently expanded these requirements in the 2014
Edition Final Rule to require clinical information reconciliation and
incorporation for three data types: problems, medications, and
medication allergies (77 FR 54222). We noted in the 2010 interim final
rule that there was, ``. . . great promise in making this
[reconciliation] capability more comprehensive'' and that we
``anticipate exploring ways to improve the [reconciliation] utility of
this capability. . .'' (75 FR 44613). In the 2014 Edition Final Rule we
also noted our agreement with public comments that said providers
``should have some control over how exactly they want to be able to
incorporate data into their EHR technology as part of their practice/
organization'' (77 FR 54219).
Building on our CIRI strategy and in response to public feedback,
we propose to revise Sec. 170.315(b)(2) to require Health IT Modules
to support reconciliation and incorporation of all USCDI data elements.
In the context of the CIRI workflow in Sec. 170.315(b)(2), we propose
that upon receipt of a transition of care/referral summary all USCDI
data elements must be supported, at a minimum, for reconciliation and
incorporation by a user in Sec. 170.315(b)(2)(v). We also propose in
Sec. 170.315(b)(2)(vi) user configuration functionality to enable a
user to set individual or organizational rules that allow automatic
reconciliation and incorporation for each data class included in at
least one of the versions of the USCDI standard in Sec. 170.213,
including functionality that allows the
[[Page 63523]]
user to select trusted data and trusted data sources for automatic
reconciliation and incorporation. Finally, as part of our proposed
revision to the CIRI certification criterion in Sec. 170.315(b)(2), we
propose system verification functionality in Sec. 170.315(b)(2)(vii)
that requires Health IT Modules to be able to create a file formatted
according to the Continuity of Care Document template.
We propose to implement this by requiring Health IT Modules
certified to Sec. 170.315(b)(2) to meet the requirements inSec.
170.315(b)(2)(i), (ii), (iii), and (vii), or the requirements in (iv),
(v), (vi) and (vii) for the time period up to and including December
31, 2027. On and after January 1, 2028, we propose that Health IT
Modules certified to Sec. 170.315(b)(2) must meet the requirements in
Sec. 170.315(b)(2)(iv), (v), (vi), and (vii).
Our proposed revised CIRI requirements in Sec. 170.315(b)(2)(iv),
(v), and (vi) include reorganizing and generalizing the CIRI workflow
requirements currently in the certification criterion in Sec.
170.315(b)(2)(i), (ii), and (iii). Specifically, we have generalized
and combined requirements currently in Sec. 170.315(b)(2)(i) and (ii)
in proposed Sec. 170.315(b)(iv) and we have replicated requirements
currently in Sec. 170.315(b)(2)(iii) in proposed Sec. 170.315(b)(v)
under ``user reconciliation,'' with the aforementioned proposal to
reference all data classes and data elements in the USCDI standard in
Sec. 170.213 instead of the currently referenced ``medications,''
``allergies and intolerance,'' and ``problems'' data elements.
Additionally, we propose to move our system verification requirements
currently finalized in Sec. 170.315(b)(2)(iv) into Sec.
170.315(b)(2)(vii) and we propose, for clarity, to break these system
verification requirements up into sub-paragraphs under Sec.
170.315(b)(2)(vii).
Given the goal of USCDI to support ``data elements for nationwide,
interoperable health information exchange,'' \37\ we believe this
proposal supports interoperability and continues to advance our policy
objectives for widespread electronic health information exchange.
Additionally, we believe that these requirements would help equip
providers with additional, relevant, and sometimes critical clinical
information that can improve overall patient care. We envision that the
ability to reconcile and incorporate both structured and unstructured
data elements of the USCDI would be a welcomed functionality to improve
patient care, note bloat,\38\ and clinician burden.
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\37\ https://www.healthit.gov/isa/united-states-core-data-interoperability-uscdi.
\38\ Rule A, Bedrick S, Chiang MF, Hribar MR. Length and
Redundancy of Outpatient Progress Notes Across a Decade at an
Academic Medical Center. JAMA Netw Open. 2021;4(7): e2115334.
doi:10.1001/jamanetworkopen.2021.15334.
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We note that there can be multiple approaches for supporting user
reconciliation and we have stated previously, ``in the event that data
is in unstructured form, any method implemented by which the EHR is
capable of assisting in reconciliation is acceptable'' (77 FR 54224).
We believe that developers have technology readily available for
assisting users in reconciling and incorporating data and we maintain
that this approach would continue support for innovation.
Alternative Proposal to Revised CIRI Criterion in Sec. 170.315(b)(2)
As an alternative proposal, narrower in scope and on which we seek
public comment, we are also considering whether to limit the expansion
of our incorporation and reconciliation requirements, that must be met
on and after January 1, 2028, to just nine specific USCDI data classes
(six new data classes plus the existing three Allergies and
intolerance, Medications, and Problems data classes).
The limited data classes in USCDI v4 we have identified for this
alternative proposal are: Allergies and Intolerances, Care Team
Members, Goals and Preferences, Immunizations, Laboratory, Medications,
Medical Devices, Patient Summary and Plan, and Problems. Across these
nine data classes, the USCDI v4 includes the following:
The data elements in the Allergies and Intolerances data
class include Substance (Medication), Substance (Drug Class), Substance
(Non-Medication) and Reaction.
The data elements in the Care Team Member(s) data class
include Care Team Member Name, Care Team Member Identifier, Care Team
Member Role, Care Team Member Location, and Care Team Member Telecom.
The data elements in the Goals and Preferences data class
include Patient Goals, SDOH Goals, Treatment Intervention Preference,
and Care Experience Preference.
The one data element in the Immunizations data class is
Immunizations.
The data elements in the Laboratory data class include
Tests, Values/Results, Specimen Type, Result Status, Result Unit of
Measure, Result Reference Range, Result Interpretation, Specimen Source
Site, Specimen Identifier, and Specimen Condition Acceptability.
The data elements in Medications include Medications,
Dose, Dose Unit of Measure, Indication, Fill Status, Medications
Instructions, and Medication Adherence.
The data element in the Medical Devices data class is
Unique Device Identifier--Implantable.
The data element in the Patient Summary and Plan data
class is Assessment and Plan of Treatment.
The data elements in Problems include Problems, SDOH
Problems/Health Concerns, Date of Diagnosis, and Date of Resolution.
We selected these data classes based on feedback from industry and
existing industry support as well as our understanding of importance
for improved patient care. We believe that the standards referenced for
these data elements are mature enough or the information they relay are
important enough to patient care to warrant inclusion as part of the
CIRI workflow as part of this alternative proposal for a more moderate
expansion.
We welcome comment on expanding our CIRI certification requirements
to only a limited set of a USCDI data classes versus referencing all
USCDI. Additionally, if a limited set of different data elements within
the USCDI is preferred, we welcome comments on what subset of USCDI
data classes and elements should be referenced in the certification
criterion as most necessary for reconciliation and better patient care.
Automatic Reconciliation and Incorporation Capabilities in Revised CIRI
Criterion in Sec. 170.315(b)(2)
In addition to our proposed updated CIRI requirements that support
all USCDI, we also propose in Sec. 170.315(b)(2)(vi) new functional
requirements to enable user-driven automatic reconciliation and
incorporation for Health IT Modules certified to Sec. 170.315(b)(2).
We believe that users and health care providers are best situated to
determine which clinical data and data sources require manual review
and which are better suited to automatic reconciliation and
incorporation. To ensure that Health IT Modules certified to Sec.
170.315(b)(2) have the capability to support user-driven automatic
reconciliation and incorporation, we propose in Sec.
170.315(b)(2)(vi), that Health IT Modules certified to Sec.
170.315(b)(2) would need to provide functionality that would allow
automatic reconciliation and incorporation, without manual review, for
each of the
[[Page 63524]]
applicable USCDI data elements. We note that nothing in this proposal
would compel automatic reconciliation and incorporation for specific
workflows or use cases. Rather, our intention is to empower users in
determining the circumstances under which clinical data can be
automatically reconciled and incorporated, we also propose new
configuration requirements in Sec. 170.315(b)(2)(vi) to enable users
to set rules indicating specific data and/or specific data sources for
automatic reconciliation and incorporation.
We note that automatic incorporation means any process by which
USCDI data elements contained within C-CDAs are automatically
reconciled with information within certified health IT and incorporated
in the health IT without an action by a clinician end user or their
delegate. These processes include (1) reconciling new information from
the C-CDA into the Health IT Module, for instance, by comparison of
medication information in the Health IT Module and information in the
C-CDA; or (2) determining that no new information needs to be
incorporated into the Health IT Module. We welcome comment on this
proposal.
We believe that these revisions would provide users with the
ability to configure their workflows in such a way as to maximize
patient care while minimizing provider effort to perform reconciliation
and incorporation. As we have stated in a previous rule when expanding
CIRI requirements, ``we believe that EHR technology can be designed to
assist users in remarkable ways and that reconciling information from
multiple sources in a way that is assistive to a user is something at
which EHR technology should excel'' (77 FR 13849). We believe this
proposal is aligned with similar functionalities that many developers
are already developing. Our goal is to advance baseline functionality
while also leaving room for innovation. We propose that Health IT
Modules must support the proposed automatic reconciliation and
incorporation capabilities on and after January 1, 2028. We welcome
comment on this proposed functionality.
8. Revised Electronic Prescribing Certification Criterion
We propose to update the ``electronic prescribing'' certification
criterion in Sec. 170.315(b)(3). The proposed updates include updating
the core standard for electronic prescribing to NCPDP SCRIPT standard
version 2023011,\39\ which is cross-referenced in Sec. 170.205(b)(2)
in the proposed text in Sec. 170.315(b)(3)(ii)(A). We also propose
revisions to the transactions within the SCRIPT standard that would be
required for the updated certification criterion and propose to remove
a number of transactions that are currently identified as optional for
the criterion. Finally, we propose to remove Sec. 170.315(b)(3)(i)
from the CFR upon the effective date of this rule and reserve it as
this version of the certification criterion is no longer valid for use
in the Program.
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\39\ See https://standards.ncpdp.org/Access-to-Standards.aspx.
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a. Electronic Prescribing Standard
In the ``Medicare Program; Medicare Prescription Drug Benefit
Program; Health Information Technology Standards and Implementation
Specifications'' final rule (Part D and Health IT Standards Final
Rule), which appeared in the Federal Register on June 17, 2024 (89 FR
51238 through 51265), we adopted NCPDP SCRIPT standard version 2023011
in Sec. 170.205(b)(2). We also finalized an expiration date for NCPDP
SCRIPT standard version 2017071 of January 1, 2028, in Sec.
170.205(b)(1), which reflected a delay of one year from the expiration
date we had proposed (88 FR 78501). We also finalized the removal of
the NCPDP SCRIPT standard version 10.6, which was located in Sec.
170.205(b)(2) (89 FR 51258 and 51259). The finalization of these
policies in the Part D and Health IT Standards Final Rule, and CMS'
finalization of cross references to Sec. 170.205(b) in their
requirements for the Part D Program, reflects a unified approach to
aligning standards adoption across HHS programs that impact a common
set of participants (88 FR 78486 through 78494).
We note that we previously proposed to adopt NCPDP SCRIPT standard
version 2022011 and made other proposals in the ``Medicare Program;
Contract Year 2024 Policy and Technical Changes to the Medicare
Advantage Program, Medicare Prescription Drug Benefit Program, Medicare
Cost Plan Program, Medicare Parts A, B, C, and D Overpayment Provisions
of the Affordable Care Act and Programs of All-Inclusive Care for the
Elderly; Health Information Technology Standards and Implementation
Specifications'' proposed rule (2024 Part C/D Proposed Rule), which
appeared in the Federal Register on December 27, 2022 (87 FR 79555).
However, we subsequently withdrew these proposals in the ``Medicare
Program; Contract Year 2025 Policy and Technical Changes to the
Medicare Advantage Program, Medicare Prescription Drug Benefit Program,
Medicare Cost Plan Program, and Programs of All-Inclusive Care for the
Elderly; Health Information Technology Standards and Implementation
Specifications'' proposed rule (2025 Part C/D Proposed Rule), which
appeared in the Federal Register on November 15, 2023 (88 FR 78476),
and instead proposed to adopt the NCPDP SCRIPT standard version 2023011
in Sec. 170.205(b)(2) (88 FR 78501 through 78502).
In this proposed rule, we propose in Sec. 170.315(b)(3)(ii)(A)
that for the time period up to and including December 31, 2027, a
Health IT Module certified to the ``electronic prescribing''
certification criterion at 45 CFR 170.315(b)(3) must enable a user to
perform the following prescription-related electronic transactions in
accordance with the standard specified in Sec. 170.205(b)(1) (NCPDP
SCRIPT standard version 2017071) or Sec. 170.205(b)(2) (NCPDP SCRIPT
standard version 2023011). We also propose that on and after January 1,
2028, a Health IT Module certified to the ``electronic prescribing''
certification criterion must enable a user to perform the following
prescription-related electronic transactions in accordance with only
the standard specified in Sec. 170.205(b)(2) (NCPDP SCRIPT standard
version 2023011). This means that a health IT developer may continue to
maintain health IT certification conformance to NCPDP SCRIPT standard
version 2017071 (in Sec. 170.205(b)(1)) for the time period up to and
including December 31, 2027. On and after January 1, 2028, consistent
with our policy in Sec. 170.402(b), developers of certified health IT
with Health IT Modules certified to the ``electronic prescribing''
certification criterion will need update those Health IT Modules to the
standard in Sec. 170.205(b)(2) and provide them to customers. This is
consistent with the date of January 1, 2028, that we finalized for the
expiration of NCPDP SCRIPT standard version 2017071 in Sec.
170.205(b)(1) in the Part D and Health IT Standards Final Rule (89 FR
51259). We also propose in Sec. 170.315(b)(3)(ii)(A) that the Health
IT Module must use RxNorm (which we have adopted in Sec.
170.207(d)(1)), and, if using NCPDP SCRIPT standard version 2023011,
National Drug Codes (which we cross reference in Sec. 170.207(d)(2)).
b. Proposed Transactions
We propose the following updates and changes to the transactions
identified for the ``electronic prescribing'' certification criterion
in Sec. 170.315(b)(3)(ii).
[[Page 63525]]
New Prescriptions (NewRx) (Sec. 170.315(b)(3)(ii)(A)(1))
We propose in Sec. 170.315(b)(3)(ii)(A)(1) to revise the name used
for the NewRx transaction in our regulations from ``Create New
Prescriptions (NewRx)'' to ``New Prescriptions (NewRx).'' We propose
this change to align with updated terminology used by NCPDP within the
SCRIPT standard.
Request and Receive Medication History (Sec. 170.315(b)(3)(ii)(A)(6))
We propose to remove the request and receive medication history
transactions (RxHistoryRequest, RxHistoryResponse) as a requirement for
the ``electronic prescribing'' certification criterion in Sec.
170.315(b)(3)(ii)(A)(6) and reserve this section.
In the ONC Cures Act Final Rule, ONC finalized the request and
receive medication history transactions (RxHistoryRequest,
RxHistoryResponse) in the ``electronic prescribing'' certification
criterion (85 FR 25682). Since the final rule was published, health IT
developers and health care providers have described several challenges
meeting this requirement, including development burden; lower than
expected adoption and use; and duplicative, overlapping, and sometimes
contradictory data from multiple sources. Due in part to these
challenges and market forces that have prevented some developers from
adopting this functionality natively, developers have had to rely on
third-party applications to achieve certification, and in some cases,
are unable to achieve certification for electronic prescribing
altogether. As such, we propose these transactions would no longer be
required for certification to the ``electronic prescribing'' criterion
in Sec. 170.315(b)(3)(ii)(A)(6). We also propose to reserve section
Sec. 170.315(b)(3)(ii)(A)(6).
We continue to encourage developers to support these transactions
where possible and to follow industry efforts to advance the exchange
of patient medication histories through various means such as health
information exchanges, health information networks, and prescription
drug monitoring programs. We further note that, while health IT
developers would not be required to demonstrate compliance with these
transactions in order for a Health IT Module to be certified to the
updated version of the ``electronic prescribing'' criterion (if our
proposals are finalized), CMS still requires use of these transactions
when appropriate for electronic exchange of prescription-related
information by Part D sponsors and prescribers and dispensers of Part D
drugs for Part D eligible individuals (88 FR 78486). Health IT
developers would still need to support these transactions when
supporting customers who utilize these transactions to exchange
electronic Part D medication history information among Part D sponsors
and prescribers and dispensers of Part D drugs for Part D eligible
individuals in compliance with requirements, currently codified at 42
CFR 423.160(b)(4) and finalized to be codified at 42 CFR
423.160(b)(1)(i)(U) in the Part D and Health IT Standards Final Rule
(89 FR 51247).
We request comments on this proposal.
Electronic Prior Authorization Transactions (Sec.
170.315(b)(3)(ii)(A)(10))
We propose to require the following transactions for electronic
prior authorization for the ``electronic prescribing'' certification
criterion, at the time a health IT developer presents a Health IT
Module for certification using the standard in Sec. 170.205(b)(2)
(NCPDP SCRIPT standard version 2023011): PAInitiationRequest,
PAInitiationResponse, PARequest, PAResponse, PAAppealRequest,
PAAppealResponse, PACancelRequest, and PACancelResponse.
In the ONC Cures Act Final Rule, ONC adopted these transactions in
Sec. 170.315(b)(3)(ii)(B)(9) as optional for the ``electronic
prescribing'' certification criterion (85 FR 25678). We stated that we
adopted these transactions to support alignment with the ``Medicare
Program; Secure Electronic Prior Authorization for Medicare Part D''
proposed rule (84 FR 28450), in which CMS proposed to require Part D
sponsors to support NCPDP SCRIPT standard version 2017071 for four
electronic prior authorization transactions, and proposed that
prescribers would be required to use that standard when performing
electronic prior authorization transactions for Part D covered drugs
they wish to prescribe to Part D eligible individuals (85 FR 25685).
CMS subsequently finalized in the ``Medicare Program; Secure Electronic
Prior Authorization for Medicare Part D'' final rule in Sec.
423.160(b)(8)(ii) that beginning January 1, 2022, Part D sponsors and
prescribers must use the NCPDP SCRIPT standard version 201701 (85 FR
86832). The ONC Cures Act Final Rule allowed health IT developers
seeking certification to support these transactions through optional
testing but did not require developers to certify to these
transactions.
We have received feedback from the public in support of requiring
these transactions, most recently in response to the ``Request for
Information: Electronic Prior Authorization Standards, Implementation
Specifications, and Certification Criteria'' (Electronic Prior
Authorization RFI), which was published in the Federal Register on
January 24, 2022 (87 FR 3475). Commenters stated that requiring these
transactions for the certification criterion would help to advance
interoperability and reduce administrative burden around prior
authorization processes for medications. We agree with this input and
believe that it is appropriate to require these transactions at this
time. Therefore, we propose to remove PAInitiationRequest,
PAInitiationResponse, PARequest, PAResponse, PAAppealRequest,
PAAppealResponse, PACancelRequest, and PACancelResponse in Sec.
170.315(b)(3)(ii)(B)(9) as optional and propose to require these
transactions in Sec. 170.315(b)(3)(ii)(A)(10) for the ``electronic
prescribing'' certification criterion at the time a health IT developer
presents a Health IT Module for certification using NCPDP SCRIPT
standard version 2023011.
ONC also charged the HITAC to establish a Task Force in order to
provide input and recommendations in response to the Electronic Prior
Authorization RFI; the Task Force's recommendations were approved and
submitted to ONC on March 10, 2022.\40\ If finalized, the proposals in
this rule would implement the Task Force's recommendation to update
these prior authorization transactions from ``optional'' in the current
version of the ``electronic prescribing'' certification criterion to
``mandatory,'' to better support electronic prior authorization
processes for drugs covered under a prescription benefit.
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\40\ https://www.healthit.gov/sites/default/files/page/2022-03/2022-03-10_ePA_RFI_Recommendations_Report_Signed_508.pdf.
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We also propose to adopt the PANotification transaction in Sec.
170.315(b)(3)(ii)(A)(10) as a required transaction for the ``electronic
prescribing'' certification criterion to further support the exchange
of electronic prior authorization information. PANotification is a new
transaction introduced since NCPDP SCRIPT standard version 2017071. The
PANotification transaction is used to alert the pharmacist or
prescriber when a prior authorization has been requested or when a
prior authorization
[[Page 63526]]
determination has been received. The PANotification transaction is
intended to improve electronic communication between prescribers and
pharmacists, and to reduce duplicate submissions of prior authorization
requests to payers. Notification may occur via a NewRx, RxChange or
RxRenewal transaction, or as a standalone PANotification. We believe
that requiring the PANotification transaction is an important
complement to the other proposals related to electronic prior
authorization described above.
We request comments on these proposals.
Optional Transactions (NewRxRequest, NewRxResponseDenied,
RxFillIndicatorChange, GetMessage, Resupply, DrugAdministration,
RxTransferRequest, RxTransferResponse, RxTransferConfirm,
Recertification, REMSInitiationRequest, REMSInitiationResponse,
REMSRequest, and REMSResponse) (Sec. 170.315(b)(3)(ii)(B)(1)-(8))
We propose to remove the transactions in Sec.
170.315(b)(3)(ii)(B)(1)-(8) which are currently identified as
``optional'' for the ``electronic prescribing'' certification
criterion. We propose to revise Sec. 170.315(b)(3)(ii)(B) to include
requirements related to the exchange of race and ethnicity information
in Sec. 170.315(b)(3)(ii)(B)(1)-(4), which is discussed in greater
detail below.
Specifically, we propose to remove the following transactions in
Sec. 170.315(b)(3)(ii)(B) upon the effective date of the final rule:
NewRxRequest, NewRxResponseDenied (Sec.
170.315(b)(3)(ii)(B)(1))
RxFillIndicatorChange (Sec. 170.315(b)(3)(ii)(B)(2))
GetMessage (Sec. 170.315(b)(3)(ii)(B)(3))
Resupply (Sec. 170.315(b)(3)(ii)(B)(4))
DrugAdministration (Sec. 170.315(b)(3)(ii)(B)(5))
RxTransferRequest, RxTransferResponse, RxTransferConfirm
(Sec. 170.315(b)(3)(ii)(B)(6))
Recertification (Sec. 170.315(b)(3)(ii)(B)(7))
REMSInitiationRequest, REMSInitiationResponse, REMSRequest,
and REMSResponse (Sec. 170.315(b)(3)(ii)(B)(8))
For completeness, we note that Sec. 170.315(b)(3)(ii)(B) currently
has transactions listed in Sec. 170.315(b)(3)(ii)(B)(9) related to
electronic prior authorization. However, we proposed in the section
above to remove Sec. 170.315(b)(3)(ii)(B)(9) and add the electronic
prior authorization transactions currently in Sec.
170.315(b)(3)(ii)(B)(9) as required transactions in Sec.
170.315(b)(3)(ii)(A)(10).
In reviewing data from the Program, we have found that very few
developers have elected to certify to the optional transactions in
Sec. 170.315(b)(3)(ii)(B)(1)-(9). We believe that the low rate of
certification to these certification criteria indicates that health IT
developers do not see a benefit in obtaining optional certification to
these criteria. Accordingly, we believe that removing these optional
transactions from the program will reduce the complexity and cost of
the Program with minimal impact on health IT developers.
We further note that CMS requires use of these transactions when
appropriate for electronic exchange of prescriptions and prescription-
related information by Part D sponsors and prescribers and dispensers
of Part D drugs for Part D eligible individuals. Accordingly,
regardless of whether a health IT developer seeks to certify its Health
IT Module(s) to these optional transactions, developers will still need
to support them when supporting customers who utilize these
transactions to exchange information electronically between prescribers
and dispensers of Part D drugs for Part D eligible individuals in
compliance with requirements currently codified at 42 CFR
423.160(b)(2)(iv) and finalized to be codified at 42 CFR
423.160(b)(1)(i) in the Part D and Health IT Standards Final Rule (89
FR 51245 through 51247).
We request comment on our proposal to remove the optional
transactions in Sec. 170.315(b)(3)(ii)(B)(1)-(8) from the ``electronic
prescribing'' certification criterion. Alternatively, we considered
proposing to require the optional transactions in Sec.
170.315(b)(3)(ii)(B)(1)-(8) rather than removing them from the
criterion. However, we did not identify additional reasons to propose
to require any of these optional transactions. We request comment on
this alternative, including whether commenters believe requiring any of
the optional transactions in Sec. 170.315(b)(3)(ii)(B)(1)-(8) proposed
for removal from the ``electronic prescribing'' certification criterion
would be important to supporting interoperability between certified
Health IT Modules and entities subject to Part D electronic prescribing
requirements at 42 CFR 423.160.
We refer readers to Table 1A for a comparison of transactions
identified in the existing NCPDP SCRIPT standard version 2017071 and
the proposed certification criterion based on NCPDP SCRIPT standard
version 2023011.
c. Additional Proposals
Signatura (Sig) (Sec. 170.315(b)(3)(ii)(D))
In Sec. 170.315(b)(3)(ii)(D), we propose that a Health IT Module
certified to the ``electronic prescribing'' criterion must enable a
user to enter, receive, and transmit structured and codified
prescribing instructions in accordance with the standard specified in
Sec. 170.205(b)(2) (NCPDP SCRIPT standard version 2023011), at the
time a health IT developer presents a Health IT Module for
certification using the NCPDP SCRIPT standard version 2023011.
The Signatura or Sig is the information provided with a
prescription to communicate how a prescriber intends for a patient to
take a medication. These directions for use are essential for accurate
prescription labeling, appropriate patient counseling and education
from a pharmacist, and optimal medication use. The NCPDP Structured and
Codified Sig Format Implementation Guide,\41\ which is embedded in the
NCPDP SCRIPT standard, is intended to standardize the portion of an
electronic prescription containing the directions for use using
existing, accepted electronic transmission standards, such as NCPDP
SCRIPT. A ``structured and codified'' Sig conveys instructions in a
consistent manner by mapping these directions to a defined set of
elements representing the different components of these directions (for
instance, dosing schedules and administration instructions). The
Structured and Codified Sig Format includes 15 segments, each
containing distinct fields to capture potential elements of patient
instructions. This is intended to facilitate communication between
prescribers and pharmacists, to improve the efficiency of prescribing
and dispensing activities, and to help reduce the opportunity for
errors. The NCPDP Structured and Codified Sig Format Implementation
Guide contains the technical specifications and guidance for
implementation of a structured and codified Sig.
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\41\ See https://standards.ncpdp.org/Access-to-Standards.aspx.
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When conducting electronic prescribing, prescribers frequently
transmit the Sig Text segment as unstructured free text, which
introduces inconsistency and limits reusability of the directions
contained in the Sig, with potential impacts on patient safety and
[[Page 63527]]
clinical outcomes.\42\ Moreover, when unstructured free text is used,
prescribers and pharmacists may have to engage in back-and-forth
communication to clarify what is intended in the Sig instructions,
increasing burden. Research has shown more than half of all Sig
directions sent in an ambulatory setting can be accurately represented
by only 25 standardized concepts (e.g. the directions ``take 1 tablet
by oral route every day'' and ``Take one (1) tablet by mouth once a
day'' can both be represented as the same Sig concept ``Take 1 tablet
by mouth once daily''), indicating significant opportunities to reduce
variation by expressing these directions through the structured and
codified Sig format.\43\
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\42\ Schiff, G., Mirica, M.M., Dhavle, A.A., Galanter, W.L.,
Lambert, B., & Wright, A. (2018). A prescription for enhancing
electronic prescribing safety. Health Affairs (Project Hope),
37(11), 1877-1883. doi:https://doi.org/10.1377/hlthaff.2018.0725.
\43\ Yang, Y., Ward-Charlerie, S., Dhavle, A.A., Rupp, M.T., &
Green, J. (2018). Quality and Variability of Patient Directions in
Electronic Prescriptions in the Ambulatory Care Setting. Journal of
managed care & specialty pharmacy, 24(7), 691-699. https://doi.org/10.18553/jmcp.2018.17404.
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Previously, in the 2015 Edition Final Rule, we did not finalize our
proposal to require a Health IT Module certified to the ``electronic
prescribing'' criterion to enable a user to enter, receive, and
transmit codified Sig instructions in a structured format, based on
commenters' concerns regarding the readiness of the standard and other
issues such as limitations on the length of a Sig within the version of
the NCPDP SCRIPT Structured and Codified Sig Format v1.2 available at
the time of the proposal (80 FR 62643). We stated that we would
reconsider this stance for future rulemaking based on newer versions of
the NCPDP SCRIPT Standard Implementation Guide that may provide
implementation improvements and finalized an optional certification
provision that technology must be able to receive and transmit the
reason for the prescription using the indication elements in the SIG
segment in Sec. 170.315(b)(3)(i) (80 FR 62643). In the ONC Cures Act
Final Rule, we also finalized this optional provision in Sec.
170.315(b)(3)(ii)(D) (85 FR 25686).
Since the 2015 Edition Final Rule, NCPDP has further advanced the
structured and codified Sig format. The most recent version available
is the NCPDP Structured and Codified Sig Implementation Guide version
2.2. The structured and codified Sig segment within the NCPDP SCRIPT
standard has also been modified; changes to the Sig element from NCPDP
SCRIPT standard version 2017017 are discussed in the NCPDP SCRIPT
standard version 2023011 Implementation Guide.\44\ As a result of
additional improvements made to the structured and codified Sig format,
as well as the additional time that industry has had to grow familiar
with this functionality, we believe that it is appropriate to propose
in Sec. 170.315(b)(3)(ii)(D) to require that a Health IT Module
certified to the ``electronic prescribing'' criterion must enable a
user to enter, receive, and transmit structured and codified
prescribing instructions in accordance with the standard specified in
Sec. 170.205(b)(2) (where we have adopted NCPDP SCRIPT standard
version 2023011), at the time a health IT developer presents a Health
IT Module for certification using NCPDP SCRIPT standard version
2023011. We propose to remove the optional provision that is currently
in Sec. 170.315(b)(3)(ii)(D).
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\44\ See https://standards.ncpdp.org/Access-to-Standards.aspx.
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We request comments on this proposal.
RxNorm and National Drug Codes (NDC)
In Sec. 170.315(b)(3)(ii)(A) we require that a Health IT Module
certified to the ``electronic prescribing'' criterion enable a user to
perform specified prescription-related electronic transactions in
accordance with a specified minimum version of the RxNorm code set for
coding medications, among other standards. RxNorm, a standardized
nomenclature for clinical drugs produced by the United States National
Library of Medicine (RxNorm), is a drug terminology providing a set of
normalized medication names and codes based on a collection of commonly
used public and commercial vocabularies of drug names and their
ingredients. In section III.B.5. of this proposed rule, we propose to
adopt an updated release of RxNorm, specifically, the December 4, 2023,
Full Monthly Release, in Sec. 170.207(d)(1)(ii). In section III.B.5.
of this proposed rule, we also propose to reorganize section Sec.
170.207(d) to include the versions of RxNorm adopted in Sec.
170.207(d)(1), (2), and (3), under Sec. 170.207(d)(1).
For the ``electronic prescribing'' certification criterion, we
propose in Sec. 170.315(b)(3)(ii)(A) to remove the existing reference
to RxNorm, September 8, 2015 Release in Sec. 170.207(d)(3), and
require use of at least one of the versions of the standard adopted in
Sec. 170.207(d)(1). If finalized, this reference to Sec.
170.207(d)(1), where we have adopted multiple versions of RxNorm, would
permit a health IT developer to use any version of RxNorm that is
listed in Sec. 170.207(d)(1) and for which adoption has not expired.
This proposal would result in a requirement to use progressively more
recent releases of the RxNorm code set as the baseline version of
RxNorm which Health IT Modules must use for the ``electronic
prescribing'' certification criterion.
We also note that under NCPDP SCRIPT standard version 2020011 and
greater, including NCPDP SCRIPT standard version 2023011, the National
Drug Codes (NDC) element is required on all non-compounded medication
electronic prescriptions.\45\ National Drug Codes (NDC) provide a
unique identifier for products such as vaccines or medications. Each
product is assigned a unique 10- or 11-digit, 3-segment number that
identifies the labeler, product, and trade package size. We adopted NDC
in Sec. 170.207(d)(4) in the HTI-1 Final Rule (89 FR 1226) via a
cross-reference to 45 CFR 162.1002(b)(2) as referenced in 45 CFR
162.1002(c)(1). In section III.B.5 of this proposed rule, we propose to
relocate this cross-reference from Sec. 170.207(d)(4) to Sec.
170.207(d)(2) as part of our reorganization of this section. Consistent
with the requirement in the NCPDP SCRIPT standard version 2023011 to
include NDC with prescriptions, we propose in Sec.
170.315(b)(3)(ii)(A) that a Health IT Module certified to the criterion
must enable a user to perform specified prescription-related electronic
transactions in accordance with NDC in Sec. 170.207(d)(2). We propose
that use of NDC would be required at the time a health IT developer
presents a Health IT Module for certification using the NCPDP SCRIPT
standard version 2023011 adopted in Sec. 170.205(b)(2).
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\45\ For more information about the updates to NDC in the NCPDP
SCRIPT standard see https://ncpdp.org/NCPDP/media/images/Resources%20Items/NDC-Use-eRx-Fact-Sheet.pdf?ext=.pdf.
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Diagnoses (Sec. 170.315(b)(3)(ii)(C))
In Sec. 170.315(b)(3)(ii)(C) we require that a Health IT Module
``must be able to receive and transmit the reason for prescription
using the diagnosis elements: or ''
for the set of prescription-related transactions identified in Sec.
170.315(b)(3)(ii)(C)(1)-(2).
We propose to make changes to the list of required and optional
transactions in Sec. 170.315(b)(3)(ii)(C) to reflect the proposed
required transactions for the updated version of
[[Page 63528]]
the certification criterion in Sec. 170.315(b)(3)(ii)(A), and our
proposal to remove certain optional transactions from the updated
version of the criterion in Sec. 170.315(b)(3)(ii)(B). Specifically,
we propose in 170.315(b)(3)(ii)(C)(1) to rename ``Create New
Prescriptions (NewRx)'' to ``New Prescriptions (NewRx).'' We propose in
Sec. 170.315(b)(3)(ii)(C)(1)(vi) to remove the transaction ``Receive
medication history'' (RxHistoryResponse) and reserve this section. We
propose in Sec. 170.315(b)(3)(ii)(C)(1)(vii) to require the following
electronic prior authorization transactions (PAInitiationRequest,
PAInitiationResponse, PARequest, PAResponse, PAAppealRequest,
PAAppealResponse and PACancelRequest, PACancelResponse, PANotification)
if using NCPDP SCRIPT standard version 2023011 (adopted in Sec.
170.205(b)(2)). Lastly, we propose to remove the optional transactions
in Sec. 170.315(b)(3)(ii)(C)(2)(i) through (iv) and reserve this
section. We refer readers to Table 1A below in this rule for a
comparison of required and optional transactions identified in the
current certification criterion based on NCPDP SCRIPT standard version
2017071 and the proposed updated criterion based on NCPDP SCRIPT
standard version 2023011.
Race and Ethnicity
In 2023, the Pharmacy Interoperability and Emerging Therapeutics
Task Force provided a recommendation to the HITAC to support
interoperability between pharmacy constituents by including race and
ethnicity in the ``electronic prescribing'' certification criterion
(PhIET-TF-2023_Recommendation 26).\46\ The Task Force stated that
demographic data is not always made available through reporting such as
case reporting to public health agencies. Yet, in order to support the
ability to perform analytics, all data feeds should have relevant race
and ethnicity data, and other key demographic data, when available. The
Task Force recommended that various prescribing and laboratory results
reporting capabilities need to be able to support sharing of the
relevant data when an alternative source is not consistently available.
Additionally, the Task Force acknowledged that a prescriber will likely
already have patient race or ethnicity documented. Exchanging this
information through available transactions, such as those included in
electronic prescribing, is one way to improve consistency in
documentation of demographic data across provider types.
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\46\ See https://www.healthit.gov/sites/default/files/page/2023-11/2023-11-09_PhIET_TF_2023_Recommendations_Transmittal_Letter_508.pdf.
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Specifically, the Task Force recommended ONC include the ability to
capture and exchange race and ethnicity as part of the ``electronic
prescribing'' certification criterion and point to USCDI v4,\47\ which
references the CDC Race & Ethnicity Code System--CDCREC 1.2 (July
2021).\48\ The CDC Race & Ethnicity Code System--CDCREC 1.2 code set
facilitates use of Federal standards for classifying data on race and
ethnicity when these data are exchanged, stored, retrieved, or analyzed
in electronic form. The NCPDP SCRIPT standard version 2023011, which we
propose to incorporate in the ``electronic prescribing'' certification
criterion in this proposed rule, references reporting of race and
ethnicity using the CDCREC 1.2 associated value set ``PHVS_Race_CDC''
version 2 (December 2018 \49\) from the code system code
``PH_RaceAndEthnicity_CDC'' as optional for certain transactions within
the standard that we have also proposed to require when using the
updated version of the standard. This aligns with the code system code
in CDCREC 1.2 which is ``PH_RaceAndEthnicity_CDC,'' and is available on
the Public Health Information Network (PHIN) Vocabulary Access and
Distribution System (PHIN VADS).\50\
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\47\ See https://www.healthit.gov/isa/united-states-core-data-interoperability-uscdi.
\48\ See https://www.cdc.gov/phin/resources/vocabulary/.
\49\ See https://phinvads.cdc.gov/vads/ViewValueSet.action?id=9152A536-AEEC-E711-ACD6-0017A477041A.
\50\ See https://phinvads.cdc.gov/vads/ViewCodeSystemConcept.action?oid=2.16.840.1.113883.6.238&code=1579-2.
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Given the importance of the issues described by the Task Force, and
the alignment between the recommendation and NCPDP SCRIPT standard
version 2023011, we believe that it is appropriate to implement the
Task Force recommendation through updates to the ``electronic
prescribing'' certification criterion. Therefore, we propose in Sec.
170.315(b)(3)(ii)(B) that a Health IT Module certified to the
``electronic prescribing'' certification criterion must enable a user
to exchange race and ethnicity information for a patient when
performing the following prescription-related electronic transactions,
if using NCPDP SCRIPT standard version 2023011:
Receive fill status notifications (RxFill).
Request and respond to change prescriptions
(RxChangeRequest, RxChangeResponse).
Request to cancel prescriptions (CancelRx).
Request and respond to renew prescriptions
(RxRenewalRequest, RxRenewalResponse).
We believe the transactions above are an appropriate starting place
to include race and ethnicity in the electronic prescribing
certification criterion. We will continue to monitor changes to the
SCRIPT standard for additional updates to transactions to include race
and ethnicity data fields.
We invite comments on this proposal and request information on
whether there are other SCRIPT transactions that include data fields
for race and ethnicity we should consider specifying to enable exchange
of race and ethnicity data with providers in pharmacy settings.
Base EHR Definition
We note that, given our proposal in section III.B.9.b. to include
the proposed ``real-time prescription benefit'' certification criterion
in Sec. 170.315(b)(4) in the Base EHR definition in Sec. 170.102, we
have also proposed to add the ``electronic prescribing'' certification
criterion in Sec. 170.315(b)(3) to the Base EHR definition. Please see
section III.B.9.b. of this proposed rule for further details on this
proposal.
Multi-Factor Authentication
We propose in Sec. 170.315(b)(3)(ii)(G) that, on and after January
1, 2028, a Health IT Module certified to Sec. 170.315(b)(3) must meet
the multi-factor authentication (MFA) requirements specified in Sec.
170.315(d)(13)(ii) for user-facing authentication. We believe this
update is in line with industry information security best practice for
an important authentication use case in health IT, and that it is
necessary to help better protect electronic health information. We
refer readers to section III.B.17 for our proposal to revise our MFA
certification criterion Sec. 170.315(d)(13) and for background on the
user level authentication use case we are targeting with this
requirement.
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9. New Real-Time Prescription Benefit Criterion
a. Background
The increasing costs of prescription drugs have long been a concern
for patients, providers, and policymakers.\51\ Increased drug costs can
have several negative consequences for patients, including limited
access to healthcare,\52\ lower healthcare use,\53\ medication
nonadherence 54 55 and financial stress, especially among
underserved,\56\ uninsured and underinsured \57\ populations. Merely
having health insurance coverage does not necessarily confer medication
affordability on patients.\58\ These challenges continue to be the
focus of legislation, such as the Inflation Reduction Act of 2022 (Pub.
L. 117-169, August 16, 2022), which includes several provisions that
are expected to decrease prescription drug costs and improve access to
prescription drugs for the more than 65 million Americans enrolled in
the Medicare program, including allowing Medicare to directly negotiate
prescription drug prices for the first time, eliminating cost sharing
for adult vaccines, capping out-of-pocket costs for insulin, and
capping Part D enrollee out-of-pocket spending at $2,000 annually
starting in 2025 (see sections 11406, 11401, 1194, and 11201). E. O.
14087, Lowering Prescription Drug Costs for Americans, directed further
actions to lower the cost of prescription drugs.
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\51\ A.S. Kesselheim, J. Avorn, A. Sarpatwari, The high cost of
prescription drugs in the United States: origins and prospects for
reform. JAMA, 316 (8) (2016), pp. 858-871.
\52\ Daher, Al Rifai, M., Kherallah, R. Y., Rodriguez, F.,
Mahtta, D., Michos, E. D., Khan, S. U., Petersen, L. A., & Virani,
S. S. (2021). Gender disparities in difficulty accessing healthcare
and cost-related medication non-adherence: The CDC behavioral risk
factor surveillance system (BRFSS) survey. Preventive Medicine, 153,
106779-106779. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9291436/.
\53\ Roebuck, Liberman, J. N., Gemmill-Toyama, M., & Brennan, T.
A. (2011). Medication adherence leads to lower health care use and
costs despite increased drug spending. Health Affairs, 30(1), 91-99.
https://doi-org.ezproxyhhs.nihlibrary.nih.gov/10.1377/hlthaff.2009.1087.
\54\ SG Morgan, A. Lee. Cost-related non-adherence to prescribed
medicines among older adults: a cross-sectional analysis of a survey
in 11 developed countries. BMJ Open, 7 (1) (2017), Article e014287.
\55\ DiMatteo MR, Giordani PJ, Lepper HS, Croghan TW. Patient
adherence and medical treatment outcomes: a meta-analysis. Med Care.
2002; 40 (9): 794-811.
\56\ Whaley C, Reed M, Hsu J, Fung V (2015) Functional
Limitations, Medication Support, and Responses to Drug Costs among
Medicare Beneficiaries. PLoS ONE 10(12): e0144236. https://doi.org/10.1371/journal.pone.0144236.
\57\ Collins SR, Rasmussen PW, Beutel S, Doty MM. The problem of
underinsurance and how rising deductibles will make it worse:
findings from the Commonwealth Fund Biennial Health Insurance
Survey, 2014. New York: Commonwealth Fund; 2015.
\58\ Zhao, J., Zheng, Z., Han, X., Davidoff, A. J., Banegas, M.
P., Rai, A., Jemal, A., & Yabroff, K. R. (2019). Cancer History,
Health Insurance Coverage, and Cost-Related Medication Nonadherence
and Medication Cost-Coping Strategies in the United States. Value in
health: the journal of the International Society for
Pharmacoeconomics and Outcomes Research, 22(7), 762-767. https://doi.org/10.1016/j.jval.2019.01.015.
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Research also suggests provider-patient discussions during clinical
encounters about costs and affordability may lead to an overall
reduction in out-of-pocket costs.\59\ Real-time prescription benefit
tools empower providers and their patients to compare the patient-
specific cost of a drug to the cost of a suitable alternative, compare
prescription costs at different pharmacy locations, view information
about out-of-pocket costs, and learn whether a specific drug is subject
to utilization management restrictions such as prior authorization,
step therapy, or quantity limits. We believe, when appropriate, use of
these tools can allow the provider and patient to choose among
clinically acceptable alternative medication treatments while weighing
coverage and point-in-time costs. Access to this data within the
electronic prescribing workflow may also help to reduce provider burden
associated with coverage determination and prior authorization appeals.
We believe widespread adoption of such tools, along with increased
awareness of drug cost information among patients and providers will
likely spur more robust evaluations over time.
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\59\ Carroll JK, Farah S, Fortuna RJ, et al. Addressing
medication costs during primary care visits: a before-after study of
team-based training. Ann Intern Med. 2019;170(suppl 9): S46-S53.
doi:10.7326/M18-2011.
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Section 119 of Title I, Division CC of the Consolidated
Appropriations Act of 2021, (Pub. L. 116-260, December 27, 2020) (CAA,
2021), requires sponsors of prescription drug plans to implement one or
more real-time benefit tools (RTBTs) after the Secretary has adopted a
standard for RTBTs and at a time determined appropriate by the
Secretary. The law specified that a qualifying RTBT must meet technical
standards named by the Secretary, in consultation with ONC. Section
119(b) also amended the definition of a ``qualified electronic health
record'' in section 3000(13) of the Public Health Service Act (PHSA) to
specify that a qualified electronic health record ``includes, or is
capable of including, a real-time benefit tool that conveys patient-
specific real-time cost and coverage information with respect to
prescription drugs that, with respect to any health information
technology certified for electronic prescribing, the technology shall
be capable of incorporating the information described in clauses (i)
through (iii) of paragraph (2)(B) of section 1860D-4(o) of the Social
Security Act.'' The information specified in (2)(B)(i)-(iii) of section
1860D-4(o) of the Social Security Act, as added by section 119(a) of
the CAA, 2021, is:
A list of any clinically appropriate alternatives to such
drug included in the formulary of such plan.
Cost-sharing information and the negotiated price for such
drug and such alternatives at multiple pharmacy options, including the
individual's preferred pharmacy and, as applicable, other retail
pharmacies and a mail order pharmacy; and
The formulary status of such drug and such alternatives
and any prior authorization or other utilization management
requirements applicable to such drug and such alternatives included in
the formulary of such plan.
The provision further specifies that the change to the definition
of a ``qualified electronic health record'' shall be implemented ``at a
time specified by the Secretary but not before the Secretary adopts a
standard for such tools.''
In the HTI-1 Proposed Rule (88 FR 23848 through 23855), we included
a request for information (RFI) about issues related to establishing a
real-time prescription benefit certification criterion utilizing the
NCPDP Real-Time Prescription Benefit (RTPB) standard, and ways in which
the Program could ensure real-time prescription benefit capabilities
are implemented effectively for providers. We received many comments on
this RFI and appreciate the input provided by commenters.
In order to implement section 119(b) of the CAA, 2021, we propose
to establish a ``real-time prescription benefit'' health IT
certification criterion in Sec. 170.315(b)(4) and to include this
certification criterion in the Base EHR definition in Sec.
170.102(3)(iv).
b. Revision to the Base EHR Definition and Health IT Module Dependent
Criteria Requirements
As noted above, section 119(b) of the CAA, 2021, amended the
definition of a ``qualified electronic health record'' (Qualified EHR)
in section 3000(13) of the PHSA to specify that a qualified electronic
health record ``includes, or is capable of including, a real-time
benefit tool that conveys patient-specific real-time cost and coverage
information with respect to prescription drugs.'' In the 2014 Edition
Final Rule, we established the term ``Base EHR,'' based on the
Qualified EHR definition in PHSA
[[Page 63531]]
section 3000(13), for use within the Program (77 FR 54262). We define
Base EHR in Sec. 170.102, and this definition currently includes
certification criteria under the Program that align with the elements
of the Qualified EHR definition in the PHSA.
Given that the statutory definition of Qualified EHR is implemented
in regulation through the Base EHR definition in Sec. 170.102, we
believe it is necessary to propose to update the Base EHR definition
consistent with Congress' modification of the statutory definition of
Qualified EHR to address real-time benefit tool functionality.
Specifically, consistent with PHSA section 3000(13), as amended by
section 119(b) of the CAA, 2021, we propose to revise the Base EHR
definition in Sec. 170.102 to add paragraph (3)(iv) to include the
real-time prescription benefit certification criterion proposed in
Sec. 170.315(b)(4) on and after January 1, 2028. We believe including
the ``real-time prescription benefit'' certification criterion as part
of the Base EHR definition will increase the use of real-time
prescription benefit tools and promote widespread adoption which will
help to lower drug costs for Medicare beneficiaries, consistent with
section 119 of the CAA. Use of real-time prescription benefit tools
enable Medicare providers and enrollees to make cost-informed decisions
about prescriptions, and a standardized approach will ensure that
critical drug and drug price data is available to providers when they
need it.
We note that in the Part D and Health IT Standards Final Rule CMS
finalized to require Part D plan sponsors to adhere to NCPDP RTPB
standard version 13 as part of requirements to provide a prescriber
real-time benefit tool by January 1, 2027 in the Part D and Health IT
Standards Final Rule (89 FR 51259 and 51260). We request comment on
whether we should seek to align the date when the ``real-time
prescription benefit'' certification criterion in Sec. 170.315(b)(4)
would be effective for the Base EHR definition (proposed to be January
1, 2028) with the date finalized in the Part D and Health IT Standards
Final Rule for Part D plan sponsors' real-time benefit tools to adhere
to the NCPDP RTPB standard version 13 (January 1, 2027) (89 FR 51260).
The amended definition of a Qualified EHR in PHSA section
3000(13)(c) further specifies that ``with respect to any health
information technology certified for electronic prescribing, the
technology shall be capable of incorporating the information described
in clauses (i) through (iii) of paragraph (2)(B).'' We interpret this
provision to mean, for the purposes of the Program, that any health IT
presented for certification for electronic prescribing capabilities
should also be capable of incorporating the real-time benefit
information specified in clauses (i) through (iii) of paragraph (2)(B)
of section 1860D-4(o) of the Social Security Act, as described above.
Real-time prescription benefit functionality is closely related to
electronic prescribing functionality, which provides the basic workflow
within which a provider may seek to identify information about a
patient's coverage for a certain prescription before transmitting that
electronic prescription to the pharmacy. In most cases, we expect
health IT developers seeking certification to Sec. 170.315(b)(4) will
already be certified to Sec. 170.315(b)(3), though there will be some
variation due to the modularity of Program criteria. Accordingly, we
propose to revise Sec. 170.550(g) to add paragraph (g)(6) in order to
require that any developer that obtains certification for the
``electronic prescribing'' certification criterion in Sec.
170.315(b)(3) must also obtain certification for the proposed ``real-
time prescription benefit'' criterion in Sec. 170.315(b)(4).
While we propose to establish this dependency with the ``electronic
prescribing'' certification criterion, this certification criterion is
not included as part of the current Base EHR definition in Sec.
170.102. Although electronic prescribing is a widely used and
fundamental capability of health IT, we have, to date, not included
this certification criterion in the Base EHR definition for several
reasons. First, the Qualified EHR definition in section 3000(13) of the
PHSA does not specify electronic prescribing as a required element of a
Qualified EHR and we have generally sought to limit the Base EHR
definition in Sec. 170.102, which implements the Qualified EHR
definition, to those capabilities that are required for the Qualified
EHR definition by statute. Second, many health care providers have
historically been required to adopt certified technology for electronic
prescribing in order to meet the requirements of the Medicare EHR
Incentive Programs, now known as the Medicare Promoting
Interoperability Program and the Promoting Interoperability performance
category of the Merit-Based Incentive Payment System (MIPS).\60\
Objectives and measures for eligible professionals, eligible hospitals,
and CAHs under these programs have included measures related to
electronic prescribing throughout the course of the programs. Section
1848(o)(2)(A)(i) of the Social Security Act also requires that
demonstration of use of certified EHR technology in a meaningful manner
by an eligible professional ``shall include the use of electronic
prescribing.''
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\60\ The Medicaid EHR Incentive Program sunset in 2021 (84 FR
42592).
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However, given our proposal to include the proposed ``real-time
prescription benefit'' certification criterion in Sec. 170.315(b)(4)
in the Base EHR definition, we believe it is also appropriate to add
the ``electronic prescribing'' certification criterion in Sec.
170.315(b)(3) to the Base EHR definition. While we previously did not
include this capability in the Base EHR definition for the reasons
described above, we believe that the inclusion of closely related
``real-time prescription benefit'' functionality in Sec. 170.315(b)(4)
necessitates the inclusion of electronic prescribing functionality. We
therefore propose to include the ``electronic prescribing''
certification criterion in Sec. 170.315(b)(3) within the Base EHR
definition in Sec. 170.102. We further propose to specify that this
criterion would be effective for the Base EHR definition on and after
January 1, 2028, which aligns with the date when the proposed ``real-
time prescription benefit'' certification criterion in Sec.
170.315(b)(4) would be effective for the Base EHR definition.
We request comment on these proposals, especially regarding the
impact of these proposals on health IT developers seeking to ensure
their products meet the Base EHR definition that are not currently
separately certified to the ``electronic prescribing'' criterion. We
seek information on the additional burden to developers of requiring
the ``electronic prescribing'' certification criterion as part of the
Base EHR definition in addition to the proposed ``real-time
prescription benefit'' certification criterion. We also request comment
on the implications for interoperability of electronic prescribing if
we were to finalize our proposal to include the ``real-time
prescription benefit'' certification criterion within the Base EHR
definition but not finalize our proposal to include the ``electronic
prescribing'' certification criterion in the Base EHR definition.
Lastly, we request comment on the impact this proposed policy would
have on any health care providers participating in the Medicare
Promoting Interoperability Program and the Promoting Interoperability
performance category of the Merit-Based Incentive Payment System (MIPS)
who have historically been able to claim an exclusion from electronic
prescribing
[[Page 63532]]
measures in these programs, and, as a result have not adopted certified
health IT for electronic prescribing in order to complete the actions
associated with these measures. The definitions of certified EHR
technology at 42 CFR 495.4 and 42 CFR 414.1305, which define technology
requirements for these programs, cross-reference the Base EHR
definition at 45 CFR 171.102. Thus, as a result of the statutory change
implemented by Congress, and if our proposals to add these
certification criteria to the Base EHR definition are finalized, all
providers participating in these programs would have to have at a
minimum, health IT certified to the proposed ``real-time prescription
benefit'' certification criterion and the ``electronic prescribing''
certification criterion. This would include participants that currently
successfully participate in these programs without possessing certified
health IT that supports these capabilities. We request comment on
whether finalizing these proposals would impose significant burden on
these health care providers.
c. Real-Time Prescription Benefit Standard
We propose in Sec. 170.315(b)(4)(i) that a Health IT Module
certified to the proposed ``real-time prescription benefit''
certification criterion must enable a user to perform certain real-time
prescription benefit electronic transactions in accordance with at
least one of the versions of the standard adopted in Sec. 170.205(c).
Under this paragraph, ONC adopted the NCPDP RTPB standard version 13
\61\ on behalf of HHS in Sec. 170.205(c)(1) in the Part D and Health
IT Standards Final Rule, which appeared in the Federal Register on June
17, 2024 (89 FR 51238 through 51265). If we adopt subsequent versions
of the NCPDP RTPB standard in Sec. 170.205(c), our proposal to require
the use of at least one of the versions of the standard adopted in
Sec. 170.205(c) would enable health IT developers to use any version
of the standard adopted under this paragraph, unless we specify an
adoption ``expiration'' date which indicates a certain version of the
standard may no longer be used after that date.
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\61\ See https://standards.ncpdp.org/Access-to-Standards.aspx.
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The NCPDP RTPB standard version 13 enables the exchange of patient
eligibility, product coverage, and benefit financials for a chosen
product and pharmacy, and identifies coverage restrictions and
alternatives when they exist. The benefits of the more recent NCPDP
RTPB standard version 13 relative to NCPDP RTPB standard version 12
include improvements to the NCPDP RTPB Patient Segment, Product and
Alternative Product Segments, and new elements, new values, and updated
values to the schema, as well as administrative corrections that
support consistency and clarity.
Because the NCPDP RTPB standard is relatively new and not yet
widely implemented, we expect additional enhancements and improvements
to the standard over time as more health IT developers adopt and
implement the standard and more exchange partners engage in the
standards development process with NCPDP. We encourage developers to
remain familiar with updates occurring in newer versions of the NCPDP
RTPB standard.
d. Sending and Receiving Real-Time Prescription Benefit Information
In order to execute real-time prescription benefit checks in
accordance with the NCPDP RTPB standard version 13, a provider
originates the request for prescription benefit information for a
specific patient from within their health IT. In return, a processor,
pharmacy benefit manager, or adjudicator provides the appropriate
response. We propose in Sec. 170.315(b)(4)(i) that a Health IT Module
certified to the ``real-time prescription benefit'' criterion must
enable a user to perform specified transactions in accordance with at
least one of the versions of the standard adopted in Sec. 170.205(c)
(where we have adopted the NCPDP RTPB standard version 13), as well as
one of the versions of the standard in Sec. 170.207(d)(1) (where we
have adopted RxNorm) and the standard in Sec. 170.207(d)(2) (where we
have cross-referenced National Drug Codes (NDC)).
We propose in Sec. 170.315(b)(4)(i)(A) that a Health IT Module
certified to the proposed criterion must enable a user to request
patient-specific prescription benefit information, estimated cost
information, and therapeutic alternatives, in accordance with the
RTPBRequest transaction. We propose in Sec. 170.315(b)(4)(i)(B) that a
Health IT Module certified to the proposed criterion must enable a user
to receive patient-specific prescription benefit information, estimated
cost information, and therapeutic alternatives in response to a
request, in accordance with the RTPBResponse transaction. RTPBRequest
and RTPBResponse transactions are determined by patient, benefit, and
product-specific information. Each request and response are unique with
information conditioned on factors associated with each transaction.
Health IT Modules certified to the proposed certification criterion
should support transaction segments and associated data elements
necessary to reflect both the information needed for a successful
RTPBRequest and the information contained in a detailed RTPBResponse.
As such, a Health IT Module must have the capability to send and
receive both mandatory and situational transaction segments and
associated data elements for RTPBRequests and RTPBResponse transactions
as specified in NCPDP RTPB standard version 13. Finally, we propose in
Sec. 170.315(b)(4)(i)(C) that a Health IT Module certified to the
proposed criterion must enable a user to be notified of errors when
there is a problem with a real-time prescription benefit transaction,
in accordance with the RTPBError transaction.
We request comments on these proposals and whether we should
consider other capabilities for the certification criterion in the
future.
Use of XML Format
We propose in Sec. 170.315(b)(4)(i) that a Health IT module
certified to the criterion must enable a user to perform the specified
transactions using the XML format. While the NCPDP RTPB standard
version 13 supports both EDI and XML formats, in response to the RFI
included in the HTI-1 Proposed Rule (88 FR 23746), we received many
comments in support of testing the XML format of the RTPB standard
alone or with the EDI format as optional. Additionally, commenters
recommended that ONC should test the format each individual health IT
developer has chosen for its own system to be tested in. Some
commentors also shared a desire to move away from XML and EDI
altogether, preferring the JSON format instead, noting industry plans
for the future retirement of XML and EDI. One commenter suggested
certification in either format, with requirements that health IT be
capable of demonstrating translation capabilities between EDI and XML.
After considering these comments, we believe that proposing to only
require use of the XML format will simplify testing for health IT
developers. ONC will continue to monitor syntax and format updates and
development for real-time benefit transactions and associated
standards.
e. Additional Topics
Display
We propose in Sec. 170.315(b)(4)(ii) that a Health IT Module
certified to the criterion must display to a user in
[[Page 63533]]
human readable format patient-specific prescription benefit
information, estimated cost information, and therapeutic alternatives
in accordance with at least one of the versions of the standard in
Sec. 170.205(c) (where we have adopted NCPDP RTPB standard version
13). The ability to display RTPB data provides access to this
information and is essential for a user to be able to use the
information to inform shared decision-making as the provider and
patient determine the treatment that will be best for them.
Scope
The NCPDP RTPB standard version 13 supports real-time prescription
benefit requests and responses for a variety of items manufactured for
sale such as medications, vaccines, and medical devices or
supplies.\62\ While the majority of products covered by an individual's
pharmacy benefit will be medications, Part D drugs, as defined at 42
CFR 423.100, can include prescription medications, vaccines, and
supplies associated with the injection of insulin (e.g., syringes,
alcohol pads, gauze), and are represented by RXCUIs \63\ on the
formulary file.
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\62\ See https://www.ncpdp.org/Access-to-Standards.aspx.
\63\ An RXCUI is a machine-readable code or identifier that
points to the common meaning shared by the various source names
grouped and assigned to a particular concept. More information can
be found at https://www.nlm.nih.gov/research/umls/rxnorm/overview.html.
---------------------------------------------------------------------------
In the HTI-1 Proposed Rule we requested comment on the appropriate
scope for a ``real-time prescription benefit'' certification criterion,
including whether a ``real-time prescription benefit'' certification
criterion should require support for products that are not defined as
medications but may also be included in a RTPB transaction, namely
vaccines and medical devices or supplies (87 FR 23853). We received
several comments in response to our request for information on this
topic, with several commenters encouraging an initial focus on
medications for the certification criterion.
In addition to medications, we believe it is important to require
Health IT Modules certified to the ``real-time prescription benefit''
criterion to be able to support vaccines, and note that under Part D
regulations and guidance, plans include most commercially available
vaccines on their formularies.\64\ However, we are not proposing to
include devices and supplies in the proposed certification criterion at
this time. We note that the NCPDP RTPB standard version 13 does yet not
support the FDA Unique Device Identification System unique device
identifiers (UDIs), which are identified as the standard for the Unique
Device Identifier--Implantable data element in the Medical Devices data
class in the USCDI.\65\ Additionally, devices covered under a pharmacy
benefit may be defined as a drug under Section 201(g) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 321(h)) rather than a device
under Section 201(h) and therefore are not assigned a Unique Device
Identifier for Implantable Devices. ONC will continue to monitor
advancements to the NCPDP RTPB standard to support unique identifiers
for devices, any related developments at the FDA, and updates to the
standardization and exchange of device and supplies data.
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\64\ See ``Medicare Prescription Drug Benefit Manual: Chapter
6--Part D Drugs and Formulary Requirements'' 30.2.7 at https://www.cms.gov/medicare/prescription-drug-coverage/prescriptiondrugcovcontra/downloads/part-d-benefits-manual-chapter-6.pdf.
\65\ See USCDI v4: https://www.healthit.gov/isa/taxonomy/term/821/uscdi-v4.
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In summary, we propose in Sec. 170.315(b)(4)(iii) that scope of
the criterion is limited to medications and vaccines covered by a
pharmacy benefit. We invite comments on this proposal.
Formulary and Benefit
In the HTI-1 Proposed Rule, we requested comment on whether we
should further explore capabilities for Health IT Modules to support
access to formulary and benefits information and provided detail about
how access to formulary and benefits information was previously
supported within the Program. We noted that in the 2015 Edition Final
Rule, ONC included a ``Drug-formulary and preferred drug list checks''
certification criterion in Sec. 170.315(a)(10). However, ONC did not
adopt the proposed NCPDP Formulary and Benefit standard version 3.0 to
support this criterion due to comments received in response to the 2015
Edition Proposed Rule (80 FR 16821). The drug formulary and preferred
drug list checks Sec. 170.315(a)(10) certification criterion was later
removed from the Program in the ONC Cures Act Final Rule (85 FR 25660)
because this functionality was widely available, and there was not
sufficient reason to justify the burden on developers and providers of
meeting Program compliance requirements specific to this criterion. We
noted that updates, enhancements, and corrections have been made to the
NCPDP Formulary and Benefit standard since we considered adopting
version 3.0, and many of these updates addressed concerns commenters
expressed previously (87 FR 23854).
Subsequently, in the Part D and Health IT Standards Final Rule, we
finalized adoption of NCPDP Formulary and Benefit standard version 60
in Sec. 170.205(u) (89 FR 51260), reflecting an aligned approach with
the Part D Program to adoption of standards that support electronic
prescribing. In the same rulemaking, CMS finalized to cross-reference
NCPDP Formulary and Benefit standard version 60 in the requirements for
transmitting formulary and benefit information between prescribers Part
D sponsors proposed at 42 CFR 423.160(b)(3) (89 FR 51250 and 51251).
However, we did not make any updates to the Program to incorporate the
proposed Formulary and Benefit standard as part of certification
criteria.
In response to our request for comment in the HTI-1 Proposed Rule,
some commenters supported incorporation of capabilities to access
formulary and benefits information within the Program based on the
NCPDP Formulary and Benefit standard. However, many stated that a
certification criterion based on the standard is not necessary as this
functionality is already widespread in the industry due to existing CMS
regulatory requirements. Furthermore, these commenters stated that a
criterion based on the NCPDP Formulary and Benefit standard may limit
innovation around other approaches to obtaining formulary and benefit
information currently being explored by the industry.
We have considered the comments received in response to the RFI and
have determined not to propose new functionality related to formulary
and benefits information within the Program at this time. We also note
that we have proposed to adopt the HL7 FHIR Da Vinci--Payer Data
Exchange (PDex) US Drug Formulary Implementation Guide, version 2.0.1--
STU 2, in Sec. 170.215(m)(i) in this proposed rule and have referenced
this standard as part of the ``patient access API'' certification
criterion proposed in Sec. 170.315(g)(30)(iii).
Negotiated Price
Section 1860D-4(o)(2)(B)(ii) of the Social Security Act, as added
by section 119(a) of the CAA, 2021, specifically requires real-time
benefit tools capable of providing information on ``cost-sharing
information and the negotiated price'' for drugs and alternatives.
However, we note that we have not proposed to include negotiated price
in the proposed Sec. 170.315(b)(4) certification criterion. The NCPDP
RTPB
[[Page 63534]]
standard version 13 does not include fields to support the exchange of
negotiated price. We solicited comments regarding negotiated price in
response to the RFI, and commenters expressed strong disapproval for
the inclusion of negotiated price in RTBTs. Additionally, concerns were
shared that plan negotiated prices may be confusing to providers and
patients and are not likely to assist or improve the utility or
usability of technology certified to a real-time prescription benefit
certification criterion. We also note that CMS does not require the
exchange of negotiated price by Part D sponsors when implementing an
electronic real-time benefit tool. NCPDP RTPB standard version 13,
which we have proposed to incorporate into the proposed ``real-time
prescription benefit'' certification criterion, is the best available
standard for use currently to provide patient specific cost-sharing
information. Unfortunately, we have not identified a standard or any
consistent approach to deliver reliable negotiated price information in
real-time. ONC will continue to work with CMS and other interested
parties to determine how negotiated price information may be made
available and what technical approaches exist to support transparency
in negotiated prices of drugs.
10. Electronic Health Information (EHI) Export--Single Patient EHI
Export Exemption
a. Background
In the ONC Cures Act Final Rule (85 FR 25690 through 25700), we
finalized a new certification criterion in Sec. 170.315(b)(10) for
Electronic Health Information (EHI) Export. The certification
criterion's conformance requirements were intended to support two
contexts in which we believe that all EHI produced and electronically
managed by a developer's technology should be made readily available
for export as a capability of certified health IT. First, we finalized
in Sec. 170.315(b)(10)(i) that health IT certified to this criterion
must support single patient EHI export upon a valid request by a
patient or a user on the patient's behalf. Second, we finalized in
Sec. 170.315(b)(10)(ii) that the product would support the export of
all EHI when a health care provider chooses to transition or migrate
information to another health IT system. Furthermore, we established in
Sec. 170.402(a)(4), as part of the Assurances Condition of
Certification requirement, that any certified Health IT Module that is
part of a health IT product which electronically stores EHI must
certify to the certification criterion in Sec. 170.315(b)(10).
For the single patient EHI export functionality, we also
established in Sec. 170.315(b)(10)(i)(B) that a user must be able to
execute this capability at any time the user chooses and without
subsequent developer assistance to operate. Subsequently, ONC has heard
from developers that some certified Health IT Modules act primarily as
intermediaries between systems and, through integration, function
without any direct human interaction. As an example, a Health IT Module
may facilitate public health reporting by processing existing EHI into
a required format for report submission without any user interactions.
In such circumstances, a human user may not interact with the certified
Health IT Module itself; and even though the Health IT Module stores
EHI or causes EHI to be stored, this EHI may be a differently formatted
copy of the EHI that already exists in a different, yet integrated,
certified Health IT Module.
b. Proposal for EHI Export
ONC continues to believe that access to EHI export in such
circumstances is critical. However, we recognize the potential burden
in requiring the technology development and implementation of
functionality to execute the capability of single patient EHI export at
any time the user chooses and without subsequent developer assistance
to operate, as established in Sec. 170.315(b)(10)(i)(B), for those
products that act primarily as intermediaries between systems and,
through integration, function without any direct human interaction.
Therefore, we propose to exempt Health IT Modules that act
primarily as intermediaries between systems and, through integration,
function without any direct human interaction from the requirement in
Sec. 170.315(b)(10)(i)(B) to provide functionality without subsequent
developer assistance to operate. We propose this new exemption in Sec.
170.315(b)(10)(i)(F), and we caveat the availability of this exemption
in two ways. First, in Sec. 170.315(b)(10)(i)(F)(1) we propose to
require that the EHI stored, or caused to be stored, by the Health IT
Module certified to Sec. 170.315(b)(10) must be a copy, whether in the
same or another format, of EHI also stored by another Health IT Module
with which the Health IT Module certified to Sec. 170.315(b)(10) is
integrated. Second, in order to ensure that such an exemption is
appropriately limited to Health IT Modules that primarily function
without user interaction and from which users would only rarely seek
single patient EHI export consistent with Sec. 170.315(b)(10)(i), we
further propose in Sec. 170.315(b)(10)(i)(F)(2) that any Health IT
Module for which the developer receives more than 10 requests in the
immediately preceding calendar year for a single patient EHI export
would no longer qualify for this exemption and would need to provide
functionality under Sec. 170.315(b)(10)(i)(B) without subsequent
developer assistance to operate. For purposes of this exemption, we
clarify that requests for a single patient EHI export would be counted
at the product-level rather than the individual instance-level. This
means any request made across all deployed settings or deployed
instances of the Health IT Module would count towards this proposed
threshold. We note that the developer must still meet all other
requirements in Sec. 170.315(b)(10), but that such an exemption would
allow them flexibility in how single patient EHI export is provided
under Sec. 170.315(b)(10)(i), including providing the export with
developer assistance similar to how they provide patient population EHI
export under Sec. 170.315(b)(10)(ii).
We note that the limited circumstance defined here would not be
applicable to health information exchanges or networks. ONC believes
that patients and users assisting patients have a continued need for
access to all single patient EHI, and products in which EHI is
aggregated (such as health information exchanges and networks) should
facilitate full and unfettered access to such information.
We welcome comments on this proposal, including on the threshold of
10 requests across all deployed settings (or deployed instances) of the
Health IT Module per calendar year to qualify for the exemption.
c. Proposal for Associated Assurances Requirements for Single Patient
EHI Export Exemption
To ensure that a developer of certified health IT with a Health IT
Module certified to Sec. 170.315(b)(10) does not inappropriately use
the proposed exemption for single patient EHI export in Sec.
170.315(b)(10)(i)(F) to block information or inhibit the appropriate
access, exchange, and use of EHI, we propose a new Assurances
Maintenance of Certification requirement. We propose in Sec.
170.402(b)(2)(iii) that developers of certified health IT with Health
IT Modules certified to Sec. 170.315(b)(10) that claim the exemption
proposed in
[[Page 63535]]
Sec. 170.315(b)(10)(i)(F) would need to report the number of requests
for single patient EHI export on an annual basis to their ONC-ACB(s).
Specifically, in Sec. 170.402(b)(2)(iii)(A) we propose that on and
after January 1, 2028, a health IT developer of a Health IT Module
certified to the certification criterion in Sec. 170.315(b)(10) and
meets the requirements of paragraph (b)(10)(i)(F) must report to its
ONC-ACB no later than March 1 of each calendar year how many requests
it received during the immediately preceding calendar year. We welcome
comments on this proposal.
11. Revised End-User Device Encryption Criterion
a. Background
In the final rule titled ``Health Information Technology:
Standards, Implementation Specifications, and Certification Criteria
for Electronic Health Record Technology, 2014 Edition; Revisions to the
Permanent Certification Program for Health Information Technology''
(2014 Edition Final Rule) we included end-user device encryption
requirements in Sec. 170.315(d)(7) focused on designing EHR technology
to secure EHI on end-user devices in accordance with the approach
recommend by the Health IT Standards Committee (HITSC) at the time (77
FR 54236). Since finalizing this certification criterion in the 2014
Edition Final Rule, encryption technology has continued to advance
significantly, and we have identified a gap in our current
requirements, which only include end-user device encryption
requirements and exclude server-side encryption requirements.
When finalizing our end-user device encryption requirements in
Sec. 170.315(d)(7) in the 2014 Edition Final Rule, we posited that
end-user device encryption was ``more practical, effective and easier
to implement'' than the general encryption requirement we had finalized
originally in the ONC 2011 Edition certification criteria, which
included server encryption requirements (77 FR 54236). Encryption
technology and availability have significantly improved in the time
since the 2014 Edition Final Rule. For example, developers using
Microsoft Windows Server version 2016 and later versions have BitLocker
disk encryption software readily available, and Linux-based server
developers have free and open-source disk encryption utilities like
Cryptsetup.\66\ These tools, and others like them, make it easy for
server developers to take advantage of the numerous benefits of server
encryption.
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\66\ Microsoft documentation explaining how to deploy BitLocker
disk encryption on Windows Server 2016 and later: https://docs.microsoft.com/en-us/windows/security/information-protection/bitlocker/bitlocker-how-to-deploy-on-windows-server. Homepage for
the Cryptsetup utility that can be used for Linux hard disk
encryption: https://gitlab.com/cryptsetup/cryptsetup/. Note that
these tools would need to be configured to use Approved Security
Functions for FIPS PUB 140-2 to meet ONC's proposed server
encryption requirements outlined later in this section. Approved
Security Functions for FIPS PUB 140-2 are here: https://csrc.nist.gov/files/pubs/fips/140-2/upd2/final/docs/fips1402annexa.pdf.
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Encryption of server-side data prevents unauthorized data access in
many scenarios, including those involving a server breach, theft, or
improper disposal. Mitigating these risks using encryption is a best
practice for all server developers and, given the unique
characteristics of EHI, is especially important for health IT server
developers. EHI is considered one of the most valuable types of
personal information for theft because of the breadth of information
included in electronic health records and the long shelf life of this
information. However, despite its high value, EHI often is not being
properly protected, and the problem is getting worse according to data
published on the Department of Health and Human Services Office for
Civil Rights (OCR) website. Between 2010 and 2022, OCR received 5,144
reports of breaches affecting 500 or more individuals, impacting a
total of 394,236,737 individuals.\67\ The frequency of breaches
affecting 500 individuals or more has increased significantly over the
past few years, with almost two such breaches reported per day in 2022,
nearly double the frequency in 2018.\68\ These statistics indicate that
vulnerabilities and risks exist in technology storing EHI in the United
States. While no single solution can fully protect EHI, data breach
risks can be mitigated by encryption of data maintained on servers.
---------------------------------------------------------------------------
\67\ See https://ocrportal.hhs.gov/ocr/breach/breach_report.jsf.
These numbers are based on breach reports made to OCR as of May 17,
2024.
\68\ See https://ocrportal.hhs.gov/ocr/breach/breach_report.jsf.
These numbers are based on breach reports made to OCR as of May 17,
2024.
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b. Proposal
To better protect electronic health information stored in Health IT
Modules certified under the Program, we propose to clarify the scope of
information that needs to be protected in Health IT Modules certified
to Sec. 170.315(d)(7) and revise the order and sequence of existing
requirements in Sec. 170.315(d)(7) to include new requirements for
server-side encryption.
First, to clarify the scope of electronic health information that
needs to be protected in Health IT Modules certified to Sec.
170.315(d)(7), we propose that on and after January 1, 2026 the
information that must be protected within Health IT Modules certified
to this revised criterion in Sec. 170.315(d)(7) include all personally
identifiable information (PII). This includes, but is not limited to,
individually identifiable health information meeting the definition of
electronic protected health information in 45 CFR 160.103, regardless
of whether the information is held by or for a HIPAA covered entity or
entity required to comply with the Privacy Act of 1974 (5 U.S.C. 552a),
as amended.
Second, we propose to revise existing requirements in Sec.
170.315(d)(7) to include new requirements for server-side encryption
and include the PII encryption requirements for servers in a way that
maintains our existing end-user device encryption requirements and
applies the existing encryption standard and the default settings
requirements broadly in one criterion.
We propose to change the name of Sec. 170.315(d)(7) to ``health IT
encryption,'' to better describe the end-user and proposed server-side
requirements together. We also propose moving our existing end-user
device encryption requirements, in Sec. 170.315(d)(7)(i) and (ii),
into paragraph Sec. 170.315(d)(7)(i) that expires on January 1, 2026
and is replaced by a new PII encryption requirement for end-user
devices in Sec. 170.315(d)(7)(ii) that must be met on and after
January 1, 2026.
Additionally, we propose including the new server-side encryption
requirement in Sec. 170.315(d)(7)(iii) that must be met on and after
January 1, 2026. We propose that this new server encryption requirement
in Sec. 170.315(d)(7)(iii) state that technology designed to store PII
must encrypt the stored PII after use of the technology on those
servers stops.
We also propose to move the encryption standard and default
settings requirements that are currently in Sec. 170.315(d)(7)(i)(A)
and (B) respectively into their own higher-level sections in Sec.
170.315(d)(7)(iv) and (v) respectively. Additionally, we propose that
these encryption standard and default settings requirements apply to
the new server encryption requirement. Pointing to an encryption
standard and requiring that default settings be in place for encryption
capabilities in Sec. 170.315(d)(7) is consistent with our existing
requirements for end-user device encryption, and we believe these
[[Page 63536]]
settings are necessary for our proposed new server encryption
requirement as well.
While certain conformance requirements within the proposed Sec.
170.315(d)(7) have been reorganized, as is outlined in the previous
paragraphs, health IT developers with Health IT Modules certified to
this criterion will continue to have traceability. If we were to
finalize the updates to Sec. 170.315(d)(7) as proposed, developers
with Health IT Modules already certified to Sec. 170.315(d)(7) would
only need to consider updates to the applicable encryption standards,
server-side encryption, and encryption of any non-encrypted PII for the
purposes of maintaining Health IT Module certification in the future.
The permissible encryption algorithms for our proposed new server
encryption requirement are listed in Annex A of The National Institute
of Standards and Technology (NIST) Federal Information Processing
Standards (FIPS) Publication 140-2, October 12, 2021, which specifies
the security requirements for cryptographic modules.\69\ We believe
Annex A of FIPS Publication 140-2 is appropriate for our proposed
server-side encryption requirements for the same reasons it was
considered appropriate for end-user device encryption requirements--it
provides clear requirements and flexibility in demonstrating compliance
(75 FR 44622). We note that the October 12, 2021, draft is the most
recent version of Annex A: Approved Security Functions for FIPS
Publication 140-2, and elsewhere in this Proposed Rule at III.B.4, we
describe our proposal to revise the standard in Sec. 170.210(a) to
include this updated version of Annex A (Draft, October 12, 2021).
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\69\ Annex A of FIPS PUB 140-2: https://csrc.nist.gov/files/pubs/fips/140-2/upd2/final/docs/fips1402annexa.pdf.
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Together, we believe that end-user device and server encryption
requirements help better protect PII. We clarify that in the context of
this certification criterion, a server is a system designed to store
PII. We also clarify that in the context of our proposed new server
encryption requirement in Sec. 170.315(d)(7)(iii), ``stops'' means
that PII on a server is not actively in use and is not actively moving
(i.e., PII that is not being processed, updated, or otherwise acted
upon). We welcome comments on these proposed changes and additions to
Sec. 170.315(d)(7).
12. Revised Criterion for Encrypt Authentication Credentials
a. Background
In the ONC Cures Act Final Rule, we finalized an authentication
credential encryption requirement in Sec. 170.315(d)(12) (85 FR
25700). We established an approach that requires health IT developers
with Health IT Modules certified to the criterion to be transparent
about whether their certified Health IT Module encrypts stored
authentication credentials according to industry standards by attesting
``yes'' or ``no.'' These ``yes'' or ``no'' attestations are made public
on ONC's Certified Health IT Product List (CHPL), which is available at
https://chpl.healthit.gov/.
We established this approach in acknowledgement that some Health IT
Modules certifying to the certification criterion in Sec.
170.315(d)(12) may not be designed to store authentication credentials.
We included a provision in Sec. 170.315(d)(12)(ii) that permits health
IT developers attesting ``no'' to explain why their Health IT Module
does not support encrypting authentication credentials. We noted in the
ONC Cures Act Final Rule that the information regarding the security
capabilities of certified health IT provided by the attestation
increased transparency and aided health IT users in making informed
decisions on how best to protect health information and comply with
applicable security regulations (e.g., the HIPAA Security Rule \70\)
(85 FR 25701).
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\70\ The HIPAA Security Rule is located at 45 CFR part 160 and
subparts A and C of part 164.
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b. Proposal
We now propose to revise the requirements in the ``Encrypt
authentication credentials'' certification criterion in Sec.
170.315(d)(12). We propose to expire our current ``yes'' or ``no''
attestation requirements by moving them to Sec. 170.315(d)(12)(i) and
indicating they are applicable only for the time period up to and
including December 31, 2025. We propose to replace the attestation
requirements by revising Sec. 170.315(d)(12) to include new
requirements in Sec. 170.315(d)(12)(ii) that become effective on and
after January 1, 2026. Additionally, we propose that a health IT
developer may meet the proposed revised certification criterion's
requirements by satisfying the new conformance requirements proposed in
Sec. 170.315(d)(12)(ii) in lieu of Sec. 170.315(d)(12)(i) prior to
paragraph (i)'s December 31, 2025, expiration.
With these new requirements, we propose that Health IT Modules
designed to store authentication credentials must protect the
confidentiality and integrity of their stored authentication
credentials. These revisions include requirements in Sec.
170.315(d)(12)(ii)(A) and (B) for authentication credentials to be
protected using either encryption and decryption according to the
latest version of the Federal Information Processing Standards (FIPS)
140-2 (October 12, 2021) standard in Sec. 170.210(a) or by hashing in
accordance with the FIPS 180-4 standard specified in Sec.
170.210(c)(2). As discussed more fully below, we believe that revising
Sec. 170.315(d)(12) to require Health IT Modules protect stored
authentication credentials according to updated industry standards in
Sec. 170.210(a) is necessary and important to improve the security of
certified health IT. We note in section III.B.4 in this preamble our
proposal to adopt the latest available FIPS Publication 140-2 standard
version in Sec. 170.210(a)(3) and expire the old FIPS Publication 140-
2 standard in Sec. 170.210(a)(2) as of January 1, 2026.
Healthcare data breaches have trended significantly upward in
recent years with around two breaches affecting 500 or more individuals
reported per day in 2023, nearly double the frequency in 2018.\71\
During this same period, we also found that public CHPL attestation
data for Health IT Modules certified to Sec. 170.315(d)(12) indicates
that less than 73% of products meeting the Base EHR Definition in Sec.
170.102 included a ``yes'' attestation to encrypting authentication
credentials.\72\ Given that protecting stored authentication
credentials according to industry standards is a critical defensive
step to help ensure that stolen or leaked authentication credentials
are useless to an attacker, we believe it is important to require that
a Health IT Module designed to store authentication credentials must
protect the confidentiality and integrity of its stored authentication
credentials according to Sec. 170.315(d)(12)(ii).
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\71\ https://ocrportal.hhs.gov/ocr/breach/breach_report.jsf.
These numbers are based on breach reports made to OCR as of February
12, 2024.
\72\ Percentages are based on data retrieved in February 2023
from https://chpl.healthit.gov/#/ search for ``Active,'' ``2015
CURES UPDATE'' listings certified to ``170.315 (D)(12): ENCRYPT
AUTHENTICATION CREDENTIALS (CURES UPDATE) and ``170.315 (D)(13):
MULTI-FACTOR AUTHENTICATION (CURES UPDATE)''
---------------------------------------------------------------------------
We have chosen to reference the FIPS 140-2 (Sec. 170.210(a)) and
FIPS 180-2 (Sec. 170.210(c)(2)) standards in Sec. 170.315(d)(12)(ii)
because they are the seminal, comprehensive, and most appropriate
standards for protecting
[[Page 63537]]
sensitive information within computer systems. Referencing these
standards also remains consistent with our references to these
standards in other certification criteria in our Program.
To reflect our proposed revisions to Sec. 170.315(d)(12), we
propose to rename the certification criterion from ``Encrypt
authentication credentials'' to ``Protect stored authentication
credentials.'' We believe ``protect'' is a broader term that more
clearly includes methods like hashing that can be used to safeguard
stored authentication credentials. In the ONC Cures Act Final Rule we
clarified that ``encrypting authentication credentials could include
password encryption or cryptographic hashing'' (85 FR 25700). Despite
this clarification, we have received inquiries asking if we consider
hashing an acceptable form of ``encryption'' in the context of this
certification criterion. We propose updating the certification
criterion title and regulation text to address such concerns. We invite
comments on our proposal to revise Sec. 170.315(d)(12) to require a
Health IT Module designed to store authentication credentials to
protect the confidentiality and integrity of its stored authentication
credentials according to updated industry standards.
13. Health IT Modules Supporting Public Health Data Exchange
a. Background
Public health promotes and protects the health of all people and
their communities. To accomplish this mission, public health
authorities (PHAs) rely on public health data exchange to acquire the
information they need to provide critical functions for society and to
keep communities healthy.\73\ However, the nation's public health
infrastructure, the technology in place within PHAs, and the methods of
data exchange are often siloed, dated, and incapable of quickly
providing timely, actionable data needed by PHAs and their partners,
resulting in delays in detecting and responding to public health
threats.\74\ As documented in numerous studies, and illustrated by the
COVID-19 pandemic, there is an ongoing challenge for PHAs at all levels
to obtain timely, accurate, representative, and actionable information
from electronic health records and other related systems.\75\ However,
as noted in a 2022 Government Accountability Office (GAO) report, PHAs
do not always have access to--or, often, the ability to share--data
needed to address public health needs (emergent or otherwise). This is
due, in part, to the lack of common standards utilized in the reported
data, variable reporting requirements, limited interoperability of
systems, and an inadequate public health data infrastructure.\76\
Addressing these challenges can improve public health response
readiness and the nation's healthcare system, enabling better-informed
decision making, more comprehensive data analytics, and faster, more
coordinated responses to public health threats and
emergencies.77 78
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\73\ https://www.healthit.gov/sites/default/files/page/2023-03/2023-02-08_HITAC_Annual_Report_for_FY22_supplemental_background_research_508_1.pdf.
\74\ Data Modernization Initiative Strategic Implementation
Plan. December 22, 2021. Available at https://www.cdc.gov/surveillance/pdfs/FINAL-DMI-Implementation-Strategic-Plan-12-22-21.pdf.
\75\ See Public Health Data Modernization: Listening Session on
Real-World Testing of 21st Century Cures Act Requirements. Available
at https://www.cdc.gov/surveillance/pubs-resources/dmi-summary/index.html; Alonzo Plough, Gail C Christopher, Equity-Centered
Public Health Data Demands New Voices at the Table, Health Affairs
(April, 20222) available at https://www.healthaffairs.org/do/10.1377/forefront.20220427.865970/; Robert Wood Johnson Foundation,
Transforming Public Health Data Systems, available at https://www.rwjf.org/en/insights/our-research/2021/09/transforming-public-health-data-systems.html, and Bipartisan Policy Center, Call to
Action for State, Territorial, and Local Policymakers to Move Public
Health Forward, December, 2021, available at https://bipartisanpolicy.org/download/?file=/wp-content/uploads/2021/12/PHF-Call-to-Action-Policymakers-1.pdf.
\76\ https://www.gao.gov/products/gao-22-106175.
\77\ https://cdn.ymaws.com/www.cste.org/resource/resmgr/pdfs/pdfs2/Driving_PH_Print.pdf.
\78\ https://www.cdc.gov/surveillance/pdfs/20_319521-D_DataMod-Initiative_901420.pdf.
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Congress recognized the need to modernize our public health data
infrastructure and in response to the COVID-19 pandemic passed
legislation that included funding and directives related to such
activities. Section 2301 of the American Rescue Plan of 2021 (ARP)
(Pub. L. 117-2, enacted March 11, 2021) included funding for
information technology, standards-based data, and public health
reporting enhancements, including improvements to support standards-
based exchange of data related to vaccine distribution and
vaccinations.\79\ The Coronavirus Aid, Relief, and Economic Security
Act (CARES Act) (Pub. L. 116-136, enacted March 27, 2020) provided
funding to support enhancement of public health information system
capabilities to address COVID-19 reporting needs.\80\
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\79\ https://www.congress.gov/117/plaws/publ2/PLAW-117publ2.pdf.
\80\ https://www.congress.gov/116/plaws/publ136/PLAW-116publ136.pdf.
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Several promising Federal efforts have been initiated to address
the urgent need to improve public health infrastructure and health IT
for public health to enable PHAs to get better and more timely access
to the information they need to protect and improve the health of our
nation. In this proposed rule, we use the phrase ``health IT for public
health'' to mean hardware, software, integrated technologies or related
licenses, IPs, upgrades, or packaged solutions sold as services that
are designed to support public health use cases for the electronic
creation, maintenance, access, or exchange of public health
information, which is consistent with the ``health IT'' definition in
section 13101(5) of the HITECH Act and 45 CFR 170.102. In 2020, CDC
launched the Data Modernization Initiative (DMI) to modernize public
health data and surveillance infrastructure.\81\ More recently, CDC has
released its Public Health Data Strategy (Ph.D.S), which outlines the
data, technology, policy, and administrative actions essential to
exchange critical core data efficiently and securely across healthcare
and public health.\82\ The strategy is designed to describe a path to
address gaps in public health data and help the nation become response-
ready, promote health equity, and improve health outcomes for all.
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\81\ https://www.cdc.gov/surveillance/data-modernization/basics/index.html.
\82\ https://www.cdc.gov/ophdst/public-health-data-strategy/index.html.
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ONC actively works with CDC and other Federal partners on
initiatives that complement, support, and extend CDC's efforts under
the Ph.D.S, including USCDI+ Public Health and Helios, a Fast
Healthcare Interoperability Resources[supreg] (FHIR[supreg])
accelerator through HL7[supreg], to help address DMI priorities around
data interoperability.\83\ USCDI+ is intended to build upon the core
dataset established in the United States Core Data for Interoperability
(USCDI), a standardized set of health data classes and data elements
for nationwide, interoperable health information exchange, discussed in
more detail in section III.B.1 of this proposed rule. We launched
USCDI+ Public Health in October 2021 to capture the data needs of
public health that extend beyond USCDI to ultimately improve the
availability and consistency of data necessary to support various
aspects of public health.\84\ In November 2021, HL7
[[Page 63538]]
launched Helios in collaboration with CDC and ONC.\85\
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\83\ https://www.cdc.gov/surveillance/policy-standards/interoperability.html.
\84\ https://www.healthit.gov/buzz-blog/health-it/thinking-outside-the-box-the-uscdi-initiative; see also https://www.healthit.gov/topic/interoperability/uscdi-plus.
\85\ https://confluence.hl7.org/display/PH/Helios+FHIR+Accelerator+for+Public+Health+Home.
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The Health Information Technology Advisory Committee (HITAC) was
established by the Cures Act and is governed by the provisions of the
Federal Advisory Committee Act (FACA) \86\ which sets forth standards
for the formation and use of Federal advisory committees. Section 3002
of the PHSA, as amended by section 4003(e) of the Cures Act,
established that the FACA applies to the HITAC and that the HITAC would
advise and make recommendations to the National Coordinator on
different aspects of standards, implementation specifications, and
certification criteria relating to the implementation of a health IT
infrastructure, nationally and locally, that advances the electronic
access, exchange, and use of health information. The HITAC created a
Public Health Data Systems Task Force in 2021 (2021 Task Force) to
develop recommendations in response to President Biden's Executive
Order on Ensuring a Data-Driven Response to COVID-19 and Future High
Consequence Public Health Threats,\87\ which tasked HHS with reviewing
the ability of the public health infrastructure to address such
threats.\88\ The 2021 Task Force recommended the inclusion of
``certification of information systems for both senders and receivers''
for public health data.\89\ In 2022, the HITAC convened a second Public
Health Data Systems Task Force (2022 Task Force) and directed it to
build on the recommendations from the 2021 Task Force to more
specifically examine the existing ``(f) criteria'' within our Program,
which certifies health IT for its ability to support various
transmissions to PHAs.\90\ The 2022 Task Force found that improvements
were needed with respect to the flow of data for public health across
the healthcare ecosystem and for robust support of public health in the
Program. In particular, the 2022 Task Force highlighted that while the
Program has certification criteria related to transmitting data to
PHAs, it has not included sufficient real-world testing requirements or
the ability of technology used by PHAs to receive and utilize data
transmitted according to standards required for certified health
IT.\91\ The 2022 Task Force had several recommendations approved by
HITAC, including that we establish certification criteria for Health IT
Modules supporting public health use cases focused on interoperability
functions such as access, exchange, and use of data, and to provide a
common floor for addressing public health interoperability needs.\92\
The 2022 Task Force emphasized that the intent of certification
criteria related to health IT for public health would be to create a
base level of interoperability inclusive of all providers and PHAs and
the methods by which data is primarily electronically exchanged--not to
restrict public authorities from requesting and receiving data in the
manner needed to fulfill their mission.
---------------------------------------------------------------------------
\86\ Federal Advisory Committee Act (FACA), Pub. L. 92-463
(1972), codified as amended at, 5 U.S.C. Chapter 10 (formerly 5
U.S.C. App. 2).
\87\ https://www.whitehouse.gov/briefing-room/presidential-
actions/2021/01/21/executive-order-ensuring-a-data-driven-response-
to-covid-19-and-future-high-consequence-public-health-threats/
#:~:text=It%20is%20the%20policy%20of,a%20better%20public%20health%20i
nfrastructure.
\88\ https://www.healthit.gov/sites/default/files/page/2021-08/2021-07-14_PHDS_TF_2021_HITAC%20Recommendations%20Report_Signed_508_0.pdf.
\89\ https://www.healthit.gov/sites/default/files/page/2022-11/2022-11-10_PHDS_TF_Recommendations_Report_Transmittal_Letter_508.pdf.
\90\ Id.
\91\ https://www.healthit.gov/sites/default/files/facas/2022-11-10_HITAC_Meeting_Notes_508_1.pdf.
\92\ Id.
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In response to these HITAC recommendations in 2021 and 2022 and
consistent with the PHSA sections 3001 and 3004 previously described
(see section II.A), we are proposing several changes to existing
certification criteria as well as the creation of new certification
criteria related to health IT for public health. These proposals are
responsive to the HITAC recommendations to ONC of increasing the
adoption and use of health IT standards for electronic lab reporting,
electronic case reporting, and syndromic surveillance, among others.
These updates and additions to the certification criteria related to
health IT for public health additionally address the HITAC's
recommendations to ONC to position CDC, and other Federal partners, to
be nimble, responsive, and resilient during the next public health
emergency.
Additionally, CDC's Advisory Committee to the Director (ACD)
recommended that a certification program for health IT for public
health would help address core problems with data infrastructure and
exchange.\93\ The ACD recommendations include that CDC and ONC should
work together to develop and implement a coordinated and phased
approach for certifying health IT for public health, grounded in the
use of shared data standards. Both the ACD and the HITAC
recommendations highlight the shared consensus regarding the need to
develop a standards-based certification program to improve the
availability and interoperability of important health information
between healthcare providers and PHAs.
---------------------------------------------------------------------------
\93\ https://www.cdc.gov/about/pdf/advisory/dsw-recommendations-report.pdf.
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We have also addressed public health data exchange as part of
efforts related to the Trusted Exchange Framework and Common
Agreement\TM\ (TEFCA\TM\),\94\ which includes public health as a
specific ``exchange purpose,'' and work is underway with the Recognized
Coordinating Entity[supreg] (RCE\TM\) to develop a Standard Operating
Procedure (SOP) for the public health exchange purpose under TEFCA to
support the ability of providers and PHAs to exchange information, as
well as standardized, secure interoperability for PHAs to exchange
information with each other.\95\ Additionally, we funded the
Association of State and Territorial Health Officials (ASTHO) to launch
a Health Information Exchange (HIE) and Immunization Information System
(IIS) COVID-19 Data Management: Immunization Data Exchange, Advancement
and Sharing (IDEAS) program focused on expanding partnerships between
state, regional, and local HIEs and IISs.\96\ As a program deliverable,
ASTHO conducted an environmental scan focusing on data sharing between
HIEs and IISs.\97\ Findings included the need for data exchange
partners to use the same vocabularies and coding systems and for the
use of a standard messaging format and transmission method for data
exchange.\98\
---------------------------------------------------------------------------
\94\ https://www.healthit.gov/topic/interoperability/policy/
trusted-exchange-framework-and-common-agreement-
tefca#:~:text=The%20overall%20goal%20of%20the,for%20interoperability%
20across%20the%20country.
\95\ https://rce.sequoiaproject.org/tefca-and-rce-resources/.
\96\ https://www.healthit.gov/topic/onc-funding-opportunities/funding-announcements.
\97\ https://www.astho.org/globalassets/report/immunization-information-systems-and-health-information-exchanges.pdf.
\98\ https://www.astho.org/globalassets/report/immunization-information-systems-and-health-information-exchanges.pdf.
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b. Regulatory History
In addition to the efforts described above, we have adopted several
standards, implementation specifications, and certification criteria
related to public health as part of the Program. While the Program
itself is voluntary for health IT developers, compliance with Program
standards, implementation specifications, and
[[Page 63539]]
certification criteria is encouraged through CMS incentive programs.
The American Recovery and Reinvestment Act of 2009 (ARRA) (Pub. L. 111-
5, enacted February 17, 2009) authorized incentive payments to eligible
professionals, eligible hospitals, and critical access hospitals (CAHs)
to promote the adoption and meaningful use of CEHRT. In 2011, CMS
established the Medicare and Medicaid Electronic Health Record (EHR)
Incentive Programs to encourage eligible professionals, eligible
hospitals, and CAHs to adopt and make meaningful use of CEHRT. CMS
changed the name of the EHR Incentive Programs to the Medicare and
Medicaid Promoting Interoperability Programs in April 2018.\99\ The
Medicaid Promoting Interoperability Program ended in 2022, and the
program is currently known as the Medicare Promoting Interoperability
Program for eligible hospitals and CAHs.\100\ The Medicare Promoting
Interoperability Program is also a performance category component of
CMS' Merit-Based Incentive Payment System (MIPS), a program that
determines Medicare payment adjustments.
---------------------------------------------------------------------------
\99\ https://www.cms.gov/medicare/regulations-guidance/promoting-interoperability-programs.
\100\ https://www.cms.gov/regulations-and-guidance/legislation/
ehrincentiveprograms#:~:text=About%20the%20Promoting%20Interoperabili
ty%20Program&text=Beginning%20in%20calendar%20year%20(CY,for%20eligib
le%20hospitals%20and%20CAHs.
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As we have described in prior rulemakings, Congress tied the
standards, implementation specifications, and certification criteria
adopted as part of the Program to the incentives available under CMS
Programs by requiring the meaningful use of CEHRT (75 FR 44591).
Generally, we support the use of certified health IT under CMS
incentive programs by establishing standards, implementation
specifications, and certification criteria for health IT as part of the
Program that are then incorporated into the CMS definition of CEHRT
relied upon by health care providers and other users of health IT to
receive incentives from CMS programs. For example, for calendar year
2023, to be considered a meaningful user and avoid a downward payment
adjustment, eligible hospitals and CAHs attesting to the Medicare
Promoting Interoperability Program are required to use CEHRT that has
been updated to meet the 2015 Edition Cures Update certification
criteria.\101\
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\101\ https://www.cms.gov/Regulations-and-Guidance/Legislation/
EHRIncentivePrograms/
Certification#:~:text=In%20order%20to%20efficiently%20capture,data%20
in%20a%20structured%20format.
---------------------------------------------------------------------------
In the 2010 interim final rule with comment period entitled
``Health Information Technology: Initial Set of Standards,
Implementation Specifications, and Certification Criteria for
Electronic Health Record Technology'' (75 FR 2014), we first
established standards and certification criteria related to public
health. These included standards and certification criteria for the
electronic submission of laboratory results to PHAs, electronic
submission to PHAs for surveillance or reporting, and electronic
submission to immunization registries. These standards and
certification criteria were updated in the 2010 final rule entitled
``Health Information Technology: Initial Set of Standards,
Implementation Specifications, and Certification Criteria for
Electronic Health Record Technology'' (75 FR 44590).
In the 2012 final rule entitled ``Health Information Technology:
Standards, Implementation Specifications, and Certification Criteria
for Electronic Health Record Technology, 2014 Edition; Revisions to the
Permanent Certification Program for Health Information Technology'' (77
FR 54163), we expanded the public health related standards and
certification criteria and codified the 2014 Edition EHR certification
criteria in Sec. 170.314, with the public health certification
criteria organized in Sec. 170.314(f). The public health certification
criteria in the 2012 final rule included:
Sec. 170.314(f)(1) ``Immunization information'';
Sec. 170.314(f)(2) ``Transmission to immunization
registries'';
Sec. 170.314(f)(3) ``Transmission to public health
agencies--syndromic surveillance'';
Sec. 170.314(f)(4) ``Inpatient setting only--transmission
of reportable laboratory tests and values/results''; and,
two ``optional'' certification criteria:
[cir] Sec. 170.314(f)(5) ``Optional--ambulatory setting only--
cancer case information''; and,
[cir] Sec. 170.314(f)(6) ``Optional--ambulatory setting only--
transmission to cancer registries.''
Then, in the 2014 final rule entitled ``2014 Edition Release 2
Electronic Health Record (EHR) Certification Criteria and the ONC HIT
Certification Program; Regulatory Flexibilities, Improvements, and
Enhanced Health Information Exchange'' (79 FR 54430), we added an
optional, ambulatory-setting only certification criterion for syndromic
surveillance in Sec. 170.314(f)(7).
In the 2015 final rule entitled ``2015 Edition Health Information
Technology (Health IT) Certification Criteria, 2015 Edition Base
Electronic Health Record (EHR) Definition, and ONC Health IT
Certification Program Modifications'' (2015 Edition Final Rule) (80 FR
62601), we revised the public health certification criteria to include
the following:
Sec. 170.315(f)(1) ``Transmission to immunization
registries,'' revised as compared to the 2014 Edition;
Sec. 170.315(f)(2) ``Transmission to public health
agencies--syndromic surveillance,'' revised as compared to the 2014
Edition;
Sec. 170.315(f)(3) ``Transmission to public health
agencies--reportable laboratory tests and values/results,'' revised as
compared to the 2014 Edition;
Sec. 170.315(f)(4) ``Transmission to cancer registries,''
revised as compared to the 2014 Edition;
a new certification criterion Sec. 170.315(f)(5)
``Transmission to public health agencies--electronic case reporting;''
a new certification criterion Sec. 170.315(f)(6)
``Transmission to public health agencies--antimicrobial use and
resistance reporting,'' and,
a new certification criterion Sec. 170.315(f)(7)
``Transmission to public health agencies--health care surveys.''
In the in the 2020 final rule entitled ``21st Century Cures Act:
Interoperability, Information Blocking, and the ONC Health IT
Certification Program'' (85 FR 25642), we revised the public health
certification criterion Sec. 170.315(f)(5) ``Transmission to public
health agencies--electronic case reporting'' to incorporate the USCDI
v1 standard and C-CDA companion guide (85 FR 25671). However, in the
subsequent Interim Final Rule with comment period entitled
``Information Blocking and the ONC Health IT Certification Program:
Extension of Compliance Dates and Timeframes in Response to the COVID-
19 Public Health Emergency'' (85 FR 70064), we further revised that
requirement so that health IT developers certifying to Sec.
170.315(f)(5) were required to conform to data classes expressed in the
USCDI standard in Sec. 170.213 or the Common Clinical Data Set for the
period before December 31, 2022 (85 FR 70076). Additionally, in a final
rule titled, ``Health Data, Technology, and Interoperability:
Certification Program Updates, Algorithm Transparency, and Information
Sharing'' (HTI-1 Final Rule) (89 FR 1192), we revised the
``Transmission to public health agencies--electronic case reporting''
certification criterion in Sec. 170.315(f)(5) to replace the
functional requirements
[[Page 63540]]
with standards and implementation guides (IGs) and updated vocabulary
standards in Sec. 170.207(a), (c), and (e) that are referenced in
several public health certification criteria.
Currently, the Program includes seven certification criteria
related to public health (see Sec. 170.315(f)). We are referring to
these seven certification criteria as the ``(f) criteria'' in this
proposed rule and may refer to them in that way in future rulemaking.
These (f) criteria are:
Sec. 170.315(f)(1) Transmission to immunization
registries
Sec. 170.315(f)(2) Transmission to public health
agencies--syndromic surveillance
Sec. 170.315(f)(3) Transmission to public health
agencies--reportable laboratory tests and values/results
Sec. 170.315(f)(4) Transmission to cancer registries
Sec. 170.315(f)(5) Transmission to public health
agencies--electronic case reporting
Sec. 170.315(f)(6) Transmission to public health
agencies--antimicrobial use and resistance reporting
Sec. 170.315(f)(7) Transmission to public health
agencies--healthcare surveys
Generally, the certification criteria listed above include report
generation and transmission functionalities, require Health IT Modules
to adhere to specific standards and implementation guides, and provide
assurances that the certified Health IT Module performs as intended.
However, we note that the certification criteria do not include all
functionalities that may be of interest to public health, nor does the
Program certify data quality or the technology that receives incoming
submissions. Additionally, most of these certification criteria have
not been substantially updated since 2015, as described above.
c. Proposal Overview
As indicated in the regulatory history, we have not updated the
Program's certification criteria related to public health since 2015,
with the exception of standards and IGs being added to the requirements
for the ``Transmission to public health agencies--electronic case
reporting'' certification criterion in Sec. 170.315(f)(5) and updates
to several vocabulary standards in the HTI-1 Final Rule. Standards
referenced in Sec. 170.315(f)(5), Sec. 170.315(f)(6), and Sec.
170.315(f)(7) have advanced through the Standards Version Advancement
Process (SVAP), which allows health IT developers to voluntarily use
more recent versions than those adopted in regulation as part of
certification under the Program.\102\
---------------------------------------------------------------------------
\102\ https://www.healthit.gov/topic/standards-version-advancement-process-svap.
---------------------------------------------------------------------------
Considering the urgent need for greater public health data exchange
and access to more actionable data by PHAs, we propose a multi-pronged
approach that takes advantage of and builds upon the various efforts
described above, including advancements in FHIR-based solutions and
evolving standards related to public health interoperability. For
example, a CDC report on public health data modernization found that
enabling greater flow of health information from electronic health
records to PHAs using HL7 FHIR-based standards could allow public
health to take advantage of advanced data science capabilities such as
predictive analysis, enhanced surveillance, personalized
communications, and streamlining of data sharing while protecting
patient privacy.\103\
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\103\ https://www.cdc.gov/surveillance/data-modernization/index.html.
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We propose to revise the Program's current certification criteria
related to public health in Sec. 170.315(f); add several new
functional requirements and adopt newer versions of standards within
the current (f) criteria; add two additional certification criteria in
the current (f) criteria for birth reporting and bi-directional
exchange with a prescription drug monitoring program (PDMP); adopt new
certification criteria for health IT for public health in Sec.
170.315(f)(21) through (29); adopt enhancements to the standardized API
for patient and population services in Sec. 170.315(g)(10) (see
section III.B.19); and adopt a new certification criterion for a
standardized FHIR-based API for public health data exchange in Sec.
170.315(g)(20), which we also propose to adopt as part of the Base EHR
definition. Additionally, we propose to revise the naming of the (f)
criteria to reflect first the public health use case, followed by the
functionality the certification criterion supports. We believe this
will help support clarity for both the use case and the specific
capabilities as we continue to expand health IT supports for public
health data exchange. While the proposed (f) criteria updates and
additions focus primarily on health IT for public health, we believe it
is likely that these certification criteria may be used in other use
cases and settings.
In general, we seek to frame health IT certification criteria so
that the certified health IT can be used by a wide range of entities in
a different setting--including by health care providers, researchers,
PHAs, or third-party entities supporting public health use cases
defined in Sec. 170.315(f), such as health information networks or
other types of registries. For these public health use cases, we
propose to group functions within use cases based on the implementation
guides and the transactions within a bi- or multi-directional
information exchange workflow. These functions may be part of a wide
range of technologies, employed by a wide range of users, and we remain
agnostic to the specific entity that may purchase any health IT product
certified to the functionality. As such, we use the term ``health IT
for public health'' to support the functions and transactions in the
public health use cases in Sec. 170.315(f)(21) through (29).
Accordingly, we propose to revise the naming of the current (f)
criteria as follows:
Sec. 170.315(f)(1) Immunization registries--Bi-
directional exchange
Sec. 170.315(f)(2) Syndromic surveillance--Transmission
to public health agencies
Sec. 170.315(f)(3) Reportable laboratory results--
Transmission to public health agencies--and Laboratory Orders--Receive
and validate
Sec. 170.315(f)(4) Cancer registry reporting--
Transmission to public health agencies
Sec. 170.315(f)(5) Electronic case reporting--
Transmission to public health agencies
Sec. 170.315(f)(6) Antimicrobial use and resistance
reporting--Transmission to public health agencies
Sec. 170.315(f)(7) Health care surveys--Transmission to
public health agencies
The new (f) criteria for public health data exchange and for health
IT for public health that we propose to adopt are:
Sec. 170.315(f)(8) Birth reporting--Transmission to
public health agencies
Sec. 170.315(f)(9) Prescription Drug Monitoring Program
(PDMP) Databases--Query, receive, validate, parse, and filter
Sec. 170.315(f)(21) Immunization information--Receive,
validate, parse, filter, and exchange--response.
Sec. 170.315(f)(22) Syndromic surveillance--Receive,
validate, parse, and filter
Sec. 170.315(f)(23) Reportable laboratory test values/
results--Receive, validate, parse, and filter
Sec. 170.315(f)(24) Cancer pathology reporting--Receive,
validate, parse, and filter
Sec. 170.315(f)(25) Electronic case reporting--Receive,
validate, parse, filter, electronic initial case reports and
[[Page 63541]]
reportability response; and create and transmit reportability response
Sec. 170.315(f)(28) Birth reporting--Receive, validate,
parse, and filter
Sec. 170.315(f)(29) Prescription Drug Monitoring Program
(PDMP) Data--Receive, validate, parse, filter prescription data,
support query and exchange
We also propose revisions to the ``Computerized provider order
entry--laboratory'' certification criterion in Sec. 170.315(a)(2) that
relate to the proposed updates to the public health certification
criteria listed above. Please see section III.B.18 for detail on those
proposed updates to Sec. 170.315(a)(2).
We propose this multi-pronged approach--updating existing
requirements, adding new requirements for receipt, updating standards,
and including a glidepath for transitioning to FHIR-based exchange in
the future--to harmonize data exchange across the industry and further
advance public health infrastructure to be response-ready, scalable,
and flexible. We intend for this approach to allow for systems to
mature and advance in an aligned fashion, reduce the need for manual
workarounds and intervention, and lead to wider adoption of modern
standards-based capabilities.
We understand that some health IT certification terms used in ONC's
regulations for specific technical actions or capabilities may not be
the same uses of the terms by the public health or healthcare sector
when discussing programmatic activities. For example, in the Program we
use the term ``validate'' in reference to the technical capability to
correctly identify if a structured document or message received is
conformant to a standard and if formats or vocabulary standards are
valid or invalid. This is a necessary technical step to map data
received in an interoperable manner. Public health or quality reporting
related organizations may use the term ``validate'' to refer to an
organizational or programmatic process to support program integrity,
data accuracy, and data quality. In order to maintain consistency
within the Program and to provide clarity for health IT developers, we
use terms that describe health IT software functions that--while they
may enable such activities by users--are specific to technical
requirements. In addition, we use terms that are consistent across
certification criteria--such as receive, validate, parse, and filter--
to clearly and consistently define health IT functions in a manner that
supports health IT developers participating in the Program. The
capabilities we propose in this manner are intended to advance tools
which can be used in a variety of ways to support greater efficacy
across multiple programmatic and organizational use cases and processes
for the public health and healthcare community.
Prior experiences with the Program demonstrated an imperative to
test both the sending and receiving of information, particularly in HL7
messages and documents. The initial requirement of Continuity of Care
Documents (CCDs) in early iterations of the Program only included the
functionality to create and send, resulting in multiple deviations and
variations of the same document type and creating challenges with
receiving the same standard from different vendors. Such variability
included different formatting, such as line and page breaks or
representation of date, as well as including or excluding specific data
elements, such as onset time of problem.\104\ These variations, while
allowed under the Program at the time, made receiving, integrating, and
interpreting CCDs challenging. However, when certification requirements
and associated testing expectations were updated to include the receipt
of CCDs as well, there was a noticeable improvement in consistency.
Over time, implementation guides developed through standards
development organizations became more constrained, with fewer areas of
optionality, and companion guides supplemented these IGs, reducing the
variations discussed above, and improving interoperability.
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\104\ D'Amore JD, Sittig DF, Wright A, Iyengar MS, Ness RB. The
promise of the CCD: challenges and opportunity for quality
improvement and population health. AMIA Annu Symp Proc. 2011;
2011:285-94. Epub 2011 Oct 22. PMID: 22195080; PMCID: PMC3243208.
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These lessons in the early implementation of the Program were
considered when developing the current proposals. For public health
reporting, only sending systems--namely health IT used by health care
providers--have been held to requirements for transmission. Similar
divergence in minimum system capabilities and variable adoption and use
of established national standards between certified health IT
developers and health IT for public health have created challenges for
PHAs, which have struggled to make use of data that is not consistent,
even when it conforms to a healthcare standard. At best, these
differences result in significant inefficiencies, as PHAs must develop
manual workarounds and custom tools that standardize and format
incoming data to reduce processing time and improve receipt, data
mapping, and parsing processes. At worst, these differences impede
public health's ability to quickly translate data it receives from
healthcare into actions that protect and support the health of all
people and their communities.
By establishing minimum functional capabilities and exchange
standards for health IT and health IT for public health to send and
receive public health data, we expect to enhance interoperability
across healthcare and public health and provide a long-term mechanism
for alignment as data exchange matures over time. Modernization efforts
across health IT and health IT for public health will progress and
upgrade on the same timeline, using the same standards in their
entirety.
d. Revised Certification Criteria for Health IT Modules Supporting
Public Health Data Exchange
We propose to revise the current certification criteria located in
Sec. 170.315(f) as described below.
i. Sec. 170.315(f)(1)--Immunization Registries--Bi-directional
Exchange
While immunization reporting is one of the most advanced components
of the public health data exchange ecosystem, challenges remain.
Throughout the COVID-19 pandemic, certain issues rose in prominence,
such as individuals needing access to their personal immunization
histories from health IT systems and providers being unable to
consistently query or view vaccines given at different places of care.
Further, there were challenges with Health IT Modules being unable to
consistently provide bulk access on vaccinated populations to
immunization systems (e.g., to understand if students were up to date
on vaccines for vaccine-preventable diseases).
The current certification criterion in Sec. 170.315(f)(1) has been
widely implemented in Health IT Modules but has not been updated since
2015, with the exception of the vocabulary standards in Sec.
170.207(e) that are referenced in the certification criterion and
updated in the HTI-1 Final Rule (89 FR 1226). We propose to update the
Immunization Messaging Implementation Guide (IG) standard in Sec.
170.205(e) to the HL7 v2.5.1 IG for Immunization Messaging, Release
1.5, Published October 2018, which is a compilation of the Release 1.5
version and the Addendum from 2015 referenced in the current Program,
and incorporate it by reference in Sec. 170.299. We are aware that the
HL7 Public Health Workgroup will work on further updates to the IG,
based in part on
[[Page 63542]]
lessons learned from the pandemic, but that this new version will
likely not be published until mid-to-late 2024. We welcome comments on
advances beyond the current 1.5 version of the IG and encourage
participation in the HL7 Public Health Workgroup. We also propose that
adoption of the standard in Sec. 170.205(e)(4) expires on January 1,
2028. Additionally, as described in the ``Minimum Standards Code Sets
Updates'' section (III.B.5), we propose to update the vocabulary
standards in Sec. 170.207(e) that are referenced in Sec.
170.315(f)(1) and thus are proposing to update Sec.
170.315(f)(1)(i)(B) to reference the new proposed Sec. 170.207(e)(5)
and to update Sec. 170.315(f)(1)(i)(C) to reference the new proposed
Sec. 170.207(e)(6).
We propose to add a functional requirement in Sec.
170.315(f)(1)(iii) to receive incoming patient-level immunization-
specific query or request from external systems and respond. We propose
to revise the name of the certification criterion in Sec.
170.315(f)(1) to ``Immunization registries--Bi-directional exchange''
to more accurately represent the capabilities included in the
certification criterion. We note that we additionally propose a
requirement in support of requests for multiple patients' data as a
group using an application programming interface in Sec.
170.315(g)(20)(ii) and direct readers to section III.B.13.f for further
information on that related proposal, in addition to our proposed
revisions to Sec. 170.315(g)(10) which includes capabilities to
support multiple patients' data as a group using an application
programming interface (section III.B.19). We expect these changes to
enable more approaches for bi-directional exchange of immunization
information. Further, we propose patient access to their immunization
information stored in Health IT Modules using SMART Health Cards
``verifiable health records'' in proposed Sec. 170.315(g)(10) and
direct readers to section III.B.19 for further information on that
proposal.
We expect these proposed changes would improve patient access to
more complete and standardized immunization information stored in
Health IT Modules, and request feedback on this approach. Specifically,
we request feedback on the standard referenced in Sec. 170.205(e) and
whether we should consider adopting that soon-to-be most current
version in a final rule, as we are aware that an updated version of the
standard is due to be published in mid-2024. We request feedback on the
functional requirement to respond to patient-level, immunization-
specific queries from external systems and request comment on if the
standard referenced in Sec. 170.205(e) is sufficient for the proposed
functional requirement to respond to incoming patient-level and
immunization-specific queries, or if that is better handled through the
IG currently going through HL7 processes for updates.
We propose to revise the certification criterion in Sec.
170.315(f)(1) to include revised minimum standard code set
requirements, updated implementation specifications, and new
functionality. We propose that, for the time period up to and including
December 31, 2026, a Health IT Module may continue to be certified to
the existing version of the certification criterion as described in
Sec. 170.315(f)(1)(i), with proposed modifications for clarity and
with a proposed revision to include the minimum standard code set
updates for representation of historic and administered vaccines
proposed for adoption in Sec. 170.207(e), or it may be certified to
the newly proposed certification criteria in Sec. 170.315(f)(1)(ii)
and (iii). We propose the new and revised certification criteria in
Sec. 170.315(f)(1)(ii) and (iii) to replace the existing certification
criterion in Sec. 170.315(f)(1)(i) beginning on January 1, 2027.
Specifically, the proposed revisions to the certification criterion in
Sec. 170.315(f)(1)(ii) include updates to the minimum standards
specified in Sec. 170.207(e), use of newer versions of implementation
specifications proposed for adoption in Sec. 170.205(e), and new
functionality to enable a user to receive and respond to incoming
patient-level immunization-specific query or request from external
systems. We propose that a Health IT Module certified to Sec.
170.315(f)(1) must be updated to meet the requirements of the revised
certification criterion in Sec. 170.315(f)(1)(ii) and the requirements
in Sec. 170.315(f)(1)(iii), and that a health IT developer must
provide such updated technology to their customers by no later than
December 31, 2026. We propose that any Health IT Module seeking
certification to the certification criterion in Sec. 170.315(f)(1) on
and after January 1, 2027, must meet the revised requirements in Sec.
170.315(f)(1)(ii) and the requirements in Sec. 170.315(f)(1)(iii).
ii. Sec. 170.315(f)(2)--Syndromic Surveillance--Transmission to Public
Health Agencies
Syndromic surveillance has proven to be a vital component of public
health data exchange and surveillance. Such data provide early
indicators of public health threats, identify changes in occurrence of
disease, illness, or injury patterns, and detect population-wide
hazards. Today, the Program references an implementation guide last
updated in 2015. Due to outdated cardinality within the standard and
customization in the implementation of the standard, there are often
missing or incomplete data elements.
The current certification criterion in Sec. 170.315(f)(2) has not
been updated since 2015 and references a 2015 ADT-based IG published
through CDC's Public Health Information Network (PHIN). The current
version of the IG, Version 2.5.1 Implementation Guide: Syndromic
Surveillance, Release 1--US Realm Standard for Trial Use, July 2019
published by HL7, more specifically defines the required data elements
and message specifications for an ADT-based interface implemented
specifically for syndromic surveillance. This standard includes new and
updated data elements to aid in public health surveillance, including,
but not limited to, patient discharge disposition, patient class,
diagnosis code, reason for admission, and service location.
Additionally, the observation component within the implementation guide
now contains additional required elements relevant to public health,
including, but not limited to, pregnancy status, travel history, and
acuity. These new and updated data elements provide additional
information for PHAs to inform assessment of emerging threats and the
proceeding action.
We propose to revise the standard in Sec. 170.205(d), which is
referenced in Sec. 170.315(f)(2), to reference the most recent IG, HL7
Version 2.5.1 Implementation Guide: Syndromic Surveillance, Release 1--
US Realm Standard for Trial Use, July 2019 in Sec. 170.205(d)(1) and
incorporate it by reference in Sec. 170.299. We also propose to add an
expiration date of January 1, 2027 for the standards previously adopted
in Sec. 170.205(d)(2) and (d)(4). However, we propose that the
standard adopted in Sec. 170.205(d)(2) shall include an indication
that the expiration is for the purposes of the certification criteria
in Sec. 170.315(f). We propose that the adoption of the standard in
Sec. 170.205(d)(2) on behalf of HHS shall be otherwise maintained as
it is currently referenced by HHS programs for other use cases. We
propose that any health IT module certified to Sec. 170.315(f)(2)
would be required to meet at least one implementation specification
that is (1) adopted in Sec. 170.205(d) or approved for SVAP and (2)
not expired at the time of use. We propose that a health IT developer
must update any health IT module certified to Sec. 170.315(f)(2) and
provide such
[[Page 63543]]
updated module to its customers by the expiration date of the
applicable standard in order to maintain certification of the health IT
module. These revisions to the certification criterion in Sec.
170.315(f)(2) would support additional data elements being shared with
syndromic surveillance programs. We further propose to change the name
of the criterion in Sec. 170.315(f)(2) to Syndromic surveillance--
Transmission to public health agencies.
iii. Sec. 170.315(f)(3)--Reportable Laboratory Results--Transmission
to Public Health Agencies--and Laboratory Orders--Receive and Validate
The COVID-19 pandemic brought issues with laboratory data
interoperability and associated reporting challenges to light. However,
many of these issues are not specific to the pandemic and are instead
due to the existing infrastructure and low adoption of current
standards. Health IT Modules currently exchange older versions of the
electronic laboratory reporting standard that no longer fully meet the
needs of public health. We recognize there are also issues facing
laboratory reporting and interoperability related to local codes and
the manual effort involved with mapping local codes to standard codes.
We received feedback about the challenges and time it takes for the
mapping needed for exchange, and the downstream issues that occur if
the mapping is not completed. However, we do not believe this can be
solved solely through updates to the Program, which can require that
technology support standard codes but cannot mandate that users record
data using such standard codes. We will continue to partner with
industry and others on addressing these broader challenges. We propose
that health IT presented for certification support use of at least one
of the versions of Systemized Nomenclature of Medicine--Clinical Terms
(SNOMED CT[supreg]),\105\ Logical Observation Identifiers Names and
Codes (LOINC[supreg]),\106\ and the Unified Code for Units of Measure
(UCUM) \107\ code sets specified in Sec. 170.207(a), (c), and (m)
respectively to include updated code sets.
---------------------------------------------------------------------------
\105\ https://www.snomed.org/.
\106\ https://loinc.org/.
\107\ https://ucum.org/.
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We propose to revise the certification criterion in Sec.
170.315(f)(3) to include these revised minimum standard code set
requirements, as well as updated implementation specifications, and new
functionality. The proposed revisions to the certification criterion
include the same minimum standards updates in Sec. 170.207(a), (c),
and (m), use of newer versions of implementation specifications
proposed for adoption in Sec. 170.205(g), and new functionality to
enable a user to receive and validate reportable laboratory order
consistent with the new standards proposed for adoption in Sec.
170.205(g).
The certification criterion in Sec. 170.315(f)(3) is specific to
lab results being transmitted to PHAs and has been applied primarily to
Health IT Modules reporting laboratory values/results to jurisdictional
PHAs. The certification criterion currently only includes transmission
of laboratory results and does not cover functions related to the
laboratory order. We propose to update the certification criterion to
also include functionality for Health IT Modules to receive, validate,
parse, and filter laboratory orders, according to the standard proposed
in Sec. 170.205(g)(2). We also propose to update the certification
criterion to reference the standard proposed in Sec. 170.205(g)(3) for
the transmission of laboratory results.
We propose to revise the content and exchange standards for
electronic transmission of lab results to PHAs in Sec. 170.205(g). In
Sec. 170.205(g) we propose to reorganize the paragraph to include the
current standard HL7 2.5.1, HL7 Version 2.5.1 Implementation Guide:
Electronic Laboratory Reporting to Public Health, Release 1 (US Realm)
(ELR) with Errata and Clarifications, and ELR 2.5.1 Clarification
Document for EHR Technology Certification adopted in Sec. 170.205(g)
and incorporated by reference in Sec. 170.299 into a new paragraph
(1). We propose an expiration date of January 1, 2028 for the standard
in Sec. 170.205(g)(1). We propose to adopt the standard for HL7
Version 2.5.1 Implementation Guide: Laboratory Orders (LOI) from EHR,
Release 1, STU Release 4--US Realm in Sec. 170.205(g)(2) and
incorporate it by reference in Sec. 170.299. We propose to adopt in
Sec. 170.205(g)(3), and incorporate by reference in Sec. 170.299, the
standard for HL7 Version 2.5.1 Implementation Guide: Laboratory Results
Interface, Release 1 STU Release 4--US Realm (LRI), and to specify the
use of the Public Health Profile, in addition to the ELR IG.
We propose to revise Sec. 170.315(f)(3)(ii) to reference LRI in
addition to the HL7 Version 2.5.1 Implementation Guide: Electronic
Laboratory Reporting to Public Health, Release 1 (US Realm) (ELR). We
propose to revise the standards in Sec. 170.207(a), (c), and (m),
which are referenced in Sec. 170.315(f)(3)(i) and (ii), to reference
the latest versions of SNOMED CT, LOINC, and UCUM respectively. We
further propose to add a functional requirement in Sec.
170.315(f)(3)(ii) requiring the ability to receive, validate, parse,
and filter reportable laboratory orders according to the standards
proposed in Sec. 170.205(g)(2) and (g)(3). Additionally, we propose to
rename the certification criterion in Sec. 170.315(f)(3) to
``Reportable laboratory results--Transmission to public health
agencies--and Laboratory Orders--Receive and validate.''
The proposed changes to the certification criterion in Sec.
170.315(f)(3) would help increase the data shared between healthcare
providers, laboratories, and PHAs and would increase interoperability
among the different systems in place at each entity. Our proposed
changes would also provide more complete patient-level information for
contact tracing, patient outreach, direct care, and other clinical and
public health activities.
The use of the LRI IG would provide more specificity than ELR,
which can decrease the need for one-off mapping. Given the benefit of
the LRI IG, we propose adding the LRI as an option for reporting to
PHAs, in addition to the existing ELR IG. Additionally, the LRI and LOI
IGs could have use beyond public health reporting, which can reduce
implementation and maintenance burden for hospitals and providers, as
both the LOI and LRI standards have multiple use cases defined in the
IGs, allowing for more flexibility, reusability, and scalability. We
are proposing to add the option of the public health profile in the LRI
IG, given that it is an updated version of the ELR R1 IG, but request
comment on whether there are additional profiles that should also be
included within the LRI IG as part of the updated Sec. 170.315(f)(3)
certification criterion.
The LOI IG makes important patient demographic information
required, including race, ethnicity, sex, and contact information,
which may allow PHAs to get more complete data in circumstances when
the laboratory has these data elements and can appropriately fill the
fields. This demographic information can also be used to improve
patient matching, which in turn improves patient care and the
efficiency of care. In one study, electronic laboratory reports were
missing data on race more than one-third of the time and data on
ethnicity were present less than one-fifth of the time.\108\ Missing
data in laboratory
[[Page 63544]]
results to PHAs also remains a problem, which has not been solved
through various attempts within industry. However, there is currently
low uptake of the LOI and LRI standards, despite the increased
specificity. We believe that including both standards in the Program
will lead to more complete demographic information and higher rates of
adoption.
---------------------------------------------------------------------------
\108\ Electronic health information quality challenges and
interventions to improve public health surveillance data and
practice.--Abstract--Europe PMC. https://europepmc.org/article/PMC/3804098.
---------------------------------------------------------------------------
We propose that for the time period up to and including December
31, 2027, a Health IT Module may continue to be certified to the
existing version of the certification criterion as described in Sec.
170.315(f)(3)(i), with proposed modifications for clarity and with a
proposed revision to include the minimum standard code set updates in
Sec. 170.207(a), (c), and (m). We propose that a Health IT Module
certified to Sec. 170.315(f)(3) must be updated to meet the
requirements of the revised certification criterion in Sec.
170.315(f)(3)(ii) and that a health IT developer must provide such
updated technology to their customers by no later than December 31,
2027. We propose that any Health IT Module seeking certification to the
certification criterion in Sec. 170.315(f)(3) on and after January 1,
2028, must meet the revised requirements in Sec. 170.315(f)(3)(ii). We
welcome comment on this proposal.
We recognize that there is a high volume of laboratory reporting
interfaces in place today, for clinical and public health purposes,
among others. As such, we request comment on whether the time period to
phase out the ELR IG is sufficient, or if there needs to be a longer
transitional period where both LRI and ELR are allowed for the purposes
of transmitting laboratory results/values to PHAs. If January 1, 2028,
is not feasible for the shift to only using LRI, we request comment on
a feasible date for this transition.
We further request comment on whether we should specify the LOI IG
standard, or whether we should instead include the functional
requirements for the receipt, validation, parsing, and filtering of
orders without referencing a specific standard. We also request comment
on whether there are specific profiles within the LOI IG that should be
referenced rather than the IG in its entirety.
iv. Sec. 170.315(f)(4)--Cancer Registry Reporting--Transmission to
Public Health Agencies
Cancer reporting is an important, mandatory component of cancer
control efforts in the United States. State registries collect
information on diagnosed cases of cancer, treatments, and demographic
information. Such information informs interventions and helps allocate
resources in communities and populations affected by high rates of
cancer. For example, in areas where high rates of breast cancer are
diagnosed, PHAs can work with healthcare organizations and providers on
programs and efforts to increase early screening and other preventative
interventions.
We propose to revise the certification criterion in Sec.
170.315(f)(4) to include revised minimum standard code set
requirements, updated implementation specifications, and new
functionality. Since our last rulemaking cycle, there have been minor
updates to the CDA Implementation Guide for Cancer Registry
Reporting,\109\ which is currently referenced in Sec. 170.205(i)(2)
and is required by the certification criterion. There is also a FHIR IG
for cancer registry reporting that has been used in several pilots:
Central Cancer Registry Reporting Content IG 1.0.0--STU 1.\110\
---------------------------------------------------------------------------
\109\ http://www.hl7.org/implement/standards/product_brief.cfm?product_id=398.
\110\ https://build.fhir.org/ig/HL7/fhir-central-cancer-registry-reporting-ig/usecases.html.
---------------------------------------------------------------------------
We propose to modify the certification criterion to specify that a
Health IT Module would need to support the creation and submission of
cancer registry reports using either (at least one) of these standards:
The cancer FHIR reporting bundle and accompanying profiles
according to the HL7 FHIR Central Cancer Registry Reporting Content IG
1.0.0--STU1 in Sec. 170.205(i)(3), with the requirement that all data
elements indicated as ``mandatory'' and ``must support'' in the IG must
be supported, including support for the requirements described in the
``Central Cancer Registry Reporting HER Capability Statement,'' or
The HL7 CDA[supreg] Release 2 Implementation Guide:
Reporting to Public Health Cancer Registries from Ambulatory Healthcare
Providers, Release 1, DSTU Release 1.1--US Realm in Sec.
170.205(i)(2).
Our intent would be that a certified Health IT Module supports at
least one of these kinds of standards, but we do not preclude a Health
IT Module from supporting both. However, we request comment on this
approach and on whether we should instead require a Health IT Module
certified to this certification criterion to support both the CDA IG
and the FHIR reporting bundle and accompanying profiles within the
Central Cancer Registry Reporting Content IG for the purpose of cancer
registry reporting. We also note our proposal to create a standardized
API for public health in Sec. 170.315(g)(20) as described section
III.B.13.f, which also addresses standards-based API information
exchange for public health.
We also propose the inclusion of an additional requirement within
the cancer registry reporting certification criterion, to include
cancer pathology reporting. Cancer pathology reporting is an important
component of diagnosing cancer and understanding how advanced cases are
at the point of diagnosis. Pathology reporting for this certification
criterion has not been part of our Program in the past, but we have
heard feedback that pathology laboratory data is not being collected or
exchanged in a standard way. Having standardized, electronic pathology
reports would be an important foundation to more complete and accurate
understanding of cancer diagnoses and assessing the stage at diagnosis.
However, for cancer registries to receive all the information needed
for accurate assessment, the data elements within the LRI IG are not
enough for cancer pathology reporting. As such, CDC's National Program
of Cancer Registries has been actively working with state PHAs and
pathology partners, including the College of American Pathologists
(CAP), to develop and pilot a FHIR Implementation Guide for cancer
pathology reporting: Cancer Pathology Data Sharing 1.0.0--STU1. Early
results of these pilots demonstrate that use of this implementation
guide will reduce the need for manual intervention and data cleansing,
aid in more timely reporting, and include data elements that are
important for public health action.
We propose to adopt the standard HL7 FHIR Cancer Pathology Data
Sharing, 1.0.0--STU1 in Sec. 170.205(i)(4) and incorporate it by
reference in Sec. 170.299. We also propose to revise Sec.
170.315(f)(4)(ii) to add a requirement in Sec. 170.315(f)(4)(ii)(C) to
create and transmit cancer pathology laboratory values and results in
accordance with the proposed standard referenced in Sec.
170.205(i)(4), Cancer Pathology Data Sharing, 1.0.0--STU1, including
support for all ``mandatory'' and ``must support'' data elements within
the IG, including support for the requirements described in the
``Central Cancer Registry Reporting Pathology EHR Capability
Statement.'' We also propose changes to the name of this certification
criterion. Specifically, we propose to change the name from
``Transmission to cancer registries'' to ``Cancer registry
[[Page 63545]]
reporting--Transmission to public health agencies''. We welcome
comments on the above proposal.
Finally, we propose to add a timeline to allow certification of a
Health IT Module to the current certification criterion in Sec.
170.315(f)(4) for the period up to and including December 31, 2027,
after which period only the revised certification criterion in Sec.
170.315(f)(4)(ii) would be available for certification. We propose
that, for the time period up to and including December 31, 2027, a
Health IT Module may continue to be certified to the existing version
of the certification criterion as described in Sec. 170.315(f)(4)(i),
with modifications for clarity and with a proposed revision to include
the minimum standard code set updates. The proposed revisions to the
certification criterion include updates to the same minimum standards
updates, use of newer versions of implementation specifications, and
new functionality as described above. We propose that a Health IT
Module certified to Sec. 170.315(f)(4) must be updated to meet the
requirements of the revised certification criterion and that a health
IT developer must provide such updated technology to their customers by
no later than December 31, 2027. We propose that a Health IT Module
seeking certification to Sec. 170.315(f)(4) on and after January 1,
2028, must meet the requirements described in Sec. 170.315(f)(4)(ii).
We welcome comments on the above proposal.
v. Sec. 170.315(f)(5) Electronic Case Reporting--Transmission to
Public Health Agencies
In the HTI-1 Final Rule, we finalized requirements in Sec.
170.315(f)(5) for compliance with specific standards for electronic
case reporting to PHAs (89 FR 1231). Based on commenters' response to
the proposal, we finalized allowing either the CDA or FHIR standard for
the transmission of electronic case reports and reportability responses
(RRs), as well as the ability to consume and process electronic case
reporting trigger codes based on a match from the Reportable Conditions
Trigger Code (RCTC) value set as specified in the HL7 FHIR electronic
case reporting (eCR) IG. As finalized in the HTI-1 Final Rule, after
December 31, 2025, developers would only be able to certify to case
reporting using the standards-based approach described Sec.
170.315(f)(5)(ii), and previously certified products would need to
update their certification to the standards-based approach described in
Sec. 170.315(f)(5)(ii) by December 31, 2025 (89 FR 1228).
We believe requiring Health IT Modules to conform to a single
standard, specifically the HL7 FHIR standard, would coalesce industry,
PHAs, and other interested parties to dedicate resources towards
improved functionality and interoperability for electronic case
reporting. The use of HL7 FHIR-based solutions encourages more
flexibility and reduced burden for both initial development as well as
maintenance for healthcare information technology developers and aligns
with CDC's Public Health Data Strategy. The Public Health Data Strategy
prioritizes electronic case reporting as an important automation that
reduces burden and encourages more complete and timely data exchange.
We propose no changes to the capabilities specified within the
certification criterion in Sec. 170.315(f)(5), but we do propose to
update the standard used for the certification criterion in Sec.
170.205(t)(2). Given the potential benefits of adopting a single
standard, and our overall progress toward shifting to HL7 FHIR-based
standards and solutions when appropriate and feasible, we propose that
adoption of the CDA-based standard in Sec. 170.205(t)(2) expires on
January 1, 2028. This proposal would have the effect of requiring all
Health IT Modules certified to Sec. 170.315(f)(5) to use the eICR
profile of the HL7 FHIR eCR IG in Sec. 170.205(t)(1). We propose that
Health IT Modules be required to support the HL7 FHIR-based IGs
beginning January 1, 2028 to allow developers, intermediaries, and PHAs
to make the needed updates to the HL7 FHIR eCR IG and develop needed
system upgrades and solutions to transmit electronic case reports and
receive RRs that adhere to the HL7 FHIR eCR IG implementation
specification adopted in Sec. 170.205(t)(1).
We propose to maintain in Sec. 170.315(f)(5)(ii) adherence to
specific aspects of the HL7 FHIR eCR IG to allow for flexibility: the
electronic initial case report (eICR) profiles and the RR profile of
the HL7 FHIR eCR IG, and the ability to consume and process electronic
case reporting trigger codes and identify a reportable patient visit or
encounter based on a match from the Reportable Conditions Trigger Code
value set as specified in the HL7 FHIR eCR IG. We welcome comments on
this proposal.
vi. Sec. 170.315(f)(6)--Antimicrobial Use and Resistance Reporting--
Transmission to Public Health Agencies
The monitoring of antimicrobial use and resistance is a vital
component of public health reporting, particularly as antimicrobial
resistance rates continue to rise across the United States.\111\ In
order to adequately address this issue, timely reporting to PHAs is
important; such reporting can allow for prescribers to receive feedback
regarding prescribing practices and improve the appropriate use of
antimicrobials.
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\111\ https://www.cdc.gov/nhsn/pdfs/pscmanual/11pscaurcurrent.pdf.
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CDC's National Healthcare Safety Network (NHSN) collects
information on antimicrobial use and resistance from inpatient
facilities enrolled in and reporting to its Patient Safety Component,
including (but not limited to) general hospitals, CAHs (critical access
hospitals), children's hospitals, long term acute care hospitals,
military and veterans' hospitals, psychiatric hospitals, and
rehabilitation hospitals. CDC uses antimicrobial use and resistance
data reported through NHSN to generate metrics that states, facilities,
and other users, such as hospital associations, use to improve clinical
care and guide public health action. These data also provide a national
picture of the threat posed by antimicrobial overuse and resistance.
Given the importance of these data for patient safety and national
efforts to combat antibiotic resistance, in FY 2022, CMS finalized a
requirement that eligible hospitals and CAHs participating in the
Medicare Promoting Interoperability Program must begin reporting a new
Antimicrobial Use and Resistance (AUR) Surveillance measure for
Electronic Health Record (EHR) reporting periods in calendar year (CY)
2024 (87 FR 49335 through 49337).
We propose minimal changes to the certification criterion in Sec.
170.315(f)(6), specifically, revising to reference the standard in
Sec. 170.205(r) instead of the current reference to Sec.
170.205(r)(1). We then propose several revisions to the standard
adopted in Sec. 170.205(r). Specifically, we propose the adoption of
the standard in Sec. 170.205(r)(1) would expire on January 1, 2027. We
also propose that the standard in Sec. 170.205(r)(1) only requires
conformance to Sec. 170.205(r)(1)(i) and (ii) for the time period up
to and including December 31, 2025. We propose to add an updated
version of the standard in Sec. 170.205(r)(2) to include HL7
CDA[supreg] R2 Implementation Guide: Healthcare Associated Infection
(HAI) Reports, Release 3--US Realm, December 2020 and to incorporate it
by reference in Sec. 170.299. The updated IG can lead to more specific
and complete information being shared with PHAs, allowing for follow-up
activities and research to address rising rates of antimicrobial
resistance. The updated version
[[Page 63546]]
includes new and updated templates and value sets that enable more
advanced reports. This proposal would mean that the updated templates
in the new IG would replace the two specific components of the prior IG
in Sec. 170.205(r)(1) identified for expiration on January 1, 2026,
and then upon the expiration of the prior standard in its entirety on
January 1, 2027, the updated template in the new IG in Sec.
170.205(r)(2) would become the only applicable version of the
specifications for certification to the certification criterion.
This updated version of the standard was previously advanced for
voluntary adoption under our SVAP process for two of the three sections
required within the current certification criteria: HAI Antimicrobial
Use and Resistance (AUR) Antimicrobial Resistance Option (ARO) Report
(Numerator) specific document template in Section 2.1.2.1 and
Antimicrobial Resistance Option (ARO) Summary Report (Denominator)
specific document template in Section 2.1.1.1. We propose advancing to
the updated version by expiring the adoption of the prior standard
components on January 1, 2026, for two of the required sections of the
implementation guide referenced within current certification criteria
given benefits listed above and advancement of system capabilities to
support the standard since previous SVAP cycles. The third required
component, ``Antimicrobial Use (AUP) Summary Report (numerator and
denominator)'' should continue to use the standard HL7 Implementation
Guide for CDA Release 2--Level 3: Healthcare Associated Infection
Reports, Release 1, U.S. Realm, until the expiration date of the entire
standard on January 1, 2027. The two required components that are in
the updated IG are HAI Antimicrobial Use and Resistance (AUR)
Antimicrobial Resistance Option (ARO) Report (Numerator); Antimicrobial
Resistance Option (ARO) Summary Report (Denominator).
We also propose minimal changes to the name of the certification
criterion in Sec. 170.315(f)(6) to be ``Antimicrobial use and
resistance reporting--Transmission to public health agencies.'' We
welcome comments on the above proposal.
vii. Sec. 170.315(f)(7)--Health Care Surveys--Transmission to Public
Health Agencies
Data from the National Health Care Surveys, sent to CDC's National
Center for Health Statistics, provides information on healthcare
utilization, and includes information related to symptoms, diagnoses,
and procedures. These surveys are nationally representative, provider-
based, and cover a broad spectrum of healthcare settings. Within each
setting, data are collected from a sample of organizations that provide
care and from samples of patient (or discharge) encounters within the
sampled organizations. Data are collected not only from traditional
healthcare settings such as hospitals and physicians' offices, but also
from long-term care providers and community health centers. These
surveys help provide insight to inform policy, research, and quality;
sending them electronically allows for wider representation from
hospitals and healthcare organizations, as well as reduces manual
burden on the reporters.\112\ Improving the process for electronic
collection of survey data, including the use of standards, could make
these important surveys easier to administer.
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\112\ https://www.cdc.gov/nchs/dhcs/index.htm?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fnchs%2Fdhcs.htm.
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We propose minimal changes to the certification criterion in Sec.
170.315(f)(7), specifically, revising to reference the standard in
Sec. 170.205(s) instead of the current reference to Sec.
170.205(s)(1). We then propose to add an expiration date of January 1,
2027, to the standard for healthcare survey information for electronic
transmission specified in Sec. 170.205(s)(1). We also propose to
revise Sec. 170.205(s)(2), which is currently reserved, to reference
HL7 CDA R2 Implementation Guide: National Health Care Surveys (NHCS),
R1 STU Release 3.1--US Realm and incorporate it by reference in Sec.
170.299. To advance the electronic transmission of healthcare surveys
and include the relevant and needed information to achieve its intent,
we propose this version of the standard, as it includes new and updated
templates with important context. These revisions include, but are not
limited to, changes to sections for emergency department encounters,
patient information sections, gender identity observation, and number
of visits over the past 12 months. Such information will provide
additional insight on trends in hospitalization, surveillance of
symptomology and diagnoses, and demographics that can highlight
disparities and better inform interventions.
We are aware that the HL7 FHIR Health Care Surveys Content
Implementation Guide has gone through the HL7 approval process and was
published in 2023. We are further aware that a FHIR pilot project for
using FHIR standards to send survey information was initiated in fall
of 2023. We have not proposed to include this newer, FHIR-based
standard for healthcare survey information at this time, but request
feedback on whether it should be an option for health care surveys.
Specifically, we request comment on whether we should consider
modifying the certification criterion to require a Health IT Module
certified to this criterion to support creation and submission using at
least one of these standards:
The HL7 FHIR Health Care Surveys Content IG; or,
The HL7 CDA R2 Implementation Guide: National Health Care
Surveys (NHCS), R1 STU Release 3.1--US Realm.
Under this alternative, a Health IT Module certified to this
criterion would be required to support at least one of these kinds of
standards but would not be precluded from supporting both. We welcome
comment on this proposal--in particular, on current usability and
maturity of the FHIR IG and readiness among certified health IT vendors
to implement it.
We also propose minimal changes to the name of this certification
criterion in Sec. 170.315(f)(7) to be ``health care surveys--
transmission to public health agencies.'' We welcome comment on this
proposal, including on FHIR-based approaches.
e. New Certification Criteria for Health IT Modules Supporting Public
Health Data Exchange
We propose to establish new certification criteria as described
below for Health IT Modules supporting public health data exchange.
These certification criteria would certify the ability of Health IT
Modules to receive HL7 v2, CDA-based, and/or FHIR reports for birth
reporting and Prescription Drug Monitoring Programs (PDMPs).
Additionally, certification criteria proposed in this section would
certify receive, validate, parse, and filter capabilities related to
immunization information, syndromic surveillance, cancer pathology
reports, electronic case reporting, birth reporting, and PDMP data.
i. Sec. 170.315(f)(8)--Birth Reporting--Transmission to Public Health
Agencies
Providers currently rely on manual and duplicative data entry
processes to report information on live births to state vital records
offices. With most U.S. births occurring in hospitals or free-standing
birthing facilities, birth reporting typically entails clinicians
supplying the medical and health information for the birth certificate
to a
[[Page 63547]]
state web-based Electronic Birth Registration System (EBRS) or
nonclinical hospital staff reviewing the hospital medical records for
the information and entering it into the state EBRS. The legal and
demographic information is typically collected directly from the mother
using a standardized worksheet, and the information is then entered
into the State EBRS by nonclinical hospital staff. This information is
then sent to the state and a birth certificate is then issued by the
state vital records authority. Much of the medical and health
information collected for the birth certificate necessary to report a
live birth is also dually entered into EHRs by health care providers.
As a result, birth reporting processes are duplicative and burdensome
for providers and hospital systems.
Low adoption of standards to exchange data between EHRs and EBRSs
have resulted in an overall lack of interoperability between all
systems involved in birth reporting processes. CDC has provided
significant funding and resources to support the adoption of EBRSs by
PHAs and providers. Recent funding has also been provided to PHAs to
develop and advance the use of the FHIR standard to report information.
Despite investments made by CDC towards standards-based exchange with
EBRSs, there has been very little uptake of these standards and
associated functionalities by health IT developers.
We propose to adopt a new certification criterion, ``Birth
reporting--Transmission to public health agencies.'' As a part of this
new certification criterion, we propose to adopt the HL7 FHIR Vital
Records Birth and Fetal Death Reporting-1.1.0--STU 1.1 in Sec.
170.205(v) for electronically submitting medical and health information
from birth certificate reports to PHAs.\113\ However, if an updated
version of this IG is published prior to the publication of a final
rule, and made available to the public, it would be our intent to
consider adopting the updated IG if it best aligns with and supports
effective implementation of this proposed certification criterion.
Based on public comments on HTI-1 and prior rulemakings, we believe
that the health IT industry, healthcare standards developers, and
health care providers expect and support ONC making such determinations
so that the adopted version of standards are the most up-to-date
available and are feasible for real-world implementation (see 89 FR
1215). We encourage commenters to comment on the preferred version
associated with this proposal.
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\113\ Please see https://hl7.org/fhir/us/bfdr/2024Jan/.
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Additionally, we request comment specifically on whether the
content specified in the IG can be exchanged using transport mechanisms
defined in Sec. 170.315(g)(10) and in the proposed Sec.
170.315(g)(20) certification criteria. The selected information
included in the standard in Sec. 170.205(v) was piloted by the
Michigan Health and Human Services Division for Vital Records and
Health Statistics with four Michigan hospitals and their EHRs. In
Michigan, the pilot has found increased data completion and accuracy
for many data items when births are reported using the FHIR standard
and a SMART-on-FHIR app when compared to reports completed manually by
hospital staff.\114\ We believe the standard, when adopted broadly,
could aid in timely, more complete, and accurate reporting from
hospitals with reduced burden on the reporting facilities. We seek
comment from those who have implemented and used the IG on its
readiness for nationwide adoption.
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\114\ Final Report submitted to Centers for Disease Control and
Prevention In response to Request for Task Order Proposal No. (MI
2020-Q-45799), June 16, 2023.
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As an alternative to the IG proposed above, we propose, and seek
comment on, adoption of an interim standards-agnostic functional
criterion for electronically transmitting medical and health
information from birth certificate reports to PHAs based on the data
elements outlined in CDC National Vital Statistics System's ``Guide to
Completing the Facility Worksheets for the Certificate of a Live Birth
and Report of Fetal Death.'' \115\ We further seek comment on the
potential benefits and risks of adopting a functional approach,
particularly as CDC's NCHS has retired and will not be actively
updating the HL7 Version 2.6 Implementation Guide: Vital Records Birth
and Fetal Death Reporting, Release 1 STU Release 2 and the HL7 CDA R2
Implementation Guide: Birth and Fetal Death Reporting, Release 1, STU
Release 2--U.S. Realm standards. Finally, we request comment on whether
a functional approach--if adopted--should be time-limited and require a
transition to a standards-based approach as of a specific timeline. For
example, a functional approach could be permitted for certification up
to and including December 31, 2026, and then the standards-based
approach for conformance would be required thereafter.
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\115\ https://www.cdc.gov/nchs/nvss/facility-worksheets-guide.htm.
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ii. Sec. 170.315(f)(9)--Prescription Drug Monitoring Program (PDMP)
Databases--Query, Receive, Validate, Parse, and Filter
We propose to adopt a new certification criterion to enable the bi-
directional interaction and electronic data exchange between Health IT
Modules and PDMP databases (referred to hereafter as PDMPs).
Specifically, we propose a certification criterion to enable the query
of prescription drug monitoring systems and the receipt, validation,
parsing, and filtering of medication information from PDMPs. This
aligns with a current requirement in CMS' Medicare Promoting
Interoperability Program where Query of PDMP is a required measure.
PDMP Background
ONC has engaged in collaborative work to understand health IT's
role in addressing the opioid crisis, including the opportunities
created by state-run health IT systems known as PDMPs.\116\ PDMPs are
state-run electronic databases that provide critical health information
to physicians and other health care providers about an individual's
history of controlled substance prescriptions (and, in some states,
more complete histories of all prescriptions). Evaluations of PDMPs
suggest their use supports changes in prescribing behaviors, reduces
use of multiple providers by patients, and decreases treatment
admissions associated with substance misuse.\117\
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\116\ See for reference: https://www.healthit.gov/sites/default/files/page/2023-03/LPASO_Landscape_Assessment_508.pdf.
\117\ See for reference: https://www.cdc.gov/drugoverdose/pdmp/index.html.
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Beginning in 2012, ONC, in collaboration with the Substance Abuse
and Mental Health Services Administration (SAMHSA), sought to identify
ways to use health IT to improve access to PDMPs. The collaborative
project resulted in the development of the ``Enhancing Access to
Prescription Drug Monitoring Programs Using Health Information
Technology: Work Group Recommendations Report,'' \118\ and 13 pilot
studies to test the feasibility of connecting PDMPs with health IT
systems.\119\
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\118\ Enhancing Access to Prescription Drug Monitoring Programs
Using Health Information Technology. (2012). https://www.healthit.gov/sites/default/files/work_group_document_integrated_paper_final_0.pdf; see also https://www.cdc.gov/drugoverdose/pdf/pehriie_report-a.pdf.
\119\ https://www.healthit.gov/topic/health-it-health-care-settings/enhancing-access-pilot-reports.
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Bipartisan legislation aimed to address the opioid crisis--the 21st
Century Cures Act (Cures Act) of 2016
[[Page 63548]]
(Pub. L. 114-255),\120\ and the Substance Use Disorder Prevention that
Promotes Opioid Recovery and Treatment for Patients and Communities Act
(SUPPORT Act) of 2018 (Pub. L. 115-271).\121\ Additionally, the
Commission on Combating Drug Addiction and the Opioid Crisis
(Commission) was established in 2017 \122\ to develop recommendations
to address the opioid epidemic. In November 2017, the Commission
released a final report with recommendations focused on reducing
barriers and supporting programs and innovations aimed at strengthening
Federal, state, and local responses to the opioid overdose
epidemic.\123\ Several of the report's recommendations include the use
of state-run programs and health IT to address substance use disorder
(SUD) and opioid use disorder (OUD).
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\120\ 21st Century Cures Act. (2016). https://www.gov info.gov/content/pkg/PLAW-114publ255/pdf/PLAW-114publ255.pdf.
\121\ Substance Use-Disorder Prevention that Promotes Opioid
Recovery and Treatment for Patients and Communities Act. (2018).
https://www.congress.gov/bill/115th-congress/house-bill/6/text.
\122\ The White House. (2017). https://trumpwhitehouse.archives.gov/presidential-actions/president-donald-j-trump-signs-executive-order-establishing-presidents-commission-combating-drug-addiction-opioid-crisis/.
\123\ The Commission on Combating Drug Addiction and the Opioid
Crisis. (2017). https://www.whitehouse.gov/sites/whitehouse.gov/files/images/Final_Report_Draft_11-15-2017.pdf.
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These laws included important provisions related to PDMPs, health
IT supports for OUD, and the integration of health IT supports into
clinical workflows for OUD prevention and treatment. Section 1944(b) of
the Social Security Act, as added by Section 5042(a) of the SUPPORT
Act, also requires that states implement a qualified PDMP and defines
the requirements for a qualified PDMP including that the PDMP
administered by the state, at a minimum: \124\
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\124\ Section 1944(b) of the Social Security Act [42 U.S.C.
1396w-3a] as added by section 5042(a) of the Substance Use Disorder
Prevention that Promotes Opioid Recovery and Treatment for Patients
and Communities Act (SUPPORT Act) of 2018 (Pub. L. 115-271).
---------------------------------------------------------------------------
Facilitates access by a covered provider with respect to a
covered individual--in as close to real time as possible--of patient-
specific information for prescription drug history with regard to
controlled substances, the number and type of controlled substances
prescribed and filled in at least the most recent 12-month period, and
information relating to each covered provider of such medications; and
Facilitates the integration of the information into the
workflow of a covered provider, which may include the electronic system
the covered provider uses to prescribe controlled substances.
In addition, Section 1944(a) of the Social Security Act, as added
by Section 5042(a) of the SUPPORT Act, directs states to implement
requirements that certain covered Medicaid Providers check the
qualified PDMP for Medicaid beneficiaries' prescription information
prior to prescribing applicable controlled substances.\125\
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\125\ Section 1944(a) of the Social Security Act [42 U.S.C.
1396w-3a] as added by section 5042(a) of the SUPPORT Act of 2018
(Pub. L. 115-271). See also https://www.medicaid.gov/federal-policy-guidance/downloads/faq051519.pdf.
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The establishment and operation of PDMPs vary given that each PDMP
is subject to existing policies and management of their own respective
state. While PDMPs may operate differently, there are system components
guidance that CDC promotes to improve PDMP functionality as a public
health tool.\126\ Those include:
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\126\ CDC Clinical Practice Guidelines for Prescribing Opioids
(Dowell D, Ragan KR, Jones CM, Baldwin GT, Chou R. CDC Clinical
Practice Guideline for Prescribing Opioids for Pain--United States,
2022. MMWR Recomm Rep 2022;71(No. RR-3):1-95. DOI:http://dx.doi.org/10.15585/mmwr.rr7103a1).
---------------------------------------------------------------------------
Universal use among clinicians and/or their delegates (for
example, nurse practitioners or physician assistants) within a state;
More timely or real-time data contained within a PDMP;
Actively managing the PDMP in part by sending proactive
reports to clinicians to inform prescribing; and
Ensuring that PDMPs are easy to use and accessible by
clinicians.
As of the publication of this proposed rule, 50 states, the
District of Columbia, and three territories have established PDMPs,
each with various requirements for querying and reporting from pharmacy
information systems. Of these 54 PDMPs, 51 have additionally
implemented regulations mandating the use of the state PDMP when
prescribing controlled substances, sometimes for new patients or other
scenarios.\127\ However, despite the increase in PDMP utilization and
promising, though mixed, evidence of their effectiveness, PDMPs are
only able to truly impact care if prescribers and pharmacists use them,
and when PDMP data are easily accessible in clinical workflows and
accessible across state lines. While requirements are in place for
providers to access PDMPs at the state level, states generally do not
have specific requirements for PDMPs to support direct queries--in
practice this leads to indirect query workflows and multiple
translation points, creating gaps in interoperability. Additionally,
there are no widespread established practices for integrating query
information into clinical workflows within health IT systems--despite
recommendations from CDC that, when prescribing initial opioid therapy
for acute, subacute, or chronic pain, clinicians should review a
patient's history of controlled substance prescriptions as well as non-
opioid therapies using state PDMP data.\128\ In addition, health IT
systems may lack sufficient capabilities to reconcile query data from
PDMP systems as discrete data element(s). At the same time, PDMPs also
need to be able to respond to a query from a certified Health IT Module
with discrete data.
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\127\ https://www.medicaid.gov/medicaid/data-and-systems/downloads/rtc-5042-state-challenges.pdf.
\128\ CDC Clinical Practice Guideline for Prescribing Opioids
for Pain--United States, 2022 [verbar] MMWR.
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Today, authorized users may have to access PDMP data that is not
integrated into their workflow, as it is accessed through a separate
portal, which may add to clinical burden and decrease the likelihood of
checking and utilizing the PDMP data.\129\ These pieces--integrating
query information into health IT systems and informing workflow
integration practices based on established guidelines, along with
reconciling query data as discrete data elements for both the PDMP and
certified Health IT Module--are supported by the functions we propose
below.
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\129\ https://www.healthit.gov/sites/default/files/page/2023-03/LPASO_Landscape_Assessment_508.pdf.
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From 2018 to 2022, ONC and CDC collaborated on the Advancing PDMP
and EHR Integration project. The purpose of this project was to advance
and scale vendor agnostic PDMP integrations with health IT systems in a
variety of hospital, primary care, and outpatient settings. This effort
produced an Integration Framework and Integration Toolkit to serve as
technical resources for organizations interested in integrating PDMP
with a variety of health IT systems.\130\ The Integration Framework
includes how best to implement advanced technologies such as electronic
CDS systems that clinicians are increasingly using to combat the opioid
crisis as well as information to help improve integration of state
PDMPs within clinicians' workflows. The Integration Framework
[[Page 63549]]
also includes helpful resources, such as MOU, auditing, and testing
guidance, which can help advance and scale PDMP integration with health
IT systems (e.g., EHR systems, health information exchanges, and
pharmacy systems) in a variety of hospital, primary care, and
outpatient settings.\131\
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\130\ HHS ONC/CDC Health Information Technology: Integration
Framework for PDMP-EHR Integration: June, 2021: https://www.cdc.gov/opioids/pdf/Integration-Framework.pdf.
\131\ ``Using Health IT Integration to Address the Drug Overdose
Crisis'' August 2022: https://www.healthit.gov/buzz-blog/electronic-health-and-medical-records/using-health-it-integration-to-address-the-drug-overdose-crisis.
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In 2018, CMS issued frequently asked questions outlining how a
state could ensure that its qualified PDMP aligns with and incorporates
industry standards, consistent with 42 CFR 433.112(b)(12), and
encouraged states to refer to the information on standards in the
Interoperability Standards Advisory (ISA) published by the ONC,
specifically the section of the ISA describing, ``A Prescriber's
Ability to Obtain a Patient's Medication History from a Prescription
Drug Monitoring Program,'' which outlined recommended industry
standards for PDMP and EHR integration informed by the efforts of ONC
and CDC to advance PDMP best practices.\132\
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\132\ https://www.medicaid.gov/federal-policy-guidance/downloads/faq051519.pdf.
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The 2022 CDC Clinical Practice Guideline for Prescribing Opioids
for Pain \133\ (2022 Clinical Practice Guideline) includes information
that updates and replaces the 2016 CDC Guideline for Prescribing
Opioids for Chronic Pain. The 2022 Clinical Practice Guideline provides
evidence-based recommendations for prescribing opioid pain medication
for acute, subacute, and chronic pain for outpatients aged 18 years or
older, excluding pain management related to sickle cell disease,
cancer-related pain treatment, palliative care, and end-of-life care.
The 2022 Clinical Practice Guideline takes into account new science and
data, along with lessons learned about the challenges faced by patients
managing pain and pain care. The 2022 Clinical Practice Guideline also
includes a key update that specifies which recommendations apply to
patients who are being considered for initial treatment with
prescription opioids versus those that have already been receiving
opioids as part of ongoing care.
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\133\ CDC Clinical Practice Guideline for Prescribing Opioids
for Pain--United States, 2022 https://www.cdc.gov/mmwr/volumes/71/rr/rr7103a1.htm.
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In March of 2023, ONC published a report from the Leveraging PDMPs
and Health IT for Addressing SUD/OUD (LPASO) Project landscape
assessment. The LPASO Project was originally established in 2018 to
examine how jurisdictions utilize PDMPs and health IT to support SUD/
OUD identification, prevention, and treatment. Specifically, ONC was
interested in identifying and describing the policy and technical
approaches to addressing the opioid overdose epidemic related to PDMPs
for several key characteristics termed ``indicators'' (bolded for
emphasis).\134\ The PDMP indicators included in this analysis were:
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\134\ Leveraging Prescription Drug Monitoring Programs and
Health Information Technology for Addressing Substance Use Disorder
and Opioid Use Disorder: A Landscape Assessment of Prescription Drug
Monitoring Programs and Health Information Technology Indicators--
March 2023: https://www.healthit.gov/sites/default/files/page/2023-03/LPASO_Landscape_Assessment_508.pdf.
---------------------------------------------------------------------------
PDMP data placement in health IT systems: State statutes
and policies that allow PDMP data to be stored in another system such
as the EHR (e.g., included in provider notes, medication history, etc.)
as compared to a one-time view of the PDMP data.
Interpretation of PDMP data: State statutes and policies
related to the use of PDMP data for predictive analytics such as risk
scores.
PDMP access roles: Categories of professionals who are
authorized by state statute or other policies to access PDMP data.
PDMP hospital integration: Prevalence of PDMP integration
within the clinical workflow. This indicator examined whether hospitals
provided access to the PDMP within the hospital's EHR system or outside
of the hospital's EHR system via a PDMP portal or secure website.
Data standards and hubs used for PDMP data capture,
exchange, and reporting: Health IT components and data standards in use
for the transport, interpretation, and integration of PDMP data
including those used for interstate data sharing.
The LPASO report presented the findings of the landscape analysis
for each of these indicators, which is summarized below. The LPASO
Project identified that where state law permitted the care team access
to the PDMP data within a medical record and to incorporate the data as
a discrete data element--as opposed to view only access--clinicians are
better able to coordinate care, to assess prescribing practices across
the organization, and to implement OUD prevention and treatment best
practices.\135\ Further, the LPASO Project found that clinical decision
support tools can help clinicians across a wide range of specialties to
better identify at-risk patients and facilitate best practices for OUD
prevention and treatment. However, some clinicians have expressed
concern at the potential risk of such analytics tools including
variations in threshold values, lack of transparency for algorithms,
and the potential for scores to over-simplify risk that could be
identified with a more detailed review of PDMP data.\136\ The LPASO
report also found that the content received in response to a PDMP query
varied in terms of clinical usefulness and, after querying, receiving a
risk score based on a proprietary algorithm was of limited utility and
inconsistently predictive of negative outcomes.\137\ Additionally,
state laws and regulations determine the categories of users who are
authorized to access and use a state's PDMP data, and there is
considerable variability in the number and types of access roles
identified in each state. A 2018 analysis of the PDMP Training and
Technical Assistance Center's (TTAC) data revealed that there are 63
unique access roles identified across all states and jurisdictions.
This analysis indicated:
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\135\ Ibid.
\136\ Call for better validation of opioid overdose risk
algorithms [verbar] Journal of the American Medical Informatics
Association [verbar] Oxford Academic (oup.com).
\137\ https://pubmed.ncbi.nlm.nih.gov/31356498/.
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In all states and jurisdictions, prescribers and
pharmacists are allowed access to the PDMP.
A majority of states and jurisdictions (more than 50) also
allow access for law enforcement, physician assistants, nurse
practitioners, and prescriber delegates.
A majority of states and jurisdictions (more than 40) also
include an access role for ``patient.'' \138\
---------------------------------------------------------------------------
\138\ Prescription Drug Monitoring Program Training and
Technical Assistance Center. (2018). http://www.pdmpassist.org/content/state-profiles.
---------------------------------------------------------------------------
The Prescription Monitoring Information Exchange (PMIX) Healthcare
Roles document was developed by the PDMP Training and Technical
Assistance Center (PDMP-TTAC) to provide states with a resource to
assist in defining a harmonized set of healthcare access roles for PDMP
data. The PDMP hospital integration indicator examined whether
hospitals provided access to the PDMP within the hospital's EHR system
or outside of the hospital's EHR system via a PDMP portal or secure
website. In the assessment, less than half of hospitals reported
integration of PDMP checks within their EHR workflows. In addition, the
variability of tools used to exchange, store, and report PDMP data
contributed to the complexity of PDMP
[[Page 63550]]
ecosystems.\139\ Finally, the LPASO report analyzed several standards
that today support PDMP data exchange workflows, including the American
Society for Automation in Pharmacy (ASAP) and Prescription Monitoring
Information Exchange (PMIX) standards.\140\ These standards, and
additional standards for electronic prescribing of controlled
substances (EPCS) (such as those referenced for the certification
criterion in Sec. 170.315(b)(3)), support specific capabilities that
are individually well suited to the task for which they were designed.
However, they are not all directly harmonized, which creates challenges
when data are moving from one system and one standard to another--for
example from the standard transmitted by the clinician to the pharmacy
and from the pharmacy to the PDMP. The request/response messages have
the same information regardless of the standards in use, but the
standards have different naming conventions for the message data,
making it necessary to translate requests and responses to enable
seamless communication across systems.
---------------------------------------------------------------------------
\139\ LPASO--fix citation.
\140\ https://www.healthit.gov/isa/allows-exchange-state-prescription-drug-monitoring-program-pdmp-data.
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The applicable standards for the different parts of PDMP workflows
are widely adopted to support pharmacy dispense reporting and
interstate exchange, but further work in industry is necessary to align
current standards with open, consensus-based standards, and
specifically with HL7 FHIR.\141\ The HL7 US Meds PDMP FHIR
Implementation Guide is intended to define how an EHR or an app or
other clinical system can access a patient's controlled substance
prescription history from the State PDMP systems. This IG holds promise
to advance health IT supports for PDMPs in a more interoperable manner
including through new API-enabled transactions, which may also reduce
the current translation challenges. However, the IG is based on the HL7
FHIR Release 3, and significant work is needed to advance, ballot, and
test a version of the IG that is consistent with API standards adopted
in 45 CFR 170.215.
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\141\ HL7 ``US Meds Prescription Drug Monitoring Program (PDMP)
FHIR Implementation Guide'': http://hl7.org/fhir/us/meds/pdmp.html.
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While HL7 FHIR-based standards for PDMP exchange are developing and
maturing, we propose to adopt functional requirements for exchanging
data with PDMPs to make certain that applicable health IT can support
capabilities required to engage with a PDMP meeting the requirements
under Section 1944(b) of the Social Security Act, as added by Section
5042(a) of the SUPPORT Act.\142\ These capabilities include enabling
health IT systems to support integration of query into clinical
workflows and to support requirements for the capability to reconcile
queried data as discrete data elements (not just as read only). These
requirements are also intended to enable the PDMP to respond to a query
from a certified Health IT Module with discrete data. As described
previously, Section 1944(b) of the Social Security Act defines specific
capabilities for a PDMP to be considered a ``Qualified PDMP'' \143\ and
there are capabilities that Health IT Modules could support, agnostic
to a specific standard, that would be of value to enable engagement
with a Qualified PDMP:
---------------------------------------------------------------------------
\142\ Section 1944(b) of the Social Security Act [42 U.S.C.
1396w-3a] as added by section 5042(a) of the Substance Use Disorder
Prevention that Promotes Opioid Recovery and Treatment for Patients
and Communities Act (SUPPORT Act) of 2018 (Pub. L. 115-271).
\143\ Ibid.
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Enabling a user to query controlled substance prescription
history from their state PDMP for a specific patient.
Enabling a user to receive a response to their PDMP
queries containing patient-specific controlled substance prescribed and
dispensed prescription data.
Supporting that all transactions can be sent and received
from within electronic prescribing or EPCS workflows.
In order to support clinical and public health programs targeting
the prevention and treatment of SUD/OUD, there are additional
capabilities that Health IT Modules could support, agnostic to a
specific standard, that would be of value. These include considerations
of what should be a part of the PDMP (e.g., interstate query) as well
as related to the PDMP indicators data placement, interpretation,
access roles, and integration into clinical workflows. Based on the
findings of the LPASO report for each PDMP indicator, public forums
with clinical and behavioral health care providers, and the 2022
Clinical Practice Guideline recommendations, these capabilities
include:
Enabling a user to query controlled substance prescription
history from another state's PDMP for a specific patient.
Enabling a user to receive a response to their interstate
PDMP queries containing patient-specific controlled substance
prescribed and dispensed prescription data.
Enabling a user to validate, parse, and filter the PDMP
data included in the responses received as discrete data elements--
including to reconcile the data into a patient's medication list.
Enabling access roles for clinicians and pharmacists, and
with additional capabilities to create and allow customized access
roles for any delegate or surrogate under applicable law such as
physician assistants, nurse practitioners, and clinician delegates.
Enabling an audit log of PDMP access.
Enabling the use of clinical decision support tools that
support clinical prescribing guideline recommendations such as those
described in the 2022 Clinical Practice Guideline.
Enabling automated or passive queries for specific common
workflows consistent with state requirements and best practice
guidelines
Enabling implementation of the capabilities within other
applicable workflows--such as administrative or transition of care
workflows--consistent with SUD/OUD prevention and treatment best
practice guidelines.
Given the current state of PDMP data exchange, we believe it is not
yet feasible to adopt certification criteria leveraging the individual
standards that currently support PDMP data exchange workflows. While
standards developing organizations (SDOs) continue to work toward open
API-enabled solutions for PDMPs, continued commitment and development
effort is needed to advance FHIR-based implementation specifications to
achieve readiness for widespread adoption and use.
In the interim, we believe inclusion of a functional criterion
within the Program may help to advance systems to support the
capabilities described in the SUPPORT Act \144\ and implement
recommendations and best practices per the 2022 Clinical Practice
Guideline (i.e., Recommendation 9 to check PDMPs) as well as addressing
the impact factors identified in the LPASO report. Therefore, we
propose to adopt a new certification criterion to improve
interoperability between health IT and PDMPs. Specifically, we propose
a new certification criterion in Sec. 170.315(f)(9) entitled
``Prescription Drug Monitoring Program (PDMP) Databases--Query,
receive, validate, parse, and filter.'' We propose that this criterion
would be a functional criterion agnostic to a specific PDMP standard,
but would include transport, content, and vocabulary standards where
appropriate. We additionally propose to include functional requirements
for
[[Page 63551]]
access controls including access roles and audit logs within this new
criterion.
---------------------------------------------------------------------------
\144\ Ibid.
---------------------------------------------------------------------------
We propose requirements in Sec. 170.315(f)(9) to enable a user to
query a PDMP, including bi-directional interstate exchange, to receive
PDMP data in an interoperable manner, to establish access roles in
accordance with applicable law, and to maintain records of access and
auditable events.
We propose requirements in Sec. 170.315(f)(9)(i) to enable both
passive and active bi-directional query of a PDMP, including an
interstate exchange query, and send an acknowledgement message in
response to receipt of data after a query is performed. We propose
requirements in Sec. 170.315(f)(9)(i)(A) to initiate a passive or
automated query upon the recording, change, or access of a medication
order; upon the creation and transmission of an electronic prescription
for a controlled substance; and upon entry of controlled substance
medication data into a medication list or reconciliation of a
medication list including controlled substance medication data. We also
propose requirements in Sec. 170.315(f)(9)(i)(B) to enable an active
or user-initiated query of a PDMP including an interstate exchange
query. In Sec. 170.315(f)(9)(i)(C), we propose to send an
acknowledgement message in response to receipt of data after a query is
performed.
We propose requirements in Sec. 170.315(f)(9)(ii) to enable a user
to receive, validate, parse, and filter electronic PDMP information. We
propose requirements in Sec. 170.315(f)(9)(ii)(A) to enable a user to
receive electronic controlled substance medication prescription
transmitted through a method that conforms to the standard in Sec.
170.202(d), from a service that has implemented the standard specified
in Sec. 170.202(a)(2); through a method that conforms to the standard
in Sec. 170.205(p)(1) when the technology is also using an SMTP-based
edge protocol; and via an application programming interface in
accordance with the standard specified in Sec. 170.215(a)(1). We
propose an optional capability to enable a user to receive electronic
PDMP information governed by Trusted Exchange Framework and Common
Agreement (TEFCA). In other words, that the Health IT Module is
connected via the network enabled by TEFCA and can demonstrate that it
can exchange data using it.
We propose requirements in Sec. 170.315(f)(9)(ii)(B) to
demonstrate the ability to detect valid and invalid electronic
controlled substance medication prescription received. We propose
requirements that a Health IT Module certified to this certification
criterion include the capability to identify valid electronic
controlled substance medication prescription received and process the
data elements including any necessary data mapping to at least one of
the versions of the USCDI standard in Sec. 170.213 to enable use as
discrete data elements, aggregation with other data, incorporation into
a patient medication list, and parsing and filtering in accordance with
the requirement proposed in Sec. 170.315(f)(9)(ii)(C) described below.
We also propose requirements that a Health IT Module certified to this
certification criterion include the capability to: correctly interpret
empty sections and null combinations; detect errors in electronic
controlled substance medication prescription received, including
invalid vocabulary standards and data not represented using a
vocabulary standard; and record errors encountered and allow a user
through at least one method to be notified of the errors produced,
review the errors produced, and store or maintain error records for
audit or other follow up action.
We propose requirements in Sec. 170.315(f)(9)(ii)(C) to enable a
user to parse and filter electronic PDMP information received and
validated in accordance with paragraph Sec. 170.315(f)(9)(ii)(B) at a
minimum for any data element identified in at least one of the versions
of the USCDI standard in Sec. 170.213.
We propose requirements in Sec. 170.315(f)(9)(iii) to enable
access controls. This includes enabling access roles and recording
access, including actions for auditable events and tamper-resistance.
We propose requirements in Sec. 170.315(f)(9)(iii)(A) to enable access
roles for clinicians and pharmacists and to enable a user to customize
additional roles for any delegate or surrogate under applicable law.
Additionally, we propose requirements in Sec. 170.315(f)(9)(iii)(B) to
record access actions and maintain an audit log of actions.
We note that in our proposed certification criterion, we describe a
passive or automated query as well as an active query. A passive or
automated query is a query initiated by the system when another related
action occurs--for example, a system automatically initiates a query on
behalf of the clinician when the clinician uses an electronic
prescribing module to send a prescription for a controlled substance.
In such a case, the system may be configured to pair with a certified
or non-certified Health IT Module that enables the EPCS in order to
initiate the query without additional action by the clinician. An
active query refers to a query of the PDMP initiated by the user to
specifically query the PDMP based on their own clinical considerations.
An active query might also be in conjunction with other clinical
actions, but it should also enable the user to elect to initiate a
query as part of other workflows such as administrative or care
coordination actions. We welcome public comment on the inclusion of
these query types, as well as the specific functions for which a
passive query is required.
In addition, we note the inclusion of audit requirements and
reference to auditable events. We propose that auditable events would
include the same functions previously adopted for Sec. 170.315(d)(2),
(3), and (10). We note these include referenced standards in Sec.
170.210(e) and (h). However, we have not proposed to specifically adopt
auditable event or audit and disclosure log standards for the proposed
certification criterion in Sec. 170.315(f)(9) because the specific
audit requirements vary across states, access roles, and use cases.
However, we seek comment on the potential applicability of such
standards for the proposed PDMP data certification criterion.
We welcome public comment on this proposal. In addition, we seek
public comment specifically on the following areas:
Should ONC consider additional functional requirements, or
additional constraints on functional requirements, relating to the
passive or automated query of a PDMP within EPCS or CPOE workflows?
Should ONC consider either additional or reduced
specificity within the minimum functions supporting receipt of the PDMP
information as discrete data elements?
Should ONC further specify or further constrain access
roles? For example, should ONC consider adding a ``patient'' access
role to the requirements? What access roles would be most beneficial to
define more clearly in any final rule or supportive sub-regulatory
guidelines? \145\
---------------------------------------------------------------------------
\145\ See, for example, access roles described in the LPASO
report, March 2023 at: https://www.healthit.gov/sites/default/files/page/2023-03/LPASO_Landscape_Assessment_508.pdf.
---------------------------------------------------------------------------
Are there additional functional capabilities that would
support effective SUD/OUD prevention and treatment that should be
considered for a future version of the proposed certification
criterion?
We additionally refer readers to section III.B.13.e.ix describing a
new
[[Page 63552]]
proposed certification criterion in Sec. 170.315(f)(29) that relates
to this proposed certification criterion in Sec. 170.315(f)(9).
iii. Sec. 170.315(f)(21) Immunization Information--Receive, Validate,
Parse, Filter, and Exchange--Response
Immunization reporting is a vital component of public health data,
and is used by all 50 states, Washington DC, Puerto Rico, and many
large local jurisdictions. States that have immunization information
systems (IIS) consolidate immunization histories and exchange
information with vaccination providers, with the goals of improving
vaccination rates and reducing vaccine-preventable diseases. In order
to achieve the stated goals of immunization information exchange, PHAs
must have the technology in place to perform corresponding functions to
certified health IT and receive the same standard included in Sec.
170.315(f)(1).
We propose to adopt a new certification criterion for health IT for
public health that would focus on immunization information--receipt,
validation, parsing, and filtering--adhering to the same standard as
required in Sec. 170.315(f)(1). We further propose a requirement for
responding to queries from external systems, as well as seek comment on
patient access as a complement to the proposed updated requirements in
Sec. 170.315(f)(1). Such updates will provide clinicians with querying
access to IISs in order to better determine the vaccination status of
their patients, among other benefits. By including functions performed
by health IT for public health within a certification criterion, the
Program advances its focus on bi-directional interoperability between
healthcare and PHAs. Such functionality for receipt, validation, query/
response, and patient access should enable more users, including those
using a variety of health IT systems, to have the most complete and
accurate vaccine history for individuals. This functionality can help
advance EHRs, IISs, and intermediaries in alignment, with the same
foundational functionalities, and keep data moving with the speed of
care. If an individual receives a vaccine from a pharmacy, from a
community health clinic, away from their home state, or at their
provider's office, any approved user regardless of their health IT
should be able to have access to their complete, accurate vaccine
history. We believe these proposed requirements, coupled with the
proposed Sec. 170.315(g)(20) and updates to Sec. 170.315(f)(1), can
move the nation closer to this ideal state.
These new capabilities include: receive, validate, parse, and
filter incoming data in accordance with at least one of the versions of
the standard and applicable implementation specification specified in
Sec. 170.205(e); transmission of immunization information
electronically in accordance with at least one of the versions of the
standard and applicable implementation specification in Sec.
170.205(e); and technical capability to respond to incoming patient-
level and/or immunization-specific queries from external systems. We
request feedback on the functional requirement to respond to patient-
level, immunization-specific queries from external systems and request
comment on if the standard referenced in Sec. 170.205(e) is sufficient
for the proposed functional requirement to respond to incoming patient-
level and immunization-specific queries. We seek comment on if we
should also require health IT for public health to share immunization
information on a population of patients using the standard specified in
Sec. 170.315(g)(20)(ii) in our proposals in section III.B.16, and
whether health IT for public health should also be able to support
patient access using SMART Health Cards for Immunization Criteria
according to Sec. 170.315(j)(22). We specifically request comment on
readiness and feasible timelines for these capabilities.
Additionally, we recognize that due to the work and collaboration
of state immunization programs, IIS vendors, CDC's National Center for
Immunization and Respiratory Diseases (NCIRD), and the American
Immunization Registry Association (AIRA), immunization systems can do
much of what is described above already. Through these NCIRD sponsored
and established programmatic requirements and optional testing programs
conducted by AIRA, many IISs already meet most of, if not all, of the
requirements in the proposed certification criterion. We applaud the
work done already, and the intent of our proposal is to ground the
certification requirements in what already exists without additional
burden or cost for IISs that already participate in the NCIRD
requirements. However, we know it is important to codify these
functional requirements in the Program to demonstrate the success of
modern approaches to data exchange and clinician access to data, and to
create a shared floor of functionality for all health IT contributing
to immunization information sharing.
We propose requirements in Sec. 170.315(f)(21) to enable health IT
for public health to receive, validate, parse, and filter electronic
immunization information. We also propose requirements in Sec.
170.315(f)(21) to enable health IT for public health to exchange
immunization information. These proposed requirements are described
below.
We propose requirements in Sec. 170.315(f)(21)(i) to enable health
IT for public health to receive electronic immunization information
transmitted through a method that conforms to Simple Object Access
Protocol (SOAP)-based transport. Optionally, to meet the received
requirements, a developer (serving as a Participant or Subparticipant
of a Qualified Health Information Network\TM\ (QHIN\TM\), or who is a
QHIN) may demonstrate receipt through a connection governed by the
Trusted Exchange Framework and Common Agreement, receipt through a
method that conforms to the standard specified in Sec. 170.205(p)(1)
when the technology is also using an Simple Mail Transfer Protocol
(SMTP)-based edge protocol, or receipt via an application programming
interface in accordance with the standard specified in Sec.
170.215(a)(1) or at least one of the versions of the standard specified
in Sec. 170.215(d).
We propose requirements in Sec. 170.315(f)(21)(ii) to demonstrate
the ability to detect valid and invalid electronic immunization
information received and formatted in accordance with the standards
specified in Sec. 170.207(e)(5) and Sec. 170.207(e)(6). In order to
meet the validate requirements, the health IT for public health must
include the capability to identify valid electronic immunization
information received and process the data elements required for the
standards specified in Sec. 170.207(e)(5) and Sec. 170.207(e)(6).
Processing must include any necessary data mapping to enable use as
discrete data elements, aggregation with other data, and parsing and
filtering in accordance with the parse and filter requirements in the
proposed Sec. 170.315(f)(21)(iii). Additionally, in order to meet the
validate requirements, the health IT for public health must correctly
interpret empty sections and null combinations; detect errors in
immunization information received, including invalid vocabulary
standards and codes not specified in the standards specified in Sec.
170.207(e)(5) and Sec. 170.207(e)(6); and record errors encountered
allowing a user to be notified of the errors produced, to review the
errors produced, and to store or maintain error records for audit or
other follow up action.
We propose that Health IT Modules certified to Sec.
170.315(f)(21)(iii) support users to parse and filter immunization
[[Page 63553]]
information received and validated in accordance with validate
requirements in the proposed Sec. 170.315(f)(21)(ii) according to the
standard specified in Sec. 170.207(e)(5) or Sec. 170.207(e)(6).
We propose functional requirements in Sec. 170.315(f)(21)(iv) to
respond to both incoming patient-level and immunization-specific
queries from external systems.
We welcome comment on these proposals.
iv. Sec. 170.315(f)(22) Syndromic Surveillance--Receive, Validate,
Parse, and Filter
We propose to adopt a new criterion for the functional requirement
to receive, validate, parse, and filter incoming syndromic surveillance
information in accordance with at least one of the versions of the
standards adopted in Sec. 170.205(d) and not expired for the purposes
of certification to criteria in Sec. 170.315(f) at the time of
certification. As discussed in Sec. 170.315(f)(2), syndromic
surveillance information is vital to the monitoring and early detection
of potential public health events. Syndromic surveillance data help
provide PHAs the information they need to prevent a public health
threat from becoming a public health emergency. Further, since these
threats do not respect boundaries, the cross-jurisdictional exchange
and national awareness of syndromic surveillance data is vital. The
transmission of information electronically, according to the standard
specified in Sec. 170.205(d), must be accompanied by the ability to
receive and validate information according to the same standard in
order to facilitate use of the standardized data for analysis and
decision-making. Such functions--receipt and validation--are needed to
reduce the need for manual effort or manipulation related to data
integration and processing, and to allow for the prompt intake and
analysis of information. This process also includes the recipients of
reported information in the testing of the workflow at data submission,
confirming that what is sent is formatted accurately and allows for
validation and processing.
Syndromic surveillance has proven to be a highly effective tool for
detecting localized trends in outbreaks, and in larger scale monitoring
for seasonal illnesses.\146\ The National Syndromic Surveillance
Program (NSSP) receives data from over 77% of non-Federal emergency
departments nationwide as of July 2023, and does so via jurisdictional
PHAs, using the standard specified in Sec. 170.205(d). Many of the
systems used today for such monitoring also assisted in predicting
trends in the COVID-19 pandemic and estimating future spread.\147\ The
pandemic also raised the importance of certain data elements being
included in the standard in order to better assess hot spots and inform
response, including travel status, pregnancy status, acuity, and
admission information--all of which are reflected in the updated
version of the standard specified in Sec. 170.205(d).
---------------------------------------------------------------------------
\146\ Buehler, J.W., Sonricker, A., Paladini, M., Soper, P., &
Mostashari, F. (2008). Syndromic surveillance practice in the United
States: findings from a survey of state, territorial, and selected
local health departments. Advances in Disease Surveillance, 6(3), 1-
20.
\147\ Ibid.
---------------------------------------------------------------------------
We propose to require at least one of the versions of the standards
and implementation specifications specified in Sec. 170.205(d) for the
receipt, validation, parsing, and filtering of incoming syndromic
surveillance information. We note that given the widespread
implementation of syndromic surveillance, most jurisdictions have
technology that can already fulfill many of the proposed requirements.
However, we believe that adopting this certification criterion for
health IT for public health will reinforce the importance of a
foundational functionality requirement for all syndromic surveillance
systems to be able to validate and assess incoming information quickly
to identify emerging threats. While receipt is a function that most
syndromic surveillance systems can accomplish today, our proposal to
certify this functionality for health IT for public health would allow
for several additional benefits. First, it would include both sending
and receiving systems in testing the shared standard, finding issues,
and aligning on how to constrain specifications to limit variability.
Second, it would advance syndromic surveillance technology on the same
path as the systems reporting data to them, to allow all involved
systems to grow and align when it comes to data exchange--eliminating
the need for manual workarounds or costly third parties to fill the
gaps between functionalities. Third, the coordination between sending
and receiving systems would compel nationwide upgrades and transitions
as public health needs and use cases evolve and shift.
We propose that consistent with at least one of the versions of the
standards and implementation specifications specified in Sec.
170.205(d), Health IT Modules certified to Sec. 170.315(f)(22) enable
a user to receive, validate, parse and filter electronic syndrome-based
public health surveillance information in accordance with the proposed
Sec. 170.315(f)(22)(i) through (iii).
Specifically, we propose to require Health IT Modules certified to
Sec. 170.315(f)(22)(i) to receive electronic syndrome-based public
health surveillance information transmitted through a method that
conforms to a Secure File Transfer Protocol (SFTP) connection. SFTP is
designed for securely moving large volumes of data, and syndromic
surveillance reporting involves moving thousands of HL7 messages in a
single batch. Even though this protocol does not function in real-time,
unlike modern application programming interface (API)-based exchanges,
and introduces the possibility of human error, this is the preferred
protocol in use by NSSP for transport today and is also a key protocol
supported by the current CDC architecture. Optionally, to meet the
receive requirements, a developer (serving as a Participant or
Subparticipant of a QHIN, or who is a QHIN) may demonstrate receipt
through a connection governed by the Trusted Exchange Framework and
Common Agreement or receipt via an application programming interface in
accordance with the standard specified in Sec. 170.215(a)(1) or at
least one of the versions of the standard specified in Sec.
170.215(d).
We propose in Sec. 170.315(f)(22)(ii) that Health IT Modules
certified to that criterion would demonstrate the ability to detect
valid and invalid electronic syndrome-based public health surveillance
information received and formatted in accordance with at least one of
the versions of the standards specified in Sec. 170.205(d). To meet
the validate requirements, a Health IT Module certified to this
criterion must include the capability to identify valid syndrome-based
public health surveillance information received and process the data
elements required for at least one of the versions of the standards
specified in Sec. 170.205(d). Processing must include any necessary
data mapping to enable use as discrete data elements, aggregation with
other data, and parsing and filtering in accordance with parse and
filter requirements in the proposed Sec. 170.315(f)(22)(iii). A Health
IT Module certified to Sec. 170.315(f)(22) must also include the
capability to correctly interpret empty sections and null combinations;
detect errors in syndrome-based public health surveillance information
received, including invalid vocabulary standards and codes not
specified in at least one of the versions of the standards specified in
Sec. 170.205(d); and, record
[[Page 63554]]
errors encountered allowing a user to be notified of the errors
produced, to review the errors produced, and to store or maintain error
records for audit or other follow up action.
We propose that Health IT Modules certified to Sec.
170.315(f)(22)(iii) would need to enable a user to parse and filter
electronic syndrome-based public health surveillance information
received and validated in accordance with the validate requirements in
the proposed Sec. 170.315(f)(22)(ii).
We welcome comment on these proposals.
v. Sec. 170.315(f)(23) Reportable Laboratory Test Values/Results--
Receive, Validate, Parse, and Filter
Laboratory-based test results workflow is initiated when a
clinician orders a diagnostic test for a patient who presents with
symptoms related to a notifiable disease. Laboratory orders are often,
but not always, initiated in EHR systems. After the order is placed,
the laboratory conducts the test(s) and returns the result(s) to the
clinician. The performing laboratory provides the results in various
ways, but many laboratories provide the results of the test, ideally
electronically, using a Laboratory Information Management Systems
(LIMS) or Laboratory Information Systems (LIS). PHAs must also be able
to receive the electronically transmitted reportable laboratory test
values/results in their system(s) in order to conduct contact tracing,
understand disease spread, and have early indications of potential
outbreaks.
As described in section III.B.18, we propose a requirement in Sec.
170.315(a)(2) that would require a user of a certified Health IT Module
to be able to create and transmit laboratory orders electronically
according to the standard specified in Sec. 170.205(g)(2). We
additionally propose in section III.B.13.d.iii a requirement in Sec.
170.315(f)(3) to create laboratory tests and values/results for
electronic transmission, according to specified standards.
In order to align all of the technical aspects related to
reportable lab data across the different public health and health care
entities involved, we propose to adopt a certification criterion in
Sec. 170.315(f)(23) to require the functionality for Health IT Modules
certified to the criterion to be able to receive, validate, parse, and
filter incoming reportable laboratory test values/results. By adopting
a certification criterion for health IT for public health to receive
results and values back electronically (according to national
standards), such systems would be able to support delivering more
complete patient information to clinicians throughout the laboratory
workflow and to PHAs for public health action.
For reportable conditions with associated laboratory results, the
laboratory is responsible for sending an electronic laboratory report
to the relevant jurisdictional PHAs. We have required the ELR IG as the
standard for reporting to PHAs in Sec. 170.315(f)(3) throughout the
Program. We understand that most laboratory systems already have the
capability of transmitting results to PHAs according to the ELR IG, as
demonstrated by the high level of connectedness of laboratories and
PHAs. The PHA receiving the related laboratory result or value often,
however, does not receive all of the information needed for action,
such as patient demographics, creating gaps in understanding and issues
with contact tracing and patient outreach to slow the spread of
infectious disease. We propose the transition to the LRI IG--the public
health profile--to send results to PHAs. This should enable increased
completeness of data for public health action.
Accordingly, and consistent with at least one of the standards in
Sec. 170.205(g)(1) and (3), we propose requirements in Sec.
170.315(f)(23) to enable Health IT Modules certified to the criterion
to receive, validate, parse, and filter electronic reportable
laboratory test values/results according to either the ELR IG or the
LRI IG as described below. We propose that either standard will meet
this requirement until the ELR IG expires on January 1, 2028, and we
propose a transition to the LRI IG after that date. We note that
because Sec. 170.205(g) includes the expiration dates for the
applicable standards, they are not duplicated within this certification
criterion. We request comment on if this timeline is feasible for this
transition.
We propose requirements in Sec. 170.315(f)(23)(i) to receive
electronic reportable laboratory test values/results transmitted at a
minimum through a method that conforms to the standards specified in
Sec. 170.202(d), from a service that has implemented the standard
specified in Sec. 170.202(a)(2); and, through a method that conforms
to the standard in Sec. 170.205(p)(1) when the technology is also
using an SMTP-based edge protocol. Optionally, to meet the receive
requirements, a developer (serving as a Participant or Subparticipant
of a QHIN, or who is a QHIN) may demonstrate receipt through a
connection governed by the Trusted Exchange Framework and Common
Agreement, or receipt via an application programming interface in
accordance with the standard specified in Sec. 170.215(a)(1) or at
least one of the standards specified in Sec. 170.215(d).
We propose requirements in Sec. 170.315(f)(23)(ii) to demonstrate
the ability to detect valid and invalid electronic reportable
laboratory test values/results received and formatted consistent with
the standard in Sec. 170.205(g)(1) or the Public Health Profile within
the implementation specification in Sec. 170.205(g)(3). To meet the
validate requirements, health IT for public health must include the
capability to identify valid electronic reportable laboratory test
values/results received and process the data elements as required by
the standard in Sec. 170.205(g)(1) or the standard in Sec.
170.205(g)(3). Processing must include any necessary data mapping to
enable use as discrete data elements, aggregation with other data, and
parsing and filtering in accordance with parse and filter requirements
in the proposed Sec. 170.315(f)(23)(iii). Health IT for public health
must also include the capability to correctly interpret empty sections
and null combinations; detect errors in electronic reportable
laboratory test values/results received including invalid vocabulary
standards and codes not specified in the Sec. 170.205(g)(1) or (3)
standards; and record errors encountered allowing a user to be notified
of the errors produced, to review the errors produced, and to store or
maintain error records for audit or other follow up action.
We propose requirements in Sec. 170.315(f)(23)(iii) to enable
Health IT Modules certified to the criterion to parse and filter
electronic reportable laboratory values/results received and validated
in accordance with validate requirements in the proposed Sec.
170.315(f)(23)(ii). We welcome comment on these proposals.
vi. Sec. 170.315(f)(24) Cancer Pathology Reporting--Receive, Validate,
Parse, and Filter
We propose to adopt a new certification criterion that is focused
specifically on health IT for public health's ability to receive and
validate incoming cancer pathology reports according to the proposed
standard in Sec. 170.205(i)(4), Cancer Pathology Data Sharing 1.0.0--
STU1 and require conformance with its requirements across the
certification criterion. As stated in the discussion above regarding
proposed revisions to Sec. 170.315(f)(4), cancer reporting informs
cancer control efforts, including programs for preventative
interventions. An
[[Page 63555]]
important component of diagnosing cancer, and particularly in
understanding how advanced cases are at the point of diagnosis, is
pathology reporting. In section III.B.13.d.iv.4 above, we propose to
include cancer pathology reporting as a component of the transmission
to cancer registry certification criteria in Sec. 170.315(f)(4). For
cancer registries to receive, validate, parse, and filter these reports
according to the required standard, we propose to include an
accompanying requirement for the receipt, validation, parsing, and
filtering of cancer pathology reports in Sec. 170.315(f)(24). Our
proposal not only would support cancer registries in having the
functionality to accept information in the same standard as sending
systems, but it would help sending and receiving health IT progress at
the same rate, with aligned functionality.
CDC's National Program of Cancer Registries has been actively
working with state PHAs and pathology partners, including the College
of American Pathologists (CAP), to develop and pilot a FHIR
Implementation Guide for cancer pathology reporting. Early results of
these pilots demonstrate that use of FHIR by all involved systems will
reduce the need for manual intervention and data cleansing, aid in more
timely reporting, and include more complete information, including the
demographic information needed to confirm reporting is happening within
the patient's state of residence, rather than the state of treatment,
as well as for patient matching.148 149
---------------------------------------------------------------------------
\148\ Blumenthal W, Alimi TO, Jones SF, Jones DE, Rogers JD,
Benard VB, Richardson LC. Using informatics to improve cancer
surveillance. J Am Med Inform Assoc. 2020 Jul 1;27(9):1488-1495.
doi: 10.1093/jamia/ocaa149. PMID: 32941600; PMCID: PMC7647312.
\149\ Ayaz M, Pasha MF, Alzahrani MY, Budiarto R, Stiawan D. The
Fast Health Interoperability Resources (FHIR) Standard: Systematic
Literature Review of Implementations, Applications, Challenges and
Opportunities. JMIR Med Inform. 2021 Jul 30;9(7):e21929. doi:
10.2196/21929. Erratum in: JMIR Med Inform. 2021 Aug 17;9(8):e32869.
PMID: 34328424; PMCID: PMC8367140.
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The inclusion of receipt, validation, parsing, and filtering of
electronic cancer pathology reporting in the Program would result in
more complete, accurate diagnostic information being received by state
cancer registries, and contribute to data analysis and early
preventative intervention.
We propose that consistent with the standard(s) and implementation
specification(s) specified in Sec. 170.205(i)(4), Health IT Modules
certified to Sec. 170.315(f)(24) enable a user to receive, validate,
parse and filter cancer pathology reports in accordance with the
proposed Sec. 170.315(f)(24)(i) through (iii).
We propose requirements in Sec. 170.315(f)(24)(i) to receive
electronic cancer pathology reports transmitted via an application
programming interface in accordance with the standard specified in
Sec. 170.215(a)(1) or at least one of the versions of the standard
specified in Sec. 170.215(d). Optionally, to meet the receive
requirements, a developer (serving as a Participant or Subparticipant
of a QHIN, or who is a QHIN) may demonstrate receipt through a
connection governed by the Trusted Exchange Framework and Common
Agreement.
We propose requirements in Sec. 170.315(f)(24)(ii) to demonstrate
the ability to detect valid and invalid electronic cancer pathology
reports received and formatted in accordance with the standards
specified in Sec. 170.205(i)(4). To meet the validate requirements,
Health IT Modules certified to the criterion must include the
capability to identify valid electronic cancer pathology reports and
process the data elements required for the standards specified in Sec.
170.205(i)(4). Processing must include any necessary data mapping to
enable use as discrete data elements, aggregation with other data, and
parsing and filtering in accordance with parse and filter requirements
in the proposed Sec. 170.315(f)(24)(iii). Health IT Modules certified
to the criterion must also include the capability to correctly
interpret empty sections and null combinations; detect errors in
electronic cancer pathology reports received, including invalid
vocabulary standards and codes not specified in the standards specified
in Sec. 170.205(i)(4); and, record errors encountered allowing a user
to be notified of the errors produced, to review the errors produced,
and to store or maintain error records for audit or other follow up
action.
We propose requirements in Sec. 170.315(f)(24)(iii) to enable
Health IT Modules certified to the criterion to parse and filter
electronic reportable cancer pathology reports received and validated
in accordance with the validate requirements proposed in Sec.
170.315(f)(24)(ii).
We welcome feedback on these proposals.
vii. Sec. 170.315(f)(25) Electronic Case Reporting--Receive, Validate,
Parse, Filter Electronic Initial Case Reports and Reportability
Response; and Create and Transmit Reportability Response
Case reporting is a vital component of public health surveillance
and case management. Case reports act as early notification of emerging
infectious disease outbreaks, as well as early indicators of other
threats. For example, case reports demonstrating a rise in human rabies
cases could help public health officials understand if there are
problems in the local animal population. Case reporting goes beyond
COVID-19 and public health emergencies and serves as a key activity to
assess, monitor, investigate, and address disease in the community.
Therefore, case reporting requires solutions be in place to support
these foundational public health services. These activities are
achieved by getting data reliably and consistently into health IT for
public health for action.
In the HTI-1 Final Rule, we finalized requirements in Sec.
170.315(f)(5) for compliance with either the CDA or the FHIR IGs for
electronic case reporting to PHAs (89 FR 1226 through1231). However, in
section III.B.13.d.v of this proposed rule, we propose updating the
Sec. 170.315(f)(5) certification criterion and its standards
conformance requirements specified in Sec. 170.205(t) to require
adherence only to the HL7 eCR FHIR IG to be updated and provided by
December 31, 2027, as part of a predictable multi-year strategy to
facilitate the transition from CDA or FHIR to just FHIR. We believe
adherence to a single standard, particularly the FHIR IG, will
encourage consistent implementation and lead to greater
interoperability compared to referencing multiple standards. Upgrading
health IT for public health to support APIs and FHIR payload, as
included in the HL7 FHIR eCR IG, creates greater flexibility to respond
to emergency issues. Improvements in consistent implementation and
interoperability would enable PHAs to have an improved picture of where
and when disease outbreaks occur.
Based on feedback we have heard from PHAs and other public health
partners that there are current challenges with technology in place at
PHAs to receive, validate, parse, and filter incoming electronic case
reports, we recognize that the eCR paradigm's newness for PHAs will
mean that it will likely take time to fully utilize the data in public
health surveillance systems and registries. Because of the variations
and inconsistencies in electronic case reports received from Health IT
Modules, PHAs often take manual steps and use additional tools in order
to be able to parse case reports. Incoming information frequently needs
to be re-formatted and filtered, among other steps, for it to be usable
to conduct case investigations. Such steps reduce
[[Page 63556]]
efficiency and have the potential to delay time-sensitive public health
action.
We propose to adopt a certification criterion for health IT for
public health that focuses on the receipt, validation, parsing, and
filtering of electronic case reports and reportability response and
creation and transmission of the RR according to at least one of the
standards referenced in Sec. 170.205(t). Technology in place at PHAs
for case reporting and surveillance must be able to receive, validate,
parse, and filter electronic case reports, as well as create and
electronically transmit RRs. This requirement should reduce burden on
PHAs associated with processing reported data and reduce the need for
manual intervention. Further, it advances the health IT for public
health that receives reported data to align with the technology that
transmits the reports, adhering to the same foundational functions and
standards. Supporting this alignment allows the industry to advance in
harmony and creates a more scalable infrastructure in daily activities
as well as in times of emergency.
We note that some PHAs use intermediaries or shared service tools
to implement components of the proposed certification criterion. As
noted in relied upon software guidance, developers can demonstrate
conformance with certification criteria requirements by developing the
necessary functionality themselves or by relying on the functionality
provided by a different software developer.\150\ While we do not have
the ability to require, or provide incentives for, PHAs to adopt
certified Health IT Modules, other entities (e.g., another Federal or
state agency) could choose to do so.
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\150\ https://www.healthit.gov/sites/default/files/relieduponsoftwareguidance.pdf.
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We propose that consistent with at least one of the standards and
implementation specifications specified in Sec. 170.205(t), Health IT
Modules certified to Sec. 170.315(f)(25) enable a user to receive,
validate, parse, and filter electronic case reporting information in
accordance with the proposed Sec. 170.315(f)(25)(i) through (iii), and
to create and transmit a reportability response in accordance with the
proposed Sec. 170.315(f)(25)(iv).
We propose requirements in Sec. 170.315(f)(25)(i) to receive
electronic case reports and reportability responses transmitted via an
application programming interface in accordance with the standard
specified in Sec. 170.215(a)(1) or at least one of the versions of the
standard specified in Sec. 170.215(d). Optionally, to meet the receive
requirements a developer (serving as a Participant or Subparticipant of
a QHIN, or who is a QHIN) may demonstrate receipt through a connection
governed by the Trusted Exchange Framework and Common Agreement; or
through a method that conforms to the standard specified in Sec.
170.205(p)(1) when the technology is also using an SMTP-based edge
protocol.
We propose requirements in Sec. 170.315(f)(25)(ii) to demonstrate
the ability to detect valid and invalid electronic case reporting
information received and formatted in accordance with at least one of
the Sec. 170.205(t) standards. To meet the validate requirements,
Health IT Modules certified to the certification criterion must include
the capability to identify valid electronic case reporting information
received and process the data elements for, at a minimum, the data
classes expressed in at least one of the versions of the USCDI standard
specified in Sec. 170.213. Processing must include any necessary data
mapping to enable use as discrete data elements, aggregation with other
data, and parsing and filtering in accordance with parse and filter
requirements in proposed Sec. 170.315(f)(25)(iii). Health IT Modules
certified to the criterion must also include the capability to
correctly interpret empty sections and null combinations; detect errors
in electronic case reporting information received including invalid
vocabulary standards and codes not specified in the Sec. 170.205(t)
standards; and record errors encountered allowing a user to be notified
of the errors produced, to review the errors produced, and to store or
maintain error records for audit or other follow up action.
We propose requirements in Sec. 170.315(f)(25)(iii) to enable
Health IT Modules certified to the criterion to parse and filter
electronic case reporting information received and validated in
accordance with validate requirements in the proposed Sec.
170.315(f)(25)(ii) of this section, at a minimum, for any data element
identified in at least one of versions of the USCDI standard specified
in Sec. 170.213.
We propose requirements in Sec. 170.315(f)(25)(iv) to enable a
user to create and transmit a response in accordance with the RR
profile in the HL7 eCR FHIR IG in Sec. 170.205(t)(1).
We welcome comments on these proposals.
viii. Sec. 170.315(f)(28)--Birth Reporting--Receive, Validate, Parse,
and Filter
As discussed earlier in the section regarding proposed revisions to
Sec. 170.315(f)(8), the process of birth reporting has traditionally
relied on a provider manually entering data into a web portal, which is
used by the jurisdiction's office of vital statistics to produce a
birth certificate and report selected data items to CDC's National
Center for Health Statistics. Birth reporting helps inform public
health programs on important health indicators, including birth rates
and infant mortality rates, is used for research, and is used to
produce the birth certificates needed for proof of identification,
accessing benefits, and other administrative purposes. Our proposal for
Sec. 170.315(f)(8) would provide an electronic birth reporting
option--that could greatly reduce manual effort if adopted--using the
new proposed standard in Sec. 170.205(v).
In order to create alignment between sending and receiving systems,
we propose a technical capability for health IT for public health to
demonstrate the receipt, validation, parsing, and filtering of incoming
birth reports according to the standard referenced in Sec. 170.205(v).
Adopting a certification criterion to demonstrate receiving birth
reports, and that such technology can do so according to the specified
standard, could reduce implementation and maintenance burden and lead
to greater consistency and completeness in the reported information.
While most states have adopted an electronic birth registry system
(EBRS), these systems today are primarily portal-based, requiring birth
information to be entered manually into electronic forms.\151\ As
described earlier in this proposal, current workflows involve dual-
entry based processes. Despite investments made by CDC towards
standards-based exchange with EBRS, there remains a gap in
jurisdictional office of vital statistics' ability to receive and
integrate data within applicable health IT for public health,
particularly for data received using FHIR-based standards.
---------------------------------------------------------------------------
\151\ National Research Council (US) Committee on National
Statistics. Vital Statistics: Summary of a Workshop. Washington
(DC): National Academies Press (US); 2009. B, The U.S. Vital
Statistics System: A National Perspective. Available from: https://www.ncbi.nlm.nih.gov/books/NBK219884/.
---------------------------------------------------------------------------
In consultation with CDC and its programmatic experience, we
understand that there has been low implementation of the CDA-based IG
as documented by CDC programs, and significant progress has been made
on
[[Page 63557]]
testing and piloting of the FHIR IG for birth reporting. As a result,
we propose to adopt the FHIR-based approach (as referenced in the
proposed Sec. 170.205(v)) for receipt of birth reporting. Adoption of
the FHIR-based approach would align the health IT used by public health
receiving birth reports with those sending birth reports. Inclusion of
the ability to receive and validate FHIR-specific birth reporting
within applicable health IT for public health will also provide a
baseline set of capabilities that vendors of health IT for public
health can build on as additional FHIR-based approaches emerge for
public health, including bulk import of data and FHIR Questionnaires.
The receipt of FHIR formatted birth records also supports investments
being made by CDC to receive FHIR messages downstream through the Data
Modernization Initiative.\152\
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\152\ https://www.cdc.gov/surveillance/data-modernization/technologies/cdc-front-door.html.
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However, as discussed in section III.B.13.e.i, due to the minimal
adoption of the FHIR IG, we propose and seek comment on if we should
adopt an interim standards-agnostic functional criterion for
electronically transmitting selected medical and health information
from birth certificate reports to PHAs based on the data elements
outlined in CDC's National Vital Statistics System's ``Guide to
Completing the Facility Worksheets for the Certificate of a Live Birth
and Report of Fetal Death.'' \153\ We seek comment from those who have
implemented and used the FHIR IG on its readiness for nationwide
adoption. We further seek comment on--if we were to adopt a functional
criterion--whether such a criterion should be time-limited to
transition to a standards-based criterion as of a specific timeline,
for example at 24 months after the timeline for implementation of any
such functional criterion.
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\153\ https://www.cdc.gov/nchs/nvss/facility-worksheets-guide.htm.
---------------------------------------------------------------------------
We propose that consistent with the standard(s) and implementation
specification(s) specified in Sec. 170.205(v), Health IT Modules
certified to Sec. 170.315(f)(28) enable a user to receive, validate,
parse, and filter birth reporting information in accordance with the
proposed Sec. 170.315(f)(28)(i) through (iii).
We propose requirements in Sec. 170.315(f)(28)(i) to receive
electronic birth reports transmitted via an application programming
interface in accordance with the standard specified in Sec.
170.215(a)(1) or at least one of the versions of the standard specified
in Sec. 170.215(d). Optionally, to meet the receive requirements a
developer (serving as a Participant or Subparticipant of a QHIN, or who
is a QHIN) may demonstrate receipt through a connection governed by the
Trusted Exchange Framework and Common Agreement; receipt through a
method that conforms to the standard specified in Sec. 170.202(d),
from a service that has implemented the standard specified in Sec.
170.202(a)(2); or, receipt through a method that conforms to the
standard in Sec. 170.205(p) when the technology is also using an SMTP-
based edge protocol.
We propose requirements in Sec. 170.315(f)(28)(ii) to demonstrate
the ability to detect valid and invalid electronic birth reports
received and formatted in accordance with the standards specified in
Sec. 170.205(v). To meet the validate requirements, Health IT Modules
certified to the criterion must include the capability to identify
valid electronic birth reports received and process the data elements
required for the standards specified in Sec. 170.205(v). Processing
must include any necessary data mapping to enable use as discrete data
elements, aggregation with other data, and parsing and filtering in
accordance with parse and filter requirements proposed in Sec.
170.315(f)(28)(iii). Health IT Modules certified to the criterion must
also include the capability to correctly interpret empty sections and
null combinations; detect errors in electronic birth reports received
including invalid vocabulary standards and codes not specified in the
standards specified in Sec. 170.205(v); and record errors encountered
allowing a user to be notified of the errors produced, to review the
errors produced, and to store or maintain error records for audit or
other follow up action.
We propose requirements in Sec. 170.315(f)(28)(iii) to enable
Health IT Modules certified to the criterion to parse and filter
electronic birth reports received and validated in accordance with
validate requirements in the proposed Sec. 170.315(f)(28)(ii).
We welcome comment on these proposals.
ix. Sec. 170.315(f)(29)--Prescription Drug Monitoring Program (PDMP)
Data--Receive, Validate, Parse, Filter Prescription Data, Support Query
and Exchange
We propose to introduce a functional certification criterion
focused on the ability of health IT for public health to receive and
validate reported PDMP information, to respond to queries from
providers or other PDMP databases and hubs, and to initiate queries to
those other PDMP databases and hubs. As mentioned in the earlier
discussion regarding a new proposed certification criterion in Sec.
170.315(f)(9), a provider's ability to query information from a PDMP
``can help identify patients who may be at risk for overdose.'' \154\
PDMP data can also ``be helpful when patient medication history is
unavailable and when care transitions to a new clinician.'' \155\ To
complement our proposal to support certification of health IT used by
providers to be capable of requesting data from PDMP databases, we also
believe it is important to certify the capability of health IT for
public health, in this case PDMPs, to respond to queries submitted.
While it is expected that most PDMPs support this requirement today,
inclusion of the functionality in the Program will support PDMPs
capabilities in alignment with requirements for health IT systems to
request and validate PDMP information. Our proposal will also require
that functionality is based on open, consensus-based practices where
possible, allowing PDMPs to have the ability to exchange information
without undue burden. Additionally, PDMPs should have the capability to
support interstate data sharing (or queries) to better inform
prescribing practices, improve patient care and safety, monitor patient
behaviors that contribute to the opioid epidemic, and facilitate a
nimble and targeted response.
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\154\ https://www.cdc.gov/opioids/healthcare-professionals/pdmps.html.
\155\ Id.
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Concerns have been raised within the health IT industry regarding
the lack of interoperability between different systems and data hubs
involved in interstate queries, and these concerns have hindered policy
objectives described in several statutes to address the opioid crisis.
A lack of consistent interoperability requirements between PDMPs,
systems, and data hubs involved in interstate exchange makes such
queries burdensome on both the querying and responding systems.
Inclusion of a functional certification criterion in the Program in
Sec. 170.315(f)(29) would help states conform to functionalities
specified in section 1944(b) of the Social Security Act, as added by
section 5042(a) of the SUPPORT Act,\156\ to support interjurisdictional
query and response, and to receive and validate data into health IT.
Further, this approach is
[[Page 63558]]
aligned with CMS requirements on funding state systems in 42 CFR
433.112(b)(10), which specify the conditions that a system must meet,
including the ``Use [of] a modular, flexible approach to systems
development, including the use of open interfaces and exposed
application programming interfaces . . .''
---------------------------------------------------------------------------
\156\ Section 1944(b) of the Social Security Act [42 U.S.C.
1396w-3a] as added by section 5042(a) of the Substance Use Disorder
Prevention that Promotes Opioid Recovery and Treatment for Patients
and Communities Act (SUPPORT Act) of 2018 (Pub. L. 115-271).
---------------------------------------------------------------------------
We also propose that Health IT Modules certified to this criterion
be able to receive and validate data reported in a manner consistent
with the PDMP technology transmitting, reporting, or querying that
data. As expressed elsewhere within this proposal, while PDMP
technology currently is capable of receiving and validating data, we
believe it is necessary to include functionality for PDMP technology to
support the receipt of information in accordance with section 1944(b)
of the Social Security Act, as added by section 5042(a) of the SUPPORT
Act,\157\ and that PDMP technology can accept data according to the
same functionality required for transmission under Sec. 170.315(f)(9).
---------------------------------------------------------------------------
\157\ Ibid.
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As stated in section III.B.13.e.ii, we believe that further work in
the health IT industry is necessary to align current consensus-based
standards, specifically FHIR. We also believe that previously described
projects to map current standards to FHIR will greatly benefit
functionality proposed here, specifically regarding the exchange of
information between PDMPs. While HL7 FHIR-based standards are
developing and maturing, we propose a set of functional criteria for
receiving and validating reported data and initiating and responding to
queries from applicable health IT, including other state PDMPs, to
support applicable health IT capabilities that may be utilized to meet
requirements under section 1944(b) of the Social Security Act, as added
by section 5042(a) of the SUPPORT Act.
As described above in section III.B.13.e.ii, section 1944(b) of the
Social Security Act, as added by section 5042(a) of the SUPPORT Act,
describes a Qualified PDMP, with respect to a State, as a program
which, at a minimum, satisfies the following two criteria. First, the
program facilitates access by a covered provider to, at a minimum, the
following information with respect to a covered individual, in as close
to real-time as possible: information regarding the prescription drug
history of a covered individual with respect to controlled substances;
the number and type of controlled substances prescribed to and filled
for the covered individual during at least the most recent 12-month
period; and the name, location, and contact information (or other
identifying number selected by the State, such as a national provider
identifier issued by the National Plan and Provider Enumeration System
of the Centers for Medicare & Medicaid Services) of each covered
provider who prescribed a controlled substance to the covered
individual during at least the most recent 12-month period. Second, the
program facilitates the integration of information described in the
first criteria above into the workflow of a covered provider, which may
include the electronic system the covered provider uses to prescribe
controlled substances.
Section 1944(f) of the Social Security Act, as added by section
5042(a) of the SUPPORT Act, includes an increase to Federal Medical
Assistance Percentage (FMAP) and Federal Matching Rates for Certain
Expenditures Relating to Qualified Prescription Drug Monitoring
Programs under Section 1903(a).\158\ The requirements proposed in Sec.
170.315(f)(29) are, therefore, written to be consistent with the
Section 1903(a) funding requirements in 42 CFR 433.112. Specifically,
Sec. Sec. 433.112(b)(10) and (12) include requirements for the use of
open interfaces and exposed application programming interfaces, and
alignment with, and incorporation of, standards and implementation
specifications for health information technology adopted by the Office
of the National Coordinator for Health IT in 45 CFR part 170, subpart
B. Section 433.112(b)(16) also requires interoperability with health
information exchanges, public health agencies, human services programs,
and community organizations providing outreach and enrollment
assistance services as applicable.
---------------------------------------------------------------------------
\158\ Section 1944(f) of the Social Security Act [42 U.S.C.
1396w-3a] as added by section 5042(a) of the Substance Use Disorder
Prevention that Promotes Opioid Recovery and Treatment for Patients
and Communities Act (SUPPORT Act) of 2018 (Pub. L. 115-271).
---------------------------------------------------------------------------
We propose requirements in Sec. 170.315(f)(29) to enable
technology to receive, validate, parse, and filter electronic
prescription information for controlled substance medications and
support query and exchange of PDMP data as described below.
We propose requirements in Sec. 170.315(f)(29)(i) to receive
electronic controlled substance medication prescription information
transmitted through a method that conforms to the standard in Sec.
170.202(d), from a service that has implemented the standard specified
in Sec. 170.202(a)(2); through a method that conforms to the standard
in Sec. 170.205(p)(1) when the technology is also using an SMTP-based
edge protocol; and, via an application programming interface in
accordance with the standard specified in Sec. 170.215(a)(1) or at
least of the versions of the standard specified in Sec. 170.215(d).
Optionally, to meet the receive requirements, a developer may
demonstrate receipt through a connection governed by the Trusted
Exchange Framework and Common Agreement.
We propose requirements in Sec. 170.315(f)(29)(ii) to demonstrate
the ability to detect valid and invalid electronic controlled substance
medication prescription information received. To meet the validate
requirements, the Health IT Module certified to this criterion must
include the capability to identify valid electronic controlled
substance medication prescription information received and process the
data elements including any necessary data mapping or translation
between standards. The Health IT Module certified to this criterion
must also include the capability to correctly interpret empty sections
and null combinations; detect errors in electronic controlled substance
medication prescription information received, including invalid
vocabulary standards and codes; and record errors encountered allowing
a user to be notified of the errors produced, to review the errors
produced, and to store or maintain error records for audit or other
follow up action.
We propose requirements in Sec. 170.315(f)(29)(iii) to enable a
user to parse and filter electronic controlled substance medication
prescription information received and validated in accordance with
requirements in the proposed Sec. 170.315(f)(29)(ii).
We propose requirements in Sec. 170.315(f)(29)(iv) to enable
patient-level query and exchange. The proposed requirement is to enable
patient-level queries from external systems of electronic controlled
substance medication prescription information of the PDMP including an
interstate exchange query. This proposed requirement includes
exchange--response requirements to respond to incoming patient-level
queries from external systems and exchange--patient access requirements
to enable patient access to view electronic controlled substance
medication prescription information.
We welcome public comment on this proposed new certification
criterion.
[[Page 63559]]
f. New Standardized API for Public Health Data Exchange
i. Background
Despite advances made over the last decade in public health data
exchange and health IT interoperability, challenges and gaps remain in
exchange capabilities and technical infrastructure. Current efforts
have been hampered by a history of bespoke solutions and a multitude of
projects, contracts, and implementations that struggled to scale or
sustain adequate funding, limiting adoption of resulting standards or
implementation guides. This limited adoption of standards and
mechanisms for electronic public health data exchange, among other
challenges, has resulted in poor interoperability that often relies on
manual effort, such as phone calls, faxes, and data entry.
The COVID-19 pandemic stressed our public health system and
surfaced flaws in the data that public health officials obtain from
health care providers--both in the data itself, but also the ways in
which data are reported. As a result, public health officials' access
to critical health data during public health emergencies or disasters
lags, and their experience varies with respect to the use of technology
to glean insights to inform decisions on quarantines, hospital
capacity, public health education campaigns, distribution of critical
medical supplies, school closures, reopening after a pandemic, and many
other essential public health decisions.
Without modern standards and consistent requirements to adopt
standards-based IT systems, public health data exchange often relies on
custom, siloed solutions, and manual workarounds. Currently, most
public health data exchange relies on older versions of HL7 v2 or CDA
standards. HL7 v2 and CDA standards support simple, single-patient,
event-based submission of documents from healthcare to PHAs, but these
standards do not adequately support more complex data exchange use
cases, such as bulk exchange of patients who received a specific
vaccine. However, now that the majority of hospitals and office-based
clinicians nationwide have adopted FHIR-based APIs with Health IT
Modules certified to Sec. 170.315(g)(10) for patient and population
level services, the technical landscape has evolved, and today's health
IT infrastructure presents the public health ecosystem with vastly
improved options to engage in more granular data exchange. The shift to
HL7 FHIR is needed to support a wide-scale public health response, and
we believe broad adoption of HL7 FHIR would reduce burden of
implementation and maintenance for data exchange between and among
healthcare organizations, providers, and PHAs.
The following describes our proposal to adopt a new certification
criterion in Sec. 170.315(g)(20) that would establish requirements for
a standardized HL7 FHIR-based API for public health data exchange and
extend the capabilities included in the standardized API for patient
and population services in Sec. 170.315(g)(10). This new certification
criterion would support ongoing and future development of public health
FHIR IGs leveraging a core set of existing, modular, and extensible
capabilities and standards. Standards referenced in the proposed Sec.
170.315(g)(20) support FHIR capabilities such as API-based event
notifications (i.e., HL7 FHIR Subscriptions), SMART App Launch, and
Bulk Data Export. Our proposals in Sec. 170.315(g)(20) would also
include constrained, specific requirements for health IT for public
health such as compliance with the United States Public Health Profiles
Library Implementation Guide (USPHPL IG), referenced in the proposed
Sec. 170.215(b)(2).
We propose this approach for several reasons. First, we believe
that establishing a standardized API for public health data exchange is
a necessary first step towards furthering a FHIR-based ecosystem that
would support a wide array of public health data exchange use cases,
including those established in the Program currently, those being
proposed as new certification criteria in the Program, and for future
use cases. Importantly, we believe that a FHIR-based ecosystem will
better streamline and reduce reporting burden for healthcare
organizations and developers, while expanding PHA's access to critical
data for action, such as identification of at-risk or infected
individuals during an outbreak.
Second, we believe that a standard API for public health data
exchange--with a consistent set of standards-based functionalities and
capabilities for Health IT Modules certified to the Sec.
170.315(g)(20) certification criterion--would support innovation and
longer-term public health modernization and would establish baseline
capabilities for public health use cases. The consistent
functionalities established in the combination of Sec. 170.315(g)(10)
and Sec. 170.315(g)(20) would support the creation or revision of
health IT for public health IGs necessary to advance interoperability
for specific use cases, such as cancer pathology reporting, which has a
draft FHIR IG, or immunization reporting, which is currently only
supported by a HL7 v2-based IG. Using HL7 FHIR-based APIs, PHAs and
healthcare partners could create an ecosystem where health IT for
public health can securely query data directly from the source, in real
time, when needed, based on an initial push of relevant data. Helios
tested this approach and participants were able to successfully query
EHRs for additional patient-level information after an initial trigger,
and we are working with CDC to pilot and scale this approach.\159\
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\159\ https://confluence.hl7.org/display/FHIR/2024+-+01+Helios+Query+and+Response+Track.
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Third, we believe that the proposed certification criterion in
Sec. 170.315(g)(20) would serve as a glidepath towards an eventual
transition to broader HL7 FHIR-based reporting for public health data
exchange. We propose that Health IT Modules certified to Sec.
170.315(g)(20) would support modular and foundational capabilities and
standards, such server support for subscriptions in Sec.
170.315(j)(23), and support a public health specific set of HL7 FHIR
profiles that extend the requirements in Sec. 170.315(g)(10) to
support a public health transition to HL7 FHIR.
Finally, we believe this approach will minimize development burden
by relying heavily on the standards and capabilities already required
of Health IT Modules certified to Sec. 170.315(g)(10), while
supporting near-term development and authoring of public health use
case-specific HL7 FHIR IGs, where necessary, to transmit relevant data
to PHAs. We emphasize for clarity that just because we propose to adopt
a public health-focused API certification criterion in Sec.
170.315(g)(20), developers of certified health IT are not required to
build one API per criterion (if they are also certified to Sec.
170.315(g)(10) for example). Developers of certified health IT would
have flexibility to certify and deploy APIs scoped however they want,
if and as they certify Health IT Modules to multiple API-based
certification criteria, including those proposed to be included as part
of the Base EHR definition in Sec. 170.102, including certification
criteria in Sec. 170.315(g)(10), (g)(20), (g)(30) and (g)(34).
We believe that this rulemaking is necessary to set the stage for
our long-term strategy to advance public health data modernization in
partnership with CDC. We anticipate that requirements to support a
standard API for public health exchange would lead to increased
capacity for data exchange and spur additional pilots. As use case-
specific HL7 FHIR IGs are authored for specific
[[Page 63560]]
data exchange needs and are refined through successful pilots and
approved for widespread adoption by relevant standards development
organizations, we intend to consider referencing these HL7 FHIR IGs in
future rulemaking. We will continue to work with partners, such as
Helios--the public health FHIR accelerator made up of ONC, CDC, PHAs,
health IT vendors, and HL7--to support PHAs in more easily receiving
and accessing data to further their numerous objectives and missions.
ii. Adoption of Generalizable and Public Health-Specific Standards and
Functionality in the Standardized API for Public Health Data Exchange
We propose to adopt some of the functional and standards-based
requirements from our existing requirements in Sec. 170.315(g)(10) as
part of the certification criterion proposed in Sec. 170.315(g)(20).
For example, in Sec. 170.315(g)(10), section III.B.19, we propose to
rely on modular functionalities proposed and described in proposed
Sec. 170.315(j) to support both functional and dynamic registration,
authentication and authorization for system access, and we propose to
rely on HL7 FHIR-based IGs familiar to developers of certified health
IT with Health IT Modules certified to Sec. 170.315(g)(10), such as
the SMART App Launch IG in Sec. 170.215(c), and the FHIR Bulk Data
Access IG in Sec. 170.215(d). We also propose that Health IT Modules
certified to Sec. 170.315(g)(20) support new subscriptions
capabilities proposed in Sec. 170.315(j)(23), and we propose that
Health IT Modules certified to Sec. 170.315(g)(20) support HL7 FHIR
Resources as profiled by the USPHPL IG proposed in Sec. 170.215(b)(2).
Specifically, we propose that Health IT Modules certified to Sec.
170.315(g)(20) support functional registration, according to the
requirements proposed in Sec. 170.315(j)(1) as well as dynamic
registration according to the requirements proposed in Sec.
170.315(j)(2) in Sec. 170.315(g)(20)(i). The capability to support
functional registration in Sec. 170.315(g)(20)(i)(A) is the same as
those currently in Sec. 170.315(g)(10)(iii) for functional
registration, which are required for Health IT Modules certified to
Sec. 170.315(g)(10). We additionally propose in Sec.
170.315(g)(20)(i)(B) to require support for dynamic registration
according to the certification criterion proposed in Sec.
170.315(j)(2). Dynamic registration of apps is intended to reduce the
burden of application registration through automated processes. Please
see the section titled ``New Requirements to Support Dynamic Client
Registration Protocol in the Program'' for more details about our
dynamic registration proposal (see section III.B.15).
We also propose that Health IT Modules certified to Sec.
170.315(g)(20) support authentication and authorization capabilities to
support public health data access to provider systems. We propose to
require such capabilities in Sec. 170.315(g)(20)(ii). Specifically, we
propose in Sec. 170.315(g)(20)(ii)(A) to require support for SMART
Backend Services system authentication and authorization according to
the proposed certification criterion in Sec. 170.315(j)(7) for system
applications functionally registered according to the capabilities in
Sec. 170.315(g)(20)(i)(A). These capabilities are the same as those
currently in Sec. 170.315(g)(10)(v) and (vii) which are required for
Health IT Modules certified to Sec. 170.315(g)(10). Furthermore, we
propose in Sec. 170.315(g)(20)(ii)(B) to require support for
asymmetric certificate-based system authentication and authorization
according to the requirements proposed in Sec. 170.315(j)(8) for
system apps dynamically registered using the capabilities in Sec.
170.315(g)(20)(i)(B). These requirements would support authentication
and authorization for dynamically registered system apps. The proposed
requirements to support system authentication and authorization for
functionally and dynamically registered system apps will ensure that
Health IT Modules certified to Sec. 170.315(g)(20) criterion support
authorization server capabilities to enable public health authorization
to provider servers.
In Sec. 170.315(g)(20)(iii), we propose a set of requirements
necessary to facilitate PHA access to provider system data. These
include identification of specific HL7 FHIR Resources often needed by
PHAs, capabilities to read and search these data, and support for the
subscription of event-based topics that PHAs can leverage in the
development of IGs for various public health reporting use cases. We
propose that Health IT Modules certified to Sec. 170.315(g)(20)
support read and search capabilities for each HL7 FHIR Resource
identified in Sec. 170.315(g)(20)(iii)(A) according to the standards
and implementation specifications adopted in Sec. 170.215(b)(2). This
would enable an API User to read and search patient data that are
profiled according to the USPHPL IG in Sec. 170.215(b)(2), including
the following HL7 FHIR Resources: Condition; Encounter; Location;
Observation; Organization; Patient; and PractionerRole, identified in
Sec. 170.315(g)(20)(iii)(A)(1)-(7).
In referencing the USPHPL IG in Sec. 170.215(b)(2), our intention
is to leverage a public health-specific data set of common data
elements necessary to support core public health exchange use cases.
The USPHPL IG contains reusable content profiles that represent common
data PHAs and public health officials receive and use. It was created
as a complement to the US Core IG--the USPHPL IG re-uses US Core
profiles whenever possible, and only adds new profiles when there is a
need for specific profiles for public health data exchange, and no
corresponding profile in US Core IG. We believe the USPHPL IG would
enable the exchange of health data from healthcare organizations to
PHAs with minimal implementation burden, due to its foundation in the
US Core IG, and through the reuse of common profiles for public health
data exchange purposes. We welcome comment on these proposed
information access requirements described in 170.315(g)(20)(iii)(A).
In Sec. 170.315(g)(20)(iii)(B) we propose that Health IT Modules
support read and search API calls and bulk FHIR API calls.
Specifically, in Sec. 170.315(g)(20)(iii)(B)(1)(i) we propose that
Health IT Modules support the ability for a system client to read HL7
FHIR Resources using the ``id'' data element for the data elements
identified in Sec. 170.315(g)(20)(iii)(A), and return the Resources
profiled according to the USPHPL IG in Sec. 170.215(b)(2). Similarly,
we propose that Health IT Modules support the ability for a system
client to search HL7 FHIR Resources according to the applicable search
requirements in the ``US Core Server CapabilityStatement'' for the
Resources included in Sec. 170.315(g)(20)(iii)(A) and return the
information profiled according to the implementation specification in
Sec. 170.215(b)(2). Together, these requirements would enable public
health systems to extract data from provider systems, consistent with
scopes and interactions identified in the SMART App Launch IGs in Sec.
170.215(c). Once those data are read by the API call, the receiving
system is then able to parse, process, and update receiving systems.
Through this standards-based approach, Health IT Modules certified to
Sec. 170.315(g)(20) would enable consistent and predictable access to
health data from which apps, systems, and other public health services
can be informed and developed.
Additionally, in Sec. 170.315(g)(20)(ii)(2), we propose that the
Health IT Module certified to
[[Page 63561]]
Sec. 170.315(g)(20) must support Bulk FHIR queries by responding to
requests for data according to the implementation specifications
adopted in Sec. 170.215(a) and at least one of the versions of the
implementation specifications adopted in Sec. 170.215(d) for the
Resources listed in Sec. 170.315(g)(20)(iii)(A) and return the
information profiled according to the USPHL IG proposed in Sec.
170.215(b)(2). We also propose in Sec. 170.315(g)(20)(ii)(2) that for
the time period up to and including December 31, 2027, the Health IT
Module must support either the ``GroupLevelExport'' operation or the
``_type'' query parameter of at least one of the versions of the
implementation specifications adopted in Sec. 170.215(d), or a Health
IT Module may support both the ``GroupLevelExport'' operation and the
``_type'' query parameter of at least one of the versions of the
implementation specifications adopted in Sec. 170.215(d). On and after
January 1, 2028, a Health IT Module certified to Sec. 170.315(g)(20)
must meet both the ``GroupLevelExport'' operation and the ``_type''
query parameter for each of the data included in Sec.
170.315(g)(20)(iii)(A) according to at least one of the versions of the
implementation specifications adopted in Sec. 170.215(d).
We welcome comment on our proposals for public health information
access and our proposals to require support of HL7 FHIR Profiles as
specified in the USPHPL IG as the foundation for Health IT Modules
certified to Sec. 170.315(g)(20). We recognize that the USPHPL IG does
not support all data elements referenced in implementation
specifications that support public health use cases represented by the
current certification criteria in Sec. 170.315(f). Nor does the USPHPL
IG include all data elements necessary for proposed public health
reporting in Sec. 170.315(f). We understand this gap, and we intend to
support updates to the USPHPL IG through current HL7 activities and
processes, future edits, additions, and updates to the HL7 FHIR
profiles contained within the USPHPL IG. For example, we anticipate
that future versions of the USPHPL IG could include additional use
case-specific data elements that are identified in USCDI+ Public
Health.
iii. Incorporation and References to Criteria in Sec. 170.315(j) as
Part of the Standardized API for Public Health Data Exchange
As stated previously, we propose that Health IT Modules certified
to Sec. 170.315(g)(20) include modular capabilities and foundational
standards to support a transition to HL7 FHIR-based public health data
exchange. As described in section III.B.16 of this proposed rule, we
describe a new category of ``modular API capabilities'' certification
criteria in Sec. 170.315(j). Specifically, in Sec.
170.315(g)(20)(iii)(C) we propose that a Health IT Module certified to
Sec. 170.315(g)(20) support subscriptions according to the
requirements in Sec. 170.315(j)(23), including support for a client to
subscribe to notifications and then send notifications for event-based
interactions. In addition to the support for the framework,
subscription topics, and filters in Sec. 170.315(j)(23), we propose in
Sec. 170.315(g)(20)(iii)(C)(1) that a Health IT Module certified to
Sec. 170.315(g)(20) enable a client to subscribe to notifications
filtered according to the conditions ``Encounter.reasonCode,'' and
``Encounter.subject'' when a patient encounter starts and the
conditions ``Encounter.reasonCode,'' and ``Encounter.subject'' when a
patient encounter ends. When an encounter starts or ends, we propose
that Health IT Modules certified to Sec. 170.315(g)(20) can send
notifications for the event-based interactions identified in Sec.
170.315(g)(20)(iii)(C)(1)(i) and (ii) according to the standard in
Sec. 170.215(a) and implementation specification in Sec.
170.215(h)(1). Taken together, we believe that these capabilities would
ensure that PHAs will have consistent access of discrete
functionalities, defined capabilities, and standardized data from
providers using certified health IT systems for a range of public
health use cases. We welcome comment on these proposals.
We also invite comment on whether there is utility in requiring
future support of other emerging HL7 FHIR standards, such as CDS Hooks
proposed as ``workflow triggers for decision support interventions--
services'' in Sec. 170.315(j)(23) as part of the certification
criterion in Sec. 170.315(g)(20), to support public health data
exchange use cases.
14. Bulk Data Enhancements
a. Background
In the ONC Cures Act Final Rule, we adopted the HL7[supreg]
FHIR[supreg] Bulk Data Access (Flat FHIR) (v1.0.0: STU 1)
implementation specification (referred to as the Bulk v1 IG), including
mandatory support for the ``group-export'' ``OperationDefinition,'' in
Sec. 170.215(a)(4) to enable consistent implementation of API-enabled
``read'' services for multiple patients (85 FR 25742). In the HTI-1
Final Rule we moved this Bulk v1 IG standard to Sec. 170.215(d)(1) (89
FR 1283). The Bulk v1 IG builds off the FHIR Asynchronous Pattern to
define a standardized process for authenticated and authorized clients
to ``request a Bulk Data Export from a server, receive status
information regarding progress in the generation of the requested
files, and retrieve these files.'' \160\ The widespread adoption of
Bulk Data APIs enables automated communication between health systems
to support use cases like public health surveillance and reporting,
clinical research, data analytics, electronic clinical quality measure
reporting and more.
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\160\ https://hl7.org/fhir/uv/bulkdata/export.html#bulk-data-export-operation-request-flow.
---------------------------------------------------------------------------
Support for the ``group-export'' ``OperationDefinition'' operation
enables ``application developers interacting with Sec. 170.315(g)(10)-
certified Health IT Modules to export the complete set of FHIR
resources . . . for a pre-defined cohort of patients'' (85 FR 25742).
As we have stated previously, these cohorts are ``defined at the
discretion of the user . . . including, for example, a group of
patients that meet certain disease criteria or fall under a certain
insurance plan'' (85 FR 25742, 25743). We have also noted previously
that the Bulk v1 IG ``has optional parameters which can be used to
filter results to a period of time, or one or several specified FHIR
resources'' (85 FR 25744).
b. Proposal
We propose to adopt the HL7 FHIR Bulk Data Access (v2.0.0: STU 2)
implementation specification (Bulk v2 IG) in Sec. 170.215(d)(2) and
incorporate it by reference as a subparagraph in Sec. 170.299.
Additionally, we propose that the adoption of the Bulk v1 IG in Sec.
170.215(d)(1) would expire on January 1, 2028. We clarify that both the
Bulk v1 IG and Bulk v2 IG would be available for purposes of
certification where certification criteria reference the implementation
specification in Sec. 170.215(d) until the Bulk v1 IG adoption
expiration date of January 1, 2028, after which time only the Bulk v2
IG would be available for certification, if we finalize our rule as
proposed.
We believe that raising the floor for certification of bulk data
export capabilities would help enable performant and consistent
population service APIs. The Bulk v2 IG includes additional
clarifications and expanded definitions based on industry feedback
related to implementation of the Bulk v1 IG and HL7 workgroup
consensus. We
[[Page 63562]]
believe adopting the Bulk v2 IG would not add significant burden for
Certified API Developers with Health IT Modules certified to
certification criteria that reference the implementation specification
in Sec. 170.215(d) who have already implemented the Bulk v1 IG. The
new requirements included in the Bulk v2 IG are generally incremental
updates to Bulk v1 IG requirements, and only a handful of the updates
are in scope for testing and certification.\161\
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\161\ We already include testing support for the Bulk v2 IG,
since it was included as a 2022 Approved Standard via the Standards
Version Advancement Process (SVAP), and in the Inferno testing tool
we only needed three new tests for testing the Bulk v2 IG in
comparison to the Bulk v1 IG.
---------------------------------------------------------------------------
One of the pertinent new requirements in the Bulk v2 IG is required
server support for the ``_since'' parameter, which allows for filtering
by date and time on bulk exports. This parameter can be used to help
improve API performance by reducing total resources exported and
overall export time. This parameter is also defined in the Bulk v1 IG,
but it is marked as ``optional'' for server support there. The Bulk v2
IG contains added clarifications and expanded definitions for the
``_since'' parameter, and the parameter is marked as ``required'' for
server (i.e., Health IT Module) support in the Bulk v2 IG.
The added requirement for the ``_since'' parameter, along with all
the other clarifications and expanded definitions across the whole Bulk
v2 IG, are aspects that we believe will help provide consistent
implementation guidance and thus improve access, exchange, and use of
EHI because developers will have more guidance to refer to when
implementing their Bulk Data APIs. We welcome comment on our proposal
to adopt the HL7 FHIR Bulk Data Access (v2.0.0: STU 2) implementation
specification.
Our proposal to adopt the Bulk v2 IG in Sec. 170.215(d)(2)
implicates all certification criteria that reference the implementation
specification in Sec. 170.215(d), and in this proposed rule these
certification criteria are: Sec. 170.315(f)(23), (f)(25), (g)(10),
(g)(20), (g)(31), (g)(32), and (g)(33). Note that Sec. 170.315(f)(23),
(f)(25), (g)(20), (g)(31), (g)(32), and (g)(33) are new Program
certification criteria proposed in this rule, and the only currently
finalized certification criterion in the Program that includes
reference to Sec. 170.215(d) is Sec. 170.315(g)(10).
We propose to continue requiring mandatory support for the ``group-
export'' ``OperationDefinition'' defined in the Bulk v2 IG for
certification to Sec. 170.315(g)(10); and we propose to require
support for the ``group-export'' ``OperationDefinition'' in our
proposed new certification criteria in Sec. 170.315(g)(20), (31),
(32), and (33). We refer readers to sections III.B.13.f and III.B.20.c
for additional discussion on our proposed new certification criteria in
Sec. 170.315(g)(20), (31), (32), and (33) and proposed Bulk IG
requirements.
We additionally propose to require support for the Bulk v2 IG
``optional'' query parameter known as ``_type'' for testing and
certification to Sec. 170.315(g)(10), (20), (31), (32), and (33)
because we believe that implementation of the ``_type'' parameter will
meaningfully improve API performance by reducing total resources
exported and overall export time. The ``_type'' filter allows a
requesting system to provide a list of FHIR resource types for the
responding system to use, which limits the resources returned to a
specific subset. Like the ``_since'' parameter, we believe that this
requirement to use ``_type'' parameter is an incremental step that will
encourage further industry adoption. As of Spring 2023, 73.7% of
deployed Bulk FHIR certified Health IT Modules already support this
optional parameter.\162\ We welcome comment on our proposal to require
support for the ``_type'' parameter for certification.
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\162\ Market share numbers come from this briefing: https://www.hhs.gov/sites/default/files/2022-02-17-1300-emr-in-healthcare-tlpwhite.pdf. Support for this parameter was gathered by reviewing
developer documentation.
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Finally, we welcome comment on the issues hindering the effective
exchange of population data using Bulk FHIR APIs and additional steps
ONC can take to help address those issues. Our research and findings to
date, on the use of deployed ONC-certified Bulk FHIR APIs, indicate
that there are significant challenges and barriers hindering
interoperability. We have consistently heard about challenges creating
the groups necessary for invoking the ``group-export'' operation,
including that there is not a standard process for creating groups and
that group sizes are being limited. We have also heard about
significant performance issues, with Bulk FHIR exports in some cases
taking days or even weeks to complete.\163\
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\163\ Jones, James R., et al. ``Real World Performance of the
21st Century Cures Act Population Level Application Programming
Interface.'' medRxiv (2023): 2023-10. https://www.medrxiv.org/content/10.1101/2023.10.05.23296560v2.
---------------------------------------------------------------------------
For currently certified Bulk FHIR APIs, we expect that Sec.
170.315(g)(10) certified Health IT Modules support complete patient
cohorts (i.e., groups) that enable automated communication between
health systems without needing to parse data across multiple exports.
For future rulemaking, we are interested in considering testable
minimum expectations and/or thresholds for certified Bulk FHIR API
performance. We acknowledge that there is variability in Bulk FHIR
group exports and performance based on things like system architectures
and the variability of resources per patient in a patient cohort. We
seek input on Bulk FHIR API performance experiences from users in the
field and seek comment on any potential performance bases,
expectations, thresholds, industry standards, etc. that we could
consider in the future for Certified Bulk FHIR APIs as a baseline. We
also welcome comment on the latest developments in the Bulk FHIR space,
like the early-stage proposals for Bulk FHIR import functionality that
are intended to address data ``push'' use cases as opposed to the data
``pull'' flow modeled by Bulk FHIR export.\164\
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\164\ FHIR Bulk Data Import early stage proposals can be found
here: https://github.com/smart-on-fhir/bulk-import/blob/master/import.md.
---------------------------------------------------------------------------
We welcome comment on experiences using Bulk FHIR APIs deployed in
Health IT Modules certified to Sec. 170.315(g)(10)(i)(B) and (ii)(B)
(note that elsewhere in this proposed rule we are proposing to
restructure Sec. 170.315(g)(10) and move the Bulk FHIR API
requirements in Sec. 170.315(g)(10) to Sec. 170.315(g)(10)(iii)). We
also welcome comment on performance experiences and minimum
expectations for future iterations of our Bulk FHIR API requirements
for different use cases, insofar as we should be thinking about
performance differently for different use cases.
15. New Requirements To Support Dynamic Client Registration Protocol In
the Program
a. Background to Dynamic Client Registration
In the ONC Cures Act Proposed Rule's preamble (84 FR 7483) we
discussed that we considered proposing to require the OAuth 2.0 Dynamic
Client Registration Protocol (DCRP) as per RFC 7591 \165\ as the
mechanism for application registration in the proposed Sec.
170.315(g)(10)(iii). However, in the ONC Cures Act Final Rule (85 FR
25745), we noted that DCRP had low industry adoption at the time, and
we subsequently finalized the application registration requirement in
Sec. 170.315(g)(10)(iii) without the DCRP
[[Page 63563]]
standard. We also encouraged health IT developers to coalesce around
the development of a common industry standard for application
registration.
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\165\ See RFC 7591--OAuth 2.0 Dynamic Client Registration
Protocol. Available at: https://datatracker.ietf.org/doc/html/rfc7591.
---------------------------------------------------------------------------
In addition, we also finalized in the ONC Cures Act Final Rule the
API Maintenance of Certification requirement of authenticity
verification and registration for production use in Sec. 170.404(b)(1)
(85 FR 25763 through 25764). This requirement permits a Certified API
Developer to implement an objective and uniform process to verify the
authenticity of API Users, where ``API Users'' is defined at 45 CFR
170.404(c) and complete this process within ten business days. We also
finalized in Sec. 170.404(b)(1)(ii) that the Certified API Developer
must register and enable all applications for production use within
five business days of completing its verification of an API User's
authenticity.
In the years since finalization of requirements in Sec.
170.315(g)(10)(iii) and Sec. 170.404(b)(1) in the ONC Cures Act Final
Rule, ONC has received feedback that the non-standard application
registration process can be burdensome to API Users. The manual nature
of some registration processes does not enable efficient registration
across multiple certified Health IT Module deployments, and the absence
of standardized requirements may cause varying, disparate registration
processes across certified Health IT Modules, making widespread
registration burdensome. To reduce the registration burden for API
Users, we propose to adopt a standard for application registration in
Sec. 170.215(o)(1) and adopt a new certification criterion in Sec.
170.315(j)(2) for dynamic registration as part of the suite of revised
and new certification criteria proposed as modular API capabilities
(See section III.B.16).
Consistent with our proposed new approach to leverage modular API
capabilities in Sec. 170.315(j) across various API-related
certification criteria, we propose to revise the certification
criterion in Sec. 170.315(g)(10) by referencing Sec. 170.315(j)(2)
and requiring support for a dynamic registration pathway. We propose to
revise the API Maintenance of Certification requirements in Sec.
170.404(b) to require support for publication of information necessary
to dynamically register apps. Additionally, we propose to adopt the
standard for dynamic application registration as part of the
certification criteria in Sec. 170.315(g)(20), (30), (32)-(35).
(Please see section III.B.13.d for details on the Sec. 170.315(g)(20)
Standardized API for public health data exchange certification
criterion proposal and section III.B.20.c for details on our Patient,
Provider, and Payer APIs Sec. 170.315(g)(30), (32)-(35) proposals).
b. Adoption of HL7 UDAP Security IG v1
The OAuth 2.0 framework enables a third-party application to obtain
limited access to a Hypertext Transfer Protocol (HTTP) service, either
on behalf of a resource owner by orchestrating an approval interaction
between the resource owner and the HTTP service, or by allowing the
third-party application to obtain access on its own behalf. Given that
the Sec. 170.315(g)(10) certification criterion's authorization model
is based on the OAuthAuthorization Framework, registration is required
before an app can access information via an API conformant to the Sec.
170.315(g)(10) certification criterion. A Sec. 170.315(g)(10)
certified Health IT Module's authorization server must support app
registration, as required per the current requirements in Sec.
170.315(g)(10)(iii).
To standardize the application registration approach in Program API
criteria, we propose to adopt the HL7[supreg] Unified Data Access
Profiles (UDAPTM) Security for Scalable Registration,
Authentication, and Authorization Implementation Guide Release 1.0.0
(UDAP Security IG v1) in Sec. 170.215(o)(1). The UDAP Security IG v1
enables dynamic registration in alignment with the OAuth 2.0 security
paradigm already in use in the Program. The SMART App Launch IG, which
profiles the OAuthAuthorization Framework established in RFC 6749, is
currently required in the Program in the Sec. 170.315(g)(10)
certification criterion to enable secure authorization of apps to
receive a single patient's data via FHIR. Additionally, the SMART
Backend Services specification, also profiling OAuth 2.0, already
required in the Program in the Sec. 170.315(g)(10) certification
criterion for authorization to retrieve multiple patient's data. The
UDAP Security IG v1 would augment the existing OAuth 2.0 found in the
Program by enabling scalable and standardized application registration
capabilities compatible with FHIR and the SMART App Launch IG to be
referenced as requirements in Program API criteria. While the UDAP
Security IG v1 defines additional capabilities beyond dynamic
registration, Program API criteria requirements proposed in this rule
focus on dynamic registration and subsequent authorization requests of
dynamically registered apps. To achieve this focus, the Program API
proposals referencing the UDAP Security IG v1 require only specific
sections relevant to those capabilities.
Scalable dynamic registration in the UDAP Security IG v1 relies
upon ``trust communities.'' Trust communities enable scalable trust by
establishing common policies that all participants agree to abide by,
thereby forgoing the need for individual agreements between
organizations for establishing trusted relationships. Participation in
a trust community can be represented in a secure and trustworthy manner
in the form of cryptographically secure digital certificates. These
certificates enable an application to prove to a server that it and its
developer are trusted to meet the expectations of the trust community.
With the certificate as proof of the trustworthiness of an API User and
their application, registration can proceed in an automated manner
without the need to perform manual or non-standardized trust
verification.
We note that for the purposes of our proposals in Sec.
170.315(g)(10), (20), (30), (32)-(35), and Sec. 170.404(b)(1) an API
User and the certified API technology that an API Information Source
uses must be part of the same trust community for dynamic registration
to occur according to the UDAP Security IG v1. Depending on the
scenario, Certified API Developers as well as API Information Sources
would be best positioned to determine which trust communities are
supported for dynamic registration at a specific deployment. Under this
proposal to adopt the UDAP Security IG v1, we have not proposed to
require that all trust communities be supported by a Certified API
Developer, nor have we specified a particular trust community. However,
if an API User seeks to connect an application that is part of the same
trust community as the deployed certified API technology, then dynamic
registration must be made available to the API User's application.
We are aware that there is a planned update to UDAP Security IG v1,
UDAP Security IG v1.0.1, that may publish after the publication of this
proposed rule. We anticipate that UDAP Security IG v1.0.1 will fix
errors within the UDAP Security IG v1 and not include substantial
revisions. As an alternative proposal to adopting the UDAP Security IG
v1 in Sec. 170.215(o)(1), we propose to adopt UDAP Security IG v1.0.1
in Sec. 170.215(o)(1) if it is published prior to publication of a
final rule finalizing policies proposed in this proposed rule.
Interested parties may review the current version of the UDAP Security
IG v1.0.1 at https://build.fhir.org/ig/HL7/fhir-udap-security-ig/.
[[Page 63564]]
c. Revision of Standardized API for Patient and Population Services To
Support Dynamic Client Registration
To reduce API User burden when registering their applications and
facilitate accessibility of patient health data, we propose to revise
the Sec. 170.315(g)(10) certification criterion to require on and
after January 1, 2028, dynamic registration of confidential apps,
including patient-facing, user-facing, and system apps, and subsequent
authorization and authentication support for such dynamically
registered apps. We note for this proposal that ``user'' is as defined
in 77 FR 54168. First, we propose to modify the existing registration
requirements currently in Sec. 170.315(g)(10)(iii) to require a
standardized dynamic registration pathway supporting patient-facing,
user-facing, and system confidential apps according to the UDAP
Security IG v1. As proposed in section III.B.19 of this rule, the
registration requirements for the Sec. 170.315(g)(10) certification
criterion are proposed to be organized under Sec. 170.315(g)(10)(i).
Therefore, we propose this new requirement for a dynamic registration
pathway in Sec. 170.315(g)(10)(i)(B). This new standardized dynamic
registration pathway would exist alongside the functional registration
pathway currently required in Sec. 170.315(g)(10)(iii) and proposed in
this rule to be included in Sec. 170.315(g)(10)(i)(A). Second, we
propose to require support for authentication and authorization for
dynamically registered patient-facing, user-facing, and system
confidential apps. Please see section III.B.19 for further details on
the proposed re-structuring of the Sec. 170.315(g)(10) certification
criterion.
As described in the ``Revised Standardized API for Patient and
Population Services Criterion to Align with Modular API Capabilities''
section of this rule, we propose to restructure and move to Sec.
170.315(g)(10)(ii)(A) the existing requirements in Sec.
170.315(g)(10)(v)(A) for authorization for functionally registered
patient-facing apps and user-facing apps according to the SMART App
Launch IG. In section III.B.19, we propose moving the authorization
requirements for functionally registered patient-facing apps to the
proposed Sec. 170.315(g)(10)(ii)(A)(1)(i) and functionally registered
user-facing apps to the proposed Sec. 170.315(g)(10)(ii)(A)(2)(i). We
refer readers to section III.B.19 of this proposed rule for additional
details regarding this and other related proposals. As described in
more detail in subsequent paragraphs, we propose to require support for
authorization for dynamically registered patient-facing apps in
accordance with the requirements at the proposed Sec.
170.315(g)(10)(ii)(A)(1)(i) and for dynamically registered user-facing
apps in accordance with the requirements at the proposed Sec.
170.315(g)(10)(ii)(A)(2)(i).
On and after January 1, 2028, we propose to require support for
authentication in accordance with the UDAP Security IG v1 of
dynamically registered patient-facing apps in accordance with the
requirements at the proposed Sec. 170.315(g)(10)(ii)(A)(1)(ii) and for
dynamically registered user-facing apps in accordance with the
requirements proposed in Sec. 170.315(g)(10)(ii)(A)(2)(ii). We
describe the details of these proposed authentication requirements in
subsequent paragraphs.
On and after January 1, 2028, we propose to require support for
authentication and authorization in accordance with the UDAP Security
IG v1 of dynamically registered system apps in accordance with the
requirements at the proposed Sec. 170.315(g)(10)(iii)(A)(2). We
describe the details of these proposed authentication and authorization
requirements in subsequent paragraphs. These proposed authorization
requirements would establish a consistent, standardized method for
authorizing dynamically registered patient-facing, user-facing, and
system apps to retrieve patient data.
We propose in Sec. 170.315(g)(10)(i)(B) to require on and after
January 1, 2028, support for a dynamic registration pathway in the
Sec. 170.315(g)(10) certification criterion for confidential apps,
including patient-facing, user-facing, and system apps, standardized
according to the UDAP Security IG v1. Using this proposed pathway,
patient-facing, user-facing, and system confidential apps capable of
supporting the UDAP Security IG v1 would be able to dynamically
register with the Health IT Module's authorization server in an
automated manner. Apps incapable of dynamic registration according to
UDAP Security IG v1 would still be able to be registered using the
current functional, non-standardized registration pathway currently
specified in Sec. 170.315(g)(10)(iii), which is proposed to be moved
to Sec. 170.315(g)(10)(i)(A) according to the proposal in section
III.B.19 of this rule. We propose in Sec. 170.315(g)(10)(i)(B) to
require Health IT Modules certified to Sec. 170.315(g)(10) to support
dynamic registration of confidential apps according to the requirements
in Sec. 170.315(j)(2), which requires support for dynamic registration
of confidential apps according to the UDAP Security IG v1 proposed in
Sec. 170.215(o). This includes mandatory support for sections
``Home,'' ``Discovery,'' and ``Registration'' as well as the
``community'' query parameter as defined in section ``Multiple Trust
Communities.'' We propose requiring mandatory support for the
aforementioned sections as they are the sections from the UDAP Security
IG v1 relevant to supporting dynamic registration. We note that trust
communities are responsible for enforcing their own policies regarding
security and trust, and we encourage such communities to address the
topics mentioned in section ``Trust Community Checklist'' of the UDAP
Security IG v1 in order to further support for dynamic registration
processes.
We clarify in this proposal that Health IT Modules certified to
Sec. 170.315(g)(10), through reference to Sec. 170.315(j)(2) in Sec.
170.315(g)(10)(i)(B), must support the otherwise optional ``community''
query parameter as defined in section ``Multiple Trust Communities'' of
the UDAP Security IG v1 to facilitate an app's ability to retrieve
dynamic registration metadata particular to a specific trust community.
The ``community'' query parameter enables an application to receive
metadata integral to the dynamic registration process which may
otherwise be obscured if the Health IT Module certified to Sec.
170.315(g)(10) supports multiple trust communities.
Next, we propose to require on and after January 1, 2028, support
for client authentication for dynamically registered patient-facing
confidential apps according to section ``Consumer-Facing'' of the UDAP
Security IG v1 in Sec. 170.315(g)(10)(ii)(A)(1)(ii) by referencing the
proposed certification criterion in Sec. 170.315(j)(5). The proposed
certification criterion in Sec. 170.315(j)(5), in turn, requires
support for authentication as detailed in section ``Consumer-Facing''
of the UDAP Security IG v1 proposed in Sec. 170.215(o). It is through
this series of cross-references that we propose, in Sec.
170.315(g)(10)(ii)(A)(1)(ii), to require support for client
authentication for dynamically registered patient-facing confidential
apps according to section ``Consumer-Facing'' of the UDAP Security IG
v1.
Further, we propose to require on and after January 1, 2028,
support for client authentication for dynamically
[[Page 63565]]
registered user-facing confidential apps according to the ``Business-
to-Business'' section of the UDAP Security IG v1 in Sec.
170.315(g)(10)(ii)(A)(2)(ii) by referencing the proposed certification
criterion in Sec. 170.315(j)(11). The proposed certification criterion
in Sec. 170.315(j)(11), in turn, requires support for authentication
for the ``authorization_code'' grant type as detailed in section
``Business-to-Business'' of the UDAP Security IG v1 proposed in Sec.
170.215(o). It is through this series of cross-references that we
propose, in Sec. 170.315(g)(10)(ii)(A)(2)(ii), to require support for
client authentication for dynamically registered user-facing
confidential apps according to section ``Business-to-Business'' of the
UDAP Security IG v1.
We propose requiring the ``Consumer Facing'' and ``Business-to-
Business'' sections of the UDAP Security IG v1 as they provide
authentication requirements for dynamically registered patient-facing
apps and user-facing apps respectively during the authorization
process. The conformance expectation for support for patient-facing
apps for this proposal is that the SMART App Launch capabilities,
required in Sec. 170.315(g)(10)(ii)(A)(1)(i) by referencing the
certification criterion proposed in Sec. 170.315(j)(9), would be
required to be supported for both functionally registered and
dynamically registered patient-facing apps. We propose the exception
that client authentication for dynamically registered apps would be
required to be supported according to section ``Consumer-Facing'' of
the UDAP Security IG v1 as proposed in Sec.
170.315(g)(10)(ii)(A)(1)(ii) instead of client authentication according
to the SMART App Launch implementation guide.
Similarly, the requirement for support for user-facing apps for
this proposal is that both functionally and dynamically registered
user-facing apps would be required to be supported according to the
SMART App Launch capabilities required in Sec.
170.315(g)(10)(ii)(A)(2)(i) by referencing Sec. 170.315(j)(10)(i).
However, client authentication for dynamically registered user-facing
applications would be required to be supported according to the
``Business-to-Business'' section of the UDAP Security IG v1 as proposed
in Sec. 170.315(g)(10)(ii)(A)(2)(ii) instead of the SMART App Launch
implementation guide.
This proposal does not propose to change the authentication and
authorization requirements for patient-facing apps and user-facing apps
registered using the functional registration pathway proposed in Sec.
170.315(g)(10)(i)(A). Authentication and authorization for functionally
registered patient-facing apps would be expected to occur according to
the requirements proposed in Sec. 170.315(g)(10)(ii)(A)(1)(i), which
would by reference to the proposed Sec. 170.315(j)(5) require SMART
App Launch capabilities relevant to patient-facing app authentication
and authorization. Similarly, authentication and authorization for
functionally registered user-facing apps would be expected to occur
according to the requirements proposed in Sec.
170.315(g)(10)(ii)(A)(2)(i), which would by reference to Sec.
170.315(j)(10)(i) require SMART App Launch capabilities relevant to
user-facing app authentication and authorization. We refer readers to
the ``Revised Standardized API for Patient and Population Services
Criterion to Align with Modular API Capabilities'' section of this rule
for additional information about the proposed requirements in Sec.
170.315(g)(10)(ii)(A)(1)(i) and (2)(i) and how those proposed
requirements relate to current Sec. 170.315(g)(10) requirements for
authentication and authorization for functionally registered patient-
facing apps and user-facing apps.
We also propose in Sec. 170.315(g)(10)(iii)(A)(2) that on and
after January 1, 2028, authentication and authorization for dynamically
registered system confidential apps must be supported according to the
``Business-to-Business'' section of the UDAP Security IG v1 by
referencing the proposed Sec. 170.315(j)(8). Proposed Sec.
170.315(j)(8) would require authentication and authorization for the
``client_credentials'' grant type according to the ``Business-to-
Business'' section of the UDAP Security IG v1 proposed in Sec.
170.215(o). We propose the system authentication and authorization
requirements in Sec. 170.315(g)(10)(iii)(A)(2) to require support for
a system authorization process which provides client authentication
consistent with the proposed dynamic registration process for system
confidential apps.
This proposal does not propose to change the authentication and
authorization requirements for system apps registered using the
functional registration pathway proposed in Sec. 170.315(g)(10)(i)(A).
Authentication and authorization for functionally registered system
apps would be expected to occur according to the requirements proposed
in Sec. 170.315(g)(10)(iii)(A)(1), which would by reference to
proposed Sec. 170.315(j)(7) require the ``Backend Services'' section
of at least one implementation specification adopted in Sec.
170.215(c). We refer readers to the ``Revised Standardized API for
Patient and Population Services Criterion to Align with Modular API
Capabilities'' section of this rule for additional information about
the proposed requirements in Sec. 170.315(g)(10)(iii)(A)(1) and how
those proposed requirements relate to current Sec. 170.315(g)(10)
requirements for authentication and authorization for functionally
registered system apps.
We note that we propose in sections III.B.13.d and III.B.20.c to
adopt dynamic registration according to the UDAP Security IG v1 for
Health IT Modules certified to Sec. 170.315(g)(20), (30), (32)-(35).
We invite readers to review those sections for details related to those
proposals.
d. Removal of Reference to OpenID Connect Core Specification
In the ONC Cures Act Final Rule, we adopted the OpenID Connect Core
1.0 specification in Sec. 170.215(b) and clarified that only the
components included in the SMART App Launch Framework 1.0.0
Implementation Guide adopted in Sec. 170.215(a)(3) were in scope for
testing and certification (85 FR 25742). Relatedly, we finalized
requirements for the Sec. 170.315(g)(10) certification criterion in
(g)(10)(v)(A)(1)(i) that required for first time connections that
authentication and authorization must occur during the process of
granting access to patient data in accordance with SMART App Launch
Framework 1.0.0 and OpenID Connect Core 1.0 (85 FR 25746). Subsequently
in the HTI-1 Final Rule, we finalized moving the regulatory reference
of the OpenID Connect Core 1.0 standard from Sec. 170.215(b) to Sec.
170.215(e)(1) (89 FR 1283).
We no longer believe it is necessary to reference the OpenID
Connect Core 1.0 specification separately in the API criteria
requirements in the Program since the relevant end-user authentication
requirements are sufficiently described through the ``sso-openid-
connect'' capability from the versions of the SMART App Launch
implementation guide currently and as proposed to be adopted in Sec.
170.215(c). We believe requiring the ``sso-openid-connect'' capability
from the implementation specification in Sec. 170.215(c) is sufficient
to specify the intended end-user authentication requirements related to
the Sec. 170.315(g)(10), (30), and (34) certification criteria. The
``sso-openid-connect'' capability is proposed to be required in the
Sec. 170.315(g)(10), (30),
[[Page 63566]]
and (34) certification criteria by requiring the ``Single Sign-on''
section from the implementation specifications in Sec. 170.215(c),
which is required by referencing the proposed Sec. 170.315(j)(9)
certification criterion in (g)(10)(ii)(A)(1)(i) and (g)(30)(ii)(A) and
by referencing the proposed Sec. 170.315(j)(10) certification
criterion in (g)(10)(ii)(A)(2)(i) and (g)(34)(ii)(A)(3)(i). Additional
details regarding the proposed adoption of the ``sso-openid-connect''
capability in the Sec. 170.315(g)(10) certification criterion is in
section III.B.19, and section III.B.20 for the Sec. 170.315(g)(30) and
(34) certification criteria.
Since we are proposing to adopt the ``sso-openid-connect''
capability in the Sec. 170.315(g)(10) certification criterion, we
propose to remove reference to the Sec. 170.215(e)(1) from the current
requirements in Sec. 170.315(g)(10)(v)(A)(1)(i) (as finalized in HTI-1
Final Rule), which are proposed to be moved to Sec.
170.315(g)(10)(ii)(A)(1)(i) according to the proposal in section
III.B.19 of this rule.
e. API Conditions and Maintenance Updates To Support Dynamic Client
Registration
As discussed in the ONC Cures Act Proposed and Final Rules, Section
4002 of the Cures Act requires the Secretary of HHS to establish
Conditions and Maintenance of Certification requirements for the
Program (84 FR 7465, 85 FR 25647). To implement this, ONC established
the Conditions and Maintenance of Certification requirements in the ONC
Cures Act Final Rule, including API Conditions and Maintenance
requirements in Sec. 170.404, which establish baseline technical and
behavioral requirements for Certified API Developers and their
certified API technology. The API Conditions and Maintenance
requirements established in the ONC Cures Act Final Rule implemented
the Cures Act requirement that certified API technology allow ``health
information from such technology to be accessed, exchanged, and used
without special effort through the use of APIs or successor technology
or standards, as provided for under applicable law'' (85 FR 25647). The
API Condition of Certification includes three main conditions that
focus on transparency, fees, and openness and pro-competitiveness. To
complement these conditions, we also adopted in Sec. 170.404(b)
Maintenance of Certification requirements that address ongoing, and, at
times, frequent experiences Certified API Developers would face, such
as app registration with certified API technology.
We propose to revise the app registration-oriented maintenance
requirements in Sec. 170.404(b) to align with the proposed
registration requirements as part of the certification criteria in
Sec. 170.315 (g)(10), (20), (30), and (32)-(35). First, we propose to
revise the authenticity verification API Maintenance of Certification
requirement in Sec. 170.404(b)(1)(i) to not apply to API Users that
are part of a trust community submitting registration requests via the
proposed dynamic client registration pathways in the certification
criteria in Sec. 170.315 (g)(10), (20), (30), and (32)-(35).
Specifically, if the API User is part of a trust community supported by
the certified API technology used by an API Information Source and the
API User's request to register is conformant to the UDAP Security IG
v1, then this Maintenance of Certification requirement shall not apply.
We propose to revise the requirement in this manner because API Users
that are part of a supported trust community will have already
undergone the authenticity verification processes required by the trust
community to receive a trust community certificate, and their
authenticity for registration can be rapidly proven via verification of
their trust community certificate. Therefore, we believe that an
additional verification process according to Sec. 170.404(b)(1)(i) by
a Certified API Developer for verification of API Users possessing a
supported trust community certificate and dynamically registering an
app is unnecessary and would hinder dynamic registration of apps at
scale.
Second, we propose to revise the registration for production use
API Maintenance of Certification requirement in Sec. 170.404(b)(1)(ii)
so that the registration timeframe for API Users submitting dynamic
registration requests according to the UDAP Security IG v1 is one
business day, rather than five business days as otherwise applies.
Specifically, if the API User is part of a supported trust community
and their request to register is valid and conformant to the UDAP
Security IG v1, then the Certified API Developer must register and
enable the application for production use within one business day. We
propose to revise the requirement in this manner to reflect the reduced
time necessary to process the automated dynamic registration request.
Third, we propose to add a new API Maintenance of Certification
requirement by revising paragraph Sec. 170.404(b)(2)(iv) to require a
Certified API Developer to publish information regarding the trust
communities supported at each service base URL published as part of the
requirements in Sec. 170.404(b)(2)(iii) that can be used by patients
to access their EHI. This proposal includes publication of the trust
community name, contact information, and web address, and identifying
URL in a machine-readable format at no charge for each service base URL
published in accordance with Sec. 170.404(b)(2)(iii) on and after
January 1, 2028. We propose that Health IT Modules certified to Sec.
170.315(g)(10) may, but are not required, to support trust community
discovery for dynamic registration in Sec. 170.404(b)(2)(iv) for the
period up to and including December 31, 2027. Additionally, we propose
in Sec. 170.404(b)(2)(i)(B) that these trust community details be
reviewed quarterly, and, as necessary, updated by Certified API
Developers. Finally, we propose to change the title of Sec.
170.404(b)(2) to ``publication of API discovery details for patient
access'' to better reflect the requirements we have proposed for this
section.
We believe that these requirements would better facilitate
individuals' access, exchange, and use of EHI, consistent with the
Cures Act, and build upon the existing foundations established in the
ONC Cures Act Final Rule by leveraging more advanced standards and
enable individuals to access, exchange, and use health data without
special effort via dynamic registration using applications of their
choice. We welcome public comment on if the requirements for
publication of API discovery details for Sec. 170.315(g)(10) should
include endpoints enabling provider, bulk, and system access to EHI.
Publication of information regarding supported trust communities
enables API Users to know if a trust community they are participating
in is also supported at a certified API technology's endpoint
conformant to Sec. 170.315(g)(10) or Sec. 170.315(g)(30), and thus if
dynamic client registration is supported at that endpoint for patient-
facing apps. Without required publication of supported trust
communities, API Users may have to query the metadata for each
individual certified API technology's endpoint to confirm if their
trust community is supported at that endpoint, which would hinder the
registration of apps at scale. This requirement for Certified API
Developers to publish trust community information would enable API
access, exchange, and use of health data ``without special effort'' by
ensuring API User access to information necessary for
[[Page 63567]]
scalable dynamic registration of patient-facing apps with certified API
technology certified to Sec. 170.315(g)(10) or Sec. 170.315(g)(30).
We refer readers to the ONC Cures Act Proposed Rule (84 FR 7477) for
additional discussion regarding why we believe access to trust
community, endpoint, and other API discovery details is a necessary
attribute to enable API access, exchange, and use of health data
``without special effort.''
We clarify that Certified API Developers must publish the
identifying URI as defined by the trust community, if such a UR is
available. Otherwise, Certified API Developers are permitted to
establish and publish a unique identifying URI for a trust community.
For the purposes of this proposal, trust community URIs defined by the
Certified API Developer must be used consistently to uniquely identify
a trust community. We welcome comment on our proposal for publication
of trust community details in Sec. 170.404(b)(2)(iv).
As an alternative to requiring trust community details be published
in any machine-readable format at no charge, we seek comment on
standards-based publication strategies and formats for the trust
community information we propose for Sec. 170.404(b)(2)(iv). We note
our proposal earlier in this preamble in section III.B.3 to require
service base URLs and related organization details be published in
aggregate vendor-consolidate Brand Bundle format according to the User-
access Brands and Endpoints (Brands) specification. We seek comment
from Certified API Developers on whether they would consider augmenting
their Brand Bundle with trust community information. The Brands
specification profiles do not specifically account for trust community
information, but given the breadth and extensibility of FHIR, the trust
community information could theoretically be included in a Brand Bundle
in FHIR format (e.g., using a FHIR extension). If this information is
not included in the Brand Bundle, it would need to be published
separately in some machine-readable format. We also seek comment from
third party-app developers on how this information can best be
published to support them in discovering and connecting to FHIR
endpoints.
16. New Certification Criteria for Modular API Capabilities
a. Proposal Background
We propose to add a new paragraph (j) to Sec. 170.315 titled
``modular API capabilities.'' This new certification criteria category
would promote the Program's modular certification approach and,
importantly, would enable different combinations of capabilities across
Health IT Modules depending on future use case needs. In general, we
expect the capabilities in Sec. 170.315(j) would be standards-based
and include a combination of new and existing standards, many of which
are currently referenced in Sec. 170.315(g)(10). Additionally, we
anticipate that the proposed capabilities in Sec. 170.315(j) would
enable the Program to better support a growing number of clinical,
public health, and administrative use cases over the long-term, as well
as foster innovation and competition in these spaces by providing
flexibility for modular development approaches among developers of
certified health IT.
Section 4002 of the Cures Act requires health IT developers, as a
condition of certification, to publish APIs that allow ``health
information from such technology to be accessed, exchanged, and used
without special effort through the use of APIs or successor technology
or standards, as provided for under applicable law.'' (emphasis added).
The Cures Act's API Condition of Certification requirement also states
that a developer must, through an API, ``provide access to all data
elements of a patient's electronic health record to the extent
permissible under applicable privacy laws.'' In the ONC Cures Act Final
Rule (85 FR 25740), we described our approach to adopting a
standardized API for patient and population services certification
criterion in Sec. 170.315(g)(10). The Standardized API for Patient and
Population Services in Sec. 170.315(g)(10) certification criterion
includes conformance requirements for a combination of standards--
including data content standards (such as the USCDI standard) and
technical standards (such as the SMART App Launch implementation
specification for authentication and authorization)--and functional
criteria for other technical capabilities (such as application
registration and token introspection). Since 2020, the standards
development community has undertaken work to: (1) update existing
standards and implementation specifications (e.g., US Core IG from
version 3.1.1 to 7.0.0) \166\; (2) formalize previously functional
capabilities as part of implementation specifications (e.g., token
introspection is now part of SMART App Launch 2.0) \167\; and (3)
support new and revised capabilities that are modular and use case
agnostic (e.g., HL7 CDS Hooks,\168\ FHIR Subscriptions,\169\ and UDAP
Security FHIR IG).\170\ These developments have changed the heath IT
landscape and helped support a wider range of potential technical
solutions for healthcare use cases that previously may not have been
supported, or were ineffectively supported, by health IT.
---------------------------------------------------------------------------
\166\ https://hl7.org/fhir/us/core/history.html.
\167\ https://hl7.org/fhir/smart-app-launch/STU2/token-introspection.html.
\168\ https://cds-hooks.hl7.org/.
\169\ https://hl7.org/fhir/uv/subscriptions-backport/STU1.1/.
\170\ https://build.fhir.org/ig/HL7/fhir-udap-security-ig/branches/main/index.html.
---------------------------------------------------------------------------
Over time, we have made updates to previously adopted certification
criteria based on the evolution of available standards to support more
advanced use cases leveraging similar functionality and increasingly
interconnected health IT systems. In addition, we have sought to
continuously improve the extensibility of specific conformance
requirements so that those conformance requirements can support
functionality in different types of health IT, and so that complex
systems can be certified in a modular fashion. By using the term
``modular'' we mean certification criteria in the Program that are
scoped to limited capabilities to enable health IT developers to
certify to the specific certification criteria that apply to Health IT
Modules they wish to certify, rather than large, multi-functionality,
and all-encompassing certification criteria that would give developers
less flexibility for certifying in the Program. The work to support
extensibility and modularity of certification criteria within the
Program has included cross-referencing aligned standards or
capabilities across other certification criteria, which support
consistent standards and functionality for related actions both across
and within certified capabilities. For example, the certification
criterion in Sec. 170.315(b)(2) clinical information reconciliation
and incorporation references the same standards referenced throughout
the transitions of care certification criterion in Sec. 170.315(b)(1),
including Sec. 170.205(a)(3) through (5), and the privacy and security
certification criteria in Sec. 170.315(d) are conditionally required
for certification according to Health IT Module certification
requirements for ONC-ACBs described in the privacy and security
certification framework in Sec. 170.550(h). Establishing the privacy
and security certification framework in Sec. 170.550(h) for ONC-ACBs
ensures that Health IT Modules are subject to more specific privacy
safeguards and provides more flexibility for certified health IT
developers than would be the case if we had a single,
[[Page 63568]]
multi-functionality privacy and security criterion.
Throughout the Program's history, we have also adopted both
certification criteria that include the full scope of a complex
transaction (e.g., Sec. 170.315(b)(3) electronic prescribing) and
certification criteria that include a discrete portion of a transaction
(e.g., Sec. 170.315(c)(1)-(4) clinical quality measures). These
different approaches are intended to align our Program requirements to
real world implementation scenarios which necessitate both contained
execution of complex transactions and the ability to implement related
processes across a range of systems in a modular fashion. Our adoption
of these varying types of certification criteria allows ONC to
administer a more effective and efficient Program, gives developers of
certified health IT more nuanced certification options to meet their
customers' needs, and promotes a more dynamic marketplace of certified
Health IT Modules than would be the case if we bundled different
functionalities and standards under fewer certification criteria.
Based on our analysis of the continued evolution of standards and
the real-world implementation scenarios for certified health IT to
enable FHIR-based APIs, we are proposing to adopt new certification
criteria supporting API capabilities for public health data exchange
and patient, provider, and payer data exchange (see sections III.B.13
and III.B.20 respectively). As described in this section, we are
proposing to revise Sec. 170.315(g)(10) through references to modular
API capabilities proposed as certification criteria in Sec.
170.315(j). These certification criteria include standards,
functionalities, and certification conformance requirements that align
with or are the exact same as the standards, functionalities, and
certification conformance requirements currently referenced in Sec.
170.315(g)(10). In addition, we are proposing to update the Sec.
170.315(g)(10) certification criterion to cross-reference newly
proposed requirements. Specifically, we propose to adopt a suite of
modular API capabilities as certification criteria in Sec. 170.315(j)
where each criterion focuses on one specific certification conformance
requirement, and we propose to reference these certification criteria
as applicable in the proposed revisions to the Sec. 170.315(g)(10)
certification criterion (see section III.B.19). For example, we propose
to include in Sec. 170.315((j)(1) functional registration, (j)(6)
SMART App Launch user authorization, (j)(7) SMART Backend Services
system authentication and authorization, (j)(9) SMART Patient Access
for Standalone Apps, (j)(10) SMART Clinician Access for EHR Launch.
However, we also propose to include in these proposed certification
criteria in Sec. 170.315(j) new certification conformance requirements
that reflect more recent API standards advancements (e.g., workflow
triggers, verifiable health records, and subscriptions) further
described below.
b. Modular API Capabilities Certification Criteria
We propose to adopt fourteen new modular API technology
certification criteria in Sec. 170.315(j) at (j)(1)-(2), (5)-(11), and
(20)-(24). We propose to reserve (j)(3)-(4) and (12)-(19). These new
certification criteria would be available for certification based on
certain contexts or other programs requiring the use of the specified
certified capabilities. Many of these certification criteria are
substantially similar to capabilities currently referenced in Sec.
170.315(g)(10)(iii) through (vii). We invite readers to review 85 FR
25739 through 25748 for discussion relevant to capabilities currently
referenced in Sec. 170.315(g)(10).
In Sec. 170.315(j)(1), we propose the ``Functional registration''
certification criterion which would require that a Health IT Module
demonstrate the ability for applications to register with its
authorization server. The process of registration is necessary in many
health IT workflows and enables an authorization server to establish a
scope of information access for applications and share authentication
credentials if applicable. This requirement would be similar to what
currently exists in Sec. 170.315(g)(10)(iii) ``Application
registration,'' which has a functional requirement to ``enable an
application to register with the Health IT Module's `authorization
server.' '' We clarify that for the proposed requirement in Sec.
170.315(j)(1) Health IT Modules presented for testing and certification
must support application registration regardless of the scope of
patient search utilized by the application (e.g., single or multiple).
Additionally, this proposed certification criterion would require a
health IT developer to demonstrate its registration process without
requiring the use of an identified standard.
In Sec. 170.315(j)(2), we propose the ``Dynamic registration''
certification criterion where a Health IT Module demonstrates the
ability to dynamically register confidential apps according to the
implementation specifications adopted in Sec. 170.215(o), including
mandatory support for sections ``Home,'' ``Discovery,'' and
``Registration'' as well as the ``community'' query parameter as
defined in the ``Multiple Trust Communities'' section of the
implementation specifications adopted in Sec. 170.215(o). As described
in more detail at section III.B.15 of this proposed rule, the UDAP
Security IG v1 would provide a more uniform, standardized, and
automated registration pathway for applications.
We propose to reserve Sec. 170.315(j)(3) and (j)(4) for future
potential registration capabilities.
In Sec. 170.315(j)(5), we propose to adopt the ``Asymmetric
certificate-based authentication for patient access'' certification
criterion where a Health IT Module's authorization server must support
authentication during the process of granting access to patient data to
patients according to the implementation specifications adopted in
Sec. 170.215(o), including support for asymmetric certificate-based
authentication as detailed in section ``Consumer-Facing'' of the
implementation specifications adopted in Sec. 170.215(o). Asymmetric
certificate-based authentication is a process by which the client and
server use public and private keys along with digital certificates for
authentication. It is a similar process to asymmetric authentication
with the modification that both the client and server verify each
other's participation in a trust community. The client and server
represent their participation in a trust community through a digital
certificate issued by the trust community's certificate authorities. We
note that asymmetric certificate-based authentication supports the
dynamic client registration proposals included in this rule for
adoption in Sec. 170.215(o)(1) (see the section titled New
Requirements to Support Dynamic Client Registration Protocol in the
Program).
In Sec. 170.315(j)(6) we propose to adopt the ``SMART App Launch
user authorization'' certification criterion where a Health IT Module's
authorization server must support user authorization during the process
of granting access to patient data according to at least one
implementation specification adopted in Sec. 170.215(c). We note for
this proposal that ``user'' refers to the end-user of an application,
and may refer to either a patient, or a healthcare professional or his
or her office staff. We clarify for the purposes of certification to
this criterion that support for one type of user is sufficient (e.g.,
support for a patient user, or
[[Page 63569]]
support for a healthcare professional or his or her office staff user).
The specific requirements include requiring support for Health IT
Modules to issue a refresh token valid for a period of no less than
three months to confidential apps and native apps capable of securing a
refresh token in Sec. 170.315(j)(6)(i), receive and validate tokens
issued by the Health IT Module in accordance with at least one
implementation specification adopted in Sec. 170.215(c) in Sec.
170.315(j)(6)(ii), and enable for confidential apps persistent access
to patient information without requiring user re-authentication or re-
authorization until authorization revocation at the user's direction in
Sec. 170.315(j)(6)(iii). We further propose in Sec. 170.315(j)(6)(iv)
that a Health IT Module's authorization server must be able to revoke
and must revoke an authorized application's access at a user's
direction within 1 hour of the request. This proposed certification
criterion includes the same functions for refresh tokens from Sec.
170.315(g)(10)(v)(A) ``Authentication and authorization for patient and
user scopes'' as well as authorization revocation and token
introspection functions from Sec. 170.315(g)(10)(vi) and (vii),
respectively. Regarding support for the issuance of refresh tokens for
native apps for this certification criterion, we mirror the conformance
expectations established in the Information Blocking and the ONC Health
IT Certification Program: Extension of Compliance Dates and Timeframes
in Response to the COVID-19 Public Health Emergency Interim Final Rule
(85 FR 70076), namely that health IT developers can determine the
method(s) they use to support interactions with native apps and that
health IT developers are not required to support all methods that
third-party application developers seek to use.
In Sec. 170.315(j)(7), we propose to adopt the ``SMART Backend
Services system authentication and authorization'' certification
criterion where a Health IT Module would support system authentication
and authorization during the process of granting a system access to
patient data in accordance with the backend services profile of at
least one implementation specification adopted in Sec. 170.215(c).
This certification criterion's conformance requirements are derived
from what currently exists in Sec. 170.315(g)(10)(v)(B)
``Authentication and authorization for system scopes,'' proposed in
Sec. 170.315(j)(7), as well as the token introspection requirements
from Sec. 170.315(g)(10)(vii), proposed in Sec. 170.315(j)(7)(i). The
proposed token introspection requirements in Sec. 170.315(j)(7)(i)
include requiring that a Health IT Module's authorization server must
be able to receive and validate tokens it has issued in accordance with
at least one implementation specification adopted in Sec. 170.215(c).
The HL7 standards community re-organized their standards and moved the
``SMART Backend Services: Authorization Guide'' from the Bulk v1 IG
(adopted in Sec. 170.215(d)(1)) into the ``Backend Services'' section
of the SMART Application Launch Implementation Guide Release 2.0.0
(adopted in Sec. 170.215(c)(2)).
In Sec. 170.315(j)(8), we propose to adopt the ``Asymmetric
certificate-based system authentication and authorization''
certification criterion where a Health IT Module would support system
authentication and authorization for the ``client_credentials'' grant
type during the process of granting access to patient data according to
the implementation specifications adopted in Sec. 170.215(o),
including support for the ``Business-to-Business'' section of the
implementation specifications adopted in Sec. 170.215(o). This
certification criterion would support system authentication and
authorization for business-to-business access use cases within
supported trust communities. This certification criterion would be
similar in function to the certification criterion proposed in Sec.
170.315(j)(7) in that it would require system authentication and
authorization capabilities but would additionally require support for
contextual information and certificates as detailed in the UDAP
Security IG v1 to enable authentication and authorization within a
trust community. Additionally, we propose to include a section for
``Token introspection'' in Sec. 170.315(j)(8)(i), where a Health IT
Module's authorization server must be able to receive and validate
tokens it has issued in accordance with at least one implementation
specification adopted in Sec. 170.215(c). This requirement would be
similar to what currently exists in Sec. 170.315(g)(10)(vii) ``Token
introspection'' and is aligned with similar token introspection
requirements in Sec. 170.315(j)(6)(ii) and (7)(i).
In Sec. 170.315(j)(9), we propose to adopt the ``SMART Patient
Access for Standalone Apps'' certification criterion where the Health
IT Module would support patient authorization and authorization
revocation at a patient's direction according to the requirements in
Sec. 170.315(j)(6). The capabilities described in the SMART
Application Launch Framework Implementation Guide have matured and
changed over time, and to support a health IT developer's ability to
certify using any of the available implementation specifications in
Sec. 170.215(c) we propose allowing health IT developers to support
one of the following sets of SMART capabilities listed in paragraph
(j)(9)(i), (ii), and (iii). We also note that versions of the SMART
Application Launch Framework Implementation Guide adopted in Sec.
170.215(c) will expire on January 1, 2026 for Sec. 170.215(c)(1), and
January 1, 2028 for Sec. 170.215(c)(2), and this proposed structure in
Sec. 170.315(j)(9) will support the transition to newer versions of
the implementation specification. The first set of SMART capabilities
requires up to and including December 31, 2025, support for the
``Patient Access for Standalone Apps'' Capability Set, as well as the
capabilities of ``launch-standalone'' and ``context-standalone-
patient,'' and the capabilities in subsections ``Client Types,''
``Single Sign-on,'' and ``Permissions'' except the ``permission-user''
from Sec. 170.215(c)(1). The second set of SMART capabilities requires
up to and including December 31, 2027, support for ``Patient Access for
Standalone Apps'' Capability Set as well as the capabilities of
``launch-standalone'' and ``context-standalone-patient,'' and the
capabilities in subsections ``Authorization Methods,'' ``Client
Types,'' ``Single Sign-on,'' and ``Permissions'' except the
``permission-online'' and ``permission-user'' capabilities from Sec.
170.215(c)(2). The third set of SMART capabilities requires on and
after January 1, 2028, support the ``Patient Access for Standalone
Apps'' Capability Set as well as the capabilities of ``launch-
standalone'' and ``context-standalone-patient,'' and the capabilities
in subsections ``Authorization Methods,'' ``Client Types,'' ``Single
Sign-on,'' and ``Permissions'' except the ``permission-online'' and
``permission-user'' capabilities from Sec. 170.215(c)(3). In addition
to requiring the foundational SMART App Launch capabilities for user
authorization from proposed Sec. 170.315(j)(6), this certification
criterion adds requirements to support SMART App Launch capabilities to
enable patients to authorize apps to access information using the SMART
standalone launch process.
In Sec. 170.315(j)(10), we propose the ``SMART Clinician Access
for EHR Launch'' certification criterion where the Health IT Module
would support user authorization and authorization revocation at a
user's direction according to the requirements in
[[Page 63570]]
Sec. 170.315(j)(6)(i)-(iii), including mandatory support for one of
three sets of SMART capabilities to facilitate user access using EHR
launch, proposed in Sec. 170.315(j)(10)(i)(A), (B), and (C). The
proposal describes that for the time period up to and including
December 31, 2025, a Health IT Module must meet either the requirements
specified in paragraph Sec. 170.315(j)(10)(i)(A), (B), or (C); for the
time period up to and including December 31, 2027, a Health IT Module
must meet either the requirements specified in paragraph Sec.
170.315(j)(10)(i)(B) or (C); and finally on and after January 1, 2028,
a Health IT Module must meet the requirements specified in paragraph
Sec. 170.315(j)(10)(i)(C).
The first set of SMART capabilities proposed in Sec.
170.315(j)(10)(A) requires support for the ``Clinician Access for EHR
Launch'' Capability Set as well as the capabilities of ``launch-ehr,''
``context-banner,'' ``context-style,'' and ``context-ehr-patient'' as
well as the capabilities in subsections ``Client Types,'' ``Single
Sign-on,'' and ``Permissions'' according to the implementation
specification adopted in Sec. 170.215(c)(1). The second set of SMART
capabilities proposed in Sec. 170.315(j)(10)(B) requires support for
the ``Clinician Access for EHR Launch'' Capability Set as well as the
capabilities of ``launch-ehr,'' ``context-banner,'' ``context-style,''
``context-ehr-patient,'' and ``context-ehr-encounter,'' and the
capabilities in subsections ``Authorization Methods,'' ``Client
Types,'' ``Single Sign-on,'' and ``Permissions'' except the
``permission-online'' capability according to the implementation
specification adopted in Sec. 170.215(c)(2). The third set of SMART
capabilities proposed in Sec. 170.315(j)(10)(A) requires support for
the ``Clinician Access for EHR Launch'' Capability Set as well as the
capabilities of ``launch-ehr,'' ``context-banner,'' ``context-style,''
``context-ehr-patient,'' and ``context-ehr-encounter,'' and the
capabilities in subsections ``Authorization Methods,'' ``Client
Types,'' ``Single Sign-on,'' and ``Permissions'' except the
``permission-online'' capability according to the implementation
specification adopted in Sec. 170.215(c)(3). In addition to requiring
the foundational SMART App Launch capabilities for user authorization
from proposed Sec. 170.315(j)(6)(iv), this certification criterion
adds requirements to support SMART App Launch capabilities to enable
users to authorize apps to access information using the SMART EHR
launch process.
As discussed in section ``SMART App Launch 2.2'' of this rule, we
propose to no longer reference specific capabilities and sections of
the SMART App Launch implementation guide under Sec. 170.215(c).
Instead, Program criteria would specify required capabilities of the
SMART App Launch implementation guide. In alignment with that proposal,
we propose the SMART capabilities as adopted in HTI-1 in Sec.
170.215(c)(1) for SMART App Launch 1.0.0 and Sec. 170.215(c)(2) for
SMART App Launch 2.0.0 be moved to the proposed Sec. 170.315(j)(6)-
(10) certification criteria. We propose the SMART App Launch 1.0.0
capabilities relevant to patient access for standalone apps be
specified at proposed Sec. 170.315(j)(9)(i) and the capabilities
relevant to clinician access for EHR launch be specified at proposed
Sec. 170.315(j)(10)(i)(A). Similarly, we propose the SMART App Launch
2.0.0 capabilities relevant to patient access for standalone apps be
specified at proposed Sec. 170.315(j)(9)(ii) and the capabilities
relevant to clinician access for EHR launch be specified at proposed
Sec. 170.315(j)(10)(i)(B). Finally, we propose to include the SMART
App Launch 2.2.0 capabilities in Sec. 170.315(j)(9)(iii) for patient
access and Sec. 170.315(j)(10)(i)(C) for clinician access. We propose
moving token introspection according to SMART App Launch 2.0.0 as
adopted in Sec. 170.215(c)(2) in HTI-1 Final Rule to requirements in
the proposed certification criteria in Sec. 170.315(j)(6)-(8), which
includes (j)(6)(ii), (7)(i), and (8)(i). The proposed certification
criteria in Sec. 170.315(j)(9) and (10) would also include conformance
dates for each set of required SMART App Launch capabilities that would
enable developers as they present their products for certification to
move to the newer requirements when they are ready and prior to when a
particular conformance requirement may expire, and the other(s) become
the new baseline.
In Sec. 170.315(j)(11), we propose the ``Asymmetric certificate-
based authentication for B2B user access'' certification criterion
where the Health IT Module would support asymmetric certificate-based
authentication for the ``authorization_code'' grant type during the
process of granting access to patient data to users according to the
implementation specifications adopted in Sec. 170.215(o), including
support for asymmetric certificate-based authentication as detailed in
the ``Business-to-Business'' section of the implementation
specifications adopted in Sec. 170.215(o). This certification
criterion would be similar to the certification criterion proposed in
Sec. 170.315(j)(5) in that it would require support for certificate-
based authentication according to the UDAP Security IG v1. However,
this certification criterion would be focused on business-to-business
authentication requirements to enable users, not patients, access to
information in a within a trust community.
We intend to reserve Sec. 170.315(j)(12) through (j)(19) in
anticipation of future standards-based capabilities that would be
complementary to the certification criteria proposed for adoption in
Sec. 170.315(j)(1) through (j)(11).
Beginning in Sec. 170.315(j)(20), we propose a set of new
standards-based capabilities. These capabilities are not derived from
the existing conformance requirements specified in Sec.
170.315(g)(10). Rather, they reflect more advanced capabilities enabled
by the HL7 FHIR standard and related implementation guides. We propose
to adopt ``workflow triggers for decision support interventions--
clients'' in Sec. 170.315(j)(20) and Workflow triggers for decision
support interventions--services at (j)(21); ``Verifiable health
records'' in Sec. 170.315(j)(22); and ``Subscriptions--server'' in
Sec. 170.315(j)(23) and ``Subscriptions--client'' at (j)(24). We
propose these modular certification criteria to be broadly applicable
to various clinical, public health, and administrative use cases.
Below, we describe and provide our rationale for each of these advanced
capabilities proposed for inclusion in Sec. 170.315(j)(20) through
(24).
i. Sec. 170.315(j)(20) and (21) Workflow Triggers for Decision Support
Interventions
We propose to adopt the CDS Hooks Release 2.0 implementation
specification in Sec. 170.215(f)(1) to support Program requirements
for API-based workflow triggers for decision support interventions (as
described in more detail in the next paragraph) in the proposed
certification criteria in Sec. 170.315(j)(20) and (j)(21). These
certification criteria are proposed separately but are both related to
the underlying specification in Sec. 170.215(f)(1). The certification
criterion proposed in Sec. 170.315(j)(20) includes requirements for
``clients'' participating in API-based workflow triggers for decision
support, and the certification criterion proposed in Sec.
170.315(j)(21) includes requirements for ``services'' providing
decision support services to clients.
[[Page 63571]]
CDS Hooks is a specification that describes a ``hook''-based
pattern for invoking or triggering decision support from within a
clinician's workflow (typically the ``client'' side of this pattern).
This pattern facilitates a clinician's ability to either pull in
results from decision support directly into a clinician's workflow or
can be used to launch an interactive application.
We propose that a Health IT Module presented for certification to
Sec. 170.315(j)(20) support the requirements of the implementation
specification in Sec. 170.215(f)(1) as a ``CDS Client'' including
support for the registration of ``CDS Services'' according to the
implementation specification in Sec. 170.215(f)(1) in Sec.
170.315(j)(20)(i) and support for authentication and authorization
\171\ according to the implementation specification in Sec.
170.215(f)(1) in Sec. 170.315(j)(20)(ii). We also propose in Sec.
170.315(j)(20)(iii) that Health IT Modules certified to Sec.
170.315(j)(20) support the execution of decision support workflow
triggers in accordance with the implementation specification in Sec.
170.215(f)(1), as well as demonstrate the ability to send a decision
support request to a CDS Service according to the implementation
specification in Sec. 170.215(f)(1), in Sec. 170.315(j)(20)(iv). As
part of the capability to send a decision support request to a CDS
Service, we propose in Sec. 170.315(j)(20)(iv)(A) that a Health IT
Module support the ability to deliver a CDS Hook request with
prefetched information according to the ``Prefetch Template'' section
of the implementation specification in Sec. 170.215(f)(1); support
access to HL7 FHIR Resources via a RESTful API to support decision
support intervention workflows according to the ``FHIR Resource
Access'' section of the implementation specification in Sec.
170.215(f)(1) in Sec. 170.315(j)(20)(iv)(B); and support the receipt
of a decision support response according to the implementation
specification in Sec. 170.215(f)(1) in Sec. 170.315(j)(20)(iv)(C),
including support the display of the contents of a decision support
response to an end-user and support the ability to launch internal apps
and SMART apps from decision support responses according to the
implementation specification in Sec. 170.215(f), including support for
the ``Link'' field ``appContext,'' in Sec. 170.315(j)(20)(iv)(C)(1)
and Sec. 170.315(j)(20)(iv)(C)(2), respectively.
---------------------------------------------------------------------------
\171\ CDS Hooks Release 2.0 includes authentication and
authorization of endpoints and identity of the CDS Client. We direct
readers to the implementation specification for more detail.
---------------------------------------------------------------------------
We propose that a Health IT Module presented for certification to
Sec. 170.315(j)(21) support the complementary aspects of the workflow
trigger implementation specification in Sec. 170.215(f)(1).
Specifically, we propose these Health IT Modules support the
requirements of the implementation specification in Sec. 170.215(f)(1)
as a ``CDS Service'' including support for registration of CDS Clients
in Sec. 170.315(j)(21)(i) and authentication and authorization
according to the implementation specification in Sec. 170.215(f)(1) in
Sec. 170.315(j)(21)(ii). In Sec. 170.315(j)(21)(iii), we propose a
Health IT Module respond to requests for recommendations and guidance
via a RESTful API according to the implementation specification in
Sec. 170.215(f)(1), including capabilities to receive and process
decision support requests in Sec. 170.315(j)(21)(iii)(A); the ability
to receive pre-fetched information according to the ``Prefetch
Template'' section of the implementation specification Sec.
170.215(f)(1) in Sec. 170.315(j)(21)(iii)(A)(1); and the ability to
fetch HL7 FHIR Resources via an API according to the ``FHIR Resource
Access'' section of the implementation specification Sec.
170.215(f)(1) in Sec. 170.315(j)(21)(iii)(A)(2). Finally, we propose
in Sec. 170.315(j)(21)(iii)(B) that Health IT Modules support
returning a decision support response according to the implementation
specification in Sec. 170.215(f)(1), including support for the
``Link'' field ``appContext.''
We note that the proposed workflow triggers criteria in Sec.
170.315(j)(20) and (j)(21) do not define or propose specific workflows
associated with decision support, including how and when clinicians use
decision support capabilities. Rather, we propose to include standards-
based interfaces in Sec. 170.315(j)(20) and (j)(21) to enable clinical
systems to call other systems offering decision support services in a
standardized manner to support the exchange and use of these
services.172 173 174 We request comment on these proposals.
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\172\ Bradshaw, R.L., Kawamoto, K., Kaphingst, K.A., Kohlmann,
W.K., Hess, R., Flynn, M. C., . . . Del Fiol, G. (2022). GARDE: a
standards-based clinical decision support platform for identifying
population health management cohorts. Journal of the American
Medical Informatics Association: JAMIA, 29(5), 928-936. doi:10.1093/
jamia/ocac028.
\173\ Morgan, K.L., Kukhareva, P., Warner, P.B., Wilkof, J.,
Snyder, M., Horton, D., . . . Kawamoto, K. (2022). Using CDS Hooks
to increase SMART on FHIR app utilization: a cluster-randomized
trial. Journal of the American Medical Informatics Association:
JAMIA, 29(9), 1461-1470. doi:10.1093/jamia/ocac085.
\174\ Watkins, M., & Eilbeck, K. (2020). FHIR Lab Reports: using
SMART on FHIR and CDS Hooks to increase the clinical utility of
pharmacogenomic laboratory test results. AMIA Summits on
Translational Science proceedings, 2020, 683-692.
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ii. Sec. 170.315(j)(22) Verifiable Health Records
We propose that a Health IT Module presented for certification to
Sec. 170.315(j)(22) support the issuance of verifiable health records
according to the SMART Health Cards Framework version 1.4.0 standard
(SMART Health Cards), which we propose to adopt in Sec.
170.215(g)(1)(i). SMART Health Cards specifies a framework for issuing
records represented using HL7 FHIR structured information to users that
can be verified by another party.\175\ SMART Health Cards is based on
international open standards. In addition to HL7 FHIR, SMART Health
Cards incorporate DEFLATE Compression, JSON Web Token (JWT), JSON Web
Key (JWK), JSON Web Key (JWK) Thumbprint, and HMAC-SHA-256.\176\ SMART
Health Cards support a decentralized infrastructure and addresses
common concerns around verifying portable data. Once a SMART Health
Card is generated, the data becomes verifiable to a point in time,
which can then be shared at the patient's discretion via Quick-Response
Code (QR code). QR Codes are two dimensional barcodes that can encode
up to about 3Kb of data.\177\ The QR Codes can be easily scanned via
smartphones to access the SMART Health Card. We also propose to adopt
the SMART Health Cards: Vaccination and Testing Implementation Guide
version 1.0.0-rc--STU 1 Release Candidate,'' in Sec. 170.215(g)(2)(i),
an HL7 FHIR implementation guide that leverages the SMART Health Cards
Framework to describe standards-based methods for the issuance of
verifiable health records for vaccination status and infectious
disease-related laboratory testing.
---------------------------------------------------------------------------
\175\ https://smarthealth.cards/en/.
\176\ https://spec.smarthealth.cards/#what-software-libraries-are-available-to-work-with-smart-health-cards.
\177\ https://www.qrcode.com/en/about/.
---------------------------------------------------------------------------
The SMART Health Cards standard has seen rapid adoption in the past
few years as a reliable and easy way for consumers to receive and share
verifiable clinical information. Some notable use cases for verifiable
records that have been implemented in clinical settings using the SMART
Health Cards standard occurred during the COVID-19 public health
emergency to support verifiable COVID-19 test results and
[[Page 63572]]
COVID-19 vaccination records.178 179 In support of these and
related use cases, we propose in Sec. 170.315(j)(22)(i) that Health IT
Modules support the ``data minimization'' and ``allowable data''
profiles of the following according to the implementation specification
adopted in Sec. 170.215(g)(2)(i): ``Immunization Bundle,'' ``COVID-19
Labs Bundle,'' and ``Generic Labs Bundle,'' ``Patient--United States,''
``Vaccination,'' ``Lab results COVID-19,'' and ``Lab results--
Generic.'' We propose in Sec. 170.315(j)(22)(ii) that Health IT
Modules support the ``$health-cards-issue'' operation via a
standardized API according to the implementation specification adopted
in Sec. 170.215(g)(1)(i). We are also aware that the SMART Health
Cards standard is going through the ballot and publication process at
HL7 over the next several months. ONC encourages the community to
follow along and can access the current CI Build at https://build.fhir.org/ig/HL7/smart-health-cards-and-links/cards-specification.html. If there is a published version of the SMART Health
Cards standard prior to the publication of the final rule, we will
consider adopting that version. We welcome comment on our proposals.
---------------------------------------------------------------------------
\178\ Braunstein, M.L. (2022). SMART on FHIR. In: Health
Informatics on FHIR: How HL7's API is Transforming Healthcare.
Health Informatics. Springer, Cham. https://doi-org.hhsnih.idm.oclc.org/10.1007/978-3-030-91563-6_10.
\179\ https://www.thecommonsproject.org/shc.
---------------------------------------------------------------------------
We also note that while we have not proposed nor are we seeking
comment on the SMART Health Links technical specification that we are
closely following its advances as well as industry uses for future
rulemakings.
iii. Sec. 170.315(j)(23) and (24) Subscriptions
The HL7 FHIR Subscriptions Framework describes a standardized
method for clients to subscribe to notifications from servers based on
pre-negotiated criteria. Once the subscription is established, servers
can proactively notify a client when new information has been added or
existing information has been updated in its system. Once a
notification has been received by a client, the client can take
appropriate action, including querying the server for the desired
information. The HL7 FHIR Subscriptions Framework also describes
methods to transmit payloads with notifications, which may help
simplify some interorganizational transactions by enabling real-time
updates, selective data transmission, and interoperability, making data
exchange between organizations more efficient and effective.
We anticipate that API-based subscriptions will support several use
cases across clinical, public health, administrative and research
domains. Specific to public health use cases, we envision that future
implementation guides could leverage the HL7 FHIR Subscriptions
Framework for case reporting processes, immunization reporting
processes, syndromic surveillance, reportable laboratory tests and
values, and transmitting cancer case information to state cancer
registries, among others. We welcome comments on this approach,
particularly with respect to the readiness of this standard to support
public health reporting and any potential benefits or limitations to
this approach that we should consider.
The HL7 FHIR Subscriptions Framework has undergone a significant
redesign during the development of the HL7[supreg] FHIR[supreg] Release
5 (R5) standard, including the use of ``SubscriptionTopic'' HL7 FHIR
Resources that define the criteria for standardized subscription
notifications. We have structured our proposals in Sec. 170.315(j)(23)
and (24) to best accommodate health IT developers and the industry's
maturity so that API-based subscriptions can be more easily implemented
in the current health IT landscape. While the HL7 FHIR Subscriptions
Framework in HL7[supreg] FHIR[supreg] R5 is well developed, the health
IT industry is largely using HL7[supreg] FHIR[supreg] Release 4,
Version 4.0.1 (HL7[supreg] FHIR[supreg] R4), for HL7 FHIR standards-
based exchange. Updating all the criteria in the Program to HL7[supreg]
FHIR[supreg] R5 to accommodate the updated HL7 FHIR Subscriptions
Framework would not be practicable nor prudent given the full-scale
industry redesign that would be necessary to do so and impacts on
users. In order to enable health IT developers using HL7[supreg]
FHIR[supreg] R4, to support the improvements made in the HL7 FHIR
Subscriptions Framework in HL7[supreg] FHIR[supreg] R5, the HL7
standards community created the Subscriptions R5 Backport
Implementation Guide version 1.1.0, which specifies some of the
HL7[supreg] FHIR[supreg] R5 Subscriptions Framework enhancements in a
way that is compatible with HL7[supreg] FHIR[supreg] R4.
We propose that a Health IT Module presented for certification to
Sec. 170.315(j)(23) or Sec. 170.315(j)(24) support API-based
subscriptions according to HL7 FHIR Subscriptions Framework included in
the HL7 FHIR Subscriptions R5 Backport Implementation Guide version
1.1.0 (hereafter referred to as ``Subscriptions IG''), which we propose
to adopt in Sec. 170.215(h)(1). The proposals in Sec. 170.315(j)(23)
and (24) specify constraints on the implementation specification
proposed in Sec. 170.215(h)(1), which intend to ensure that Health IT
Modules certified to Sec. 170.315(j)(23) or (24) can conform to
separate but related aspects and functions of the implementation
specification in Sec. 170.215(h). Similar to the proposals in Sec.
170.315(j)(20) and (21), we propose that Health IT Modules certified to
Sec. 170.315(j)(23) support subscriptions as a ``server'' and Health
IT Modules certified to Sec. 170.315(j)(24) support subscriptions as a
``client'' according to the implementation specification proposed in
Sec. 170.215(h)(1).
Recognizing the importance of reducing burden on health IT
developers while also striving to improve nationwide interoperability,
we propose to adopt the Subscriptions IG in Sec. 170.215(h)(1) support
certification criteria for API-based subscriptions in Sec.
170.315(j)(23) subscriptions--server and Sec. 170.315(j)(24)
subscriptions--client requirements. The Subscriptions IG includes API-
based subscription functionality that goes beyond the scope of FHIR R4,
but for the purposes of the Program, we propose in Sec.
170.315(j)(23)(i) and (24)(i), for servers and clients respectively,
that Health IT Modules support the requirements specified in section
``1.6 Topic-Based Subscriptions--FHIR R4'' of the implementation
specification in Sec. 170.215(h)(1).
Additionally, we propose in Sec. 170.315(j)(23)(ii) and (24)(ii),
for servers and clients respectively, that Health IT Modules support
the ``R4/B Topic-Based Subscription'' profile as specified in the
Subscriptions IG. We note that while this profile is compatible with
both HL7[supreg] FHIR[supreg] R4, and HL7[supreg] FHIR[supreg] R4B, we
propose it for use with HL7[supreg] FHIR[supreg] R4, at this time.
We also propose in Sec. 170.315(j)(23)(iii) that Health IT Modules
support the requirements described in the ``R4 Topic-Based Subscription
Server Capability Statement'' of the implementation specification in
Sec. 170.215(h)(1), including support for ``create,'' ``update,'' and
``delete'' interactions for HL7 FHIR Subscription Resources according
to the implementation specification in Sec. 170.215(h)(1). We propose
corresponding requirements for clients in Sec. 170.315(j)(24)(iii),
specifically that Health IT Modules support the accompanying client
capabilities for the minimum requirements included in the ``R4
[[Page 63573]]
Topic-Based Subscription Server Capability Statement'' of the
implementation specification in Sec. 170.215(h)(1), including support
for ``create,'' ``update,'' and ``delete'' interactions for HL7 FHIR
Subscription Resources according to the implementation specification in
Sec. 170.215(h)(1). We propose to require servers support the
``create,'' ``update,'' and ``delete'' interactions so that a client
will be enabled to create, modify, and delete subscriptions on a server
using a standardized API.
Finally, we propose in Sec. 170.315(j)(23)(iv) that Health IT
Modules support the ability to send subscription notifications to
subscribed clients, and in 170.315(j)(24)(iv) that Health IT Modules
support the ability to receive subscription notifications, according to
the ``1.6 Topic-Based Subscriptions--FHIR R4'' section of the
implementation specification in Sec. 170.215(h)(1). We propose to
include in Sec. 170.315(j)(23)(iv)(A) and (24)(iv)(A), for servers and
clients respectively, that support for ``id-only'' Payload Types is
required as specified in the ``Payload Types'' section of the
implementation specifications in Sec. 170.215(h)(1). There are three
options available when specifying contents of a notification: empty,
id-only, and full-resource. We believe that id-only provides a good
balance between security and performance.
Additionally, we propose in Sec. 170.315(j)(23)(v) that Health IT
Modules support the ability for a client to subscribe to a subscription
topics and parameters defined in notifications by the subscription
topics as defined in Sec. 170.315(j)(23)(v)(A) and Sec.
170.315(j)(23)(v)(B)(1)-(19). We propose in Sec. 170.315(j)(23)(A) to
require Health IT Modules support USCDI change notifications which
allows a client to subscribe to receive notifications filtered by a
patient identifier and send notifications when any of the Resources
specified in Sec. 170.315(j)(23)(v)(B) are created or updated as
applicable according to the standard in Sec. 170.215(a) and
implementation specification in Sec. 170.215(h)(1). We further propose
in Sec. 170.315(j)(23)(v)(B) that Health IT Modules support resource
notifications supporting the ability for a client to subscribe to
notifications filtered according to the conditions below and send
notifications for the following Resource interactions according to the
standard in Sec. 170.215(a) and implementation specification in Sec.
170.215(h)(1):
``AllergyIntolerance'' Resource is created or updated,
including support for filtering subscription notifications using
``category,'' ``code,'' and ``patient'' data elements.
``CarePlan'' Resource is created or updated, including
support for filtering subscription notifications using ``category'' and
``subject'' data elements.
``CareTeam'' Resource is created, or updated, including
support for filtering subscription notifications using ``category'' and
``subject'' data elements.
``Condition'' Resource is created or updated, including
support for filtering subscription notifications using ``category,''
``code,'' and ``subject'' data elements.
``Coverage'' Resource is created or updated, including
support for filtering subscription notifications using ``beneficiary''
and ``type'' data elements.
``DiagnosticReport'' Resource is created or updated,
including support for filtering subscription notifications using
``category,'' ``code,'' and ``subject'' data elements.
``DocumentReference'' Resource is created or updated,
including support for filtering subscription notifications using
``subject'' and ``type'' data elements.
``Encounter'' Resource is created or updated, including
support for filtering subscription notifications using ``reasonCode,''
``subject,'' and ``type'' data elements.
``Goal'' Resource is created or updated, including support
for filtering subscription notifications using ``category,''
``description,'' and ``subject'' data elements.
``Immunization'' Resource is created or updated, including
support for filtering subscription notifications using ``patient,'' and
``vaccineCode'' data elements.
``MedicationDispense'' Resource is created or updated,
including support for filtering subscription notifications using
``category,'' ``medication[x],'' and ``subject'' data elements.
``MedicationRequest'' Resource is created or updated,
including support for filtering subscription notifications using
``category,'' ``medication[x],'' and ``subject'' data elements.
``Observation'' Resource is created or updated, including
support for filtering subscription notifications using ``category,''
``code,'' and ``subject'' data elements.
``Patient'' Resource is updated, including support for
filtering subscription notifications using the ``identifier'' data
element.
``Procedure'' Resource is created or updated, including
support for filtering subscription notifications using ``category,''
``code,'' and ``subject'' data elements.
``QuestionnaireResponse'' Resource is created or updated,
including support for filtering subscription notifications using the
``subject'' data element.
``RelatedPerson'' Resource is created or updated,
including support for filtering subscription notifications using the
``patient'' data element.
``ServiceRequest'' Resource is created or updated,
including support for filtering subscription notifications using
``category,'' ``code,'' and ``subject'' data elements.
``Specimen'' Resource is created or updated, including
support for filtering subscription notifications using ``patient'' and
``type'' data elements.
We believe our proposal in Sec. 170.315(j)(23)(v) reflects the
public feedback we received during the HTI-1 rulemaking process.
Several commenters recommended that the subscription criterion focus on
retrieving patient data associated with a specific patient ID as a
starting point.
Proposals in Sec. 170.315(j)(23) and Sec. 170.315(j)(24) included
in this section reflect public feedback we received in the HTI-1
Proposed Rule. For Sec. 170.315(j)(23), in the HTI-1 Proposed Rule, we
received feedback supporting subscription notification for patient data
associated with a specific patient ID that allows for notifications
based on new or updated data associated with the patient's resources.
The proposed resources specified in Sec. 170.315(j)(23)(v)(B) are a
subset of USCDI/US Core IG Resources filtered to include those that are
part of the HL7 FHIR ``Compartment Patient'' \180\ and are widely
supported across the healthcare industry. We believe that aligning
subscription requirements with US Core resources that are required
across several ONC certification Program criteria will contribute to
better data exchange, improved patient care, and more effective health
IT systems.
---------------------------------------------------------------------------
\180\ https://hl7.org/fhir/R4/compartmentdefinition-patient.html.
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We seek public comment on the listed US Core resources in Sec.
170.315(j)(23)(v)(B), and we alternately propose to require client
servers to support the ability for a client to subscribe to
notifications filtered by all, meaning any, USCDI/US Core resources for
``category,'' ``code,'' and ``subject'' data elements where applicable.
We additionally propose to include in Sec. 170.315(j)(23)(iv)(B)
that at a minimum, support for the ``REST-Hook'' channel is required
for sending subscription notifications to clients as specified in the
``Channels'' section of the implementation specifications in Sec.
170.215(h)(1). The REST-hook channel
[[Page 63574]]
uses the RESTful model which is extensively used in FHIR standard and
is considered to present the lowest bar for implementation. Finally, we
propose to include in Sec. 170.315(j)(24)(iv)(B) required support for
consuming notifications via the ``REST-Hook'' channel as specified in
the ``Channels'' section of the implementation specifications in Sec.
170.215(h)(1).
We note that we have included references to the proposed
certification criterion in Sec. 170.315(j)(23) in two proposed
certification criteria in Sec. 170.315(g)(20) and Sec. 170.315(g)(35)
and refer readers to those sections for more information on the
proposals. Additionally, we have included a reference to the proposed
certification criterion in Sec. 170.315(j)(24) in the proposed
certification criterion in Sec. 170.315(g)(34) and refer to that
section for more information on the proposals.
We believe our proposal and alternative proposals in Sec.
170.315(j)(23) and Sec. 170.315(j)(24) reflect the public feedback we
received during the HTI-1 rulemaking process. We acknowledge that the
standards may have matured beyond the prior recommended feedback from
the HTI-1 Proposed Rule and request comment on these proposals and
whether interested individuals and organizations would prefer to
implement other standards listed in the Subscriptions IG, including
API-based subscriptions based on HL7 FHIR R5.
17. Multi-Factor Authentication Criterion
a. Background
In the ONC Cures Act Final Rule, we finalized a ``multi-factor
authentication'' (MFA) certification criterion in Sec. 170.315(d)(13)
and applied it to all certification criteria across the privacy &
security (P&S) certification framework (85 FR 25700). Through this
certification criterion and the P&S Certification Framework, we
established an approach that required health IT developers to be
transparent about whether their certified Health IT Module supports
MFA. As part of the certification process, developers' ``yes'' or
``no'' attestations are made public on ONC's Certified Health IT
Product List (CHPL) which is accessible here: https://chpl.healthit.gov/.
We established this approach in acknowledgement that ``MFA may not
be appropriate or applicable in all situations'' and that ``there is a
wide variation in authentication needs and approaches throughout the
industry'' (85 FR 25701). We also acknowledged some of the challenges
with adopting MFA in healthcare, noting comments expressing concern
that it could increase provider burden (85 FR 25701). We therefore
finalized our current approach to allow for developers to attest ``no''
as a certification option, and to promote increased transparency into
these ``no'' attestations, we included a provision that permitted
health IT developers attesting ``no'' to explain why their Health IT
Module does not support MFA. Any optional explanations provided were
also made available to the public on the CHPL as part of the
certification process.
b. Proposal
We propose to update the requirements in the ``Multi-factor
authentication'' certification criterion in Sec. 170.315(d)(13) to
increase support for MFA in certified health IT without imposing
additional requirements on health care providers. We believe these
updates match industry information security best practice for important
authentication use cases in health IT and that it is necessary to help
better protect electronic health information. We propose to expire our
current ``yes'' or ``no'' attestation requirements by moving them to
Sec. 170.315(d)(13)(i) and including an applicability date for the
time period up to and including December 31, 2027 in Sec.
170.315(d)(13). We propose to replace the attestation requirements by
revising Sec. 170.315(d)(13) to include the new requirements in Sec.
170.315(d)(13)(ii) that become required for continued conformance on
and after January 1, 2028. We propose with these new requirements to
require, in Sec. 170.315(d)(13)(ii)(A), Health IT Module support for
authentication, through multiple elements of the user's identity,
according to industry recognized standards. Additionally, we propose,
in Sec. 170.315(d)(13)(ii)(B), to require that Health IT Modules
certified to the criterion provide functionality that allows users
(e.g., providers and patients) to configure, enable and disable these
multi-factor authentication capabilities. Lastly, we propose that a
health IT developer may meet the proposed revised certification
criterion's requirements just by satisfying the new conformance
requirements proposed in Sec. 170.315(d)(13)(ii) in lieu of Sec.
170.315(d)(13)(i) prior to paragraph (i)'s December 31, 2027,
expiration.
We expect that Health IT Modules certifying to this MFA criterion
must have the ability to authenticate users using multiple means to
confirm that users are who they claim to be. Multiple means of
authentication in this context includes using two or more of the
following: (i) Something people know, such as a password or a personal
identification number (PIN); (ii) something people have, such as a
phone, badge, card, RSA token or access key; and (iii) something people
are, such as fingerprints, retina scan, heartbeat, and other biometric
information (85 FR 25701). Examples of industry recognized standards
for MFA include NIST Special Publication 800-63B Digital Identity
Guidelines, and ISO 27001.\181\ As we stated in 2019, when we first
proposed MFA requirements in the Program, a government led initiative
and numerous organizations and groups recommend the use of MFA (84 FR
7451). More recently, the HHS Office for Civil Rights has identified
weakened healthcare authentication measures as one of the biggest
causes of data breaches in recent years.\182\ We believe our proposal
helps improve security by increasing access to MFA. This is because it
is less likely that an unauthorized individual or entity will be able
to succeed in proving one's identity when more than one authentication
factor is used.
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\181\ NIST Special Publication 800-63B: https://pages.nist.gov/800-63-3/sp800-63b.html; ISO 27001: https://www.iso.org/standard/27001.
\182\ https://www.hhs.gov/hipaa/for-professionals/security/guidance/cybersecurity-newsletter-june-2023/index.html.
---------------------------------------------------------------------------
We also propose corresponding revisions in the principles of proper
conduct for ONC-ACBs in Sec. 170.523(m) and the privacy and security
certification framework in Sec. 170.550(h)(3). In Sec. 170.523(m)(3)
we propose to time-limit the applicability of Sec. 170.315(d)(13) for
the time period up to and including December 31, 2027. After this date,
ONC-ACBs will no longer be required to obtain a record of updates from
health IT developers to describe MFA use cases. Additionally, we
propose to apply the updated MFA requirements to each of the
certification criteria in Sec. 170.315(b)(3), (e)(1), (g)(10), and
(g)(30). Specifically, in Sec. Sec. 170.315(b)(3)(ii)(G),
170.315(e)(1)(iii), 170.315(g)(10)(ii)(A)(1)(iii), and
170.315(g)(30)(ii)(C) we propose to include a requirement that on and
after January 1, 2028, Health IT Modules certified to any of these
criteria are also certified to Sec. 170.315(d)(13)(ii). Given our
proposal to embed Sec. 170.315(d)(13) references into the
certification criteria we propose requiring MFA support in, Sec.
170.315(d)(13) does not need to also be referenced in Sec.
170.550(h)(3)(i) through (ix). Therefore, we propose to expire all the
references to Sec. 170.315(d)(13) in Sec. 170.550(h)(3)(i) through
(ix) by time-limiting the applicability of Sec. 170.315(d)(13) in
Sec. 170.550(h)(3)(i)
[[Page 63575]]
through (ix) for the time period up to and including December 31, 2027.
We clarify that Health IT Modules certified to Sec. 170.315(g)(10)
and Sec. 170.315(g)(30), on and after January 1, 2028, would be
required to support MFA for patient scopes or patient-facing
authentication use cases, rather than non-patient (i.e., clinical user)
and system-level use cases. We also clarify that Health IT Modules
certified to Sec. 170.315(b)(3) on and after January 1, 2028, would
have the option of meeting the requirement to support MFA in this
certification criterion by supporting user level MFA for electronic
prescribing of a controlled substance.\183\ With respect to Health IT
Modules certified to Sec. 170.315(b)(3) that do not support electronic
prescribing of a controlled substance, we propose that they must still
demonstrate support for MFA for some other user authentication use
case. We welcome comment on these proposals. We also request comment on
whether we should consider in the final rule exempting Health IT
Modules from the MFA requirement when they are only designed to support
non-controlled substance electronic prescribing. We would also
appreciate any statistics, if available, on the market segment that
would be affected by this specific policy.
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\183\ Multi-factor authentication for electronic prescribing of
controlled substances is required to meet the Electronic Prescribing
of Controlled Substances (EPCS) requirements set by Drug Enforcement
Administration (DEA).
---------------------------------------------------------------------------
Finally, we propose to modify Sec. 170.550(h)(3)(viii) to require
that Health IT Modules certified to Sec. 170.315(g)(20) and (g)(30)
through (36), in addition to Sec. 170.315(g)(7) through (g)(10) as is
currently required, are also certified to the certification criteria
specified in Sec. 170.315(d)(1), (9), (12), and, for the time period
up to and including December 31, 2027, Sec. 170.315 (d)(13); and
(d)(2)(i)(A) and (B), (d)(2)(ii) through (v), or (10). We similarly
propose, in Sec. 170.550(h)(3)(x), that Health IT Modules certified to
any criterion proposed in Sec. 170.315(j) are also certified to the
certification criteria specified in Sec. 170.315(d)(1), (d)(2)(i)(A)
and (B), (d)(2)(ii) through (v), (d)(3), and (12). We welcome comment
on this proposal including whether we should require testing for Sec.
170.315(d)(13) in any of the certification criteria in Sec.
170.315(j).
18. Revised Computerized Provider Order Entry--Laboratory Criterion
The laboratory-based workflow is initiated when a clinician orders
a test (such as part of a routine screening or a diagnostic work up).
If the clinician does not provide all of the information requested in
the test order, or if the test order does not request specific data,
the laboratory or the public health authority receiving the laboratory
results will not have complete information. Such missing information
could include patient demographics, creating gaps in understanding and
addressing issues related to health equity, in addition to direct
issues with contact tracing and patient outreach that could slow down
the spread of infectious disease.
Laboratory orders are often initiated in EHR systems when ordered
by clinicians practicing in hospitals or large healthcare
organizations. The laboratory provides the results from the test back
to the ordering clinician by various means via their Laboratory
Information Management Systems (LIMS) or Laboratory Information Systems
(LIS). Ensuring that systems that create orders are also capable of
transmitting orders and receiving associated results and values back
electronically, according to national standards, will create more
complete patient information available to clinicians throughout the
laboratory workflow.
We propose to revise the ``computerized provider order entry--
laboratory'' certification criterion in Sec. 170.315(a)(2) by
requiring Health IT Modules certified to this criterion to create and
transmit laboratory orders electronically, to be performed according to
the Lab Orders Interface (LOI) Implementation Guide proposed at
170.205(g)(2) and the Lab Results Interface (LRI) Implementation Guide
proposed in Sec. 170.2015(g)(3). Specifically, we propose to implement
our proposed revisions by moving our existing Sec. 170.315(a)(2)
requirements into paragraphs Sec. 170.315(a)(2)(i) that expire on
January 1, 2026, and by including new standards-based requirements for
lab orders in Sec. 170.315(a)(2)(ii) that must be met on and after
January 1, 2028.
We propose to revise Sec. 170.315(a)(2) by establishing a new
subparagraph in Sec. 170.315(a)(2)(ii) to include requirements for
Health IT Modules certified to Sec. 170.315(a)(2) to enable a user to
create and transmit laboratory orders electronically, to be performed
according to the LOI Implementation Guide (Sec. 170.205(g)(2)) cross-
referenced in Sec. 170.315(a)(2)(ii)(B). We further propose to require
Health IT Modules certified to Sec. 170.315(a)(2) to enable a user to
receive and validate laboratory results according to the LRI
Implementation Guide (Sec. 170.205(g)(3)) cross-referenced in Sec.
170.315(a)(2)(ii)(C).
As discussed in our proposals relevant to Sec. 170.315(f)(3), in
section III.B.13.d., the LRI and LOI IGs reduce some of the optionality
that is present in currently implemented specifications, which may
improve the completeness of information. For example, the LRI and LOI
implementation guides require ordering provider, patient address,
patient phone number, and patient race. Further, the LRI IG aligns with
Clinical Laboratory Improvement Amendments of 1988 (CLIA) requirements
in place for laboratories. The update to these specifications, and the
inclusion of the receipt of orders in Sec. 170.315(f)(3), as well as
the receipt of results in Sec. 170.315(a)(2), ensure that functions
throughout the lifecycle of the laboratory order, from entry, to
result, to reporting to public health authority, is covered by
electronic requirements with the associated national standard.
We propose that for the time period up to and including December
31, 2027, a Health IT Module certified to Sec. 170.315(a)(2) must meet
either the requirements specified in paragraph (a)(2)(i), or the
requirements specified in paragraph (a)(2)(ii). On and after January 1,
2028, for Health IT Modules certified to Sec. 170.315(a)(2), we
propose that such Health IT Modules must meet the requirements
specified in paragraph (a)(2)(ii).
We welcome comment on these proposals.
19. Revised Standardized API for Patient and Population Services
Criterion To Align With Modular API Capabilities
As part of our overall proposal, we propose to revise the structure
of the regulation text in Sec. 170.315(g)(10) for clarity as well as
phrasing consistency with other proposed API certification criteria in
this proposed rule (e.g., the proposed applicable Sec. 170.315(j)
criteria). These revisions to the regulation text's structure are
intended to improve readability and how the certification criterion's
requirements are organized. Generally, these specific reorganizing
revisions are not intended to introduce substantive changes to current
conformance requirements. A notable exception is the proposed reference
to certification criterion requirements proposed in Sec.
170.315(j)(10)(ii), which would be a new requirement for user
authorization revocation. We also note that we have included proposals
that introduce new, substantive requirements as well to Sec.
170.315(g)(10) with applicable conformance timing. These details are
discussed below and, as applicable,
[[Page 63576]]
proposed Sec. 170.315(j) certification criteria requirements will be
discussed along with current and proposed Sec. 170.315(g)(10)
requirements to show a complete view of all proposed revisions to the
Sec. 170.315(g)(10) certification criterion's regulation text.
We propose to revise the Sec. 170.315(g)(10) certification
criterion to reference applicable proposed Sec. 170.315(j)
certification criteria to make the regulation text of Sec.
170.315(g)(10) more concise, clear, and consistent with the other
proposed API certification criteria. In section III.B.16 of this
proposed rule, we discuss our proposal to add a new category of
certification criteria in Sec. 170.315(j) titled ``Modular API
capabilities.'' The Sec. 170.315(j) certification criteria, if
finalized, would allow for specific API certification requirements to
be demonstrated independently or in different combinations through the
Program in circumstances where meeting all of Sec. 170.315(g)(10)'s
requirements would not be applicable. These proposed changes, taken
together, would help the Program support APIs across clinical, public
health, administrative, and other use cases.
a. Proposed Revisions for Registration
We propose to reorganize and rephrase the application registration
requirements currently in Sec. 170.315(g)(10)(iii). The current
application registration requirements in Sec. 170.315(g)(10)(iii)
require support for an application to register with the Health IT
Module's ``authorization server'' to support retrieval of data for a
single patient's data and multiple patients' data. No standard is
currently specified for registration. We propose to rename Sec.
170.315(g)(10)(i) as ``Registration,'' and move the existing
application registration requirements from Sec. 170.315(g)(10)(iii) to
Sec. 170.315(g)(10)(i). We also propose to clarify in Sec.
170.315(g)(10)(i) which app types are currently required to be
supported for functional registration (confidential and public apps).
Clarifying these app types required for functional registration does
not introduce new requirements since confidential and public apps were
already required to be supported for functional registration according
to the current requirements in Sec. 170.315(g)(10)(iii). We note that
we propose to no longer specifically reference the ``confidential app''
profile from the SMART App Launch implementation guide in the Sec.
170.315(g)(10) certification criterion. Instead, we propose to refer to
the app types of ``confidential app'' and ``public app'' as described
in the section of this rule titled ``SMART App Launch 2.2.'' In
addition to this move and clarification, we also propose that on and
after January 1, 2028, both the capabilities proposed in Sec.
170.315(g)(10)(i)(A) and (B) would be required to support the full
scope of API capabilities required in the Sec. 170.315(g)(10)
certification criterion. This includes as part of the regulation text
reordering new proposed language in Sec. 170.315(g)(10)(i)(A) to
reference Sec. 170.315(j)(1) to support ``functional registration''
and new proposed language in Sec. 170.315(g)(10)(i)(B) to reference
Sec. 170.315(j)(2) to support ``dynamic registration.'' We clarify
that the capability described at proposed Sec. 170.315(g)(10)(i)(A) is
not intended to substantively change the application registration
requirements with which health IT developers are currently familiar,
but instead clarify the nature of the functional requirements and
detail which app types are required to be supported for functional
registration (confidential and public apps). To accommodate the
distinct proposal to require dynamic client registration as part of
Sec. 170.315(g)(10), the proposed Sec. 170.315(g)(10)(i)(B) focuses
on dynamic client registration for patient and user access as proposed
in Sec. 170.315(g)(10)(ii) and system access at (iii).
b. Proposed Revisions for Patient and User Access
In the context of retrieving data for a single patient, we propose
to restructure and rephrase the data response requirements currently in
Sec. 170.315(g)(10)(i)(A), supported search operations requirements in
Sec. 170.315(g)(10)(ii)(A), secure connection requirements in Sec.
170.315(g)(10)(iv)(A), authentication and authorization for patient and
user scopes requirements in Sec. 170.315(g)(10)(v)(A), and patient
authorization revocation requirements in Sec. 170.315(g)(10)(vi). We
propose reorganizing those requirements to all be under proposed Sec.
170.315(g)(10)(ii) to make clear which requirements support data
retrieval for a single patient's data. Specifically, we propose to
rename Sec. 170.315(g)(10)(ii) to be ``Patient and user access'' and
include these paragraphs as follows.
We propose to revise the paragraph in Sec. 170.315(g)(10)(ii)(A)
and add subparagraphs in Sec. 170.315(g)(10)(ii)(A)(1) and (2) to
include, with revisions, the requirements for secure connection
currently in Sec. 170.315(g)(10)(iv)(A), authentication and
authorization for patient and user scopes currently under Sec.
170.315(g)(10)(v)(A), and patient authorization revocation requirements
currently in Sec. 170.315(g)(10)(vi). We also propose to add a multi-
factor authentication requirement in Sec.
170.315(g)(10)(ii)(A)(1)(iii) for patient-facing uses. The specific
alignment between current regulatory text paragraphs and proposed new
paragraphs is detailed in each of the bullets that follow.
Proposed Sec. 170.315(g)(10)(ii)(A)(1)(i), Sec.
170.315(g)(10)(ii)(A)(2)(i), and Sec. 170.315(g)(10)(ii)(B)(1)
maintain the existing requirement in Sec. 170.315(g)(10)(iv)(A) to
support a secure connection and authentication and authorization for
apps requesting patient and user scopes according to the SMART App
Launch and US Core implementation guides. We propose to no longer
explicitly mention ``secure connection'' since we believe it is
redundant as the referenced implementation guides already include such
requirements for secure connections. The ``App Protection'' section of
the SMART App Launch IG requires the use of secure TLS connections and
is required as part of the requirements at proposed Sec.
170.315(g)(10)(ii)(A)(1)(i) and Sec. 170.315(g)(10)(ii)(A)(2)(i) by
reference to proposed Sec. 170.315(j)(9) and Sec. 170.315(j)(10)(i)
respectively. Proposed Sec. 170.315(j)(9) and Sec. 170.315(j)(10)(i)
require support for authorization according to capabilities from one of
the SMART App Launch IGs adopted in Sec. 170.215(c), which in turn
necessitates the use of secure TLS connections as required in the ``App
Protection'' section of the SMART App Launch IG. Additionally, the
``Security'' section of the US Core IG requires the use of secure TLS
connections and is required as part of the requirements at proposed
Sec. 170.315(g)(10)(ii)(B)(1). Proposed Sec. 170.315(g)(10)(ii)(B)(1)
requires support for responding to requests for patient data according
to the one of the US Core IGs adopted in Sec. 170.215(b)(1), which in
turn necessitates the use of secure TLS connections as required in the
``Security'' section of the US Core IG.
We propose to revise the organization of authentication
and authorization requirements for patient-facing apps and use-facing
apps for Sec. 170.315(g)(10) to be under Sec. 170.315(g)(10)(ii)(A).
We propose authentication and authorization requirements for patient
access to be under Sec. 170.315(g)(10)(ii)(A)(1) and authentication
and authorization requirements for user access be under
[[Page 63577]]
Sec. 170.315(g)(10)(ii)(A)(2). The proposed revisions in Sec.
170.315(g)(10)(ii)(A)(1)(i) and Sec. 170.315(g)(10)(ii)(A)(2)(i)
maintain the requirements currently in Sec. 170.315(g)(10)(v)(A) for
authentication and authorization for patient and user scopes (scopes
being information access permissions as represented in the OAuth 2.0
Authorization Framework) according to SMART App Launch capabilities as
currently referenced in Sec. 170.215(c) and OpenID Connect Core as
currently referenced in Sec. 170.215(e). The proposed revisions in
Sec. 170.315(g)(10)(ii)(A)(1)(i) reference the proposed certification
criterion in Sec. 170.315(j)(9) ``SMART patient access for standalone
apps,'' which requires the SMART App Launch capabilities that are
currently required to be supported for authentication and authorization
of patient-facing apps. The proposed revisions in Sec.
170.315(g)(10)(ii)(A)(2)(i) reference the proposed certification
criterion in Sec. 170.315(j)(10) ``SMART clinician access for EHR
launch,'' which requires the SMART App Launch capabilities currently
required for authentication and authorization of user-facing apps.
Current OpenID Connect Core requirements would also be maintained by
the proposed references to Sec. 170.315(j)(9) ``SMART patient access
for standalone apps'' and (10) ``SMART clinician access for EHR
launch'' since those proposed certification criteria require the ``sso-
openid-connect'' SMART App Launch capability by requiring the ``Single
Sign-on'' section of one of the SMART App Launch IGs adopted in Sec.
170.215(c). In addition to maintaining current requirements from Sec.
170.315(g)(10)(v)(A) for authentication and authorization for patient
and user scopes, the proposed references in the Sec. 170.315(g)(10)
certification criterion to Sec. 170.315(j)(9) and (10) would also add
requirements to support SMART App Launch capabilities for
authentication and authorization for patient-facing apps and user-
facing apps according to the implementation specification of SMART App
Launch 2.2.0, proposed in this rule to be adopted in Sec.
170.215(c)(3). The proposed certification criteria in Sec.
170.315(j)(9) and (10) would also include conformance dates for each
set of required SMART capabilities. Conformance to each set of required
SMART capabilities would be in alignment with the following: (1)
expiration of SMART App Launch 1.0.0, adopted in Sec. 170.215(c)(1),
for use in the Program on January 1, 2026 as finalized in the HTI-1
Final Rule (89 FR 1292); (2) the proposed expiration of SMART App
Launch 2.0.0, adopted in Sec. 170.215(c)(2), for use in the Program on
January 1, 2028; and (3) the proposed adoption of SMART App Launch
2.2.0 in Sec. 170.215(c)(3). Please see the section titled ``SMART App
Launch 2.2'' of this rule for additional details regarding the proposed
expiration and adoption of SMART App Launch 2.0.0 and 2.2.0
respectively. For more information regarding how SMART App Launch
capabilities as currently required and proposed to be required
correspond to the proposed certification criteria in Sec.
170.315(j)(9) and (10), including specific capabilities and their
conformance dates, please refer to section III.B.16 ``New Certification
Criteria for Modular API Capabilities.''
The requirements currently in Sec.
170.315(g)(10)(v)(A)(1)(ii), Sec. 170.315(g)(10)(v)(A)(1)(iii), and
Sec. 170.315(g)(10)(v)(A)(2) regarding the issuance of refresh tokens
are mirrored in the proposed paragraphs in Sec.
170.315(g)(10)(ii)(A)(1)(i) and (2)(ii) via cross references to the
certification criteria proposed in Sec. 170.315(j)(9) ``SMART patient
access for standalone apps'' and (10) ``SMART clinician access for EHR
launch'' respectively, which reference the proposed certification
criterion in Sec. 170.315(j)(6) ``SMART App Launch user
authorization,'' wherein the language has been simplified to
consolidate existing refresh token requirements and remove extraneous
references to refresh token requirements already included in referenced
implementation guides. Additionally, we include the authentication and
authorization requirements that are currently in Sec.
170.315(g)(10)(ii)(A)(1)(i) and (ii) in our proposals in Sec.
170.315(g)(10)(ii)(A)(1) ``Authentication and authorization for patient
access'' and (2) ``Authentication and authorization for user access,''
which reference the proposed criteria at Sec. 170.315(j)(9) ``SMART
patient access for standalone apps'' and (10) ``SMART clinician access
for EHR launch,'' which both reference the proposed certification
criterion in Sec. 170.315(j)(6) ``SMART App Launch user
authorization.'' We reiterate the existing conformance expectations
established in the COVID-19 Public Health Emergency Interim Final Rule
(85 FR 70076) that health IT developers can determine the method(s)
they use to support interactions with native apps and that health IT
developers are not required to support all methods that third-party
application developers seek to use. Further, we propose to revise the
requirements that enable persistent access to confidential apps on
subsequent connections which are currently required in Sec.
170.315(g)(10)(v)(A)(2)(ii) to instead require support for a user to
enable for confidential apps persistent access to patient information
without requiring user re-authentication or re-authorization until
authorization revocation at the user's direction. Additionally, we
propose moving this requirement to part of one of the modular API
capabilities in (j), specifically in Sec. 170.315(j)(6)(iii). As
proposed, Sec. 170.315(j)(6)(iii) is referenced by the proposed
certification criteria in Sec. 170.315(j)(9) ``SMART patient access
for standalone apps'' and (10) ``SMART clinician access for EHR
launch,'' which are referenced by the proposed revised certification
criterion in Sec. 170.315(g)(10). Revising the requirement in this
manner is intended to provide developers more flexibility in
implementing persistent access for confidential apps while maintaining
the requirement that patients and users can authorize persistent access
to patient data to confidential apps until revoking that access.
We propose to move the current ``patient authorization
revocation'' requirement in Sec. 170.315(g)(10)(vi) to Sec.
170.315(j)(6) ``SMART App Launch user authorization,'' specifically
Sec. 170.315(j)(6)(iv) ``User authorization revocation.'' These
requirements are referenced by the proposed certification criterion in
Sec. 170.315(j)(9) ``SMART patient access for standalone apps'' which
is referenced by the proposed revised certification criterion in Sec.
170.315(g)(10)(ii)(A)(1)(i). We propose a new requirement to require
support for user authorization revocation in Sec.
170.315(g)(10)(ii)(A)(2)(i) which references the requirements at the
proposed certification criterion in Sec. 170.315(j)(10)(ii), and is
proposed to take effect on and after January 1, 2028. This would
require a Health IT Module's authorization server to be able to revoke
and must revoke an authorized application's access at a user's
direction within 1 hour of the request. This is distinct from the
existing patient authorization revocation requirement currently in
Sec. 170.315(g)(10)(vi) and proposed in Sec. 170.315(j)(6)(iii) which
requires support for revocation of a patient's authorization but does
not require support for revocation of a clinician's authorization. We
propose introducing this requirement in Sec.
170.315(g)(10)(ii)(A)(2)(i) to support revocation of clinician
authorizations to enable clinicians to have greater control
[[Page 63578]]
over their authorizations for applications to access patient data.
We propose new requirements for authentication for
dynamically registered patient-facing and user-facing apps in Sec.
170.315(g)(10)(ii)(A)(1)(ii) and (2)(ii) respectively, with a
compliance date on and after January 1, 2028. We refer readers to the
``Revision of Standardized API for Patient and Population Services to
Support Dynamic Client Registration'' in section III.B.15.c of this
proposed rule for additional details of the proposed Sec.
170.315(g)(10) requirements for authentication and authorization of
dynamically registered patient-facing apps and dynamically registered
user-facing apps.
The proposed revisions in Sec.
170.315(g)(10)(ii)(A)(1)(iii) would require multi-factor authentication
to be supported for patient-facing authentication on and after January
1, 2028, according to the requirements specified in the proposal at
Sec. 170.315(d)(13)(ii). We believe this update aligns with industry
information security best practices, and that it is necessary to help
better protect electronic health information. See the proposal for
updating Sec. 170.315(d)(13) and referencing Sec. 170.315(d)(13)(ii)
across certain certification criteria with authentication use cases at
section III.B.17.
We propose to reorganize as part of Sec. 170.315(g)(10)(ii)(B) the
text for the current requirements for single patient data response
currently in Sec. 170.315(g)(10)(i)(A) and single patient supported
search operations requirements currently in Sec.
170.315(g)(10)(ii)(A), with proposed subparagraphs as follows:
The proposed language in Sec. 170.315(g)(10)(ii)(B)(1)
maintains the existing requirements for data response and search
support but simplifies the language by consolidating references to
implementation guides. As part of our revisions, we propose to no
longer explicitly mention the requirement in the API certification
criteria language regarding ``mandatory'' and ``must support'' because
this was done for emphasis in our prior rulemaking and, we believe,
consistent with long standing Program policy, that when we adopt
standards and implementation specifications that all requirement
aspects of those need to be addressed for conformance purposes.
Additionally, to reflect our policy interests to advance imaging
availability as described in section III.B.6, we propose to also
include support for imaging links in Sec. 170.315(g)(10)(ii)(B)(1)
indicating that imaging links must be supported as part of data
response and search requirements on and after January 1, 2028.
We also propose in Sec. 170.315(g)(10)(ii)(B)(2) that on
and after January 1, 2028, support for the issuance of verifiable
health records as specified by the requirements in proposed Sec.
170.315(j)(22) be supported. We propose requiring support for
verifiable health records in Sec. 170.315(g)(10)(ii)(B)(2) to support
the ability for patients to access their immunization and infectious
disease-related laboratory test information in a format that is easily
portable and verifiable by third parties, which is the underlying
benefit of the SMART Health Card standard proposed as part of Sec.
170.315(j)(22).
Proposed Sec. 170.315(g)(10)(ii)(B)(3) requires on and
after January 1, 2028, support for subscriptions as a server for
patient-facing apps and user-facing apps according to the requirements
specified in Sec. 170.315(j)(23). We refer readers to subsequent
section III.B.19.e for additional details about this proposal.
c. Proposed Revisions for System Access
We propose reorganizing under Sec. 170.315(g)(10)(iii) the data
response requirements currently in Sec. 170.315(g)(10)(i)(B),
supported search operations requirements currently in Sec.
170.315(g)(10)(ii)(B), secure connection requirements in Sec.
170.315(g)(10)(iv)(B), and authentication and authorization for system
scopes requirements currently in Sec. 170.315(g)(10)(v)(B). We believe
these proposals will make it more efficient to understand the
requirements necessary to support data retrieval for multiple patients'
data. Specifically, we propose to revise Sec. 170.315(g)(10)(iii) to
be called ``System access'' and include the following paragraphs.
We propose to organize authentication and authorization
requirements for system access under the paragraph in Sec.
170.315(g)(10)(iii)(A). We propose to add a paragraph in Sec.
170.315(g)(10)(iii)(A)(1) which, by reference to the proposed
certification criterion in Sec. 170.315(j)(7), maintains requirements
for secure connection currently in Sec. 170.315(g)(10)(iv)(B) and
authentication and authorization for system scopes in accordance with
the ``SMART Backend Services: Authorization Guide'' currently in Sec.
170.315(g)(10)(v)(B). We do not include specific mention of ``secure
connection'' in the proposed paragraphs in Sec.
170.315(g)(10)(iii)(A)(1) or Sec. 170.315(j)(7) since we believe it is
redundant as the referenced implementation guides already include such
requirements for secure connections. The proposed paragraph in Sec.
170.315(g)(10)(iii)(A)(1) maintains the existing system authentication
and authorization requirements currently in Sec. 170.315(g)(10)(v)(B)
by referencing the proposed Sec. 170.315(j)(7) certification
criterion. Proposing to require conformance to the proposed Sec.
170.315(j)(7) certification criterion maintains the requirements for
SMART Backend Services while using consistent language across API
certification criteria in the Program. The Sec. 170.315(j)(7)
certification criterion also facilitates reference to the updated
location of the SMART Backend Services specification, which has been
moved from the Bulk Data Access guide to the SMART App Launch guide in
subsequent versions of those guides. We also propose to include
language in Sec. 170.315(g)(10)(iii)(A)(1) which clarifies that
authentication and authorization for system access in accordance with
SMART Backend Services is only required for functionally registered
system apps.
Proposed Sec. 170.315(g)(10)(iii)(A)(2) would support the
dynamic registration proposal described in section III.B.15.c of this
proposed rule to support authentication and authorization of
dynamically registered system apps. The paragraph in Sec.
170.315(g)(10)(iii)(A)(2) describes the new proposed requirements to
support authentication and authorization for dynamically registered
system apps according to the ``Business-to-Business'' section of the
UDAP Security IG v1 proposed in Sec. 170.215(o) and proposes that a
Health IT Module certifying to Sec. 170.315(g)(10) must support the
specified sections of the UDAP Security IG v1 on and after January 1,
2028 for system apps dynamically registered using the capabilities in
proposed Sec. 170.315(g)(10)(i)(B). We refer readers to the ``Revision
of Standardized API for Patient and Population Services to Support
Dynamic Client Registration'' in section III.B.15.c of this proposed
rule for additional details of the proposed Sec. 170.315(g)(10)
requirements for authentication and authorization of dynamically
registered system apps.
We propose to organize system information access
requirements under proposed paragraph Sec. 170.315(g)(10)(iii)(B). We
propose to maintain the data response requirements currently in Sec.
170.315(g)(10)(i)(B) and include those requirements in proposed Sec.
170.315(g)(10)(iii)(B)(2) and (i). We note that the existing supported
search operations requirements at current Sec. 170.315(g)(10)(ii)(B)
are not applicable
[[Page 63579]]
to the export of multiple patients' data according to the Bulk Data
Access implementation guide adopted under Sec. 170.215(d), since
search requests are not distinct from the data export requests as
defined in that guide. As a result, we propose to remove the existing
requirements language currently in Sec. 170.315(g)(10)(ii)(B) but do
not anticipate any change to the substance of the Sec. 170.315(g)(10)
certification criterion requirements given such requirements are
subsumed by the data response requirements proposed in Sec.
170.315(g)(10)(iii)(B)(2) and (i). The proposed language in Sec.
170.315(g)(10)(iii)(B)(2) and (i) maintains the existing requirements
for data response but simplifies the language by removing redundant
language for requirements already required through reference to
implementation guides and thus as we noted above, we have removed the
explicit reference to ``mandatory'' and ``must support'' in this
revised paragraph. Additionally, to reflect our policy interests to
advance imaging availability as described in section III.B.6, we
propose to also include support for imaging links in Sec.
170.315(g)(10)(iii)(B)(2) and (i) indicating that imaging links must be
supported as part of data response requirements for multiple patients
on and after January 1, 2028. The requirements as proposed at and under
Sec. 170.315(g)(10)(iii)(B)(2) are rephrased such that the Bulk Data
Access implementation guide features required for the Sec.
170.315(g)(10) certification criterion (e.g., group export) are
explicitly enumerated in the criterion instead of in the reference to
Bulk Data Access implementation guide in Sec. 170.215(d). Also, to
accommodate the distinct proposal to support the ``_type'' query
parameter in Sec. 170.315(g)(10) described in section III.B.14 of this
rule, we propose adding paragraph Sec. 170.315(g)(10)(iii)(B)(2)(ii)
indicating that parameter must be supported. Both the ``_type'' query
parameter and use of the parameter to support bulk data retrieval of
imaging links would need to be supported on and after January 1,
2028.We propose that the paragraph in Sec. 170.315(g)(10)(iii)(B)(1)
requires support to respond to requests from system apps for patient
data consistent with the search criteria included in the FHIR standard
adopted in Sec. 170.215(b) and one of the US Core IGs as adopted in
Sec. 170.215(b)(1) for each of the data classes and data elements
included in at least one of the versions of the USCDI standard adopted
in Sec. 170.213 and, on and after January 1, 2028, imaging links. We
refer readers to subsequent section III.B.19.e for additional details
about this proposal. Proposed Sec. 170.315(g)(10)(iii)(B)(3) requires
on and after January 1, 2028, support for subscriptions as a server for
system apps according to the requirements specified in Sec.
170.315(j)(23). We refer readers to subsequent section III.B.19.e for
additional details about this proposal.
d. Other Restructured Requirements
We propose to continue to require the token introspection
requirements currently in Sec. 170.315(g)(10)(vii) by moving such
requirements language to the proposed Sec. 170.315(j)(6) and (7) API
certification criteria, and then referencing those criteria directly or
indirectly where appropriate in the Sec. 170.315(g)(10) certification
criterion. The existing token introspection requirements apply to
tokens issued for both patient and user scopes, and system scopes.
Thus, we propose in Sec. 170.315(g)(10)(ii)(A)(1)(i) to continue to
require token introspection for tokens issued to patient-facing apps by
referencing Sec. 170.315(j)(9), which references Sec. 170.315(j)(6).
Next, we propose in Sec. 170.315(g)(10)(ii)(A)(2)(i) to continue to
require token introspection for user-facing apps by referencing Sec.
170.315(j)(10), which references Sec. 170.315(j)(6). Next, we propose
in Sec. 170.315(g)(10)(iii)(A)(1) to continue to require token
introspection for system apps by referencing Sec. 170.315(j)(7).
Furthermore, we propose a new requirement in Sec.
170.315(g)(10)(iii)(A)(2), by requiring conformance to Sec.
170.315(j)(8) on and after January 1, 2028, to require token
introspection according to the SMART App Launch implementation guide
for dynamically registered system apps on and after January 1, 2028.
Lastly, we propose to move the API documentation requirements
currently required in Sec. 170.315(g)(10)(viii) to the API Conditions
and Maintenance of Certification requirements in Sec.
170.404(a)(2)(i), which would result in this paragraph no longer being
part of Sec. 170.315(g)(10) as part of the overall revision to this
certification criterion. We do not intend to introduce new
documentation requirements for the Sec. 170.315(g)(10) certification
criterion with this proposal. Instead, the goal of this proposal is to
consolidate API documentation requirements across the Program where
possible as described in additional detail in section III.B.20.d. We
seek comment on the proposed revisions we have discussed for Sec.
170.315(g)(10).
e. Proposed Requirements for System Read and Search API, Subscriptions,
and Workflow Triggers for Decision Support Interventions
We propose several new requirements for the Standardized API for
Patient and Population Services certification criterion in Sec.
170.315(g)(10) to support enhanced interoperability and advanced
workflows to overall reduce developer burden and barriers to accessing
and utilizing patient health information. We propose support for a
``Read and search API'' for system access in Sec.
170.315(g)(10)(iii)(B)(1), HL7 FHIR subscriptions for patient and user
access in Sec. 170.315(g)(10)(ii)(B)(3) and system access in Sec.
170.315(g)(10)(iii)(B)(3), and workflow triggers for decision support
interventions in Sec. 170.315(g)(10)(iv), as described further below.
We previously only required Health IT Modules certified to Sec.
170.315(g)(10) to support the ``Bulk FHIR API'' for system access, and
only required the US Core IG read and search capabilities for patient
and user scopes. We propose to include a read and search API according
to the ``US Core Server CapabilityStatement'' for each of the data
classes and data elements included in at least one of the versions of
the USCDI standard adopted in Sec. 170.213 in Sec.
170.315(g)(10)(iii)(B)(1) in order to explicitly require that certified
Health IT Modules support system applications to perform read and
search operations for patient health information using a standardized
API. The proposal includes optional support for imaging links requests
as of the effective date of the rule. On and after January 1, 2028,
requests for imaging links must be supported.
We propose support for HL7 FHIR subscriptions as part of the
Standardized API for Patient and Population Services for patient and
user access in Sec. 170.315(g)(10)(ii)(B)(3) and for system access in
Sec. 170.315(g)(10)(iii)(B)(3). The proposals require Health IT
Modules to support subscriptions as a server according to the
requirements specified in Sec. 170.315(j)(23), which includes several
infrastructure capabilities to support HL7 FHIR Subscriptions and a
list of HL7 FHIR Resources that must be supported for subscription
notifications and accompanying data elements that must be supported for
subscription filtering. The proposed certification criterion in Sec.
170.315(j)(23) is discussed further in this rule in section
III.B.15.b.iii.
We propose to require support for workflow triggers for decision
support interventions under proposed
[[Page 63580]]
Sec. 170.315(g)(10)(iv). We propose that the Health IT Module must
support capabilities in Sec. 170.315(j)(20) (where we have proposed to
adopt the ``workflow triggers for decision support interventions''
certification criterion) to enable workflow triggers to call decision
support services, including support for ``patient-view'' and ``order-
sign'' CDS Hooks according to at least one of the versions of the
implementation specification adopted in Sec. 170.215(f)(1). We propose
support for ``patient-view'' and ``order-sign'' because these CDS Hooks
are at maturity level ``5--Mature'' according to the CDS Hooks IG and
can be used to support a wide variety of workflow processes. We further
clarify and propose in 170.315(g)(10)(iv) that developers may support
workflow triggers for decision support interventions for the time
period up to and including December 31, 2027 and must support workflow
triggers for decision support interventions on and after January 1,
2028.
20. Patient, Provider, and Payer APIs
In this section, we propose to adopt a set of certification
criteria in Sec. 170.315(g)(30)-(36) to support data exchange between
health care payers, providers, and patients. These proposed
certification criteria would enable the exchange of data including
clinical and coverage information, drug formulary information, and
prior authorization information, between patients, providers, and
payers as appropriate to each exchange. These proposed certification
criteria are based on a series of recent policies finalized by CMS
which we describe in detail in the following section. If finalized,
these certification criteria would be available for health IT
developers (which may include payers and other developers providing
technology to payers) seeking voluntary certification for health IT
products supporting these use cases.
a. Background on CMS Interoperability Rulemaking
On May 1, 2020, the ``Medicare and Medicaid Programs; Patient
Protection and Affordable Care Act; Interoperability and Patient Access
for Medicare Advantage (MA) Organization and Medicaid Managed Care
Plans, State Medicaid Agencies, CHIP Agencies and CHIP Managed Care
Entities, Issuers of Qualified Health Plans on the Federally-
Facilitated Exchanges, and Health Care Providers'' final rule (85 FR
25510) was published in the Federal Register (hereinafter referred to
as the ``CMS Interoperability and Patient Access Final Rule''). CMS
required impacted payers \184\ to implement and maintain a FHIR-based
Patient Access API to allow patients, through the health application of
their choice, to easily access their claims and encounter information
as well as clinical data, including laboratory results, and provider
remittances and enrollee cost-sharing pertaining to such claims, if
maintained by the impacted payer (85 FR 25559). CMS also required
impacted payers to implement a Provider Directory API to make available
information such as contracted provider names, addresses, and phone
numbers (85 FR 25563).
---------------------------------------------------------------------------
\184\ For the purposes of the CMS Interoperability and Patient
Access and Interoperability and Prior Authorization Final Rules
discussed in this section, impacted payers include Medicare
Advantage (MA) organizations, state Medicaid fee-for-service (FFS)
programs, state Children's Health Insurance Program (CHIP) FFS
programs, Medicaid managed care plans, CHIP managed care entities,
and Qualified Health Plan (QHP) issuers on the Federally-facilitated
Exchanges (FFEs).
---------------------------------------------------------------------------
On February 8, 2024, the ``Medicare and Medicaid Programs; Patient
Protection and Affordable Care Act; Advancing Interoperability and
Improving Prior Authorization Processes for Medicare Advantage
Organizations, Medicaid Managed Care Plans, State Medicaid Agencies,
Children's Health Insurance Program (CHIP) Agencies and CHIP Managed
Care Entities, Issuers of Qualified Health Plans on the Federally-
Facilitated Exchanges, Merit-Based Incentive Payment System (MIPS)
Eligible Clinicians, and Eligible Hospitals and Critical Access
Hospitals in the Medicare Promoting Interoperability Program'' (CMS
Interoperability and Prior Authorization Final Rule) was published in
the Federal Register (89 FR 8758). Final policies in this rule
included: expanding the content available via the existing Patient
Access API to include information about prior authorizations; requiring
impacted payers to implement and maintain a Provider Access API to make
patient data available to in-network providers with whom the patient
has a treatment relationship; and requiring impacted payers build and
maintain a Payer-to-Payer API to exchange patient data when a patient
moves between payers or has concurrent payers. CMS also required
impacted payers to implement and maintain a Prior Authorization API to
facilitate electronic prior authorization processes. Finally, the rule
added electronic prior authorization measures to the Medicare Promoting
Interoperability Program and the MIPS Promoting Interoperability
performance category.
In the CMS Interoperability and Patient Access Final Rule (85 FR
25510 through 25640) and the CMS Interoperability and Prior
Authorization Final Rule (89 FR 8758 through 8988), CMS requires
impacted payers to use certain standards and implementation guides
which ONC has adopted in Sec. 170.215, as well as the USCDI standard
in Sec. 170.213. Specifically, CMS has finalized technical
requirements for the following APIs: Patient Access API (85 FR 25558
through 25559, 89 FR 8784 through 8787), Provider Access API (89 FR
8817 through 8820), Payer-to-Payer API (89 FR 8855 through 8856), Prior
Authorization API (89 FR 8897 through 8901), and the Provider Directory
API (85 FR 25563 through 25564). In the CMS Interoperability and Prior
Authorization Final Rule, CMS also recommended a number of
implementation guides that may be used to support effective
implementation of the required payer APIs (89 FR 8945).
b. Proposal Overview
We propose certification criteria below in Sec. 170.315(g)(30)-
(36) for Health IT Modules that can be used to support more effective
exchange of clinical, coverage, and prior authorization information.
The proposed certification criteria, if finalized, would support the
availability of health IT that can enable payers and health care
providers to meet requirements established in the Interoperability and
Patient Access Final Rule (85 FR 25522 through 25569) and the
Interoperability and Prior Authorization Final Rule (89 FR 8768 through
8946). As part of the proposals below, we include further discussion of
how each proposed certification criterion would support the
availability of information and enable functionality CMS has identified
as part of corresponding requirements. We intend to continue to work
with CMS in the future to ensure Health IT Modules certified to the
proposed criteria in Sec. 170.315(g)(30)-(36) enable efficient and
effective support for CMS policies.
In general, we believe that use of technology meeting these
certification criteria would help to enable exchange of information
that promotes a more effective marketplace, increases competition, and
provides benefits to patients, including: increased consumer choice,
improved outcomes in healthcare services, and more robust care
coordination through improved availability and exchange of health care
provider information. Increased electronic exchange and automation of
such information, as supported by the proposed certification criteria,
would
[[Page 63581]]
enable patients to better manage their own care, allow providers to
make more timely and informed treatment decisions, and reduce costs for
both payers and providers by reducing the amount of manual intervention
required in the exchange and authorization processes addressed by the
proposed certification criteria.
These proposed certification criteria reference a set of API
implementation specifications that ONC proposes to adopt, on behalf of
the Secretary, in Sec. 170.215(j), (k), (m), and (n).\185\ These
specifications are based upon HL7[supreg] FHIR[supreg] R4. In concert
with CMS, ONC has led or participated in a variety of activities
related to monitoring and evaluating the standards and implementation
specifications identified in this proposed rule, utilizing available
mechanisms for gathering input on these standards from stakeholders and
experts. Several of these proposed implementation specifications were
developed by the HL7[supreg] Da Vinci Project.\186\ The Da Vinci
Project is a private sector initiative that brings together payers,
health IT developers, providers, and other public participants to
facilitate the definition, design, and creation of use case specific
reference implementations of solutions based upon the HL7 FHIR platform
that involve managing and sharing clinical and administrative data
between industry partners. Because the Da Vinci Project is aligned with
HL7, solutions developed through the project may become industry
standards. The Da Vinci Project's use case requirements, test
scenarios, and test data, as well as the resulting implementation
guides and reference implementations, are available without licensing
requirements.
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\185\ For a more detailed discussion of APIs generally, we refer
readers to the Application Programming Interfaces Condition of
Certification and Maintenance of Certification preamble language in
the ONC Cures Act Final Rule at 85 FR 25739.
\186\ For more information about the Da Vinci Project, please
visit https://www.hl7.org/about/davinci/.
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The proposed implementation specifications referenced in the
proposed certification criteria in Sec. 170.315(g)(30)-(36) include
the required and recommended implementation specifications identified
in CMS' finalized policies for payer API requirements (89 FR 8945). We
propose to adopt current versions of the IGs that CMS recommended in
the CMS Interoperability and Prior Authorization Final Rule and propose
to require these IGs as part of the certification criteria proposed in
Sec. 170.315(g)(30)-(36). In the CMS Interoperability and Prior
Authorization Final Rule, CMS discussed its approach to recommending,
rather than requiring, certain IGs for payer APIs. CMS stated that its
goal in recommending the specific IGs for each API was to provide
directional guidance to the industry without locking payers into the
versions available at the time of the CMS Interoperability and Prior
Authorization proposed rule, due to the maturity of the versions
available at that time (89 FR 8921). CMS sought to ensure that payers
could use subsequent versions of those IGs without being restricted to
those versions. CMS further stated that it intended to monitor IG
development and would consider proposing to require versions of these
IGs in future rulemaking (89 FR 8937).
We believe that proposing to adopt the current versions of the IGs
recommended by CMS in the rulemaking described above is appropriate for
the proposed certification criteria at this time. Adopting and
specifying use of these IGs is necessary to ensure that Health IT
Modules certified to the criteria proposed in this section are
implemented consistently and enable interoperable exchange of
information. We also note that adoption of these IGs would support CMS
policies established in their Interoperability and Prior Authorization
Final Rule. Furthermore, if the adoption of these IGs is finalized, we
would review and potentially approve future versions of these standards
under the SVAP for voluntary use in the Program as they become
available. The flexibility provided under the SVAP would ensure that
developers are able to voluntarily update to later versions of these
standards as future improvements are made, without waiting for updated
versions to be proposed and finalized in regulation. In addition, we
will continue to work with CMS to identify updated versions of these
standards for potential future adoption in regulation at appropriate
intervals so that the adopted versions of standards are the most up-to-
date available and are feasible for real-world implementation.
The proposed certification criteria in Sec. 170.315(g)(30)-(36)
also incorporate certification criteria for modular API capabilities
proposed in Sec. 170.315(j) in section III.B.17 of this proposed rule,
including capabilities for registration (Sec. 170.315(j)(1)-(2)),
authentication and authorization (Sec. 170.315(j)(5)-(7)), workflow
triggers for decision support interventions (Sec. 170.315(j)(20)-
(21)), and subscriptions (Sec. 170.315(j)(23)-(24)).
Below, we describe each certification criterion and our intent to
certify Health IT Modules to these certification criteria to support
interoperability. However, we note that the certification of any Health
IT Module by a health IT developer is voluntary. The proposals in this
proposed rule would not establish requirements for health IT beyond
those Health IT Modules submitted for certification for these criteria
under the Program, nor does the availability of these certification
criteria require any individual or entity to use certified health IT,
including payers subject to the CMS requirements. Our goal in proposing
these certification criteria and the related implementation
specifications is to support health IT developers building these
capabilities (and customers implementing them) in a manner that is
consistent with nationally recognized standards and supports testing
and conformance to these standards through the ONC Health IT
Certification Program. ONC's adoption of certification criteria,
standards, and implementation specifications are part of an effort to
advance a set of minimum technical requirements, increase the
availability of health IT leveraging such requirements, and provide the
healthcare community with an improved, interoperable health IT
infrastructure.
We reiterate that, if finalized, certification to these criteria
would be available for health IT developers (which may include payers
and other developers providing technology to payers) seeking voluntary
certification and any requirements for a certification criterion are
only required in the sense that they are necessary to achieve
certification. ONC does not establish requirements for whether and in
what ways patients, health care providers, payers or others use health
IT. Instead, we enable the certification of Health IT Modules that may
support a wide range of users. In this way, the Program helps to
advance standards for certified Health IT Modules and increases the
availability of interoperable health IT across healthcare and health
related use cases.
Finally, we note that CMS has not proposed to require that impacted
payers subject to the API requirements in the CMS Patient Access and
Interoperability and CMS Interoperability and Prior Authorization Final
Rules obtain or implement Health IT Modules certified to the criteria
in this proposed rule. We also note that CMS has not identified health
IT certified to the ``prior authorization API--provider'' criterion
proposed below in Sec. 170.315(g)(34) as necessary to complete the
finalized electronic prior
[[Page 63582]]
authorization measures in the Medicare Promoting Interoperability
Program and the Promoting Interoperability performance category of
MIPS. If this certification criterion is finalized, we would work with
CMS on appropriate updates to the Medicare Promoting Interoperability
Program and the MIPS Promoting Interoperability performance category to
identify health IT certified to this criterion as an element of CEHRT
necessary to report on the electronic prior authorization measures. As
CMS noted in the Interoperability and Prior Authorization Final Rule,
use of health IT certified to support electronic prior authorization
transactions can help to ensure that the actions associated with these
measures are executed in a consistent fashion across the health care
providers participating in these programs (89 FR 8802).
c. Proposed Certification Criteria
We propose to adopt the following new certification criteria for
Patient, Provider, and Payer APIs:
i. Patient Access API (Sec. 170.315(g)(30))
We propose to adopt a ``patient access API'' certification
criterion in Sec. 170.315(g)(30) to specify requirements for Health IT
Modules that can enable patients to access their health and
administrative information by using a health application of their
choice. While many of the requirements introduced in the ONC Cures Act
Final Rule (85 FR 25642) expanded patient access to clinical
information contained within health IT, such as EHRs, broadening this
electronic access to include coverage and payer information can help
expand the information available to help patients with decision-making.
We propose in Sec. 170.315(g)(30)(i) to require support for two
registration pathways for a Health IT Module certified to the ``patient
access API'' criterion: a functional registration pathway for
applications that are unable to meet the requirements for dynamic
registration and a dynamic registration pathway for applications that
can support automated, scalable registration. We propose in Sec.
170.315(g)(30)(i)(A) that the Health IT Module must support functional
registration according to the requirements included in Sec.
170.315(j)(1) whereby confidential and public apps can register using a
non-standardized method. We propose in Sec. 170.315(g)(30)(i)(B) to
require the Health IT Module to support a dynamic registration pathway
for confidential apps according to the requirements in Sec.
170.315(j)(2).
We propose in Sec. 170.315(g)(30)(ii) to require authentication
and authorization for patient access. To enable patients to authorize
access to patient data by functionally and dynamically registered apps,
we propose in Sec. 170.315(g)(30)(ii)(A) that the Health IT Module
must support authentication and authorization according to the SMART
App Launch IG during the process of granting access to patient data,
according to the requirements in Sec. 170.315(j)(9). To enable
authentication of dynamically registered apps, we propose in Sec.
170.315(g)(30)(ii)(B) that the Health IT Module must support asymmetric
certificate-based authentication according to the requirements in Sec.
170.315(j)(5) for patient-facing apps dynamically registered using the
capabilities in Sec. 170.315(g)(30)(i)(B). We refer readers to the
proposals in sections III.B.16. (``New Certification Criteria for
Modular API Capabilities'') and III.B.15. (``New Requirements to
Support Dynamic Client Registration Protocol in the Program'') for more
information about our proposed certification criteria in Sec.
170.315(j) and proposal for dynamic registration respectively.
We propose later in this section that Certified API Developers with
API technology certified to the criterion in Sec. 170.315(g)(30) would
need to adhere to the API Condition and Maintenance of Certification
requirements proposed in Sec. 170.404. This would mean that such
developers would need to publish trust community information necessary
for dynamic registration, as proposed in Sec. 170.404(b)(2)(iii).
We propose in Sec. 170.315(g)(30)(ii)(C) to require multi-factor
authentication for patient-facing authentication on and after January
1, 2028, as proposed in Sec. 170.315(d)(13)(ii) in section III.B.17.
of this proposed rule. We believe this update is in line with industry
information security best practice for an important authentication use
case in health IT and that it is necessary to help better protect EHI.
To make information available about a payer's list of preferred
drugs, we propose in Sec. 170.315(g)(30)(iii) that the Health IT
Module must publish information regarding the payer's drug formulary
information according to at least one of the versions of the
implementation specification adopted in Sec. 170.215(m), including the
requirements described in the ``US Drug Formulary Server Capability
Statement.'' We propose to adopt the HL7 FHIR[supreg] Da Vinci--Payer
Data Exchange (PDex) US Drug Formulary Implementation Guide, Version
2.0.1--STU2 (PDex US Drug Formulary IG) \187\ in Sec. 170.215(m)(1)
and incorporate it by reference in Sec. 170.299. We propose to adopt
this implementation specification under PHSA section 3004 and make it
available for HHS use. This implementation specification can enable
consumers, members, and patients to understand the costs and
alternatives for drugs that have been prescribed, and to compare their
drug costs across different insurance plans. If we adopt subsequent
versions of the PDex US Drug Formulary IG under the paragraph in Sec.
170.215(m), our proposals that require the use of at least one of the
versions of the implementation specification adopted in Sec.
170.215(m) would enable health IT developers to use any version adopted
at this location, unless we specify an ``expiration'' date which
indicates a certain version of the specification may no longer be used
after that date.
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\187\ See https://hl7.org/fhir/us/davinci-drug-formulary/STU2.0.1/.
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To support the exchange of formulary data that is integrated with
protected health information (PHI) or personally identifiable
information (PII), such as enabling a payer to provide personalized
information to the patient based on their medications, we propose in
Sec. 170.315(g)(30)(iii)(A) that the Health IT Module must provide
support for the ``Authenticated API'' according to at least one of the
versions of the implementation specification adopted in Sec.
170.215(m) (where we have proposed to adopt the PDex US Drug Formulary
IG Version 2.0.1--STU2) and the requirements proposed in Sec.
170.315(g)(30)(i) and (ii) related to registration as well as
authentication and authorization. To support the exchange of formulary
data that is publicly available, and which does not contain PHI or PII,
we propose in Sec. 170.315(g)(30)(iii)(B) that the Health IT Module
must provide support for an ``Unauthenticated API'' according to at
least one of the versions of the implementation specification adopted
in Sec. 170.215(m).
We propose in Sec. 170.315(g)(30)(iv) requirements for a Health IT
Module certified to the ``patient access API'' criterion to support
access to patient health, coverage, and claims information. We propose
in Sec. 170.315(g)(30)(iv)(A) that the Health IT Module must allow
patients to access and share clinical and coverage information via a
standardized API(s) according to at least one of the versions of the
implementation specification adopted in Sec. 170.215(k)(2). Under this
paragraph, in Sec. 170.215(k)(2)(i), we propose to adopt the HL7 FHIR
Da Vinci
[[Page 63583]]
Payer Data Exchange (PDex) Implementation Guide Version 2.0.0--STU2
\188\ and incorporate it by reference in Sec. 170.299. We propose to
adopt this implementation specification under PHSA section 3004 and
make it available for HHS use. This implementation specification
enables a payer to create a member's health history using clinical
resources based on US Core profiles. If we adopt subsequent versions of
the PDex IG in Sec. 170.215(k)(2), our proposals that require use of
at least one of the versions of the implementation specification
adopted in Sec. 170.215(k)(2) would enable health IT developers to use
any version adopted at this location, unless we specify an
``expiration'' date which indicates a certain version of the
specification may no longer be used after that date.
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\188\ See https://hl7.org/fhir/us/davinci-pdex/STU2/.
---------------------------------------------------------------------------
We note that a version 2.1.0 of the PDex IG is currently under
development and available for interested parties to review.\189\ We
propose as an alternative, to adopt PDex IG version 2.1.0 if the
standard is balloted and published before the issuance of the HTI-2
Final Rule. We note several important enhancements to the PDex IG
version 2.1.0 from 2.0.0--STU2 to align with the Interoperability and
Patient Access Final Rule (85 FR 25522 through 25569) and the
Interoperability and Prior Authorization Final Rule (89 FR 8768 through
8946). For example, version 2.1.0 supports US Core 6.1.0, which
supports USCDI v3, as well as drops required support for aspects of
prior authorization that are viewed as unnecessary or complicating to
successful execution of the transaction in version 2.0.0 of the PDex
IG. Version 2.1.0 also includes an important use case for bulk data
access based on the finalization of the Bulk Data Access IG as a
required standard under the Payer API requirements finalized in CMS'
rules.
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\189\ See https://build.fhir.org/ig/HL7/davinci-epdx/.
---------------------------------------------------------------------------
We believe that continued alignment among industry, government, and
standards development organizations involved with the payer data
exchange use cases is necessary and we believe that if PDex IG version
2.1.0 is balloted and published before issuance of the HTI-2 Final
Rule, adoption of version 2.1.0 would support such alignment.
In order to enable patient access to information and allow patients
to incorporate their data into apps or systems of their choice with
minimal effort, we propose in Sec. 170.315(g)(30)(iv)(A)(1) that the
Health IT Module must support the ability for patients to authenticate
and share information with an application, service, or health plan
according to at least one of the versions of the implementation
specification adopted in Sec. 170.215(k)(2) (where we have proposed to
adopt the PDex IG version 2.0.0--STU2). Specifically, we propose in
Sec. 170.315(g)(30)(iv)(A)(1)(i) that the Health IT Module must
support the requirements associated with the ``OAuth2.0 or SMART-on-
FHIR Member-authorized Exchange'' exchange method, including the
requirements in the section ``OAuth and FHIR API.'' We propose in Sec.
170.315(g)(30)(iv)(A)(1)(ii) that the Health IT Module must support the
requirements included in the ``PDEX Server CapabilityStatement'' and
the HL7 FHIR Profiles, Resources, and operations included in Section
4.5.4 ``CapabilityStatement'' \190\ according to at least one of the
versions of the implementation specification adopted in Sec.
170.215(k)(2) (where we have proposed to adopt the PDex IG version
2.0.0--STU2).
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\190\ For more information, see https://hl7.org/fhir/us/davinci-pdex/STU2/introduction.html#capabilitystatement.
---------------------------------------------------------------------------
Finally, in Sec. 170.315(g)(30)(iv)(A)(1)(iii) we propose that the
Health IT Module must support the capabilities described in ``US Core
Server CapabilityStatement'' according to at least one of the versions
of the implementation specification adopted in Sec. 170.215(b)(1)
(where we have adopted US Core IG version 3.1.1, which expires on
January 1, 2026, US Core IG version 6.1.0, which we propose will expire
on January 1, 2028, and where we propose to adopt US Core IG version
7.0.0). We further propose that the Health IT Module must support the
capabilities in ``US Core Server CapabilityStatement'' for each of the
data classes and data elements included in at least one of the versions
of the USCDI standard adopted in Sec. 170.213 (where we have adopted
USCDI version 1, which expires on January 1, 2026, USCDI version 3,
which we propose will expire on January 1, 2028, and where we propose
to adopt USCDI version 4). We note that while most of the USCDI and US
Core requirements are met through the PDEX Server CapabilityStatement
requirements in Sec. 170.315(g)(30)(iv)(A)(1)(iii), we have added this
requirement to ensure the Health IT Module supports availability of all
of the data classes and data elements in at least one of the versions
of the USCDI adopted in Sec. 170.213.
We note that in section III.B.6 of this proposed rule, ``New
Imaging Requirements for Health IT Modules,'' we propose to revise
certification criteria for ``transitions of care'' in Sec.
170.315(b)(1); ``application access--all data request'' in Sec.
170.315(g)(9); and ``standardized API for patient and population
services'' in Sec. 170.315(g)(10) by adding new provisions to include
support of a link to diagnostic imaging. The CMS API requirements for
impacted payers, which we are seeking to support with the proposed
certification criteria in Sec. 170.315(g)(30)-(36), reference the
versions of the USCDI available in Sec. 170.213, which do not include
imaging links as a data element at this time. Therefore, in order to
maintain alignment with current CMS requirements for impacted payers,
we have not proposed to separately require support for imaging links by
a Health IT Module certified to the proposed certification criteria in
Sec. 170.315(g)(30), (32), and (33). We request comment on our
decision to not propose to include imaging links, and whether
interested parties believe a requirement to support imaging links, in a
manner similar to the proposed requirements for the certification
criteria mentioned above, would be appropriate and desirable for the
proposed certification criteria in Sec. 170.315(g)(30), (32), and
(33).
We propose in Sec. 170.315(g)(30)(iv)(B) that the Health IT Module
must allow patients to access their claims information via a
standardized API(s) according to at least one of the versions of the
implementation specification adopted in Sec. 170.215(k)(1). In Sec.
170.215(k)(1)(i), we propose, independent of the certification
criterion proposal, to adopt the HL7 FHIR Consumer Directed Payer Data
Exchange (CARIN IG for Blue Button[supreg]) Implementation Guide
version 2.0.0--STU 2 \191\ and incorporate it by reference in Sec.
170.299. We propose to adopt this implementation specification under
PHSA section 3004 and make it available for HHS use. This
implementation specification supports providing a set of resources that
payers can display to consumers, primarily financial (claims and
encounter) data, with some limited associated clinical data. If we
adopt subsequent versions of the CARIN IG for Blue Button[supreg] in
Sec. 170.215(k)(1), our proposals that require the use of at least one
of the versions of the implementation specification adopted in Sec.
170.215(k)(1) would enable health IT developers to use any version
adopted at this location, unless we specify an ``expiration'' date
[[Page 63584]]
which indicates a certain version of the specification may no longer be
used after that date.
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\191\ See https://hl7.org/fhir/us/carin-bb/.
---------------------------------------------------------------------------
We propose in Sec. 170.315(g)(30)(iv)(B)(1) that the Health IT
Module must support the ``Authentication and Authorization
Requirements'' section of at least one of the versions of the
implementation specification adopted in Sec. 170.215(k)(1) (where we
have proposed to adopt the CARIN IG for Blue Button[supreg] version
2.0.0--STU 2). These requirements establish authentication and privacy
requirements to protect patient health information. We propose in Sec.
170.315(g)(30)(iv)(B)(2) that the Health IT Module support the
requirements described in the ``C4BB CapabilityStatement'' according to
at least one of the versions of the implementation specification
adopted in Sec. 170.215(k)(1).
We request comments on this proposal.
Support for CMS Requirements
The ``patient access API'' certification criterion proposed in
Sec. 170.315(g)(30), if finalized, would support the availability of
certified health IT that can enable impacted payers \192\ to meet CMS
requirements to implement and maintain a Patient Access API, as
specified in 42 CFR 422.119, 431.60, 457.730, 438.242(b)(5), and
457.1233(d) and 45 CFR 156.221. Specifically, a Health IT Module
certified to the proposed ``patient access API'' would facilitate
access to data held by the payer, including: adjudicated claims
(including cost); encounters with capitated providers; provider
remittances; enrollee cost-sharing; all data classes and data elements
included in a version of the USCDI standard at 45 CFR 170.213,
formularies or preferred drug lists, and certain information about
prior authorizations requests and decisions, as finalized in the CMS
Interoperability and Patient Access Final Rule (85 FR 25542) and the
CMS Interoperability and Prior Authorization Final Rule (89 FR 8784).
We further note that we have proposed in section III.B.20.d. of this
proposed rule to apply the API Conditions of Certification Sec.
170.404(a), including transparency requirements in Sec. 170.404(a)(2),
and certain API Maintenance of Certification requirements in Sec.
170.404(b), to the proposed ``patient access API'' and other criteria.
These Conditions of Certification would, among other provisions, align
with the API requirements finalized by CMS related to ``Documentation
requirements for APIs,'' for instance, the requirement at 42 CFR
422.119(d) for MA organizations.
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\192\ As noted above, for the purposes of the CMS
Interoperability and Patient Access and Interoperability and Prior
Authorization Final Rules discussed in this section, impacted payers
include Medicare Advantage (MA) organizations, state Medicaid fee-
for-service (FFS) programs, state Children's Health Insurance
Program (CHIP) FFS programs, Medicaid managed care plans, CHIP
managed care entities, and Qualified Health Plan (QHP) issuers on
the Federally-facilitated Exchanges (FFEs).
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ii. Provider Access API--Client (Sec. 170.315(g)(31)) and Provider
Access API--Server (Sec. 170.315(g)(32))
We propose to adopt ``provider access API--client'' and ``provider
access API--server'' certification criteria in Sec. 170.315(g)(31) and
Sec. 170.315(g)(32), respectively. The proposed certification criteria
would enable a health care provider to access information on patients'
claims, including information about the patient's encounters,
providers, organizations, locations, dates of service, diagnoses
(conditions), procedures and observations. The proposed certification
criteria could further enable access by a health care provider to
clinical information maintained by the payer from sources other than
claims, such as: laboratory results, clinical data from documents
formatted in accordance with the Common Clinical Data Architecture (C-
CDA), information from admit, discharge, and transfer (ADT) messages,
information received from immunization registries, and information
related to medications from pharmacy networks. Such information can
provide a more complete clinical profile for the provider, as well as
allow the provider to make appropriate treatment decisions based on
both the clinical information and the patient's individual coverage
information.
We propose that a Health IT Module certified to the ``provider
access API--client'' in Sec. 170.315(g)(31) support specified
capabilities to enable a provider to request and receive patient
clinical and coverage information from a payer and receive and process
the response. We propose in Sec. 170.315(g)(31)(i) that the Health IT
Module must support the ability to request patient history according to
at least one of the versions of the implementation specification
adopted in Sec. 170.215(k)(2) (where we have proposed to adopt the
PDex IG version 2.0.0--STU2).
Under Sec. 170.315(g)(31)(ii), we propose that the Health IT
Module must support specified API interactions as a client. First, in
Sec. 170.315(g)(31)(ii)(A) we propose that the Health IT Module
support the capability to read and search the API. Specifically, in
Sec. 170.315(g)(31)(ii)(A)(1) we propose that the Health IT Module
support the ability to interact with a ``PDEX Server'' as a client
including support for all the corresponding client capabilities for
requirements described in the ``PDEX Server CapabilityStatement'' and
the HL7 FHIR Profiles, Resources, and operations included in Section
4.5.4 ``CapabilityStatement,'' according to at least one of the
versions of the implementation specification adopted in Sec.
170.215(k)(2) (where we have proposed to adopt the PDex IG version
2.0.0--STU2). In Sec. 170.315(g)(31)(ii)(A)(2) we propose that the
Health IT Module must support all the corresponding client capabilities
for requirements included in the ``C4BB CapabilityStatement'' according
to at least one of the versions of the implementation specification
adopted in Sec. 170.215(k)(1) (where we have proposed to adopt the
CARIN IG for Blue Button[supreg] version 2.0.0--STU 2). In Sec.
170.315(g)(31)(ii)(A)(3) we propose that the Health IT Module must
support the corresponding client capabilities described in ``US Core
Server CapabilityStatement'' according to an implementation
specification adopted in Sec. 170.215(b)(1) (where we have adopted US
Core IG versions 3.1.1, which expires on January 1, 2026, US Core IG
version 6.1.0, and proposed to adopt the US Core IG version 7.0.0) for
each of the data classes and data elements included in at least one of
the versions of the USCDI standard adopted in Sec. 170.213 (where we
have adopted USCDI version 1, which expires on January 1, 2026, USCDI
version 3, which we propose will expire on January 1, 2028, and where
we propose to adopt USCDI version 4).
To support the transfer of information on groups of patients, we
propose in Sec. 170.315(g)(31)(ii)(B) that the Health IT Module must
support the ability to request and receive information as a client
according to at least one of the versions of the standard adopted in
Sec. 170.215(a) (where we have adopted FHIR[supreg] R4) and at least
one of the versions of the implementation specification adopted in
Sec. 170.215(d) (where we have adopted the Bulk Data Access IG
v1.0.0--STU 1, which we have proposed for expiration on January 1,
2028, and the Bulk Data Access IG v2.0.0--STU 2) for each of the data
included in Sec. 170.315(g)(31)(ii)(A), as described above.
Additionally, we propose for the time period up to and including
December 31, 2027, the Health IT Module must meet either the
requirements specified in paragraph (g)(31)(ii)(B)(1) (proposed
[[Page 63585]]
to be the ``GroupLevelExport'' operation) or both (1) and (2) (proposed
to be the ``_type'' query parameter for each of the data included in
170.315(g)(31)(ii)(A)) of this section according to at least one of the
versions of the implementation specification adopted in Sec.
170.215(d). We propose that on and after January 1, 2028, the Health IT
Module must meet the requirements specified in paragraph
(g)(31)(ii)(B)(1) and (2) of this section according to at least one of
the versions of the implementation specification adopted in Sec.
170.215(d). For further discussion of these proposed requirements,
which we have also proposed to include in other certification criteria
that reference the Bulk Data Access IG, we refer readers to section
III.B.14 of this proposed rule.
We propose in Sec. 170.315(g)(31)(iii) that the Health IT Module
must support the ability to receive, parse, and write patient health
history and coverage information to the Health IT Module for the
following information. For clinical and coverage information, we
propose in Sec. 170.315(g)(31)(iii)(A) to include all FHIR Profiles
and Resources included in the ``PDEX Server CapabilityStatement'' and
the FHIR Profiles and Resources included in the Section 4.5.4 ``FHIR
CapabilityStatement'' according to at least one of the versions of the
implementation specification adopted in Sec. 170.215(k)(2) (where we
have proposed to adopt the PDex IG version 2.0.0--STU2). In Sec.
170.315(g)(31)(iii)(B) we propose to include the information included
in the ``C4BB CapabilityStatement'' according to at least one of the
versions of the implementation specification adopted in Sec.
170.215(k)(1) (where we have proposed to adopt CARIN IG for Blue
Button[supreg] version 2.0.0--STU 2). Finally, in Sec.
170.315(g)(31)(iii)(C) we propose to include the capabilities described
in the ``US Core Server CapabilityStatement'' according to at least one
of the versions of the implementation specification adopted in Sec.
170.215(b)(1) (where we have adopted US Core IG version 3.1.1, which
expires on January 1, 2026, US Core IG version 6.1.0, which we propose
will expire on January 1, 2028, and where we propose to adopt US Core
IG version 7.0.0) for each of the data classes and data elements
included in at least one of the versions of the USCDI standard adopted
in Sec. 170.213 (where we have adopted USCDI version 1, which expires
on January 1, 2026, USCDI version 3, which we propose will expire on
January 1, 2028, and where we propose to adopt USCDI version 4).
We propose that a Health IT Module certified to the ``provider
access API--server'' certification criterion in Sec. 170.315(g)(32)
would support capabilities to enable providers to request and receive
patient health history and coverage information from payers. Similar to
the ``patient access API'' certification criterion proposed in Sec.
170.315(g)(30), we propose to require support for two registration
pathways for Health IT Modules certified to the criterion. We propose
in Sec. 170.315(g)(32)(i)(A) that the Health IT Module must support
functional registration for confidential apps according to the
requirements included in Sec. 170.315(j)(1). We propose in Sec.
170.315(g)(32)(i)(B) that the Health IT Module must support dynamic
registration according to the requirements in Sec. 170.315(j)(2).
We propose in Sec. 170.315(g)(32)(ii) the authentication and
authorization requirements for a Health IT Module certified to the
``provider access API--server'' criterion. We propose in Sec.
170.315(g)(32)(ii)(A) that the Health IT Module must support the
ability to authenticate and authorize an app during the process of
granting access to patient data to users according to at least one of
the versions of the implementation specification adopted in Sec.
170.215(k)(2) (where we have proposed to adopt the PDex IG version
2.0.0--STU2) and at least one implementation specification adopted in
Sec. 170.215(c) (where we have adopted the SMART Application Launch
Framework IG Release 1.0.0, which expires on January 1, 2026, the SMART
App Launch IG Release 2.0.0, which we have proposed for expiration on
January 1, 2028, and proposed to adopt the SMART App Launch IG Release
2.2.0). We propose in Sec. 170.315(g)(32)(ii)(A)(1) that the Health IT
Module must support asymmetric certificate-based authentication
according to the requirements in Sec. 170.315(j)(11) for user-facing
apps dynamically registered using the capabilities in Sec.
170.315(g)(32)(i)(B).
We propose authentication and authorization requirements for system
access in Sec. 170.315(g)(32)(ii)(B), including that the Health IT
Module must support the ability to authenticate and authorize an app
during the process of granting access to patient data to system apps
according to at least one of the versions of the standard adopted in
Sec. 170.215(a) (where we have adopted FHIR R4) and at least one of
the versions of the implementation specification adopted in Sec.
170.215(d) (where we have adopted the Bulk Data Access IG v1.0.0--STU
1, which we have proposed for expiration on January 1, 2028, and
proposed to adopt the Bulk Data Access IG v2.0.0--STU 2). We propose in
Sec. 170.315(g)(32)(ii)(B)(1) that the Health IT Module must support
system authentication and authorization according to the requirements
in Sec. 170.315(j)(7) for system apps functionally registered using
the capabilities in Sec. 170.315(g)(32)(i)(A). We also propose in
Sec. 170.315(g)(32)(ii)(B)(2) the Health IT Module must support
asymmetric certificate-based system authentication and authorization
according to the requirements in Sec. 170.315(j)(8) for system apps
dynamically registered using the capabilities in Sec.
170.315(g)(32)(i)(B).
We propose in Sec. 170.315(g)(32)(iii) that the Health IT Module
must support specified capabilities to allow a provider to request
patient health history and coverage information from a payer and to
receive a response. Specifically, we propose in Sec.
170.315(g)(32)(iii)(A) that the Health IT Module must support the
ability for a client to request patient health history, coverage, and
claims information according to at least one of the versions of the
implementation specification adopted in Sec. 170.215(k)(2) (where we
have proposed to adopt the PDex IG version 2.0.0--STU2). We propose in
Sec. 170.315(g)(32)(iii)(B) that the Health IT Module support the
ability to identify patient clinical, coverage, and claims information
based on the information provided by the client in
170.315(g)(32)(iii)(A).
We propose in Sec. 170.315(g)(32)(iii)(C)(1) that the Health IT
Module must support the requirements described in the ``PDEX Server
CapabilityStatement'' and the HL7 FHIR Profiles and operations included
in Section 4.5.4 ``CapabilityStatement'' via a standardized API
according to at least one of the versions of the implementation
specification adopted in Sec. 170.215(k)(2). We propose in Sec.
170.315(g)(32)(iii)(C)(2) that the Health IT Module support claims
information by supporting the requirements included in the ``C4BB
CapabilityStatement'' according to at least one of the versions of the
implementation specification adopted in Sec. 170.215(k)(1) (where we
have proposed to adopt CARIN IG for Blue Button[supreg] version 2.0.0--
STU 2). We propose in Sec. 170.315(g)(32)(iii)(C)(3) that the API must
support the capabilities described in ``US Core Server
CapabilityStatement'' according to at least one of the versions of the
implementation specification adopted in Sec. 170.215(b)(1) (where we
have
[[Page 63586]]
adopted the US Core IG versions 3.1.1, which expires on January 1,
2026, the US Core IG version 6.1.0, and proposed to adopt the US Core
IG version 7.0.0) for each of the data classes and data elements
included in at least one of the versions of the USCDI standard adopted
in Sec. 170.213 (where we have adopted USCDI Version 1, which expires
on January 1, 2026, USCDI version 3, which we propose will expire on
January 1, 2028, and where we propose to adopt USCDI version 4).
We propose in Sec. 170.315(g)(32)(iii)(D) that the Health IT
Module must support returning patient clinical, coverage, and non-
financial claims and encounter information according to at least one of
the versions of the implementation specification in Sec. 170.215(k)(2)
(where we have proposed to adopt the PDex IG version 2.0.0--STU2) for
each of the data included in Sec. 170.315(g)(32)(iii)(C)(1), (2) and
(3), as described above.
To support the transfer of information on groups of patients, we
propose in Sec. 170.315(g)(32)(iii)(E) that the Health IT Module must
support responding to requests for patient data according to at least
one of the versions of the standard adopted in Sec. 170.215(a) (where
we have adopted FHIR R4), and at least one of the versions of the
implementation specification adopted in Sec. 170.215 (d) (where we
have adopted the Bulk Data Access IG v1.0.0--STU 1, which we have
proposed for expiration on January 1, 2028, and the Bulk Data Access IG
v2.0.0--STU 2) for each of the data included in Sec.
170.315(g)(32)(C)(1), (2) and (3), as proposed above. For the time
period up to and including December 31, 2027, we propose that the
Health IT Module must meet either the requirements specified in
(g)(32)(iii)(E)(1) (proposed to be the ``GroupLevelExport'' operation)
or both (1) and (2) (proposed to be the ``_type'' query parameter for
each of the data included in Sec. 170.315(g)(32)(C), (D) and (E)), of
this section according to at least one of the versions of the
implementation specification adopted in Sec. 170.215(d). On and after
January 1, 2028, we propose the Health IT Module must meet the
requirements specified in paragraph Sec. 170.315(g)(32)(iii)(E)(1) and
(2) of this section according to at least one of the versions of the
implementation specification adopted in Sec. 170.215(d).
We request comments on this proposal.
Support for CMS Requirements
The ``provider access API--server'' certification criterion
proposed in Sec. 170.315(g)(32), if finalized, would support the
availability of certified health IT that can enable impacted payers
\193\ to meet CMS requirements to implement and maintain a Provider
Access API as specified in 42 CFR 422.121(a), 431.61(a), 457.731(a),
438.242(b)(7), and 457.1233(d) and 45 CFR 156.222(a). Specifically, a
Health IT Module certified to the proposed ``provider access API--
server'' criterion would facilitate access to data held by the payer,
including: claims and encounter data (excluding provider remittances
and patient cost-sharing information), all data classes and data
elements derived from a version of the USCDI standard adopted at 45 CFR
170.213, and certain information about prior authorizations requests
and decisions, as required in the CMS Interoperability and Prior
Authorization Final Rule (89 FR 8817).
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\193\ As noted above, for the purposes of the CMS
Interoperability and Patient Access and Interoperability and Prior
Authorization Final Rules discussed in this section, impacted payers
include Medicare Advantage (MA) organizations, state Medicaid fee-
for-service (FFS) programs, state Children's Health Insurance
Program (CHIP) FFS programs, Medicaid managed care plans, CHIP
managed care entities, and Qualified Health Plan (QHP) issuers on
the Federally-facilitated Exchanges (FFEs).
---------------------------------------------------------------------------
In addition, the proposed ``provider access API--client''
certification criterion in Sec. 170.315(g)(31) would establish the
requirements for APIs to facilitate a provider request for this
information, to ensure that providers can use certified health IT to
access the information made available through a payer's Provider Access
API.
iii. Payer-to-Payer API (Sec. 170.315(g)(33))
We propose to adopt a ``payer-to-payer API'' certification
criterion in Sec. 170.315(g)(33) to specify requirements for Health IT
Modules that can be used by payers to support electronic exchange
between payer systems when patients transition between payers. Payer-
to-payer data exchange that allows health data to follow the patient
when they switch payers can enable improved coordination of care,
increased patient empowerment, and reduced administrative burden.
Similar to the proposed ``provider access API--client'' and
``provider access API--server'' certification criteria, the proposed
``payer-to-payer API'' certification criterion would support the
electronic request and sending of payer information related to both
beneficiary coverage information and the clinical condition and care of
the patient.
We propose two registration pathways for a Health IT Module
certified to the proposed ``payer-to-payer API'' criterion. We propose
in Sec. 170.315(g)(33)(i)(A) that the Health IT Module must support
registration for confidential apps according to the functional
registration requirements in Sec. 170.315(j)(1). We further propose in
Sec. 170.315(g)(33)(i)(B) that the Health IT Module must support
dynamic registration according to requirements in Sec. 170.315(j)(2).
We propose requirements for authentication and authorization in
Sec. 170.315(g)(33)(ii). In Sec. 170.315(g)(33)(ii)(A) we propose
that the Health IT Module must support system authentication and
authorization according to the requirements in Sec. 170.315(j)(7) for
system apps functionally registered using the capabilities in Sec.
170.315(g)(33)(i)(A). In Sec. 170.315(g)(33)(ii)(B), we propose that
the Health IT Module must support asymmetric certificate-based system
authentication and authorization according to the requirements in Sec.
170.315(j)(8) for system apps dynamically registered using the
capabilities in Sec. 170.315(g)(33)(i)(B).
We propose in Sec. 170.315(g)(33)(iii)(A) that the Health IT
Module must support the requirements included in the ``Payer-to-Payer
Exchange'' section of at least one of the versions of the
implementation specification adopted in Sec. 170.215(k)(2) (where we
have proposed to adopt the PDex IG version 2.0.0--STU2), as a client
and server, including support for the following ``Data Retrieval
Methods'' to allow access to information in Sec.
170.315(g)(33)(iii)(B), (C), and (D): ``Query all clinical resource
individually,'' ``$patient-everything operation,'' and ``Bulk FHIR
Asynchronous protocols.'' We specifically request comment on the ``Data
Retrieval Methods'' we should require as part of the ``payer-to-payer
API'' certification criterion.
To support the transfer of information on groups of patients, we
propose in Sec. 170.315(g)(33)(iii)(A)(2) that, for the time period up
to and including December 31, 2027, the Health IT Module must respond
to requests for patient data according to at least one of the versions
of the standard adopted in Sec. 170.215(a) (where we have adopted FHIR
R4), and at least one of the versions of the implementation
specification adopted in Sec. 170.215(d) (where we have adopted the
Bulk Data Access IG v1.0.0--STU 1, which we have proposed for
expiration on January 1, 2028, and the Bulk Data Access IG v2.0.0--STU
2) for each of the data included in Sec. 170.315(g)(33)(iii)(B), (C)
and (D), as described below. Additionally, we propose for the time
[[Page 63587]]
period up to and including December 31, 2027, the Health IT Module must
meet either the requirements specified in paragraph
(g)(33)(iii)(A)(2)(i) (proposed to be the ``GroupLevelExport''
operation) or both (i) and (ii) (proposed to be the ``_type'' query
parameter for each of the data classes and data elements included in at
least one of the versions of the USCDI standard adopted in Sec.
170.213) of this section according to at least one of the versions of
the implementation specification adopted in Sec. 170.215(d). We
propose that on and after January 1, 2028, the Health IT Module must
meet the requirements specified in paragraph (g)(33)(iii)(A)(2)(i) and
(ii) of this section according to at least one of the versions of the
implementation specification adopted in Sec. 170.215(d).
We propose in Sec. 170.315(g)(33)(iii)(B) that the Health IT
Module must support the requirements described in the ``PDEX Server
CapabilityStatement'' as a client and server via a standardized API
according to at least one of the versions of the implementation
specification adopted in Sec. 170.215(k)(2) (where we have proposed to
adopt the PDex IG version 2.0.0--STU2). We propose in Sec.
170.315(g)(33)(iii)(C) that the Health IT Module must support sharing
of claims information by supporting the data included in the ``C4BB
CapabilityStatement'' according to at least one of the versions of the
implementation specification adopted in Sec. 170.215(k)(1) (where we
have proposed to adopt CARIN IG for Blue Button[supreg] version 2.0.0--
STU 2). We propose in Sec. 170.315(g)(33)(iii)(D) that the Health IT
Module must support the capabilities described in ``US Core Server
CapabilityStatement'' according to the implementation specification in
Sec. 170.215(b)(1) (where we have adopted US Core IG version 3.1.1,
which expires on January 1, 2026, US Core IG version 6.1.0, which we
propose will expire on January 1, 2028, and where we propose to adopt
US Core IG version 7.0.0) for each of the data classes and data
elements included in at least one of the versions of the USCDI standard
adopted in Sec. 170.213 (where we have adopted USCDI version 1, which
expires on January 1, 2026, USCDI version 3, which we propose will
expire on January 1, 2028, and where we propose to adopt USCDI version
4).
We request comments on this proposal.
Support for CMS Requirements
The ``payer-to-payer API'' certification criterion proposed in
Sec. 170.315(g)(33), if finalized, would support the availability of
certified health IT that can enable impacted payers \194\ to meet CMS
requirements to implement and maintain a Provider Access API as
specified in 42 CFR 422.119, 431.60, 457.730, 438.242(b)(5), and
457.1233(d) and 45 CFR 156.221. Specifically, a Health IT Module
certified to the ``payer-to-payer API'' criterion would facilitate
sharing between payers of claims and encounter data (excluding provider
remittances and patient cost-sharing information), all data classes and
data elements in at least one of the versions of the USCDI standard in
Sec. 170.213, and certain information about prior authorization
requests and decisions, as required in the CMS Interoperability and
Prior Authorization Final Rule (89 FR 8855).
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\194\ As noted above, for the purposes of the CMS
Interoperability and Patient Access and Interoperability and Prior
Authorization Final Rules discussed in this section, impacted payers
include Medicare Advantage (MA) organizations, state Medicaid fee-
for-service (FFS) programs, state Children's Health Insurance
Program (CHIP) FFS programs, Medicaid managed care plans, CHIP
managed care entities, and Qualified Health Plan (QHP) issuers on
the Federally-facilitated Exchanges (FFEs).
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iv. Prior Authorization API--Provider (Sec. 170.315(g)(34)) and Prior
Authorization API--Payer (Sec. 170.315(g)(35))
Background on Electronic Prior Authorization
Prior authorization processes \195\ have contributed significantly
to patient and provider burden, for instance, through delays
experienced by patients and clinicians as they seek to satisfy the
requirements associated with prior authorization rules set by
payers.\196\ ONC's Strategy on Reducing Regulatory and Administrative
Burden Relating to the Use of Health IT and EHRs,\197\ released in
2020, identified challenges associated with the prior authorization
process faced by patients and health care providers, including: (i)
difficulty in determining whether an item or service requires prior
authorization; (ii) difficulty in determining payer-specific prior
authorization requirements for those items and services; (iii)
inefficient use of provider and staff time to navigate communications
channels such as fax, telephone, and various web portals; and (iv)
unpredictable and lengthy amounts of time to receive payer decisions.
The Strategy noted that payers and health IT developers have addressed
prior authorization in an ad hoc manner with interfaces that reflect
individual payer technology considerations, payer lines of business,
and customer-specific constraints. A 2022 physician survey conducted by
the American Medical Association demonstrated significant negative
impacts associated with the current prior authorization and beneficiary
information exchange processes.\198\ Nearly 94 percent of physicians
reported care delays associated with prior authorization, and 80
percent reported that issues related to the prior authorization process
can sometimes lead to treatment abandonment. In addition, survey
respondents reported that physicians and their staff spend almost two
business days each week completing prior authorizations, with nearly 35
percent of physicians retaining staff who work exclusively on prior
authorizations. Today, hospitals and provider practices widely continue
to use telephone and fax to conduct prior authorization processes.
According to the Council for Affordable Quality Healthcare, only 28
percent of 228 million prior authorization contacts were fully
electronic in 2022.\199\
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\195\ Generally defined as rules imposed by healthcare payers
that require approval for a medication, procedure, device, or other
medical service be obtained prior to payment for the item or
service.
\196\ Office of the National Coordinator for Health Information
Technology. Strategy on Reducing Regulatory and Administrative
Burden Relating to the Use of Health IT and EHRs [PDF file].
February 2020. Retrieved from https://www.healthit.gov/sites/default/files/page/2020-02/BurdenReport_0.pdf.
\197\ Office of the National Coordinator for Health Information
Technology. Strategy on Reducing Regulatory and Administrative
Burden Relating to the Use of Health IT and EHRs [PDF file].
February 2020. Retrieved from https://www.healthit.gov/sites/default/files/page/2020-02/BurdenReport_0.pdf.
\198\ https://www.ama-assn.org/practice-management/prior-authorization/prior-authorization-research-reports.
\199\ https://www.caqh.org/sites/default/files/2023-05/2022-caqh-index-report.pdf.
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In 2020, ONC charged the HITAC to establish the Intersection of
Clinical and Administrative Data (ICAD) Task Force to produce
information and considerations related to the merging of clinical and
administrative data for electronic prior authorization. The ICAD Task
Force's final report,\200\ approved in November 2020, recommended that
ONC work with CMS, other Federal actors, and standards development
organizations to ``establish standards for prior authorization
workflows.'' Specifically, the Task Force recommended that entities
should develop API specifications ``such that the authorization and
related documentation may be triggered in workflow in the relevant
workflow
[[Page 63588]]
system where the triggering event for the authorization is created.''
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\200\ https://www.healthit.gov/sites/default/files/facas/ICAD_TF_FINAL_Report_HITAC_2020-11-06_508_0.pdf.
---------------------------------------------------------------------------
In January 2021, ONC published an RFI titled ``Request for
Information: Electronic Prior Authorization Standards, Implementation
Specifications, and Certification Criteria'' to seek input from the
public regarding electronic prior authorization standards,
implementation specifications, and certification criteria that could be
adopted within the ONC Health IT Certification Program (87 FR 3475).
ONC received approximately 130 responses to this RFI from a wide range
of entities. Comments on the RFI broadly supported the incorporation of
electronic prior authorization capabilities within the Program, while
highlighting concerns about the current readiness and maturity of
available implementation specifications to support these capabilities.
Commenters also provided input on how certification criteria related to
electronic prior authorization should be structured and how
certification criteria should address other Federal requirements around
the use of standards for electronic prior authorization transactions.
Finally, commenters provided input on the benefits of improving
electronic prior authorization for patients, providers, health IT
developers and payers, as well as potential challenges associated with
implementation.
ONC also charged the HITAC to establish a Task Force in order to
provide input and recommendations in response to the RFI; the Task
Force's recommendations were approved and submitted to ONC on March 10,
2022.\201\ The proposals in this section would implement several
recommendations from the Task Force, specifically recommendations to:
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\201\ https://www.healthit.gov/sites/default/files/page/2022-03/2022-03-10_ePA_RFI_Recommendations_Report_Signed_508.pdf.
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Create a suite of electronic prior authorization health IT
certification criteria for health IT systems supporting both providers
and payers that can enable health IT developers to certify to one or
more specific functional capabilities that together, across
participating health IT systems, enable the full electronic prior
authorization workflow.
Ensure new certification criteria for electronic prior
authorization provide for health IT systems that perform prior
authorization on behalf of payers to ensure that their solutions are
compliant to consensus-based standards for electronic prior
authorization and are able to send and receive information needed to
meet the prior authorization business case.
Work with the Da Vinci Project and key healthcare
stakeholders (e.g., providers, developers, patients) to develop
appropriate health IT certification criteria that incorporate key
functional capabilities for prior authorization.
Ensure certification requirements that allow a FHIR-
enabled process for prior authorization transactions do not require
translation to X12.
Prioritize criteria based on the Da Vinci Prior
Authorization Support (PAS) IG that allow data, C-CDA or FHIR documents
to be provided in a FHIR construct.
Proposals
We propose to adopt a ``prior authorization API--provider''
certification criterion in Sec. 170.315(g)(34), which establishes
requirements for Health IT Modules that can be used to facilitate a
provider's request of coverage information and request for a prior
authorization decision. We also propose to adopt a complementary
``prior authorization API--payer'' certification criterion in Sec.
170.315(g)(35), which establishes requirements for Health IT Modules
that can be used by a payer to accept prior authorization requests from
a provider, send requested documentation and coverage information, and
send prior authorization decisions. Together, these certification
criteria would support real-time access for providers to payer approval
requirements, documentation, and rules at point of service, as well as
enable providers to request and receive authorization. We believe that
technology certified to these capabilities would help to automate and
streamline the prior authorization process for health care providers
and payers, to ensure treatment decisions are made in a timely fashion,
avoid delays in care, and reduce administrative burden on health care
providers and payers associated with assembling and reviewing required
documentation.
Both certification criteria are based on the HL7 FHIR Da Vinci
Burden Reduction IGs, which we propose to adopt in Sec. 170.215(j) and
incorporate by reference in Sec. 170.299:
HL7 FHIR Da Vinci--Coverage Requirements Discovery (CRD)
Implementation Guide, Version 2.0.1--STU 2 (proposed in Sec.
170.215(j)(1)(i)) \202\
---------------------------------------------------------------------------
\202\ See https://hl7.org/fhir/us/davinci-crd/.
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HL7 FHIR Da Vinci--Documentation Templates and Rules (DTR)
Implementation Guide, Version 2.0.1--STU 2 (proposed in Sec.
170.215(j)(2)(i)) \203\
---------------------------------------------------------------------------
\203\ See https://hl7.org/fhir/us/davinci-dtr/.
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HL7 FHIR Da Vinci--Prior Authorization Support (PAS)
Implementation Guide, Version 2.0.1--STU 2 (proposed in Sec.
170.215(j)(3)(i)) \204\
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\204\ See https://hl7.org/fhir/us/davinci-pas/.
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We propose to adopt these implementation specifications under PHSA
section 3004 and make them available for HHS use. Taken together, these
implementation specifications support a comprehensive workflow for
conducting electronic prior authorization transactions. The proposed
certification criteria below include proposals that require the use of
at least one version for each of the implementation specifications
adopted in Sec. 170.215(j)(1)-(3). If we adopt subsequent versions of
the implementation specifications in Sec. 170.215(j)(1) (CRD IG),
(j)(2) (DTR IG), and (j)(3) (PAS IG), respectively, proposals that
require the use of at least one implementation specification adopted in
one of these locations would enable health IT developers to use any
version adopted at the specified location, unless we specify an
adoption ``expiration'' date which indicates a certain version of the
specification may no longer be used after that date.
First, we propose in Sec. 170.315(g)(34)(i) and Sec.
170.315(g)(35)(i) that the ``prior authorization API--provider'' and
``prior authorization API--payer'' certification criteria,
respectively, must support capabilities related to coverage discovery.
These proposals are intended to facilitate the automation of both
information exchange and prior authorization and reduce the need for
provider-end manual intervention. Health IT Modules certified to these
certification criteria would be able to request coverage information
from a payer, for instance when a future encounter is being scheduled
for a patient, and to initiate prior authorization electronically when
a treatment decision has been made. These requirements will ensure that
providers can request and receive a wide variety of information
including updates to coverage information, alternative services or
products, documentation requirements and rules related to coverage,
forms, and templates to complete, and indications of whether prior
authorization is required.
For the ``prior authorization API--provider'' certification
criterion, in Sec. 170.315(g)(34)(i), we propose that a Health IT
Module certified to the
[[Page 63589]]
criterion must support capabilities to initiate and exchange
information with payer systems as a client to support the
identification of coverage requirements. In Sec. 170.315(g)(34)(i)(A)
we propose that the Health IT Module must support the requirements
described in the ``Privacy, Security, and Safety'' section of at least
one of the versions of the implementation specification adopted in
Sec. 170.215(j)(1) (where we have proposed to adopt the CRD IG version
2.0.1--STU 2). In Sec. 170.315(g)(34)(i)(B), we propose that the
Health IT Module must support capabilities in Sec. 170.315(j)(20)
(where we have proposed to adopt the ``workflow triggers for decision
support interventions'' certification criterion) to enable workflow
triggers to call decision support services, including support for
``appointment-book,'' ``encounter-start,'' ``encounter-discharge,''
``order-dispatch,'' ``order-select,'' and ``order-sign'' CDS Hooks
according to at least one of the versions of the implementation
specification adopted in Sec. 170.215(j)(1) and requirements in Sec.
170.315(j)(20).
In Sec. 170.315(g)(34)(i)(C), we propose that the Health IT Module
must support the requirements applicable to ``CRD Clients'' in at least
one of the versions of the implementation specification in Sec.
170.215(j)(1) including, as proposed in Sec. 170.315(g)(34)(i)(C)(1),
the requirements in the ``CRD Client CapabilityStatement,'' and, as
proposed in Sec. 170.315(g)(34)(i)(C)(2) support for the ``SHOULD''
requirements applicable to ``CRD Clients'' in Section 5.8 ``Additional
Data Retrieval.'' We request public input on whether we should instead
finalize a policy that these ``SHOULD'' requirements are treated as
``SHALL'' requirements.
For the ``prior authorization API--payer'' certification criterion,
we propose in Sec. 170.315(g)(35)(i) that a Health IT Module certified
to the criterion must support specified capabilities to exchange
information with provider systems to support the identification of
coverage requirements. We propose in Sec. 170.315(g)(35)(i)(A) that
the Health IT Module must support the ability to receive and respond to
decision support requests as a service by supporting the capabilities
in Sec. 170.315(j)(21). In Sec. 170.315(g)(35)(i)(B) we propose that
the Health IT Module must support the requirements applicable to ``CRD
Server'' included in at least one of the versions of the implementation
specification adopted in Sec. 170.215(j)(1) (where we have proposed to
adopt the CRD IG version 2.0.1--STU 2) including the requirements in
the ``CRD Server CapabilityStatement.''
In Sec. 170.315(g)(34)(ii) and Sec. 170.315(g)(35)(ii)(B) we
propose requirements for the ``prior authorization API--provider'' and
``prior authorization API--payer'' certification criteria,
respectively, related to documentation and rules exchange. The DaVinci
DTR and CRD IGs utilize Clinical Quality Language (CQL) to allow payers
to inspect a patient's record for the necessary information related to
the required documentation for a proposed item (such as durable medical
equipment), medication, procedure, or other service. The DTR IG details
the use of a payer provided Questionnaire resource and results from CQL
execution to generate a QuestionnaireResponse resource containing the
necessary information. This IG can allow payer APIs to specify how
rules may be executed in a provider context so that documentation
requirements are met, while at the same time reducing provider burden
by reducing manual data entry.
For the ``prior authorization API--provider'' certification
criterion, we propose in Sec. 170.315(g)(34)(ii) that a Health IT
Module certified to the criterion must support the ability to request
and populate prior authorization documentation templates and rules from
payer systems according to at least one of the versions of the
implementation specification adopted in Sec. 170.215(j)(2) (where we
have proposed to adopt the DTR IG version 2.0.1--STU 2).
``Light'' DTR capabilities are applicable to EHRs that rely on a
SMART on FHIR application to handle the form filling function of DTR.
This requires the server to provide access to the specified resources
to allow such an app to retrieve and edit QuestionnaireResponses and
related resources. In Sec. 170.315(g)(34)(ii)(A)(1), we propose the
Health IT Module must support the capabilities included in the ``Light
DTR EHR'' CapabilityStatement according to at least one versions of the
implementation specification adopted in Sec. 170.215(j)(2) (where we
have proposed to adopt the DTR IG version 2.0.1--STU 2). In Sec.
170.315(g)(34)(ii)(A)(2)(i), we propose that the Health IT Module must
support functional registration of the ``DTR SMART Client'' according
to the requirements included in Sec. 170.315(j)(1). We also propose in
Sec. 170.315(g)(34)(ii)(A)(2)(ii) that the Health IT Module must
support dynamic registration of the ``DTR SMART Client'' according to
the requirements included in Sec. 170.315(j)(2).
In Sec. 170.315(g)(34)(ii)(A)(3), we propose that the Health IT
Module must support launching the ``DTR SMART Client'' according to at
least one of the versions of the implementation specification adopted
in Sec. 170.215(j)(2) (where we have proposed to adopt the DTR IG
version 2.0.1--STU 2) to allow providers to launch an app to complete
documentation for prior authorization according to at least one of the
versions of the implementation specification in Sec. 170.215(j)(2). In
Sec. 170.315(g)(34)(ii)(A)(3)(i) we propose that the Health IT Module
must support authentication and authorization during the process of
granting access to patient data to users according to the requirements
in Sec. 170.315(j)(10). In Sec. 170.315(g)(34)(ii)(A)(3)(ii) we
propose that the Health IT Module must support asymmetric certificate-
based authentication according to the requirements in Sec.
170.315(j)(11) for the ``Light DTR Client'' dynamically registered
using the capabilities in Sec. 170.315(g)(34)(ii)(A)(2)(ii).
In contrast to ``Light DTR EHR'' capabilities, ``full'' DTR
capabilities are relevant to EHRs that manage the form filling
functions of DTR internally. In Sec. 170.315(g)(34)(ii)(B), we propose
that the Health IT Module must support the capabilities included in the
``Full DTR EHR'' CapabilityStatement according to at least one of the
versions of the implementation specification adopted in Sec.
170.215(j)(2) (where we have proposed to adopt the DTR IG version
2.0.1--STU 2). Such EHRs need only support client capabilities for the
Questionnaire Package, ValueSet Expand, and Next Question operations.
For the ``prior authorization API--payer'' certification criterion,
we propose in Sec. 170.315(g)(35)(ii) that a Health IT Module
certified to the criterion must support specified capabilities to
exchange prior authorization documentation requirements with provider
systems. In Sec. 170.315(g)(35)(ii)(A)(1), we propose that the Health
IT Module support functional registration for the ``DTR SMART Client''
and ``Full DTR EHR'' according to the requirements included in Sec.
170.315(j)(1). In Sec. 170.315(g)(35)(ii)(A)(2), we propose that the
Health IT Module support dynamic registration for the ``DTR SMART
Client'' and ``Full DTR EHR'' according to the requirements included in
Sec. 170.315(j)(2).
In Sec. 170.315(g)(35)(ii)(B)(1) we propose that the Health IT
Module support system authentication and authorization according to the
requirements in Sec. 170.315(j)(7) for the ``DTR SMART Client'' and
``Full DTR
[[Page 63590]]
EHR'' functionally registered using the capabilities in Sec.
170.315(g)(35)(ii)(A)(1). In Sec. 170.315(g)(35)(ii)(B)(2) we propose
that the Health IT Module support asymmetric certificate-based system
authentication and authorization according to the requirements in Sec.
170.315(j)(8) for the ``DTR SMART Client'' and ``Full DTR EHR''
dynamically registered using the capabilities in Sec.
170.315(g)(35)(ii)(A)(2).
In Sec. 170.315(g)(35)(ii)(C) we propose that the Health IT Module
support the ability to receive and respond to a prior authorization
documentation request with documentation templates and rules, according
to at least one of the versions of the implementation specification
adopted in Sec. 170.215(j)(2) (where we have proposed to adopt the DTR
IG version 2.0.1--STU 2), including in Sec. 170.315(g)(35)(ii)(C)(1),
the capabilities included in the ``DTR Payer Service''
CapabilityStatement, according to at least one of the versions of the
implementation specification adopted in Sec. 170.215(j)(2).
Finally, in Sec. 170.315(g)(34)(iii) and Sec.
170.315(g)(35)(iii), we propose that the ``prior authorization API--
provider'' and ``prior authorization API--payer'' certification
criteria must support capabilities related to the submission, receipt,
and response to a prior authorization request.
For the ``prior authorization API--provider'' certification
criterion, we propose in Sec. 170.315(g)(34)(iii)(A) that the Health
IT Module must support the ability to submit a prior authorization
request to a payer system according to at least one of the versions of
the implementation specification adopted in 170.215(j)(3) (where we
have proposed to adopt the PAS IG version 2.0.1--STU 2). Specifically,
we propose in Sec. 170.315(g)(34)(iii)(A)(1) that the Health IT Module
include support for the ``EHR PAS Capabilities'' CapabilityStatement
according to at least one of the versions of the implementation
specification adopted in Sec. 170.215(j)(3).
We propose in Sec. 170.315(g)(34)(iii)(A)(2) that the Health IT
Module support the ability to include documentation created in Sec.
170.315(g)(34)(ii) in a prior authorization request to a payer system
according to at least one of the versions of the implementation
specification adopted in Sec. 170.215(j)(3). We propose in Sec.
170.315(g)(34)(iii)(A)(3) that the Health IT Module support the ability
to consume and process a ``ClaimResponse'' according to at least one of
the versions of the implementation specification adopted in Sec.
170.215(j)(3). Finally, we propose in Sec. 170.315(g)(34)(iii)(A)(4)
that the Health IT Module support subscriptions as a client according
to the requirements in Sec. 170.315(j)(24) and an implementation
specification in Sec. 170.215(j)(3), in order to support ``pended
authorization responses.''
For the ``prior authorization API--payer'' certification criterion,
we propose in Sec. 170.315(g)(35)(iii)(A)(1) that the Health IT Module
must support functional registration according to the requirements
included in Sec. 170.315(j)(1), and propose in Sec.
170.315(g)(35)(iii)(A)(2) to require support for dynamic registration
according to the requirements included in Sec. 170.315(j)(2). We
propose in Sec. 170.315(g)(35)(iii)(B)(1) that the Health IT Module
must support system authentication and authorization according to the
requirements in Sec. 170.315(j)(7) for system apps functionally
registered using the capabilities in Sec. 170.315(g)(35)(iii)(A)(1).
We propose in Sec. 170.315(g)(35)(iii)(B)(2) that the Health IT Module
must support asymmetric certificate-based system authentication and
authorization according to the requirements in Sec. 170.315(j)(8) for
system apps dynamically registered using the capabilities in Sec.
170.315(g)(35)(iii)(A)(2).
In Sec. 170.315(g)(35)(iii)(C)(1)-(4), we propose that the API
must support the ability to receive, process, and respond to a prior
authorization request according to at least one of the versions of the
implementation specification adopted in Sec. 170.215(j)(3) (where we
have proposed to adopt the PAS IG version 2.0.1--STU 2). Specifically,
we propose in Sec. 170.315(g)(35)(iii)(C)(1) that the Health IT Module
support ``Intermediary PAS Capabilities.'' We propose in Sec.
170.315(g)(35)(iii)(C)(2) that the Health IT Module support an endpoint
for receiving prior authorization requests. We propose in Sec.
170.315(g)(35)(iii)(C)(3) that the Health IT Module support the ability
to respond to a prior authorization request with a ``ClaimResponse.''
Finally, we propose in Sec. 170.315(g)(35)(iii)(C)(4) that the Health
IT Module must support subscriptions as a server according to the
requirements in Sec. 170.215(j)(3) to support ``pended authorization
responses'' according to at least one of the versions of the
implementation specification in Sec. 170.215(j)(3).
We request comments on this proposal.
Organization of the Proposed Prior Authorization API Criteria
In the January 2021 ``Request for Information: Electronic Prior
Authorization Standards, Implementation Specifications and
Certification Criteria,'' we requested comment on the most appropriate
way to structure health IT certification criteria enabling a health
care provider to conduct electronic prior authorization transactions
(87 FR 3480). We received a wide range of input on this topic with
commenters noting that different types of systems, including EHRs,
revenue cycle and patient management systems, and third-party
applications may be responsible for different elements of the
electronic prior authorization workflow. Some commenters recommended
that ONC consider proposing individual criteria that map to each of the
Da Vinci IGs (the CRD, DTR, and PAS IGs) which we discussed in the RFI
and have proposed to adopt in this proposed rule. Other commenters
suggested creating more granular certification criteria which reflect
specific capabilities and key interactions within the prior
authorization workflow, so that these capabilities can be implemented
as stand-alone solutions to provide incremental value. The Task Force
charged by the HITAC to provide a response to the January 2021 RFI also
provided recommendations on this topic.\205\
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\205\ https://www.healthit.gov/sites/default/files/page/2022-03/2022-03-10_ePA_RFI_Recommendations_Report_Signed_508.pdf.
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In this proposed rule, we have proposed a single prior
authorization certification criterion for health care providers in
Sec. 170.315(g)(34). However, existing guidance in the Program could
provide flexibility around the use of distinct technology products that
may be utilized to perform the capabilities that are outlined in the
proposed certification criterion. Specifically, health IT developers
are permitted to use ``relied upon software'' (76 FR 1276) to
demonstrate compliance with certification criteria adopted at 45 CFR
part 170, subpart C.\206\ Relied upon software is typically third-party
software that is not developed by the health IT developer presenting
its health IT for testing and certification. Relied upon software may
be used to demonstrate compliance with a portion of an adopted
certification criterion or an entire certification criterion. When a
health IT developer relies upon software to demonstrate compliance with
a certification criterion, such relied upon software must be included
in the scope of the certification issued to the Health IT Module or
Complete EHR. In cases where a Health IT Module may be
[[Page 63591]]
paired with multiple ``relied upon software'' products for the same
capability, it must be tested with at least one such product to
demonstrate compliance with a certification criterion's requirements.
Afterwards, the Health IT Module developer is permitted to list all
additional ``relied upon software'' products for the same capability
paired with the certified Health IT Module without having to test each
one with the ONC-ATL. A health IT developer always remains responsible
for its product's conformance to a certification criterion even when
the ``relied upon software'' contributes to, or is the cause of, a non-
conformity.
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\206\ For more guidance on relied upon software, see: https://www.healthit.gov/sites/default/files/relieduponsoftwareguidance.pdf.
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We invite additional comments on the most appropriate way to
structure the proposed ``prior authorization API--provider''
certification criterion, as well as the ``prior authorization API--
payer'' certification criterion. Specifically, we are interested in the
public's input on how organization of the proposed certification
criteria would affect the ability of developers to effectively offer
certified health IT products that meet the criteria, and what impact
the organization of the proposed criteria would have on customers who
may already possess technology products that can be used to conduct
electronic prior authorization transactions. We also request comment on
whether or to what degree existing guidance for the Program, such as
the relied upon software policy described above, would address
scenarios in which distinct health IT products are used to support
different elements of the prior authorization workflow. Finally, we
invite comments on alternative approaches to organizing the ``prior
authorization API'' certification criteria.
Support for CMS Requirements
The ``prior authorization API--payer'' certification criterion
proposed in Sec. 170.315(g)(35), if finalized, would support the
availability of certified health IT that can enable impacted payers
\207\ to meet CMS requirements to implement and maintain a Prior
Authorization API as specified in 42 CFR 422.122(b), 431.80(b),
457.732(b), 438.242(b)(7), and 457.1233(d) and 45 CFR 156.223(b),
respectively. Specifically, a Health IT Module certified to the ``prior
authorization API--payer'' certification criterion would enable payers
to make available information about documentation required for approval
of any items or services that require prior authorization; support an
automated process for prior authorization request and response; and
communicate whether the payer approves the prior authorization request
(and the date or circumstance under which the authorization ends),
denies the prior authorization request (with a specific reason), or
requests more information, as required in the CMS Interoperability and
Prior Authorization Final Rule (89 FR 8897).
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\207\ As noted above, for the purposes of the CMS
Interoperability and Patient Access and Interoperability and Prior
Authorization Final Rules discussed in this section, impacted payers
include Medicare Advantage (MA) organizations, state Medicaid fee-
for-service (FFS) programs, state Children's Health Insurance
Program (CHIP) FFS programs, Medicaid managed care plans, CHIP
managed care entities, and Qualified Health Plan (QHP) issuers on
the Federally-facilitated Exchanges (FFEs).
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The ``prior authorization API--provider'' certification criterion
proposed in Sec. 170.315(g)(34), if finalized, would support the
availability of certified health IT that can enable health care
providers to interact with the APIs established pursuant to the payer
API requirements referenced above, using certified health IT. CMS
finalized Electronic Prior Authorization measures for the Medicare
Promoting Interoperability Program and the MIPS Promoting
Interoperability Performance Category in the CMS Interoperability and
Prior Authorization Final Rule (89 FR 8909) which are intended to
incentivize health care providers to interact with these APIs in order
to submit prior authorization requests. If finalized, adopting and
using technology certified to this criterion would enable eligible
clinicians, and eligible hospitals and CAHs, to complete the prior
authorization request actions associated with these measures using
certified health IT.
Administrative Simplification Requirements Under HIPAA
We note that, pursuant to the administrative simplification rules
established under HIPAA, the Secretary must adopt electronic standards
for use by ``covered entities,'' which is defined as including health
plans, healthcare clearinghouses, and certain health care
providers.\208\ The two standards adopted for referral certification
and authorization transactions under the HIPAA administrative
simplification rules (45 CFR 162.1302) include: NCPDP Version D.0 for
retail pharmacy drugs; and X12 Version 5010x217 278 (X12 278) for
dental, professional, and institutional request for review and response
for items and services. HHS has also proposed to adopt the X12 275
standard, which is used to transmit additional documentation to support
the exchange of the additional information that is required for prior
authorization, in the ``Administrative Simplification: Adoption of
Standards for Health Care Attachments Transactions and Electronic
Signatures, and Modification to Referral Certification and
Authorization Transaction Standard'' proposed rule (87 FR 78438).
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\208\ For more information, see https://www.cms.gov/priorities/key-initiatives/burden-reduction/administrative-simplification.
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Nothing in our proposed certification criteria related to
electronic prior authorization would alter requirements for covered
entities to use adopted HIPAA transaction standards. Moreover, the FHIR
specifications we propose to adopt for these certification criteria
would not conflict with the use of the adopted HIPAA standard, and we
would expect covered entities using technology certified to these
criteria to ensure compliance with applicable requirements.
We note that in March 2021, the CMS National Standards Group (NSG),
on behalf of HHS, approved an application \209\ from an industry group
of payers, providers, and vendors for an exception under 45 CFR 162.940
from the HIPAA transaction standards for Da Vinci payers and their
trading partners when using the FHIR standard for prior authorization.
Under this exception, the group would test a prior authorization
exchange using the HL7 FHIR Da Vinci standard without the X12 278
standard to determine whether this alternative standard for prior
authorization could improve efficiency. HHS provides information about
requests for exceptions from standards to permit testing of proposed
modifications on the CMS HIPAA administrative simplification
website.\210\
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\209\ See https://confluence.hl7.org/display/DVP/Da+Vinci+HIPAA+Exception?preview=/113675673/113675685/Approval%20%232021031001.pdf.
\210\ Centers for Medicare & Medicaid Services (2022). Go-to-
Guidance, Guidance Letters. Retrieved from https://www.cms.gov/priorities/key-initiatives/burden-reduction/administrative-simplification/subregulatory-guidance/letters.
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On February 28, 2024, CMS NSG, on behalf of HHS, announced an
application of enforcement discretion for HIPAA covered entities that
implement FHIR-based Prior Authorization APIs as described in the CMS
Interoperability and Prior Authorization Final Rule (89 FR 8758).\211\
HHS stated that this action was in response to feedback received on
multiple notices of proposed rulemaking and extensive stakeholder
outreach and is intended to promote efficiency in the prior
authorization
[[Page 63592]]
process. Specifically, HHS stated that HIPAA Administrative
Simplification enforcement action will not be taken against HIPAA
covered entities that choose not to use the X12 278 standard as part of
an electronic FHIR prior authorization process. HHS will continue to
evaluate the HIPAA prior authorization transaction standards, including
continuing to seek stakeholder input and evaluating the results of
testing an all-FHIR-based transaction.
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\211\ See https://www.cms.gov/files/document/discretion-x12-278-enforcement-guidance-letter-remediated-2024-02-28.pdf.
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v. Provider Directory API--Health Plan Coverage (Sec. 170.315(g)(36))
We propose to adopt a ``provider directory API--health plan
coverage'' certification criterion in Sec. 170.315(g)(36) which would
specify technical requirements for Health IT Modules that can enable
publishing of information regarding the providers that participate in a
payer's network. For beneficiary coverage and clinical information to
be both useful to and utilized by patients and providers, it is
necessary for patients to understand which providers, facilities, and
pharmacies are covered by their current or future plan.
The proposed certification criterion is based on the HL7 FHIR Da
Vinci Payer Data Exchange Plan Net (PDex Plan Net) Implementation Guide
version 1.1.0--STU1.1.\212\ We propose, independent of the
certification criterion proposal, to adopt this implementation
specification in Sec. 170.215(n)(1) and incorporate it by reference in
Sec. 170.299. We propose to adopt this implementation specification
under PHSA section 3004 and make it available for HHS use. Use of this
implementation specification can enable third parties to develop
applications through which consumers and providers can query the
participants in a payer's network that may provide services that
address their healthcare needs. We propose in Sec. 170.315(g)(36) that
a Health IT Module certified to the criteria must support the ability
to publish a payer's insurance plans, their associated networks, and
the organizations and providers that participate in these networks
according to at least one of the versions of the implementation
specification adopted in Sec. 170.215(n), including the requirements
described in the ``Plan-Net CapabilityStatement.'' If we adopt
subsequent versions of the PDex Plan Net IG in Sec. 170.215(n), our
proposal to require the use of at least one of the versions of the
implementation specification adopted in Sec. 170.215(n) would enable
health IT developers to use any version adopted at this location,
unless we specify an adoption ``expiration'' date, which indicates a
certain version of the specification may no longer be used after that
date.
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\212\ See https://hl7.org/fhir/us/davinci-pdex-plan-net/STU1.1/.
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Support for CMS Requirements
The ``provider directory API--health plan coverage'' certification
criterion proposed in Sec. 170.315(g)(36), if finalized, would support
the availability of certified health IT that can enable impacted payers
\213\ to meet CMS requirements to implement and maintain a Provider
Directory API in 42 CFR 422.120, 431.70, 457.760, 438.242(b)(6), and
457.1233(d)(3), respectively. Specifically, a Health IT Module
certified to the ``provider directory API--health plan coverage''
certification criterion would facilitate the availability of
standardized information about a payer's provider networks, as well as
pharmacy directory data, as required in the CMS Interoperability and
Patient Access Final Rule (85 FR 25563).
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\213\ As noted above, for the purposes of the CMS
Interoperability and Patient Access and Interoperability and Prior
Authorization Final Rules discussed in this section, impacted payers
include Medicare Advantage (MA) organizations, state Medicaid fee-
for-service (FFS) programs, state Children's Health Insurance
Program (CHIP) FFS programs, Medicaid managed care plans, CHIP
managed care entities, and Qualified Health Plan (QHP) issuers on
the Federally-facilitated Exchanges (FFEs).
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We request comments on this proposal.
d. Revision and Addition of API Condition and Maintenance of
Certification Requirements
Given that we have proposed to adopt new certification criteria
that would be applicable to certified API technology under the Program,
we propose to extend the applicability of the API Conditions of
Certification in Sec. 170.404(a) and certain API Maintenance of
Certification requirements in Sec. 170.404(b) to Certified API
Developers with Health IT Modules certified to the criteria proposed
for adoption in Sec. 170.315(g)(20), Sec. 170.315(g)(30)-(36), and
Sec. 170.315(j). If our proposals are finalized, this would mean that
the API Condition and Maintenance of Certification requirements would
include within its scope the certification criteria adopted in Sec.
170.315(g)(7)-(10), Sec. 170.315(g)(20), Sec. 170.315(g)(30)-(36),
and Sec. 170.315(j). We propose to make corresponding and conforming
edits to Sec. 170.404, including revisions to both Sec. 170.404(a)
and in Sec. 170.404(b), to specify which API-related certification
criteria apply in the context of each Condition and Maintenance of
Certification requirement. We believe this approach is essential to
continue to fulfill the statutory requirements set forth in PHSA Sec.
3001(c)(5)(D)(iv), in particular Congress' requirement that a developer
of certified health IT has ``published application programming
interfaces and allows health information from such technology to be
accessed, exchanged, and used without special effort.'' As we described
in the ONC Cures Act Final Rule (84 FR 7476 through 7477), we
established the API Condition and Maintenance of Certification
requirements to, among other outcomes, promote transparency and pro-
competitive business practices among Certified API Developers in
pursuit of a policy that would result in access, exchange, and use of
EHI ``without special effort.'' We believe that these same requirements
should apply to developers of these new API-related certification
criteria in Sec. 170.315(g)(20) and (g)(30)-(36), and that the
proposals to reference these certification criteria in Sec. 170.404
would continue to adhere to our statutory charge to advance nationwide
interoperability.
We propose in Sec. 170.404(a)(2) to consolidate and establish
documentation requirements that are currently required in Sec.
170.315(g)(7)(ii), Sec. 170.315(g)(9)(ii), and Sec.
170.315(g)(10)(viii). Correspondingly, we propose to remove those three
specified ``documentation'' paragraphs from those respective
certification criteria because the consolidated conformance
requirements would now be stated in the proposed Sec. 170.404(a)(2).
We believe that these documentation requirements should also pertain to
the other API-related criteria we propose to adopt in Sec.
170.315(g)(20), (g)(30)-(36), and Sec. 170.315(j), and we believe that
such requirements better fit as a generally applicable API Condition of
Certification requirement than a functional requirement specified in
each individual API-related certification criterion.
Specifically, we propose in Sec. 170.404(a)(2) that a Certified
API Developer must publish complete business and technical
documentation, including the documentation described in Sec.
170.404(a)(2)(i)-(ii), via a publicly accessible hyperlink that allows
any person to directly access the information without any preconditions
or additional steps. In Sec. 170.404(a)(2)(i), we propose that this
should include technical documentation currently in Sec.
170.315(g)(7), (9), and (10) such as API syntax, function names,
required and optional parameters supported and their
[[Page 63593]]
data types, return variables and their types/structures, exceptions and
exception handling methods and their returns. We propose that Sec.
170.315(g)(7)(ii) and Sec. 170.315(g)(9)(ii) be reserved. Further, we
propose in Sec. 170.404(a)(2)(i)(B) that this technical documentation
should include the software components and configurations that would be
necessary for an application to implement in order to be able to
successfully interact with the API and process its response(s); and in
Sec. 170.404(a)(2)(i)(C) that all applicable technical requirements
and attributes necessary for an application to be registered with a
Health IT Module's authorization server. We propose to revise Sec.
170.404(a)(2)(ii) to require that API(s) must include complete
accompanying business documentation that contains, at a minimum, the
existing requirements currently in Sec. 170.404(a)(2)(ii)(A) and (B).
In addition to the proposed modifications to Sec. 170.404(a), we
propose to revise the Maintenance of Certification requirements for
Application Programming Interfaces, in Sec. 170.404(b). Specifically,
we propose that the same authenticity verification and registration
requirements currently in Sec. 170.404(b)(1) apply to Certified API
Developers with a Health IT Module certified to one or more of the
certification criteria in of Sec. 170.315(g)(10), (20), (30), (32)-
(35). Similarly, we propose in Sec. 170.404(b)(1)(i) that a Certified
API Developer is permitted to institute a process to verify the
authenticity of API Users so long as such process is objective and the
same for all API Users and completed within ten business days of
receipt of an API User's request to register their software application
for use with the Certified API Developer's Health IT Module certified
to any of the certification criteria in Sec. 170.315(g)(10), (20),
(30), (32)-(35). We propose that this process shall not apply to API
Users that are part of a trust community supported at an API
Information Source deployment submitting registration requests
conformant to the specifications in Sec. 170.215(o). In Sec.
170.404(b)(1)(ii) we propose that a Certified API Developer must
register and enable all applications for production use within five
business days of completing its verification of an API User's
authenticity, pursuant to paragraph (b)(1)(i) of this section. If the
API User is part of a trust community supported at an API Information
Source deployment and submitted a valid registration request conformant
to the specifications in Sec. 170.215(o), we propose that the
application must instead be enabled for production use within one
business day.
We propose in Sec. 170.404(b)(2) to modify the existing
publication and format requirements for service base URLs. We propose
to refer to service base URLs as ``API discovery details'' and propose
in Sec. 170.404(b)(2)(i)(A) that these must be published publicly and
at no charge for all customers regardless of whether the Health IT
Module is centrally managed by the Certified API Developer or locally
deployed by an API Information Source. We also propose in Sec.
170.404(b)(2)(i)(B) that these API discovery details are reviewed
quarterly and updated as necessary.
We also propose revisions to the formatting requirements of these
API discovery details by adding to the current regulation text in Sec.
170.404(b)(2)(i)-(iii) an option to publish API discovery details and
related API Information source details, including the API Information
Source's name, location, and facility identifier, according to the
``User-access Brands and Endpoints'' specification in at least one
implementation specification adopted in Sec. 170.215(c). We propose
this at revised Sec. 170.404(b)(2)(iii) and consolidate the regulation
text currently in Sec. 170.404(b)(2)(i)-(iii) as Sec.
170.404(b)(2)(ii)(A)-(C). We propose that publication of API discovery
details for patient access applies to Certified API Developers with
Health IT Modules certified to either of the criteria in Sec.
170.315(g)(10) and (g)(30) and we have established timelines for Health
IT Modules certified to these criteria to conform to requirements in
Sec. 170.404(b).
Specifically, we propose that for the time period up to and
including December 31, 2027, Certified API Developers with Health IT
Modules certified to Sec. 170.315(g)(10) must meet either the API
discovery detail requirements in (i) and (ii) or the requirements in
(i), (iii), and (iv) of this section. On and after January 1, 2028, all
Certified API Developers with Health IT Modules certified to Sec.
170.315(g)(10) must meet the requirements in (i), (iii), and (iv) of
this section. Certified API Developers with Health IT Modules certified
to Sec. 170.315(g)(30) must meet the requirements in (i), (iii), and
(iv) of this section. We believe this cadence and combination of
requirements will support a gradual improvement in consistently
available, standards-based access for patients seeking to access their
health information via APIs.
These Maintenance of Certification requirements are already
established for Certified API Developers with a Health IT Module
certified to the certification criterion adopted in Sec.
170.315(g)(10), and we believe that extending these requirements to
Sec. 170.315(g)(30) is appropriate because this proposed certification
criterion supports patient access to health and administrative (e.g.,
payer) information. Requirements in Sec. 170.404(b)(1) and (2)
facilitate the use of patient-facing applications and enable patient
users to discover details necessary to connect to their data using an
application of their choice.
We request comment on these proposals.
In Sec. 170.404(b)(3), we propose new Maintenance of Certification
requirements for Certified API Developers with a Health IT Module
certified to the certification criteria adopted in Sec.
170.315(g)(32), Sec. 170.315(g)(33), Sec. 170.315(g)(35), or Sec.
170.315(g)(36) to publish API discovery details. We propose in Sec.
170.404(b)(3)(i) that the developer must publicly publish the API
discovery details for all its customers, with Health IT Modules
certified to Sec. 170.315(g)(32), Sec. 170.315(g)(33), Sec.
170.315(g)(35) or Sec. 170.315(g)(36) regardless of whether the Health
IT Modules are centrally managed by the Certified API Developer or
locally deployed by an implementer of the Certified API Developer.
We propose in Sec. 170.404(b)(3)(ii) that the network information
and related API Information Source details, including the API
Information Source's name, location, and facility identifier, must be
published in an aggregate vendor-consolidated Bundle according to the
``User-Access Brands and Endpoints'' specification in at least one
implementation specification adopted in Sec. 170.215(c). In Sec.
170.404(b)(3)(iii) we propose that all API discovery details for payer
information published according to this section must be reviewed
quarterly and as necessary updated by the Certified API Developer.
While we recognize that this will require ongoing coordination
between health IT developers and users of the Health IT Modules, as
well as regular updates to the publicly available network information,
we believe that making such information public is critical to
establishing ongoing interoperability of administrative data. We
welcome comment on these proposals.
Finally, we propose revisions to two key terms in Sec. 170.404(c).
We propose to revise certified API technology to mean the capabilities
of Health IT Modules that are certified to any of the API-focused
certification criteria adopted in Sec. 170.315(g)(7) through (10),
(g)(20), (g)(30) through (36), and (j). This revision would support our
proposed
[[Page 63594]]
application of requirements in Sec. 170.404 to the proposed APIs in
Sec. 170.315(g) and the proposed modular API capabilities in Sec.
170.315(j). We also propose to revise Certified API Developer to mean a
health IT developer that creates ``certified API technology.'' We
believe this simplified definition for Certified API Developer will
similarly support this term's application to the proposed API
capabilities in Sec. 170.315(g) and proposed modular API capabilities
in Sec. 170.315(j).
We request comment on these proposals.
e. Revisions to Real World Testing Requirements
The Cures Act requires, as Condition and Maintenance of
Certification requirements under the Program, that health IT developers
successfully test the real world use of the technology for
interoperability \214\ in the type of setting in which such technology
would be marketed. As discussed in the ONC Cures Act Final Rule, the
objective of real world testing is to verify the extent to which
certified health IT deployed in production contexts continues to
demonstrate conformance to the full scope of applicable certification
criteria and functions with the intended use cases as part of the
overall maintenance of a health IT's certification (85 FR 25766).
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\214\ Interoperability is defined in statute in section 3000 of
the Public Health Service Act (as modified by section 4003 of the
Cures Act) and defined in regulation at 45 CFR 170.102.
---------------------------------------------------------------------------
For reasons similar to our proposal to expand requirements in Sec.
170.404 to the proposed certification criteria in Sec. 170.315(g)(20),
(g)(30) through (36), and 170.315(j), we propose to revise the real
world testing requirements in Sec. 170.405 by adding these proposed
certification criteria in Sec. 170.405(a). Given that each of these
proposed new certification criteria is focused on interoperability and
data exchange, we believe it is important that developers of certified
health IT with Health IT Module(s) certified to these criteria
participate in both Condition and Maintenance of Certification
requirements. Per requirements in Sec. 170.405(b) we also propose that
developers of certified health IT with Health IT Modules certified to
any one or more of the certification criteria in Sec. 170.315(g)(20),
(g)(30) through (36), and 170.315(j) also submit annual real world
testing plans as well as annual real world testing results, which
applies to any one or more of the criteria referenced in 170.405(a). We
note that by including these criteria in Sec. 170.405(a), that health
IT developers may voluntarily avail themselves of SVAP flexibility so
long as they ensure that their annual real world testing plans and real
world testing results submissions address all the versions of all the
standards and implementation specifications to which each Health IT
Module is certified.
Given that we are proposing to reference several certification
criteria in Sec. 170.315(j) across various certification criteria in
Sec. 170.315(g), we clarify that a health IT developer with Health IT
Module(s) certified to any one or more criteria in Sec. 170.315(g)
that successfully tests the real world use of those Health IT Module(s)
will be considered conformant to the real world testing requirements
for the corresponding certification criteria in Sec. 170.315(j). We do
not intend for Health IT Modules certified to any certification
criterion in Sec. 170.315(g) to submit duplicative real world testing
plans or results for corresponding certification criterion in Sec.
170.315(j) and believe this clarification will help reduce potential
confusion for developers certified to criteria in Sec. 170.315(g).
We request comments on this proposal.
f. Addition of Criteria to the Base EHR Definition
Two of the certification criteria proposed in this section pertain
to certified Health IT Modules intended for use by health care
providers, specifically the ``provider access API--client'' and the
``prior authorization API--provider'' certification criteria in Sec.
170.315(g)(31) and Sec. 170.315(g)(34), respectively. We believe both
certification criteria reflect fundamental capabilities, which would be
appropriate for adoption by any health care provider using certified
health IT. Technology certified to the ``provider access API--client''
criterion would enable a provider to receive key clinical and
administrative information from a healthcare payer. Technology
certified to the ``prior authorization API--provider'' criterion would
enable a health care provider to conduct prior authorization requests
and related interactions with payers that are widely used today.
We propose in Sec. 170.102 in the definition of Base EHR to add
the proposed certification criteria in Sec. 170.315(g)(31) and Sec.
170.315(g)(34) to the set of certification criteria adopted by the
Secretary that are necessary to meet the Base EHR definition. We
propose that the ``provider access API--client'' certification
criterion in Sec. 170.315(g)(31) would be necessary to meet the Base
EHR definition on and after January 1, 2028. However, for the ``prior
authorization API--provider'' certification criterion in Sec.
170.315(g)(34), we propose that this criterion would be necessary to
meet the Base EHR definition on and after January 1, 2027. This date is
consistent with the policy finalized in CMS Interoperability and Prior
Authorization Final Rule, which finalized an Electronic Prior
Authorization measure in the Medicare Promoting Interoperability
program and the MIPS Promoting Interoperability performance category
which program participants must report on beginning with the CY 2027
EHR reporting period and CY 2027 performance period/2029 MIPS payment
year, respectively (89 FR 8910).
We request comments on this proposal.
C. Conditions and Maintenance of Certification Requirements--Insights
and Attestations
1. Insights Condition and Maintenance of Certification Requirements
a. Background
The Cures Act specified requirements in section 4002(c) to
establish an Electronic Health Record (EHR) Reporting Program to
provide reporting on certified health IT in the categories of
interoperability, usability and user-centered design, security,
conformance to certification testing, and other categories, as
appropriate to measure the performance of EHR technology. Data
collected and reported would address information gaps in the health IT
marketplace and provide insights on the use of certified health IT. In
the HTI-1 Final Rule (89 FR 1311), we established the EHR Reporting
Program as the ``Insights Condition and Maintenance of Certification''
(also referred to as the ``Insights Condition'') and finalized in Sec.
170.407 the first set of measures to reflect the interoperability
category required by section 3009A(a)(3)(A)(iii) of the PHSA.
We refer readers to the HTI-1 Proposed Rule (88 FR 23831) for
detailed background on how we engaged with the health IT community for
the purpose of identifying measures that developers of certified health
IT would be required to report on as a Condition and Maintenance of
Certification under the Program, and how our proposals to modify the
measures that the Urban Institute developed is consistent with section
3009A(a)(4) of the PHSA. Our proposals with respect to each requirement
continue to reflect how we propose to
[[Page 63595]]
modify the set of measures in Urban Institute's final report.\215\ As
such, we propose modifications in this proposed rule as part of the
next iteration of the Insights Condition and Maintenance of
Certification requirements and welcome comments on our proposals below.
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\215\ https://www.urban.org/research/publication/electronic-health-record-ehr-reporting-program-developer-reported-measures.
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b. Process for Reporting Updates
In the HTI-1 Proposed Rule (88 FR 23847), we stated that there may
be other factors that could impact a developer of certified health IT's
ability to easily collect data to comply with the Insights Condition's
requirements. For example, a developer of certified health IT may have
contracts or business agreements that inhibit the health IT developer's
ability to collect data from its customers. We also proposed in the
HTI-1 Proposed Rule that in such scenarios, developers of certified
health IT would need to renegotiate their contracts. We further
explained that we expected developers of certified health IT would work
to mitigate any issues and provisions affecting their ability to comply
with the Insights Condition requirements.
In the HTI-1 Final Rule (89 FR 1347), we did not finalize our
proposal to require developers of certified health IT to renegotiate
contracts, when needed, with their customers to comply with the
Insights Condition requirements. Instead, we finalized in Sec.
170.407(a)(1)(i)(C) that health IT developers will need to provide ONC
with information on the degree to which the data they submit are
complete, specifically by reporting the percentage of their total
customers as represented by hospitals for products used in inpatient
settings and clinician users for products used in outpatient settings,
that are included in their reported data for each metric for which they
submit a response. We stated that the percentage of health care
providers that are represented in the data provides transparency
regarding the degree to which the data are complete.
Detailed information regarding health care providers that are
represented in the data would also help us further interpret the
results of the data received and allow us to assess whether the data is
nationally representative. This would also allow us to report results
indicating whether, and how, the data are skewed. Therefore, we propose
to add Sec. 170.407(a)(1)(i)(D) to require developers of certified
health IT to provide health care provider identifiers (e.g., National
Provider Identifier (NPI), CMS Certification Number (CCN), or other
type of unique national identifier) for providers included in the data
submitted. Note, given this proposal, we propose to make conforming
grammatical edits to the list structure in Sec. 170.407(a)(1)(i)(B)
and (C) to accommodate the proposed addition of (D). We also propose to
revise Sec. 170.407(a)(1)(i)(C) to remove the word ``sites'' from
``hospital sites'' to align with our proposal relating to the minimum
reporting qualifications requirement described in detail further below.
The additional health care provider identifier information would
help determine the representativeness of the data. Using the unique
health care provider identifiers, we could link to other data sources
such as the National Provider and Payer Enumeration System (NPPES) and
CMS program participant data that would allow us to identify the types
of providers included in the data. Knowing the different types of
providers included in the data would allow us to determine if the data
are skewed towards providers with certain characteristics associated
with differences in health IT adoption and use, such as size, rural
location and ownership.216 217 218 For example, based upon
surveys of hospitals, larger hospitals tend to engage more in
interoperability compared to smaller hospitals.\219\ If the data
disproportionately consist of larger hospitals, this could potentially
skew the results towards higher performance on interoperability. To
reduce burden, we intend to provide a template for developers of
certified health IT to submit the data electronically, in a structured
format, if our proposal is finalized.
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\216\ Strawley C., Everson J., Barker W. Hospital use of APIs to
Enable Data Sharing Between EHRs and Apps. Office of the National
Coordinator for Health Information Technology. Data Brief: 68. 2023.
https://www.healthit.gov/data/data-briefs/hospital-use-apis-enable-data-sharing-between-ehrs-and-apps.
\217\ Pylypchuk Y., J. Everson. (January 2023). Interoperability
and Methods of Exchange among Hospitals in 2021. ONC Data Brief, no.
64. Office of the National Coordinator for Health Information
Technology: Washington DC. https://www.healthit.gov/data/data-briefs/interoperability-and-methods-exchange-among-hospitals-2021.
\218\ Pylypchuk Y., J. Everson, D. Charles, and V. Patel.
(February 2022). Interoperability Among Office-Based Physicians in
2015, 2017, and 2019. ONC Data Brief, no.59. Office of the National
Coordinator for Health Information Technology: Washington DC.
https://www.healthit.gov/data/data-briefs/interoperability-among-office-based-physicians-2019.
\219\ Pylypchuk Y., J. Everson. (January 2023). Interoperability
and Methods of Exchange among Hospitals in 2021. ONC Data Brief, no.
64. Office of the National Coordinator for Health Information
Technology: Washington DC. https://www.healthit.gov/data/data-briefs/interoperability-and-methods-exchange-among-hospitals-2021.
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We welcome comments on our proposal, and welcome comments on other
alternatives that would offer a consistent approach for all health IT
developers to report on the representativeness of the data provided to
ONC. We continue to believe reporting the percentage of ``clinicians''
(for products primarily used in outpatient settings) and ``hospitals''
(for products primarily used in inpatient settings) in Sec.
170.407(a)(1)(i)(C) is the best approach given that this aligns with
CMS programs and is used to determine whether developers meet the
threshold for reporting on the Insights Condition of Certification,
however, we are open to considering alternatives that provide a
consistent manner for developers to provide transparency on the degree
to which the data are complete. This may also include removing the
requirement for developers to provide the percentage of total customers
that are represented in the data in Sec. 170.407(a)(1)(i)(C), and
instead only require developers to provide health care provider
identifiers if that would provide a more consistent approach across
developers and also allow us to gauge the representativeness of the
data while reducing burden. We seek public feedback on approaches to
understand the types and number of providers that are included in the
data submitted, relative to the broader population of providers using
the products of a developer of certified health IT. We also request
comments for alternatives that may shift measurement from provider-
based measures to patient-centered measures such as percentage and/or
number of encounters or patients included in the data.
In the HTI-1 Final Rule (89 FR 1346), we finalized the Insights
Condition reporting frequency to annually (once per year) for any
Health IT Module that has or has had an active certification at any
time under the ONC Health IT Certification Program during the prior six
months in Sec. 170.407(b). We stated that developers of certified
health IT who do not meet the minimum reporting qualifications would
submit a response to specify that they do not meet the qualifications
under the Insights Condition. In this way, all developers of certified
health IT would report on all measures, even if some report that they
do not meet the minimum reporting qualifications (89 FR 1345).
We propose to revise Sec. 170.407(b)(1) to make clear that all
developers must provide responses to the Insights Condition of
Certification on an annual basis regardless of how long a developer
[[Page 63596]]
has or has had an active certification under the Program. Since all
developers of certified health IT within the Program are required to
submit a response, as finalized in HTI-1 Final Rule (89 FR 1345), we
believe this revision will simplify and clarify expectations.
We propose in Sec. 170.407(b)(1)(ii) that the response a developer
of certified health IT submits per the requirements of the Insights
Condition, must be applicable to all their certified health IT as of
January 1st of each year, beginning January 2026. For example, a
developer of certified health IT who is submitting their response July
2027, would include data from all their applicable certified health IT
from the prior year between January to December 2026 for their July
2027 submission. This has been the expectation from what we finalized
in HTI-1 (89 FR 1348); however, we believe codifying the date of
January 1st is necessary so that all health IT developers can determine
whether they are required to report on a measure 18 months in advance
of the response submission. This is similar to real world testing
reporting requirements which has a specified date for all developers of
certified health IT to assess their eligibility on submitting a real
world testing plan per Sec. 170.405. We strongly encourage developers
of certified health IT to assess whether they meet the minimum
reporting qualifications for the Insights Condition on January 1st of
each year beginning in 2026. We intend to provide resources, outreach
efforts, and other communications to aid developers of certified health
IT in understanding the Insights Condition requirements. Our goal is to
ensure there is adequate time allotted for reporting, clarity related
to requirements, and an ability to address developers' questions and
educational needs well in advance of any reporting deadlines. We
welcome comments on our proposal and welcome alternative approaches
that helps us achieve this goal.
We include a table below as an example, and welcome comments on
this approach and the proposed date, such as whether the date of
January 1st should be earlier in the year (such as August 31st to align
with Real World Testing eligibility date) \220\ to allow more time for
developers to assess whether or not it meets the minimum reporting
requirements for the upcoming data collection period.
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\220\ See HTI-1 Final Rule Inherited Certified Status 89 FR 1198
[GRAPHIC] [TIFF OMITTED] TP05AU24.001
We also propose in Sec. 170.407(b)(2) that if developers update
their certified health IT using Inherited Certified Status after
January 1 of the year prior in which the responses are submitted, a
health IT developer must include the newer version of the certified
Health IT Module(s) in its annual responses to the Insights Condition
of Certification. Many health IT developers update their certified
Health IT Module(s) on a regular basis, leveraging the flexibility
using Inherited Certified Status. This updating can cause an existing
certified Health IT Module to be recognized as new within the Program
due to the way ONC issues certification identifiers, and could result
in existing certified Health IT Modules being inadvertently excluded
from the Insights Condition requirements.
In the HTI-1 Final Rule (89 FR 1344), we stated that we intend to
make responses (the metrics and required documentation) to the Insights
Condition made publicly available on ONC's website. We also stated that
if health IT developers wish to provide additional information as part
of the optional documentation, we strongly encourage them to not
include any proprietary, trade secret, or confidential information in
their submission. We also indicated that we intend to provide a method
for health IT developers to first indicate whether they plan to share
proprietary, trade secret, and/or confidential information for purposes
of either required or optional documentation, and if a health IT
developer provided an affirmative indication, ONC would engage the
developer in dialogue about potential alternative means of meeting
either required documentation requirements or providing optional
documentation (e.g., in other generalized or descriptive ways that may
achieve the same goal) (89 FR 1344 through 1345).
To improve alignment and consistency with ONC's other certification
requirements, we propose to revise Sec. 170.407(a)(1)(i)(B) to specify
that documentation must be available via a publicly accessibly
hyperlink instead. We note that this applies to both required and
optional documentation. This avoids health IT developers from sharing
any potential proprietary, trade secret, and/or confidential
information with ONC. We note that this process is consistent with
other documentation reporting processes that are part of the Program.
c. Minimum Reporting Qualifications
In the HTI-1 Final Rule (89 FR 1345 through 1346), we finalized
minimum reporting qualifications in a way that does not unduly
disadvantage small and startup developers of certified health IT. We
finalized in Sec. 170.407(a)(2) that a developer of certified health
IT must have at least 50 hospital sites or 500 individual clinician
users across the developer's certified health IT to report on the
measure. We noted that the 50 hospital sites threshold is applicable to
Health IT Modules used in inpatient or emergency department settings,
while the 500 individual clinician users' threshold is applicable to
Health IT Modules used in outpatient/ambulatory settings (non-
inpatient). We propose to revise Sec. 170.407(a)(2) by removing
``sites'' from hospital sites as the term could be misinterpreted.
[[Page 63597]]
In addition, to ensure consistency in how health IT developers are
interpreting and reporting on these terms, and to ensure there is no
confusion regarding the types of hospitals and clinicians included, we
clarify that the term ``hospital'' refers broadly to include various
types of hospitals and is not limited to non-Federal acute care
hospitals. This could include (but is not limited to) long term care
hospitals, critical care hospitals, federally owned hospitals such as
those operating under the U.S. Department of Veterans Affairs (VA), the
U.S. Department of Defense (DOD), or the Indian Health Service (IHS),
children's hospitals, psychiatric hospitals, etc. These hospitals could
be identified with a CMS Certification number (CCN) or other unique
identifier such as NPI or the American Hospital Association identifier.
We clarify the term ``clinician users,'' to include health care
professionals consisting of a variety of backgrounds, including but not
limited to:
Physicians (including Doctor of Medicine, osteopathy, dental
surgery, dental medicine, podiatric medicine, and optometry)
Osteopathic practitioners
Chiropractors
Physician assistants
Nurse practitioners
Clinical nurse specialists
Certified registered nurse anesthetists
Physical therapists
Occupational therapists
Clinical psychologists
Qualified speech-language pathologists
Qualified audiologists
Registered dietitians or nutrition professionals
Clinical social workers
Certified nurse midwives
Although we seek to broadly define both ``hospitals'' and
``clinicians'' we realize that there may be benefits to aligning these
terms with existing definitions as these are known and have been
utilized over time. We are considering various options regarding
whether to align the minimum reporting qualifications with definitions
established for hospitals and clinicians by CMS, or in the Public
Health Service Act (PHSA). For example, we are considering referring to
the definition of ``health care provider'' as defined in section
3000(3) of the PHSA for ``hospitals'', however, this definition may be
too broad for the purposes of the Insights Condition. We are also
considering the definition of ``clinicians'' as defined by CMS \221\ in
their Merit-based Incentive Payment System (MIPS) program which would
provide alignment and scope for provider types but may also be too
restrictive since we require reporting from developers beyond those
participating under CMS programs. Although the types of clinicians we
provided as examples above are defined by CMS as ``clinicians'', we do
not wish to limit reporting for the Insights Condition to data that
only relates to those participating in CMS programs given that many
clinicians do not participate fully in these programs.\222\ We seek
comment on whether to keep our approach, or to align it with existing
definitions to provide greater clarification and alignment with other
requirements. Commenters are encouraged to specify alternatives that we
should consider that would bring consistency and comparability across
developers who will report under the Insights Condition. We are also
considering and seek input from commenters on excluding clinicians who
may only have an administrative role, which we would define as a
clinician who does not treat patients. We note that this exclusion
would not apply to a clinician conducting clinical research if the
clinician directly treats patients.
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\221\ https://qpp.cms.gov/mips/how-eligibility-is-determined.
\222\ Apathy NC, Everson J. High Rates of Partial Participation
in The First Year of The Merit-Based Incentive Payment System.
Health Aff (Millwood). 2020 Sep;39(9):1513-1521. doi: 10.1377/
hlthaff.2019.01648. PMID: 32897783; PMCID: PMC7720898.
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d. Measure Updates
Individuals' Access to Electronic Health Information Through Certified
Health IT Measure
In the HTI-1 Final Rule (89 FR 1314), we finalized the
``individuals' access to electronic health information through
certified health IT'' measure in Sec. 170.407(a)(3)(i), which states
that if a health IT developer has a Health IT Module certified to Sec.
170.315(e)(1) or (g)(10) or both, the developer must submit responses
for the number of unique individuals who access electronic health
information (EHI) overall and by different methods of access through
certified health IT. We specified that the related metrics only count
individuals' access to their EHI and stated in the HTI-1 Final Rule
that we may incorporate patient-authorized representatives in future
rulemaking (89 FR 1315). Therefore, we propose to revise Sec.
170.407(a)(3)(i) to include both individuals and individuals'
authorized representatives accessing their EHI (rather than just
individuals alone).
We believe it would be beneficial to align our measure with the
Medicare Promoting Interoperability Program (PI) Measure for patient
access (``Provide Patients Electronic Access to Their Health
Information''),\223\ which counts access by patients or their
authorized representatives for measuring patient access using portals
or apps. Therefore, we propose to expand the measuring of access to
include access by individuals or their authorized representatives in
Sec. 170.407(a)(3)(i). We do not expect this additional measurement
specificity will add substantive development effort for health IT
developers as this proposal would align with how CMS operationalizes
their measure for patient access.
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\223\ https://qpp.cms.gov/docs/pi_specifications/Measure%20Specifications/2023MIPSPIMeasuresProvidePatientsElectronicAccess.pdf.
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C-CDA Reconciliation and Incorporation Through Certified Health IT
Measure
In the HTI-1 Final Rule (89 FR 1317), we finalized the
``consolidated clinical document architecture (C-CDA) problems,
medications, and allergies reconciliation and incorporation through
certified health IT'' measure in Sec. 170.407(a)(3)(ii). The measure
is intended to capture the use of C-CDAs in alignment with capabilities
specified for the ``clinical information reconciliation and
incorporation'' certification criterion in Sec. 170.315(b)(2). Given
the proposed updates to Sec. 170.315(b)(2) discussed elsewhere in this
proposed rule, we also propose conforming updates for this measure to
ensure alignment with the certification criterion. We refer readers to
section III.B.7 of this proposed rule for detailed discussion on the
proposed revisions specific to Sec. 170.315(b)(2). Therefore, we
propose to revise the name of this measure to ``C-CDA reconciliation
and incorporation through certified health IT'' in Sec.
170.407(a)(3)(ii).
In further alignment with the proposed revisions to the
certification criteria in Sec. 170.315(b)(2), we propose to require
developers to submit responses on specific data classes and elements
from C-CDA documents obtained and subsequently reconciled and
incorporated both through manual and automated processes in Sec.
170.407(a)(3)(ii)(E). Note, given this proposal, we propose to make
conforming grammatical edits to the list structure in Sec.
170.407(a)(3)(ii)(C) and (D) to accommodate the proposed addition of
(E). If finalized as proposed in Sec. 170.407(a)(3)(ii)(E), we would
also provide technical updates resulting in
[[Page 63598]]
additional metrics in the accompanying measure specification sheet
which we discuss in further detail below under ``technical updates.''
To provide adequate time for associated technical development and
then reporting, we propose in Sec. 170.407(b)(1)(i)(D) that any
metrics in the accompanying measure specification sheet related to
Sec. 170.407(a)(3)(ii)(E) would be reported beginning July 2030, with
data collection starting in 2029. We expect that several developers
would likely provide information similar to the metrics described above
in their 2023 Real World Testing Results, which would indicate the
feasibility of generating these metrics.\224\ We welcome comments on
our proposals.
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\224\ https://www.eclinicalworks.com/wp-content/uploads/2024/01/eCW-Real-World-Testing-2023-Results-Report-Jan-2024.pdf.
https://www.epic.com/content/epiccare2023results.pdf.
https://www.oracle.com/a/ocom/docs/industries/healthcare/2023-cerner-real-world-testing-results.pdf.
https://www.azaleahealth.com/wp-content/uploads/2024/01/2023-RWT-Results-Report-Azalea-EHR.pdf.
https://cantatahealth.com/wp-content/uploads/2024/01/Cantata-Health-Real-World-Testing-Results.pdf.
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Technical Updates in Measure Specification Sheets
As proposed above, the proposed ``individuals' access to electronic
health information through certified health IT'' measure consists of
three metrics, as specified in the measure specification sheet, one of
which is the number of unique individuals who accessed their EHI using
technology certified to the ``standardized API for patient population
services'' under Sec. 170.315(g)(10). As we stated in the HTI-1 Final
Rule (89 FR 1313), the measure specification sheets provide granular
definitions and other information needed to operationalize the metrics
to ensure they are implemented in a consistent manner across health IT
developers. In the measure specification sheet, we defined measuring
access to EHI for this measure by counting an individual's
authorization, as indicated by an access token, at least once during
the reporting period.\225\ We intend to modify this definition in an
updated version of the measure specification sheet as a technical
update as it does not change the substance of this measure, since there
may be instances where individuals authorize access to their data (via
an access token) but no requests are made to retrieve the data. Given
that our intent is to measure individuals' access to EHI (versus just
authorizing access), we plan to update this definition in the measure
specification sheet for this metric to further specify that access to
EHI should be measured by counting the number of individuals where at
least one FHIR resource was returned when using the ``standardized API
for patient population services'' under Sec. 170.315(g)(10) during the
reporting period.
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\225\ https://www.healthit.gov/sites/default/files/page/2023-12/Measure_Spec_Individual_Access_508.pdf.
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We request comment on whether this definition should be updated in
the measure specification in this manner, or alternatively, whether we
should update it so that access to EHI is measured by counting the
number of individuals where at least one FHIR request was made to
access information using the ``standardized API for patient population
services'' under Sec. 170.315(g)(10) during the reporting period. We
acknowledge that there may be concerns related to defining in terms of
FHIR requests as we may technically be including unauthorized requests
as a measure of access to EHI. We welcome comments and suggestions
regarding modifying the original definition. As stated above, our
website at the following link (www.healthit.gov/proposedrule) will have
an accompanying measure specification sheet reflecting the technical
specifications related to the substantive proposals in this proposed
rule for commenters to view and consider. We refer readers to the HTI-1
Final Rule (89 FR 1312) where we explained that while the substantive
requirements for each measure are defined through rulemaking, we
determined that measure specification sheets are a logical and
accessible method for the public to view the technical specifications
that support those requirements.
We stated in the HTI-1 Final Rule (89 FR 1322) that if regulatory
baselines associated with the metrics change in the future--such as a
revision to a criterion through notice and comment rulemaking--the
measure specification would also be changed to ensure alignment with
the revised criterion. Therefore, we expect to update the metrics for
the proposed ``C-CDA reconciliation and incorporation through certified
health IT'' measure, within the accompanying measure specification
sheet to align with the proposed broader set of data referenced by the
criterion specified in Sec. 170.315(b)(2) if finalized as proposed. As
stated above, the accompanying measure specification sheet reflecting
the technical updates to align with the proposed broader set of data in
this proposed rule will be available on ONC's website for review to
support public comment in a transparent manner. Specifically, we intend
to replace references in the measure specification sheet for problems,
medications, and allergies and intolerances with a reference to the
proposed data specified in Sec. 170.315(b)(2) and, consistent with the
policy established in the HTI-1 Final Rule (see 89 FR 1312), we intend
to continue to align measure specification sheets with any
modifications to certification criteria finalized via notice and
comment rulemaking--in this instance, specifically for Sec.
170.315(b)(2). The specific data classes and elements proposed in Sec.
170.407(a)(3)(ii)(E), that we intend to list in the measurement
specification sheet as technical updates, are selected from the
additional data that would be included in proposed Sec. 170.315(b)(2)
listed below:
The data elements Substance (Medication) and Substance
(Drug Class) in the Allergies and Intolerances data class.
The data elements Patient Goals and SDOH Goals in the
Goals data class.
The data element Immunizations in the Immunizations data
class.
The data element Values/Results in the Laboratory data
class
The data element Medications in the Medications data
class.
The data element Unique Device Identifier--Implantable for
a patient's implantable device(s) in the Medical Devices data class.
The data element Assessment and Plan of Treatment in the
Assessment and Plan of Treatment data class.
The data element Problems and SDOH Problems/Health
Concerns in the Problems data class.
We would provide technical updates resulting in additional metrics
in the accompanying measure specification sheet that capture (1) the
number of specific data elements obtained in the reporting period, and
(2) the reconciliation of specific data, such as the number of problems
reconciled and incorporated by various means. Together, this data would
allow ONC to calculate how often problems and other data elements are
reconciled and incorporated by various means using the number of each
data element obtained and other existing metrics (such as the number of
encounters) as denominators. We request comment on whether that
approach would provide beneficial information commensurate with the
potential burden for developers.
Given the number of data elements that Health IT Modules certified
to
[[Page 63599]]
Sec. 170.315(b)(2) would be able to reconcile and incorporate
following the proposed revisions for the certification criteria, we
have specified a limited set of Data Elements and Data Classes for
which developers would count the number of Elements obtained and the
number of Elements reconciled and incorporated for the Insights
Condition in the measurement specification accompanying this proposed
rule. We request comment on the specific Data Classes or Elements on
which such metrics should focus. For instance, metrics specifically
focused on reconciliation of medications may provide the most value in
informing how often medication information is updated to accurately
reflect care received from other organizations and allow for effective
decision support; in contrast, metrics on reconciliation and
incorporation of vital signs may provide relatively limited value.
We also request comment on whether metrics should focus on specific
data elements or should aggregate data elements to the data class
level. For example, it may be more valuable and feasible to include a
metric on the aggregate total number of substance (Medication) and
substance (Drug Class) data elements within the Allergies and
Intolerances data class rather than two separate metrics, one focused
on Substance (Medication) and another focused-on Substance (Drug
Class). We request comment on the feasibility and value of separate
metrics by Data Element and aggregate elements by some or all Data
Elements within a Data Class, which may differ by specific Element and
Class.
We are also considering approaches to capture use of the proposed
requirements for Sec. 170.315(b)(2), if finalized as proposed, to
support automatic reconciliation and incorporation in the accompanying
measure specification sheet. As in prior versions of the measurement
specification, the metric on the number of total C-CDAs obtained equals
the sum of the metric on the number of total C-CDA documents obtained
that were pre-processed and the metric on the number of total C-CDA
documents obtained that were not pre-processed. We clarify that all
documents for which reconciliation and incorporation is completed
through fully automated processes would be considered to have been pre-
processed for the purpose of this metric.
The measurement specification sheet further differentiates four
metrics for pre-processed C-CDA documents: the first and second metrics
respectively count pre-processed C-CDA documents that had data
reconciled and incorporated via manual processes and fully automated
processes, and the third and fourth metrics respectively count pre-
processed C-CDA documents that were determined to have no data that
modifies the patient record through manual processes and fully
automated processes. These four metrics address pre-processed C-CDA
documents that are manually acted upon or fully automated for
reconciliation and incorporation but do not capture those C-CDAs that
were obtained and pre-processed but not further acted upon by manual or
fully automated processes.
The metric on the number of total C-CDA documents obtained that
were not pre-processed is further differentiated by two metrics: the
first metric counts C-CDA documents that were not pre-processed that
had data reconciled and incorporated via manual processes, and the
second metric counts C-CDA documents that were not pre-processed that
were determined to have no data that modifies the patient record
through manual processes. These two metrics account for all C-CDAs that
are obtained, not pre-processed, and are then acted upon and do not
include those C-CDAs that are obtained, not pre-processed, and not
acted upon. While these sets increase the number of metrics to report,
we believe they will clarify and simplify measuring and categorizing C-
CDA documents.
In the HTI-1 Final Rule, we defined ``Reconciled and Incorporated
via Any Method'' to be an approach to reconciling and incorporating
information in the Health IT Module, including but not limited to,
manual processes performed by a clinician or their delegate only; a mix
of manual and automated processes; or fully automated processes (89 FR
1319). Given the focus on automatic reconciliation and incorporation
capabilities in this proposed rule for Sec. 170.315(b)(2), we
anticipate aligning the measure specification sheet by dividing the
metrics that call for reporting on the total number of C-CDA documents
that were reconciled and incorporated by ``any method'' into two
categories: (1) C-CDA documents where data were reconciled and
incorporated via manual processes performed by a clinician or their
delegate only; and (2) a C-CDA documents where any data was reconciled
and incorporated via fully automated processes. These additional
metrics are intended to generate insight into the use of automatic
capabilities and how often C-CDAs are reconciled and incorporated by
fully automatic means.
We have chosen these two categories to capture instances where the
reconciliation and incorporation process is at least partly completed
by automated means and because we believe that instances in which all
data contained in a C-CDA are reconciled and incorporated via fully
automated processes will be rare given the scope of data proposed to be
included in the proposed Sec. 170.315(b)(2). Alternatively, we could
include an additional metric in the measure specification sheet to
capture documents in which data is reconciled and incorporated through
a mix of manual and automated processes, which would occur, for
example, when problems were reconciled by automated processes and
medications were reconciled by manual processes.
We also intend to complement the existing metric focused on C-CDA
documents that were determined to have no new information by pre-
processes or fully automated processes with an additional metric. The
additional metric would capture the number of C-CDA documents that were
determined to have no new information by manual processes performed by
a clinician or their delegate only. These two metrics focused on
determining that there was no new information would therefore directly
mirror the two metrics focused on reconciliation and incorporation
following pre-processes. In revising these metrics, we are also
considering alternatives that would describe the varied ways in which
data contained within C-CDAs could lead to modification or
reconciliation with the patients record. We request comment on whether
metrics in the updated measure specification sheet that include the
term 'no new data' clearly exclude instances where information in C-
CDAs lead to a change to the patient's record. For example, if
information in the patient record is deleted or modified in response to
information in the C-CDA, the intention is that this be counted as an
instance where information is reconciled and incorporated (either via
manual or automated processes) and NOT as an instance where documents
were determined to have no new data. If the current metrics are not
clear, would it be more effective to revise the metrics on ``no new
data'' as listed below:
Number of total C-CDA documents obtained that were pre-
processed and determined to have no data specified in Sec.
170.315(b)(2) that modifies the patient record by manual processes
performed by a clinician or their delegate.
Number of total C-CDA documents obtained that were pre-
processed and
[[Page 63600]]
determined to have no data specified in Sec. 170.315(b)(2) that
modifies the patient record by pre-processes or fully automated
processes.
Number of total C-CDA documents obtained that were not
pre-processed and determined to have no new data specified in Sec.
170.315(b)(2) that modifies the patient record via manual processes
performed by a clinician or their delegate only.
As noted earlier, please see the measure specification sheet that
will be posted on ONC's website for review.
We request public comment on the definitions provided in that
measure specification sheet for manual processes, and fully automated
process as well as the feasibility of separately measuring those
processes. We also request comment on whether the resulting separate
metrics would effectively capture the use of the proposed new
capabilities to automatically reconcile and incorporate information for
Sec. 170.315(b)(2), and request comment on the value of including a
metric capturing when a ``mix'' of automated and manual processes were
used to reconcile and incorporate data.
We also plan to make a technical update by revising the number of
unique patients with an associated C-CDA document measure to instead
capture the number of unique patients with an encounter and associated
C-CDA document. The revised metric would be a direct subset of the
existing metric Number of Unique Patients with an Encounter. The
current metric comprehensively captures the number of patients with C-
CDAs but may include some C-CDAs for patients who are not treated by a
provider using the product during the reporting period. We do not
anticipate any change in burden, and are requesting comment on the
relative value of the altered metric.
In the HTI-1 Final Rule (89 FR 1326), we finalized the ``use of
FHIR in apps through certified health IT'' in Sec. 170.407(a)(3)(iv).
This measure captures the volume and type of FHIR resources transferred
to apps from certified health IT relative to the number of active
certified API technology deployments. We intend to make a technical
update in the accompanying measure specification sheet to provide
additional implementation information specifying that reporting by user
type should be done according to three mutually exclusive categories:
patient-facing only, non-patient facing only, and both patient-facing
and non-patient facing.
In the HTI-1 Final Rule (89 FR 1332), we finalized the
``immunization administrations electronically submitted to immunization
information systems through certified health IT'' measure in Sec.
170.407(a)(3)(vi). We stated that this measure would report on the
volume of immunization administrations electronically submitted to an
immunization information system through certified health IT. In the
accompanying measure specification sheet, we indicated that the number
of immunizations administered that were electronically submitted
successfully to IISs overall was defined as the total number of
messages submitted to IISs, minus acknowledgements with the error of
severity level E. We intend to make a few technical updates to this
measure specification sheet. First, we intend to add metrics to
separately count the number of immunizations administered
electronically submitted to IISs that returned with an acknowledgement
with the error of severity level E during the reporting period overall,
and by IIS and age category. These additional metrics would enable us
to identify potential issues associated with submissions to the IIS. We
do not expect any additional burden associated with reporting this
metric. We also request comment on the value and burden associated if
we have the metrics count the immunizations administered electronically
returned by their acknowledgement code (by IIS and age) instead, which
would allow us to understand the number of messages that were rejected,
had errors, and were accepted by IIS and age.
We also intend to make another technical update to the measure
specification sheet by adding metrics to separately count the number of
immunizations administered that were electronically submitted to IIS
where an acknowledgement from an IIS is not received by certified
health IT overall, and by IIS and age category. The current measure
specification sheet indicates health IT developers optionally report on
number of submissions that did not receive acknowledgement as part of
the supplemental documentation. These separate metrics would enable
monitoring the occurrence of these communication failures between
certified health IT and IIS more systematically. We do not expect
substantive additional burden associated with this metric. We also
request comment on the value and burden associated with reporting a
count of the subset of messages sent to third party intermediaries
where the third-party intermediary does not provide an acknowledgement
that the message was sent to an IIS. Finally, we intend to make a
technical update that would clarify that the immunization
administration submitted would include HL7 Z22 messages, and request
comment on this approach. This aligns with the ``immunization history
and forecasts through certified health IT'' measure specification sheet
where we indicate that ``the successful response received from IIS''
include HL7 Z42 and Z32 messages.
In the HTI-1 Final Rule (89 FR 1336), we finalized the
``immunization history and forecasts through certified health IT''
measure in Sec. 170.407(a)(3)(vii). This measure captures the use of
certified health IT to query information from an IIS under the
``transmission to immunization registries'' (Sec. 170.315(f)(1))
criterion. In the accompanying measure specification sheet, we
indicated that the number of immunization queries sent to IISs overall
metric would be defined as the total number of messages sent to IISs,
minus acknowledgements with errors (severity level E). We intend to
make a technical update and modify this definition in the measure
specification sheet as it does not change the substance of this
measure. We plan to update this definition so that the number of
immunization queries sent to IISs overall metric should be measured by
only counting the total number of immunization queries sent to IISs
during the reporting period. This metric no longer requires subtracting
the number of acknowledgements with the error of severity level E.
Instead, we are adding separate metrics in the measure specification
sheet which would report on the total number of queries responses that
returned with acknowledgements that had an error of severity level E,
overall and by IIS, during the reporting period. This would enable us
to understand how many queries were rejected by an IIS (as indicated by
an ``E'' code) during the reporting period. We do not expect any
additional burden associated with metric. We also plan to make a
technical update to the definition of ``queries sent'' to IISs such
that the definition of queries sent applies to HL7 Z34 and HL7 Z44
messages. This approach would provide consistency in how queries sent
are defined across developers. Additionally, it would align the
definition of ``queries sent'' with ``successful response received from
IIS,'' which is based upon the receipt of HL7 Z42 and Z32 messages. We
also request comment on the value and burden associated if we have the
metrics count the query responses returned by their acknowledgement
code (by IIS) instead,
[[Page 63601]]
which would allow us to understand the number of queries sent where
data was found, no data was found, or multiple candidates exist, or
where query messages that were rejected, had errors, and were accepted
by IIS.
In the HTI-1 Final Rule (89 FR 1338) we also received a couple
comments noting that a significant portion of messaging failures are
communication failures where there will be no response received. A
commenter suggested that messages with no response from the IIS (in the
case of downtime, for example) would be considered successful (89 FR
1338). In response, we stated that at this time, we will not require
health IT developers to provide separate counts for communication
failures and counts of the descriptive context levels, and encouraged
developers capture information about communication failures as their
functionality permits and include this explanation in the supplemental
documentation. We also stated that we would collaborate with the
community to monitor how these instances impact the measure's
interpretation and determine if it should be revised in the future.
Given the potential value of understanding the frequency of these
communication failures, we plan to make a technical update in the
accompanying measure specification sheet to create additional metrics
which would report on the total number of queries sent but where no
acknowledgement was received from the IIS overall, and by IIS. The
separate metric to count no acknowledgements would allow us and the CDC
to monitor the occurrence of these communication failures between
certified health IT and IIS rather than relying on supplemental
reporting to gather this information. We do not expect substantive
additional burden associated with this metric. We also request comment
on the value and burden associated with reporting a count of the
queries sent to third party intermediaries where the third-party
intermediary does not provide an acknowledgement the query was sent
onto an IIS.
2. Attestations Condition and Maintenance of Certification Requirements
The Cures Act amended section 3001(c)(5) of the PHSA by adding the
requirements that a health IT developer, as a Condition and Maintenance
of Certification requirement under the Program, provide assurances to
the Secretary, unless for legitimate purposes specified by the
Secretary, that it will not take any action that constitutes
information blocking as defined in section 3022(a) of the PHSA, or any
other action that may inhibit the appropriate exchange, access, and use
of EHI. In the ONC Cures Act Final Rule, we established both Assurances
(Sec. 170.402) and Attestations (Sec. 170.406) Conditions and
Maintenance of Certification requirements (88 FR 75718 and 88 FR 25781,
respectively).
In the HTI-1 Proposed Rule (88 FR 23782) and Final Rule (89 FR
1237), we proposed and finalized the adoption of the certification
criterion, ``decision support interventions'' in Sec. 170.315(b)(11)
as part of the ``care coordination certification criteria,'' in Sec.
170.315(b). In the HTI-1 Final Rule, we narrowed the overall scope of
technologies impacted by finalized requirements in Sec. 170.315(b)(11)
(89 FR 1251 through 1252). We finalized minimal, uniform requirements
for all Health IT Modules certified to Sec. 170.315(b)(11) while also
maintaining a construction that enables a developer of certified health
IT to certify a Health IT Module to Sec. 170.315(b)(11) without being
obligated to author, develop, or otherwise directly provide Predictive
DSIs to its customers. Specifically, we finalized a configuration nexus
for several requirements in Sec. 170.315(b)(11) that centered on
whether the developer of certified health IT supplied a Predictive DSI
as part of its Health IT Module.
We also finalized in the HTI-1 Final Rule a supportive Maintenance
of Certification requirement as part of the Assurances Condition of
Certification in Sec. 170.402(b) for Sec. 170.315(b)(11). We
finalized in Sec. 170.402(b)(4) that starting January 1, 2025, and on
an ongoing basis, developers of Health IT Modules certified to Sec.
170.315(b)(11) must review and update, as necessary, source attribute
information in Sec. 170.315(b)(11)(iv)(A) and (B), risk management
practices described in Sec. 170.315(b)(11)(vi), and summary
information provided through Sec. 170.523(f)(1)(xxi) (89 FR 1253
through 1254). These policies establish ongoing requirements for
developers of certified health IT with Health IT Modules certified to
Sec. 170.315(b)(11) to address circumstances where a developer chooses
to supply a Predictive DSI as part of its Health IT Module after its
initial certification to Sec. 170.315(b)(11), as well as circumstances
where a developer that formerly supplied a Predictive DSI as part of
its Health IT Module when initially certifying to Sec. 170.315(b)(11)
no longer chooses to do so.
We propose to add a conforming update to the Attestation Condition
of Certification by revising Sec. 170.406(a)(2) to address the
Assurance Maintenance of Certification requirement in Sec.
170.402(b)(4). We note that as a function of providing attestations
twice yearly, developers of certified health IT with Health IT Modules
certified to Sec. 170.315(b)(11) would be expected to affirm
conformance to the Assurances Maintenance of Certification requirement
in Sec. 170.402(b)(4); specifically, they would attest that they have
reviewed and updated, as necessary, the required attribute information
and documentation during the time covered by the attestation. We
welcome comment on this proposal.
D. Administrative Updates
1. Program Correspondence
We propose to revise the Program correspondence provision (Sec.
170.505(a)(2)) to clarify that under Program regulations, the applicant
for ONC-Authorized Testing Lab (ONC-ATL) status, the applicant for an
ONC-Authorized Certification Body (ONC-ACB), an ONC-ONC-ACB, an ONC-
ATL, health IT developer or any party to proceeding under subpart E of
part 170 will be considered to have received correspondence or other
written communications from ONC or the National Coordinator when the
first of the following three scenarios occurs: (1) the date on which
ONC or the National Coordinator receives a response to the
correspondence via written or verbal communication methods; (2) the
date of the delivery confirmation to the address on record for
correspondence sent by express or certified mail; or (3) the date of
the seventh business day after the date on which the email, express, or
certified mail was sent.
ONC explained in the ONC Cures Act Proposed Rule preamble that ``we
consider a `business day' to include the normal workdays and hours of
operation during a week (Monday through Friday), excluding Federal
holidays and weekends.'' \226\ We propose to codify in 45 CFR 170.102 a
definition of ``business days'' that would include the same days as our
explanation in the ONC Cures Act Proposed Rule. ONC's definition of
business days for purposes of 45 CFR part 170 would also include those
days on which the Office of Personnel Management has announced that
Federal agencies in the Washington, DC area are closed, reflecting the
nationwide scope of the Program. The ``business days'' definition
proposed in Sec. 170.102 would provide clarity about
[[Page 63602]]
which days would be counted when determining the date of the seventh
business day after the date on which the email, regular, express, or
certified mail was sent, as proposed in Sec. 170.505(a)(2)(iii).
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In the ONC Cures Act Proposed Rule at 84 FR 7503, referencing a
statement the Enhanced Oversight and Accountability Final Rule (EOA
Final Rule) (81 FR 72404), we signaled our intent to send notices of
potential non-conformity, non-conformity, suspension, proposed
termination, and termination via certified mail (81 FR 72429). We
solicited comments on the ONC Cures Act Proposed Rule regarding the
nature and types of non-conformities with the Conditions and
Maintenance of Certification requirements that ONC should consider in
determining the method of correspondence. Specifically, we asked
whether certain types of notices under direct review should be
considered more critical than others and, thus, might require a
specific method of correspondence (84 FR 7504). In the ONC Cures Act
Final Rule, we finalized the proposal to use the provisions in Sec.
170.505 for correspondence regarding compliance with the Conditions and
Maintenance of Certification requirements with minor revisions
outlining specific considerations for when we would provide notice
beyond email (85 FR 25784).
When we finalized our proposal in the ONC Cures Act Final Rule, we
did not anticipate the several challenges we encountered with certain
correspondence beyond email during the COVID-19 pandemic. As the volume
of correspondence and communication required to fulfill ONC review and
enforcement responsibilities for the Conditions and Maintenance of
Certification requirements (subpart D of 45 CFR part 170) has
increased, we have experienced difficulties with delivery of paper-
based correspondence that we did not experience with email.
To avoid undue delays in addressing non-conformities with Program
requirements or resolving other matters, we propose in Sec.
170.505(a)(2)(iii) that seven business days after a written
communication is sent is the latest of three dates on which we would
consider the communication to have been received by the recipient. In
Sec. 170.505(a)(2)(i), where we receive a communication from the ONC-
ACB, ONC-ATL, applicant, developer, or other party in response to a
written correspondence, we believe that response is sufficient to
demonstrate the communication has been received. Similarly, in Sec.
170.505(a)(2)(ii) a delivery confirmation date, such as from the United
States Postal Service (USPS) for certified mail, that is fewer than
seven business days after the communication was sent would be
considered the day the communication was received.
We welcome comments on this proposal and whether we should consider
moving away from using non-electronic means of communication for
anything except courtesy copies of communications.
2. ONC-Authorized Certification Bodies (ACB) Surveillance of Certain
Maintenance of Certification Requirements
a. Background and Proposal Summary
To better support health IT developers' ability to consistently
meet their obligations under subpart D of 45 CFR part 170, we propose
to adopt new requirements in Sec. 170.523 principles of proper conduct
(PoPCs) for ONC-ACBs and new procedures for in-the-field surveillance
of the maintenance of certification for Health IT in Sec. 170.556 that
would build on ONC-ACBs' existing surveillance responsibilities and
obligations. More specifically, we propose to adopt new surveillance
reporting requirements in Sec. 170.523(i), reporting for corrective
action plan (CAP) non-compliance in Sec. 170.523(x), new oversight
responsibilities of certain Maintenance of Certification requirements
in Sec. 170.523(p) and (q), new and revised surveillance requirements
in Sec. 170.556(b), and new and revised procedures for CAPs in Sec.
170.556(d).
We believe these proposed new and revised surveillance and PoPC
requirements would promote Program efficiency and encourage Program-
participating developers to maintain, or when necessary, regain,
conformity with Program requirements for the applicable Maintenance of
Certification requirements as required by the Program regulations
promulgated under the Cures Act. Section 4002(a) of the Cures Act
amended section 3001(c)(5) of the PHSA by adding paragraph (c)(5)(D),
which requires the Secretary, through notice and comment rulemaking, to
require certain conditions of certification and maintenance of
certification for the Program. In the ONC Cures Act Final Rule, we
established Conditions and Maintenance of Certification requirements
pursuant to PHSA 3001(c)(5)(D)(i) through (vi) in subpart D of 45 CFR
part 170 (85 FR 25783). In the HTI-1 Final Rule, we established the
Insights Condition and Maintenance of Certification requirements (Sec.
170.407) pursuant to PHSA 3001(c)(5)(D)(vii) and the Assurances
Maintenance of Certification requirement for health IT developers to
update and provide their Health IT Modules (Sec. 170.402(b)(3). We
also established in Sec. 170.402(b)(4) an Assurances Maintenance of
Certification requirement for Predictive Decision Support Intervention
transparency (89 FR 1371), and in section III.C.2 of this proposed
rule, we propose to establish a conforming update to the Attestation
Condition and Maintenance of Certification in Sec. 170.406(a)(2) to
address the adopted Sec. 170.402(b)(4) DSI Maintenance of
Certification requirement.
In addition to the Conditions and Maintenance of Certification
requirements, in the ONC Cures Act Final Rule we established that ONC
would enforce compliance with the 45 CFR subpart D Condition and
Maintenance of Certification requirements (85 FR 25783). However, we
also established ONC-ACB responsibilities (PoPCs). These
responsibilities included the review and approval for submission of
developers' Sec. 170.406 attestations (Sec. 170.523(q)) and Sec.
170.405 real world testing plans and results (Sec. 170.523(p)) (85 FR
25951). The ONC Cures Act Final Rule also established a PoPC in Sec.
170.523(s) requiring ONC-ACBs to report any information that could
inform whether ONC should exercise direct review of noncompliance with
the Conditions and Maintenance of Certification requirements to ONC (85
FR 25783).
ONC-ACBs' PoPC responsibilities under the currently codified
requirements in Sec. 170.523(p) have encouraged and helped Program-
participating developers to achieve a high rate of compliance with the
real world testing Maintenance of Certification requirements in Sec.
170.405. Under Sec. 170.523(p), ONC-ACBs are required to confirm the
completeness of developers' real world testing plans and results, and
to confirm the developer timely submitted materials for public
availability in accordance with Sec. 170.405(b). We believe a
similarly supportive dynamic exists for developers' compliance with
attestations requirements in Sec. 170.406 and insights reporting
requirements in Sec. 170.407, for which ONC-ACBs have explicitly
aligned PoPC responsibilities as described in Sec. 170.523(q) and (u).
Informed by our experience with ONC-ACB support in monitoring and
encouraging developers' compliance with certain 45 CFR 170 subpart D
requirements over the past three years, and pursuant to the authority
in PHSA
[[Page 63603]]
section 3001(c)(5)(E) to ``encourage compliance with the conditions of
certification,'' we now propose new ONC-ACB PoPC requirements in Sec.
170.523 to encourage and support developers' compliance with
Maintenance of Certification requirements in Sec. 170.402 and 170.404.
In parallel, we propose to update ONC-ACBs' responsibilities for
conducting reactive surveillance in accordance with Sec. 170.556(b)
and working with developers to encourage remediation of observed non-
conformities with Program requirements in Sec. 170.556(d).
Our proposal in Sec. 170.556(b) would require ONC-ACBs to initiate
surveillance when they become aware of facts or circumstances that
would cause a reasonable person to question whether a health IT
developer has satisfied certain Maintenance of Certification
requirements. As a result of our proposals in Sec. 170.556(b) and
additional proposals in Sec. 170.523(i), we are proposing to require
ONC-ACBs perform reactive and randomized surveillance based on the
specified Maintenance of Certification requirements in Sec. Sec.
170.402(b)(1)-(4), 170.404(b)(1) and (2), 170.405(b)(1) and (2),
170.406(b), and 170.407(b). In case of non-conformities, we would
require an ONC-ACB to notify health IT developers and require a CAP, in
addition to the existing requirements in Sec. 170.556 consistent with
their accreditation under PoPCs in Sec. 170.523(a) and ISO/IEC 17065.
In Sec. 170.556(d), we further propose revisions to the required
elements of a CAP for identified non-conformities with respect to
Program requirements codified in subpart D for which we propose an ONC-
ACB would have responsibility under Sec. 170.523. Under these
proposals in Sec. 170.523 and Sec. 170.556, an ONC-ACB would have the
duty to confirm a health IT developer's compliance with, and initiate
surveillance whenever it becomes aware of each non-conformity to, the
Maintenance of Certification requirements in Sec. Sec. 170.402(b)(1)-
(4), 170.404(b)(1) and (2), 170.405(b)(1) and (2), 170.406(b), and
170.407(b).
b. Updates to Principles of Proper Conduct for Maintenance of
Certification Requirements
In the ONC Cures Act Final Rule, we adopted Conditions and
Maintenance of Certification requirements for health IT developers
outlined in section 4002 of the Cures Act (85 FR 25717) and implemented
them with further specificity in the Program, expressing initial and
ongoing certification requirements for the health IT developers and
their certified health IT products (85 FR 25718). We adopted certain
responsibilities for the ONC-ACB's to ensure developers have met their
obligations for certain Conditions and Maintenance of Certification
requirements. We also provided that, if the monitoring processes
implemented by ONC-ACBs are not adhered to by developers, the ONC-ACB,
in accordance with Program reporting requirements, should follow its
processes to institute a CAP. Should the developer fail to engage in
the CAP process the ONC-ACB would alert ONC of the developer's failure
to comply with the Conditions and Maintenance of Certification
requirements (85 FR 25720 through 25721).
To ensure developers of health IT were meeting the requirements of
the Program, we adopted requirements for ONC-ACBs in Sec. 170.523.
Specifically, we adopted PoPCs for ONC-ACBs in Sec. Sec. 170.523(m),
170.523(p), 170.523(q), and 170.523(t) that aligned with certain
Maintenance of Certification requirements, tasking ONC-ACBs to review
and confirm certain information is submitted by health IT developers in
response to the real world testing and attestation Maintenance of
Certification requirements. ONC-ACBs are required to share additional
information, as it relates to certain Maintenance of Certification
requirements, with the National Coordinator regarding developer
compliance with Program requirements (85 FR 25784 through 25785).
We now propose to expand an ONC-ACB's responsibilities to require
additional oversight of certain Maintenance of Certification
requirements be included in the ONC-ABC's surveillance reports and to
provide certain documentation to the National Coordinator as part of
its surveillance. We propose new PoPC requirements for ONC-ACBs
specifically aligned to encourage transparency and support developers'
compliance with Maintenance of Certification Requirements in 45 CFR
part 170 subpart D, including redesignating Sec. 170.523(p) through
(u) as paragraphs (r) through (w). We propose to revise Sec.
170.523(p) to add new requirements that ONC-ACBs verify and confirm a
health IT developer's compliance with Attestation Maintenance of
Certification requirements in accordance with Sec. 170.402(b), and
revise Sec. 170.523(q) to add oversight requirements for developer
compliance with API Maintenance of Certification requirements in
accordance with Sec. 170.404(b). Our proposed redesignation would mean
the current requirements in Sec. 170.523(p) real world testing, Sec.
170.523(q) attestations, Sec. 170.523(r) test results from ONC-ATLs,
Sec. 170.523(s) information for direct review, Sec. 170.523(t) Health
IT Module voluntary standards and implementation specifications updates
notices, and Sec. 170.523(u) insights would be shifted to Sec.
170.523(r), (s), (t), (u), (v), and (w), respectively. We note that we
do not propose to revise the requirements in proposed Sec. 170.523(r),
(s), (t), (u), (v) or (w) (currently codified as Sec. 170.523(p), (q),
(r), (s), (t), and (u), respectively).
Under these proposals in Sec. 170.523, we would require that an
ONC-ACB confirm and verify a health IT developer's compliance with the
requirements in Sec. Sec. 170.402(b)(1)-(4), 170.404(b)(1) and (2),
170.405(b)(1) and (2), 170.406(b), and 170.407(b) and, where a non-
conformity rather than compliance is observed, to initiate surveillance
in accordance with our proposals in Sec. 170.556 (discussed in
III.D.2.c below) and notify the health IT developer of each observed
non-conformity. Each proposal in Sec. 170.523(p) references a
corresponding requirement for health IT developers in Sec. 170.402(b),
so that requirements in Sec. 170.523(p)(1) references Sec.
170.402(b)(1), our proposal for Sec. 170.523(p)(2) references Sec.
170.402(b)(2) and (b)(3), and our proposal for Sec. 170.523(p)(3)
references Sec. 170.402(b)(4). Health IT developer requirements in
Sec. 170.404(b)(1) and (2) are also incorporated into our proposals
for APIs in Sec. 170.523(q). Similarly, the insights requirement in
Sec. 170.523(w) (finalized in the HTI-1 Final Rule as Sec. 170.523(u)
(89 FR 1435)) for ONC-ACBs was proposed and finalized simultaneously
with corresponding developer requirements for Insights Condition and
Maintenance of Certification requirements in Sec. 170.407.
We propose to limit the ONC-ACB oversight requirements to those
certain Maintenance of Certification requirements mentioned above
because of the administrative nature of these requirements (comparative
to requiring, for example, investigation, analysis, or assessment). As
stated above, ONC-ACBs already have responsibilities in Sec.
170.523(p), (q), and (u) (which we propose to shift to Sec.
170.523(r), (s), and (t), respectively) to verify and confirm that
developers are meeting their obligations in Sec. Sec. 170.405(b)(1)
and (2), 170.406, and 170.407. These Maintenance of Certification
requirements require developers to submit documentation to ONC-ACBs,
notify ONC-ACBs when a non-
[[Page 63604]]
conformity arises during real world testing, and provide an attestation
for compliance with certain certification criteria under the Program.
We consider these obligations as strictly administrative, and their
successful completion does not implicate developer behaviors that rise
to the level of oversight that would be necessary for initial ONC
review. Likewise, we consider the Maintenance of Certification
requirements in Sec. Sec. 170.402(b)(1)-(4) and 170.404(b)(1) and (2)
to also be administrative in nature. We believe the proposed addition
of Sec. 170.402(b)(1)-(4) in Sec. 170.523(p)(1)-(3) and Sec.
170.404(b)(1) and (2) in Sec. 170.523(q)(1) and (2) is suitable
considering the ONC-ACBs experience with confirming and verifying that
a developer has met the requirements in Sec. Sec. 170.405(b)(1) and
(2), 170.406, and 170.407.
We note that we do not propose to include in Sec. 170.523 the
oversight of a health IT developer's compliance with the requirements
in Sec. 170.401, Information Blocking, and Sec. 170.403(b),
Communications Maintenance of Certification requirements. Unlike the
requirements in Sec. 170.402(b)(1)-(4) and Sec. 170.404(b)(1) and
(2), which we consider administrative, the oversight and enforcement of
Information Blocking addresses practices that interfere with the
access, exchange or use of EHI, and the Communications Maintenance of
Certification requirements focuses on the update of agreements with
clients that could limit ongoing collaboration and coordination. These
Maintenance of Certification requirements compel developers to design,
implement, and maintain business practices that align with ONC
standards, facilitate data exchange, and actively engage in practices
that ensure that their products remain compliant. Centralizing the
oversight of these Maintenance of Certification requirements under ONC
removes the possibility of having these conflicts, ensuring a
standardized and consistent approach to enforcing these requirements.
While we consider the ONC-ACBs' Maintenance of Certification
responsibilities as administrative, we also believe transparency is
important regarding all Program requirements and propose to revise and
add new PoPC surveillance reporting requirements for ONC-ACBs in Sec.
170.523(i). As discussed, in Sec. 170.556(b) and (d) we propose to add
the Maintenance of Certification requirements proposed in Sec. 170.523
to the ONC-ACBs' surveillance responsibilities. We propose that this
responsibility would include initiating surveillance (Sec.
170.556(b)(2) and (3)), initiating CAP procedures (Sec.
170.556(d)(1)), initiating suspensions (Sec. 170.556(d)(5)) when a
developer fails to engage with the CAP process for Maintenance of
Certification non-conformities, and withdrawals (Sec. 170.556(d)(6))
when the health IT developer does not complete the actions necessary to
reinstate the suspended certification (we refer readers to section
III.D.2.c below for a discussion of these proposals). To better achieve
transparency of the proposed surveillance activities, we propose to
revise Sec. 170.523(i)(2)(iii) to require ONC-ACBs, when conducting
surveillance of certified health IT in accordance with their
accreditation, to include the Maintenance of Certification requirements
it surveilled in its quarterly surveillance results report.
We also propose to add a requirement in Sec. 170.523(i)(4) that an
ONC-ACB, as part of its responsibilities to conduct surveillance of
certified health IT in accordance with its accreditation, and proposed
requirements in Sec. 170.556, shall notify the National Coordinator
prior to initiating the suspension or withdrawal of a certification as
specified in Sec. 170.556 for a non-conformity pertaining to a
Maintenance of Certification requirement for which the ONC-ACBs have
responsibilities. We propose this revision because, as a common
practice, ONC-ACBs notify ONC before suspending a certification for a
certified Health IT Module when a developer fails to engage with the
CAP process pertaining to a certification requirement non-conformity,
and before withdrawing a certified Health IT Module when the health IT
developer has not completed the actions necessary to reinstate the
suspended certification. We propose to explicitly codify this practice
for enforcement activities pertaining to certain Maintenance of
Certification non-conformities.
To further our stated goals of increased transparency in the
Program and encourage developer compliance, we also propose to add a
new PoPC in Sec. 170.523(x) ``Reporting for non-compliance with
approved corrective action plans.'' We propose to require that ONC-ACBs
report to ONC, pursuant to our proposal in Sec. 170.556(d)(7)(ii),
(discussed in detail in section III.D.2.c.iv below), the developer's
failure to timely complete a CAP specific to a Maintenance of
Certification requirement for which an ONC-ACB has specific
responsibilities under Sec. 170.523. We propose to require the ONC-
ACBs to include all documentation pertaining to the identified non-
conformity, including but not limited to the following information: (1)
the Health IT Module and associated product(s); (2) the nature of the
non-conformity(ies); (3) the corrective action plan documentation; (4)
communications and records of proceedings; and (5) any additional
information requested by ONC.
We believe the proposed required documentation in Sec. 170.523(x)
is necessary and valuable to support the National Coordinator's review
of a health IT developer's actions or practices without requiring ONC
to engage in duplicative fact-finding processes for applicable cases of
non-conformities. The proposed documentation in Sec. 170.523(x) would
also inform the National Coordinator on whether the ONC-ACB met their
obligations to notify the developer of the non-conformity and initiate
corrective action procedures under Sec. Sec. 170.523 and 170.556.
Furthermore, requiring the proposed stated documentation would provide
clarity and consistency for developers of health IT and ONC-ACBs on our
expectations for the degree of accuracy and detail required for
documenting a non-conformity with a Maintenance of Certification
requirement for which an ONC-ACB has specific responsibilities under
Sec. 170.523. The documentation requirements would also help construct
an accurate record that could inform whether the National Coordinator
should exercise direct review under Sec. 170.580(a).
Lastly, in Sec. 170.523(i)(1), as part of an ONC-ACBs obligations
to conduct surveillance of certified health IT in accordance with its
accreditation and Sec. 170.556, ONC requires ONC-ACBs to submit an
annual surveillance plan to the National Coordinator. The ONC-ACBs
submit their annual plans in September with an effective date of
January 1 in the following year. As such, if we adopt the Maintenance
of Certification requirements proposals in Sec. Sec. 170.523 and
170.556, ONC-ACBs would need to include them as part of their annual
surveillance plans for January 1, 2026.
We welcome comments on these proposals.
c. Updates to Surveillance for Maintenance of Certification
Requirements
In the 2015 Edition Final Rule, we finalized that CAP requirements
applied across-the-board to all types of surveillance and confirmed
non-conformities (80 FR 62714). We reiterated that our goal for
surveillance requirements was to ensure that health IT users,
implementers, and purchasers
[[Page 63605]]
would be alerted to potential non-conformities in a timely and
effective manner, consistent with the patient safety, program
integrity, and transparency objectives described in the 2015 Edition
Proposed Rule (80 FR 62716 through 62717). We received support from
commenters to specify certain required elements and procedures for CAPs
(80 FR 62716). We also finalized reporting requirements for CAPs and
extended these requirements to all cases in which an ONC-ACB confirms a
non-conformity and subsequently approves a CAP (80 FR 62717).
We continued to build upon surveillance and CAP requirements by
adopting the ONC direct review regulatory framework in the EOA Final
Rule (81 FR 72468 through 72471), which permits the Program to provide
enhanced oversight for safety and health IT developer accountability.
The EOA Final Rule emphasized the importance of protecting public
health and safety while also strengthening transparency and
accountability in the Program. Following the EOA Final Rule, in the ONC
Cures Act Final Rule we addressed enforcement processes for new
requirements established in the Cures Act. Section 4002(a) of the Cures
Act adds (in section 3001(c)(5)(D) of the PHSA) Program requirements
aimed at addressing health IT developers' actions and business
practices through the Conditions and Maintenance of Certification
requirements, which expanded the focus of the Program requirements
beyond the certified health IT itself (85 FR 25648 through 25649).
Equally important, section 4002(a) of the Cures Act also provides (in
section 3001(c)(5)(E) of the PHSA) that the Secretary may encourage
compliance with the Conditions and Maintenance of Certification
requirements and take action to discourage noncompliance. In the ONC
Cures Act Final Rule, we, therefore, finalized an enforcement framework
for the Conditions and Maintenance of Certification requirements in
Sec. Sec. 170.580 and 170.581 to encourage consistent compliance with
the requirements. More specifically, we finalized processes in Sec.
170.580 for ONC to review potential or known instances where a
Condition or Maintenance of Certification requirement under the Program
has not been met or is not being met by a health IT developer. We also
finalized in Sec. Sec. 170.580 and 170.581 requirements to utilize the
processes previously established for ONC direct review of certified
health IT in the enforcement of the Conditions and Maintenance of
Certification requirements.
We noted that the new Conditions and Maintenance of Certification
requirements in section 4002 of the Cures Act focus on the actions and
business practices of health IT developers (e.g., information blocking
and appropriate access, use, and exchange of electronic health
information) as well as technical interoperability of health IT (e.g.,
APIs and real world testing) (85 FR 25782 through 25783). When we
originally distinguished between the Conditions and Maintenance of
Certification requirements that focus on actions and business practices
of health IT developers versus technical interoperability of health IT,
we did not further distinguish exclusively administrative functions
that are required of a health IT developer to meet certain Maintenance
of Certification requirements in part 170 subpart D. Rather, we
determined that ONC should be responsible for addressing non-
conformities pertaining to all Maintenance of Certification
requirements (85 FR 25782 through 25783). We also clarified that ONC-
ACBs are not responsible for enforcement of the Conditions and
Maintenance of Certification requirements, and that they must report
any information that could inform whether ONC should exercise direct
review of noncompliance with the Conditions and Maintenance of
Certification requirements to ONC. We noted that ONC-ACBs also address
non-conformities with technical and other Program requirements through
surveillance and by working with health IT developers through CAPs. We
stressed that, as finalized in the EOA Final Rule (81 FR 72427 through
72428) and per Sec. 170.580(a)(3)(v), ONC may refer the applicable
part of its review of certified health IT to the relevant ONC-ACB(s) if
ONC determines this would serve the effective administration or
oversight of the Program (85 FR 25785).
Since publication of the ONC Cures Act Final Rule, we now have
enforcement experience with Maintenance of Certification requirements
in 45 CFR 170 subpart D. More specifically, ONC conducted 13 direct
reviews in 2023, of which 10 were in connection to the non-conformity
to the API Maintenance of Certification requirement in Sec.
170.404(b)(3) for failure to comply with the rollout of Sec.
170.315(g)(10); two for failure to submit their real world testing
results leading to a non-conformance with Sec. 170.406(b)(2); and, one
for failure to submit their annual attestation related to Sec.
170.406(b). We have conducted multiple direct reviews of non-
conformities specific to developers of certified health IT missing a
document-submission or other deadline for Maintenance of Certification
requirements in 45 CFR 170 subpart D. During these direct reviews, we
have coordinated with the ONC-ACBs the corrective actions and
communications with the developers. Based on this enforcement
experience, we have found that some non-conformities specific to
certain Maintenance of Certification requirements may be better and
more quickly resolved without immediate ONC involvement in certain
cases and are better suited to initial oversight by the ONC-ACBs.
With this experience, we recognize that ONC-ACBs are equally well
suited to conduct surveillance and work with developers of certified
health IT through CAPs to remedy non-conformities beyond certification
requirements in certain circumstances. We no longer believe that
keeping enforcement for certain Maintenance of Certification
requirements exclusively within ONC oversight benefits the Program and
could, in fact, result in Program inefficiencies to the detriment of
the Program, users of certified health IT, and developers of certified
health IT. The inclusion of certain Maintenance of Certification
requirements within ONC-ACB oversight would increase transparency and
result in more expedient determinations of whether a non-conformity
exists, along with its resolution. In our experience, the collaboration
between ONC-ACBs, health IT developers of certified health IT, and
users in examining potential non-conformities, along with ONC-ACB's
oversight of specific Maintenance of Certification requirements,
facilitates quicker resolutions leading to more efficiency in the
Program. This efficiency stems from the ONC-ACBs' capacity to engage
and communicate with developers promptly as well as their extensive
expertise in surveilling certified Health IT Modules for continued
conformity to the requirements of their certifications.
i. Reactive Surveillance
We propose to revise the reactive surveillance requirements in
Sec. 170.556(b) to account for the specified Maintenance of
Certification requirements in subpart D for which an ONC-ACB would have
oversight pursuant to revisions to Sec. 170.523. We propose in Sec.
170.556(b) to require an ONC-ACB to initiate surveillance (including,
as necessary, in-the-field
[[Page 63606]]
surveillance required by paragraph (a) of this section) whenever it
becomes aware of facts or circumstances that would cause a reasonable
person in the ONC-ACB's position to question one or more of the
following: (1) a certified Health IT Module's continued conformity to
the requirements of its certification; (2) a developer's satisfaction
of the Maintenance of Certification requirements in Sec.
170.402(b)(1); and (3) an applicable developer's satisfaction of the
Maintenance of Certification requirements for which an ONC-ACB has a
responsibility under Sec. 170.523 to confirm compliance.
We propose the surveillance requirements for the Maintenance of
Certification requirements in Sec. 170.556(b)(2) and (3) as two
distinct elements because of the diverse obligations in 45 CFR part 170
subpart D that health IT developers must satisfy to remain in
compliance with the Program. To ensure health IT developer
accountability, and as discussed above, we have adopted the Maintenance
of Certification requirements in part 170 subpart D to express ongoing
requirements for health IT developers and their applicable Health IT
Module(s) certified to specific certification criteria. The Maintenance
of Certification requirements in 45 CFR part 170 subpart D do not
always apply to all health IT developers participating in the Program.
The Program is voluntary and health IT developers may certify their
Health IT Module(s) to one, some, or all the certification criteria
adopted by the Secretary, and they are not required to certify their
Health IT Module(s) to every certification criterion to participate in
the Program. Also as discussed in the previous section, we propose in
Sec. 170.523(p)(1) that ONC-ACBs confirm that health IT developers
retain all records and information necessary to demonstrate initial and
ongoing compliance with the requirements of the Program in accordance
with Sec. 170.402(b)(1). Our proposal in Sec. 170.523(p)(1) would
require ONC-ACBs to confirm that health IT developers are meeting the
requirements in Sec. 170.402(b)(1) and, in the proposed Sec.
170.523(i)(2)(iii), we would require the ONC-ACBs to conduct
surveillance of the Maintenance of Certification requirements and
include the results in its quarterly report to the National
Coordinator, in accordance with its accreditation and Sec. 170.556(a)
and (e)(1). To support the PoPC proposals in Sec. 170.523, our
proposal in Sec. 170.556(b)(2) would require an ONC-ACB to initiate
surveillance (including, as necessary, in-the-field surveillance)
whenever it becomes aware of facts or circumstances that would cause a
reasonable person in the ONC-ACB's position to question a developer's
satisfaction of the Maintenance of Certification requirements in Sec.
170.402(b)(1). The proposed requirements in Sec. 170.523(i)(2)(iii)
and in Sec. 170.523(p)(1), taken together with our proposal in Sec.
170.556(b)(2), would result in the ONC-ACB initiating and conducting
surveillance of a health IT developers' satisfaction of its obligations
in Sec. 170.402(b)(1).
Similar to our proposal in Sec. 170.523(p)(1), we propose in Sec.
170.523(p)(2) and (3), 170.523(q), (r), (s), and (w) to require the
ONC-ACBs to confirm health IT developers are meeting their obligations,
as applicable, under the Maintenance of Certification requirements in
Sec. Sec. 170.402(b)(2)-(4), 170.404(b)(1) and (2), 170.405(b)(1) and
(2), 170.406(b), and 170.407(b); and in Sec. 170.523(i)(2)(iii) to
conduct surveillance of the Maintenance of Certification requirements
listed in Sec. 170.523, in accordance with their accreditation and
Sec. 170.556(b)(3). To help meet these obligations, for the proposed
requirement in Sec. 170.556(b)(3), we propose to require an ONC-ACB to
initiate surveillance (including, as necessary, in-the-field
surveillance) when it becomes aware of facts or circumstances that
would cause a reasonable person in its position to question an
applicable developer's satisfaction of the Maintenance of Certification
requirements for which an ONC-ACB has a responsibility under Sec.
170.523 (that is, Sec. Sec. 170.402(b)(2)-(4), 170.404(b)(1) and (2),
170.405(b)(1) and (2), 170.406(b), and 170.407(b)).
Overall, the proposals in Sec. 170.556(b)(2) and (3) would mean
that as part of the requirement to confirm a health IT developer met
its obligation(s) in part 170 subpart D, an ONC-ACB must initiate
surveillance when it reasonably finds a health IT developer failed to
meet the Maintenance of Certification subpart D requirements for which
the ONC-ACB would have oversight of in Sec. 170.523. We propose to
distinguish between the proposed requirements in Sec. 170.556(b)(2)
and (3) because all health IT developers participating in the Program
are required to comply with requirements in Sec. 170.402(b)(1),
whereas only health IT developers with Health IT Modules certified to
those certification criteria listed in the requirements in Sec. Sec.
170.402(b)(2)-(4), 170.404(b)(1) and (2), 170.405(b)(1) and (2),
170.406(b), and 170.407(b) are required to comply with the applicable
Maintenance of Certification requirements. Given these considerations
and our proposal to expand ONC-ACB oversight of specific Maintenance of
Certification requirements listed in Sec. 170.523, we propose to
include requirements that ONC-ACBs must initiate surveillance of the
specified Maintenance of Certification requirements in Sec.
170.556(b)(2) and (3) reactive surveillance whenever it becomes aware
of facts or circumstances that would cause a reasonable person in the
ONC-ACB's position to question a developer's satisfaction of its
obligations under 45 CFR part 170 subpart D.
Additionally, we propose to revise Sec. 170.556(b)(1) by moving
the current verification requirements of Sec. 170.523(k) listed in
Sec. 170.556(b)(1) to be part of Sec. 170.556(b)'s overall language.
Our proposal would not change or modify the ONC-ACBs' current
responsibilities to initiate in-the-field-surveillance requirements in
Sec. 170.556(a) or the randomized surveillance considerations in Sec.
170.556(c).
We welcome comments on these proposals.
ii. Corrective Action Plan and Procedures
In the 2015 Edition Final Rule, we adopted requirements in Sec.
170.556(d)(1) that require an ONC-ACB to notify a developer when it
determines that a non-conformity exists and require the developer to
submit a proposed CAP for the applicable certification criterion,
certification criteria, or certification requirement (80 FR 62758). We
propose to revise the corrective action plan and procedures in Sec.
170.556(d)(1) to include the Maintenance of Certification requirements
specified in subpart D for which we propose an ONC-ACB would have
responsibilities for under Sec. 170.523 (discussed in the section
III.D.2.b above). We expect the ONC-ACB to initiate surveillance as
necessary to assess whether the developer has met the Condition and
Maintenance of Certification requirements obligations under subpart D
of part 170--for which we propose the ONC-ACB to have oversight
responsibilities--in the same manner as it initiates surveillance for
other Program requirements. We propose to require that an ONC-ACB
notify the developer of health IT, when an ONC-ACB determines, through
surveillance under Sec. 170.556 or otherwise, that the health IT
developer is out of compliance with the specified Maintenance of
Certification requirement and to require the developer submit a
proposed CAP for the applicable Maintenance of Certification
requirement.
[[Page 63607]]
In addition to the corrective action procedures adopted in the 2015
Edition Final Rule, ONC also specified certain baseline required
elements for CAPs in Sec. 170.556(d)(3) (80 FR 62758 through 62759).
Specifically, we finalized in Sec. 170.556(d)(3)(i)-(vi) six minimum
required elements that an ONC-ACB must verify are included in the CAP
submitted by the developer of health IT. We now propose to revise Sec.
170.556(d)(3), which requires the ONC-ACB to verify the elements of the
CAP, to account for the proposed addition of certain Maintenance of
Certification requirements that we propose an ONC-ACB must include in
its surveillance activities.
We do not find all existing CAP requirements equally necessary for
non-conformities that involve the proposed new responsibilities for
ONC-ACBs to initiate corrective procedures for specified subpart D
Maintenance of Certification requirements, we also propose to specify
different minimum required CAP elements based on the type of non-
conformity the plan addresses. We believe that establishing certain
minimum expectations and procedures for initiating CAP procedures for
specified subpart D Maintenance of Certification requirements would
provide ONC-ACBs, as well as health IT developers and users, with
greater clarity and predictability regarding this aspect of the
Program. Furthermore, ONC-ACBs have unique experience working directly
with developers to remedy identified non-conformities to the
requirements of certification codified in subparts A, B, C, and E, as
well as verifying and confirming a developer has met its obligations
with the Maintenance of Certification requirements for real world
testing and attestations. This experience translates well to having
ONC-ACBs conduct surveillance for certain Maintenance of Certification
requirements for which we propose the ONC-ACBs have specific
responsibilities. We note that our expectations regarding an ONC-ACBs'
surveillance responsibilities specific to the oversight and enforcement
requirements of certification would not change with the addition of
certain Maintenance of Certification requirements under our revisions
and additions proposed in Sec. 170.556(b) reactive surveillance and
(d) corrective action plan and procedures.
To better differentiate the requirements for each CAP, in Sec.
170.556(d)(3)(i), we propose to list the minimum required elements for
all CAPs pertaining to all non-conformities. In Sec.
170.556(d)(3)(ii), we propose to list the minimum required elements for
non-conformities with respect to any Program requirement codified in
subparts A, B, C, or E of part 170. In Sec. 170.556(d)(3)(iii), we
propose to list the minimum required elements for non-conformities with
respect to any Program requirement codified in subpart D of this part
for which the ONC-ACBs would have responsibility under Sec. 170.523.
We discuss each proposed list of elements in detail in the following
paragraphs.
We are retaining in Sec. 170.556(d)(3) the currently required
elements for identified non-conformities with respect to any Program
requirements codified in subparts A, B, C, or E with proposed
restructuring of the paragraph levels and minor proposed modifications.
For the currently codified CAP elements, we propose to move the
requirements in Sec. 170.556(d)(3)(i), (v), and (vi) to Sec.
170.556(d)(3)(i)(A), (B), and (C), respectively. We also propose to
shift the currently codified CAP elements in Sec. 170.556(d)(3)(ii),
(iii), and (iv) to Sec. 170.556(d)(3)(ii)(A), (B), and (C),
respectively. The proposed revised elements are substantially the same
elements currently codified in Sec. 170.556(d)(3)(i)-(vi), and we do
not propose revisions to the regulatory text in the newly shifted Sec.
170.556(d)(3)(i)(A), (B), and (C) or Sec. 170.556(d)(3)(ii)(A). For
these elements, we only propose to revise the level of paragraphs.
To account for the proposed shifting of elements and the addition
of the Maintenance of Certification to the ONC-ACBs' oversight
responsibilities, we propose to revise paragraph (d)(3)(i) to specify
that for each identified non-conformity with respect to any Program
requirement, the ONC-ACB must verify that the associated CAP includes
the following, at a minimum: a description of the identified non-
conformities (Sec. 170.556(d)(3)(i)(A)); the timeframe under which
corrective action will be completed (Sec. 170.556(d)(3)(i)(B)); and,
an attestation by the developer that it has completed all elements of
the approved CAP (Sec. 170.556(d)(3)(i)(C)). The proposed required
elements would apply to proposed CAPs that aim to remedy identified
non-conformities for a certified Health IT Module that does not conform
to the applicable requirements of its certification and/or when the
health IT developer is out of compliance with Maintenance of
Certification requirements specified in subpart D of this part for
which the ONC-ACB has specific responsibilities under Sec. 170.523. We
propose to require the minimum required elements in Sec.
170.556(d)(3)(i)(A), (B), and (C) because we believe that certain
elements should serve as the baseline of information for any type of
non-conformity the CAP addresses.
We also believe certain minimum required elements should still
apply regarding non-conformities with respect to any Program
requirement codified in subparts A, B, C, or E of part 170. To account
for our restructuring of the current minimum six elements in Sec.
170.556(d)(3), in Sec. 170.556(d)(3)(ii), we propose to shift and
revise the other three remaining minimum required elements in
paragraphs (d)(3)(ii), (iii), and (iv) as Sec. 170.556(d)(3)(ii)(A),
(B), and (C). For a Health IT Module that does not conform to the
certification requirements codified in subparts A, B, C, or E of part
170, we propose in Sec. 170.556(d)(3)(ii) that for each CAP submitted
by the developer, the ONC-ACB shall verify the CAP includes the
required elements specified in proposed Sec. 170.556(d)(3)(ii)(A)
through (C), in addition to the proposed required elements identified
in Sec. 170.556(d)(3)(i)(A), (B) and (C). We note that these proposed
three minimum required elements are the same three minimum required
elements that are codified in Sec. 170.556(d)(3)(ii)-(iv), with
proposed minor modifications. We propose to distinguish the elements in
this way to account for the proposed elements identified in Sec.
170.556(d)(3)(iii)(A) and (B) that we would not require for CAPs
pertaining to non-compliance with the certification requirements
codified in subparts A, B, C, and E of part 170.
The proposed elements listed in Sec. 170.556(d)(3)(ii)(A) through
(C) are substantially the same elements currently codified in Sec.
170.556(d)(3)(ii) through (iv), with proposed minor modifications. For
clarity, we propose to revise the proposed CAP element identified in
Sec. 170.556(d)(3)(ii)(B) (currently designated in Sec.
170.556(d)(3)(iii)). We clarify that this required element for CAPs
does not mean that on-site surveillance at a deployed site is the only
means through which an ONC-ACB could identify a technical non-
conformity. Thus, we propose in Sec. 170.556(d)(3)(ii)(B) that the
ONC-ACBs may identify a technical non-conformity at any location where
surveillance procedures have been conducted resulting in an identified
non-conformity, and for all other potentially affected customers and
users.
We also propose a minor revision in Sec. 170.556(d)(3)(ii)(C)
(currently codified in Sec. 170.556(d)(3)(iv)) to improve the
readability of the required element. We note that in Sec.
170.556(d)(3)(ii)(C), part of
[[Page 63608]]
the CAP required element addresses how the developer will ensure that
all affected, and potentially affected customers and users are alerted
to the identified non-conformities, including a detailed description of
how the developer will assess the scope and impact of the problem and
identify all potentially affected customers. We clarify our expectation
with this requirement is two pronged. Satisfying the element would
include (1) how the health IT developer identifies the potentially
affected customers and (2) identifying who is the actual affected
customer(s) by including a detailed description of how the health IT
developer will promptly ensure that all potentially affected customers
are notified of the non-conformity and plan for resolution. During the
CAP process, an ONC-ACB instructs the developer to submit a proposed
CAP, or a revised proposed CAP, to remedy the non-conformity. The ONC-
ACB also verifies the attestation by the developer that it has
completed all elements of the approved CAP (Sec. 170.556(d)(3)(i)(C)).
We believe requiring developers to identify affected customers during
the CAP approval process as part of the element in Sec.
170.556(d)(3)(ii)(C) is helpful for several reasons, most notably that
it aligns with the requirements in our enforcement mechanisms in Sec.
170.580. It would also be useful information when we need to verify
communications with a customer(s), as well as aid with Federal agency
coordination by identifying the names and the number of affected
customers who participate in other HHS programs. We welcome comment on
our expectations and whether we should consider codifying this element
as two separate requirements.
Recognizing the diversity of non-conformities, we propose, in Sec.
170.556(d)(3)(iii), different required minimum elements for CAPs
submitted for addressing non-compliance with Maintenance of
Certification requirements specified in subpart D. We propose to
require that an ONC-ACB verify that the proposed minimum required
elements in Sec. 170.556(d)(3)(i)(A), (B), and (C) are included in a
CAP pertaining to Maintenance of Certification requirements.
Additionally, to better address the variations in types of non-
conformities to Program requirements, we propose in Sec.
170.556(d)(3)(iii)(A) and (B) to implement specific required elements
for each identified non-conformity with respect to any Program
requirement codified in subpart D of this part for which the ONC-ACB
has responsibilities under Sec. 170.523 of this part (we refer readers
to section III.D.2.b for a list of these proposed responsibilities in
Sec. 170.523). Thus, for all Maintenance of Certification requirement
non-conformities, an ONC-ACB must verify that a CAP includes the
proposed elements identified in Sec. 170.556(d)(3)(iii)(A) and (B), in
addition to the three minimum required elements identified in Sec.
170.556(d)(3)(i)(A), (B), and (C).
The proposed required elements identified in Sec.
170.556(d)(3)(iii)(A) and (B) would require ONC-ACBs to confirm how the
developer will address and resolve identified non-conformities with
Maintenance of Certification requirements for which the ONC-ACBs have
responsibilities under proposed Sec. 170.523. We propose to set forth
different elements in Sec. 170.556(d)(3)(iii)(A) and (B) for CAPs
addressing non-conformities with certain Maintenance of Certification
requirements because of the administrative nature of these requirements
compared to, for example, the certification requirements of subparts A,
B, C. The elements in Sec. 170.556(d)(3)(iii)(A) and (B) enhance the
process for developers to regain compliance with the Maintenance of
Certification requirements in several ways. The proposal in Sec.
170.556(d)(3)(iii)(A) would require a developer to outline the actions
needed to address non-conformities related to Maintenance of
Certification requirements, providing clarity in addressing the non-
conformity; while the requirement in Sec. 170.556(d)(3)(iii)(B)
underscores the importance of ensuring comprehensive resolution for all
identified non-conformities specific to the Maintenance of
Certification requirements. These elements will aid developers in
crafting CAPs tailored to the distinct challenges posed by Maintenance
of Certification requirements, contributing to a clearer regulatory
framework. By specifying actions related to Maintenance of
Certification requirements, the elements offer explicit requirements,
reduce ambiguity, and align requirements with the regulatory intent of
maintaining industry-wide compliance and quality standards. This
specificity supports ONC-ACBs' effective oversight, allowing them to
assess the adequacy and thoroughness of CAPs and ensuring ongoing
compliance with certification requirements. We welcome comments on
these proposals.
iii. Additional Optional Elements
The proposed minimum CAP elements in Sec. 170.556(d)(3)(i)--(iii)
should be seen as a starting point and represent a minimum, and not a
limit, on the elements that may be required by the ONC-ACBs. In other
words, with the proposed changes to CAP minimum element specifications,
an ONC-ACB may require that a developer include additional elements in
any given CAP beyond those that would be the minimum required under
Sec. 170.556(d)(3), as proposed. This flexibility is consistent with
prior surveillance requirements, and we would continue to give ONC-ACBs
substantial flexibility and discretion to decide how to implement these
requirements as part of their overall approach to surveillance (80 FR
16880). Such flexibility is important for minimizing the burden of
surveillance on all interested parties, while ensuring that an ONC-ACB
can approach surveillance in a way that effectively encourages and
supports developers' successful correction of non-conformities with
Program requirements. Accordingly, we also propose to revise Sec.
170.556(d) by adding Sec. 170.556(d)(3)(iv) to allow an ONC-ACB to
require that the CAP include elements beyond those specified in
proposed Sec. 170.556(d) as the minimum.
Table 1C below includes the proposed revised elements described in
this rule that an ONC-ACB would be required to verify in a CAP.
[[Page 63609]]
[GRAPHIC] [TIFF OMITTED] TP05AU24.002
To aid readers, we offer the following scenario to illustrate the
required elements in a CAP that an ONC-ACB must verify based on the
specific Program requirements implicated by each identified non-
conformity. We note that this scenario is merely illustrative, and the
outcomes provided in this scenario are hypothetical. The outcome of
this scenario should not be construed as legal precedent for similarly
situated fact patterns.
Scenario
The ONC-ACB receives signals indicating a potential non-conformity,
sourced from user complaints, adverse event reports, or routine
surveillance activities. Upon detecting possible certification criteria
non-conformities within the certified Health IT Module of a developer,
the ONC-ACB initiates surveillance to address the Sec. 170.315(b)
requirements. During this surveillance, the ONC-ACB receives
information indicating the developer may have failed to submit a real
world testing plan that demonstrates compliance to the full scope of
the applicable certification criteria and functions requirements,
including Sec. 170.315(b). A certified Health IT Module that fails to
successfully demonstrate full compliance of certification capabilities
is treated as any other observation of a failure to meet specific
Program requirements. As a result, the ONC-ACB also initiates a second
surveillance, this time to address the Sec. 170.405(b)(1) real world
testing plan.
Once the surveillance activities substantiate non-conformity(ies),
the ONC-ACB notifies the developer of its findings and requires the
developer to produce a proposed CAP addressing the identified issues,
such as interoperability challenges, ineffective decision support,
delayed updates, and outdated documentation.
Because the ONC-ACB has identified a non-conformity pertaining to
Maintenance of Certification requirements in Sec. 170.405(b), the ONC-
ACB must verify the CAP includes the proposed required elements
identified in Sec. 170.556(d)(3)(i)(A), (B), (C), and Sec.
170.556(d)(3)(iii)(A) and (B). The CAP outlines a step-by-step approach
and timeline for the developer to address the non-conformities. The
ONC-ACB would require, under the proposed elements in Sec.
170.556(d)(3), that the CAP address the non-conformity with Sec.
170.315(b) and include the required elements in Sec.
170.556(d)(3)(i)(A) through (C); and Sec. 170.556(d)(3)(ii)(A) through
(C) as it pertains to a non-conformity for subparts A, B, C, or E of
this part. The ONC-ACB may also require the developer to include
elements in the CAP beyond those specified in proposed Sec. 170.556(d)
as the minimum required elements, according to the proposed addition of
Sec. 170.556(d)(3)(iv).
With the ONC-ACBs guidance, the developer is able to provide an
acceptable proposed CAP to the ONC-ACB addressing the two identified
non-conformities, who verifies all the required elements to ensure
effective resolution of the identified non-conformities and approves
them. The CAP provides a roadmap for the developer to rectify real
world testing Maintenance of Certification non-conformities, enhance
interoperability, optimize decision support features, ensure timely
updates, and update documentation and training materials.
The ONC-ACB continues its monitoring of the certified Health IT
Module, including implementation of the CAP and progress towards
resolution of the non-conformities. Follow-up assessments may be
scheduled to confirm sustained compliance, aligning with the ONC-ACB's
commitment to continuous improvement in the EHR system's reliability
and adherence to certification criteria. The ONC-ACB ensures successful
resolution of identified non-conformities and confirms that the Health
IT Module now complies with all applicable certification criteria and
Maintenance of Certification requirements for real world testing.
iv. Suspension, Withdrawals, and Notification Procedures
In some circumstances, despite an ONC-ACB's effort to engage and
encourage the developer, a developer's non-conformity with Maintenance
of Certification or other Program requirements may not be successfully
addressed. Under existing regulations, ONC-ACBs shall initiate
suspension procedures for a Health IT Module for the following reasons:
a developer does not submit a proposed CAP in the
[[Page 63610]]
allotted time (Sec. 170.556(d)(5)(i)); a developer does not submit a
revised proposed CAP within the allotted time resulting in the ONC-ACB
being unable to approve a CAP (Sec. 170.556(d)(5)(ii)); and, if the
developer does not complete the corrective actions specified in the
approved CAP (Sec. 170.556(d)(5)(iii)). We propose to revise Sec.
170.556(d)(5) to require that an ONC-ACB to initiate suspension
procedures where a developer fails to propose a CAP, fails to propose
an acceptable CAP, or fails to successfully complete an approved CAP
for identified non-conformities with respect to those Maintenance of
Certification requirements for which an ONC-ACB would have PoPC and
surveillance responsibilities. This proposal would be a parallel
complement to the existing requirement for an ONC-ACB to initiate
suspension procedures for analogous failures of corrective action
procedures to successfully resolve non-conformities of a Health IT
Module to the requirements of its certification.
We note that under current requirements in Sec. 170.556(d)(6),
which we do not propose to substantively revise in this proposed rule,
if a certified Health IT Module's certification has been suspended,
then an ONC-ACB is permitted to initiate certification withdrawal
procedures for the Health IT Module (consistent with its accreditation
to ISO/IEC 17065 and procedures for withdrawing a certification) when
the health IT developer has not completed the actions necessary to
reinstate the suspended certification. Therefore, if an ONC-ACB
initiates suspension procedures in accordance with proposed Sec.
170.556(d)(5) with respect to an identified non-conformity for a
Program requirement codified in subpart D for which the ONC-ACB has
responsibilities under Sec. 170.523, it may initiate certification
withdrawal procedures in accordance with Sec. 170.556(d)(6).
While the Maintenance of Certification requirements pertain to
developer behaviors, we consider the specific Maintenance of
Certification requirements that an ONC-ACB would have for PoPC and
surveillance responsibilities to be entirely administrative in nature.
The ONC-ACBs would not make a determination to suspend or withdraw
certification based on developer behavior, such as non-compliance with
information blocking requirements as specified in Sec. 170.401.
Instead, the ONC-ACB would carry out its obligations specified in Sec.
170.556(d)(5) and (6) in response to a developer's failure to meet the
CAP related to administrative and routine activities such as submitting
a real world testing plan on time. Furthermore, ONC-ACBs and developers
have experience with initiating suspensions and withdrawals for
developers who fail to engage in the CAP process pertaining to
certification non-conformities, and we anticipate that the ONC-ACBs
could transition to applying Sec. 170.556(d)(5) and (6) procedures to
the proposed CAP procedures for Maintenance of Certification non-
conformities without much additional effort. Developers too are also
familiar with the process so we expect engaging in the suspension and
withdrawal processes for Maintenance of Certification non-conformities
would not place much additional burden on them.
We note that delegating suspensions and withdrawal responsibilities
to ONC-ACBs for Maintenance of Certification non-conformities would not
mean the National Coordinator does not have authority to review ONC-ACB
action(s). As discussed in detail in the section III.D.2.b, we propose
to revise the PoPCs to add a requirement in Sec. 170.523(iii)(4) that
ONC-ACBs must notify the National Coordinator prior to initiating a
suspension or withdrawal as specified in Sec. 170.556 for a non-
conformity pertaining to a Maintenance of Certification requirement for
which the ONC-ACBs have responsibilities. We also note in Sec.
170.580(a)(3)(ii) that ONC may assert exclusive review of certified
health IT as to any matters under review by ONC, and any similar
matters under surveillance by an ONC-ACB.
While we believe that ONC-ACBs are well suited to conducting
surveillance and coordinating with developers of certified health IT to
resolve certain Maintenance of Certification requirement non-
conformities, we also acknowledge that there may be instances when a
developer fails to timely submit an acceptable proposed CAP or complete
an approved CAP, despite an ONC-ACBs efforts to gather and verify this
information. In these instances, we believe it is necessary for an ONC-
ACB to notify the National Coordinator that a developer failed to
submit or complete a CAP addressing these specific Maintenance of
Certification non-conformities so that the National Coordinator may
review the information and proceed accordingly. Therefore, we propose
to add, as paragraph (d)(7) of Sec. 170.556, new requirements for an
ONC-ACB to report specific information to ONC when a developer fails to
timely submit or complete an approved CAP. This proposal would apply to
an identified non-conformity with respect to any Program requirement
codified in subpart D for which the ONC-ACB has responsibilities under
Sec. 170.523.
Under the proposal in Sec. 170.556(d)(7), we would require an ONC-
ACB to notify the National Coordinator when the ONC-ACB's requirement
to initiate suspension procedures is triggered by the developer's
failure to engage (successfully or failure to engage at all, as
applicable) with the CAP process for a non-conformity to a Maintenance
of Certification requirement. Specifically, we propose in Sec.
170.556(d)(7)(i) that an ONC-ACB must immediately notify the National
Coordinator if one or more of the following occurs: 1) the developer
has not submitted a proposed CAP; 2) the ONC-ACB cannot approve a CAP
because the developer has not submitted a revised proposed CAP; or 3)
the developer has not completed the corrective actions specified by an
approved CAP within the time specified therein. We propose this
requirement to strengthen transparency within the Program as well as
encourage developer compliance with the Program. Additionally, this
information would inform the National Coordinator whether the ONC-ACB
met its obligations to notify the developer of the surveillance
activity, if there was an identified non-conformity, and how to
remediate the non-conformity, including guidance on the required
elements in the CAP, as well as the developer's response and level of
engagement with the CAP process.
To further accomplish our goal of increased transparency and
encouraging developer compliance, we propose in Sec. 170.556(d)(7)(ii)
that an ONC-ACB must report certain information to ONC when a developer
fails to submit a proposed CAP that can be approved, or complete an
approved CAP with respect to any Program requirement codified in
subpart D for which an ONC-ACB has responsibilities under Sec.
170.523. We propose to add the requirement that an ONC-ACBs shall
report the information specified in Sec. 170.523(x) (discussed in
section III.D.2.b above) to the National Coordinator pursuant to the
requirements specified in Sec. 170.556(d)(7)(i), and we propose to add
the requirement in Sec. 170.556(d)(7)(ii)(A) that an ONC-ACBs must
notify the developer immediately when an ONC-ACB begins the
notification procedures in Sec. 170.556(d)(7)(i).
Lastly, we propose to revise 45 CFR 170.556 to correct regulatory
text errors. First, we propose to revise Sec. 170.556(d)(6) by
removing the ``or''
[[Page 63611]]
within the description of ``Withdrawal'' because this was a
typographical error. We also propose to revise Sec. 170.556(e)(3) by
removing the reference to Sec. 170.523(f)(2)(xi). In the ONC Cures Act
Final Rule, Sec. 170.523(f)(2) was removed and reserved. Therefore, we
propose to remove this reference from Sec. 170.556(e)(3) to correct
this technical error.
We welcome comment on these proposals.
3. Updates to Principles of Proper Conduct for API Discovery Details
In the ONC HTI-1 Final Rule, we finalized requirements in Sec.
170.404(b)(2) for Certified API Developers to publish certain service
base URLs and related organization details in a standardized
FHIR[supreg] format (89 FR 1287). This included a requirement, in Sec.
170.404(b)(2)(iii)(B), that Certified API Developers review this
information quarterly and update it as necessary.
We propose a conforming policy, applicable to ONC-ACBs beginning
January 1, 2027, to support the regular reporting of API discovery
details including service base URLs and related organization details
according to our proposed requirements in Sec. 170.404(b)(2) and (3)
(see elsewhere in this preamble at III.B.2, III.B.3, III.B.15, and
III.B.20.d our proposals for revising Sec. 170.404(b)(2)).
Specifically, we propose to add a new paragraph in Sec. 170.523(m)(6)
to require ONC-ACBs to obtain a record of all updates to API discovery
details for Sec. 170.404(b)(2) and (3) on a quarterly basis each
calendar year. This would ensure that ONC is aware of the latest API
Discovery Details published on a quarterly basis by Certified API
Developers meeting the requirements in Sec. 170.404(b)(2) and (3) and
would support ONC in hosting a link to developers' API discovery
details on the Certified Health IT Product List (CHPL) or another
website hosted by ONC. Our proposed requirement for Sec. 170.523(m)(6)
is consistent with similar existing requirements for adaptations and
updates in Sec. 170.523(m), which require ONC-ACBs to obtain records
on a quarterly basis. Further, this same requirement is already in
place for a related certification criterion, Sec. 170.315(d)(13),
which requires health IT developers to publish information and has a
corresponding requirement for ONC-ACBs to obtain a record on a
quarterly basis in Sec. 170.523(m)(3).
4. New ONC-ACB Principle of Proper Conduct for Notice of Program
Withdrawal
To date, we have handled the infrequent occurrence of an ONC-ACB
withdrawing from the Program by working collaboratively with that
departing ONC-ACB and the other remaining ONC-ACBs to enable an orderly
transition of certifications administered by the departing ONC-ACBs.
However, as the Program has matured and the scope of an ONC-ACB's
responsibilities has increased (including proposals in this proposed
rule), a requirement for an ONC-ACB to provide notice to the National
Coordinator when it intends to withdraw from the Program would further
support an orderly transition. Accordingly, we propose in Sec.
170.523(y) a new Principle of Proper Conduct for ONC-ACBs requiring an
ONC-ACB to give the National Coordinator sufficient notice of its
intent to withdraw its authorization under the Program. We believe that
notice provided 180 days (day is defined in Sec. 170.102 as a calendar
day or calendar days) prior to the ONC-ACB's withdraw from the Program
would be sufficient time for ONC to work with the ONC-ACB to ensure the
ONC-ACB's planned withdrawal does not interrupt Program operations and
activities, put its clients at risk of losing their certification(s)
under the Program, and/or impact end users' ability to meet their
business needs and requirements for participation in other Federal and/
or state programs that require the use of certified health IT.
When an ONC-ACB withdraws its authorization from the Program, ONC
must work with that ONC-ACB to ensure the ONC-ACB's clients are able to
transition to another ONC-ACB and maintain their certified status. For
an ONC-ACB to onboard a new client and issue a new certificate based on
the evidence supporting a certificate previously issued by another ONC-
ACB, it must possess the evidence that supports the prior ONC-ACB's
decision. The transition requires the transfer of test records and
other documented evidence supporting the certification. Consistent with
Sec. 170.523(g)(1), ONC-ACBs are required to retain all records
related to the certificates they issue, and per Sec. 170.523(g)(2)
make such records available to HHS upon request during the specified
retention period. Therefore, to maintain the integrity of the
certifications impacted by the ONC-ACB withdrawal, ONC will request
records (per Sec. 170.523(g)(2)) from the withdrawing ONC-ACB. These
records will provide evidence of conformity with certification
requirements to support the remaining ONC-ACBs that take on the
withdrawing ONC-ACB's clients. These steps are important because, once
an ONC-ACB withdraws from the Program, ONC no longer has authority over
the actions of that organization. Furthermore, the influx of incoming
business for the ONC-ACBs accepting requests from the withdrawing ONC-
ACB's clients must be managed along with their existing workload.
Specifically, we propose to add two paragraphs in Sec. 170.523(y).
In Sec. 170.523(y)(1), we propose to require the withdrawing ONC-ACB
to provide ONC with notice of its intent to withdraw from the Program
180 days before its actual withdrawal. In Sec. 170.523(y)(2), we
propose to require the withdrawing ONC-ACB to submit all of its
certification records to ONC pursuant to the retention requirements it
followed in Sec. 170.523(g). We believe the combination of these two
proposals will give all parties involved (i.e., ONC, the withdrawing
ONC-ACB, and remaining ONC-ACBs) sufficient time to manage transition
activities with minimal interruption to Program activities.
5. Updates to ONC Direct Review Procedures
In the EOA Final Rule, we created a regulatory framework for ONC's
``direct review'' of health IT certified under the Program, including,
when necessary, requiring the correction of non-conformities found in
health IT certified under the Program, and suspending and terminating
certifications issued to such health IT (81 FR 72404). The EOA Final
Rule established bases on which ONC would initiate direct review, and
procedures for ONC to follow in the event ONC's direct review of
certified health IT substantiated a non-conformity. Under the framework
established in the EOA Final Rule, inquiry into certified health IT's
conformance with Program requirements may be conducted by ONC or a
third party on ONC's behalf, and the term ``direct review'' is used to
distinguish inquiries and enforcement actions taken under the 45 CFR
170.580 framework from ONC-ACBs' assessments and reviews as part of the
ONC-ACB's surveillance and other responsibilities under the Program (85
FR 25738).
In the ONC Cures Act Final Rule (85 FR 25642), we finalized use of
substantially the same processes established in the EOA Final Rule (81
FR 72404) for the enforcement of the
[[Page 63612]]
Conditions and Maintenance of Certification requirements for four
stated reasons (85 FR 25783). First, these processes were designed to
address non-conformities with Program requirements. Conditions and
Maintenance of Certification requirements have been adopted as Program
requirements and, as such, any noncompliance with the Conditions and
Maintenance of Certification requirements constitutes a Program non-
conformity. Second, health IT developers were already familiar with the
ONC direct review framework that had been put in place by the EOA Final
Rule. Third, 45 CFR 170.580 provides thorough and transparent processes
for identifying, notifying, and addressing non-conformities in the
Program through coordination with health IT developers to craft a CAP
that will remedy Program non-conformities. Fourth, the updated direct
review framework provides equitable opportunities for health IT
developers to respond to ONC actions and appeal certain ONC
determinations. We confirmed in the ONC Cures Act Final Rule that we
would continue to use the term ``direct review'' to describe activities
of ONC (or a third party on ONC's behalf) under the 45 CFR 170.580
framework and to differentiate them from ONC-ACBs' reviews of certified
health IT under their surveillance responsibilities outlined in 45 CFR
170.556 (85 FR 25783).
In this proposed rule, we propose to revise parts of the ONC direct
review regulatory framework in 45 CFR 170.580, including:
45 CFR 170.580(b) and (c) requirements for timeliness and
content of health IT developers' CAPs in response to a notice that ONC
has confirmed a non-conformity with Program requirements (discussed
below in section III.D.3.a);
45 CFR 170.580(d) and (f) provisions for suspension and
termination of certification for failure of certified health IT
products or a Program-participating health IT developer to meet Program
requirements (discussed below in section III.D.5.b); and
45 CFR 170.580(g) opportunity and procedures for heath IT
developer appeals of ONC enforcement actions under Sec. 170.580(d) or
(f) and Sec. 170.581 (discussed below in section III.D.5.b of this
proposed rule).
a. Health IT Developers' Response to Notices of Non-conformity and
Corrective Action Plan Requirements
We propose to revise regulatory provisions specific to the timing
and content of health IT developers' responses to notices of non-
conformity, as well as the mandatory minimum content of developers'
CAPs, to improve efficiency for both ONC and developers under direct
review.
We propose to revise paragraph Sec. 170.580(b)(2)(ii)(A)(3) to
require that, where multiple responses are provided pursuant to this
paragraph, information provided in earlier responses be labeled as
previously submitted. The intent of this proposed revision is to
increase efficiency for ONC by making it clear that repeated submission
of the same information in response to the same Notice of Non-
Conformity should generally be avoided.
We propose to leave in place the flexibility that health IT
developers currently have to re-submit the same information in multiple
communications in response to any particular Notice of Non-Conformity.
Because the information that a developer may need to provide in
response to a Notice of Non-Conformity can include detailed technical
or business practices data, we propose to balance this developer
flexibility with a requirement that if a developer does elect to
resubmit the same data or information, that it must label such data or
information as having been previously submitted in response to the same
Notice of Non-Conformity. The labeling of any resubmitted materials
would promote efficiency by enabling ONC reviewers to immediately focus
on updates, addenda, or refreshed discussion of the resubmitted data.
As discussed in section III.D.2.c above, we now have some
experience evaluating non-conformities associated with developers
failing to comply with administrative Maintenance of Certification
requirements in 45 CFR 170 subpart D. We have learned from this
experience that some of the mandatory minimum elements that Sec.
170.580(c)(2) currently requires for all CAPs are not equally valuable
with respect to all non-conformities. For example, an assessment and
description of the nature, severity, and extent of the non-conformity
(the element specified in Sec. 170.580(c)(2)(i)) would likely be
necessary where the ONC-substantiated non-conformity is that a
certified Health IT Module is causing or contributing to a serious risk
to public health or safety. The Sec. 170.580(c)(2)(i) element would
also likely be necessary in cases where a certified Health IT Module is
found to be non-conforming by virtue of failing to satisfy the
requirements of all 45 CFR 170 subpart C certification criteria to
which it is certified. By contrast, the Sec. 170.580(c)(2)(i) element
is not likely to be necessary in many instances where the non-
conformity is a failure to meet an administrative requirement under
subpart D, such as to timely submit real world testing documentation
pursuant to Sec. 170.405(b), or to submit required attestations
pursuant to Sec. 170.406. Timely submission of attestations is a pass/
fail, readily observed non-conformity for which inclusion of the Sec.
170.580(c)(2)(i) element would not provide helpful or additional
information. Similarly, where the resolution of the non-conformity
amounts to submitting the overdue attestations or real world testing
documentation, the successful resolution is self-documenting, so a
detailed description of supporting documentation a developer would
provide to demonstrate the identified non-conformity is resolved (as
specified in Sec. 170.580(c)(2)(vi), emphasis added) generally would
not be necessary or add value to the direct review process.
We propose to revise paragraph (c)(2) of Sec. 170.580 to establish
flexibility for ONC to identify, for any particular non-conformity, the
subset of the elements listed in subparagraphs (i) through (viii)
relevant to demonstrating the resolution to each non-conformity. We
propose the National Coordinator may explicitly waive any of the subset
of elements listed in subparagraphs (i) through (viii). ONC would
continue to provide direction to the health IT developer as to the
required elements of the CAP for each identified non-conformity.
b. Suspension, Termination, and Appeals
We propose modifications to our suspension, termination, and
appeals regulations for several reasons. Some proposed revisions would
simply ensure clarity as to who makes, and where ultimate
accountability lies with respect to, certain decisions. Other proposed
revisions would update procedures to reflect other Program changes
proposed elsewhere in this rule or update regulatory text to remove
now-obsolete terminology.
Suspension, Termination, and Appeals Decisions
We propose to clarify in our regulatory text that our procedures
for decisions to terminate the certification of Health IT Modules or
issue certification bans under Sec. 170.581 are made by the National
Coordinator, whom the Secretary appoints to head ONC pursuant to 42.
U.S.C. 300jj-11. We also propose to revise Sec. 170.580 and Sec.
170.581 to explicitly provide for the Secretary to have an opportunity
to exercise direct oversight of these
[[Page 63613]]
determinations as well as for hearing officer determinations under 45
CFR 170.580(g). Specifically, we propose to revise paragraphs (d), (f),
and (g) of Sec. 170.580 (and to revise Sec. 170.581, as discussed in
section III.D below).
We propose to modify Sec. 170.580(d) and Sec. 170.580(f) to
reflect that the National Coordinator makes determinations to suspend
or terminate a certification, and to cancel a suspension or to rescind
a termination determination. But, to ensure that it is clear,
notwithstanding the decision of the National Coordinator, that the
Secretary, a principal officer of the United States, retains ultimate
responsibility for such decision-making, we propose that the Secretary
may, at the Secretary's discretion, review a determination of the
National Coordinator. The Secretary may direct the National Coordinator
to cancel a suspension (paragraph (d)(6)(ii)) or review a termination
determination made by the National Coordinator before such suspension
or the termination would become effective (paragraph (f)(5)). We
propose in Sec. 170.580(f)(5) that, should the Secretary direct the
National Coordinator to rescind a termination, ONC may resume (Sec.
170.580(f)(5)(i)) or end (Sec. 170.580(f)(5)(ii)) all or part of its
review of certified health IT or a health IT developer's actions or
practices under this section unless the Secretary specifically directs
otherwise.
Updates to Align with Other Proposals in This Proposed Rule
We propose to modify paragraph (f) of Sec. 170.580 to align with
proposed added responsibilities of ONC-ACBs for confirming and
encouraging compliance with certain Maintenance of Certification
requirements codified in subpart D of 45 CFR part 170 (discussed in
section III.D.2 of this proposed rule, above). Specifically, we propose
in Sec. 170.580(f)(1)(iv) to provide for the National Coordinator to
terminate a certification based on ONC review of the information and
documentation reported by the ONC-ACB pursuant to the principles of
proper conduct (PoPC) proposed in paragraph (x) of Sec. 170.523
(discussed in section III.D.2.b) that the developer did not fulfill its
obligation under a CAP. This would explicitly establish that the
National Coordinator may make a termination determination without ONC
being required to engage in duplicative fact-finding in applicable non-
conformity cases. Applicable cases would be those where the information
and documentation provided in the ONC-ACB's Sec. 170.523(x) report is,
in the National Coordinator's view, sufficient to substantiate that a
developer has failed to resolve a Program non-conformity related to a
Maintenance of Certification requirement within the required timeframe
of the CAP verified and approved by the ONC-ACB. The National
Coordinator's consideration of the record submitted by the ONC-ACB
pursuant to Sec. 170.523(x) would include assessing whether the ONC-
ACB had met its obligations to notify the developer of the non-
conformity and initiate corrective action procedures under Sec. Sec.
170.523 and 170.556.
We also propose revisions to Sec. 170.580(a)(3)(iii), (a)(3)(v),
and (a)(4)(ii) to clarify that the: (1) National Coordinator's
determination on matters under ONC direct review is controlling and
supersedes any determination by an ONC-ACB; (2) National Coordinator
may end all or any part of ONC's review of certified health IT or a
health IT developer's actions at any time; and (3) National Coordinator
may rely on HHS Office of Inspector General (OIG) findings to form the
basis of a direct review action. We also propose revisions to Sec.
170.580(b)(2)(ii)(B) and Sec. 170.580(b)(2)(iii) clarifying that the
National Coordinator may adjust the 30-day timeline under Sec.
170.580(b)(2)(ii)(A)(3) and that the National Coordinator makes a
determination under Sec. 170.580(b)(2)(iii) after receiving the health
IT developer's written explanation and supporting documentation. We
propose to revise Sec. 170.580(c)(1) clarifying that if the National
Coordinator determines that certified health IT or a health IT
developer's action or practice does not conform to requirements of the
Program, ONC will notify the health IT developer of its determination
and require the health IT developer to submit a proposed CAP. In Sec.
170.580(c)(2), we propose that the CAP shall include such required
elements that the National Coordinator determines necessary. The CAP
shall include, for each specific non-conformity, all the elements in
Sec. 170.580(c)(2) except when the elements are explicitly waived by
the National Coordinator. We also propose to update Sec. 170.580(c)(7)
to provide that a CAP may be reinstituted by ONC if the National
Coordinator later determines that a health IT developer has not yet
fulfilled all its obligations under the CAP.
We also propose revisions to Sec. 170.580(e)(1), (e)(1)(vii),
(e)(2), and (e)(4) clarifying the actions that the National Coordinator
can take with a proposed termination and updating the existing language
to clarify that certain decisions are made by the National Coordinator,
with ultimate accountability for the National Coordinator's decisions
vested in the Secretary as discussed above. More specifically, we
propose that: (1) excluding situations of noncompliance with a
Condition or Maintenance of Certification requirement under subpart D
of this part, the National Coordinator may propose to terminate a
certification issued to a Health IT Module when a health IT developer
fails to respond timely to a communication from ONC, fails to provide
sufficient access or information to ONC, or the National Coordinator
concludes that a certified health IT's non-conformity(ies) cannot be
cured (Sec. 170.580(e)(1) and (e)(1)(vii)); (2) ONC will notify the
health IT developer of the proposed termination through a notice of
proposed termination when the National Coordinator decides to propose
to terminate a certification (Sec. 170.580(e)(2)); and, (3) upon
receipt of the health IT 'developer's written response to a notice of
proposed termination, the National Coordinator has up to 30 days to
make a determination based on ONC's review of the information submitted
by the health IT developer and the National Coordinator may extend this
timeframe if the complexity of the case requires additional time for
ONC review (Sec. 170.580(4)).
c. Appeals
The ONC direct review regulatory framework established in the EOA
Final Rule (81 FR 72404) included (in Sec. 170.580(g)) procedural
provisions for developers to appeal certification termination
determinations made by the National Coordinator under Sec. 170.580(f)
as well as Program bans issued under Sec. 170.581. In the ONC Cures
Act Final Rule, we established that we would use the processes
previously put in place for ONC direct review of certified health IT in
the enforcement of the Conditions and Maintenance of Certification
requirements. In doing so, we finalized modifications to Sec.
170.580(g) provisions to address the inclusion of Condition and
Maintenance of Certification requirements under Sec. 170.580(f) and
Sec. 170.581 (85 FR 25649 and 25787).
We propose to rename Sec. 170.580(g)(5) to ``Assignment of a
hearing officer'' and clarify the text to explain that the National
Coordinator will arrange for assignment of the case to a hearing
officer to adjudicate the appeal on the National Coordinator's behalf,
and add subparagraph (iii) that the hearing officer must be an officer
properly appointed by the Secretary of Health and Human Services.
[[Page 63614]]
We propose to explicitly provide in Sec. 170.580(g)(7)(ii) for the
Secretary, at the Secretary's discretion, to review and revise or
rescind hearing officer decisions before these decisions become the
final decision of HHS. This proposed change would ensure the regulatory
text is explicit that the Secretary, as a principal officer of the
United States, holds appropriate oversight and accountability for the
hearing officer's decisions.
We welcome comments on these proposals.
6. Certification Ban
We propose to update paragraphs (a) and (b) of the certification
ban provisions in Sec. 170.581 to explicitly provide for the Secretary
to review, at the Secretary's discretion, the National Coordinator's
determination to impose a ban before the ban becomes effective. We
further propose updates to Sec. 170.581(a)(2) and (d)(4) to indicate
that the National Coordinator as a duly appointed officer of the United
States, rather than ONC as an organization, would make any
determination to impose a certification ban on a developer. These
proposed revisions are similar to those we discussed above for
suspension and termination.
We propose to update the wording of Sec. 170.581(a)(1)(i) to
replace a reference to termination of a Health IT Module ``under the
ONC Health IT Certification Program'' to cross-reference the paragraph
within Sec. 170.580 specific to termination of a certification in the
context of ONC direct review. We believe the specific cross-reference
would make it easier for developers, ONC-ACBs, and other interested
parties to read and understand Sec. 170.581(a)(1)(i).
In parallel to our proposed addition of PoPCs and surveillance
responsibilities for ONC-ACBs specific to certain Maintenance of
Certification requirements in subpart D of 45 CFR part 170 (both in
Sec. 170.523), we propose to explicitly establish in Sec.
170.581(a)(2) that the National Coordinator would have the option of
determining a certification ban is appropriate based on the information
and documentation provided in an ONC-ACB's Sec. 170.523(x) report. We
believe this is important to ensure that the National Coordinator can
take prompt action, without duplicative data gathering or fact finding,
where the information and record submitted by the ONC-ACB indicates to
the National Coordinator that a program ban is appropriate.
We welcome comment on these proposals.
7. Updates Pursuant to 2014 Edition Removal
We propose to remove the ``Complete EHR'' and ``EHR Module'' terms
from certain sections within subpart E of 45 CFR 170. By the time we
would finalize any proposal in this proposed rule, the terms would no
longer be relevant, as described below, due to the amount of time that
will have elapsed since the June 30, 2020, effective date of the ONC
Cures Act Final Rule's removal of the 2014 Edition from subparts A, B,
and C of part 170. We believe removing obsolete terms as the Program
evolves over time maintains clarity of the regulatory text and Program
provisions, particularly for regulated entities and interested parties.
a. Removal of ``Complete EHR'' References
The ONC Cures Act Final Rule removed the 2014 Edition certification
criteria in Sec. 170.314 from the Program regulations in 45 CFR part
170 (85 FR 25656). The rule also finalized our proposals (84 FR 7434
through 7435) to remove terms and definitions specific to the 2014
Edition from Sec. 170.102, including the ``2014 Edition Base EHR,''
``2014 Edition EHR certification criteria,'' and ``Complete EHR, 2014
Edition'' definitions. As explained in the 2015 Edition Final Rule (80
FR 62719), the ``Complete EHR'' concept was discontinued for the 2015
Edition. In conjunction with the removal of the 2014 Edition, we also
removed references to ``Complete EHR'' from Sec. 170.545 and removed
the standards and implementation specifications found in Sec. Sec.
170.200, 170.202, 170.204, 170.205, 170.207, 170.210, and 170.299 that
were referenced only in the 2014 Edition certification criteria (85 FR
25656). In the HTI-1 Final Rule, we removed the ``Complete EHR''
language from all reference points in Sec. Sec. 170.523 and 170.524
(89 FR 1209 through 1210).
Although we removed terms, standards, and certification criteria
that were applicable only to the 2014 Edition in the ONC Cures Act
Final Rule, we have retained until now reference to ``Complete EHRs''
in certain provisions within subpart E of 45 CFR part 170:
The definition of ``gap certification'' (Sec. 170.502);
Authorization scope for ONC-ATL status (Sec. 170.511);
Requirements for ONC-ACBs to refund fees to developers
seeking certification under certain circumstances (Sec.
170.523(j)(3)); and
Applicability of a newer version of a minimum standard
(Sec. 170.555(b)(2)).
Retaining reference to ``Complete EHRs'' in these part 170 subpart
E requirements has supported continuity following the removal of the
2014 Edition's standards and certification criteria from 45 CFR part
170. For example, in the update of ONC-ACB record retention
requirements in Sec. Sec. 170.523 and 170.524 to align with the
transition of the Program's structure and terminology away from annual
themed ``editions,'' the ``Complete EHR'' concept remained relevant to
these provisions at that time because the 2014 Edition was not removed
from the CFR until the ONC Cures Act Final Rule (85 FR 25655). The ONC
Cures Act Final Rule became effective on June 30, 2020, and records for
the 2014 Edition were required to be retained (including Complete EHRs)
until June 30, 2023, under 45 CFR 170.523(g)(1).
Beginning with the 2015 Edition, Complete EHR certifications could
no longer be issued and December 31, 2023, has passed. Thus, we now
propose to remove references to ``Complete EHRs'' from Sec. Sec.
170.502,170.511, 170.523(j)(3), and 170.555(b)(2) as of the effective
date of a subsequent final rule for this rulemaking.
b. Removal of ``EHR Modules'' References
In the 2011 ``Establishment of the Permanent Certification Program
for Health Information Technology'' Final Rule (76 FR 1261), we used
the Complete EHR and EHR Module terms and phrasing ``Complete EHRs and/
or EHR Modules.'' In the rule, we stated our initial focus would be on
EHR technology and supporting the EHR Incentive Programs, which at the
time, focused on the ambulatory and inpatient settings (76 FR 1294).
As we explained in the 2015 Edition Final Rule (80 FR 62601), we
changed the name of the ONC HIT Certification Program to the ``ONC
Health IT Certification Program'' (Program). We also modified the
Program in ways that make it more accessible to other types of health
IT beyond EHR technology, and for health IT that supports care and
practice settings beyond the ambulatory and inpatient settings (80 FR
62604). These modifications also served to support other public and
private programs that may reference the use of health IT certified
under the Program (80 FR 62604).
Consistent with the three-year records retention requirement for
ONC-ACBs (45 CFR 170.523(g)(1), June 30, 2023, marked the end of a
three-year minimum retention period (36 calendar months) since we
finalized, in the ONC Cures Act Final Rule, the removal of the 2014
Edition from 45 CFR subparts A,
[[Page 63615]]
B, and C (85 FR 25656). Similarly, December 31, 2023, marked the end of
the third calendar year following the calendar year in which the ONC
Cures Act Final Rule became effective. Because we have now passed both
rules' three-year retention requirements for ONC-ACBs and the term
``EHR Module'' is no longer relevant, we propose to remove from Sec.
170.523(f) reference to ``EHR Modules.''
8. Definition of Serious Risk to Public Health or Safety
We propose to revise 45 CFR 170.102 to include a definition of
serious risk to public health or safety. The purpose of this proposed
definition is to enhance understanding among developers and users of
certified health IT of the types of conditions, events, or phenomena
that would constitute egregiously dangerous non-conformities with
Program requirements. Such events could be caused or contributed to by
health IT certified as a Health IT Module or as part of a certified
Health IT Module even if the certified Health IT Module(s) continued to
pass lab testing procedures, in-the-field surveillance testing, or both
with respect to the technical standards and certification criteria
adopted in subparts B and C of part 170. Within the proposed regulation
text for this proposed definition of serious risk to public health or
safety, we have included fact patterns in (1) through (6) that would
always meet the definition of serious risk to public health or safety.
For purposes of these examples, a ``user'' of a certified Health IT
Module would be any human being or any software application, process,
or service that is authorized, intended, and enabled to create, read,
update, or delete (CRUD) or to command the certified Health IT Module
to execute specific CRUD functions on specific data entries. We request
public comment on this definition, including but not limited to the
illustrative examples.
We would continue to expect, as we reiterated in the EOA Final
Rule, that ONC direct review on the bases of risk to public safety or
where ONC-ACBs may be unable to respond effectively would occur
relatively infrequently (cf., e.g., 81 FR 72404 at 72415 or 74216). As
we explained in the EOA Final Rule, we do not believe every risk to
public health or safety necessitates ONC's direct review. We also
recognize the need to prioritize ONC's limited resources by focusing on
the kinds of problems and other issues that, if not addressed through
ONC's direct review, are most likely to lead to harm to patients or the
public and undermine confidence in health IT and the integrity of the
Program (81 FR 72419). This proposed definition would not change this
need to prioritize ONC's resources.
9. Removal of Time-Limited Criteria
In the ONC Cures Act Final Rule, we finalized Sec. 170.550(m)
``time-limited certification and certification status for certain 2015
Edition certification criteria'' which provided that for five specific
certification criteria, an ONC-ACB may only issue a certification to a
Health IT Module and permit continued certified status for a specified
time period (85 FR 25952). The five criteria with time-limited
certification and certification status are found in Sec.
170.315(a)(10), (a)(13), (b)(6), (e)(2), and (g)(8). Because the
specified time periods for certification to these criteria have
elapsed, we propose to remove all of the certification criteria
referenced in Sec. 170.550(m) in one action by removing and reserving
Sec. 170.550(m) in its entirety. We also propose to remove and reserve
these aforementioned certification criteria from the specific CFR
locations in which they are adopted. In the ONC Cures Act Final Rule,
we also finalized revisions in Sec. 170.315(b)(7)(ii) and (b)(8)(i)(B)
to allow security tagging of Consolidated-Clinical Document
Architecture (C-CDA) documents at the document level only for the
period until 24 months after publication date of the final rule (85 FR
25667). Because that time period has elapsed, we propose to revise
Sec. 170.315(b)(7) and (8) to remove Sec. 170.315(b)(7)(ii) and
(b)(8)(i)(B). We describe our detailed proposals below.
The requirements finalized in the ONC Cures Act Final Rule in Sec.
170.550(m)(1) permit ONC-ACBs to issue certificates for the ``drug-
formulary and preferred drug list checks'' certification criterion in
Sec. 170.315(a)(10) up until January 1, 2022 (85 FR 25661). We stated
in the ONC Cures Act Final Rule that we believed the functionality in
Sec. 170.315(a)(10) was ubiquitous due to widespread adoption of
health IT certified to the 2014 Edition and that we did not believe it
was necessary to continue to require certification to it under the
Program in order to ensure it remains widely available (85 FR 25661).
We also stated that because the certification criterion did not require
use of standards or directly drive interoperability, we did not believe
its continued inclusion in the Program would provide sufficient value
to providers or patients to justify the burden on developers and
providers (85 FR 25661). We propose to remove and reserve Sec.
170.315(a)(10).
In the ONC Cures Act Final Rule, we finalized requirements in Sec.
170.550(m)(1) permitting ONC-ACBs to issue certificates for the
``patient-specific education resources'' certification criterion in
Sec. 170.315(a)(13) up until January 1, 2022 (85 FR 25661). We stated
that we believed that health IT's capabilities to identify appropriate
patient education materials was widespread among health IT developers
and their customers, and noted innovation had occurred for these
capabilities, including the use of automation and algorithms to provide
appropriate education materials to patients in a timely manner (85 FR
25661). We also stated that we believed this certification criterion
was no longer the best way to encourage innovation and advancement in
the capabilities of health IT to support clinician-patient interactions
and relationships (85 FR 25661). We propose to remove and reserve Sec.
170.315(a)(13).
The requirements finalized in the ONC Cures Act Final Rule in Sec.
170.550(m)(1) permitted ONC-ACBs to issue certificates for the ``secure
messaging'' certification criterion in Sec. 170.315(e)(2) up until
January 1, 2022 (85 FR 25662). In the ONC Cures Act Final Rule, while
we did not finalize removal of the requirements in Sec. 170.315(e)(2),
we stated that we no longer believed that a separate certification
criterion focused on a health IT's capabilities to send and receive
secure messages between health care providers and patients was
necessary and that the certification criterion would also no longer be
associated with an objective or measure under the CMS PI Programs (85
FR 25662). We propose to remove and reserve Sec. 170.315(e)(2).
In the ONC Cures Act Final Rule, we finalized requirements in Sec.
170.550(m)(2) permitting ONC-ACBs to issue certificates for the ``data
export'' certification criterion in Sec. 170.315(b)(6) up until May 1,
2023 (85 FR 25662). This date was later extended to December 31, 2023,
in the Information Blocking and the ONC Health IT Certification
Program: Extension of Compliance Dates and Timeframes in Response to
the COVID-19 Public Health Emergency Interim Final Rule (85 FR 70070).
We noted in the ONC Cures Act Final Rule that Sec. 170.315(b)(6) was
replaced by the ``EHI export'' certification criterion in Sec.
170.315(b)(10) and removed from the 2015 Edition Base EHR definition in
Sec. 170.102, and that this would encourage movement toward the
interoperability opportunities afforded by new criteria
[[Page 63616]]
(85 FR 25699). We propose to remove and reserve Sec. 170.315(b)(6).
The requirements finalized in the ONC Cures Act Final Rule in Sec.
170.550(m)(2) permit ONC-ACBs to issue certificates for the
certification criterion in Sec. 170.315(g)(8) ``application access--
data category request'' up until May 2, 2022 (85 FR 25666). This date
was later extended to December 31, 2022, in the Information Blocking
and the ONC Health IT Certification Program: Extension of Compliance
Dates and Timeframes in Response to the COVID-19 Public Health
Emergency Interim Final Rule (85 FR 70070). We noted in the ONC Cures
Act Final Rule that we had adopted a new API certification criterion in
Sec. 170.315(g)(10) to replace the certification criterion in Sec.
170.315(g)(8) and added the new certification criterion to the updated
2015 Edition Base EHR definition (85 FR 25645). We propose to remove
and reserve Sec. 170.315(g)(8).
In the ONC Cures Act Final Rule, we finalized revisions in Sec.
170.315(b)(7)(ii) and (b)(8)(i)(B) to allow certification of health IT
to demonstrate security tagging of Consolidated-Clinical Document
Architecture (C-CDA) documents at the document level only for the
period until 24 months after publication date of the final rule (85 FR
25707). This date was later extended to December 31, 2022, in the
Information Blocking and the ONC Health IT Certification Program:
Extension of Compliance Dates and Timeframes in Response to the COVID-
19 Public Health Emergency Interim Final Rule (85 FR 70070). We noted
in the ONC Cures Act Final Rule that only requiring tagging C-CDA
documents at the document level did not permit providers the
flexibility to address more complex use cases for representing patient
privacy preferences (85 FR 25645). We now propose to revise Sec.
170.315(b)(7) and (b)(8) to remove Sec. 170.315(b)(7)(ii) and
(b)(8)(i)(B).
10. Privacy and Security Framework Incorporation of DSI Criterion
In the ONC HTI-1 Final Rule, we established a revised certification
criterion (``decision support interventions'' (Sec. 170.315(b)(11)) to
replace the ``clinical decision support'' certification criterion
(Sec. 170.315(a)(9)) effective January 1, 2025 (89 FR 1196 through
1197). When finalizing the ``decision support interventions''
certification criterion, we did so by adopting a substantially similar
structure to the structure of the ``clinical decision support''
certification criterion. However, we neither proposed nor finalized
corresponding privacy and security certification requirements for
Health IT Modules certifying to the ``decision support interventions''
certification criterion. This omission was an oversight. We now propose
to add the ``decision support interventions'' certification criterion
(Sec. 170.315(b)(11)) to the list of certification criteria in Sec.
170.550(h)(3)(ii). This proposal would ensure that the same privacy and
security certification requirements that apply to the ``clinical
decision support'' certification criterion (Sec. 170.315(a)(9)) also
apply to Health IT Modules certified to the ``decision support
interventions'' certification criterion.
To provide developers of certified health IT time to comply with
these proposed requirements, we specifically propose to require, in
Sec. 170.550(h)(3)(ii), that Health IT Modules certified to the
``decision support interventions'' (Sec. 170.315(b)(11)) must also be
certified to the specific privacy and security certification criteria
on and after January 1, 2028. These specific privacy and security
certification criteria are: ``authentication, access control, and
authorization'' in Sec. 170.315(d)(1); ``auditable events and tamper-
resistance'' in Sec. 170.315(d)(2); ``audit report(s)'' in Sec.
170.315(d)(3); ``automatic access time-out'' in Sec. 170.315(d)(5);
``end-user device encryption'' in Sec. 170.315(d)(7); ``encrypt
authentication credentials'' in Sec. 170.315(d)(12); and ``multi-
factor authentication'' in Sec. 170.315(d)(13).
We note that should we finalize our proposed revisions to ``encrypt
authentication credentials'' in Sec. 170.315(d)(12) (as discussed in
section III.B.12) and finalize our proposal to revise Sec.
170.550(h)(3)(ii) as described above, those revised requirements would
apply to Health IT Modules certified to the ``decision support
interventions'' certification criterion (Sec. 170.315(b)(11)).
However, we further note that should we finalize our proposed revisions
to the ``multi-factor authentication'' certification criterion in Sec.
170.315(d)(13) as described in section III.B.17, and should we finalize
our proposal to revise Sec. 170.550(h)(3)(ii) as described above,
Health IT Modules certified to the ``decision support interventions''
certification criterion would not be required to support the new multi-
factor authentication requirements, due to the timing included in our
proposed updates in Sec. 170.550(h)(3)(ii), unless those Health IT
Modules are also certified to Sec. 170.315(b)(3), Sec. 170.315(e)(1),
Sec. 170.315(g)(10), or Sec. 170.315(g)(30) and required to meet the
multi-factor authentication requirements in those certification
criteria in Sec. 170.315(b)(3)(ii)(G), Sec. 170.315(e)(1)(iii), Sec.
170.315(g)(10)(ii)(A)(1)(iii), or Sec. 170.315(g)(30)(ii)(c)
respectively.
E. Correction--Privacy and Security Certification Framework
We propose to make a correction to the Privacy and Security
Certification Framework in Sec. 170.550(h). We revised Sec.
170.550(h) in the ONC Cures Act Final Rule but intended for Sec.
170.550(h)(4) to remain unchanged. However, when we drafted the
amendatory instructions, we erroneously included the instruction to
revise all of paragraph (h) (85 FR 25952). Therefore, when the Code of
Federal Regulations (CFR) was updated, Sec. 170.550(h)(4) was removed.
We now propose to add back to the CFR 170.550(h)(4) [45 CFR
170.550(h)(4) (Jan. 1, 2020)] as it existed prior to the ONC Cures Act
Final Rule. The language in Sec. 170.550(h) to be added to paragraph
(4) is, ``Methods to demonstrate compliance with each privacy and
security criterion. One of the following methods must be used to meet
each applicable privacy and security certification criterion listed in
paragraph (h)(3) of this section: (i) Directly, by demonstrating a
technical capability to satisfy the applicable certification criterion
or certification criteria; or (ii) Demonstrate, through system
documentation sufficiently detailed to enable integration, that the
Health IT Module has implemented service interfaces for each applicable
privacy and security certification criterion that enable the Health IT
Module to access external services necessary to meet the privacy and
security certification criterion.
IV. Information Blocking Enhancements
A. Defined Terms
1. Health Care Provider
Health care provider, as defined in 45 CFR 171.102 for purposes of
the information blocking regulations, has the same meaning as `health
care provider' in 42 U.S.C. 300jj. As finalized in the ONC Cures Act
Final Rule (85 FR 25642), this definition cites to the entirety of 42
U.S.C. 300jj (section 3000 of the Public Health Service Act (PHSA)). We
now propose to provide additional regulatory clarity for the ``health
care provider'' definition and for certain types of health care
providers referenced by the ``health care provider'' definition. We
propose to revise Sec. 171.102 to explicitly reference the ``health
care provider'' definition in 42 U.S.C. 300jj(3) and the definitions of
[[Page 63617]]
``laboratory'' in 42 U.S.C. 300jj(10) and ``pharmacist'' in 42 U.S.C.
300jj(12).
In the ONC Cures Act Final Rule (85 FR 25794), we adopted a
definition of ``health care provider'' citing 42 U.S.C. 300jj,
indicating we had noted in the ONC Cures Act Proposed Rule (84 FR 7510)
that the PHSA section 3000(3) definition is different from the
definition of ``health care provider'' in 45 CFR 160.103 for purposes
of the HIPAA Privacy and Security Rules. We now propose to revise the
definition of ``health care provider'' in Sec. 171.102 to explicitly
cite 42 U.S.C. 300jj(3).
In addition, we propose to explicitly incorporate the PHSA section
3000 definitions of ``laboratory'' and ``pharmacist.'' The ``health
care provider'' definition in paragraph (3) of PHSA section 3000 (cited
in the regulatory text as 42 U.S.C. 300jj(3)) references these types of
health care providers without further definition. While our
interpretation of these types of health care providers has always
relied on the 42 U.S.C. 300jj(10) and (12) definitions of
``laboratory'' and ``pharmacist,'' we now propose to formally
incorporate these definitions into the health care provider definition
codified in Sec. 171.102. Specifically, we propose to add to the Sec.
171.102 definition of ``health care provider'' subparagraphs designated
as (1) and (2) and citing, respectively, paragraphs (10) and (12) of 42
U.S.C. 300jj. In 42 U.S.C. 300jj(10), ``laboratory'' has the meaning
given such term in 42 U.S.C. 263a(a) (PHSA section 353(a)). In 42
U.S.C. 300jj(12), ``pharmacist'' has the meaning given such term in 21
U.S.C 384(a)(2). For ease of reference, we provide in the following
paragraphs of this preamble the laboratory and pharmacist definitions
cross-referenced by 42 U.S.C. 300jj(10) and (12).
As stated in 42 U.S.C. 263a(a): ``laboratory'' or ``clinical
laboratory'' means ``a facility for the biological, microbiological,
serological, chemical, immuno-hematological, hematological,
biophysical, cytological, pathological, or other examination of
materials derived from the human body for the purpose of providing
information for the diagnosis, prevention, or treatment of any disease
or impairment of, or the assessment of the health of, human beings.''
In addition to having been cited by 42 U.S.C. 300jj since the HITECH
Act added Title XXX to the PHSA in 2009, this definition of
``laboratory'' or ``clinical laboratory'' has stood since the Clinical
Laboratory Improvement Amendments of 1988 amended section 353 of the
PHSA (42 U.S.C. 263a(a)) to include this definition.\227\
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\227\ See section 2 of the Clinical Laboratory Improvement
Amendments of 1988 (Pub. L. 100-578,102 Stat. 2903). See also 42
U.S.C. 263a(a) authority citations (available online at https://uscode.house.gov/view.xhtml?req=granuleid:U.S.C.-prelim-title42-section263a&num=0&edition=prelim).
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As stated in 21 U.S.C. 384(a)(2), the term ``pharmacist'' means ``a
person licensed by a State to practice pharmacy, including the
dispensing and selling of prescription drugs.'' While the text of 42
U.S.C. 300jj(12) cites ``the meaning given such term in section 384(2)
of title 21'' the only definition of ``pharmacist'' appearing in 21
U.S.C. 384 is found in paragraph (a)(2).\228\
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\228\ Note 3 to 42 U.S.C. 300jj as it appears in the U.S. Code
as maintained by the Office of law Revision Counsel of the U.S.
House of Representatives reads: So in original. Probably should be
``(a)(2)''. (Available online at: https://uscode.house.gov/view.xhtml?req=granuleid%3AUSC-prelim-title42-chapter6A-subchapter28&saved=%7CZ3JhbnVsZWlkOlVTQy1wcmVsaW0tdGl0bGU0Mi1zZWN0aW9uMzAwamotNTI%3D%7C%7C%7C0%7Cfalse%7Cprelim&edition=prelim#300jj_3_target.)
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We welcome comment on this proposal.
2. Health Information Technology or Health IT
We propose to codify in Sec. 171.102 that, for purposes of the
information blocking regulations in 45 CFR part 171, both ``health
information technology'' and its shorter form, ``health IT,'' have the
same meaning as ``health information technology'' in 42 U.S.C.
300jj(5). The health information technology definition was added to the
Public Health Service Act (PHSA) (section 3000(5)) by the HITECH Act
(see Title XIII, Subtitle A, section 13101 of the American Recovery and
Reinvestment Act of 2009, Pub. L. 111-5). The PHSA defines health
information technology as ``hardware, software, integrated technologies
or related licenses, intellectual property, upgrades, or packaged
solutions sold as services that are designed for or support the use by
health care entities or patients for the electronic creation,
maintenance, access, or exchange of health information.''
Because the 21st Century Cures Act added the information blocking
statute to Title XXX of the PHSA as section 3022 (42 U.S.C. 300jj-52),
we believe the most applicable definition of the term ``health
information technology'' in the context of PHSA section 3022 and our
regulations in 45 CFR part 171 is the definition found at 42 U.S.C.
300jj(5). We believe that codifying this interpretation will increase
certainty for actors \229\ and other interested parties that when we
refer to ``health information technology'' or ``health IT'' in 45 CFR
part 171, we mean the 42 U.S.C. 300jj(5) definition unless otherwise
specified in or for a specific subpart or section.
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\229\ Throughout Section IV of this proposed rule, we use
``actor'' as it is defined in Sec. 171.102. (We do not propose in
this rule to revise that codified definition.)
---------------------------------------------------------------------------
We leveraged the definition of ``health information technology''
from Title XXX of the PHSA (specifically, section 3000(5) of the PHSA)
in finalizing the definition of ``interoperability element'' in Sec.
171.102, but we did not use it in its entirety and did not explicitly
cite it, in the ``interoperability element'' definition (85 FR 25956,
see also preamble discussion at 85 FR 25807). This proposal to adopt a
definition for ``health information technology'' in Sec. 171.102 would
not change the definition of ``interoperability element'' in Sec.
171.102. Our definitions of ``health IT developer of certified health
IT'' and ``offer health IT'' as they are currently codified in Sec.
171.102 explicitly reference the definition of ``health information
technology'' in 42 U.S.C. 300jj(5). Thus, this proposal would not
change the meaning of either of those definitions.
We welcome comments on this proposal.
3. ``Interfere With'' or ``Interference''
The 21st Century Cures Act defined information blocking in part as
a practice that ``is likely to interfere with, prevent, or materially
discourage access, exchange, or use of electronic health information''
(42 U.S.C. 300jj-52(a)(1)). In the definitions section of the
information blocking regulations (Sec. 171.102), we define interfere
with or interference to mean ``to prevent, materially discourage, or
otherwise inhibit.'' We propose to add a new section (45 CFR 171.104)
to codify certain practices that constitute ``interference'' and
``interfere with'' (as defined in Sec. 171.102) for purposes of the
information blocking definition in Sec. 171.103. Although these
practices constitute an interference, we note that the list is not
exhaustive and other practices not described in this proposed new
section will also constitute an interference for purposes of the
information blocking definition.
We emphasize that these proposed provisions are practices that
constitute an interference. We do not attempt to establish facts and
circumstances in this proposed rule that would specify practices that
are information blocking
[[Page 63618]]
as the term is defined in Sec. 171.103. For a practice to be
information blocking, all elements of the definition must be met. This
means that the individual or entity that engages in the practice must
be an actor under the information blocking regulations; that the
practice must be likely to interfere with the access, exchange, or use
of EHI; and that the actor engaging in the practice meets the requisite
knowledge standard. Further, ``information blocking'' does not include
practices required by law or that meet an exception.
In the ONC Cures Act Proposed Rule (84 FR 7424), we noted that the
information blocking provision and its enforcement subsection in the
21st Century Cures Act do not define the terms ``interfere with,''
``prevent,'' and ``materially discourage.'' Based on our interpretation
of the information blocking provision, as discussed in the Cures Act
Proposed Rule, we proposed to define ``interfere with'' and
``interference'' as preventing, materially discouraging or otherwise
inhibiting access, exchange, or use of electronic health information
(84 FR 7516, 7601). We finalized the definition in the ONC Cures Act
Final Rule as proposed, but with a modification to remove the phrase
``access, exchange, or use of electronic health information'' as
unnecessary and duplicative of the information blocking definition (85
FR 25642, 25809; see also 45 CFR 171.102). The preamble discussion of
the definition of ``interfere with'' or ``interference'' in the ONC
Cures Act Final Rule provides guidance explaining the meaning of these
terms.
In the ONC Cures Act Proposed Rule, to further clarify the scope of
the information blocking provision, we provided several examples of
practices that would constitute interference. We refer readers to the
ONC Cures Act Proposed Rule (84 FR 7518 through 7521) for discussion of
those examples, which we also cited in the ONC Cures Act Final Rule (85
FR 25811). We refer readers to the ONC Cures Act Final Rule (85 FR
25811 through 25818) for additional examples of practices likely to
interfere with access, exchange, or use of electronic health
information (EHI) and additional discussion, including responses to
public comments received on the ONC Cures Act Proposed Rule.
Since publication of the ONC Cures Act Final Rule (May 1, 2020), we
have provided additional guidance in the form of information blocking
Frequently Asked Questions (FAQs). As of the time of publication of
this proposed rule, we have posted 12 FAQs in the ``Interference''
category. Links to all categories of FAQs within the information
blocking topic are available under the ``Resources'' heading of this
page of ONC's website: https://www.healthit.gov/topic/information-blocking.\230\
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\230\ The link to the interference category of FAQs directs to
this URL: https://www.healthit.gov/faqs?f%5B0%5D=subtopic%3A7031.
(Retrieved Apr. 9, 2024.)
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Certain practices have been brought to our attention through
submissions to the Report Information Blocking Portal, questions we
have received through the HealthIT.gov Feedback and Inquiry Portal,
and other interactions (including interactions with parties interested
in learning more about seeking or providing access, exchange, or use of
EHI).\231\ Often, the party will present a hypothetical scenario and
inquire if the practice constitutes information blocking. For a variety
of reasons, ONC does not opine on whether a given practice constitutes
information blocking. First, ONC does not have authority to offer
binding advisory opinions.\232\ Second, ONC cannot readily determine
whether a scenario focused on a specific action or inaction generally
constitutes information blocking because whether a practice meets the
Sec. 171.103 information blocking definition will involve an
assessment of all the elements of the information blocking definition,
as discussed above, and will be based on the facts and circumstances of
each unique situation.
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\231\ Report Information Blocking Portal URL: https://inquiry.healthit.gov/support/plugins/servlet/desk/portal/6Health IT
Feedback and Inquiry Portal URL: https://inquiry.healthit.gov/support/plugins/servlet/desk/portal/2 Other interactions with
interested parties include, for example, interactive discussion in
various public venues, such as the ``Ask Us About Information
Sharing'' sessions ONC has hosted since May 2020. (https://www.healthit.gov/newsroom/past-events)
\232\ ONC requested but did not receive advisory opinion
authority via the Congressional Appropriations Committee in fiscal
years 2023 and 2024.
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Informed by the concerns and questions that interested parties have
brought to our attention, we propose to add Sec. 171.104 to 45 CFR
part 171 to codify that certain practices will constitute interferences
for purposes of the information blocking definition.
As previously noted, the practices we propose to codify are not an
exhaustive list of all practices that constitute interferences. The
practices in the proposed Sec. 171.104 are intended to help regulated
entities and other interested parties by codifying certain practices
that constitute interferences for purposes of the information blocking
definition. The practices we propose to codify include affirmative acts
as well as omissions, because a practice, under the information
blocking definition, can be ``an act or omission committed by an
actor.''
The practices we propose to codify generally relate to:
Actions taken by an actor to impose delays on other
persons' access, exchange, or use of EHI;
Non-standard implementation of health IT and other acts to
limit interoperability of EHI or the manner in which EHI is accessed,
exchanged, or used by other persons;
Improper inducements or discriminatory contract
provisions; and
Omissions (failures to act). Some omissions which
constitute interferences in the proposed Sec. 171.104 include failures
to publish (or make available for publication) technical information
such as service base URLs for Certified API Technology. Other types of
omissions include an actor's failure to fulfill requests for access,
exchange, or use of EHI that is required by law, or failure to fulfill
requests for access, exchange, or use of EHI when it is permitted by
law and not inconsistent with any additional restrictions on access to
the individual's EHI that the individual (patient) or their personal
representative may have requested and that an actor agreed to honor.
In the proposed Sec. 171.104(a)(3), we describe ``delaying the
access, exchange, or use of EHI to or by a third-party app designated
and authorized by the patient when there is a deployed application
programming interface (API) able to support the access, exchange, or
use of the EHI.'' In this paragraph and corresponding regulatory text
(Sec. 171.104(a)(3)), the term ``app,'' as used in ``third-party
app,'' describes any number of ``applications'' (or types of
applications) a patient could use to access, exchange, or use their
EHI--on their smart phone, computer, or smart watch, for example. These
``apps'' are able to communicate with other health information
technology through an API (such as a Health IT Module certified to
Sec. 170.315(g)(10)) that permits EHI to be accessed and exchanged at
the patient's direction.
In the proposed Sec. 171.104(a)(6), we note that certain non-
compete clauses can implicate the information blocking definition. In
the ONC Cures Act Proposed Rule, we stated that one means by which
actors may restrict access, exchange, or use of EHI is through formal,
contractual restrictions (84 FR 7518). We provided several examples of
restrictive contractual clauses in that proposed rule (84 FR 7518). In
the ONC Cures Act Final Rule, we acknowledged that many
[[Page 63619]]
commenters stated that EHR developers place onerous contract terms on
developers of applications that enable patient access to EHI through
APIs (88 FR 25811). Regulated entities, software developers, and
patient advocates have continued to express concerns to ONC about
restrictive contractual clauses.
Actors are placing conditions on access to EHI in the actor's
health IT that are unrelated to security or privacy laws, and function
as anti-competitive clauses that effectively prevent certain employees
or contractors from accessing, exchanging, or using EHI in other health
IT. Therefore, we propose to identify a particular type of contractual
clause as an interference: negotiating or enforcing a clause in any
agreement that prevents or restricts an employee (other than the
actor's employees), contractor, or contractor's employee who accesses,
exchanges, or uses the EHI in the actor's health IT from accessing,
exchanging, or using EHI in other health IT in order to participate in
the design, development, or upgrade of such other health IT. This
proposal is intended specifically to make clear that it is an
interference to prevent employees of an individual or entity (other
than the actor's employees) from working on software development and
design for both Company A (actor's company) and Company B, even if the
companies are competitors or potential competitors, and even if the
work is being conducted simultaneously. We note that this interference
could be found in ``any agreement,'' even an agreement to which the
actor is not a party, provided that the actor requires another party to
include such a clause in that party's contracts with its employees or
contractors. In addition, it is an interference for the actor to
negotiate or enforce such a clause--again, in any agreement.
Recently, the Federal Trade Commission (FTC) finalized a nationwide
ban on most non-compete clauses in any employment contract (89 FR
38342). The FTC noted that non-compete clauses have many deleterious
effects, including on earnings, job creation, innovation, consumer
prices, and new business formation (80 FR 38343). Although the FTC's
rule would not cover the types of restrictions that are covered by our
proposal, we believe such clauses have the same effects on health
information technology by restricting the ability of developers to work
on different software and to enter into new contracts at the same time
that they are contracted to work with an actor's software. Although the
contractual language at issue may occasionally be couched in language
claiming to protect intellectual property, the clauses function as
anti-competitive clauses and not as clauses protecting intellectual
property from infringement or misappropriation. We note that in some
cases, there are applicable laws that prevent employees and contractors
from misusing intellectual property. Our proposal would not impact
legally permissible intellectual property protections. In addition, we
note that the Licensing Exception in Sec. 171.303 acknowledges
intellectual property rights, including the administration of a
reasonable non-disclosure agreement that is no broader than necessary
to prevent unauthorized disclosure of the actor's trade secrets.
We solicit comment on all aspects of our proposed description of
the interference in Sec. 171.104(a)(6). We specifically ask if we
should add ``including health IT for a competitor or potential
competitor'' at the end of the paragraph. We solicit comment on whether
it is necessary to say ``access, exchange, or use'' or if ``access or
use'' of EHI is sufficient. We specifically used the term ``agreement''
instead of ``contract'' because we recognize that such clauses can also
be found in licensing agreements and other agreements that are not
typically referred to as a contract. We also ask, more broadly, whether
there are other types of agreements that should specifically be
identified in the text of Sec. 171.104(a)(6), such as those specified
in the Cures Act rulemaking (84 FR 7518 and 88 FR 25811). Because we
recognize that sometimes the actor induces a contractor to include the
language in the agreement the contractor has with its employees, we use
the phrase ``negotiating or enforcing'' to ensure that an actor
inducing or forcing a customer, business associate, or any other entity
to include such restrictions would also be considered an interference.
We ask commenters to opine on whether ``negotiating or enforcing'' is
broad enough to cover the situations intended to be covered by the
description in Sec. 171.104(a)(6), and whether any terms should be
added to the definitions section of the regulation as a result of this
or other descriptions of interferences in Sec. 171.104.
We also solicit comments on the rest of the descriptions of
interferences in the proposed Sec. 171.104. Are the descriptions clear
enough for regulated entities and those whose access, exchange, or use
of EHI that might be adversely affected by the conduct to understand
the intended policy? Are there other practices that interested parties
believe should be explicitly identified in regulatory text as
constituting interference? Would codification of more or fewer
interferences be more helpful? In considering these questions, we
remind readers that ``interference'' or ``interfere with'' includes
practices that prevent, materially discourage, or otherwise inhibit the
access, exchange, and use of EHI.
Finally, we reiterate and emphasize that the descriptions in the
proposed Sec. 171.104 are of conduct constituting ``interference.''
The facts and circumstances of an actor's engaging in any of these
practices, or any other practice likely to interfere with access,
exchange, or use of EHI, would determine whether the practice
constitutes ``information blocking.'' OIG has the statutory authority
to investigate allegations of information blocking and to determine
whether information blocking has occurred.
a. Application of ``Interference'' to TEFCA\TM\ Requirements
Having discussed practices that would be considered interferences,
we want to take this opportunity to identify certain practices that we
believe would be unlikely to interfere with the access, exchange, and
use of EHI under the information blocking definition. Specifically, it
would be unlikely to be an interference for Qualified Health
Information Networks\TM\ (QHINs), Participants, or Subparticipants to
comply with required provisions of the Common Agreement and the
incorporated terms of participation and standard operating procedures,
respectively. In the ONC Cures Act Final Rule, we took a similar
approach and identified certain practices that we believed would be
unlikely to interfere with the access, exchange, and use of EHI.
Specifically, we explained that an actor's practice that focused on
educating individuals about the privacy and security risks posed by
certain applications would be unlikely to rise to the level of an
interference when certain conditions were met, and therefore would be
unlikely to meet the definition of information blocking (85 FR 25815).
Many interested parties, directly and through responses to proposed
rules and requests for information, have inquired about the
implications of following requirements of the Trusted Exchange
Framework and Common Agreement\TM\ (TEFCA\TM\), including the related
terms of participation and standard operating procedures, with respect
to the information blocking definition. In light of the concerns and
questions that interested parties have brought to our attention with
respect to TEFCA, we believe it is important to provide
[[Page 63620]]
guidance to actors who are QHINS\TM\, Participants, or Subparticipants
that practices they must undertake to comply with TEFCA requirements
would be unlikely to rise to the level of an interference under the
information blocking definition. We believe providing such guidance
with respect to TEFCA requirements is important because when actors
choose to access, exchange, and use EHI through TEFCA, their compliance
with TEFCA requirements supports the policy goals of the Cures Act and
information blocking regulations more broadly, such as to promote
confidence in health IT infrastructure and interoperability (see 85 FR
25649, 25794, 25804, 25805, and 25806) by advancing interoperability
and expanding secure access, exchange, and use of EHI. We also believe
that because the proposed Sec. 171.104 does not describe the full
universe of practices that could constitute an interference, it is
important to clarify that compliance with TEFCA requirements, in the
context of TEFCA participation by a QHIN, Participant, or
Subparticipant, is unlikely to constitute an interference under the
information blocking definition.
Actors who are QHINs, Participants, or Subparticipants have
documents relevant to their participation in TEFCA, including documents
such as the Common Agreement, terms of participation, and standard
operating procedures. These documents may for example, establish
certain standards to ensure the security of EHI, or on the manner of
exchange of EHI.
In certain cases, QHINs, Participants, or Subparticipants may
engage in practices not specifically required by the Common Agreement,
terms of participation, and standard operating procedures. Our guidance
does not extend to such permissible or optional practices. To this
point, not complying with a request for access, exchange, or use of EHI
via the standards adopted in 45 CFR 170.215, including version(s) of
those standards approved pursuant to 45 CFR 170.405(b)(8), could be an
interference, could implicate the information blocking definition, and
would not be covered by the TEFCA Manner Exception (Sec. 171.403).
Further, in general and for clarity, any practice (act or omission)
between TEFCA entities that is not one specifically required by the
Common Agreement, including its terms of participation and standard
operating procedures, as well as any practice involving or affecting
non-participants in TEFCA could also be an interference. For practices
that are not required under TEFCA and/or that affect non-participants
in TEFCA, which could constitute an interference, all of the other
voluntary exceptions in part 171 would be available, as appropriate.
We seek comments on our discussion. Does this discussion
sufficiently reassure actors interested in participating in TEFCA that
complying with the requirements of TEFCA as a QHIN, Participant, or
Subparticipant would be unlikely to constitute ``interference'' under
the information blocking definition? We also welcome comment on the
desirability of further Federal guidance or education materials on the
interaction between the information blocking regulations and the Common
Agreement, including terms of participation and standard operating
procedures.
B. Exceptions
1. Privacy Exception
a. Privacy Exception--Definition of Individual
For purposes of the Privacy Exception, the term ``individual'' is
defined in Sec. 171.202(a)(2). When the Privacy Exception in Sec.
171.202 and paragraph (a)(2) were initially established by the ONC
Cures Act Final Rule, the codified text included a typographical error
that was not identified until after publication. In the ONC Cures Act
Final Rule (at 85 FR 25957) and the current Code of Federal
Regulations, the text of Sec. 171.202(a)(2)(iii), (iv), and (v) cross-
references paragraphs (a)(1) and (2) of Sec. 171.202 instead of
paragraphs (a)(2)(i) and (ii) when referencing a person who is the
subject of EHI in defining the term ``individual.'' We now propose to
make a technical correction to cross-references within the text of
Sec. 171.202(a)(2)(iii), (iv), and (v) to accurately cross-reference
paragraph (a)(2)(i), (a)(2)(ii), or both, as applicable.
Paragraph (a)(2) of the current Sec. 171.202 defines the term
``individual'' in part by referring to its definition in 45 CFR
160.103. In Sec. 171.202(a)(2)(i), we cross-reference to the
definition of ``individual'' as defined in the HIPAA Privacy Rule at 45
CFR 160.103. In (a)(2)(ii), we provide a second definition: ``any other
natural person who is the subject of the electronic health information
being accessed, exchanged, or used.'' \233\ Then, in (a)(2)(iii), (iv),
and (v), we expand on those two definitions in order to include persons
legally acting on behalf of such individuals or their estates in
certain circumstances. However, the current text of Sec.
171.202(a)(2)(iii), (iv), and (v) incorrectly references a ``person
described in paragraph (a)(1) or (2) of this section'' instead of
referencing a ``person described in paragraph (a)(2)(i) or (ii) of this
section.''
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\233\ The definition of ``person'' for purposes of 45 CFR part
171 is codified in Sec. 171.102 and is, by cross-reference to 45
CFR 160.103, the same definition used for purposes of the HIPAA
Privacy Rule (45 CFR part 160 and subpart E of 45 CFR part 164). The
Sec. 160.103 definition of ``person'' clarifies the meaning of
``natural person'' within it. We use ``natural person'' with that
same meaning in Sec. 171.202(a)(2) and throughout this discussion
of Sec. 171.202(a)(2).
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The ONC Cures Act Final Rule preamble demonstrates our intent for
the definition of ``individual'' in paragraph (a)(2) of Sec. 171.202.
Citing the ONC Cures Act Proposed Rule at 84 FR 7526, we stated in the
ONC Cures Act Final Rule preamble (85 FR 25846 through 25847) that
``the term `individual' encompassed any or all of the following: (1) An
individual defined by 45 CFR 160.103; (2) any other natural person who
is the subject of EHI that is being accessed, exchanged or used; (3) a
person who legally acts on behalf of a person described in (1) or (2),
including as a personal representative, in accordance with 45 CFR
164.502(g); or (4) a person who is a legal representative of and can
make health care decisions on behalf of any person described in (1) or
(2); or (5) an executor or administrator or other person having
authority to act on behalf of the deceased person described in (1) or
(2) or the individual's estate under State or other law.'' Further,
still referencing the ONC Cures Act Proposed Rule preamble, we wrote at
85 FR 25845 that ``(3) encompasses a person with legal authority to act
on behalf of the individual, which includes a person who is a personal
representative as defined under the HIPAA Privacy Rule.'' The paragraph
designated as ``(a)(3)'' in the Proposed Rule at 84 FR 7602 and
referenced simply as ``(3)'' in the discussion at 85 FR 25845 was
designated as (a)(2)(iii) in Sec. 171.202 as finalized at 85 FR 25957
and currently codified.
The quotes from the ONC Cures Act Final Rule preamble above
demonstrate a consistent intention across the ONC Cures Act Proposed
and Final Rules to cross-reference in the paragraphs finalized (at 85
FR 25957) and codified in Sec. 171.202 as (a)(2)(iii), (iv), and (v)
the paragraphs finalized and codified in Sec. 171.202(a)(2)(i) and
(ii). Accordingly, we propose the technical correction in the revised
text of 45 CFR 171.202 to reflect the correct reading and intent.
In drafting our proposed technical correction to Sec.
171.202(a)(2), we determined that the cross-reference to (a)(2)(ii), a
natural person who is the subject of the EHI being exchanged other than
an individual as defined in
[[Page 63621]]
45 CFR 160.103, is not needed in describing (in (a)(2)(iii)) a person
acting as a personal representative in making decisions related to
health care specifically in accordance with 45 CFR 164.502(g). This is
because 45 CFR 164.502(g) pertains personal representatives of
individuals as defined in 45 CFR 160.103 (persons who are the subject
of PHI) under the HIPAA Privacy Rule. A person described in (a)(2)(i)
is an individual as defined in 45 CFR 170.103 for purposes of the HIPAA
Privacy Rule. However, (a)(2)(ii) describes ``any other natural person
who is the subject of the EHI being accessed, exchanged, or used''
(emphasis added) rather than an ``individual'' who is the subject of
PHI under the HIPAA Privacy Rule. Such other person (described in
(a)(2)(ii)) would not have a person who is a ``personal
representative'' specifically in accordance with the 45 CFR 164.502(g)
provisions pertaining to ``personal representatives'' under the HIPAA
Privacy Rule. Therefore, we propose to strike the unnecessary reference
to Sec. 171.202(a)(2)(ii) (a subject of EHI who does not meet the 45
CFR 160.103 (HIPAA Privacy Rule) definition of ``individual'') from the
Sec. 171.202(a)(2)(iii) description of a person who acts as a personal
representative specifically in accordance with the HIPAA Privacy Rule
provisions in 45 CFR 164.502(g). By striking an unnecessary cross-
reference, this proposal would simplify the regulatory text without
changing what the Sec. 171.202(a)(2) definition of ``individual''
means or how it applies in practice.
b. Privacy Sub-Exception--Interfering With Individual Access Based on
Unreviewable Grounds
In the ONC Cures Act Final Rule (85 FR 25856), we finalized in
Sec. 171.202(d) a sub-exception to the Privacy exception applicable to
the denial of an individual's request for electronic health information
consistent with ``unreviewable grounds'' for denial of access under 45
CFR 164.524. As we explained in the ONC Cures Act Final Rule, these
``unreviewable grounds'' are related to specific privacy risks or
interests and have been established for important public policy
purposes, such as when a health care provider is providing treatment in
the course of medical research or when a health care provider is acting
under the direction of a correctional institution (85 FR 25856). (See
45 CFR 164.524(a)(2) for the full listing of circumstances in which
individual may be denied access under 45 CFR 164.524 without the
individual being provided an opportunity for review of the denial.)
The current text of Sec. 171.202(d) is explicitly applicable when
an individual requests EHI under the HIPAA individual right of access
standard (45 CFR 164.524(a)(1)) from an actor who must comply with this
HIPAA Privacy Rule provision. Thus, the sub-exception is available only
to actors who are also HIPAA covered entities or business
associates.\234\
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\234\ See the definitions of ``covered entity'' and ``business
associate'' at 45 CFR 160.103.
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We explained how the sub-exception currently operates in the ONC
Cures Act Final Rule preamble (see 85 FR 25856 through 25857). The
current text of Sec. 171.202(d) states that the actor's practice
``must be consistent with 45 CFR 164.524(a)(2).'' The preamble
discussion of this sub-exception explains that an actor who chooses to
deny the request must, to satisfy the Sec. 171.202(d) sub-exception,
meet the actor's obligations \235\ under the HIPAA Privacy Rule. Thus,
if an actor who also must comply with 45 CFR 164.524(a)(1) denies, on
unreviewable grounds, access to some or all of the protected health
information (PHI) that is also EHI \236\ requested by the individual in
compliance with the HIPAA Privacy Rule requirements, the denial is
covered under the Sec. 171.202(d) sub-exception as currently codified.
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\235\ At 85 FR 25856, we referred to the actor's HIPAA Privacy
Rule compliance obligations in this situation as ``its
requirements.'' We use more precise wording here for clarity.
\236\ As defined in Sec. 171.102 and excluding certain
information as specified in subparagraphs (1) and (2) of this
definition, EHI is electronic protected health information (ePHI)
(defined in 45 CFR 160.103) that is or would be in the designated
record set (defined in 45 CFR 164.501). It may be helpful for
purposes of this discussion to think of EHI as a subset of PHI. The
HIPAA right of access standard (45 CFR 164.524) applies to PHI that
is not ePHI (e.g., paper records), but Sec. 171.202 would be moot
with respect to PHI that is not ePHI and therefore does not meet the
EHI definition in Sec. 171.102.
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We propose to broaden the applicability of the sub-exception so
that it is available to any actor responding to a request for EHI where
the circumstances set out in 45 CFR 164.524(a)(2)(i) through (v) apply,
and not just for actors who are also HIPAA covered entities or business
associates. Allowing the same information blocking sub-exception to
cover a practice regardless of whether the actor engaging in the
practice is also required to comply with the HIPAA Privacy Rule does
not create a misalignment for actors who are subject to both the
information blocking regulations and the HIPAA Privacy Rule. Instead,
making this sub-exception available to all actors under the same
conditions in which the sub-exception is available to HIPAA covered
entities should reduce unnecessary variation across actors, improve
compliance efficiency, and provide additional certainty as it relates
to the applicability of this exception.
We believe that broadening the applicability of the unreviewable
grounds sub-exception (Sec. 171.202(d)) to practices by actors who are
not required to comply with the HIPAA Privacy Rules will provide
greater benefit to actors than creating unique requirements for the
application of Sec. 171.202(d) to such actors' practices in the
circumstances set forth in Sec. 164.524(a)(2). Actors who are not
required to comply with the HIPAA Privacy Rule would need to
familiarize themselves with up-to-date 45 CFR 164.524 implementation
specifications that would apply to the actor's denial of access to the
EHI in question in the circumstances set forth in Sec. 164.524(a)(2)
if the actor were a HIPAA covered entity or business associate. This is
similar to such actors needing to familiarize themselves with the HIPAA
Privacy Rule definitions for ``ePHI'' and ``designated record set'' (in
Sec. Sec. 160.103 and 164.501) for purposes of understanding the EHI
definition in Sec. 171.102. Actors who are not HIPAA covered entities
or business associates and who want to obtain help in learning about
denials of individual access in the circumstances specified in Sec.
164.524(a)(2) could find a variety of educational sources to choose
from. However, most health care providers, HIN/HIEs, health information
management professionals, and health IT developers of certified health
IT throughout the United States have experience complying with the
HIPAA Privacy Rule.
To clearly establish coverage of the Sec. 171.202(d) sub-exception
for all actors' practices under the same requirements, we propose to
change the name of the sub-exception to: ``interfering with individual
access based on unreviewable grounds.'' This proposed change to the
header text is intended to express the expansion of the sub-exceptions'
availability to all actors. Additionally, the proposed regulatory text
would remove the current text's reference applying the sub-exception
only to actors required to comply with the HIPAA right of access
standards and only where the individual is making a request ``under the
right of access provision under 45 CFR 164.524(a)(1).'' Instead, the
proposed text would provide that the sub-exception applies where an
individual requests their EHI from any actor in circumstances set
[[Page 63622]]
forth in 45 CFR 164.524(a)(2). The proposed revision would, further,
cross-reference the implementation specifications set out in 45 CFR
164.524 (access of individuals to protected health information) that
HIPAA covered entities and business associates must already meet to
comply with the HIPAA Privacy Rule when denying individual access on
``unreviewable grounds'' (45 CFR 164.524(a)(2)).
We seek comments on this proposal.
c. Privacy Sub-Exception--Individual's Request Not To Share EHI
We propose to slightly modify the header of Sec. 171.202(e) for
ease of reference to ``individual's request not to share EHI.'' More
importantly, we propose to revise the sub-exception to remove the
existing limitation that applies the exception only to individual-
requested restrictions on EHI sharing that are permitted by other
applicable law. The proposal would extend the availability of the Sec.
171.202(e) sub-exception to an actor's practice of implementing
restrictions the individual has requested on the access, exchange, or
use of an individual's EHI even when the actor may have concern that
another law or instrument could attempt to compel the actor to fulfill
access, exchange, or use of EHI contrary to the individual's expressed
wishes.
The existing text and scope of 45 CFR 171.202(e) was established in
2020 by the ONC Cures Act Final Rule (85 FR 25642). When the sub-
exception was finalized, health care providers and other actors did not
raise explicit concerns regarding when they must comply with statutes,
regulations, or instruments (such as subpoenas) issued under the laws
of states in which they are not licensed, do not reside, and do not
furnish care. In 2022, the Supreme Court decision in Dobbs v. Jackson
Women's Health Organization overturned precedent that protected a
constitutional right to abortion and altered the legal and health care
landscape.\237\ Since the Court's decision, across the United States, a
variety of states have newly enacted or are newly enforcing
restrictions on access to reproductive health care. The Court's
ruling--and subsequent state restrictions--have had far-reaching
implications for health care beyond the effects on access to
abortion.\238\
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\237\ See 142 S. Ct. 2228.
\238\ See Melissa Suran, ``Treating Cancer in Pregnant Patients
After Roe v Wade Overturned,'' JAMA (Sept. 29, 2022), (available at
https://jamanetwork.com/journals/jama/fullarticle/
2797062#:~:text=The%20US%20Supreme%20Court,before%20cancer%20treatmen
t%20can%20begin), and Rita Rubin, ``How Abortion Bans Could Affect
Care for Miscarriage and Infertility,'' JAMA (June 28, 2022),
(available at https://jamanetwork-com.hhsnih.idm.oclc.org/journals/jama/fullarticle/2793921?resultClick=1). (URLs retrieved May 23,
2024.)
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In light of the changing landscape, we are concerned that actors
might deny or terminate an individual's requested restrictions on
sharing their EHI specifically due to uncertainty about whether the
actor is aware of and can account for any and all laws that might
override the individual's requested restrictions. An actor who might
otherwise be inclined to agree to an individual's request not to share
their EHI could be concerned about potential information blocking
implications of honoring those individual requests in the face of
demands for disclosure that might ultimately be enforced in a court of
competent jurisdiction. In particular, we are concerned that actors may
be unwilling to consider granting individuals' requests for
restrictions, or may prematurely terminate some or all requested
restrictions, based on uncertainty as to whether information blocking
penalties or disincentives might be imposed in addition to costs the
actor may incur to confirm whether the actor is, by other authority,
compelled to provide access, exchange, or use of EHI despite the
individual's wishes. For example, we understand actors are concerned
about potentially implicating the information blocking definition by
delaying a disclosure of EHI pursuant to a court order that the actor
is aware is being contested, so that the actor can wait to see if the
order will, in fact, compel the actor to make EHI available for access,
exchange, or use contrary to the individual's request for restrictions
to which the actor had agreed consistent with Sec. 171.202(e).
Accordingly, the removal of ``unless otherwise required by law'' from
Sec. 171.202(e) would be a useful complement to the existing
Precondition Not Satisfied sub-exception (Sec. 171.202(b)) to help
address actors' uncertainty about various state laws' applicability as
they relate to information blocking. As currently codified, Sec.
171.202(b) sub-exception of the Privacy Exception outlines a framework
for actors to follow so that the actors' practices of not fulfilling
requests to access, exchange, or use EHI would not constitute
information blocking when one or more preconditions has not been
satisfied for the access, exchange, or use to be permitted under
applicable Federal and State, or Tribal laws.
To be clear, the proposed revision to Sec. 171.202(e) would not
operate to override other law compelling disclosure against the
individual's wishes. It would, however, offer actors who elect to honor
individual requested restrictions certainty that applying those
restrictions will not be considered information blocking so long as the
actor's practices in doing so satisfy the requirements of the Sec.
171.202(e) sub-exception. Whether the courts will or should apply any
particular Federal, state, or Tribal law to any actor (or enforce
orders issued under such laws to any actor in any particular
circumstances) is beyond the scope of this proposal. If or where there
may be a law that is enforced by a court with jurisdiction over the
actor and subject matter and that requires a particular actor to
fulfill access, exchange, or use of EHI without the individual's
authorization, permission, or consent, the actor might be compelled to
comply with that law independent of the information blocking statute
and 45 CFR part 171. This would continue to be the case even if we were
to finalize the proposed revision to Sec. 171.202(e).
We also remind HIPAA covered entities and business associates that
they must comply with the HIPAA Privacy Rule, including privacy
protections in the HIPAA Privacy Rule to Support Reproductive Health
Care Privacy Final Rule and any other applicable Federal laws that
limit access, exchange, or use of EHI in particular circumstances. For
example, an actor's practice likely to interfere with an individual's
access, exchange, or use of EHI (as defined in 45 CFR 171.102) might
satisfy an information blocking exception without fully satisfying the
actor's separate obligations under 45 CFR 164.524 (HIPAA Privacy Rule's
individual right of access). In such cases, an actor that is a HIPAA
covered entity or business associate would be subject to penalties for
violating the HIPAA Privacy Rule.
We welcome comments on this proposal.
2. Infeasibility Exception
In the ONC Cures Act Final Rule, ONC established the Infeasibility
Exception (Sec. 171.204) (85 FR 25865 through 25870, and 85 FR 25958).
Under the Infeasibility Exception, it is not considered information
blocking if an actor, as defined in Sec. 171.102, does not fulfill a
request to access, exchange, or use EHI due to the infeasibility of the
request, provided the actor satisfies at least two conditions: the
Sec. 171.204(b) responding to requests condition and
[[Page 63623]]
any one of the conditions in Sec. 171.204(a).
In the HTI-1 Final Rule (89 FR 1436, see preamble at 89 FR 1373
through 1387), we finalized the following revisions to Sec. 171.204:
clarification of the Sec. 171.204(a)(1) uncontrollable
events condition requirement that the uncontrollable event must have an
actual negative impact on an actor's ability to fulfill EHI access,
exchange, or use in order for uncontrollable events condition to apply;
addition of two new conditions (third party seeking
modification use and manner exception exhausted, respectively
subparagraphs (3) and (4)) under paragraph (a); and
renumbering the infeasible under the circumstances
condition from Sec. 171.204(a)(3) to Sec. 171.204(a)(5).
However, in the HTI-1 rulemaking, we did not change the substance
of the infeasible under the circumstances condition (now codified in
Sec. 171.204(a)(5)) or the Sec. 171.204(a)(2) segmentation condition,
and we did not make any changes to Sec. 171.204(b). In this rule, we
propose to modify:
the Sec. 171.204(a)(2) segmentation condition as
described in section IV.B.2.a;
the Sec. 171.204(a)(3) third party seeking modification
use conditions as described in section IV.B.2.b; and
the Sec. 171.204(b) responding to requests condition as
discussed in section IV.B.2.c (of this proposed rule).
a. Segmentation Condition Modifications
The Sec. 171.204(a)(2) segmentation condition currently applies
where the actor is not able to fulfill a request for access, exchange,
or use of EHI specifically because the actor cannot unambiguously
segment from other requested EHI the EHI that cannot be made available
by law or due to an individual's preference, or that may be withheld in
accordance with Sec. 171.201. In practice, ``by law or due to an
individual's preference'' would include situations where: an actor has
chosen to honor an individual's request for restrictions on sharing of
some of their EHI; an individual's authorization or consent is a pre-
requisite for a particular use or disclosure of their EHI to be lawful
and the individual has not provided such authorization or consent; or
law applicable in the circumstances of the request restricts sharing of
the EHI.
We propose updates to the segmentation condition to enhance clarity
and certainty, and to provide for its application to additional
situations. We propose to update how the regulation text describes why
certain EHI cannot or will not be made available, including more
specific cross-references to relevant provisions within 45 CFR part
171.
Currently, the segmentation condition references (in subparagraph
(i) of Sec. 171.204(a)(2)) EHI that cannot be made available due to an
individual's preference or by law, and (in subparagraph (ii) of Sec.
171.204(a)(2)) EHI that the actor may choose to withhold in accordance
with the Preventing Harm Exception. We propose to revise the condition
(Sec. 171.204(a)(2)) as follows: to focus subparagraph (i) on EHI that
is not permitted by applicable law to be made available, and to
explicitly cross-reference in subparagraph (ii) the proposed Protecting
Care Access Exception (Sec. 171.206) and the existing Privacy
Exception (Sec. 171.202) in addition to the existing Preventing Harm
Exception (Sec. 171.201) (which currently has an explicit cross-
reference).
We believe that focusing Sec. 171.204(a)(2)(i) solely on EHI that
is not permitted by applicable law to be made available for a requested
access, exchange, or use will reinforce for actors and other interested
persons that actors cannot make EHI available when applicable law, such
as the HIPAA Privacy Rule or 42 CFR part 2, does not permit covered
information to be made available. Under our proposed revision of Sec.
171.204(a)(2)(i), the segmentation condition would continue to apply as
it does today when an actor cannot unambiguously segment EHI that,
under applicable law, is permitted to be available to a particular
person for a particular purpose from EHI that is not permitted to be
available to that person for that purpose. This would include
situations where the actor cannot unambiguously segment EHI for which
preconditions for permitting use or disclosure under the HIPAA Privacy
Rule (or other applicable law) have not been met from EHI for which
such preconditions have been met, as well as scenarios where use or
disclosure of specific EHI for a particular purpose is prohibited by
applicable law.
The proposed revision to Sec. 171.204(a)(2) would retain in
subparagraph (ii) explicit reference to the Preventing Harm Exception
(Sec. 171.201). Thus, the Infeasibility Exception's revised
segmentation condition would continue to apply where the actor cannot
unambiguously segment other EHI from EHI that the actor has chosen to
withhold in accordance with the Preventing Harm Exception (Sec.
171.201).
We propose to explicitly add reference to Sec. 171.202 in our
revision to subparagraph (ii) of Sec. 171.204(a)(2). This would ensure
that the segmentation condition would continue to apply where the actor
cannot unambiguously segment other EHI they could lawfully make
available from EHI for which the actor has chosen to honor the
individual's request not to share the EHI (consistent with Sec.
171.202(e) sub-exception). In addition, citing Sec. 171.202 in the
proposed revision to subparagraph (ii) of Sec. 171.204(a)(2) would
expand explicit application of the Sec. 171.204(a)(2) segmentation
condition to certain situations where an actor subject to multiple laws
with inconsistent preconditions adopts uniform privacy policies and
procedures to adopt the more restrictive preconditions (as provided for
under the Privacy sub-exception Precondition Not Satisfied, see Sec.
171.202(b)(3) as currently codified). By referencing all of the Privacy
Exception (Sec. 171.202), the proposed revised Sec. 171.204(a)(2)(ii)
would allow the Infeasibility Exception's segmentation condition to
apply where an actor (who has adopted the more restrictive of multiple
laws' preconditions for sharing of some information about an
individual's health or care consistent with Sec. 171.202(b)) cannot
unambiguously segment EHI for which a more restrictive precondition has
not been met from other EHI that the actor could lawfully share in the
jurisdictions with less restrictive preconditions.
By referencing all of the Privacy Exception (Sec. 171.202), the
proposed revision would also extend the segmentation condition's
coverage to situations where the actor is unable to unambiguously
segment EHI that could be made available from specific EHI that the
actor may choose to withhold from the individual or their (personal or
legal) representative consistent with the Sec. 171.202(d) Privacy sub-
exception ``denial of individual access based on unreviewable
grounds.''
We have identified a possibility that individuals and interested
parties could be concerned that extending the segmentation condition's
coverage could affect the speed with which actors move to adopt or
improve segmentation capabilities. Segmentation capabilities may need
to be improved to sequester the EHI that may be withheld from an
individual on certain unreviewable grounds from other EHI an actor may
have for that individual. For instance, in comparison to health
information that may need to be sequestered for other reasons,
different or additional segmentation functionality may be
[[Page 63624]]
needed to sequester from other EHI only that information created or
obtained in the course of research that includes treatment and only for
as long as the research is in progress.\239\ While the actor that is a
HIPAA covered entity would still need to satisfy the individual's right
of access to other PHI to the extent possible (see 45 CFR
164.524(d)(1)), the form and format in which the PHI is readily
producible (see 45 CFR 164.524(c)(2)) may not be supported by the same
electronic manner of access, exchange, or use that the individual would
prefer. Therefore, we invite commenters to share any concerns or other
perspectives they may wish to share relevant to this issue. We also
propose in the alternative to reference only Privacy Exception sub-
exceptions other than denial of access based on unreviewable grounds
(Sec. 171.202(d)) in the revised Sec. 171.204(a)(2) segmentation
condition. Including this alternative proposal in this proposed rule
means we could decide to finalize the revision to the Sec.
171.204(a)(2) segmentation condition with or without cross-reference to
(or that would include) ``denial of access based on unreviewable
grounds'' (Sec. 171.202(d)).
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\239\ Please see 45 CFR 164.524(a)(2)(iii) for the HIPAA Privacy
Rule's full ``unreviewable grounds for denial'' circumstances to
which this example alludes.
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For an actor's practice to be consistent with the Sec. 171.202
Privacy Exception, the practice must meet the requirements set forth in
any one of the sub-exceptions enumerated in Sec. 171.202 (b) through
(e). Referencing the entirety of Sec. 171.202 in Sec.
171.204(a)(2)(ii) would, therefore, also extend application of the
Infeasibility Exception's segmentation condition to situations where a
health IT developer of certified health IT that is not required to
comply with the HIPAA Privacy Rule may withhold EHI they could
otherwise lawfully make available based on an organizational privacy
policy consistent with the Sec. 171.202(c) sub-exception. (As used in
Sec. 171.202, ``HIPAA Privacy Rule'' means 45 CFR parts 160 and 164
(Sec. 171.202(a)(1).)
Because the Sec. 171.202(c) sub-exception is applicable only where
a health IT developer of certified health IT is not required to comply
with the HIPAA Privacy Rule, it would apply in situations where the
health IT developer of certified health IT is not required to comply
with the individual right of access in 45 CFR 164.524. We believe it is
possible that some individuals might seek health care or other services
from such developers' customers (including health care providers) who
are not HIPAA covered entities. In such situations, a State, or Tribal
law may operate to provide the individual rights to access their health
information that the actor has. (Determining what other laws may
operate, or how, in specific circumstances is beyond the scope of this
proposed rule.) Although the number of such situations may be
relatively small, we do recognize it is possible for some individuals
to find themselves in situations where no other law explicitly
guarantees them a right to access EHI of which the individual is the
subject (or the legal representative of the subject). In such
situations, the individual may rely solely on the information blocking
statute to ensure actors will not unreasonably and unnecessarily
interfere with the individual's EHI access, exchange, or use. We are,
therefore, interested in whether commenters may be concerned about
potential unintended consequences of extending the (Sec.
171.204(a)(2)) segmentation condition to situations where a health IT
developer is not required to comply with HIPAA and cannot segment EHI
they have chosen to withhold consistent with the actor's own
organizational privacy policies from other EHI. Would extending the
segmentation condition to situations where a health IT developer has
chosen to withhold EHI consistent with the Privacy sub-exception
``health IT developer of certified health IT not covered by HIPAA''
(Sec. 171.202(c)) pose too much risk of such developers avoiding
individuals' EHI requests by choosing not to develop segmentation
capabilities in the health IT they provide their customers who are not
HIPAA covered entities? We welcome commenters' thoughts on this
question. We also propose in the alternative to reference in the
revised Sec. 171.204(a)(2)(ii) segmentation condition only Privacy
Exception sub-exceptions other than Sec. 171.202(c) ``health IT
developer of certified health IT not covered by HIPAA'' sub-exception.
Including this alternative proposal in this proposed rule means we
could decide to finalize the revision to the Sec. 171.204(a)(2)(ii)
segmentation condition with or without cross-reference to (or that
would include) Sec. 171.202(c) ``health IT developer of certified
health IT not covered by HIPAA.''
As discussed in section IV.B.3 of this preamble, the Sec. 171.206
Protecting Care Access Exception would apply to practices that an actor
chooses to implement that are likely to interfere with access,
exchange, or use of specific EHI (including, but not limited to,
withholding such EHI) when relevant conditions are met. We propose to
reference Sec. 171.206 in the proposed revised Sec. 171.204(a)(2)(ii)
because the proposed Sec. 171.206(a) threshold condition's
requirements include (among others) a requirement that the actor's
practice be no broader than necessary to reduce the risk of potential
exposure of any person(s) to legal action that the actor believes could
arise from the particular access, exchange, or use of the specific EHI.
The actor's lack of technical capability to sequester only the EHI for
which relevant conditions of Sec. 171.206 have been satisfied would
not render Sec. 171.206 applicable to interference with the lawful
access, exchange, or use of other EHI pertaining to the same
individual(s). Therefore, the proposed reference to Sec. 171.206 in
the proposed revised Sec. 171.204(a)(2)(ii) would accommodate
circumstances where an actor lacks the technical capability to
unambiguously segment the EHI the actor has chosen to withhold
consistent with the Protecting Care Access Exception (Sec. 171.206, if
finalized) from other EHI that they could lawfully make available. The
requirements for an actor's practice to satisfy the proposed new Sec.
171.206 exception, including the Sec. 171.206(a) threshold condition
that would be relevant to any practice to which Sec. 171.206 could
apply as well as when the Sec. 171.206(b) patient protection or Sec.
171.206(c) care access conditions are relevant, are discussed in detail
in section IV.B.3, below in this preamble.
We solicit comments on these proposals.
b. Third Party Seeking Modification Use Condition Modifications
In the HTI-1 Final Rule (89 FR 1436) we excluded from applicability
of the third party seeking modification use condition of the
Infeasibility Exception (Sec. 171.204(a)(3)) a health care provider's
requests for modification use from an actor that is its business
associate. In the HTI-1 Final Rule, we noted that, for reasons stated
in response to comments suggesting the condition's applicability
exclusion may not be broad enough and in consideration of all comments
on our discrete proposal, we did not expand the finalized exclusion
from applicability of the condition as some commenters had requested
(89 FR 1379). We also noted that we may consider amending the third
party seeking modification use condition in the future if doing so may
be appropriate (89 FR 1379). Upon further consideration, we now propose
in Sec. 171.204(a)(3)(ii) to extend the
[[Page 63625]]
exclusion from applicability of the condition.
We now propose to revise the third party seeking modification use
condition to designate the existing exclusion from the applicability of
this condition as subparagraph (i) of Sec. 171.204(a)(3), and within
it change the words ``health care provider'' to ``covered entity as
defined in 45 CFR 160.103.'' We propose this change because the HIPAA
Privacy and Security Rules require that all covered entities and their
business associates safeguard the privacy, security, and integrity of
EHI, not just health care providers. As we noted in the HTI-1 Proposed
Rule (88 FR 23866), covered entities and business associates often have
a level of trust and contractual protections that reduce certain
concerns, such as security and data provenance, that led us to propose
the third party seeking modification use condition. In addition, as we
noted in the HTI-1 Proposed Rule discussion of the limitation of this
condition, covered entities and their business associates (as permitted
by their business associate agreements) need to access and modify
relevant EHI held by other business associates of those covered
entities on a regular basis (88 FR 23866). Therefore, we believe the
exclusion from applicability of this condition should encompass
requests from all covered entities to their business associates.
We also propose to exclude from applicability of the condition
requests from any health care provider (as defined in Sec. 171.102),
who is not a HIPAA covered entity (as defined in 45 CFR 160.103) but
who is requesting modification use from an actor whose activities would
make the actor a business associate of that same health care provider
if that health care provider were a HIPAA covered entity. Even if a
health care provider is not a HIPAA covered entity, a health care
provider likely has obligations and responsibilities under State law
\240\ and according to accreditation organizations' requirements \241\
and payers' requirements \242\ to keep and maintain medical records.
Those responsibilities will likely require a health care provider to be
able to regularly access and modify EHI held by entities who perform
the functions of a business associate (as defined in 45 CFR 160.103)
and would be considered a business associate of the health care
provider if the health care provider were a covered entity. Further, it
is our expectation that even if a health care provider is not a HIPAA
covered entity and, therefore, does not have a HIPAA business associate
agreement with an actor who maintains EHI or health IT system(s) or
application(s) for the health care provider, the health care provider
likely would have a pre-existing relationship with the actor similar to
the relationship that a covered entity health care provider would have
with their business associate, in terms of the existing level of trust,
responsibilities, and obligations to handle EHI safely and securely.
The health care provider who is not a HIPAA covered entity may be
asking for modification use of EHI from an actor for the same
purpose(s) that a health care provider who is a covered entity would
be. We, therefore, propose to revise the third party seeking
modification use condition by adding subparagraph (ii) of Sec.
171.204(a)(3) that would exclude from applicability of the condition
requests from health care providers (as defined in Sec. 171.102) who
are not HIPAA covered entities, requesting modification use from actors
who would be considered the health care provider's business associate
if the health care provider were a covered entity as defined in 45 CFR
160.103.
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\240\ See, e.g., https://www.healthit.gov/sites/default/files/appa7-1.pdf (accessed Feb 26, 2024), and http://www.healthinfolaw.org/comparative-analysis/medical-record-retention-required-health-care-providers-50-state-comparison (accessed Feb 26,
2024).
\241\ See, e.g., https://www.jointcommission.org/standards/standard-faqs/home-care/leadership-ld/000001197/ (accessed Feb 26,
2024).
\242\ See, e.g., https://www.cms.gov/files/document/mln4840534-medical-record-maintenance-and-access-requirements.pdf (accessed Feb
27, 2024), and https://www.healthdatamanagement.com/articles/how-to-craft-an-effective-record-retention-policy (accessed Feb 28, 2024).
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We welcome comments on these proposals.
c. Responding to Requests Condition Modifications
The Infeasibility Exception currently includes as paragraph (b) of
Sec. 171.204 a responding to requests condition. To satisfy the
Infeasibility Exception as a whole, an actor's practice must meet the
requirements of the Sec. 171.204(b) responding to requests condition
in addition to meeting at least one of the conditions in Sec.
171.204(a). To meet the Sec. 171.204(b) responding to requests
condition, if an actor does not fulfill a request for access, exchange,
or use of EHI consistent with any of the conditions in paragraph (a) of
Sec. 171.204, then the actor must provide, within ten business days of
receipt of the request, to the requestor a written reason(s) why the
request is infeasible.
We propose to modify the Sec. 171.204(b) responding to requests
condition by establishing different timeframes for sending written
responses to the requestor based on the Sec. 171.204(a) condition
under which fulfilling the requested access, exchange, or use of EHI is
infeasible. The proposed revision to Sec. 171.204(b) would retain the
requirement that actors communicate to requestors ``in writing the
reason(s) why the request is infeasible'' that we finalized in the ONC
Cures Act Final Rule (85 FR 25958, preamble discussion at 85 FR 25869).
Under this proposed revision, the condition would also continue to
provide actors wishing to avail themselves of the Infeasibility
Exception with discretion to decide the appropriate level of detail to
include in their written responses (see 85 FR 25869). In addition, we
do not propose to specify the format of the written response or a
specific delivery mechanism (such as paper mail versus email).
Therefore, the proposed revision would retain the condition's existing
flexibility specific to the format of the written response. As is the
case under the current text of Sec. 171.204(b), meeting the proposed
modified Sec. 171.204(b) would be required in conjunction with meeting
a condition in Sec. 171.204(a) in order for an actor's practice to
satisfy the Sec. 171.204 Infeasibility Exception.
We did not propose to modify the responding to requests condition
in the HTI-1 Proposed Rule, but we received comments on the proposed
rule indicating that ten business days may not allow actors sufficient
time to engage with requestors and fully evaluate all factors relevant
to meeting certain conditions in Sec. 171.204(a). We discussed such
comments in reference to the manner exception exhausted condition
(Sec. 171.204(a)(4)) in the HTI-1 Final Rule preamble (89 FR 1387). We
noted in the preamble that we did not propose changes to the ten-day
timeframe in the HTI-1 Proposed Rule and did not finalize any changes
to paragraph (b) of Sec. 171.204 in the HTI-1 Final Rule, but we
stated that we may consider those comments in relation to future
regulatory action. The concern that ten business days may not allow
actors sufficient time to engage with requestors and fully evaluate all
factors relevant to meeting certain conditions in Sec. 171.204(a) has
also been raised by various actors in both written informal
correspondence and real-time interactions since the publication of the
ONC Cures Act Final Rule (85 FR 25642). We have also received inquiries
from these same actors as to what constitutes a ``request'' for
purposes of the Infeasibility Exception. These inquiries specific to
Sec. 171.204(b) have generally centered on how we would
[[Page 63626]]
determine when the ten-day ``clock'' for providing a written response
begins.
We believe defining in regulation what constitutes a ``request'' or
``actionable request'' is unnecessary and could have more undesirable
effects than desirable effects. We believe it would be difficult to
define a single set of characteristics that every person's
communication or conduct would need to satisfy before their
communication to an actor, or other interaction with an actor or with
health IT maintained or deployed by the actor, indicating the person
seeks EHI access, exchange, or use would be considered a ``request''
for purposes of the information blocking regulations. Such
specifications would increase complexity of the regulations and risk
increasing rather than decreasing barriers to requestors' obtaining
access, exchange, or use of EHI permitted under applicable law and,
where applicable, consistent with patients' expressed individual
preferences for privacy-protective restrictions beyond those required
by law. In light of both experience over the four years since the ONC
Cures Act Final Rule was published and the revisions that were
finalized to the Sec. 171.204(a) conditions in the HTI-1 Final Rule
(89 FR 1436 through 1437, preamble discussion at 89 FR 1373 through
1387), we believe it remains appropriate to include as a condition of
the Infeasibility Exception that the actor provide written responses
within timeframes specified by the Sec. 171.204(b) responding to
requests condition. However, we have determined that the optimal
timeframes to specify in Sec. 171.204 going forward may vary based on
the specific condition in Sec. 171.204(a) that is satisfied.
We propose to retain, as new subparagraph (1) of Sec. 171.204(b),
the current Sec. 171.204(b) requirement for a written response within
ten business days of the actor receiving a request where the
infeasibility of fulfilling requested access, exchange, or use of EHI
satisfies the Sec. 171.204(a)(1) uncontrollable events condition,
Sec. 171.204(a)(2) segmentation condition, or the Sec. 171.204(a)(3)
third party seeking modification use condition. We believe ten business
days should be adequate time for an actor to recognize that a request
that the actor has received, and that the actor might otherwise be able
to fulfill, is not feasible in specific circumstances where an
uncontrollable event has adversely impacted the actor's ability to
fulfill the requested access, exchange, or use of EHI. Ten business
days should also be sufficient for an actor to recognize that they
cannot fulfill a request for EHI access, exchange, or use for reasons
consistent with Sec. 171.204(a)(2) segmentation condition or where a
third party is seeking modification use in circumstances where Sec.
171.204(a)(3) applies. However, we propose to revise the wording of the
requirement from ``receipt of'' to ``the actor receiving'' to address
what we believe some actors may experience as uncertainty regarding
when one would start counting the ten business days in circumstances
where fulfilling a request is infeasible for reasons consistent with
Sec. 171.204(a)(1).
We recognize that there is significant variation in how people make
requests and for what purposes, as well as the manners in which they
seek to achieve access, exchange, or use of EHI. We also recognize that
mechanisms and workflows for receiving and reviewing requests may vary,
even within a single actor's operations, based on characteristics of
the request. For example, fulfillment of patient requests for EHI
access, exchange, or use that can be received and supported
automatically via a cloud-based patient portal unaffected by a
particular uncontrollable event would continue to be feasible even
while the impact of an uncontrollable event on the actor's systems or
operational status has rendered the actor unable to receive other
requests from, for example, payers or health care providers.
An uncontrollable event's impact on a particular actor's systems or
operational status may render it infeasible for the actor to receive
some requests until a time when restoration or recovery efforts have
progressed far enough that the actor's staff are able to access and use
the actor's systems. For example, for some types of request and actor
workflows, it may be necessary that: (1) application(s) involved in
receiving and responding to requests for EHI access, exchange, and use
are operational; and (2) appropriate staff are able to safely and
securely log into and use the application(s). Once those two things are
true again following an uncontrollable event, we would expect the
actor's staff to resume receiving and appropriately dispositioning
requests. By revising the wording to focus explicitly on the actor
receiving the request, we hope the proposed revised wording will make
it easier for actors to consider the distinction between requests that
can be received and processed using only automated means and requests
that require a human to do something--such as log into a system or
obtain and open a piece of paper mail--in order for the actor to, in
fact, receive the request.
Similarly, we believe revising the wording to focus on the actor
receiving the request clarifies when the ten-day clock starts in
scenarios where third parties seek modification use. From the point the
actor receives the request, we believe ten business days is sufficient
time for an actor to both determine and respond in writing to the
requestor that the request is infeasible consistent with Sec.
171.204(a)(3).
In this proposed rule, we propose to define ``business day'' or
``business days'' in Sec. 170.102 for purposes of the ONC Health IT
Certification Program. For preamble discussion of this proposed
definition of ``business day'' or ``business days,'' please see section
III.D.1 of this proposed rule. We propose to adopt this same definition
in Sec. 171.102 for purposes of 45 CFR part 171. This proposal that is
specific to the definition of ``business day'' or ``business days'' for
purposes of 45 CFR part 171 is aligned with but is independent of the
proposal to adopt the proposed definition of ``business day'' or
``business days'' discussed in section III.D.1 of this proposed rule
for purposes of 45 CFR part 170. Therefore, commenters should be aware
that we could choose to adopt the full proposed definition in Sec.
171.102, instead of a cross-reference to Sec. 170.102, for purposes of
45 CFR part 171 if we do not also adopt the definition for purposes of
45 CFR part 170. We welcome comment on this proposal specific to
adoption of the definition (discussed in section III.D.1 and shown in
the proposed revisions to Sec. 170.102 in this proposed rule) for
purposes of 45 CFR part 171 in general and as it would apply to the
responding to requests condition of the Infeasibility Exception (Sec.
171.204(b)).
A proposed new subparagraph (2) in the proposed revised Sec.
171.204(b) would apply where fulfilling a request is infeasible under
the manner exception exhausted condition (Sec. 171.204(a)(4)) or the
infeasible under the circumstances condition (Sec. 171.204(a)(5)).
Under this proposal, the ten-day clock would start after the actor
determines, without unnecessary delay and based on a reasonable
assessment of the facts, that the requested access, exchange, or use of
EHI cannot be provided consistent with Sec. 171.301 or that fulfilling
the request is infeasible under the circumstances. We expect that any
actors who find themselves attempting to fulfill a request consistent
with Sec. 171.301 will be aware that the attempt to fulfill the
request could instead result in infeasibility consistent with the Sec.
171.204(a)(4) manner exception exhausted condition. Therefore, we
[[Page 63627]]
expect that any such actor would, in good faith and without unnecessary
delay, interact with the requestor to ascertain the scope and requested
manner of EHI access, exchange, or use and negotiate any necessary fees
and licensing consistent with Sec. 171.301. Similarly, we expect that
any actor who embarks on the consideration of factors in paragraph (i)
of the infeasible under the circumstances condition (Sec.
171.204(a)(5)) will be aware that their consideration of these factors
could lead to either a successful fulfilment of requested access,
exchange, or use of EHI or a determination that complying with the
request would be infeasible under the circumstances. Therefore, we
expect the actor would, in good faith and without unnecessary delay,
interact with the requestor to ascertain the scope and requested manner
of EHI access, exchange, or use and obtain any additional information
needed to support the actor's prompt consideration of the Sec.
171.204(a)(5) factors.
We welcome comments on this proposal.
We also propose in the alternative to enhance the revisions to
Sec. 171.204(b) by adopting either or both of the following
requirements specific to the circumstances where Sec. 171.204(b)(2)
would be applicable.
We propose an additional requirement for a specific
maximum timeframe for the Sec. 171.204(b)(2)(i) determination of
infeasibility related to Sec. 171.301. Under this additional
requirement, the maximum timeframe would be one of the following:
three, five, ten, twenty, or thirty business days.
We propose an additional requirement that for Sec.
171.204(b)(2) to be met, the determination and communication of
infeasibility (for reasons consistent with Sec. 171.204(a)(4) or (5))
would have to be made within the timeframe permitted under 45 CFR
164.524 for providing access to PHI where a request for EHI access,
exchange, or use is one that implicates the HIPAA Privacy Rule's
provisions for individual access to PHI (45 CFR 164.524) in addition to
implicating the information blocking regulations in 45 CFR part 171.
We welcome comments on the possible additional requirements
proposed above.
Please note, if ONC adopts the alternative proposal above that
specifically references 45 CFR 164.524 for purposes of Sec.
171.204(b)(2), we intend to apply the timeframes required under that
section when a request for individual EHI access, exchange, or use is
received by the actor. Thus, under the alternative proposal's
requirements that would limit maximum available response time under the
responding to requests condition where the request for EHI implicates
45 CFR 164.524(a)(1) the timeframe would be limited to the timeframe
required under 45 CFR 164.524. We also highlight for readers' awareness
that HHS has proposed to revise 45 CFR 164.524(b)(2) to shorten the
timeframes allowed to respond to individual requests for access to PHI
(see 86 FR 6459 through 6460 and 86 FR 6535). In the event that changes
to the 45 CFR 164.524 timeframes were to be finalized in a future HIPAA
rule, the shorter timeframes would (upon becoming effective) apply to
the alternative proposed additional requirement for responding to
requestors where paragraph (b)(2) of the Infeasibility Exception would
apply.
3. Protecting Care Access Exception
a. Background and Purpose
As we explained in the ONC Cures Act Final Rule, the information
blocking provision in PHSA section 3022 was enacted in response to
concerns about practices that ``unreasonably limit the availability and
use of electronic health information (EHI) for authorized and permitted
purposes'' because such practices ``undermine public and private sector
investments in the nation's health IT infrastructure, and frustrate
efforts to use modern technologies to improve healthcare quality and
efficiency, accelerate research and innovation, and provide greater
value and choice to healthcare consumers'' (85 FR 25790). We also noted
in the ONC Cures Act Final Rule that research suggests that information
blocking practices ``weaken competition among health care providers by
limiting patient mobility'' and ``unnecessarily impede the flow of EHI
or its use to improve health and the delivery of care'' (85 FR 25791).
As required by section 3022(a)(3) of the PHSA, we recognized that
certain reasonable and necessary activities that could otherwise meet
the definition of information blocking should not be considered
information blocking, and therefore, established the initial eight
``exceptions'' to the definition of information blocking (see 45 CFR
171 Subpart B and C; a ninth exception was established by the HTI-1
Final Rule in Subpart D). Each reasonable and necessary activity
identified as an exception to the information blocking definition does
not constitute information blocking for purposes of section 3022(a)(1)
of the PHSA if the conditions of the exception are met (85 FR 25649).
Since the first eight regulatory exceptions to the information
blocking definition were finalized in 2020 (see ONC Cures Act Final
Rule, 85 FR 25642), the legal landscape has changed significantly for
many patients seeking, and for health care providers providing,
reproductive health care. In the wake of the decision in Dobbs v.
Jackson Women's Health Organization, 597 U.S. 215 (2022) decision, some
States have newly enacted or are newly enforcing restrictions on access
to reproductive health care. Uncertainties and other concerns that
people who seek reproductive health care and people who provide or
facilitate that care have about the legal landscape in the wake of the
Supreme Court's ruling--and subsequent State restrictions on
reproductive health care--have had far-reaching implications for health
care beyond access to abortion. This changing legal landscape increases
the likelihood that a patient's EHI may be disclosed in ways that erode
trust in health care providers and the health care system, ultimately
chilling an individual's willingness to seek, or other persons'
willingness to provide or facilitate, lawful health care as well as
individuals' willingness to provide full information to their health
care providers.
As a practical matter, a person's ability to access care of any
kind depends on a variety of factors including whether the care is
available. For health care to be available, licensed health care
professionals and health care facilities must be willing to provide
it--and people other than the licensed health care professionals must
be willing to take on various roles essential to delivering care in
this modern, technology-enabled environment. Also, patients' access to
care may rely in some part on services or supports from other persons,
such as a spouse or partner.
In the current environment, various jurisdictions might enact
legislation or attempt to enforce law that purports to authorize
administrative, civil, or criminal legal action against persons who
engage in reproductive health care that is required or authorized by
Federal law or that is permitted by the law of the jurisdiction where
the care is provided. Fear of being investigated or of having to defend
themselves against potential legal liability under such laws, even
where the health care provider or other person has reasonable
confidence the defense will be successful, may impact people's
willingness to provide or assist in reproductive health care that is
lawful under the circumstances in which such health care is provided.
[[Page 63628]]
On April 26, 2024, the HHS Office for Civil Rights (OCR) issued the
``HIPAA Privacy Rule to Support Reproductive Health Care Privacy''
final rule (89 FR 32976) (2024 HIPAA Privacy Rule) to adopt a
prohibition on the use or disclosure of PHI by an entity regulated
under the HIPAA Privacy Rule, in certain circumstances, for the
following purposes:
To conduct a criminal, civil, or administrative
investigation into any person for the mere act of seeking, obtaining,
providing, or facilitating lawful reproductive health care.
To impose criminal, civil, or administrative liability on
any person for the mere act of seeking, obtaining, providing, or
facilitating reproductive health care.
To identify any person for any purpose described above.
As noted in the National Coordinator's ONC Health IT blog post
titled ``Supporting Information Privacy for Patients, Now and Always:
Four Reminders of How HHS Information Blocking Regulations Recognize
Privacy Rules,'' on and after the 2024 HIPAA Privacy Rule's effective
date, a HIPAA covered entity's or business associate's practice of
refusing to make a use or disclosure of PHI that is prohibited under
that rule is excluded from the information blocking definition (45 CFR
171.103) because that refusal is required by law. Therefore, the
practice does not need to be covered by any information blocking
exception because it is not considered information blocking to begin
with.
The 2024 HIPAA Privacy Rule also establishes a requirement for
HIPAA covered entities and business associates to obtain attestations
prior to using or disclosing PHI potentially related to reproductive
health care for certain purposes (see 45 CFR 164.509 at 89 FR 33063).
The Precondition Not Satisfied (45 CFR 171.202(b)) sub-exception of the
information blocking Privacy Exception outlines a framework actors can
follow so that the actors' practices of not fulfilling requests to
access, exchange, or use EHI would not be considered information
blocking when a precondition of applicable law has not been satisfied.
By meeting the Precondition Not Satisfied sub-exception's requirements,
the actor can have confidence that their practices of not sharing EHI
because they have not obtained the required attestation will not be
considered information blocking.
The 2024 HIPAA Privacy Rule's new protections do not prohibit use
or disclosure of PHI for various purposes other than those specified in
45 CFR 164.502(a)(5)(iii), though the protections include additional
preconditions or limitations on disclosures for certain purposes (for
more information, please see the 2024 HIPAA Privacy Rule (89 FR 32976)
and consider visiting the HHS.gov Health Information Privacy section's
HIPAA and Reproductive Health page: https://www.hhs.gov/hipaa/for-professionals/special-topics/reproductive-health/index.html). The 2024
HIPAA Privacy Rule does not require a HIPAA covered entity or business
associate to obtain the attestations specified in 45 CFR 164.509 before
disclosing PHI (including PHI potentially related to reproductive
health care) for permissible purposes other than those specified in 45
CFR 164.512(d), (e), (f), or (g)(1). For example, the HIPAA Privacy
Rule continues to provide for uses and disclosures of PHI for
treatment, payment or health care operations purposes (see 45 CFR
164.506) that do not meet any of the prohibitions set out in 45 CFR
164.524(a)(5)(iii). Thus, an actor choosing to deny requests for
access, exchange, or use of EHI for a purpose permitted under HIPAA is
not making a denial that is ``required by law'' specifically under
HIPAA. As a result, the information blocking definition could be
implicated unless another applicable law requires the denial or a
regulatory exception applies. Similarly, an actor conditioning
fulfilment of such requests on preconditions that an actor chooses to
set (such as that the requestor provides an attestation that is not
required by any privacy law that applies in the circumstances) could
implicate the information blocking definition unless an exception
applies to that practice.
It may be helpful to pause here for a brief review of how the
information blocking regulations, which are based on statutory
authority separate from HIPAA, operate (independently of regulations
promulgated under HIPAA). This background information may help readers
understand how and why an actor may be concerned about potentially
implicating the information blocking definition (and penalties or
disincentives for information blocking authorized by the information
blocking statute) if the actor engages in practices that the HIPAA
Privacy Rule would require of a HIPAA covered entity or business
associate when the actor is not required to comply with the HIPAA
Privacy Rule.
First, information blocking regulations apply to health care
providers, health IT developers of certified health IT, and health
information networks (HIN) and health information exchanges (HIE), as
each is defined in 45 CFR 171.102. Any individual or entity that meets
one of these definitions is an ``actor'' and subject to the information
blocking regulations in 45 CFR part 171, regardless of whether they are
also a HIPAA covered entity (CE) or business associate (BA) as those
terms are defined in 45 CFR 160.103. Second, for purposes of the
information blocking regulations, the definition of ``EHI'' applies to
information ``regardless of whether the group of records are used or
maintained by or for a covered entity as defined in 45 CFR 160.103''
(Sec. 171.102, emphasis added). Therefore, it is possible for an
information blocking actor that is not required to comply with the
HIPAA Privacy Rule to have EHI that is not also PHI. It is also
possible for an actor (such as a HIN/HIE) to not be a HIPAA covered
entity itself and to exchange, maintain, or otherwise handle EHI on
behalf of network participants that are not required to comply with the
HIPAA Privacy Rule.
Where an actor that is not a HIPAA covered entity has EHI that is
not maintained on behalf of a HIPAA covered entity, the actor may be
concerned about potential information blocking consequences if the
actor were to engage in a practice such as denying requests for access,
exchange, or use of EHI that indicates or potentially relates to
reproductive health care for purposes for which the 2024 HIPAA Privacy
Rule would prohibit use or disclosure of PHI or would require an
attestation as a precondition for permitting disclosure of PHI.
There is a sub-exception within the Privacy Exception currently
codified in Sec. 171.202(c) that is available to a health IT developer
of certified health IT ``not covered by HIPAA.'' The sub-exception is
available ``if the actor is a health IT developer of certified health
IT that is not required to comply with the HIPAA Privacy Rule, when
engaging in a practice that promotes the privacy interests of an
individual'' (Sec. 171.202(c), please see Sec. 171.202(c) for the
requirements to meet the exception.) However, this exception represents
a departure from our general approach of designing each information
blocking exception to be available to all actors (regardless of whether
they must comply with the HIPAA Privacy Rule). The Sec. 171.202(c)
sub-exception is also not available to actors who meet the Sec.
171.102 definition of ``health care provider'' or ``HIN/HIE'' even if
they are not required to comply with the HIPAA Privacy Rule. (We refer
actors and other persons interested in learning more about how the
information blocking regulations, and particularly the
[[Page 63629]]
exceptions, work in concert with the HIPAA Rules and other privacy laws
to support health information privacy, to the discussion of this topic
in the HTI-1 Final Rule at 89 FR 1351 through 1354.)
We have come to understand that some health care providers and
other actors may have concerns about the risk of potential exposure to
legal action flowing from the uses and disclosures of EHI indicating or
(in the case of patient health concern(s) or history) potentially
relating to reproductive health care that remains permissible under
applicable law. For example, the HIPAA Privacy Rule permits a HIPAA
covered entity to disclose an individual's PHI to a health care
provider who is not a HIPAA covered entity for treatment activities.
Once PHI is in the possession, custody, or control of an entity that is
not regulated under the HIPAA Privacy Rule, the information is no
longer protected by the HIPAA Privacy Rule.
Thus, the HIPAA Privacy Rule's strengthened protections for PHI
would not preclude a health care provider (or other recipient of PHI
for other permissible purposes) who is not a HIPAA covered entity or
business associate from further disclosing individually identifiable
health information to someone who might then use the information to
potentially impose criminal, civil, or administrative liability on any
person for the mere act of seeking, obtaining, providing, or
facilitating reproductive health care (or any other care) that was
lawful under the circumstances in which it was provided.
We reiterate that the information blocking statute is separate from
the HIPAA statute and that the information blocking regulations operate
both separately and differently from the HIPAA regulations. One point
of such difference that is key to understanding why we propose a new
``Protecting Care Access Exception'' (Sec. 171.206) is that a HIPAA
covered entity or business associate is not required by the HIPAA
Privacy Rule to make a use or disclosure that the rule merely permits.
(The HIPAA Privacy Rule does require certain uses and disclosures of
PHI but merely permit various other uses and disclosures.) Persons
subject to the information blocking regulations, however, could
implicate the information blocking definition if they ``interfere
with'' any access, exchange, or use of EHI except as required by law or
covered by an exception. It is the implication of the ``information
blocking'' definition (and the potential to incur penalties or
disincentives for engaging in information blocking) that would cause an
actor to be concerned about, for instance, refusing to disclose EHI
indicating reproductive health care for permissible purposes to an
entity not required to comply with the HIPAA Privacy Rule and whom the
actor has reason to believe does not safeguard the privacy or security
of individuals' health information in compliance with the same
standards as would be required of a HIPAA covered entity or business
associate.
In a variety of situations where a patient or an actor may be
concerned that an access, exchange, or use of EHI may implicate any
person's physical safety interests or the individual's privacy
interests, other exceptions (such as the Preventing Harm Exception in
Sec. 171.201 or three of the four sub-exceptions of the Privacy
Exception in Sec. 171.202) are available to any actor who wants to
engage in practices that are likely to interfere with EHI access,
exchange, or use consistent with the conditions of the applicable
exception.
Currently, however, there are no exceptions in 45 CFR part 171 that
are designed to accommodate concerns an actor may have about a
patient's, health care provider's, or other person's risk of potential
exposure to legal action (investigation, action in court, or imposition
of liability) that could arise from \243\ the access, exchange, or use
for permissible purposes specific EHI (that is, one or more data
points)that indicates reproductive health care was sought, obtained,
provided, or facilitated. None of the current exceptions are designed
to accommodate similar concerns an actor may have about risk of
patients' potential exposure to legal action that could arise from the
sharing for permissible purposes of EHI that indicates health
condition(s) or history for which reproductive health care is often
sought, obtained, or medically indicated.\244\ Thus, where
preconditions (under the HIPAA Privacy Rule or other applicable law--or
both, where applicable) to the provision of access, exchange, or use of
EHI have been met, and another exception (such as Privacy (Sec.
171.202) or Preventing Harm (Sec. 171.201)) does not apply, attempts
to limit the disclosure of EHI for the purposes addressed in the
patient protection or care access condition of the proposed Protecting
Care Access Exception (Sec. 171.206(b) or (c)) could currently
constitute information blocking. (An actor's practice will only meet
the statutory or regulatory definition of information blocking if it
meets all of the definition's elements, including the knowledge
standard applicable to the actor engaged in the practice.)
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\243\ For purposes of this discussion and of the proposed
Protecting Care Access Exception, a risk need not be one that is
certain to occur, or that is likely to occur immediately following,
an access, exchange, or use of EHI in order to be one that could
arise from the access, exchange, or use.
\244\ In this preamble, we at some points use for brevity and
readability ``potentially related to reproductive health care'' as
shorthand for EHI that shows or would carry a substantial risk of
supporting an inference that (as described in proposed Sec.
171.206(b)(1)(iii)) the patient has health condition(s) or history
for which reproductive health care is often sought, obtained, or
medically indicated.
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Even for actors to whom the HIPAA Privacy Rule does not apply,
other laws (Federal, State, or Tribal) may apply preconditions that
must be satisfied in order for EHI to be shared without violating these
laws. For any actor, compliance with such other applicable law does not
implicate the information blocking definition, as ONC has discussed in
the HTI-1 Final Rule preamble (see 89 FR 1351 through 1354) and in
information resources available on ONC's official website
(HealthIT.gov). However, where the preconditions under such other
applicable law are met, any practice by an actor that is likely to
interfere with access, exchange, or use of EHI could implicate the
information blocking definition (Sec. 171.103) unless the actor's
practice is covered by an exception set forth in 45 CFR part 171.
The proposed new Protecting Care Access Exception (Sec. 171.206)
would be available to any actor, regardless of whether the actor is
also a HIPAA covered entity or business associate. The proposed
exception would apply regardless of whether another exception could
also apply to an actor's practice(s) in relevant scenarios. Other
exceptions would continue to be available in circumstances where the
conditions of the Protecting Care Access cannot be met but the other
exception(s) can be met. Each information blocking exception and each
provision of each exception is designed to stand independent of any and
every other exception unless any specific provision of an exception
might explicitly reference another exception (even then the dependency
is limited to the exact provision or function of such provision that
relies upon the cross-reference).
Thus, the proposed Protecting Care Access Exception would also
operate independently of any provision of any other exception in part
171 and any provision in 45 CFR 171 that does not reference it. It is
our intent that if any provision in Sec. 171.206 were, if or when
finalized, held to be invalid or unenforceable facially, or as applied
to
[[Page 63630]]
any person, plaintiff, or stayed pending further judicial or agency
action, such provision shall be severable from other provisions of
Sec. 171.206 that do not rely upon it and from any other provision
codified in 45 CFR part 171 that does not explicitly reference Sec.
171.206 even if such provisions were to be established or modified
through this same rulemaking action.
A patient's ability to access care can be adversely affected when a
provider believes they could be exposed to legal action based on the
mere fact that care is provided. Given the demonstrated chilling effect
of some States' laws on the availability of medically appropriate care,
it is reasonable and necessary for actors to mitigate risks of
potential exposure of health care professionals and other persons who
provide or facilitate, as well as those who seek or obtain,
reproductive health care that is lawful under the circumstances in
which the care is provided to legal action based on the mere fact that
such care was sought, obtained, provided, or facilitated. Thus, a new
exception is needed to address actors' concerns about potentially
implicating the information blocking definition (Sec. 171.103) if they
choose not to share applicable EHI in the circumstances where the
Protecting Care Access Exception (Sec. 171.206) would apply. This new
proposed exception (Sec. 171.206) is important in order to ensure
health care providers do not feel the need to adopt paper or hybrid
recordkeeping methods in place of fully electronic, interoperable
formats. Thus, we believe it is reasonable and necessary for an actor
to restrict access, exchange, or use of specific EHI that indicates or
(under Sec. 171.206(b)) is potentially related to reproductive health
care so that health care providers continue to use modern,
interoperable health IT that better promotes patient safety than would
paper or hybrid recordkeeping methods. Restricting EHI sharing under
the conditions of the proposed new Protecting Care Access Exception
(Sec. 171.206) is also necessary to preserve and promote public trust
in health care professionals, health care, and the health information
infrastructure.
We propose the Protecting Care Access Exception to address actors'
concerns about potentially implicating the information blocking
definition if they choose not to share EHI in an EHI sharing scenario
that an actor believes in good faith could risk exposing a patient,
provider, or facilitator of lawful reproductive health care to
potential legal action based on what care was sought, obtained,
provided, facilitated, or (specific to the patient protection
condition) is often sought, obtained, or medically indicated for the
patient's health condition(s) or history.
The HIPAA Privacy Rule does not prohibit the use or disclosure of
PHI that indicates or is potentially related to ``reproductive health
care'' as it is now defined in 45 CFR 160.103 (see 89 FR 32976 for
definition effective June 25, 2024; see also 89 FR 33005 through 33007
for the 2024 HIPAA Privacy Rule's preamble discussion of that
definition) where the use or disclosure is not for a purpose described
at 45 CFR 164.502(a)(5)(iii) and where the use or disclosure is
otherwise required or permitted by the HIPAA Privacy Rule. Therefore,
within the information blocking regulations, the proposed new
Protecting Care Access Exception is needed where an information
blocking actor (whether or not that actor is required to comply with
the HIPAA Privacy Rule) is concerned about the risk of potential
exposure to legal action (as we propose in Sec. 171.206(e) to define
``legal action'') flowing from an access, exchange, or use of such EHI
for a permissible purpose.
We recognize that no information blocking exception can address all
of the concerns a person may have about potential legal action for the
mere act of seeking, obtaining, providing, or facilitating reproductive
health care. However, to the extent such concerns may be mitigated by
actors' withholding relevant EHI from access, exchange, or use that all
other applicable law would permit and where no other existing
information blocking exception applies, we believe such withholding of
EHI is reasonable and necessary. We are concerned that actors'
uncertainty about whether such withholding of EHI could implicate the
information blocking definition could prevent actors from withholding
EHI unless an exception applies. Thus, we believe the Protecting Care
Access Exception is needed to address actors' concerns specific to
information blocking related to the risk of providers changing or
limiting what care they are willing to offer (such as when a
professional changes practice specialty or a hospital closes a service
or department).
When providers limit what care they are willing to offer or what
new patients they are willing to accept, it may be more difficult for
those who seek care to get access to care they need. When patients'
needs are not being met, they lose trust in the health care system and
in their physicians. Trust in one's own physician, in general,
correlates with better care satisfaction and outcomes. This could also
be true of other types of health care providers. Thus, we believe that
addressing actors' uncertainty specific to information blocking with
the proposed Protecting Care Access Exception would promote better
patient satisfaction and health outcomes as well as continued
development, public trust in, and effective nationwide use of health
information technology infrastructure to improve health and care.
Moreover, actors' uncertainty about the potential information
blocking implications of not sharing all of the EHI that applicable
laws would permit them to share could undermine health care
professionals' (and other health care providers') confidence in their
ability to protect the privacy and confidentiality of their patients'
EHI. Such a lack of confidence on the part of health care providers can
in turn erode a patient's trust.
Patient trust in physician confidentiality and competence is
associated with patients being less likely to withhold information from
doctors and more likely to agree it is important for health care
providers to share information with each other. Thus, actors' narrowly
tailored restrictions on (otherwise lawful) sharing of specific EHI in
the circumstances addressed by the proposed exception in Sec. 171.206
would be reasonable and necessary to preserve patient trust in the
health IT infrastructure and information sharing, not just to protect
the availability and safety of care and to promote better care
outcomes.
One of the goals of the information blocking exceptions is ``to
accommodate practices that, while they may inhibit access, exchange, or
use of EHI, are reasonable and necessary to advance other compelling
policy interests . . .'' including ``[p]romoting public confidence in
the health IT infrastructure by supporting the privacy and security of
EHI and protecting patient safety,'' as we explained in the ONC Cures
Act Final Rule (85 FR 25791). In the absence of an information blocking
exception applicable to risks of legal actions that actors believe
could arise from the sharing EHI for permissible purposes (for
instance, with entities not required to comply with the HIPAA Privacy
Rule), we are concerned actors may be unwilling to engage in these
practices that--for example--advance public confidence in health IT
infrastructure and protect patient safety.
If actors are unwilling to engage in such practices, health care
providers may convey to patients an inability to withhold EHI even when
they believe withholding the EHI could mitigate the potential risks
cognizable under the
[[Page 63631]]
Protecting Care Access Exception. If patients are aware that health
care providers believe that they are unable to avoid sharing EHI to
mitigate risks of potentially exposing care providers, recipients, or
facilitators to legal action then patients may be less willing to be
candid with their providers about their health history, conditions, or
other information relevant to the patient's care. Without that candor,
health care providers may be unable to provide care that will best meet
the patient's needs.
In addition, a care provider's lack of confidence or competence in
their ability to adequately safeguard the privacy of information that
care recipients share with them could erode the mutual trust that
contributes to better care outcomes by promoting more effective
relationships between care providers (including clinicians) and the
individuals receiving care.
In the absence of an exception applicable to practices that the
proposed Protecting Care Access Exception would cover, we are concerned
that health IT developers of certified health IT and HINs/HIEs may be
unwilling to take the actions necessary to address their own, or their
customer health care provider's, good faith belief that particular
sharing of specific EHI could create the risk of potential exposure of
a health care provider (or persons seeking, obtaining, providing, or
facilitating care) to legal action regarding health care items and
services that are lawful under the circumstances in which such health
care is provided. Thus, health care providers in these situations may
believe they are faced with a choice between changing what care they
offer (such as when a hospital closes a department) or switching at
least some portions of their clinical records from electronic to paper
formats specifically to avoid concerns that they may be engaged in
information blocking.
For health care professionals in reproductive health care
specialties or whose practice necessarily includes patients who need
reproductive health care, a partial or complete switch to paper-based
recordkeeping for that care may seem like their only option. (Because
the information blocking definition references ``electronic health
information'' rather than all ``protected health information,'' the
information blocking regulations do not apply to health information
maintained only in paper format.)
A reversal to paper-based methods of keeping even a relatively
small portion of the records currently managed using modern health IT
would have an adverse effect on interoperability and on the development
of a nationwide health IT infrastructure that does the things
identified in section 3001(b) of the PHSA. Thus, such a reversal to
paper-based recordkeeping methods would impede the goals of promoting
public confidence in the electronic health information infrastructure
and of advancing patient safety through the use of interoperable health
IT and EHI. For example, information kept only on paper is not
available to support tools that help clinicians avoid adverse drug
events by automatically checking for potential drug-drug or drug-
allergy interactions.
For the reasons discussed above, we believe actors' practices of
limiting EHI sharing under the conditions of the proposed Sec. 171.206
exception are reasonable and necessary to preserve advances in
digitization, interoperability, and public confidence in the nationwide
health information technology infrastructure. Actors selectively
withholding EHI that indicates or is potentially related to
reproductive health care (as applicable) under the conditions of the
proposed Sec. 171.206 would also promote patient safety and improve
outcomes by fostering trust between care providers and recipients.
Maintaining advances and trust in the health information technology
infrastructure fosters better care by continuing to make information
available to more care providers and care recipients when and where the
information can help them choose the right care for each patient (care
recipient). Use of interoperable, electronic health IT and exchange of
EHI also enables providers to use decision support tools, such as drug-
drug interaction alerting, and to deliver better care.
The proposed Protecting Care Access Exception (Sec. 171.206) could
apply in some circumstances where another exception (such as Preventing
Harm (Sec. 171.201) or Privacy (Sec. 171.202)) would or could also
apply. The proposed new exception is, however, intended to stand alone
and independent of other. The proposed Protecting Care Access Exception
would not affect if, how, or when any provision of any exception that
does not explicitly reference Sec. 171.206 applies to an actor's
practice, or how any such provision operates. Moreover, where facts and
circumstances were such that an actor could choose to shape their
practice in withholding EHI to satisfy either the Protecting Care
Access Exception (if finalized) or another exception, the actor would
have discretion to choose which exception they wish to satisfy. An
actor's practice in such situation(s) would not need to satisfy both
exceptions in order for the practice to not be considered information
blocking.
One of the existing information blocking exceptions applicable in
some circumstances where the proposed Protecting Care Access Exception
could also apply is the Privacy Exception. Of particular relevance to
actors' confidence that they will not be ``information blocking'' if
they withhold EHI based on the individual's preference that their EHI
be closely held is the Privacy Exception's sub-exception ``respecting
an individual's request not to share information'' (Sec. 171.202(e)).
This Privacy sub-exception is applicable where an actor agrees to
honor an individual's request not to share their EHI even where it is
permissible to share under all applicable law. We are proposing to
strengthen and simplify that Sec. 171.202(e) Privacy sub-exception as
discussed in section IV.B.1.c of this proposed rule. The Sec.
171.202(e) sub-exception offers actors certainty that they can, if they
so choose, honor an individual's preference for restrictions on the
sharing of EHI about the individual without subjecting the actor to an
information blocking penalty or disincentive for not sharing such EHI.
However, while the Sec. 171.202(e) sub-exception does not rest on why
the individual may prefer that some or all of their EHI not be shared,
the Sec. 171.202(e) sub-exception only applies to scenarios where the
individual requests the restrictions. There may be circumstances where
an individual does not request the restriction, but when it would be
reasonable and necessary for actors to interfere with access, exchange,
or use of EHI for the purpose of addressing individuals' (let alone
providers' and others') risk of potential exposure to legal action that
could discourage availability, access, and choice of medically
appropriate reproductive health care.
We believe it would be burdensome to individuals, in the constantly
changing legal landscape, to rely exclusively on them to make or update
requests for restrictions on their EHI that indicates or is potentially
related to reproductive health care. In such a complex and uncertain
environment, any individual may experience difficulty in making timely
requests for such restrictions. Moreover, some individuals may not have
the resources--such as affordable, secure access to the internet--to
update their providers on their information sharing preferences outside
of the occasions that they interact with these providers to obtain
health care. Thus, individuals may not be able to request
[[Page 63632]]
restrictions soon enough, or that are broad enough, to protect
themselves or others from potential legal liability based on what care
they have received.
An individual's request for restrictions on sharing their EHI is
specific and limited to that individual's EHI, and (depending on what
the individual chooses to request) may be specific to identified
requestors of the individual's EHI. Thus, it is not as efficient for
actors to implement such individual restrictions as it would be to
implement restrictions based on an organizational policy that
consistently addresses a concern common to sharing any individuals' EHI
in a particular access, exchange, or use scenario--such as the actor's
good faith belief that there is a concern regarding the risk of
potential exposure to legal action that could be created or increased
by propagating to a recipient not required to comply with the HIPAA
Privacy Rule the specific EHI within a patient's record that indicates
the receipt of reproductive health care.
For these reasons, we believe that health care providers and other
actors must have available to them an information blocking exception
designed to apply to practices that the actor believes could help to
avoid creating--through sharing of EHI indicating or potentially
related to reproductive health care in relevant scenarios--a risk of
potential exposure to legal action based on the mere fact that lawful
reproductive health care was sought, obtained, provided, or facilitated
(or where the proposed patient protection condition would apply,
because the EHI indicates patient health history or condition(s) for
which reproductive health care is often sought, obtained, or medically
indicated).
When an actor has a belief consistent with the proposed Sec.
171.206(a)(1) belief requirement, we believe an exception should be
available that is designed to cover practices likely to interfere with
access, exchange, or use of EHI under certain conditions.\245\
Therefore, we propose in Sec. 171.206 a new Protecting Care Access
Exception from the information blocking definition. When its conditions
are met, the new exception would cover an actor's practices that
interfere with access, exchange or use of EHI in order to reduce
potential exposure of applicable persons to legal action (as defined in
the exception). For the proposed exception to apply, the potential
exposure to legal action that the actor believes could be created must
be one that would arise from the fact that reproductive health care was
(or may have been) sought, obtained, provided, or facilitated rather
than because the care provided was (or is alleged to have been)
clinically inappropriate or otherwise substandard.
---------------------------------------------------------------------------
\245\ These conditions would be those specified in the
exception.
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We note here that the statutory authority in PHSA section
3022(a)(3) is to ``identify reasonable and necessary activities that do
not constitute information blocking.'' Thus, practices that meet the
applicable conditions of the proposed new Protecting Care Access
Exception (Sec. 171.206) would not be considered information blocking
(as defined in PHSA section 3022(a)(1) and 45 CFR 171.103), and,
therefore, actors would not be subject to civil monetary penalties or
disincentives under HHS information blocking regulations based
specifically on those practices.
However, as is the case with exceptions already established in 45
CFR part 171, the proposed exception would not override an actor's
obligation to comply with a mandate contained in law that requires
disclosures that are enforceable in a court of law. For example, the
proposed exception would not invalidate otherwise valid court-ordered
disclosures, or disclosures (for example, infectious disease, or child
or elder abuse case reports) mandated by a Federal, State, or Tribal
law with which an actor is required to comply in relevant
circumstances. The exception is also not intended to justify an attempt
to limit the legally required production of (otherwise discoverable)
EHI in a civil, criminal, or administrative action that is brought in
the jurisdiction where a health care provider provided health care that
a patient (or their representative) alleges was negligent, defective,
substandard, or otherwise tortious. Similarly, the exception would not
apply to, and is not intended to justify, attempts to avoid disclosing
information where the actor's belief is that the information could be
useful to a legal action against the actor or other person specific to
alleged violations of Federal or other law against conduct other than
merely seeking, receiving, providing, or facilitating reproductive
health care. One example of such other conduct would be a physical
assault of any natural person, even if the assault occurred in a health
care setting.\246\
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\246\ The definition of ``person'' for purposes of 45 CFR part
171 is codified in Sec. 171.102 and is, by cross-reference to 45
CFR 160.103, the same definition used for purposes of the HIPAA
Privacy Rule (45 CFR part 160 and subpart E of 45 CFR part 164). The
Sec. 160.103 definition of ``person'' clarifies the meaning of
``natural person'' within it. We use ``natural person'' with that
same meaning in proposed Sec. 171.206(b)(3) and throughout this
discussion of proposed Sec. 171.206.
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We emphasize that if the proposed Protecting Care Access Exception
were to be finalized, actors would continue to be subject to other
Federal laws, and to State and Tribal laws. This is consistent with how
the information blocking exceptions in place today operate in harmony
with, but separate from, requirements of other statutes and
regulations--including, among others, the HIPAA Privacy Rule's
individual right of access (45 CFR 164.524).
For example, an actor that is also a HIPAA covered entity may
receive a request from an individual for access to EHI of which the
individual is the subject, in a manner (form and format) specified by
the individual. If the actor is technically unable to fulfill the
request, or if the individual and actor cannot come to agreement on
terms to fulfill the request in the manner requested or an alternative
manner consistent with Sec. 171.301(b), the actor may be able to
satisfy the Infeasibility Exception by meeting that exception's manner
exception exhausted (Sec. 171.204)(a)(4)) and the responding to
requests (Sec. 171.204(b)) conditions. By satisfying the Infeasibility
Exception, the actor's practice of failing to fulfill the request for
access, exchange, or use of EHI will not be considered information
blocking. However, the actor in this example is a HIPAA covered entity
and, therefore, must comply with the HIPAA Privacy Rule's right of
access at 45 CFR 164.524, even though the actor's practices in failing
to provide access, exchange, or use of EHI met the requirements to be
covered by the Infeasibility Exception (Sec. 171.204) for purposes of
the information blocking regulations.
Consistent with our approach to establishing the initial eight
information blocking exceptions, the conditions of the proposed
Protecting Care Access Exception (Sec. 171.206) are intended to limit
its application to the reasonable and necessary activities enumerated
within the exception. Therefore, our proposed Protecting Care Access
Exception would (for purposes of the information blocking definition in
Sec. 171.103) cover an actor's practice that is implemented to reduce
potential exposure of persons meeting the Sec. 171.202(a)(2)(i) or
(ii) definition of ``individual,'' other persons referenced or
identifiable from EHI as having sought or obtained reproductive health
care, health care providers, or persons who facilitate access to or
delivery of health care to potential threats of legal action based on
the decision to seek, obtain, provide, or facilitate reproductive
health care, or on patient health information potentially related to
[[Page 63633]]
reproductive health care, subject to the exception's conditions.
Because we propose in this rule an exception that relies on the
``reproductive health care'' definition in 45 CFR 160.103, we also
propose to add to Sec. 171.102 the following: ``Reproductive health
care is defined as it is in 45 CFR 160.103.'' We refer readers to 45
CFR 160.103or 89 FR 32976 for that definition, which became effective
for purposes of the HIPAA Privacy Rule on June 25, 2024.\247\ We refer
readers interested in learning more about this definition to 89 FR
33005 through 33007 for the 2024 HIPAA Privacy Rule's preamble
discussion of the ``reproductive health care'' definition.
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\247\ The addition of the ``reproductive health care''
definition to 45 CFR 160.103 is reflected in the Electronic Code of
Federal Regulations (eCFR) system at https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-C/part-160/subpart-A/section-160.103
at the time this proposed rule (HTI-2) is issued. The annual
revision of the published Title 45 occurs on October 1. (The eCFR is
a continuously updated online version of the CFR. Please see the
following website for more information about the eCFR system:
https://www.ecfr.gov/reader-aids/using-ecfr/getting-started.)
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For this exception to apply to an actor's practice that is likely
to interfere with EHI access, exchange, or use, the practice would have
to satisfy the threshold condition in the proposed paragraph (a), and
at least one of the other conditions (proposed paragraph (b) or (c)) of
the proposed exception. These conditions are discussed in detail below.
An actor's practice could satisfy both conditions (b) and (c) at the
same time, but the minimum requirement for the exception to apply would
be that the practice satisfy at least one of these two conditions in
complement to the threshold condition in paragraph (a).
b. Threshold Condition and Structure of Exception
The Sec. 171.206(a) threshold condition's requirements must be
satisfied in order for any practice to be covered by the proposed
exception. To meet the condition's subparagraph (a)(1) belief
requirement, the practice must be undertaken based on a good faith
belief that:
the person(s) seeking, obtaining, providing, or
facilitating reproductive health care are at risk of being potentially
exposed to legal action that could arise as a consequence of particular
access, exchange or use of specific EHI; and
the practice could reduce that risk.
To satisfy the belief requirement (Sec. 171.206(a)(1)), the
actor's belief need not be accurate, but must be held in good faith. We
are also considering, and seek comment, on whether actors, patients, or
other interested parties may view ``good faith belief'' as a standard
that is unnecessarily stringent or that could make the Protecting Care
Access Exception difficult for small actors with limited resources,
such as small and safety net health care providers, to confidently use.
We are also interested in any thoughts or concerns commenters may have
about the ``good faith belief'' standard and how such concerns could be
mitigated by the addition to Sec. 171.206 of a presumption that an
actor's belief is held in good faith.
To ensure we have flexibility to do so in case we determine it is
the optimal approach after considering public comments on the proposed
Protecting Care Access Exception, we propose in the alternative to do
one or both of the following: (1) set ``belief'' or ``honest belief''
rather than ``good faith belief'' as the substantive standard in Sec.
171.206(a); or (2) add to Sec. 171.206 a provision for HHS to presume
an actor's belief met the standard unless we have or find evidence that
the actor's belief did not meet the standard at all relevant times
(relevant times are those when the actor engaged in practices for which
the actor seeks application of the exception).
Like ``good faith belief,'' ``belief'' or ``honest belief'' would
be a subjective rather than an objective standard. Under either
alternative, the actor's belief would not be required to be accurate
but could not be falsely claimed. Unlike ``good faith,'' neither
``belief'' nor ``honest belief'' is a particularly long established and
widely used legal standard. However, we are interested in actors' and
other commenters' views on whether these standards might help to reduce
potential misunderstanding of Sec. 171.206(a) and what would be
necessary for an actor to meet the proposed ``good faith belief''
standard.
Where an actor is a business associate of another actor or
otherwise maintains EHI on behalf of another actor, this exception
would (where its requirements are otherwise fully satisfied) apply to
practices implemented by the actor who maintains EHI based on the good
faith belief and organizational policy or case-by-case determinations
of the actor on whose behalf relevant EHI is maintained. We propose in
the alternative to require that each actor rely only on their own good
faith belief in order to implement practices covered by the Protecting
Care Access Exception, including when an actor maintains EHI on behalf
of other actor(s) or any other person(s). We welcome comment on both of
these approaches to the good faith belief requirement where the actor
implementing the practice is doing so in relation to EHI maintained on
behalf of another actor.
As discussed in section IV.B.3.e, we propose to define ``legal
action'' for purposes of Sec. 171.206 to include a broad array of
criminal, civil, and administrative investigations, actions, and
proceedings as specified in the proposed Sec. 171.206(e)(1)-(3).
We emphasize that to satisfy the proposed Protecting Care Access
Exception, an actor's practice that is likely to interfere with lawful
access, exchange, or use of EHI would need to fully satisfy relevant
requirements of the threshold condition in Sec. 171.206(a) and at
least one of the other two conditions (Sec. 171.206(b) or Sec.
171.206(c)).\248\ Thus, a practice could not satisfy the exception if
implemented based on an actor's good faith belief about any access,
exchange, or use (that is permitted under HIPAA Privacy Rule and any
other applicable privacy law) that potentially creates or increases
anyone's risk of facing any legal action that would not be based upon a
person having merely sought, obtained, provided, or facilitated care
that was lawful under the circumstances in which such health care was
provided. The exception is not intended to apply to an actor's
interference with access, exchange, or use of EHI based on an actor's
belief that the practice would reduce any person's exposure to legal
action or liability based on the conduct that was not the mere act of
seeking, obtaining, providing, facilitating, or (where the patient
protection condition applies, potentially needing) reproductive health
care that was, under the circumstances in which the conduct occurred,
unlawful.
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\248\ In relevant circumstances, an actor's practice might meet
both the Sec. 171.206(b) patient protection and Sec. 171.206(c)
care access conditions simultaneously. But each of these conditions
could also apply in circumstances where the other does not. Thus,
the proposed exception is intended and designed to apply where
either or both of the patient protection and care access conditions
are met in complement to the Sec. 171.206(a) threshold condition.
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The belief requirement (subparagraph (1)) of the threshold
condition (Sec. 171.206(a)) would ensure that the exception is
applicable only in situations where an actor has a good faith belief
that their practice of interfering with the access, exchange, or use of
EHI that indicates the seeking, obtaining, providing or facilitating of
reproductive health care (not with EHI access, exchange, or use in
general or universally) could reduce a risk of potential exposure to
legal action against identifiable persons that could otherwise arise as
a consequence of the
[[Page 63634]]
particular access, exchange or use of specific EHI that is affected by
the practice. To satisfy the Sec. 171.206(a)(1) requirement, the
actor's good faith belief would need to be that persons seeking,
obtaining, providing, or facilitating reproductive health care ``are at
risk'' of being potentially exposed to legal action. This does not mean
that the exception would apply only where the actor is confident that
legal action will follow from access, exchange, or use of EHI related
to reproductive health care. ``Are at risk'' would simply mean that the
risk the actor believes might arise as a consequence of the affected
access, exchange, or use of EHI is one that could, to the best of the
actor's knowledge and understanding, arise under law that is in place
at the time the practice(s) that is based on the belief are
implemented. Thus, the proposed Sec. 171.206 exception would not apply
to practices undertaken based on a hypothetical risk of exposure to
legal action, such as one the actor postulates could perhaps become
possible if applicable law(s) were to change in the future. Similarly,
where an actor may believe a risk exists that someone could potentially
be exposed to legal action but does not believe that a particular
practice could achieve some reduction in that risk, the Sec.
171.206(a)(1) requirement would not be met by (and therefore the Sec.
171.206 exception would not apply to) that practice.
The Sec. 171.206(a) threshold condition's tailoring requirement
(Sec. 171.206(a)(2)) is intended to further restrict the exception's
coverage to practices that are no broader than necessary to reduce the
risk of potential exposure to legal action that the actor has a good
faith belief could arise from the particular access, exchange or use of
the specific EHI.
Like similar provisions in other exceptions, this tailoring
requirement ensures that the exception would not apply to an actor's
practices likely to interfere with access, exchange, or use of all of
an individual's EHI when it is only portions of the EHI that the actor
believes could create the type of risk recognized by the exception.
Where only portion(s) of the EHI an actor has pertaining to one or more
patients pose a risk of potentially exposing some person(s) to legal
action, the proposed Protecting Care Access Exception would apply only
to practices affecting particular access, exchange, or use of the
specific portion(s) of the EHI that pose the risk.
Data segmentation is important for exchanging sensitive health data
(as noted in the ONC Cures Act Final Rule at 85 FR 25705) and for
enabling access, exchange, and use of EHI (as noted in the HTI-1
Proposed Rule at 88 FR 23874). We are aware of external efforts to
innovate and mature consensus technical standards, and we hope this
will foster routine inclusion of increasingly advanced data
segmentation capabilities in more EHR systems and other health IT over
time.
However, we have received public feedback (both prior to and in
response to the HTI-1 Proposed Rule request for information on health
IT capabilities for data segmentation and user/patient access at 88 FR
23874 through 23875) indicating that there is currently significant
variability in health IT products' capabilities to segment data, such
as to enable differing levels of access to data based on the user and
purpose. We recognize there is a potential that some actors who may
wish to withhold specific EHI under the conditions specified in the
proposed Protecting Care Access Exception (Sec. 171.206) may not yet
have the technical capability needed to unambiguously segment the EHI
for which Sec. 171.206 would apply from other EHI that they could
lawfully make available for a particular access, exchange, or use.
Therefore, we propose elsewhere in this proposed rule to modify the
Infeasibility Exception's segmentation condition (Sec. 171.204(a)(2))
to explicitly provide for circumstances where the actor cannot
unambiguously segment EHI that may be withheld in accordance with
Protecting Care Access Exception (Sec. 171.206) from the EHI for which
this exception is not satisfied. (This and other proposed revisions to
Sec. 171.204(a)(2) are discussed in section IV.B.2.A of this proposed
rule.)
The implementation requirement in subparagraph (a)(3) of the
threshold condition is intended to ensure that practices are applied
fairly and consistently while providing flexibility for actors to
implement a variety of practices, and to do so through organizational
policy or in response to specific situations, as best suits their
needs. We propose that any given practice could satisfy this
implementation requirement in either of two ways. First, an actor could
undertake the practice consistent with an organizational policy that
meets the requirements proposed in Sec. 171.206(a)(3)(i). To satisfy
the proposed requirement in this first way, the organization's policy
would need to identify the connection between the particular access,
exchange, or use of the specific EHI with which the practice interferes
and the risk of potential exposure to legal action that the actor
believes could be created by such access, exchange, or use. The policy
would also need to be:
in writing;
based on relevant clinical, technical, or other
appropriate expertise;
implemented in a consistent and non-discriminatory manner;
and
structured to ensure each practice implemented pursuant to
the policy satisfies paragraphs (a)(1) and (a)(2) as well as at least
one of the conditions in paragraphs (b) or (c) of Sec. 171.206 that is
applicable to the prohibition of the access, exchange, or use of the
EHI.
In order to ensure each practice implemented pursuant to the policy
applies only to the particular access, exchange, or use scenario(s) to
which at least one of the conditions in paragraphs (b) or (c) of Sec.
171.206 is applicable, a policy would need to specify the facts and
circumstances under which it would apply a practice. Such
specifications need not be particularized to individual patients but
would need to identify with sufficient clarity for the actor's
employees and business associates (or other contractors, as applicable)
to accurately apply the practice only to relevant access, exchange, or
use scenarios. The types of facts or circumstances the policy might
need to specify may vary, but we believe might often include such
details as to what EHI (such as what value set(s) within what data
element(s)) and to what scenario(s) of access, exchange, or use the
policy will apply to a practice.
There may be value sets currently available or in development by
various parties that may help an actor to identify what EHI within the
actor's EHR or other health IT systems indicates care meeting the
reproductive health care definition in 45 CFR 160.103. However, we do
not propose to limit the application of the exception to any specific
value set(s). Because version updates of such value sets, or new value
sets, may develop more rapidly than adoption or reference of them in
regulations could occur, we believe the intended operation of the
exception will be best served by leaving actors flexibility to
identify, document in their organizational policy or case-by-case
determination(s), and then use whatever value set(s) comport with their
belief that a risk of potential exposure to legal action (consistent
with the exception's conditions) could be created or increased by
sharing specific EHI indicating or (where the patient protection
condition applies) potentially related to reproductive health care.
The proposed provision in paragraph (a)(3)(ii) offers actors the
second of the two ways to satisfy subparagraph (a)(3):
[[Page 63635]]
by making determination(s) on a case-by-case basis. To satisfy
paragraph (a)(3)(ii), any case-by-case determination would need to be
made in the absence of an organizational policy applicable to the
particular situation and be based on facts and circumstances known to,
or believed in good faith by, the actor at the time of the
determination. A practice implemented based on the determination must
also be tailored to reduce the risk of legal action the actor has a
good faith belief could result from access, exchange, or use of the
EHI. And the practice must be no broader than necessary to reduce the
risk of potential exposure to legal action (paragraphs (a)(1) and
(a)(2)).
Finally, to meet paragraph (a)(3)(ii), the determination made on a
case-by-case basis would need to be documented either before or
contemporaneous with beginning to engage in any practice(s) based on
the determination. The documentation of the determination must identify
the connection or relationship between the interference with access,
exchange, or use of EHI indicating or related to reproductive health
care and the risk of potential exposure to legal action. By identifying
the connection or relationship, this documentation would explain what
risk the actor believes the practice(s) will mitigate.
The proposed Sec. 171.206(a)(3) implementation requirement's
optionality would support the actor's interest in having flexibility to
address both relatively stable and more dynamic facts and
circumstances. Each of the options is intended to balance this interest
of the actor with the interests of others, including the actor's
current and potential competitors, in ensuring that any information
blocking exception does not apply to practices that are not necessary
for the specific purpose(s) the exception is designed to serve. The
subparagraph (a)(3)(i) organizational policy provision would allow
actors to apply relevant expertise available at the time of creating
and updating organizational policies to craft a policy that suits their
circumstances (such as technological capabilities and staffing and the
types of scenarios they have experienced or expect to experience,
perhaps with some regularity). The case-by-case determination provision
(sub-paragraph (a)(3)(ii)) ensures the proposed exception would be
available for all actors across the full array of facts and
circumstances they may encounter, including unanticipated ones.
We are considering adding to the Sec. 171.206(a) threshold
condition an additional requirement that the actor's practice must not
have the effect of increasing any fee for accessing, exchanging, or
using EHI that the actor chooses to seek from an individual (as defined
in Sec. 171.202(a)) or counsel representing the individual in an
action or claim contemplated, filed, or in progress with a Federal
agency, in Federal court, or a court in the jurisdiction where care was
provided. We propose this requirement in the alternative. This
alternative proposal would mean that the proposed exception would not
be met by an actor's practice that had such effect even if any fee that
the actor chooses to charge for access, exchange, or use of EHI would,
after such increase, continue to satisfy the Fees Exception (Sec.
171.302). We seek comment on this potential additional requirement for
an actor's practice to satisfy the proposed threshold condition (Sec.
171.206(a)).
c. Patient Protection Condition
The proposed patient protection condition in paragraph (b) of Sec.
171.206 could be met by practices implemented for the purpose of
reducing the patient's risk of potential exposure to legal action (as
legal action would be defined in Sec. 171.206(e)). Further narrowing
the practices that could satisfy the condition, paragraph (b)(1) would
require that the practice affect only specific EHI (the data point or
points) that the actor in good faith believes demonstrates, indicates,
or would carry a substantial risk of supporting a reasonable inference
that the patient has: (1) obtained reproductive health care that was
lawful under the circumstances in which such care was provided; (2)
inquired about or expressed an interest in seeking reproductive health
care; or (3) particular demographic characteristics or health
condition(s) or history for which reproductive health care is often
sought, obtained, or medically indicated.
For purposes of Sec. 171.206, we would interpret ``lawful under
the circumstances in which it was provided'' to mean that when, where,
and under relevant circumstances (such as, for health care, the
patient's clinical condition and a rendering health care provider's
scope of practice) the care was:
protected, required, or authorized by Federal law,
including the United States Constitution, in the circumstances under
which such health care is provided, regardless of the State in which it
is provided; or
not prohibited by Federal law and lawful under the law of
the jurisdiction in which it was provided.
Where care is not prohibited by Federal law and permitted under the
law of the jurisdiction in which it is provided, we would consider the
care lawful regardless of whether the same care would, under otherwise
identical circumstances, also be unlawful in other circumstances (for
instance, if provided in another jurisdiction).
The patient protection condition proposed in Sec. 171.206(b) would
provide the actor discretion and flexibility over time to determine
which EHI poses a risk of potential exposure to legal action. At the
same time, the Sec. 171.206(b)(1) requirement that the practice
``affect only the access, exchange, or use of specific electronic
health information the actor believes could expose the patient to legal
action'' because it shows or carries a substantial risk of supporting
an inference of one of the things described in subparagraphs (i)
through (iii) would preserve the expectation that the actor would share
other EHI that the actor does not believe poses such a risk unless
another exception applies, or sharing restriction(s) under other law
apply, to that other EHI in relevant circumstances.
We propose that even when an actor has satisfied the requirements
in paragraph (b)(1), the practice would be subject to nullification by
the patient if the patient explicitly requests or directs that a
particular access, exchange, or use of the specific EHI occur despite
any risk(s) the actor has identified to the patient. This requirement
(paragraph (b)(2)) is intended to respect patients' autonomy to choose
whether and when to share their own EHI. The requirement would prevent
the exception from applying where an actor is attempting to substitute
their judgment or tolerance of risks to the patient for the patient's
own judgment.\249\
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\249\ The patient protection condition in Sec. 171.206(b) would
apply to practices implemented for the purpose of reducing the
patient's risk of potential exposure to legal action (as legal
action would be defined in Sec. 171.206(e). The care access
condition in Sec. 171.206(c) would apply to practices an actor
implements to reduce potential exposure to legal action based on the
mere fact that reproductive health care occurred for persons, other
than the person seeking or receiving care, who provide care or are
otherwise involved in facilitating the provision or receipt of
reproductive health care that is lawful under the circumstances in
which it is provided. In some circumstances, an actor's practice
might meet both the Sec. 171.206(b) patient protection and Sec.
171.206(c) care access conditions simultaneously. But each of these
conditions could also apply in circumstances where the other does
not. Thus, the proposed exception is intended and designed to apply
where either or both of the patient protection and care access
conditions are met in complement to the Sec. 171.206(a) threshold
condition.
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[[Page 63636]]
We clarify in proposed paragraph (b)(3) that for purposes of the
patient protection condition ``patient'' means the natural person who
is the subject of the electronic health information or another natural
person referenced in, or identifiable from, the EHI as a person who has
sought or obtained reproductive health care. We propose to also
recognize as ``patients,'' for purposes of this condition, natural
persons other than the natural person who is the subject of the EHI
because we are aware that in the field there may be times when
information about a parent's reproductive health care is included in
the EHI of a child. (A child's parent is often identified in or
identifiable through the child's EHI.)
We note that the patient protection condition, and generally the
exception, are not intended to permit any actor to avoid legal
consequences resulting from malpractice or their own wrongdoing. The
proposed exception is also not intended to have any effect on any
obligation an actor has to comply with disclosure requirements under
Federal, State, or Tribal law that applies to the actor. Even where an
actor could deny any given access, exchange, or use of EHI for
permissible purposes consistent with an information blocking exception,
the actor who is a HIPAA covered entity or business associate would
still have to comply with the 45 CFR 164.524 individual right of
access, and any actor would still have to comply with other valid,
applicable law compelling the actor to make the EHI available for
permissible purposes.\250\ For example, the actor would still need to
comply with applicable legal discovery rules and judicial orders issued
by a court of competent jurisdiction. Non-compliance with such other
laws could subject the actor to sanctions under those other laws
regardless of whether the actor's practice would also be considered
information blocking or would instead be covered by an exception set
forth in any subpart of 45 CFR part 171.
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\250\ For purposes of the information blocking regulations,
``permissible purpose'' is defined in 45 CFR 171.102.
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We are also considering, and propose in the alternative, adding one
or more of the following explicit requirements to the patient
protection (Sec. 171.206(b)), care access (Sec. 171.206(c)), or
threshold (Sec. 171.206(a)) condition(s) so that to be covered by the
exception the actor's practice must not:
if undertaken by any actor that is also a HIPAA covered
entity or business associate, delay beyond the time allowed under 45
CFR 164.524 or otherwise interfere with any request for access,
exchange, or use of EHI that implicates the HIPAA Privacy Rule's
individual right of access in a manner or to an extent that would
constitute non-compliance with 45 CFR 164.524;
deny the individual (as defined in Sec. 171.202(a)(2)) or
an attorney representing the individual access, exchange, or use of EHI
for purposes of considering, bringing, or sustaining any claim for
benefits under any Federal law or any action against the actor under
administrative, civil, or criminal (including discovery and other
procedural) law of the jurisdiction in which care indicated by the EHI
was provided;
interfere with any use or disclosure of EHI required by
subpart C of 45 CFR part 160 as it applies to actions by the Secretary
(or by any part of HHS) with respect to ascertaining compliance by
covered entities and business associates with, and the enforcement of,
applicable provisions of 45 CFR parts 160, 162, and 164; or
prevent any EHI's use by or disclosure to a Federal agency
or a State, or Tribal authority in the jurisdiction where health care
indicated by the EHI was provided, to the extent such use or disclosure
is permitted under 45 CFR parts 160 and 164.
Each (or any) of these requirements would function as a limit on
the applicability of the exception and mean that practices not meeting
the exception for those reasons could constitute information blocking
in addition to potentially violating any other law. (Due to the
substantial variation across individual actors' circumstances, it would
be impossible to maintain in the text of 45 CFR part 171 an accurate,
comprehensive catalog of all other laws that could be implicated by an
actor's practices otherwise consistent with any exception set forth in
subparts B, C, or D of 45 CFR part 171.)
We welcome comments on the proposed exception, including whether
commenters would recommend we add to the exception (if finalized) any
or all of the above potential additional limits on applicability of the
proposed Protecting Care Access Exception (Sec. 171.206) that we
propose in the alternative.
d. Care Access Condition
The proposed care access condition would apply as specified in
paragraph (c) of Sec. 171.206 under the ``Regulatory Text'' heading of
this proposed rule. The condition could be met by practices an actor
implements to reduce potential exposure to legal action based on the
mere fact that reproductive health care occurred for persons, other
than the person seeking or receiving care, who provide care or are
otherwise involved in facilitating reproductive health care that is
lawful under the circumstances in which it is provided. Such persons
would include licensed health care professionals, other health care
providers, and other persons involved in facilitating care that is
lawful under the circumstances in which it is provided. Such persons
would include persons (friends, family, community caregivers, and
others) who help patients find, get to the site of or home from, and
afford care. For purposes of the care access condition in Sec.
171.206(c) and Sec. 171.206(b)(1)(i) (within the patient protection
condition), the reproductive health care must be ``lawful under the
circumstances in which it is provided'' as explained above in section
IV.B.3.c of this proposed rule.
To satisfy the care access condition in paragraph (c) of Sec.
171.206 as proposed, the practice must affect only access, exchange, or
use of specific EHI (one or more data points) that the actor believes
could potentially expose a care provider(s) or facilitator(s) to legal
action because that EHI shows or would carry a substantial risk of
supporting a reasonable inference that such person(s) are currently
providing or facilitating, have provided or facilitated, or both,
reproductive health care that is (or was) lawful under the
circumstances in which it is (or was) provided.\251\
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\251\ The patient protection condition in Sec. 171.206(b) would
apply to practices implemented for the purpose of reducing the
patient's risk of potential exposure to legal action (as legal
action would be defined in Sec. 171.206(e). The care access
condition in Sec. 171.206(c) would apply to practices an actor
implements to reduce potential exposure to legal action based on the
mere fact that reproductive health care occurred for persons, other
than the person seeking or receiving care, who provide care or are
otherwise involved in facilitating the provision or receipt of
reproductive health care that is lawful under the circumstances in
which it is provided. In some circumstances, an actor's practice
might meet both the Sec. 171.206(b) patient protection and Sec.
171.206(c) care access conditions simultaneously. But each of these
conditions could also apply in circumstances where the other does
not. Thus, the proposed exception is intended and designed to apply
where either or both of the patient protection and care access
conditions are met in complement to the Sec. 171.206(a) threshold
condition.
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We propose this requirement in order to ensure the Sec. 171.206(c)
care access condition would not apply to an actor's practice affecting
access, exchange, or use of EHI that the actor does not believe could
create a risk of potential exposure to legal action based on the mere
fact that reproductive health care was provided or facilitated. Actors
will often have additional EHI that applicable law would also permit
them
[[Page 63637]]
to make available for permissible purposes, which could include
information relevant to the safety, continuity, and quality of care,
such as a patient's chronic condition(s) or a medically confirmed
allergy to a substance that does not indicate or suggest reproductive
health care has, or may have, occurred (and thus poses no risk of
exposure to legal action as defined in Sec. 171.206(e)). To the extent
the actor has such other EHI that the actor can (both legally and
technically) make available for any and all permissible purposes, we
would expect the actor to do so. We recognize that in some
circumstances the actor may need to make such other EHI available in an
alternative manner rather than the manner requested by the requestor.
(We use ``manner requested'' and ``alternative manner'' here in a sense
consistent with paragraphs (a) and (b), respectively, of the Manner
Exception as currently codified in Sec. 171.301.)
We propose that when an actor's practice satisfies the threshold
condition in Sec. 171.206(a) and meets all the requirements of the
care access condition in Sec. 171.206(c), the actor's practice will
not constitute information blocking. As with any of the existing
exceptions, the proposed Protecting Care Access Exception would not
supersede or override any other valid Federal, State, or Tribal laws
that compel production of EHI for purposes of legal proceedings or that
compel other disclosures in relevant circumstances. Therefore, actors
and other interested persons will want to remember that satisfying an
exception set forth in 45 CFR part 171 does not prevent other law that
operates independently from the 45 CFR part 171 from potentially
compelling an actor to provide access, exchange, or use of EHI in
manners or for purposes the actor, or an individual, might prefer the
EHI not be accessed, exchanged, or used. As actors are likely already
aware, conduct that is not considered ``information blocking'' under 45
CFR part 171, whether on the basis of satisfying an exception or on the
basis of not meeting an element of the definition of ``information
blocking'' in the information blocking statute (42 U.S.C. 300jj-52) may
nevertheless violate, and may subject the actor to consequences
authorized by, laws separate from and operating independently of the
information blocking statute and 45 CFR part 171.
The care access condition would apply where the risk of potential
exposure to legal action is specific to the mere fact that reproductive
health care (that was lawful under the circumstances in which it was
provided) was provided or facilitated. The care access condition would
not be met where the risk of potential exposure to legal action is
based on care having been provided in circumstances where the care was
not lawful. (We refer readers again to our explanation, in Section
IV.B.3.c of this proposed rule, of how we would interpret ``lawful
under the circumstances'' in which care was provided in context of the
proposed Sec. 171.206.)
The proposed exception would not apply to a practice that precludes
the patient or an attorney representing the patient from obtaining
access, exchange, or use of the patient's EHI for purposes of filing a
benefit claim or a complaint against the actor with any agency of the
U.S. Government. It would be unreasonable for an actor to withhold from
a patient or a patient's attorney EHI that they need or seek to use in
support of a claim for a benefit that is filed with any agency of the
U.S. Government. It would also be unreasonable for the actor to attempt
to withhold EHI access, exchange, or use to impede the patient or the
patient's attorney filing, or the U.S. Government investigating, any
complaint against the actor that the patient or the patient's attorney
may file with any agency of the U.S. Government. Patients and their
attorneys should have easy access to necessary information for
considering, filing, or maintaining or pursuing such claims or
complaints.
As we have noted several times in this proposed rule, an actor that
is also required to comply with the HIPAA Privacy Rule must comply with
the individual right of access as codified in 45 CFR 164.524 regardless
of whether the actor may be able to satisfy any existing or proposed
exceptions to the Sec. 171.103 definition of ``information blocking.''
To ensure actors remain aware of this fact, we propose as the first of
several (non-exclusive) alternatives, to include in the proposed care
access condition (Sec. 171.206(c)) an additional explicit restriction
of the condition to practices that do not violate 45 CFR 164.524. We
might finalize this additional requirement even if we do not finalize
any of the other additional requirements that we propose to potentially
apply to the Protecting Care Access Exception as a whole or to the
proposed patient protection condition (Sec. 171.206(b)) (as discussed
in section IV.B.3.b, above).
The first requirement we propose in the alternative specific to the
care access condition would provide for the care access condition
(Sec. 171.206(c)) to be met by practices that could interfere with an
individual's access to EHI only to the extent that the interference
could otherwise implicate the ``information blocking'' definition in
Sec. 171.103 without also constituting non-compliance with 45 CFR
164.524 where 45 CFR 164.524 also applies. For example, under this
first proposed potential added restriction on applicability of Sec.
171.206(c), a delay of an individual's access, exchange, or use of EHI
that would rise to the level of an ``interference'' for purposes of the
``information blocking'' definition in Sec. 171.103 that satisfied all
other requirements of Sec. 171.206(a) and (c) would be covered by the
Sec. 171.206 exception only to the extent the delay of the
individual's (or their personal representative's) access to EHI did not
exceed the maximum time permitted, in the specific circumstances, for
fulfillment of access to PHI under 45 CFR 164.524. (Coverage of an
exception would be irrelevant for a delay not rising to the level of an
``interference'' because Sec. 171.103 focuses on practices not
required by law that are likely to ``interfere with'' access, exchange,
or use of EHI.) This proposed restriction to practices not violating
Sec. 164.524 would also mean Sec. 171.206 would apply where an
actor's interference involved offering fewer manners of access,
exchange, or use than would be feasible for the actor to support, but
only to the extent that the actor's limiting the manners in which EHI
is made available would not constitute a violation under 45 CFR
164.524. We welcome comment on this first additional potential
limitation on the applicability of the proposed exception.
We propose as a second (again, non-exclusive) alternative to
include in the proposed care access condition (Sec. 171.206(c)) an
additional requirement that would be applicable specifically if an
actor chooses to engage in a practice of delaying fulfillment of
requests for EHI access, exchange, or use by individuals (as defined in
Sec. 171.202(a)(2)) because the actor wants to provide, in a non-
discriminatory manner, information to the individual relevant to the
actor's good faith belief that a risk of potential exposure to legal
action could be created by the individual's choice of how to receive
their EHI or to whom the individual wishes to direct their EHI. For
example, an actor that is also a HIPAA covered entity would, under
Sec. 164.524, be required to fulfill an individual's request for
access to PHI or to transmit to a third party an electronic copy of the
individual's PHI in an EHR within the time period required under Sec.
164.524.
[[Page 63638]]
Where the Sec. 171.206 exception would apply and the third party is
not a covered entity or business associate, the actor may wish to first
provide the individual with information (that is, to the best of the
actor's knowledge and belief, accurate and factual) about the HIPAA
Privacy, Security, and Breach Notification Rules and differences in
their applicability to EHI when it is not held by a HIPAA covered
entity or business associate in comparison to when it is. Similarly, an
actor might wish to communicate such information to an individual
before enabling access, exchange, or use of EHI for a health care
provider that is not a HIPAA covered entity or business associate. The
actor might, for example, be concerned that the individual may not have
previously obtained or been provided basic information about how the
applicability of the HIPAA Privacy Rule to information held by or for a
provider that is not a HIPAA covered entity may differ from the rule's
application to the same information when it is held by or for entities
regulated under HIPAA. The actor may wish to provide the individual
such information so that the individual would have a fair opportunity
to consider the possible privacy risks. In such situations, the actor
may be concerned about potential information blocking implications of
the delay that is necessary to provide the individual with information.
Or the actor may be concerned with the delay that results when an
individual (or their personal representative) is considering the
information before confirming they want the actor to proceed with
enabling the application the individual (or their personal
representative) has chosen to receive the EHI of which the individual
is a subject. Specifically, the actor may be concerned these delays
could rise to the level of an ``interference'' and, therefore,
implicate the information blocking definition even if the time required
is less than the maximum time permitted to fulfill PHI access under 45
CFR 164.524 in the relevant circumstances.
Therefore, we are considering the second proposed additional a
requirement for Sec. 171.206. This second potential additional
requirement would apply where an actor's practice delays making EHI
available upon individual request or directive in order to provide
individuals with non-biased general information about relevant laws or
about the actor's belief that is consistent with Sec.
171.206(a)(1)(i), the delay must be of no longer duration than is
reasonably necessary to provide to the individual two things:
(1) honest information that is provided in a non-discriminatory
manner and that is relevant to the actor's belief that a risk of
potential exposure to legal action could be created by the particular
access, exchange, and use of what specific EHI, such as general
information about privacy laws or other laws that the actor believes
may be relevant; and
(2) a reasonable opportunity to consider the information and seek
additional information from other sources if the individual would like,
before the individual is asked to either confirm or revise any
specifics of their request for access, exchange, or use of their EHI.
Under this alternative proposal specific to delaying a response to
a right of access request (including the right to direct a HIPAA
covered entity to transmit to a third party an electronic copy of the
individual's PHI in an EHR), delays longer than reasonably necessary to
provide the individual with information relevant to the actor's belief
that is consistent with Sec. 171.206(a)(1) and allow the individual to
consider the actor's information and seek information from additional
source(s) (if the individual desires) would not satisfy the Sec.
171.206(c) care access condition. This proposed restriction that is
specific to delays for the purpose of informing individuals of an
actor's belief that sharing specific EHI could create risk of potential
exposure to legal action could be implemented regardless of whether we
also implement a requirement that, for the care access condition or for
the threshold condition to be met by an actor's practice, the practice
must not constitute a violation of Sec. 164.524. This potential
additional requirement would limit the applicability of the condition
in scenarios where an actor might choose to engage in delay to provide
individuals with information about potential privacy consideration, but
should not be construed as creating an affirmative requirement for any
actor to delay fulfillment of individual access requests to provide
individuals with information about potential privacy implications of
the individual's request. We reiterate that information blocking
exceptions are voluntary.
We reiterate that even in scenarios where an actor's denial of
access, exchange, or use of EHI might not be ``information blocking''
because it satisfies an exception under and for purposes of part 171,
an actor that is a HIPAA covered entity or business associate will
still need to comply with 45 CFR 164.524 (individual right of access).
(This is true of the exceptions codified in subparts B, C, and D of 45
CFR part 171 as of the date of publication of this proposed rule and
would also be true of the new exceptions proposed in this rule in the
event any of them are finalized.)
The additional requirement(s) we are considering, and as noted
above propose in the alternative, would seek to more finely tune the
exception's balance of the interests of actors and patients in
protecting reproductive health care availability by mitigating legal
risks for the people who provide that care, and for the people who
facilitate the provision of such care, with the interests of
individuals in being able to access, exchange, and use all of their EHI
however and whenever they want, and to share all of their EHI however
and with whomever they choose, at no cost for ``electronic access'' as
defined in Sec. 171.302(d). We seek comment on these proposals.
e. Clarifying Provisions: Presumption and Definition of ``Legal
Action''
For purposes of determining whether an actor's practice meets
paragraph Sec. 171.206(b)(1)(i) or Sec. 171.206(c), we propose in
Sec. 171.206(d) that care furnished by someone other than the actor
would be presumed to be lawful unless the actor has actual knowledge
that the care was not lawful under the circumstances in which it was
provided. The presumption provision proposed in Sec. 171.206(d) is
similar to the presumption provision finalized (in 45 CFR
164.502(a)(5)(iii)(C)) by the 2024 HIPAA Privacy Rule, but is
necessarily different because of differences in how the prohibition at
45 CFR 164.502(a)(5)(iii)(A) operates and how the proposed Protecting
Care Access Exception (Sec. 171.206) is intended to operate.
First, the proposed Protecting Care Access Exception (Sec.
171.206) would be voluntary. It would offer those actors who may wish
to engage in practices likely to interfere with EHI access, exchange,
or use under the exception's conditions certainty that practices
satisfying the exception will not be considered ``information
blocking.'' Nothing in Sec. 171.206 is intended to create an
affirmative obligation for any actor to evaluate whether the Protecting
Care Access Exception might apply to any access, exchange, or use of
EHI for permissible purposes.
Second, the proposed Protecting Care Access Exception (Sec.
171.206) is based on statutory authority found in section 3022 of PHSA
to identify reasonable and necessary activities that do not constitute
information blocking for purposes of the PHSA 3022 definition of the
term. We do not propose that
[[Page 63639]]
anything in Sec. 171.206 would operate to override an actor's
obligation to comply with another (applicable) law that requires the
actor to make EHI available for any permissible purpose. Thus, an actor
may still be compelled to disclose EHI in compliance with such other
law even where the exception might mean an actor's failure to comply
with such other law would not be considered ``information blocking''
under 45 CFR part 171 or PHSA 3022. (The exception would not be
relevant where an actor is also a HIPAA covered entity or business
associate would be required to comply with the prohibition at 45 CFR
164.502(a)(5)(iii) because a HIPAA covered entity's or business
associate's practice of refusing to make a use or disclosure of PHI
prohibited by the HIPAA Privacy Rule is ``required by law'' and
therefore not information blocking to begin with.)
Finally, a policy goal of the proposed Protecting Care Access
Exception is that it be easy for any actor to confidently and
efficiently meet the conditions of the proposed exception. One way the
exception's structure supports this goal is by providing (in Sec.
171.206(a)(3)(i)) for the actor to implement practices per
organizational policies that address particular types of EHI sharing
scenarios where the actor believes the risk of potential exposure to
legal action could be created even if the actor has not yet received a
request for EHI for the activities specified in 45 CFR
164.502(a)(5)(iii)(A) or any of the purposes specified in 45 CFR
164.512(d), (e), (f), or (g)(1) for which the attestations specified in
45 CFR 164.509 would be required as a precondition for disclosing PHI
potentially related to reproductive health care to be permitted under
the 2024 HIPAA Privacy Rule.
As noted elsewhere, an actor's practice satisfying the new
exception would mean the practice will not be considered information
blocking. To the extent that EHI indicates or potentially relates to
reproductive health care that was not lawful under the specific
circumstances in which it was provided, we presume that the legal
authority compelling disclosure of EHI for such purposes would have its
own enforcement provisions independent of the penalties and
disincentives authorized by PHSA 3022 for an actor determined by the
HHS OIG to have committed information blocking. Because exception would
not exempt the actor from their obligation to comply with such other
law, we do not believe it is necessary to preserve the potential for
information blocking penalties to apply in addition to any consequences
that might attach under such other law to an actor's non-compliance
with that law. On the other hand, we believe it is important to ensure
that concern about information blocking consequences would not prevent
the actor from, for example, delaying fulfillment of a demand for EHI
in order to review factual information supplied by the requestor and
determine whether that information ``demonstrates a substantial factual
basis'' (as stated in 45 CFR 164. 502(a)(5)(iii)(C)(2)) and, by
extension, whether the 2024 HIPAA Privacy Rule or applicable State law
permits, preempts, or conflicts with the law the requestor indicates
compels the actor to make the EHI available to the requestor.\252\
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\252\ We remind readers that the currently codified ``pre-
condition not satisfied'' sub-exception of the Privacy Exception
outlines a framework for actors to follow so that the actors'
practices of not fulfilling requests to access, exchange, or use EHI
would not constitute information blocking when one or more
preconditions has not been satisfied for the access, exchange, or
use to be permitted under applicable Federal and State, or Tribal
laws. Please see Sec. 171.202(b) and discussion in HTI-1 final rule
(at 89 FR 1351 through 1354) of how information blocking exception
work in concert with the HIPAA Rules and other privacy laws to
support health information privacy.
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We are, moreover, concerned that tying the proposed Sec.
171.206(d) presumption provision to the requestor not supplying
information demonstrating a substantial factual basis that the
reproductive health care was not lawful under the specific
circumstances in which it was provided would make the proposed
Protecting Care Access Exception (Sec. 171.206) more difficult for
actors to use and therefore could discourage actors from using it. We
are concerned this difficulty could discourage use of the exception
particularly by those actors--such as small and safety net health care
providers or non-profit health information networks who serve them--who
may have limited ability to divert resources to these types of legal
analyses, especially in circumstances where this exception is intended
to apply but the request for EHI access, exchange, or use may not be
coming from a law enforcement entity and the access, exchange, or use
of EHI sought may not be for a law enforcement purpose.
We propose in the alternative to add to Sec. 171.206(d), if
finalized, a provision that parallels the provision in 45 CFR
164.502(a)(5)(iii)(C)(2) and that would prevent the Sec. 171.206(d)
presumption from applying where factual information supplied by the
person requesting access, exchange, or use of EHI demonstrates a
substantial factual basis that the reproductive health care was not
lawful under the specific circumstances in which it was provided. We
welcome comments on this alternative proposal. We are particularly
interested in whether and why actors, patients, and other interested
parties may believe Sec. 171.206(d) would strike a better balance
between actors' interests in a simpler, more easily usable exception
and requestors' interests in obtaining EHI for permissible purposes
with or without the additional limit on application of the presumption
provision.
We propose in Sec. 171.206(e) to define ``legal action'' for
purposes of the Protecting Care Access Exception. Under the proposed
definition, ``legal action'' would include any of the following when
initiated or pursued against any person for the mere act of seeking,
obtaining, providing, or facilitating reproductive health care: (1)
civil, criminal, or administrative investigation; (2) a civil or
criminal action brought in a court to impose criminal, civil, or
administrative liability; or (3) an administrative action or proceeding
against any person. We emphasize that the proposed Protecting Care
Access Exception would apply where an actor's practice meets the Sec.
171.206(a) threshold condition and at least one of the other two
conditions in the exception, none of which would require the actor to
quantify a degree, amount, or probability of the risk of potential
exposure to legal action the actor believes in good faith exists and
could be reduced by the practice to which Sec. 171.206 applies.
We welcome comment on all aspects of the proposal for a new
Protecting Care Access Exception to the information blocking
definition.
4. Requestor Preferences Exception
We propose a new exception, ``Requestor Preferences,'' in Sec.
171.304 to offer actors certainty that, under the conditions specified
in this exception, it would not be considered ``information blocking''
to honor a requestor's preferences expressed or confirmed in writing
for: (1) limitations on the scope of EHI made available to the
requestor; (2) the conditions under which EHI is made available to the
requestor; and (3) the timing of when EHI is made available to the
requestor for access, exchange, or use.
Since publication of the ONC Cures Act Final Rule, actors have
indicated a preference for greater certainty as to the conditions under
which they would not be committing information blocking if they were to
honor certain preferences expressed by a requestor seeking lawful
[[Page 63640]]
access, exchange, or use of EHI. In some instances, this preference
might be that some type(s) of new EHI are not made available as quickly
as would be technically feasible or that a more limited scope of EHI is
made available than would be permitted (or required) under applicable
law based on whose EHI the requestor seeks and for what purpose(s). For
example, actors have indicated that they are uncertain of the scenarios
when honoring an individual's request for delay of EHI availability to
the individual in the patient portal would not be information blocking.
Actors have also indicated that they are unable to honor a health care
provider's expressed preference to receive only some of the EHI that an
actor has and could disclose to the provider under applicable law,
because the actor is uncertain whether honoring the health care
provider's preference would be considered information blocking. The
proposed exception (new Sec. 171.304) would address these concerns by
providing certainty of the conditions under which we would not consider
an actor to engage in information blocking when the actor honors a
requestor's preference to: (1) receive only a subset of EHI (limitation
on scope of EHI), (2) have the EHI be available to the requestor only
under specific timing or other conditions, or (3) any combination of
such preferences.
We recognize that, sometimes, a requestor who seeks access,
exchange, or use of EHI may prefer to have less EHI available to the
requestor than an actor has and would be permitted to make available
under the HIPAA Privacy Rule (and any other applicable law(s)
restricting uses and disclosures of an individual's health information
to protect the individual's privacy). We also recognize that sometimes
a requestor may not want particular EHI to be available to the
requestor immediately, perhaps preferring the EHI not be available
until a certain period of time has elapsed or until certain conditions
are met. For example, an individual who uses a patient portal or app to
access EHI of which they are the subject may not want certain test
results to be available in that patient portal or app for a certain
number of hours or until the next business day (timing preference).
Similarly, an individual may not want the results of certain diagnostic
tests performed on the individual to be available to the individual in
a patient portal or app until the doctor who ordered the test(s) has
seen the results or until a doctor, nurse, or other health care
professional is available who can explain what the results mean
(conditions for making EHI available preference). For a provider-to-
provider example, a primary-care clinician office (requestor) may ask
that for laboratory tests done more than once during a patient's stay
at a hospital, the hospital (actor) only send the clinician office the
results from the last time each test was done (scope of EHI
preference), and only send that EHI to the clinician office upon the
patient's discharge from the hospital stay (a preference for the
conditions under which EHI becomes available). As another provider-to-
provider example, a health care provider (requestor) might ask another
health care provider (actor) to not send all of the medication history
the responding actor has for a patient that the actor is legally
permitted to share with the requesting health care provider. The
requestor might ask the responding actor to send instead only the
patient's current medications and known allergies. The proposed
exception (to be codified in Sec. 171.304) would address all of these
examples and a variety of other situations. The proposed exception
(Sec. 171.304) has four separate conditions: (a) request; (b)
implementation, (c) transparency; and (d) reduction or removal. In
order for an actor's practice(s) to satisfy the proposed Requestor
Preferences Exception (Sec. 171.304), the practice(s) would have to
meet all four of the conditions at all relevant times.
The request condition (paragraph (a)) of this proposed new
exception would require that the requestor express their preferences in
writing without the actor improperly encouraging or inducing the
requestor to ask for restrictions on the scope of EHI that would be
available to the requestor, the conditions for which the EHI would be
available, or timing of when EHI would be available to the requestor.
This condition is similar to our approach under the Privacy Exception
(Sec. 171.202) for obtaining a patient's consent under sub-exception
(b), which cannot be satisfied if the actor improperly encourages or
induces the individual to withhold consent or authorization. It is also
similar to a provision of the Privacy Exception's sub-exception (e),
which can be satisfied only if the individual requests that the actor
not provide such access, exchange, or use of EHI without any improper
encouragement or inducement of the request by the actor. In addition to
disqualifying an actor's practices in response to such requests from
application of the proposed Requestor Preferences Exception, we remind
actors that any improper inducement of a patient's or other person's
request for delay or other restrictions on a requestor's access to EHI
is a practice that, on its own, could constitute an interference that
implicates the information blocking definition.
To reiterate, the request condition (Sec. 171.304(a)) requires the
requestor to document in writing their preference (or ask) for
tailoring of their access, exchange, or use of EHI. This requirement is
intended to guard against the inappropriate citation of the exception
to retroactively ``justify'' the actor's limitation of a requestor's
access, exchange, and use of EHI to suit the actor's preferences. The
documentation requirement parallels a similar requirement of the
Privacy Exception sub-exception (Sec. 171.202(e)) applicable to
honoring individuals' requests to restrict other people's access,
exchange, or use of their EHI.\253\ Subparagraphs (a)(1), (2), and (3)
of the proposed Sec. 171.304 request condition also specify, as
discussed above, the three types of preferences that the exception
would cover.
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\253\ Although we are proposing revision to Sec. 171.202(e) in
this rule (see section IV.B.1.c of this preamble), we do not propose
any change to the documentation requirement of the Sec. 171.202(e)
sub-exception. (The Sec. 171.202(e) documentation requirement was
discussed in the ONC Cures Act Final Rule; see 85 FR 25642 at
25858.)
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The implementation condition (Sec. 171.304(b)) would ensure that
an actor's practice of limiting the scope of EHI, conditions or timing
of EHI availability to the requestor, or any combination of such
limitations a requestor may ask for, are ``tailored'' to the specific
request. In this condition, ``tailored to the specific request'' means
the practice is no broader than necessary to do, and in fact does, what
the requestor asked for in writing. The Sec. 171.304(b) implementation
condition would also require (see subparagraph (2)) that the request be
implemented in a consistent and non-discriminatory manner. This
requirement parallels similar requirements in existing exceptions, such
as the Preventing Harm Exception (Sec. 171.201(f)(1)(iii)), Privacy
Exception (Sec. 171.202(b)(1), (c)(3) and (3)), and the Security
Exception (Sec. 171.203(c)). For purposes of Sec. 171.304,
discriminatory implementation practices would include, for example, the
actor moving more slowly to modify or remove tailoring restrictions
(see proposed condition (d)) from access, exchange, or use of EHI based
on whether the requestor is a business competitor of the actor or if
the requestor's access, exchange, or use of EHI is likely to facilitate
competition with the actor. As innovation in biomedical informatics
[[Page 63641]]
and health IT advances, we anticipate that the EHI a requestor needs or
wants to inform decisions related to seeking or accepting healthcare,
or for public health activities or providing or paying for healthcare
may change. Therefore, a requestor's preferences for restrictions on
the amount of EHI or the conditions or timing of EHI availability to
the requestor (or any combination of these) may well change over time.
The requirement that the actor's practice be consistent and non-
discriminatory is intended, for example, to ensure the exception will
not apply to practices that are implemented in a manner that
disadvantages competitors, potential competitors, or persons whose
access, exchange, or use of EHI may facilitate competition with the
actor in comparison to persons who are affiliates or whose access,
exchange, or use of EHI would not be expected to facilitate competition
with the actor.
The transparency condition (Sec. 171.304(c)) is intended to
mitigate a risk of a specific unintended consequence of creating an
exception that explicitly applies to an actor's choosing to agree to a
requestor's ask that EHI availability to the requestor be tailored to
the requestor's preferences. For example, to the surprise of the
requestor, the tailoring of EHI ended up being more or less restrictive
than what the requestor thought they agreed to. The risk of surprise to
the requestor may arise either when a requestor first asks for
tailoring or when an actor may no longer be able to maintain certain
tailoring that they have previously agreed to implement in response to
a requestor's ask. To mitigate the risk of surprise to a requestor, it
is important for a requestor who has asked for tailoring to be informed
of what the actor can and will do, or cannot or will not continue to
do. To meet the transparency condition (Sec. 171.304(c)), an actor
would be required to provide, in plain language, whether verbally or in
writing, at least the explanation and notification described in the
proposed Sec. 171.304(c)(1) and (2) and to document in writing any
explanation or notice that is not made in writing.
Meeting the transparency condition (Sec. 171.304(c)) would not
require a contract or other formal agreement between actors and
requestors. We also are not suggesting that we believe an actor's
agreement to tailor when, how much, or under what conditions EHI
becomes available to any given requestor should be treated as
establishing a contract or binding agreement.
To meet the requirement in subparagraph (1) of Sec. 171.304(c), an
actor would be required to explain to the requestor what they can and
will do to tailor EHI availability to the requestor. Meeting
subparagraph (2) of Sec. 171.304(c) would require an actor who
experiences a change in operational status or technical capabilities
affecting the actor's ability to maintain tailoring to make
``reasonable efforts'' to promptly notify each requestor for whom the
actor had implemented affected tailoring. We have used the ``reasonable
efforts'' standard in the existing precondition not satisfied sub-
exception of the Privacy Exception (see Sec. 171.202(b)(2)(i)). As we
stated in the ONC Cures Act Final Rule preamble discussion of the
finalized Sec. 171.202(b), a ``reasonable efforts'' standard aligns
with the case-by-case approach that is captured in the statutory
information blocking provision (see 85 FR 25852). Similar to the
``reasonable efforts'' standard in Sec. 171.202(b)(2)(i), the
``reasonable efforts'' standard in the proposed Sec. 171.304(c)(2)
would be met if the actor used reasonable efforts within its control to
promptly provide the requestor with notice of the change in the actor's
ability or willingness to continue applying the tailoring of EHI
availability to the requestor that the requestor had requested, and the
actor had implemented or agreed to implement. (We refer those who would
like to read more about the ``reasonable efforts'' standard in context
of the existing Sec. 171.202(b)(2)(i) to the preamble discussion of
the finalized Sec. 171.202(b)(2)(i) at 85 FR 25852).
``Plain language'' is the standard proposed in Sec. 171.304(c) for
required explanations and notices rather than ``plain writing'' because
we intend for the Sec. 171.304(c) transparency condition as a whole to
accommodate various methods of communication that are efficient and
effective for both the actor who wants to satisfy the exception and the
requestor who asks for tailoring. However, regardless of whether the
actor and requestor communicate verbally or in writing, plain language
would use terminology familiar to the requestor and make it easy for
the requestor to understand what tailoring of their EHI access,
exchange, or use the requestor can expect to be implemented or to have
changed.\254\
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\254\ If an actor and a particular requestor do not both have at
least limited working proficiency in any one language, the actor may
need to employ a translator (whether human or an appropriate
software application) to achieve communication with the requestor.
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To meet the transparency condition, subparagraph (c)(3) specifies
that the actor must contemporaneously document in writing any required
explanation or notice that is not provided to the requestor in writing.
This requirement, like the use of ``plain language'' rather than
``plain writing'' as a standard for the explanations and notices,
leaves flexibility for actors to communicate with requestors in
writing, verbally, or in other ways that are efficient and effective
for both the actor and requestor or otherwise mutually agreeable to
them. Contemporaneous written documentation of explanations and notices
not provided (initially made or later confirmed) to the requestor in
writing would enable the actor to demonstrate what explanation or
notice they provided and when. Contemporaneous written records of
notices made or attempted would also be relevant, where notice fails to
reach the requestor or the requestor does not recall details of the
notice, to the actor's demonstration of the efforts the actor made to
provide notice consistent with Sec. 171.304(c)(2).
The reduction or removal condition (Sec. 171.304(d)) recognizes
that a requestor's tailoring preferences may change over time and
requires that an actor's tailoring practice accommodate such changes in
requestor preferences. For the actor's practices restricting a
requestor's access, exchange, or use of EHI based on the requestor's
request to remain covered by this proposed exception when the requestor
asks for reduction or removal of restrictions, the reduction or removal
condition (Sec. 171.304(d)) would require the actor to act promptly as
feasible on that request.
We do not propose to set a specific timeframe within which an actor
would need to act on requests to reduce or remove restrictions upon
receipt of any such request from the requestor. Rather, to satisfy the
reduction or removal condition, the actor would need to act as promptly
as feasible upon receiving such a request. Basing this requirement on
what is feasible for the actor allows for consideration of the specific
facts and circumstances under which the actor received the request. We
believe this is preferable to setting a single fixed timeframe due to
the considerable variation in actors' technical capabilities and
operational circumstances at any given point in time. However, we
recognize that actors and individuals may find some value in consistent
maximum timeframe expectations for acting on a requestor's ask for
removal or reduction of previously requested restrictions on their
access, exchange, or use of EHI in individual access scenarios. (By
``individual access scenarios,'' we mean here those where the requestor
is either: (a) the individual
[[Page 63642]]
who is the subject of the EHI in question; or (b) their legal
representative, including, but not limited to, personal representatives
treated as the individual consistent with 45 CFR 164.502(g)).
Therefore, we are considering specifying in Sec. 171.304(d) that the
maximum time any actor would have to reduce or remove the tailoring in
any individual access scenario would be the time within which a HIPAA
covered entity must provide an individual (as defined in 45 CFR
160.103) or their personal representative (see 45 CFR 164.524(g))
access to PHI in the designated record set under 45 CFR 164.524. Under
this alternative proposal, the ``as promptly as feasible'' standard
would apply to all other requestor scenarios without a specified
maximum limit on the time an actor could take; but meeting the proposed
Sec. 171.304(d) reduction or removal condition in individual access
scenarios would require the actor to reduce or remove restrictions in
response to the requestor's request as promptly as feasible but in no
case later than the maximum time permitted to fulfill individual access
requests under 45 CFR 164.524. (This is an alternative proposal that is
not reflected in the draft of Sec. 171.304 in the ``Regulatory Text''
section of this proposed rule.) This alternative proposal for Sec.
171.304(d) requirements would apply to individual access scenarios
regardless of whether 45 CFR 164.524 would, in any given scenario, be
implicated (e.g., even if the actor were not a HIPAA covered entity or
business associate).
This alternative proposed timeliness requirement for the Sec.
171.304(d) reduction or removal condition specific to individual access
scenarios would establish, by cross-reference to 45 CFR 164.524, that
the maximum time the actor would have for acting on a request to reduce
or remove restrictions would be the same timeframe within which a HIPAA
covered entity must fulfill individual access under 45 CFR 164.524. For
purposes of the Sec. 171.304 exception under this alternative
proposal, the time for responding to a request for reduction or removal
of EHI access, exchange, or use tailoring in individual access
scenarios would start on the date on which the actor receives the
individual's (or their legal representative's) request for reduction or
removal of tailoring. We would craft this additional requirement in
this manner specifically so that, in the event the 45 CFR 164.524
timeliness standard were to change in the future (see, for example, the
proposal to modify that standard at 86 FR 6459 and 6535), the Sec.
171.304(d) condition would apply the same timeframe in effect for 45
CFR 164.524 at the point in time when an individual who is the subject
of the EHI (or their legal representative) requested removal or
reduction of restrictions on the individual's (or the legal
representative's) EHI access. Such requests are, effectively, the
requestor requesting their EHI be made available more promptly or
completely than they had previously requested it be available to them.
For clarity, once the reduction or removal of tailoring is complete for
purposes of this proposed exception, all future requests for access,
exchange, or use of EHI previously affected by the reduced or removed
tailoring could implicate the interference and information blocking
definition particularly Sec. Sec. 171.103 and 171.104 (new proposed
section).
If we finalize the proposed Sec. 171.304 exception, with or
without any explicit cross-reference to 45 CFR 164.524, this exception
would operate as do all other 45 CFR part 171 exceptions: independently
from the HIPAA Privacy Rule. We reiterate that an actor who is also a
HIPAA covered entity or business associate must comply with the HIPAA
Privacy Rule's requirements implicated in any circumstances or
scenario, including without limitation the individual right of access
(45 CFR 164.524(a)(1)), regardless of whether any given practice in any
given scenario might not be considered ``information blocking'' on the
basis of having satisfied any 45 CFR part 171 exception(s) to the
definition codified in Sec. 171.103.
We welcome comment on this proposed new exception.
5. Exceptions That Involve Practices Related to Actors' Participation
in The Trusted Exchange Framework and Common Agreement\TM\ (TEFCA\TM\)
In the HTI-1 Proposed Rule (88 FR 23872), we proposed to add a
TEFCA\TM\ manner condition to the proposed revised and renamed Manner
Exception. We stated that this approach ``aligns with the Cures Act's
goals for interoperability and the establishment of TEFCA by
acknowledging the value of TEFCA in promoting access, exchange, and use
of EHI in a secure and interoperable way'' (88 FR 23872). In the HTI-1
Final Rule (89 FR 1437), in Part 171, we finalized a new subpart D
``Exceptions That Involve Practices Related to Actors' Participation in
The Trusted Exchange Framework and Common Agreement (TEFCA).'' We noted
that the new subpart consists of three sections, Sec. 171.400
``availability and effect of exceptions,'' which mirrors Sec. Sec.
171.200 and 171.300, stating that a practice shall not be treated as
information blocking if the actor satisfies an exception to the
information blocking provision as set forth in subpart D by meeting all
applicable requirements and conditions of the exception at all relevant
times (89 FR 1388). We reserved Sec. 171.401 for definitions in a
future rulemaking, and also reserved Sec. 171.402 for future use. In
Sec. 171.403 we finalized a new TEFCA Manner Exception based on the
TEFCA manner condition we proposed in HTI-1 Proposed Rule.
a. Definitions
We stated that while we reserved Sec. 171.401 for possible future
use as a ``definitions'' section, we declined to finalize any
definitions in the HTI-1 Final Rule and instead referred readers to the
definitions in the most recent version of the Common Agreement (88 FR
76773) for the terms relevant to the new exception (89 FR 1388). For
example, when we refer to Framework Agreement(s), we mean any one or
combination of the Common Agreement, a Participant-QHIN Agreement, a
Participant-Subparticipant Agreement, or a Downstream Subparticipant
Agreement, as applicable (86 FR 76778). We noted that this approach
would allow us to maintain consistency and harmony between the Common
Agreement and the new subpart D regulatory text.
We now propose to include definitions in Sec. 171.401 by cross-
referencing the TEFCA definitions included in the proposed new 45 CFR
part 172, ``Trusted Exchange Framework and Common Agreement'' (see
section IV.B.5.a of this proposed rule). We specifically propose to
adopt in Sec. 171.401 the definitions from Sec. 172.102 for the
following terms: Common Agreement, Framework Agreement, Participant,
QHIN\TM\, and Subparticipant. The definitions would apply to all of
Subpart D. We welcome comment on this approach.
b. TEFCA\TM\ Manner Exception
As briefly discussed above, we finalized a new TEFCA Manner
Exception in the HTI-1 Final Rule. We stated that the new TEFCA Manner
Exception (Sec. 171.403) provides that an actor's practice of limiting
the manner in which it fulfills a request to access, exchange, or use
EHI to be providing such access, exchange, or use to only via TEFCA
will not be considered information blocking when it follows certain
conditions (89 FR 1388). Those conditions require that (1) the actor
and requestor both be part of TEFCA; (2) that
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the requestor is capable of such access, exchange, or use of the
requested EHI from the actor via TEFCA; and (3) any fees charged by the
actor and the terms for any license of interoperability elements
granted by the actor in relation to fulfilling the request are required
to satisfy, respectively, the Fees Exception (Sec. 171.302) and the
Licensing Exception (Sec. 171.303). In addition to these three
requirements, we also included a limitation in Sec. 171.403(c),
stating that the exception is available only if the request is not made
via the standards adopted in 45 CFR 170.215, which include the FHIR API
standards.
Our finalized TEFCA Manner Exception differed from the proposed
TEFCA manner condition in two ways. First, when we proposed the TEFCA
manner condition, we stated that the Fees Exception and the Licensing
Exceptions would not apply, because ``we mistakenly assumed that all
actors participating in TEFCA would have already reached overarching
agreements on fees and licensing such that there would be no need for
application of the Fees and Licensing Exceptions (See 88 FR 23872)''
(89 FR 1389). We believe that by soliciting comments specifically on
this point we provided notice to parties that we either would or would
not apply the Fees and Licensing Exceptions. In response to our
proposal, some commenters expressed concern that because the Common
Agreement prohibits fees between QHINs\TM\ but is otherwise silent on
fees between Participants and Subparticipants, the proposal could allow
actors to charge fees to access, exchange, or use EHI that did not
comply with the Fees or Licensing Exceptions. Some commenters also
expressed that this could have the effect of disincentivizing
participation in TEFCA, and could cause actors to use other options of
electronic exchange outside of TEFCA, where the actors believed the
Fees and Licensing Exceptions would apply. As such, in the HTI-1 Final
Rule, we finalized the TEFCA Manner Exception to include that any fees
charged by the actor, and any licensing of interoperability elements,
must satisfy the Fees Exception (Sec. 171.302) and the Licensing
Exception (Sec. 171.303) (89 FR 1389). While we continue to believe
that it was clear that the alternative would be to apply the
exceptions, we are requesting comment now on whether there are
drawbacks to applying the Fees and Licensing Exceptions, and if we
should continue to apply them to the TEFCA Manner Exception as
currently required in Sec. 171.403(d).
The other change made to the proposed TEFCA manner condition was
the limitation that carves out requests made for access, exchange, or
use of EHI via FHIR API standards (89 FR 1389). We finalized this
limitation in response to comments noting that a request could be made
for access, exchange, or use via FHIR-based API and an actor could
respond in a different manner and satisfy the exception (89 FR 1390
through 91). Commenters further noted that this potential outcome could
undermine our stated purpose in incentivizing TEFCA participation with
the new exception (See 89 FR 1390). We now solicit comment on this
limitation within the TEFCA Manner Exception for requests via FHIR API
standards. For example, should the limitation be expanded to include
exchange based on versions of the FHIR standards that are more advanced
than those adopted in 45 CFR 170.215 or approved through the 45 CFR
170.405(b)(8) ``Standards Version Advancement Process--voluntary
updates of certified health IT to newer versions of standards and
implementation specifications''? Currently, the limitation would only
cover requests made via FHIR API standards codified in Sec. 170.215,
including standards that may be updated from time to time through Sec.
170.405(b)(8), which may involve a delay before the version is formally
approved under Standards Version Advancement Process (SVAP).
We also seek comment on a different approach. Eventually all TEFCA
QHINs will be required to support exchange via FHIR API standards. A
Participant or Subparticipant who makes a request for access, exchange,
or use of EHI via FHIR API will at first make such a request through a
QHIN, but in time, a Participant or Subparticipant could directly
request access, exchange, or use of EHI via FHIR API standards from
another Participant or Subparticipant in a different QHIN. One option
would be to sunset the limitation in Sec. 171.403(c) once all QHINs
can support brokered FHIR. Another option would be to sunset the
limitation in Sec. 171.403(c) if all QHINs, Participants and
Subparticipants support facilitated FHIR exchange. As an alternative to
these options, we could maintain the exception as is, regardless of
FHIR API adoption among TEFCA entities. We request comment on all of
the options, including whether or not the limitation should remain as
it is currently.
V. Trusted Exchange Framework and Common Agreement\TM\
Section 3001(c)(9)(B)(i) of the PHSA provides the National
Coordinator with the authority to ``develop or support a trusted
exchange framework for trust policies and practices and for a common
agreement for exchange between health information networks.'' The
components of this Trusted Exchange Framework and Common Agreement\TM\
(TEFCA\TM\) include the Trusted Exchange Framework (a common set of
principles designed to facilitate trust between HINs) and the Common
Agreement (the agreement Qualified Health Information Networks\TM\
(QHINs\TM\) sign), which includes, among other provisions, privacy,
compliance, and security requirements). The Common Agreement also
references the QHIN Technical Framework (QTF) (which describes
technical requirements for exchange among QHINs) as well as, where
necessary, standard operating procedures (SOPs). These documents
further the statute's overall goal of ensuring full network-to-network
exchange of health information by establishing a governance, policy,
and technical floor for nationwide interoperability and securely
facilitating the exchange of information across different networks
nationwide.
By providing a common and consistent approach for the exchange of
health information across many different networks, TEFCA simplifies and
significantly reduces the number of separate networks of which
individuals, health care providers, and other interested parties need
to be a part of in order to access the health information they seek.
TEFCA establishes a method for authenticating trusted health
information network participants, potentially lowering the cost and
expanding the nationwide availability of secure health information
exchange capabilities. The establishment of technical services for
health information networks that voluntarily join TEFCA creates
interoperability at scale nationwide. These technical services, such as
an electronic address directory and security services, will be critical
to scale network exchange. In addition, the organizational and
operational policies established through TEFCA enable the exchange of
health information among health information networks and include
minimum conditions required for such exchange to occur. Health
information networks that voluntarily join TEFCA will facilitate
exchange in a secure and interoperable manner. Updates in Common
Agreement Version 2.0 reflect the latest technical specifications,
among other changes, including updates to network-based exchange using
FHIR[supreg] APIs, which are a cornerstone of the interoperability
initiatives of not only ONC but also of other Federal agencies such as
CMS, the
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CDC, HRSA, and the U.S. Department of Veterans Affairs Veterans
Affairs.
Under TEFCA, QHINs play an important role in advancing secure,
standardized health information exchange. QHINs have significant
organizational and technical capabilities, facilitate exchange at the
highest level of the TEFCA infrastructure, and are the entities with
which Participants (and their Subparticipants) interact in order to
engage in TEFCA Exchange. ``TEFCA Exchange,'' which we propose to
define in Sec. 172.102, means the transaction of electronic protected
health information (ePHI) between Nodes \255\ using a TEFCA-specific
purpose of use code, meaning a code that identifies the Exchange
Purpose for which exchange is occurring. QHINs voluntarily agree to
follow certain organizational and operational policies that allow
Participants (entities who have entered into an agreement with the QHIN
that includes the Participant/Subparticipant Terms of Participation)
and Subparticipants (entities that have entered into an agreement with
a Participant or other Subparticipant that includes the Participant/
Subparticipant Terms of Participation) to simplify their operations and
promote efficiency of scale.
---------------------------------------------------------------------------
\255\ Node: a technical system that is controlled directly or
indirectly by a QHIN, Participant, or Subparticipant and that is
listed in the RCE Directory Service.
---------------------------------------------------------------------------
QHINs must meet policy and technical requirements under the Common
Agreement. The QTF and SOPs provide additional information on how QHINs
meet those requirements. If finalized, QHINs will have to comply with
the provisions proposed in this proposed rule. QHINs also perform a
vital role by ensuring that Participants and Subparticipants meet the
requirements of TEFCA.
We propose to establish rules in 45 CFR part 172 to implement our
obligations under section 3001(c)(9)(D) of the PHSA to publish a
directory of health information networks that ``have adopted the common
agreement and are capable of trusted exchange pursuant to the common
agreement'' and to establish a process through notice-and-comment
rulemaking for health information networks to attest to adopting the
Trusted Exchange Framework and Common Agreement. These regulations
would further our obligations to ``support'' TEFCA under sections
3001(c)(9)(A) and (B) of the PHSA. The provisions included in this
proposed rule would establish the qualifications for health information
networks to receive and maintain Designation as a QHIN capable of
trusted exchange pursuant to TEFCA, as well as establish procedures
governing QHIN Onboarding and Designation, suspension, termination, and
administrative appeals to ONC as described in the sections below. We
believe establishing these provisions in regulation would strengthen
the trust of interested parties in TEFCA and support its success at
scale.
A. Subpart A--General Provisions
For the purposes of subpart A, we propose in Sec. 172.100 the
basis, purpose, and scope for the proposed TEFCA provisions in part 172
of Title 45 of the Code of Federal Regulations. We propose in Sec.
172.100(a) that the basis for these provisions would be to implement
section 3001(c)(9) of the PHSA (42 U.S.C 300jj-11(c)(9)). We propose in
Sec. 172.100(b) the dual purposes of proposed part 172: (1) to ensure
full network-to-network exchange of health information; and (2) to
establish a voluntary process for QHINs to attest to adoption of the
Trusted Exchange Framework and Common Agreement. Section 172.100(b)(1)
supports the statutory basis because the organizational and operational
policies covered by part 172 would enable the exchange of health
information among health information networks using the common set of
rules found in these regulations. Section 172.100(b)(2) supports the
statutory basis because it implements PHSA Sec. 3001(c)(9)(D). We
propose in Sec. 172.100(c) the scope for part 172, which would
include: (1) minimum qualifications needed to be Designated as a QHIN
capable of trusted exchange under TEFCA; (2) procedures governing QHIN
Onboarding and Designation, suspension, termination, and further
administrative review; (3) attestation submission requirements for a
QHIN to attest to its adoption of TEFCA; and (4) ONC attestation
acceptance and removal processes for publication of the list of
attesting QHINs in the QHIN Directory. In proposed Sec. 172.101, we
specify the applicability of part 172 by proposing that part 172 would
apply only to Applicant QHINs, QHINs, and terminated QHINs. We note
that our proposed QHIN definition in Sec. 172.102 captures suspended
QHINs (since a suspended QHIN is still a QHIN) and so we do not address
them separately in proposed Sec. 172.101. In Sec. 172.102, we propose
definitions for certain terms in part 172. We intend for the
definitions provided in the Common Agreement to be consistent with
these proposed definitions. Differences in phrasing would generally be
attributable to differences in context, though in the case of any true
conflict, we would intend for the regulatory definitions to control.
Additionally, ONC has hired a contractor to help administer and
implement TEFCA Exchange. This contractor, chosen through a competitive
solicitation, is known as the Recognized Coordinating Entity[supreg]
(RCE\TM\). While the RCE is currently one entity, in the future, ONC
may choose to assign some or all of its responsibilities to a different
entity or multiple entities. Assigning to a different or multiple
entities in the future could, for example, allow for more efficient use
of resources or best leverage expertise. In Sec. 172.103,
``Responsibilities ONC may delegate to the RCE,'' we propose that ONC
may assign certain responsibilities to such an entity or entities for
these purposes. Specifically, we propose in Sec. 172.103(a)(1)-(4)
that ONC may assign any of its responsibilities in Subpart C--QHIN
Onboarding and Designation Process; Subpart D--Suspension, Sec.
172.501 QHIN self-termination, and Sec. 172.503 Termination by mutual
agreement. In Sec. 172.103(b), we propose that any authority exercised
by the RCE under this section is subject to review by ONC under Subpart
F (``Review of RCE Decisions''). For further discussion of the current
RCE and the authority it exercises on behalf of ONC, please see the
discussion in ``C. Subpart C--QHIN Onboarding and Designation
Processes'' below.
B. Subpart B--Qualifications for Designation
In subpart B, we propose qualifications for Designation. In Sec.
172.200, we propose to tie QHIN status to meeting the requirements
specified in Sec. 172.201. We propose that an Applicant QHIN (as we
propose to define it in Sec. 172.102) would need to meet all
requirements in Sec. 172.201 to be Designated, and a QHIN would need
to continue to meet all requirements in Sec. 172.201 to maintain its
Designation. That means that the requirements we propose in Sec.
172.201 would be ongoing; a QHIN that does not meet those requirements
at all times would be subject to suspension or termination, consistent
with the regulations we propose in subparts D and E of part 172. Among
other benefits, the continuing obligation to meet the requirements in
Sec. 172.201 would help to ensure the reliability of TEFCA Exchange
and to ensure QHINs could not maintain their status based on technology
and standards that have become obsolete. Because the obligations would
be
[[Page 63645]]
ongoing, throughout this section we refer to Applicant QHINs as well as
Designated QHINs as ``QHINs'' unless there is a need to differentiate.
As we explain below, the Designation qualifications proposed in
Sec. 172.201 would describe certain requirements for Designation. For
an entity to become a QHIN, that entity must sign the Common Agreement,
thus memorializing its agreement to the comprehensive Designation
requirements--as well as other requirements--for trusted exchange under
TEFCA. The comprehensive Designation requirements in the Common
Agreement correspond to the proposed requirements included in this
subpart.
In Sec. 172.201, we propose Designation requirements in three
categories: (a) ownership; (b) exchange requirements; and (c)
Designated Network Services.
In Sec. 172.201(a), we propose the ownership requirements. In
Sec. 172.201(a)(1), we propose that a QHIN must be a U.S. Entity, as
we propose to define U.S. Entity/Entities in Sec. 172.102. Under that
proposed definition, a U.S. Entity must be a corporation, limited
liability company, partnership, or other legal entity organized under
the laws of a State or commonwealth of the United States or the Federal
law of the United States, be subject to the jurisdiction of the United
States and the State or commonwealth under which it was formed, and
have its principal place of business be in the United States under
Federal law. Additionally, we propose that none of the entity's
directors, officers, or executives, and none of the owners with a five
percent (5%) or greater interest in the entity, may be listed on the
Specially Designated Nationals and Blocked Persons List published by
the United States Department of the Treasury's Office of Foreign Asset
Control or on the Department of Health and Human Services, Office of
Inspector General's List of Excluded Individuals/Entities. This
requirement would help to promote organizational and operational
policies that enable the exchange of health information among networks
by ensuring that those who actually control the health information
exchanged under these provisions are subject to U.S. laws, and it would
help to avoid giving access to that information to actors whom the
government has previously identified as national security or fraud
risks.
We request comment on whether the above approach, including the
specific five percent (5%) threshold, will effectively limit access of
bad actors trying to join TEFCA as a QHIN, or whether commenters
believe the threshold should be a different percentage.
In Sec. 172.201(a)(2), we propose that an Applicant QHIN must not
be under Foreign Control, which is a term we propose to define in Sec.
172.102. If, in the course of reviewing a QHIN application, ONC
believes or has reason to believe the Applicant QHIN may be under
Foreign Control, ONC will refer the case to the HHS Office of National
Security (ONS) for review. If information available to ONS supports a
determination of Foreign Control, ONS will notify ONC. An application
will be denied if ONS notifies ONC that the Applicant is under Foreign
Control. Given the scale of the responsibilities that a Designated QHIN
would have with respect to supporting health information exchange and
the importance that healthcare data has to the critical infrastructure
of our nation's health care system, we believe that a QHIN should not
be under Foreign Control. We believe the requirements proposed in Sec.
172.201(a)(1) and (a)(2), in conjunction with the proposed definitions
that those provisions reference, are necessary to ensure that all QHINs
are subject to United States law and that compliance by QHINs is
enforceable under United States law. Further, these proposals are
designed to strengthen the security of the network. We believe that the
above proposals promote organizational and operational policies that
enable the exchange of health information among networks by minimizing
the risk to TEFCA that may be posed by foreign state actors who wish to
harm the United States, lessening the risks of subjecting QHINs to
potentially conflicting foreign laws, and encouraging trust in the
security of exchange under the system.
We note that within the proposed definition of U.S. Entity/Entities
in Sec. 172.102, we propose that for an entity seeking to become a
QHIN to meet the definition, none of the entity's directors, officers,
or executives, and none of the owners with a five percent (5%) or
greater interest in the entity, can be listed on the Specially
Designated Nationals and Blocked Persons List published by the United
States Department of the Treasury's Office of Foreign Asset Control or
on the Department of Health and Human Services, Office of Inspector
General's List of Excluded Individuals/Entities. We believe the five
percent (5%) threshold strikes the right balance between protecting the
security of the network from high-risk or known bad actors and
achieving practical administrability of TEFCA. Individuals with less
than five percent (5%) ownership in an entity would likely have limited
means of influencing the actions of an entity connected to TEFCA. We
believe that entities--particularly those with a large number of
shareholders--would face undue hardship without this sort of exception
for small shareholders. That said, this regulation only would provide
the standard that ONC will apply when evaluating QHINs; it would not
supersede any stricter requirements imposed by other applicable laws,
including, for example national security laws. It remains the
responsibility of QHINs (and any other entity) to comply with all
applicable laws.
In Sec. 172.201(b), we propose exchange requirements for QHINs. We
believe these exchange requirements are necessary to build a data
sharing infrastructure that is private and secure and that meets all
the requirements of PHSA section 3001(c)(9). We believe each of the
exchange requirements below is important to the implementation and
operationalization of TEFCA Exchange, as described in Sec. 172.201, at
scale. We propose that an entity seeking to become a QHIN must,
beginning at the time of application, either directly or through the
experience of its parent entity, meet certain exchange requirements,
including: (1) be capable of exchanging information among more than two
unaffiliated organizations; (2) be capable of exchanging all Required
Information (as that term is defined in Sec. 172.102); (3) be
exchanging information for at least one of the Exchange Purposes (as
that term is defined in Sec. 172.102) authorized, in the Common
Agreement or an SOP(s) n; (4) be capable of receiving and responding to
transactions from other QHINs for all Exchange Purposes; and (5) be
capable of initiating transactions for the Exchange Purposes that such
entity will permit its Participants and Subparticipants to use through
TEFCA Exchange. Collectively, we believe these requirements are
tailored to help ensure that a QHIN is capable of TEFCA Exchange,
supports a trusted exchange framework, and maintains consistent
practices of exchanging information at scale to support nationwide
interoperability.
The first requirement, proposed in Sec. 172.201(b)(1), that the
entity seeking to become a QHIN be capable of exchanging information
among more than two unaffiliated organizations, is a requirement that
would ensure a minimum technical ability exists and that exchange would
be enabled beyond just the QHIN itself.
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The second requirement, proposed in Sec. 172.201(b)(2), is also a
minimum condition, except it is directed at the minimum quantity of
data a QHIN must be capable of exchanging. This proposed requirement
would ensure that every QHIN can exchange Required Information (as that
term is defined in Sec. 171.102), and provides certainty to
Participants and Subparticipants who seek to join a QHIN that there is
a minimum scope of data that they can reliably expect to be able to
exchange via TEFCA Exchange Purposes.
The proposed requirements in Sec. 172.201(b)(3) through (5) are
intended to establish basic parameters and expectations for QHINs in
order to qualify for Designation. We propose, in Sec. 172.201(b)(3),
that a QHIN or Applicant QHIN must be exchanging information for at
least one Exchange Purpose.
If a QHIN is not exchanging information for at least one of the
Exchange Purposes authorized under TEFCA (for examples, see the
``Exchange Purpose'' definition in Sec. 172.102) at the time of
application, it is not meeting a minimum condition necessary for such
exchange to occur and cannot be Designated. While exchange for an
Exchange Purpose under TEFCA requires an Exchange Purpose Code,
Applicant QHINs can demonstrate that they are meeting the requirement
to exchange information for at least one of the Exchange Purposes by
conducting exchange for an Exchange Purpose without use of an Exchange
Purpose Code.
We propose in Sec. 172.201(b)(4) to require a QHIN to be capable
of receiving and responding to transactions from other QHINs for all
Exchange Purposes, to ensure that health information can be exchanged
among health information networks under TEFCA. For this same reason, we
propose in Sec. 172.201(b)(5) to require a QHIN to be capable of
initiating transactions for the Exchange Purposes that such entity will
permit its Participants and Subparticipants to use through TEFCA
Exchange. Ensuring that QHINs will respond to Participant or
Subparticipant requests for information, and that the Participants or
Subparticipants are able to receive the information from QHINs, enables
health information exchange among the QHINs, Participants and
Subparticipants.
A QHIN's ability to transact for all Exchange Purposes is a
threshold requirement for an entity that seeks Designation and is
essential for ensuring that the TEFCA framework facilitates exchange
for each Exchange Purpose authorized in the Common Agreement or an
SOP(s) for implementation. Without this requirement, there would be no
certainty that the TEFCA framework would advance exchange beyond the
Treatment Exchange Purpose, which is the most prevalent purpose for
health information exchange today and the purpose of use that most
health care entities seeking Designation would be most familiar with.
TEFCA's network connectivity, including this requirement that QHINs
have the ability to exchange for all Exchange Purposes, and scale would
help, for example, health care providers gain access to more
comprehensive and complete information about their patients, which can
support improved care, better outcomes, decreased provider burden, and
reduced costs.
Entities performing TEFCA Exchange as described in Sec. 172.201
will have the option to request information for all Exchange Purposes.
At the time of publication of this Proposed Rule, TEFCA supports
exchange for the following Exchange Purposes: treatment; payment;
health care operations; public health; Individual Access Services
(IAS), and government benefits determination. Over time, additional
Exchange Purposes may be added. Information regarding whether responses
are required for a given Exchange Purpose will be included in a TEFCA
standard operating procedure.
In Sec. 172.201(c), we propose that an Applicant QHIN must meet
certain Designated Network Services requirements. Based on our
experience in the health IT ecosystem, we believe adequate network
performance is important for the success of TEFCA, as those
participating in TEFCA Exchange would be most likely to trust the TEFCA
infrastructure if it is performing at a high level. Unreliable network
performance would dilute confidence in the network and discourage
participation.
In Sec. 172.201(c)(1), we propose that a QHIN must maintain the
organizational infrastructure and legal authority to operate and govern
its Designated Network. For instance, under this proposal, QHINs would
be required to have a representative and participatory group or groups
that approve the processes for fulfilling the TEFCA governance
functions and that participate in governance for the Designated
Network. In Sec. 172.201(c)(2), we propose that a QHIN must maintain
adequate written policies and procedures to support meaningful TEFCA
Exchange as described in Sec. 172.201 and fulfill all responsibilities
of a QHIN in this part (which an entity agrees to by signing the Common
Agreement). For instance, under this proposal, QHINs would be required
to have a detailed written policy that describes the oversight and
control of the technical framework that enables TEFCA Exchange.
In Sec. 172.201(c)(3), we propose that a QHIN must maintain a
Designated Network (as proposed to be defined in Sec. 172.102) that
can support a transaction volume that keeps pace with the demands of
network users. Since TEFCA is a nationwide network and will be used
daily to support various health data needs to inform care delivery,
quality assessments, public health, and health care operations, QHINs
must be capable of transacting high volumes of data reliably and at
scale. In Sec. 172.201(c)(4), we propose that a QHIN must maintain the
capacity to support secure technical connectivity and data exchange
with other QHINs. One of the most fundamental aspects of interoperable
network exchange is technical connectivity, which makes network-to-
network exchange possible and, therefore, is important to include in
this regulation.
In Sec. Sec. 172.201(c)(5)-(7), we propose certain requirements
related to governance for TEFCA to ensure all QHINs are aligned and
able to manage risk effectively. In Sec. 172.201(c)(5), we propose
that a QHIN must maintain an enforceable dispute resolution policy
governing Participants in the Designated Network that permits
Participants to reasonably, timely, and fairly adjudicate disputes that
arise between each other, the QHIN, or other QHINs. This proposed
requirement would afford flexibility to QHINs to establish their own
dispute resolution process while ensuring the process is timely and
fair. Disputes may arise for a variety of reasons, so the QHIN, as the
entity overseeing its Participants, is best placed to handle such
disputes in a way that minimizes disruptions for the rest of the
network. Ensuring that a QHIN has such a dispute resolution policy
would, therefore, likely minimize such disruptions. Similarly, in Sec.
172.201(c)(6), we propose that a QHIN maintain an enforceable change
management policy consistent with its responsibilities as a QHIN. A
change management policy establishes the standard procedures to approve
different types of changes to TEFCA documents (e.g., standard operating
procedures) and policies and will help to avoid changes that are
disruptive or in conflict across entities. In Sec. 172.201(c)(7), we
propose that a QHIN must maintain a representative and participatory
group or groups with the
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authority to approve processes for governing the Designated Network.
The participatory network governance built into the TEFCA
infrastructure is important to ensure that the requisite engagement
exists between QHINs, Participants, and Subparticipants participating
in TEFCA Exchange. We believe the above requirements are fundamental
aspects of a network-of-networks focused on participatory governance
and the ability to adapt to an ever-changing health information
exchange landscape.
Regarding the proposed requirement in Sec. 172.201(c)(7)
specifically, we emphasize that TEFCA uses a representative and
participatory governance structure. Representative and participatory
governance gives those participating in the network a role in informing
the policies and decisions that ultimately would affect them. Such a
governance structure helps to motivate health care entities and their
networks to voluntarily join TEFCA. We believe that requiring a QHIN to
have a representative and participatory group or groups that has the
ability to review and provide input on the governance requirements of
the QHIN's Designated Network is an optimal approach for this
requirement.
In Sec. 172.201(c)(8), we propose that an entity seeking to become
a QHIN must maintain privacy and security policies that permit the QHIN
to support TEFCA Exchange. These policies currently include, but are
not limited to, the following:
Maintaining certification under a nationally recognized
security framework by a qualified, independent third party that ensures
its assessments are consistent with the NIST Cybersecurity Framework
(CSF) (using both NIST 800-171 (Rev. 2) and NIST 800-53 (Rev. 5) as a
reference), that reviews the QHIN's HIPAA Security Rule risk analysis
(consistent with Sec. 164.308(a)(1)(ii)(A)), and verifies all
requirements for technical audits and assessments are met.
Having a qualified, independent third party complete an
annual security assessment consistent with the NIST Cybersecurity
Framework (CSF) (using both NIST 800-171 (Rev. 2) and NIST 800-53 (Rev.
5) as a reference). The third party would review the QHIN for
compliance with HIPAA Security Rule risk analysis requirements
consistent with Sec. 164.308(a)(1)(ii)(A). Additionally, the annual
security assessment must include comprehensive internet-facing
penetration testing, must include an internal network vulnerability
assessment, and must use methodologies and security controls consistent
with Recognized Security Practices, as defined by Public Law No: 116-
321 (42 U.S.C. 17931 and 300jj-52).
Employing a Chief Information Security Officer with
executive-level responsibility.
Disclosing any breaches of electronic protected health
information (including disclosure of any such breaches within the three
(3) years preceding applying to become a QHIN) to the RCE and to all
QHINs that are likely impacted;
Complying with 45 CFR part 164, subparts A, C, and E, as
applicable, as if the QHIN were a covered entity as described in that
regulation; and