[House Hearing, 113 Congress] [From the U.S. Government Publishing Office] HEALTH INFORMATION TECHNOLOGIES: HOW INNOVATION BENEFITS PATIENTS ======================================================================= HEARING BEFORE THE SUBCOMMITTEE ON HEALTH OF THE COMMITTEE ON ENERGY AND COMMERCE HOUSE OF REPRESENTATIVES ONE HUNDRED THIRTEENTH CONGRESS FIRST SESSION __________ MARCH 20, 2013 __________ Serial No. 113-21 Printed for the use of the Committee on Energy and Commerce energycommerce.house.gov ---------- U.S. GOVERNMENT PRINTING OFFICE 80-806 PDF WASHINGTON : 2013 ----------------------------------------------------------------------- For sale by the Superintendent of Documents, U.S. Government Printing Office Internet: bookstore.gpo.gov Phone: toll free (866) 512-1800 DC area (202) 512-1800 Fax: (202) 512-2104 Mail: Stop IDCC, Washington, DC 20402-0001 COMMITTEE ON ENERGY AND COMMERCE FRED UPTON, Michigan Chairman RALPH M. HALL, Texas HENRY A. WAXMAN, California JOE BARTON, Texas Ranking Member Chairman Emeritus JOHN D. DINGELL, Michigan ED WHITFIELD, Kentucky Chairman Emeritus JOHN SHIMKUS, Illinois EDWARD J. MARKEY, Massachusetts JOSEPH R. PITTS, Pennsylvania FRANK PALLONE, Jr., New Jersey GREG WALDEN, Oregon BOBBY L. RUSH, Illinois LEE TERRY, Nebraska ANNA G. ESHOO, California MIKE ROGERS, Michigan ELIOT L. ENGEL, New York TIM MURPHY, Pennsylvania GENE GREEN, Texas MICHAEL C. BURGESS, Texas DIANA DeGETTE, Colorado MARSHA BLACKBURN, Tennessee LOIS CAPPS, California Vice Chairman MICHAEL F. DOYLE, Pennsylvania PHIL GINGREY, Georgia JANICE D. SCHAKOWSKY, Illinois STEVE SCALISE, Louisiana JIM MATHESON, Utah ROBERT E. LATTA, Ohio G.K. BUTTERFIELD, North Carolina CATHY McMORRIS RODGERS, Washington JOHN BARROW, Georgia GREGG HARPER, Mississippi DORIS O. MATSUI, California LEONARD LANCE, New Jersey DONNA M. CHRISTENSEN, Virgin BILL CASSIDY, Louisiana Islands BRETT GUTHRIE, Kentucky KATHY CASTOR, Florida PETE OLSON, Texas JOHN P. SARBANES, Maryland DAVID B. McKINLEY, West Virginia JERRY McNERNEY, California CORY GARDNER, Colorado BRUCE L. BRALEY, Iowa MIKE POMPEO, Kansas PETER WELCH, Vermont ADAM KINZINGER, Illinois BEN RAY LUJAN, New Mexico H. MORGAN GRIFFITH, Virginia PAUL TONKO, New York GUS M. BILIRAKIS, Florida BILL JOHNSON, Missouri BILLY LONG, Missouri RENEE L. ELLMERS, North Carolina Subcommittee on Health JOSEPH R. PITTS, Pennsylvania Chairman MICHAEL C. BURGESS, Texas FRANK PALLONE, Jr., New Jersey Vice Chairman Ranking Member ED WHITFIELD, Kentucky JOHN D. DINGELL, Michigan JOHN SHIMKUS, Illinois ELIOT L. ENGEL, New York MIKE ROGERS, Michigan LOIS CAPPS, California TIM MURPHY, Pennsylvania JANICE D. SCHAKOWSKY, Illinois MARSHA BLACKBURN, Tennessee JIM MATHESON, Utah PHIL GINGREY, Georgia GENE GREEN, Texas CATHY McMORRIS RODGERS, Washington G.K. BUTTERFIELD, North Carolina LEONARD LANCE, New Jersey JOHN BARROW, Georgia BILL CASSIDY, Louisiana DONNA M. CHRISTENSEN, Virgin BRETT GUTHRIE, Kentucky Islands H. MORGAN GRIFFITH, Virginia KATHY CASTOR, Florida GUS M. BILIRAKIS, Florida JOHN P. SARBANES, Maryland RENEE L. ELLMERS, North Carolina HENRY A. WAXMAN, California (ex JOE BARTON, Texas officio) FRED UPTON, Michigan (ex officio) C O N T E N T S ---------- Page Hon. Joseph R. Pitts, a Representative in Congress from the Commonwealth of Pennsylvania, opening statement................ 1 Prepared statement........................................... 2 Hon. Frank Pallone, Jr., a Representative in Congress from the State of New Jersey, opening statement......................... 3 Hon. Michael C. Burgess, a Representative in Congress from the State of Texas, opening statement.............................. 4 Hon. Henry A. Waxman, a Representative in Congress from the State of California, opening statement............................... 6 Hon. Phil Gingrey, a Representative in Congress from the State of Georgia, prepared statement.................................... 163 Witnesses Joseph M. Smith, M.D., Ph.D., Chief Medical and Chief Science Officer, West Health Institute................................. 8 Prepared statement........................................... 11 Answers to submitted questions............................... 170 Christine Bechtel, Vice President, National Partnership for Women And Families................................................... 67 Prepared statement........................................... 69 Jim Bialick, Executive Director, Newborn Coalition............... 74 Prepared statement........................................... 76 Answers to submitted questions............................... 173 Jacqueline Mitus, M.D., Senior Vice President, Clinical Development and Strategy, McKesson Health Solutions............ 83 Prepared statement........................................... 85 Answers to submitted questions............................... 177 David Classen, M.D., Chief Medical Information Officer, Pascal Metrics, and Associate Professor of Medicine and Consultant in Infectious Diseases, University of Utah School of Medicine..... 130 Prepared statement........................................... 132 Answers to submitted questions............................... 179 Submitted Material Letter of March 20, 2013, from Kevin McCarthy to the Committee, submitted by Mr. Pitts......................................... 164 Statement of The Bipartisan Policy Center, submitted by Mr. Pitts 166 HEALTH INFORMATION TECHNOLOGIES: HOW INNOVATION BENEFITS PATIENTS ---------- WEDNESDAY, MARCH 20, 2013 House of Representatives, Subcommittee on Health, Committee on Energy and Commerce, Washington, DC. The subcommittee met, pursuant to call, at 10:00 a.m., in room 2123 of the Rayburn House Office Building, Hon. Joe Pitts (chairman of the subcommittee) presiding. Present: Representatives Pitts, Burgess, Hall, Shimkus, Blackburn, Gingrey, Lance, Guthrie, Griffith, Bilirakis, Ellmers, Pallone, Green, Barrow, Christensen, Sarbanes, and Waxman (ex officio). Staff present: Clay Alspach, Chief Counsel, Health; Matt Bravo, Professional Staff Member; Debbee Hancock, Press Secretary; Sydne Harwick, Staff Assistant; Sean Hayes, Counsel, Oversight and Investigations; Robert Horne, Professional Staff Member, Health; Carly McWilliams, Legislative Clerk; Andrew Powaleny, Deputy Press Secretary; Chris Sarley, Policy Coordinator, Environment and the Economy; Heidi Stirrup, Health Policy Coordinator; Alli Corr, Democratic Policy Analyst; Eric Flamm, FDA Detailee; Amy Hall, Democratic Senior Professional Staff Member; Elizabeth Letter, Democratic Assistant Press Secretary; Karen Nelson, Democratic Deputy Committee Staff Director for Health; Rachel Sher, Democratic Senior Counsel; and Matt Siegler, Democratic Counsel. OPENING STATEMENT OF HON. JOSEPH R. PITTS, A REPRESENTATIVE IN CONGRESS FROM THE COMMONWEALTH OF PENNSYLVANIA Mr. Pitts. The subcommittee will come to order. The chair will recognize himself for an opening statement. Today's hearing is part of a series of Energy and Commerce subcommittee hearings this week that focus on health, technology and innovation. In the last few years, health information technologies, including mobile medical applications, electronic health records, personal health records, computerized health care provider order entry systems, and clinical decision support, have transformed the provision of health care in this country. Electronic health records hold great promise for the delivery of care given and the quality of care received in this country. They have also been identified as key components of future payment reforms such as those envisioned for medical providers under the SGR. There are now mobile medical apps for wireless thermometers, apps that calculate body mass index, apps that track the number of miles a runner has jogged and those that can wirelessly transmit data to wearable insulin pumps. These apps can range from the complex, like mobile cardiac outpatient telemetry that uses wireless sensors, to those that allow users to count calories. To give you a sense of the scope of their importance, it has been estimated that 500 million people will be using medical apps by the year 2015. Therefore, it goes without saying that these technologies hold great potential for patients and providers. However, with the proliferation of these technologies have come concerns about how their use may negatively impact patients. Some have argued that federal oversight of these health information technologies is important to safeguard patients from malfunctioning technology. In response to these concerns, the Office of the National Coordinator in December of 2012 put out a proposal for a risk- based regulatory scheme for electronic health records that sought to address the needs of Americans both as consumers and patients. The Food and Drug Administration has also put forward a proposal, in the form of draft guidance issued in July 2011, indicating its intent to regulate certain apps as medical devices under section 201(h) of the Federal Food, Drug and Cosmetic Act. While FDA's attention to the needs of patients is commendable, its action requires very close scrutiny. This subcommittee has examined in the past the negative impacts that FDA regulation, with its uncertainty, high costs, and long approval times, has had on the medical device industry. If we allow the same to happen in this space, such negative impacts could cripple a still evolving and promising industry, where the average developer is small and the cost of these apps is relatively inexpensive. Some have also raised concern that the FDA may further expand the definition of ``medical device'' in the future to include other technologies, such as smartphones or tablets, and thus the medical device tax passed in the Patient Protection and Affordable Care Act could apply to them. Therefore, this hearing is an appropriate place to examine the extent to which the FDA and other federal agencies should be involved in regulation of health information technologies and what such a regulatory framework might look like. With these thoughts in mind, I want to thank our witnesses for being here today and look forward to their testimony. [The prepared statement of Mr. Pitts follows:] Prepared statement of Hon. Joseph R. Pitts Today's hearing is part of a series of Energy and Commerce subcommittee hearings this week that focus on health, technology and innovation. In the last few years, health information technologies, including mobile medical applications (apps), electronic health records, personal health records, computerized health care provider order entry systems, and clinical decision support, have transformed the provision of health care in this country. Electronic Health Records hold great promise for the delivery of care given and quality of care received in this country. They have also been identified as key components of future payment reforms such as those envisioned for medical providers under the SGR. There are now mobile medical apps for wireless thermometers; apps that calculate body mass index; apps that track the number of miles a runner has jogged and those that can wirelessly transmit data to wearable insulin pumps. These apps can range from the complex, like mobile cardiac outpatient telemetry (MCOT) that uses wireless sensors, to those that allow users to count calories. To give you a sense of the scope of their importance, it has been estimated that 500 million people will be using medical apps by 2015. Therefore, it goes without saying that these technologies hold great potential for patients and providers. However, with the proliferation of these technologies have come concerns about how their use may negatively impact patients. Some have argued that federal oversight of these health information technologies is important to safeguard patients from malfunctioning technology. In response to these concerns, the Office of the National Coordinator in December 2012 put out a proposal for a risk- based regulatory scheme for electronic health records that sought to address the needs of Americans both as consumers and patients. The Food and Drug Administration (FDA) has also put forward a proposal, in the form of draft guidance issued in July 2011, indicating its intent to regulate certain apps as medical devices under section 201(h) of the Federal Food, Drug and Cosmetic Act (FFDCA). While FDA's attention to the needs of patients is commendable, its action requires very close scrutiny. This subcommittee has examined in the past the negative impacts that FDA regulation--with its uncertainty, high costs, and long approval times--has had on the medical device industry. If we allow the same to happen in this space, such negative impacts could cripple a still evolving and promising industry, where the average developer is small and the cost of these apps are relatively inexpensive. Some have also raised concern that the FDA may further expand the definition of ``medical device'' in the future to include other technologies, such as smart phones or tablets, and thus the medical device tax passed in the Patient Protection and Affordable Care Act could apply to them. Therefore, this hearing is an appropriate place to examine the extent to which the FDA--and other federal agencies--should be involved in regulation health information technologies and what such a regulatory framework might look like. With these thoughts in mind, I want to thank our witnesses for being here today and look forward to their testimony. Mr. Pitts. And no one is seeking recognition. I will close my statement and recognize the ranking member of the Subcommittee on Health, Mr. Pallone, for 5 minutes for his opening statement. OPENING STATEMENT OF HON. FRANK PALLONE JR, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF NEW JERSEY Mr. Pallone. Thank you. Thank you, Chairman Pitts. Today is an important examination of the ways in which health information technologies can benefit patients, doctors, and the health care system as a whole. HIT is an absolutely essential underpinning to the future of delivery and payment reform. The notion that if we can improve the coordination of care, patient safety, disease management, and prevention efforts, we can save money for the entire system. It is not baseless. In fact, it has the utmost merit. Modernizing our health care system and moving into an electronic era is part of a national conversation that is occurring, and politicians of both political parties, providers, and patients all agree that HIT holds tremendous promise for improving the performance of our healthcare system in a way that will increase access, enhance quality, and indeed lower costs. That is why as chairman of this subcommittee, I worked alongside many of my colleagues, Democrat and Republican alike, and we passed the Health Information Technology for Economic and Clinical Health Act, otherwise known as HITECH or the HITECH Act. Together, we recognized with that bill that there was a need for the Federal Government to commit to expanding the use of information technology in the health care sector, and that its widespread adoption would have significant long- term benefits. This critical law contained unprecedented funding to promote the adoption of health information technology among hospitals, doctors, and health care providers through initiatives by the Office of the National Coordinator of HHS and through Medicare and Medicaid incentives. This historic investment has begun to help modernize our Nation's use of technology to truly ensure a high-performing 21st century health system, and in building an infrastructure of fundamental change. The truth is that we have made great progress so far, and there are even more opportunities that will be realized in the future through the implementation of this law. As a result of these programs, electronic health records, EHRs, and meaningful use of those records has increased dramatically in recent years, and we will hear today from some of the witnesses how it is working to make life better for patients and serving as a catalyst for innovation. Now I am afraid that my Republican friends are going to spend this day making up false stories about how the Affordable Care Act and FDA regulation is stifling innovation--how our smartphones are going to be taxed and Apple's manufacturing plants will be inspected, but I have to say this is nonsense. The reality is the future of mobile health is very bright. In fact, there is an effort underway by the Federal Government to open up large sets of data to be used by developers to create these mobile applications, and many of these apps are designed to assist both individuals and health care providers in managing health care decisions and delivery. One industry analyst estimates that the total revenues of the mobile medical app market will grow to $26 billion by 2017, and because of the HITECH Act, this open data will be able to be networked and shared with providers to improve patient health and lower costs. But I believe, and I think all of our witnesses today will agree with me, that if a technology developer is going to make health-based claims, then there must be a role for FDA to ensure it is safe and effective, and I hope that is what comes out of today's hearing is a better understanding of how the successful adoption of health information technology will have a transformative effect on the quality of health care in the United States, as well as the economy of health care. So I thank you all, thank the chairman, and I would yield back the balance of my time. Mr. Pitts. Chair thanks the gentleman, and now recognizes the vice chair of the subcommittee, Dr. Burgess, for 5 minutes for an opening statement. OPENING STATEMENT OF HON. MICHAEL C. BURGESS, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF TEXAS Mr. Burgess. I thank the chairman for the recognition. I am grateful to the chairman for holding this hearing, grateful to our panel for presenting to us today. The title of the hearing is fitting. As somebody who worked in health care, I recognize the benefit that innovation brings to patients. From the newest means to detect and diagnose conditions, to the cures and diseases that once were thought untreatable, innovation has led the way to bettering the lives of patients. Health care innovation doesn't always lower costs, but it always holds the potential to improve the quality of life and therefore is a goal worth pursuing in and of itself. The tools that future doctors will have at their disposal will be unparalleled in the history of medicine for their ability to alleviate human suffering and improve lives, but we need to get the tools in their hands. From custom biologics to nanotechnology to the promises of the human genome, we are on the cusp of a medical revolution. The President, in an Executive order, ordered federal agencies to review and remove outdated regulations. I absolutely agree with Mr. President, but the proof really remains to be seen. The biggest impediment to innovation is the uncertainty of regulation. If the Federal Government thinks about regulating something, that almost always means it is planning to over- regulate. There is the difficultly, because the lifeblood of innovation, venture capital, will be drained away from the cures that might have been. As a doctor, first do no harm. I don't want to do anything that will harm a patient. But while the FDA struggles with their core requirements that they propose to venture into new areas like mobile apps and research only products and health information technology, it really does require a soft touch. Instead of talking to stakeholders, including members of Congress, where updates may be needed from time to time, and significant proposed regulatory changes could stop innovation in their tracks, we are just not seeing it happen. Companies will build it, doctors will use it, patients will benefit if we could just get out of the way and ensure responsible regulation in a timely fashion. The reason I care about this so much is because not just today, this is about the future. This is about the men and women that will follow after us in the practice of medicine. These are about the ideas that somebody hasn't even had yet. The lack of a reliable and consistent regulatory process signals an inability to handle the events for technology in the future. Mr. Chairman, this hearing is timely. It is in conjunction with other hearings being done in other subcommittees and the full committee. Technology had a hearing yesterday. We will have a hearing in Oversight and Investigations tomorrow. But it is part of a process. I would like now to yield the balance of the time available to the gentlelady from Tennessee, the vice chair of the full committee. Mrs. Blackburn. I thank the gentleman for yielding, and welcome to each of you. We are delighted that you are here. As Dr. Burgess said, we had a Telecom Subcommittee hearing yesterday, and looked at the impediments to innovation. It was fantastic to have a group of innovators sitting at your table and talking to us about the problems that they are seeing. Now, one of my colleagues said that he feared we would spend our time making up stories about how HHS and FDA kind of get in the way, but we don't have to make them up. All we have to do is read the testimony from yesterday. One of the things that came through regularly in their words was that the uncertainty that is there from the FDA, this big gray area in the center, that you don't know if you are going to be regulated as a medical device. If you don't know how far that arm of government is going to reach and how massive the overreach will be, or will it be contained and will there be some certainty? Now, I don't think it is up to the FDA to provide that certainty. I think it is up to Congress to decide what FDA's role should be. We are seeking your thoughts and the panel yesterday and tomorrow to make certain that we approach this in the appropriate manner. What we want to be certain that we do is allow the environment for innovation to take place. As Dr. Burgess said, these are tools that today's doctors and future doctors are going to be able to use. I think 15 percent of apps are used by providers. That is something that will yield to cost savings. At the same time, patients are able to have a more active participation in their health care, from managing diseases and chronic conditions, by having access to an app that goes with them everywhere they go. So we look forward to hearing from you to setting the right path forward, and we thank you for your time. I yield back. Mr. Pitts. Chair thanks the gentlelady, and now recognizes the ranking member of the full committee, Mr. Waxman, for 5 minutes for an opening statement. OPENING STATEMENT OF HON. HENRY A. WAXMAN, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF CALIFORNIA Mr. Waxman. Thank you, Mr. Chairman. Today is our second day of hearings on this subject. This is the week that this committee decided that in three of its subcommittees, we would hold hearings to scare people that they won't be able to develop what we want to see developed, innovative ways to communicate in the health space. The Energy and Commerce Committee has a history of bipartisan accomplishments, and even in this area, and that is one of the reasons, to me, why the partisan hyperbole we have heard from some on this topic is so disappointing. Yesterday, the Telecommunications Subcommittee examined mobile medical applications and the FDA regulation of medical devices. Both sides of the aisle agree we must promote innovation in the dynamic mobile medical applications market. Both sides agree that it is essential for the FDA to ensure the safety and effectiveness of potentially dangerous medical devices, even if they are also connected to a mobile platform. But we spent far too much of yesterday's hearing debating an imaginary tax on smartphones, because in the Affordable Care Act, there is a tax on medical devices. So you have got two things to worry about. If you innovate, FDA might look at it and regulate it, and two, if it is a medical device, it may be taxed. Oh, you shouldn't sleep anymore at might worrying about these problems Republicans are dreaming up. So they said FDA is going to regulate these iPhones, the same way it regulates heart valves. Well, that is a political talking point and it is just not real. I hope today we can focus on this committee's real bipartisan accomplishments in health information technology. In the 111th Congress, the Congress before the last one, our committee passed what was called the Health Information Technology for Economic and Clinical Health Act as part of the Recovery Act. They called this the HITECH--that is the way we do it, so we got a new acronym. This law resulted in an explosion of electronic health records and other advanced health information technology--exactly what we wanted to see. Physicians, hospitals, pharmacies, health care providers across the country are building an infrastructure network as important to our Nation's future as the interstate highway system. It is just like the construction of the interstates. Building this infrastructure is challenging. Hundreds of thousands of physicians, tens of thousands of hospitals, clinics, pharmacies are going to connect to this network and HHS is--made a lot of progress by engaging a wide variety of stakeholders and driving coordination without mandating a ``one size fits all'' solution. So we are trying to develop the ability technologically to communicate, and it is an ambitious goal. A seamlessly connected health information infrastructure protects privacy while demanding the highest quality, most efficient care. We haven't reached that goal yet, but I believe we are on track to get there. So given our enormous progress, it would be rash and unwise to turn back now. This is worth doing. Similar to the health IT, our approach to mobile health applications has to strike the correct balance between innovation and patient safety. Well, we had a hearing yesterday where we made it clear that FDA wouldn't take mobile apps and regulate mobile apps, even if they had information on general health and wellness, and even if it functioned as electronic health record system. I think it is wise. We shouldn't regulate this in any way as a medical device. But if you had something on your iPhone that purports to help diagnose skin cancer or congenital heart defects, well, you got to have some appropriate regulatory scrutiny. You get a lot of false positives, you get false negatives, people are being confident in these devices, and we better know whether you can be confident in these devices, if they are going to tell you that a mole, don't worry about it, it is not cancerous, when, in fact, it could be melanoma. We don't believe in this country that buyer should beware. Well, my colleagues in Congress should act. Congress has acted, and in fact, when we had the Medical Devices User Fee Act in the last Congress, we specifically rejected in that bill a moratorium on FDA's use of its authority over medical devices that happened to be implemented as mobile applications. My last point is even if it is regulated as a medical device, it is not going to be charged with a tax. That tax only goes to certain kinds of devices. So don't be scared. Look at the law, look at the reality, and don't listen to the political rhetoric which this week has been orchestrated very carefully by my Republican colleagues. Yield back the balance of my time. Mr. Pitts. Chair thanks the gentleman. That concludes our opening statements. We have one panel today. I would like to thank our distinguished panel of experts for providing testimony today, and I will introduce them at this time. First, Dr. Joseph Smith, Chief Medical and Chief Science Officer, West Health Institute; secondly, Ms. Christine Bechtel, Vice President, National Partnership for Women and Families; third, Mr. Jim Bialick, Professor of Public Policy, Georgetown Public Policy Institute; fourth, Dr. Jacqueline Mitus, Senior Vice President, Clinical Development and Strategy, McKesson Health Solutions; and finally, Dr. David Classen, Chief Medical Information Officer, Pascal Metrics, Associate Professor of Medicine and Consultant in Infectious Diseases, University of Utah School of Medicine. Thank you all for coming this morning. You will each be given 5 minutes to summarize your testimony. Your written testimony will be entered into the record. Dr. Smith, we will start with you. You are recognized for 5 minutes for your opening summary. STATEMENTS OF JOSEPH M. SMITH, M.D., Ph.D., CHIEF MEDICAL AND CHIEF SCIENCE OFFICER, WEST HEALTH INSTITUTE; CHRISTINE BECHTEL, VICE PRESIDENT, NATIONAL PARTNERSHIP FOR WOMEN AND FAMILIES; JIM BIALICK, EXECUTIVE DIRECTOR, NEWBORN COALITION; JACQUELINE MITUS, M.D., SENIOR VICE PRESIDENT, CLINICAL DEVELOPMENT AND STRATEGY, MCKESSON HEALTH SOLUTIONS; AND DAVID CLASSEN, M.D., CHIEF MEDICAL INFORMATION OFFICER, PASCAL METRICS, AND ASSOCIATE PROFESSOR OF MEDICINE AND CONSULTANT IN INFECTIOUS DISEASES, UNIVERSITY OF UTAH SCHOOL OF MEDICINE STATEMENT OF JOSEPH M. SMITH Dr. Smith. Chairman Pitts, Ranking Member Pallone, and members of the subcommittee, thank you for the opportunity to testify today. I am Dr. Joseph Smith, Chief Medical and Science Officer for the West Health Institute, a nonpartisan, nonprofit, applied medical research organization dedicated to lowering the cost of health care for public good by research and development of innovative, patient-centered solutions. Our Nation's health care system is in dire need of dramatic change as we lead the world in health care spending, lag many of our peer nations in critical health outcomes, and face into a growing aging population a tsunami of chronic disease, with a relative shortage of physicians, it is difficult to overstate our challenges, but suffice it to say that our health care delivery system is exceeding both our Nation's budget and our provider's bin without yet meeting our patient's needs. We see an enormous opportunity to use information technology, device innovation, mobile and wireless technology, and smart and learning systems to both transform health care delivery and create empowered, informed consumers of health care. Health care must be allowed and encouraged to rapidly evolve using the same innovations that have already revolutionized banking, education, retail, computing, photography, and communication. We must take proactive steps to assure that those technologies that have enabled a revolution of decentralization, democratization, automation, and personalization, and other aspects of our lives and our economy have the same beneficial impact on health care. To enable this transformation, three elements appear required. One, streamlined, predictable, transparent, risk- based regulation that fosters innovation and investment for the benefit of patients, as well as our ailing health care system; two, a proactive regulatory and reimbursement stance on true functional interoperability, not only EHR interoperability, but specifically, medical device interoperability to create an integrated, fully coordinated web of patient-centered health care technology; and three, reimbursement policy that aligns stakeholder incentives and drives adoption of appropriate technology to improve safety, efficiency, and cost of care. At this point in time, when health care is truly a ``burning platform,'' we need to stimulate innovation and experimentation. This requires a clear, consistent, and timely approach to regulation. Outside of health care, we have witnessed a revolution in information, communication, and device technology driven by innovation and investment, all encouraged by a predictable regulatory posture. Within health care, however, we have yet to fully exploit the potent intersection of these technologies. With respect to medical apps, while we have witnessed an explosion of innovation in the health and wellness applications, we have seen relatively little activity in the critically important, but more heavily regulated, areas of remote monitoring, diagnosis and treatment of those chronic diseases that burden patients, and make up the lion's share of our health care spending. And for medical apps and clinical decision support, it is an open question of whether the existing medical device regulatory framework can be sufficiently modified to provide the applicability, clarity, predictability, and timeliness required. The FDA's draft guidance on mobile medical apps offered some improved clarity, but still described significant areas of regulatory discretion, and now after lengthy delay without becoming finalized has left an industry in limbo. Going forward, considering the frequency with which both general app user interfaces and medical treatment guidelines used in clinical decisions support algorithms that are routinely updated, the prospect of having all such changes subject to the complex regulatory process for medical device revision seems more than daunting. Whatever the process, we must drive regulation at the pace of innovation, and not vice- versa. The second priority is to use regulatory and reimbursement policy to encourage true functional interoperability of information systems, and medical devices. Health care needs to exploit a truly connected and coordinated med app technology that can be seen as originating at the patient with those surrounding or even implanted medical devices with seamless sharing of relevant information among all such devices and the background EHR. The current lack of such true functional interoperability results in safety hazards and inefficiencies that we do not tolerate in other less critical areas, and it creates additional barriers for new innovative entrants. Standards-based interoperability allows the information required for commerce and banking and communication and education to move at the speed of innovation, and yet, when it comes to our health care, information is stuck in multiple non- communicating silos as lifesaving devices are forced to work independently, despite being inches apart, all in service of the same critically ill patient. Today we released a study illustrating that true functional medical device interoperability not only brings improvements in patient safety and efficiency, but may also result in savings of more than $30 billion annually. Established labeling for medical device interoperability and inclusion of such stage three meaningful use could encourage adoption of such functional interoperability for patient benefit and health care savings. The third priority area is regulation of reimbursement policy that promotes aligned incentives. Reimbursement systems that disproportionately reward hospital-based procedures over office-based procedures, or face-to-face encounters over remote encounters need to give way to reimbursement based on outcome, not location, and value, not volume. Only in this way will we unleash the power of information communication and medical device technology. In closing, the West Health Institute believes that streamlined, predictable, transparent, risk-based regulation, a proactive regulatory and reimbursement stance on medical device interoperability, and realistic and actual policy to align stakeholder incentives can help to unleash a needed and long overdue transformation of our health care delivery system to allow it to sustainably address the needs of today's patients and meet tomorrow's challenges. Thank you very much. [The prepared statement of Dr. Smith follows:] [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT] Mr. Pitts. Chair thanks the gentleman, and now recognizes Ms. Bechtel for 5 minutes for an opening statement. STATEMENT OF CHRISTINE BECHTEL Ms. Bechtel. Good morning. I am Christine Bechtel with the National Partnership for Women and Families. We are a nonprofit, nonpartisan consumer advocacy organization. I also serve on the Federal Health IT Policy Committee. I am honored to speak today about how the EHR Incentive Program, commonly known as ``Meaningful Use'', is catalyzing fundamental change in our health care system and advancing innovation. Almost 3 years ago before this same subcommittee, I shared a story of Susan Crowson, and she is a family caregiver from Maryland, and she cared for her father, Pop. Pop was seeing five different doctors, taking three different prescription drugs, two over-the-counter drugs, and daily vitamins to manage a host of complex conditions, including Alzheimer's Disease, and arrhythmia. Susan diligently tracked all of Pop's medications, tests, lab results, and visits on a spreadsheet to help his doctors avoid medical errors and provide the best care possible in our highly fragmented system. Today, the Meaningful Use Program is making care better for people like Pop and caregivers like Susan. Providers with certified EHRs now maintain up-to-date electronic lists of patient's health conditions, diagnoses, and medications, and doctors can automatically track for drug interactions and allergies. Pop and Susan can get a summary at every office visit so they know the diagnosis and the plan. If Pop is admitted to the hospital, they can send a summary of his admission to his primary care doctor. These are just some of the early innovations in health IT. Sadly, many of these advances were not put in place quickly enough to help the Crowson family. Since I last testified, Pop has passed away. But thanks to Meaningful Use, patients and family caregivers like Susan are less likely to face these same struggles. They are now coming to expect health IT, just as technology has revolutionized so many other aspects of our life. Indeed, the arc of adoption has surpassed our expectations. At the last subcommittee hearing in 2010, we wondered if incentive payments would be effective drivers of EHR adoption. We asked if providers would be able to achieve Meaningful Use. Federal officials then offered a high end estimate of 53 percent of office-based physicians would adopt EHRs by 2015. But as of this February, 2 years before the 2015 projection, CMS reports that 40 percent of eligible professionals have already completed phase one of Meaningful Use, either in Medicare or Medicaid, and more than 70 percent have registered for it. Hospitals have been even more successful. Seventy percent are already Meaningful users, and 85 percent have registered. But there is much more work to do. To foster continued innovation, we must deploy a wider array of standards through HHS's certification program, which has been essential to breaking down technical barriers to the secure sharing of health information. It is this federal leadership which occurs in collaboration with the private sector that is critical to innovation. We also need new approaches to payment that moves us beyond fee-for-service and creative business case for care coordination and improved health outcomes. This can only be done by rewarding quality and value over volume. But we simply cannot measure and reward this kind of care without health IT. Even within these limitations, though, advancements in standardization spurred by the Meaningful Use regulations are catalyzing innovation. So for example, Medicare and the VA implemented a feature called Blue Button that allows individuals to securely view and download their health information online, and this innovation is making a world if difference for people like Beth Schindele, who cares for her father, William Graves. With his permission, Beth went to mymedicare.gov and downloaded his health information when he was in the hospital. The data from Blue Button showed that he had more than 63 providers caring for him over the course of four hospitalizations in the last year and a half, and she told me last week ``Having the data in my hands during his hospitalization allowed me to prevent the hospital from erroneously placing him on Coumadin, which is a blood thinning medication, and he had stopped taking that 2 years ago. I am so thankful that I did. Within hours of discharge, he fell and he suffered severe head and arm lacerations that would have been life-threatening had he been on Coumadin, and would have resulted in a readmission within just 5 hours of leaving the hospital.'' Blue Button is a simple, yet powerful, innovation that will help consumers play a critical role in promoting safer, more affordable, and more coordinated care. For this kind of innovation to accelerate, the challenge before us is to ensure that every provider in the country has health IT. We must expand the Meaningful Use program to connect other providers like long-term care, behavioral health, and home health. No other program in history has done this much this quickly to advance the adoption of health IT, and I am confident that along with payment reform, it will result in better care at a lower cost. Thank you. [The prepared statement of Ms. Bechtel follows:] [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT] Mr. Pitts. Chair thanks the gentlelady and now recognizes Mr. Bialick for 5 minutes for an opening statement. STATEMENT OF JIM BIALICK Mr. Bialick. Chairman Pitts, Ranking Member Pallone, members of the subcommittee, thank you for the opportunity to testify on this important issue. And thank you, Mr. Pitts, for the promotion, but I am actually the Executive Director of the Newborn Coalition. We are an all volunteer organization that came together to promote the development and use of mobile apps and technology in newborn and infant health. The catalyst for our beginning was the birth of a baby named Eve, who at 40 hours old was diagnosed with a critical congenital heart defect, the most common birth defect in the U.S. affecting nearly 1 in 100 births. Had it not been for an attentive nurse, Eve would have been discharged with a partially formed heart. While a simple screening tool, pulse oximetry, exists to identify these conditions, there is still no national requirement for routine screening. Her mother, our co-founder, started a crusade to ensure that babies like Eve would never again be sent home without first being screened. We estimate that since our efforts began, the number of babies screened for heart defects in the U.S. has increased by 4,500 percent. To date, we have aided in the drafting of legislation in 23 States and the enactment of nine laws. The first was in New Jersey, where a baby was identified with a heart defect before a discharge on the very first day of screening, and most recently, in California. We are very proud of these numbers, but we have learned that it is not enough just to screen, but we also have an obligation to accommodate the lifelong needs of those diagnosed by the screening, and consumer technology, such as mobile apps, play an important role in fulfilling that responsibility. It is important to remember that of the more than four million babies born in the U.S. every year, the majority aren't born in advanced cardiac surgery centers. They may be sent to several hospitals, be seen by more than a few doctors, be given a number of medications, which in today's less than interoperable health care system means mom and dad will be responsible for managing and reconciling most of this information on the best and worst day of their lives. After leaving the hospital, babies can be monitored continuously from home using a pulse oximeter. These babies are special because they have heart defects, but they are still just babies and their parents are still exhausted. So what do parents do? They use the same smartphone or tablet that they use to manage all of their other important information. Families and providers have come to rely on mobile apps to allow them to capture readings from remote monitoring devices. This means less time having to focus on being a nurse and more time available to be a parent. The availability of these technologies has created a revolution in how we interact with our data and engage in our health, but it has also created legitimate safety concerns that must be addressed. However, the FDA draft guidance as written would seemingly attempt to regulate the future of health care technology as a standalone medical device. In my written testimony, I have laid out a model for a risk-based framework that very intentionally delineates between health information management apps and actual medical devices. Applications and the platforms that support them have the ability to integrate and interoperate with any device that will allow it. Consumer demand for integrated technology solutions will drive the market to a wholly interoperable system that can be accessed at any time, anywhere, and by any device, and we would be foolish to believe that this integration will happen and will not include health information. Consumer technologies have evolved to leverage the Internet to share data, including with medical devices, functionally eliminating the difference between being on a network and physically linking devices with a cord. As a result, we need to be thinking about the regulation of technology differently. What we need is a new patient-centered risk-based regulatory framework for evaluating health technologies that is flexible enough to regulate what we are using today and adaptive enough to accommodate the technologies that have yet to be conceived. I know the concept of a new regulatory process is daunting, but an existing framework does not create the certainty that the emerging health care technology marketplace needs to flourish. I cringe when I hear from patient organizations that are dedicating a significant amount of their budget to develop a mobile app, because I know their product may have to go through a process that would cost them more than they can afford, rendering their initial investment worthless. I was disheartened when my wife, who is now 4 months pregnant, asked me which app she should use to track her pregnancy. I told her the one with the fewest, least complex features, because I wanted to make sure that she didn't lose all the data that she would enter throughout the pregnancy in the event the manufacturer depreciated certain functionalities to avoid the FDA. To me, that is not certainty and that is not pro-patient. This committee has the foresight to hold--has had the foresight to hold this hearing because collectively, you recognize that mobile apps are transforming how patients, families, and providers engage in the delivery of health care. Reform will not be without controversy, but it is far better to address this issue now than to wait for traditional approaches to fail at the expense of patients and families. Thank you again for this opportunity to testify. I look forward to working with you on this important issue, and I am happy to answer any questions. [The prepared statement of Mr. Bialick follows:] [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT] Mr. Pitts. Chair thanks the gentleman, and now recognizes Dr. Mitus for 5 minutes for an opening statement. STATEMENT OF JACQUELINE MITUS Dr. Mitus. Good morning, Mr. Chairman and distinguished members of the subcommittee. My name is Jackie Mitus, and I currently serve as Senior Vice President of Clinical Development and Strategy for McKesson Health Solutions. I appreciate the opportunity to appear before you today. My background as a practicing hematologist/oncologist at the Brigham and Women's Hospital in Boston, and faculty member of Harvard Medical School, as well as my responsibilities at McKesson, have provided me with a unique perspective on health information technology. I have seen first-hand how critical health IT is to advancing the care and safety of patients. As the largest health IT company in the world, McKesson has actively engaged in the transformation of health care from a system burdened by paper to one empowered by interoperable electronic solutions. I would like to make two key points today. First, health IT is foundational to improving the quality, safety and affordability of healthcare. Second, to ensure continued innovation and leverage the power of health IT, we need a new regulatory framework that is risk-based and specific to health IT. Health care in our country is undergoing fundamental changes to make it safer, better, and more efficient. Health IT is the foundation of these efforts. It provides access to current, accurate patient information such as medication history, and it supports the clinician in preventing errors, identifying gaps in care, and suggesting appropriate diagnostic and treatment paths. Health IT does not replace physician judgment, but rather, provides guidance and support. The ultimate responsibility for the care and safety of a patient always rests with the treating clinician. Today, the FDA has authority to regulate medical devices under amendments to the Food, Drug, and Cosmetic Act adopted in 1976. The definition of a medical device in the Act is broad and can be interpreted to include all health IT, including medical software. The current regulatory approach for medical devices, however, is not well-suited for health IT. For example, does an iPad that reminds a patient to refill a prescription make it a traditional medical device? What about an application that allows a clinician to access a medical journal or review an x-ray online? Should these applications and the iPad each be subject to FDA regulations? Medical software is fundamentally different from medical devices in two important ways. First, the safety of a medical device is almost entirely dependent upon how it is manufactured. The safety of health IT, on the other hand, hinges upon how it is developed and perhaps more importantly, on how it is implemented. Thus, health IT cannot safely be ensured simply through good manufacturing practice. Second, medical devices, unlike health IT, are directly involved in the treatment of a patient with little, if any, opportunity for a clinician to intervene. The majority of medical software does not directly or independently act upon a patient, but rather, provides data and guidance. The ability of a learned intermediary to utilize professional judgment distinguishes this technology from traditional medical devices. Mr. Chairman, we risk using a law enacted nearly a half century ago to regulate a rapidly changing and dynamic era of technology. In closing, I would like to highlight the work of the Bipartisan Policy Center, BPC, which last month released a report in response to the FDA Safety and Innovation Act. With the input of nearly 100 organizations, including McKesson, the BPC recommended dividing health IT into three risk categories. The first and highest risk category includes technology linked to or used to operate a medical device. This technology would continue to be regulated as a medical device. The second category includes medical software that merely guides the physician, such as clinical decision support or electronic health records. This group would be subject to rigorous accreditation by an independent third party, or perhaps ONC. Finally, the third category, non-clinical technology, such as billing and scheduling software, would not be subject to regulatory oversight. The BPC approach is flexible, protects patient safety, promotes innovation, and leverages existing quality and safety standards. In conclusion, health IT is imperative to the successful transformation of health care. It improves the quality of patient safety, enables payment and delivery reform, and promotes efficiency and lower cost. That is why it is so important that we regulate health IT thoughtfully to advance care and support innovation. That is why we need a new risk- based framework such as that proposed by the BPC. On behalf of McKesson, I thank you for the opportunity to share our thoughts. [The prepared statement of Dr. Mitus follows:] [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT] Mr. Pitts. The chair thanks the gentlelady, and now recognizes Dr. Classen for 5 minutes for an opening statement. STATEMENT OF DAVID CLASSEN Dr. Classen. Good morning, Chairman Pitts and Ranking Member Pallone, members of the subcommittee. Thank you for the opportunity to testify on this very important issue. I am a practicing infectious disease physician at the University of Utah School of Medicine, and I am the Chief Medical and Informatics Officer at Pascal Metrics, a patient safety organization. I also chair the AHRQ Formats Committee at the National Quality Forum. My background is as an infectious disease physician, medical informaticist and patient safety researcher. As such, I have been on several Institute of Medicine committees that have focused on how to improve patient safety, most recently, the one I will draw my testimony from today, Health IT and Patient Safety: Building Safer Systems for Better Care. One of the focuses of that report was how do we improve the safety of care for our patients most effectively with health IT? How do we do it in a way that doesn't injure our patients or harm them, and how do we do it in a way that does not stifle innovation? From that report, we looked back through the original To Err is Human report from the Institute of Medicine that suggested that as many as 98,000 lives a year are lost due to medical errors. In our most recent report, we suggest that those estimates of patient safety problems are probably lower than is really the story, based on newer detection problems both in hospitals and in the ambulatory setting of care. So there clearly is a large opportunity for us to use health IT to improve safety of care, both on the inpatient setting in hospitals and on the ambulatory setting. So one strategy that the Nation has turned to for safer, more effective care is the widespread use of health IT. As we have heard from other panel members, this really is the case over the last several years. We are investing billions of dollars in Meaningful Use to more broadly adopt this health IT. It is clearly playing an ever larger role in the care of patients, and clearly there is evidence that it has improved health care and reduced medical errors. Continuing to use paper records places patients at unnecessary risk for harm and substantially concerns the ability to reform health care. However, there are concerns about harm that has come from the use of health IT that led to the generation of this IOM report. In this IOM report, health IT and patient safety was defined broadly to include EHRs, patient engagement tools, personal health records, secure patient portals, health information exchanges, and mobile applications. Practicing clinicians, such as myself, expect health IT to support the delivery of high quality in several ways, including storing comprehensive health data, providing clinical decision support, facilitating communication, and reducing medical errors. It is widely believed that health IT, when designed, implemented, and used appropriately, can be a positive enabler to transform the way care is delivered. Designed and applied inappropriately, health IT can add complexities to the already complex delivery of health care, which can lead to unintended consequences, for example, dosing errors, failing to detect fatal illnesses, and delaying treatment due to poor human to computer error, actions or loss of data. Merely installing health IT in health care organizations will not result in improved care or safety. Taking together the design, implementation, and use of health IT affects its performance on improving the safety of care. Safe implementation and safe use of health IT is a complex, dynamic process that requires a shared responsibility among vendors, health care workers, and health care organizations, a partnership, if you will. Many features of software contribute to its safe use, including usability and interoperability, and can also contribute to patient safety problems if we have poor user design, poor work flow, or complex interfaces, which could be a threat to patient safety. The lack of system operability is clearly a major problem in patient safety. We do have some success stories here. Laboratory standards have added--actually facilitated the free flowing of laboratory information. However, we are not there yet and information such as problem lists and medication lists are not currently easily transmitted between health IT systems. Safety considerations need to be embedded throughout the whole health IT implementation process, including planning, deployment, stabilization, optimization, and transformation. Vendors take primary responsibility for the design and development of technologies ideally with iterative feedback from users. The users assume responsibility for safe implementation at work with vendors throughout the health IT implementation process. This partnership to develop, implement and optimize system is a shared responsibility where vendors and users help each other achieve the safest possible applications of health IT. It is important to recognize that health IT products generally cannot be installed out of the box. Users often need to ensure that products appropriately match their needs and capabilities in both functionality and complexity of operation. So therefore, in operation health IT can look very different from what it looked like on the shelf. Ongoing safe use of health IT requires diligent surveillance of evolving needs, gaps, performance issues, and mismatches between user needs and system performance, unsafe conditions, and adverse events. The IOM report believes certain actions are required by both private and public entities to monitor safety in order to protect the public's health, and provided the following recommendations to improve health IT nationwide. In my testimony, I have the recommendations in that report, but in the interest of time, I will leave them in the testimony and conclude my remarks. Thank you very much. [The prepared statement of Dr. Classen follows:] [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT] Mr. Pitts. The chair thanks the gentleman. Let me ask--start a question. I recognize myself for 5 minutes for this purpose. I will ask each of you this question. Do you believe that data, Dr. Smith, for the purposes of regulation should be classified as a medical device? Dr. Smith. Data, no, sir. Mr. Pitts. Ms. Bechtel? Ms. Bechtel. I have to say this is not my area of expertise. Mr. Pitts. Mr. Bialick? Mr. Bialick. Data, no. Mr. Pitts. Dr. Mitus? Dr. Mitus. Data per se, no. Mr. Pitts. Dr. Classen? Dr. Classen. Data, no. Mr. Pitts. Thank you. Now, Mr. Bialick, do you believe that the newborn patients you are here representing today will be best served by the FDA classifying medical apps as medical devices? Mr. Bialick. As the draft guidance is written, no. Mr. Pitts. Speaking of the FDA draft guidance, many have argued that the FDA is proposing to only regulate apps that are essentially medical devices and does not intend to go any further. And while I may disagree with this presumption, I do think it is very instructive for the purposes of today's hearing. Many years of dealing with the FDA have taught me that it is not what they say they are going to regulate today, but what they could regulate tomorrow. Are you familiar--I will stay with you, Mr. Bialick--with the term regulatory creep? Mr. Bialick. I am. Mr. Pitts. And what could regulatory creep mean for a combination who seek to innovate in this space and to the patients whose lives may depend upon this innovation for their health and welfare? Mr. Bialick. The draft guidance, as it was written, I think refers or relies on terminology like an app that even now is a little bit outdated. The concept of an app is a discreet piece of software on a device. That is really being changed by how the market has embraced cloud technology. The idea that you would have a discreet piece of an app or software that is one little piece, that is different now when an app is also the browser on your smartphone. These technologies are becoming platform agnostic, and so how do we talk about that in reference of, when the draft guidance was written, even the definition of an app has changed during this time, so the idea that we can regulate an app--but these apps are expanding, we need to have clearer lines as to how these things are--where the regulation is going to stop. Mr. Pitts. OK. Well, let me ask, and each of you can respond. Do you believe the FDA has the expertise to regulate medical app technology, and do you foresee them gaining that expertise in the foreseeable future? Let's just start and go down the line. Dr. Smith? Dr. Smith. I think it is, to a point in my testimony, making sure that regulation moves at the speed of innovation. I think it is quite challenging for the FDA and for many reasons to stay as current as possible on those things which are simply just emerging. And so the simple answer to your question is no. I think the opportunity for external expertise needs to be exploited much more thoroughly than it has been to date. Mr. Pitts. Mr. Bialick? Mr. Bialick. I think that the FDA absolutely has the experience and knowledge in-house to evaluate apps that are actually medical devices. When it talks about just some of these apps that are connecting, sharing information on networks, then no, they don't have the regulatory expertise in- house. Mr. Pitts. Dr. Mitus? Dr. Mitus. Concur with my colleagues. Today, the FDA plays a very, very important role in health care. McKesson has many solutions that are regulated by the FDA, whose expertise really is in the regulation of medical devices. Health IT, we believe, it really requires a different paradigm that is not well-suited to the current infrastructure and process under the FDA. It is less about the organization and more around the process. Mr. Pitts. Dr. Classen? Dr. Classen. Just citing from the IOM report, the IOM said that if the FDA were to get further involved in the oversight of HIT beyond medical devices, a new framework to do that should be created. Mr. Pitts. OK. Now Mr. Bialick, can you share any real world examples of patient's lives being changed through the application of new medical technologies? Mr. Bialick. Absolutely. I think, from my own experience that I can talk to you with our spread of legislation around congenital heart defect screening, like I said, not everybody is born in a city center so access to some of these remote home monitoring devices is very functional. Not only that, but the telemedicine capacity that we are seeing, especially through some of these devices, is really expanded. Someone said in the hearing yesterday, it is the new house call, and that is absolutely true. We want to keep making sure that these devices are getting to the patients that need them. Mr. Pitts. My time is expired. Chair recognizes the ranking member for 5 minutes for questions. Mr. Pallone. Thank you, Mr. Chairman. I wanted to ask some questions of Ms. Bechtel. You testified before this subcommittee in July, 2010, in the early days of the HITECH Act and the Meaningful Use Program, and at that point, the program was just getting off the ground and we heard estimates from CMS that between 21 percent and 53 percent of the eligible providers would adopt EHRs by 2015, and we have come a long way since then. As of February, 2013, 2 years before the 2015 deadline, CMS data shows that more than 70 percent of eligible providers have registered and nearly 40 percent have already successfully completed the first phase of Meaningful Use. The data for hospitals is even more promising. Eighty-five percent of those that are eligible have registered, and more than 70 percent are Meaningful Users today. So Ms. Bechtel, these adoption rates have exceeded expectations, if you would confirm or talk about that, and are we just seeing providers purchase an EHR to check a box or are we actually seeing real Meaningful Use, and then finally, other than adoption of EHRs, what other signs of progress do you see? I will throw those all into one question. Ms. Bechtel. Great. Thank you so much, Congressman. Yes, I think it is really remarkable that we have made the progress that we have, and it is a testament to the hard work of health care providers and vendors, and the regional extension centers who are helping primary care doctors and critical access hospitals every day to adopt and to implement and really use EHRs in a meaningful way. I think there are some terrific additional signs of progress, like the fact that in 2006 there were almost no e-prescribers, which is really key to eliminating handwriting errors. It creates an enormous amount of efficiency for consumers and their families, and today there are more than a half million. So there is really some amazing work that has been done, and I think number one, it is the key to helping us get to this system we all want through payment reform, and getting there faster, and number two, we have to keep up the pace and we have to keep up the progress. The design of the Meaningful Use Program is such that in the beginning, providers are adopting and they are beginning to implement and use it in some ways like I outlined in my testimony that are very meaningful to patients and families. But as they stay in the program, it is designed to create even more capabilities that benefit patients and families, improve quality, and lower costs, and so future stages will deliver even more societal benefits. I think the key now is just keeping up the pace. Mr. Pallone. All right, let me ask you another question about the mobile apps. I am afraid this hearing is really missing the forest for the trees when it comes to the government's role in the growth of mobile apps and health information technology. Far from inhibiting the growth of mobile health applications, the Administration has taken unprecedented steps to open up federal data to app developers and coders, and this public-private collaboration has led to extraordinary growth in the mobile health application space. One example is iTriage, an application created using HHS data that helps consumers locate nearby health care providers. The app has over three million downloads from the iTunes store, far from being slowed down by the Federal Government. If iTriage and scores of other apps have grown and they have grown enormously because of cooperation and openness of the Federal Government. So if you could just tell us about how open government data has contributed to the growth of mobile medical apps, and what that has meant for patients. Ms. Bechtel. Yes, I think this is a terrific example of federal leadership that is really driving innovation. Three years ago, HHS launched the Open Health Data Initiative. They created a Web site called healthdata.gov, and if you think about the absolute richness of health data that HHS as an agency has, it is really phenomenal, whether it is FDA or CDC or NIH or even CMS. And so the model for this work was actually NOAA, the National Oceanic and Atmospheric Administration, where once NOAA began to release their weather data publically, we use it in weather forecasts on television, we have it on our smartphones, and so the innovation that occurred is really the model for opening up health data. The Blue Button functionality that I talked about earlier is a great example. That was one of the first initiatives of the open health data effort, and application developers have taken what is claims data--it is not even the rich clinical data from EHRs yet, but it will be next year. They have taken the claims data and built applications that enable consumers to view their own health information online, but also now, the next step is that they are going to automate it so that I, as a consumer, can decide that I want an automatic feed anytime there is new data, and I can say I would like you to also send it to my primary care doctor. So when we talk about care coordination, which is so essential to consumers, this is a great innovation and they have held more than 20 code-a-thons where application developers and entrepreneurs and different communities have come together to create applications in real time using HHS health data that are really making a difference. U.S. News and World Reports uses it in their health insurance, their best health insurance plans. Health Grade uses it to help consumers pick the best health care providers out there. So there is really no limit to the innovation that I think can occur, because of the collaboration with the Federal Government and entrepreneurial innovators. Mr. Pallone. Thank you. Mr. Pitts. Chair thanks the gentleman and now recognizes the vice chairman, Dr. Burgess, for 5 minutes for questions. Mr. Burgess. Thank you, Mr. Chairman. Well, it begs the question then, is there going to be an app for the regulatory apps, and I guess that is what we are here to answer today. Dr. Smith, you brought up an intriguing issue about--when speaking about electronic health records and I guess Meaningful Use and where outcomes, not location actually ought to be considered. I had a physician in the office this morning, a gastroenterologist who said look, I got a problem. I have got an EHR in my office, I use it and it meets all the criteria for Meaningful Use. I go to the ambulatory surgery center. I access the same record online and use it, but because I am in an ambulatory surgery center, it does not count toward Meaningful Use, and in fact, if I spend more than 50.01 percent of my time in the surgery center, which is where I spend my time because I am doing procedures on patients who need them, then suddenly I fall out of the criteria to meet the criteria for Meaningful Use. Is that what you were referring to where you said outcome, not location? Dr. Smith. It is in part that. It is also the notion that until we realize that it is all about the outcome and really irrelevant about how we get to that outcome, we will drive rather bizarre behavior, and so when one thinks about telemedicine and the opportunity to---- Mr. Burgess. He is a gastroenterologist. Bizarre behavior goes with the territory. I am sorry, go ahead. Dr. Smith. So I am a cardiologist, and I resemble that remark. Until we focus entirely on the outcome, we will drive-- first incentive will drive instead of taking care of patients at a distance and keeping them on the straight and narrow, we will facilitate the system we have had, which is one of really emergency rescue as opposed to health care. And so I think with respect to information flow, it has to be seamless. With respect to the burden of chronic disease that we have in this country, the notion that we are best off taking care of folks only when they show up in the emergency room or in the doctor's office is clearly wrong-headed when those patients need the kind of day-to-day iterative care that some of these remote technologies and integrated interoperable systems can provide. And so that is really the point of that comment. Mr. Burgess. Now there is a difference between what a lot of us would consider traditional medical advice, and an app. I mean, an intercardiac defibrillator, a traditional medical device, can you sort of delineate the difference there for us? Dr. Smith. Oh, absolutely. So, I spent much of my life in either the implementation or even design of implantable defibrillators, and the company I was working for at the time kind of led a charge in making sure that that information that is resonant in those devices could get back to doctors wherever they were when it was most needed, instead of using the patient as a vehicle for bringing that information back to see you in the office. And so there is a huge difference between the one- to-one patient encounter that you can have--and I will point out that you can now have technology mediated encounter versus the information that you can get on the web. I mean, so whether it is an app or whether it is the web, those are really quite different things. And so I think as a physician yourself, you would realize the important differences. Mr. Burgess. Well, and the ownership of that data is important as well, and when we talk about an HHS Web site, but that is, at least in theory, the identified data, but you are talking about data that is specific to that patient, specific to that patient encounter. Dr. Smith. Absolutely. Mr. Burgess. Dr. Mitus, I was fascinated by your testimony. I remember a few years ago in the middle of the chaos of the Haitian earthquake, it was either on CNN or reading a Time magazine article where a doctor who was not an OB doctor was helping take care of a pregnant woman after the earthquake. She had a hypertensive crisis. His reflex action was to reach for an angiotensin converting enzyme inhibitor, but he looked it up on his mobile app and found that that was contraindicated in pregnancy and used something else. I think the story had a happy outcome, but it certainly underscores the power of having that medical information at your fingertips, and you just go into the app store--even as we sat--not that I wasn't paying rapt attention to all of the testimony, but you can download Harrison's Principles of Internal Medicine. You can download the Merck Manual. You can download the Washington Manual, and have that literally at your fingertips in as odd a place as a congressional hearing. So how does the regulatory environment affect that? Dr. Mitus. I completely concur that health IT has really revolutionized our ability to provide timely and safe care to patients in ways that that we could never have envisioned even 10 years ago. The power of technology enables us and is very different than a medical device. I believe, though, there is an important distinction, to return to your prior question. A device, in our mind, sits directly connected to a patient and has automation that allows it to independently act upon that patient. It is really replacing that human judgment. Whereas a physician who intervenes and accesses medical guidelines, such as a textbook online or receives an alert to potentially prevent a fatal drug interaction is allowed to use their own common sense and judgment, and that is fundamentally different than a device. Mr. Burgess. But the FDA looks at it as decision support, so therefore, it is open to regulation. Is that correct? Dr. Mitus. That is our understanding, and we believe a risk. Mr. Burgess. Thank you, Mr. Chairman. I will yield back. Mr. Pitts. Chair thanks the gentleman and now recognizes the ranking member of the full committee, Mr. Waxman, for 5 minutes for questions. Mr. Waxman. Thank you very much, Mr. Chairman. Dr. Mitus, as I understand, you are a hematologist/ oncologist. Is that right? Dr. Mitus. Correct. Mr. Waxman. OK. So let's say you had software that could-- claims to diagnose a mole and whether it is melanoma or not. Do you think the FDA ought to regulate that? Dr. Mitus. That is a very interesting question, and one that I pondered last night after you asked that yesterday. I actually looked up Dr. Mole online to understand, as I was not familiar with that technology. I think that really delineates the challenge that we have before us. What a wonderful piece of technology---- Mr. Waxman. Excuse me. I really have a limited time. Do you think it ought to be regulated by the FDA or FDA ought to review it before it is widely used? Yes or no. Dr. Mitus. I believe that there is risk and there is intelligence in that application, as I understand it, and it is--should be considered a high risk piece of software, and we believe in a risk-based system and it could potentially be regulated by the FDA, much the way mammography software is today. Mr. Waxman. OK. Now you raised a bunch of points in your testimony, and you pose a number of questions. Should an iPad application that helps track the number of steps you walk per day be regulated as a medical device, and FDA says no in their guidance. You asked if it is a reminder time to refill a prescription. FDA's guidance said no, that is not a medical device. You asked a question whether digital versions of a physician's desk reference would be subject to regulation, and FDA says no. Those are not going to be subject to regulation. So I found it puzzling, because FDA addressed them specifically in their draft guidance, a specific list of these examples of what should not be regulated. Is your concern that FDA is going to change its mind and regulate it? Dr. Mitus. My concern is that there is a spectrum of capabilities that is increasingly delivered through technology, whether on a mobile app or on a desktop, and that gray area as we just described, the ability for a doctor to receive an alert or a warning is not something in my mind that should be regulated as a medical device. Mr. Waxman. Well, I can understand that point of view but you would see the point of view that some things ought to be regulated as a medical device, wouldn't you? Dr. Mitus. Medical devices certainly should be regulated as medical devices. Mr. Waxman. Well, there is a judgment to be drawn. My colleague said well, that judgment ought to be up to Congress. Do you think Congress should make those distinctions, or should it be the FDA or some government regulatory agency that has some expertise on these kinds of issues? There is a line to be drawn. Who should draw that line? Dr. Mitus. It is a difficult line to be drawn. I am not--I won't presume to be able to tell you who should draw that line. What we would like to point out---- Mr. Waxman. Well, knowing that it is difficult doesn't help. Who should draw the line? There is some that should be regulated as medical devices and some shouldn't. I agreed with your testimony. Those things that are informational based shouldn't be regulated, and FDA agrees with that, but there are some that ought to be diagnosed. Mr. Bialick, there is a device that remotely monitors infants with congenital heart defects using a pulse oximeter. Pulse oximeters monitor the oxygen saturation of a patient's blood, and especially in the case of newborns with congenital heart defects, they are a critical tool to monitor cardiac health. This is obviously a sensitive and important device. If the device provides the wrong reading or provides faulty information, it can lead to disastrous results. Do you believe that FDA should play a role in ensuring that these types of devices are safe and effective? Mr. Bialick. That is why FDA does evaluate pulse oximeters. Mr. Waxman. And you think that is appropriate? Mr. Bialick. Pulse oximeters as medical devices, yes. The app that has the potential to connect to a covered device, that is a different story because it is not a traditional medical device. You are talking about medical software at that point. So I would like to talk about drawing the delineation here. That is the delineation I would like to make. Mr. Waxman. Well, the app transmits the information, but the information is based on this pulse oximeter. Mr. Bialick. Right, and---- Mr. Waxman. And the pulse oximeter ought to be reviewed by the FDA because if it is giving false information, it can have serious consequences, right? Mr. Bialick. I agree. Medical devices should be evaluated by the FDA. Mr. Waxman. So say, Dr. Mitus---- Mr. Bialick. I am sorry. Mr. Waxman. I am switching to Dr. Mitus. If somebody takes a picture of a mole and they say don't worry, you don't have cancer, and they are wrong, that is a serious disaster waiting to happen. We need somebody other than members of Congress to say that ought to be regulated, and the law requires, I think, FDA appropriately to regulate it. My point to all of you is there is a distinction that has to be made, and the points you raised, Dr. Mitus, were all scary things that just aren't being considered for regulation, and FDA has been very explicit about it. So I am somewhat disappointed that you would say these things are going to be regulated when FDA says they have no intention of regulating them, and so that is why I asked do you think FDA is going to reverse its stand. Is that what you are worried about? Mr. Pitts. You may respond. Mr. Waxman. To Dr. Mitus, are you worried the FDA is going to change its mind and suddenly regulate those things? Dr. Mitus. We are worried that there is a large gray area of medical health IT that could be subject to regulation. Mr. Pitts. Mr. Bialick, you wanted to say something? Mr. Bialick. To your point, Mr. Waxman, you said is this Congress's decision to make this or is this FDA's decision or is this another agency? I would like to say that this is such a big issue and such a dynamic market that no one entity should be making these decisions. There is a clear need for a framework of experts to convene to talk about what is going on at FDA, what is going on at ONC, what is going at FCC, especially as these things consider mobile apps, as well as what Congress's role is in regulating that? So the framework, absolutely Congress has a role. Congress has a role to develop this framework. Mr. Waxman. Well, FDA is required to bring in a group like that and give them guidance, but if you are giving an amorphous group to look at it with nobody having clear responsibility, nothing is going to happen and that is a very dangerous thing if a device can do harm. My time is expired. Mr. Pitts. The chair thanks the gentleman and recognizes the gentleman from Illinois, Mr. Shimkus, for 5 minutes. Mr. Shimkus. Thank you, Mr. Chairman. I enjoy following Mr. Waxman, who is obviously very thoughtful. We had part of this debate yesterday in the other hearing, and I think--and I am going to go off script just because Mr. Bialick, on this pulse oximeter--I am not a health care guy but I did read it in your testimony--your point is that that device is a taxed and monitoring. So as I was trying--you are trying to say that data is being formed by the medical device as certified. The transmission of that data to a handheld device is a concern, especially if it gets classified as a Tier III medical device. Mr. Bialick. Absolutely. Mr. Shimkus. What happens if it gets classified as a Tier III medical device? Mr. Bialick. It would be evaluated as such through the FDA process. Mr. Shimkus. And what else happens to it? Mr. Bialick. It gets pulled off the market. It has to go through the entire process. I mean---- Mr. Shimkus. And what else happens to it? It gets a big freaking tax on it, a gross tax, not a net tax. So anyway, it is always exciting to be on this committee with my friend from California. Because we talked about the chips and the shoes, too. Obviously for general fitness, just measuring steps, no, but what if that is a device that has been prescribed? Mr. Bialick. Another case. Mr. Shimkus. And my friend, Mr. Pallone, mentioned HHS health and one app. Good for them. How many apps are there? Ninety-seven thousand apps. How are the other 96,999 developed? By the private sector, by individual capital, by people assuming risk. I pulled this up--pull up your page. How many new apps are there to change your app? Notifications, you got to update your app. What happens if this whole process falls into that? So now you have an app, it has had technical problems, maybe it is a Tier II and now you want to update the app. Does that have to go back through the entire process again? These are very, very important--they belittle--the fact that we are having these questions, but the fact that we are having these questions means that we don't have answers. So what does FDA do when they go to the Institute of Medicine, right, they commission a report, which they did on MDUFA, and they kind of follow that a lot of times. Well, what did the Institute of Medicine just come out on this? Well, one member disagrees with the committee and would immediately regulate health IT as a Class III medical device as outlined in Appendix E. So they are saying all health IT--or this guy, this one respondent says this should be, and there is a fear about that, is there not, because of the things we issued before. So Mr. Bialick, if FDA regulated health IT as medical devices, would they be subject to the device tax as written in law? Mr. Bialick. I default to Congress on that. Mr. Shimkus. I already asked that. The answer is yes. What could this mean for patients, especially for telemedicine and other advancements that are starting to improve the quality and access to care for patients in rural areas, like my district, who are sometimes hours away from the care they need? Mr. Bialick. It is a very important question. I think that as telemedicine develops, we are starting to also see a development of our networks of care. So it is not just we go to the one rural doctor that we have access to---- Mr. Shimkus. Right. Mr. Bialick [continuing]. But rather, we have access to many professionals. Mr. Shimkus. Anybody else want to jump in real quick on this? Dr. Mitus. I believe it could significantly delay and put at risk the deployment---- Mr. Shimkus. Here is what I observed in my district. I have a large rural district. There are 102 counties in the State of Illinois. I represent 33. Where a lot of hospitals are moving to is obviously nurses on site, doctors at computer screens monitoring the real data, and also what they can do is--so the nurse says doc, calls him up, Doc, check this patient X. So they go into the room, the patient is laying there and he will have the nurse open up the eyelid and the camera will zoom in on the eye to make a determination. Now if you follow this debate, now you have got data flowing over in a picture form, i.e., like the mole debate, but it is a camera in essence taking a real time picture. How does that get regulated? And if it, as my colleague from California said, if that should be a Tier III because then do I not have the access to real time picture of the pupil of a patient, and an immediate doctor intervention, versus calling one from 20 miles away? My time is expired. I thank you all and I yield back my time. Mr. Pitts. Chair thanks the gentleman, and now recognizes the gentlelady from Virgin Islands, Dr. Christensen, for 5 minutes for questions. Mrs. Christensen. Thank you, Mr. Chairman, and thank you to the panelists for being here this morning. I am sorry I missed yesterday's hearing. But this hearing--this series of hearings is centered on the relationship between innovation and public--and patient safety, and I think the Meaningful Use EHR program is a great example of how government can promote technological innovation that has the potential to significantly improve patient care. Phase one of the program already enables providers to maintain up-to-date electronic lists of the health conditions, diagnoses, medication, and medication allergies. They can automatically check for drug interactions and drug allergies, as we have heard, and have the ability to send prescriptions electronically to a patient's pharmacy, reducing wait time and eliminating handwriting errors. Ms. Bechtel, can you give us some information about--some more information about how electronic health records are already helping to improve patient care, and how future phases of Meaningful Use advance our ability to improve that care, and would you add into your answer how it--how HIT--the role it can play in eliminating health disparities? Ms. Bechtel. Absolutely. So let me start with health disparities, because I actually think that that is one of the ways that the Meaningful Use Program is making a real difference for patients and families. In the first stage of Meaningful Use, there were a couple of things that were really important to help disparities. One was collecting better and more granular data about race, ethnicity, language, and gender, because those are categories where we see vulnerable populations and the greatest amount of health disparities, as you know. And so we have now created the ability to collect information like that in a standardized way, and when you do that in a computer system, you can then stratify other information by those data types to identify disparities, and the first step in eliminating them has to be identifying them. We also created a capability for electronic health records to report quality measurement, and which is key to payment later, and so the ability to look at the kind of care that you are providing for different populations that you are serving is really instrumental, and that was not standardized prior to Meaningful Use. In future stages as well, we are going to see things like a population health dashboard that is going to allow you to look at multiple populations. My hope is that, well into the future we will see things like more advanced intelligence systems that will look for disparities that we didn't even know to look for, for example. So there are some really terrific things. I think I would say that in terms of what is happening today already right now, the Commonwealth Fund, an independent organization, looked at several different hospitals and they concluded that health IT adoption has led to faster, more accurate communications, streamlined responses that have improved patient flow. It has reduced duplicative testing and sped up responses to patient inquiries, and that has been really phenomenal. Yesterday there was a study released by the Quest Collaborative, which Premiere reads, and it is really an indication of what can happen when you blend not just the health IT infrastructure that the Quest hospitals have, but the quality measurement and the public reporting and the payment and all of these things that have bipartisan support, they saved 92,000 lives and $9.1 billion over 4\1/2\ years. Mrs. Christensen. Let me try to get another question in. You sat on the Federal HIT Policy Committee and you reported that 70 percent, I think, of physicians are utilizing HIT, but have you seen the adoption in minority practices, practices in rural and poor communities, and if so, if not, is that a concern and is the committee doing anything to address that? Ms. Bechtel. Yes, and I think that is also a great question for federal officials tomorrow as well. But yes, we are. So 40 percent of rural primary care providers are working with regional extension centers and are therefore more likely to achieve Meaningful Use, so that is really good news. In terms of providers serving vulnerable populations, many of them will receive payments under the Medicaid program, and every State has, in fact, designed and has begun to implement their programs, and that is really the first step to make sure. So I think there is very good news, but it is something we must continue to monitor. Mrs. Christensen. OK, thank you. I guess I will yield back the balance of my time. I don't---- Mr. Pitts. Chair thanks the gentlelady and now recognizes the gentleman from Texas, Mr. Hall, 5 minutes for questions. Mr. Hall. Mr. Chairman, I would like to use part of my time thanking you for bringing this up. It is something I am very, very interested in. I would ask Mr. Bialick, I guess--I hope I pronounced it right. I don't believe anyone has got around to the newborns. If they have, I will wait and write--and ask for written testimony. But if not, Mr. Bialick, a lot of us remember the sleepless nights and exhausting routines that go along with a newborn at home, and if we are blessed with a child without medical problems, we have sleepless nights also but not like others. Can you share with the committee the additional challenges and/ or stresses of medical problems and how technology can be utilized to make their lives better, or--let me shorten it. How do you envision mobile medical technology devices being used to improve care for newborns, and if these technologies are subject to a lengthy bureaucratic approval process, how will that impact patients and families? Because if they apply or register when their newborns are newly born, they won't be newborns when they get around to them. Mr. Bialick. Sure. Thank you for that question. Babies with congenital heart defects are super users of the health care system. They are not only going to be using imaging services very early, they are going to need, in critical cases, either immediate intervention, maybe surgically, and then follow-up care with additional imaging throughout their lives. Now, it happens to be that, like I said, not all babies are born in advance cardiac care centers. They are not all born in coordinated care environments. Half of births in many States are Medicaid births as well, so care can often be fragmented. Right now, the way the health care system has developed, really to stay at the center of your care, you have to be the one that is coordinating it yourself, and mobile apps have allowed us to do that. We are able to hold in our hand the electronic record now, because of something like the Meaningful Use Program of Medicaid providers and maybe several different hospitals, several different specialists. And that not only is comforting to know that you have access to this information, but it is also very valuable because sometimes when you go back into a care situation, it is for a very critical reason, and having this information will help you and your provider and your care team get to answers much faster. Mr. Hall. I thank you for that. I was a father to three boys, three sons, and I was amazed because they were so intelligent. They could count. If they didn't count four eyes, they wouldn't go back to sleep. Thank you. I yield back my time. Mr. Pitts. Chair thanks the gentleman, and now recognizes the gentleman from Virginia, Mr. Griffith, 5 minutes for questions. Mr. Griffith. Thank you, Mr. Chairman. I appreciate that very much. I have gotten a sense from some of the questions that somehow this is a partisan thing, and I don't think it is, and so I am taking a step back. I am not sure really where that is coming from, but I think it is very interesting as a lawyer and I am learning all this medical stuff, and I thank you all for educating me. But it seems to me that the real question is, and what everybody seems to have agreed on is that we as Congress need to make sure there is a framework that then you can put the complicated does this fit, does that not fit, into that framework. Am I correct in that, Dr. Mitus? Dr. Mitus. Absolutely. Mr. Griffith. Dr. Smith? Dr. Smith. I might add, if you would let me. I think that we if we whisk overprescribing this framework, and I think at some point there is a role for not drawing the sharpest of line, but to give latitude to the bedside where the patient and physician can decide whether technology is appropriate in use, as opposed to trying to draw one line for the broad population. Mr. Griffith. And I think we all want to see this technology being used. It is great stuff and whatever we can do to encourage folks to use it, but I do think there is a difference if--in the case of a picture of a mole, if the mobile app is actually running it through a computer and telling you it is cancerous or not cancerous, then yes, I want the FDA looking at that. If the mobile app is getting that to an expert doctor to take a look at it, I don't see that as being a medical device, and if there is a problem with the diagnosis--and I would think that Mr. Waxman would appreciate this--there are a slew of trial lawyers who would be more than happy to help you figure out what you need to do next if there is a misdiagnosis. So I think we go from there. I am concerned that the FDA sometimes tends to be slow, and if we have got something that doesn't fit the norm, obviously if it is something serious like the app is making the decision on whether or not that mole is cancerous, yes, then I want that top thing and I kind of like the framework that you pointed out, Dr. Mitus. If we don't have that kind of a framework and they decide to review everything, wouldn't you all--and I guess I will ask Dr. Mitus and Dr. Smith this question, and Mr. Bialick and others can chime in if they wish. But isn't there a real concern that the slowness of the FDA, particularly if you are looking at something that just transmits the data, can actually slow down innovation in this area where we really want the innovation to go forward? Dr. Smith? Dr. Smith. So you know, as a practicing cardiologist, I would often get records to make decisions based on transmission through a fax machine, and at that time, it was difficult to tell the difference between a three, a five, and an eight. And so one could make wildly different decisions based on that communication transfer, which no one regulates. Now that we make it so crisp and so clear and so error-free, now I don't believe is necessarily the time to regulate that particular flow of information. I think the market has served the need in this case, and so if it is really just about transmission of information, it is difficult to see even though that information may be clinically relevant, that that is necessarily something that requires FDA oversight. Mr. Griffith. It is funny how sometimes people can interpret old rules with new technology and get it wrong or get a different answer. In my law practice, if I had a book, I got taxed on it. If it was a disc, it didn't get taxed. If I could subscribe to an online site, it didn't get taxed. But if it was a book, by golly, I had to pay tax on that book. Let me ask this about the smaller creative entrepreneurs, Mr. Bialick. Mr. Bialick. Bialick. Mr. Griffith. Bialick, thank you. In your opinion, if the FDA is successful in classifying all these medical apps, those particularly that I know we are talking about data are essential data's medical devices, do you think that might discourage some of the app makers to go into something that is easier to get their capital back out, or a quicker return on their investment? Mr. Bialick. Absolutely. The threshold for a blockbuster app is gigantic now. I mean, it is millions of dollars, and so even to get the investment now to--let's say you are going to develop it beyond just in your garage and have a large scale launch. The concern that you will have the potential for or if it is known that you will have additional regulation on top of that cuts out the bottom line, so there is an investment side to it, too. Mr. Griffith. So they are more likely to try to find the next Angry Bird as opposed to finding the next Angry Mole? Mr. Bialick. Well said. Mr. Griffith. And last--and I only have a couple of seconds left. I am just going to make a statement. I think a lot of us on this committee feel that the FDA is not only risk averse, but they are at the point of no risk. We don't want to approve something if there is any risk, and obviously every human being is a little bit different and whatever you do, there is going to be at least some risk. And so I would just encourage the FDA to work with you all and hopefully we will pass that framework that you want and get it done. Thank you, sir, and I yield back. Mr. Pitts. Chair thanks the gentleman, and now recognizes the gentleman from Texas, Mr. Green, for 5 minutes for questions. Mr. Green. Thank you, Mr. Chairman. I would like to thank our witnesses for appearing today. As mobile technology has gotten more sophisticated, applications relating to health have become more complex, but also hold more potential. The possibilities of innovation are tremendous, but there is potential risk to health safety as well. Mobile applications such as glucose monitors are being sold as a way to monitor critical health issues, or other applications having direct effect on health should be regulated in a way that ensures their effectiveness and trustworthiness. Regulation through the FDA comes with challenges. The agency is oftentimes far too slow. Obtaining approval can be costly. I worry about stifling innovation and bringing in unnecessary levels of regulation onto clever people with limited startup capital, but unlimited potential. However, even big companies have made high profit mistakes developing mobile apps. Had the recent mishap with a mapping software been a glucose monitor, there could have been serious consequences. But we must protect patient and consumer safety at all costs, but properly determining what poses as a safety risk may prove difficult. Dr. Mitus, the Bipartisan Center framework focuses on clinical and nonclinical software. It also recognizes the role for FDA oversight for medical device software. Do you agree with that approach and that FDA does have a role for the oversight of riskier MMAs? Dr. Mitus. Yes, absolutely. Mr. Green. OK. In what ways can the FDA regulate mobile medical applications as mobile devices without slowing innovation? Dr. Mitus. We believe that if a device, again, is defined as something that directly touches a patient or independently acts on a patient, that is a medical device and the software that runs that device would be considered a medical device, and subject to the current regulatory process. I think it is very important to distinguish that from the vast bulk of health IT, which is really not best categorized as a medical device. Mr. Green. OK. Dr. Classen, a lot has been discussed about risk-based framework for regulation. As I read it, there are a lot of similarities between FDA's and the Bipartisan Policy Center's approaches. In what ways do the BPC recommendations differ from the draft guidance issued by the FDA? Dr. Classen. The guidance that we focused on in our report at the Institute of Medicine, a lot of the FDA guidance excluded what we were focused on there from their oversight on mobile medical apps, and we had recommended that a new framework be created for oversight of these areas. So we would agree with BPC Center approach and framework as a next step, creating more specificity around a future framework as we have outlined. Mr. Green. I do have concerns about the capacity of the FDA to properly and efficiently regulate mobile apps. This is a topic that deserves more scrutiny by Congress and the FDA. We must find a way to ensure that the safety and effectiveness of the applications regulate only the application that posed a risk, and do so in a way that is efficient and effective. Mr. Chairman, members of Congress always doesn't do things that are efficient and effective, but in this case, because it affects the health care and how we can deliver and monitor health care in the future, it is so important not only for our subcommittee, but the full committee and Congress. Thank you, Mr. Chairman. I yield back my time. Mr. Pitts. Chair thanks the gentleman and now recognizes the gentleman from New Jersey, Mr. Lance, for 5 minutes for questions. Mr. Lance. Thank you, Mr. Chairman, and good morning to you all. I have heard from at least one app developer in my district who has been attempting to work with the FDA to approve the medical app. This involves a smartphone and corresponding app that helps patients with diabetes monitor the diabetes and so they can track their glucose levels. It is my understanding that while the procedure is currently under review at the FDA, the approval process is slow moving and there are some levels of uncertainty as to how the agency can address or regulate the technology. Your testimony this morning has involved this type of discussion. Do you believe that the experience of companies such as the one with whom I have been speaking in my district are common experiences that companies have, and should we be concerned about the FDA as it goes forward to regulate mobile apps as medical devices? To whoever wishes to respond to the question. Dr. Smith. So I do believe it is about clarity and speed, and I think we are in part here today because it was in the middle of 2011 when draft guidance was issued in this space, and we still don't have the clarity and certainty of even that guidance, which by itself, still has elements in it which maintains some vaguery. And so, I believe we are suffering the confusion of successive clarification, as opposed to enjoying the speed of appropriate regulatory efforts. And so I think it is both slow for the folks who are engaged, but perhaps even slower for those who are hesitating to engage and are finding other things to do with their time, treasure, and talent. And so I think it is fundamentally about clarity and speed, and at times, even willing to accept the imperfect now as opposed to waiting interminably for some other perfected notion of regulation. Mr. Lance. Of course. Mr. Bialick. I would like also just to say, I won't comment on the frequency with which that is a common occurrence, but I would like to say that that viewpoint and the experience of a developer like that is critical to this process. We talk about large apps, we talked about the apps that are being developed in a garage or a basement or an attic. We want to also make sure that those that are going to be engaging in this process and those that have made this market so dynamic, their viewpoint and their experience is brought into the process as well. Mr. Lance. It is clear to me that this would be helpful to those who have the condition of diabetes, and this is a well- respected group and wants to move forward in a medically responsible way. What would you suggest that we as the legislative branch do to help the FDA move through this situation to benefit the American people, particularly as it relates to such health concerns as diabetes? Dr. Mitus. We would like to reiterate what you have just articulated so well. There is a risk, barriers to entry and to this important space, the delay of important advances into health care, and really we support a risk-based approach where we continue to manage devices as they are today, and then develop other mechanisms for the important oversight of health IT that is not a device. Mr. Lance. Yes, Dr. Smith? Dr. Smith. I would like to draw attention to the impact that the delay between draft guidance and formal, permanent guidance provides. So it goes well beyond the current issue. The next draft guidance offered, if there is a doubt that that will become final, you will have no movement based on the draft. No companies will engage based on those recommendations, for fear that that process will be again derailed. And so imperfect as it may be, I think there is a value proposition that says fulfill that draft promise, or else we risk the notion that the regulatory cloud becomes even larger. And so I think there is a calculus to be performed here, but one that has implications well beyond the current discussion. Mr. Lance. Thank you. Let me say, I do not view this as a partisan issue, and I want to work in a bipartisan capacity with colleagues on the other side of the aisle, as well as with those on this side of the aisle which I am involved, because we want to do this in a responsible way, making sure that the American people can have access to these marvelous new portions of improving the health of the Nation. Thank you, Mr. Chairman. I yield back the balance of my time. Mr. Pitts. Chair thanks the gentleman and now recognizes the gentleman from Maryland, Mr. Sarbanes, for 5 minutes for questions. Mr. Sarbanes. Thank you, Mr. Chairman. This is a fascinating hearing. When we were doing the health care reform effort here, which resulted in the Affordable Care Act, one of the things that I was most excited about was this turn in the direction of prevention with our health care system and trying to come up with a system that is a health care system, rather than a sick care system, which in many ways is what we had until now. But the promise of it is that patients can become full partners in their care, and at a time when we worry about whether there is going to be enough caregivers to provide the services out there, if you begin to identify the patient themselves as a potential caregiver, you get a little less anxious. Now, you have to approach that in a sensible way, but if we are focused on so the acute care side of things, I can't help my surgeon perform surgery on me, but I can certainly help my primary care physician make me more sensible about prevention. So I really become a partner in that, and this technology holds that real promise. There was--Dr. Francis Collins, who is the director of NIH, recently highlighted the results of a mobile health clinical trial in his personal blog, and this was a trial conducted over a year by University of Maryland School of Medicine, which utilized a diabetes mobile health technology of a company that I am very familiar with called WellDoc, which is based in Baltimore. And they showed that these patients were able to demonstrate a reduction in terms of the percentage result on their blood sugar test that they would take on a regular basis, and the same system was studied in a demonstration project of Medicaid patients, where patients used this diabetes self- management system, with the result of reducing the number of diabetes-related hospital admissions and emergency room visits among that population that was using it by approximately 57 percent, which is really incredible. And a lot of times people do end up in the hospital because they have missed some basic precaution they need to be taking in their own self-management, so it just shows how important these opportunities to use technology are in terms of self-management by patients, and you have all spoken to that. My question, and I offer it to anyone here on the panel, is as we continue this effort to reduce our health care costs, and there is real potential using this technology to do that, can you point to instances where federal programs are beginning to adopt these validated technologies across the spectrum of government health care? And you can--if you want to point to Medicaid and Medicare, please do, to the Federal Employees' Health Benefits Program, TRICARE, Veterans' Affairs, what have you, because obviously we are very interested in that, given the cost and scope of those programs. Ms. Bechtel. So I will start, and I say that I think it is a terrific question, and my testimony really focused on the Meaningful Use Program in Medicare and Medicaid, because of the work that it is doing to make patients full partners in their health. Giving patients access to electronic tools is really making them members of the care team now. We are moving from a point where we used to do things to patients and for patients to now doing things with patients, and that is essential to lowering costs and making care better for them. And the online tools are really facilitating important things like shared decision making, population health outreach so that we can get reminders about being overdue for a mammography screening or immunization or--whether it is pneumonia or flu shot or something like that. And it is also facilitating the provision of education resources for patients that are very specific to their needs. So we are moving to a health care system that is much more customized and personalized and engaging for patients and families, and so that is why I think that it is essential as we move forward in the Meaningful Use Program to really keep up the pace. In the next phase, we are going to give patients online access that they can download their health information and transmit it to other care providers who need it. We are going to give them the ability to securely send an e-mail to their doctor. I mean, there are some really important advancements that are coming down the pike if we just keep our foot on the gas pedal. Mr. Sarbanes. Mr. Chairman, would you indulge one more response from Dr. Smith? Mr. Pitts. Go ahead. Dr. Smith. So I point to the VA here. Adam Darkins runs the VA telehealth program. In 2012, I think there were 1.5 million telehealth visits. The net impact of that at 150 VA medical centers is to drop emergency room visits by 40 percent, hospital admissions by 63 percent. Patients experienced a 60 percent reduction in hospital days. Nursing home admissions dropped by 63 percent, and patients reported a 95 percent satisfaction rate with their care. And that is the largest functioning telehealth program that we have in the country, and it is run by the Veterans' Administration. I think it is one of the best kept secrets of excellence inside the Veterans' Administration, and it speak to the potent opportunity that this has when we align the incentives system so that this technology is fully realized. Mr. Sarbanes. Thank you. Those are powerful statistics. I yield back. Mr. Pitts. Chair thanks the gentleman and now recognizes the gentlelady from North Carolina, Mrs. Ellmers, for 5 minutes for questions. Mrs. Ellmers. Thank you, Mr. Chairman, and thank you to all of our panelists today for this very important subcommittee hearing. First I would like to just say that across the board, health IT is so important. We have got to do everything we can to make it move forward quickly for our patients. As you all have pointed out, the very helpful information that we are gaining from it and how this truly will improve upon health care in this country, with all the hurdles that it has faced. However, having said that, I think it is incumbent upon myself to point out that it isn't quite the nirvana that has been discussed here. For instance, when we are talking about the Meaningful Use, as Ms. Bechtel, you had cited some of the statistics, the number of physicians, the number of hospitals, however, we do have to remember that this is a mandate that was put forward and physicians are participating in it because if they do not, they will receive a Medicare reimbursement cut. So it is not only very beneficial and very important; however, it is very costly and at a time in this economy when you see what we are faced with, physicians being small business owners themselves, hospitals having difficulty functioning, physicians--tens of thousands of dollars that they are having to incur to put this into place, hospitals, millions of dollars. It is a challenge. And again, the importance being duly noted, however, very difficult for many physicians to be incurring this cost. With that, I do have a question. Ms. Bechtel, you had mentioned that this situation--that we are moving forward and it is very important, and that there are many of these physicians, but you do acknowledge the fact that it is a mandate? Ms. Bechtel. Absolutely, and I think it points to the problem that we have in the larger system, which is a complete lack of payment, that really drives quality and the development---- Mrs. Ellmers. Absolutely. Ms. Bechtel [continuing]. Of functionality, as you well know, and I know you are a big supporter of health IT, when we have fee-for-service, of course we are going to see the proliferation of billing systems, and we have no problems in interoperability or adoption rates of billing systems that are designed to really focus on services. Mrs. Ellmers. And two, this is my next question. We had also discussed the fact--and I think you had mentioned that at some point in the future, patients will be able to download their own information. Now, there again, I see a big problem and this feeds into the reason that we are having this subcommittee hearing, which is the future, where are we going to go, how is FDA regulation going to affect these things, how is medical device tax going to keep technology from innovating and moving forward? One of the issues that I continuously hear about is the fact that communication or software is different, the different systems that physicians, hospitals, and others use, so there really is a communication problem right now. What timeline do you--number one, do you acknowledge that, and two, what timeline do you see that happening for patients to be able to download information on their own so that they can be partners in this? Ms. Bechtel. So you can do this if you are a veteran through the VA right now, or through the Medicare program. The ability to do it through the Meaningful Use Program, which will be from the EHRs, is going to start in October of this year for hospitals, and in January for physicians. Mrs. Ellmers. But do you--have you also heard that there is a communication problem between different facilities, physician offices and hospitals, different health care---- Ms. Bechtel. Yes. It is one of the most common complaints we hear from consumers is the lack of coordination and the lack of communication. They say over and over again, I just want my doctors to talk to each other. The problem is they are not paid to talk to each other, so Meaningful Use has done a couple of things. One is there is an open standard now called the Direct Protocol, which is essentially like secured g-mail. Physicians and soon patients can actually use it right now to talk to each other, so you can have a hospital send a care summary to a primary care clinician---- Mrs. Ellmers. OK. Can I just--I need--I only have 30 seconds left here, and I do have a question for Dr. Mitus. Now, you had mentioned that doctors are not paid to talk to each other. How do you describe that? Ms. Bechtel. Because they are not paid for care coordination, they are paid on volume for services and procedures. So my doctor doesn't get reimbursed for picking up the phone and calling my cardiologist and coordinating---- Mrs. Ellmers. So you are basing that on payment? Ms. Bechtel. Under fee-for-service. Mrs. Ellmers. OK, fee-for-service, oK. Dr. Mitus, and again, I apologize because this is such an important issue for me. The Commonwealth Alliance that you put together, what do you see Meaningful Use not doing that you feel is an issue that needs to be addressed? In other words, where are your areas of concern and the Commonwealth Alliance's concern? Dr. Mitus. May I take a few moments to answer? Mr. Pitts. You may proceed. Mrs. Ellmers. Thank you. Dr. Mitus. Thank you for raising an issue that we are very proud of, that we announced with an intention to launch, led by McKesson, Athena Health, Allscripts, Cerna, and Greenway. We are really trying to create to solve the very difficult problem of disparate health systems and the ability to communicate across those health systems. It is one thing to gather data from an electronic medical record within an individual physician's office, but that ability to aggregate information from all the sites of care is a tremendous problem. We are attempting to solve that and create interoperability and seamless communication by setting standards and creating an infrastructure to support those important processes. Mrs. Ellmers. Is there a government HHS or any other agency that is hampering this availability that you are aware of? Dr. Mitus. Not that I am aware of. Mrs. Ellmers. OK. Thank you so much, and again, thank you, Mr. Chairman, for indulging me for a few moments. Mr. Pitts. Chair thanks the gentlelady and now recognizes the gentleman from Georgia, Dr. Gingrey, for 5 minutes for questions. Mr. Gingrey. Mr. Chairman, thank you very much. This is really for all of the panelists. Some have suggested that the mobile apps may be a game changer for health care delivery and consumer engagement. Do you agree with that statement, or do you believe they have already changed? Why don't we start at the end and---- Dr. Smith. It would be sad if where we are is where we are going, and so I have to believe that we are looking at the front end--on the cusp of a transformation in health care where engaged consumers work with a coordinated and integrated health care system, and so we can realize the important benefits of having ambient health care as opposed to having the model of health care delivery that we have been living with since my grandparents. Mr. Gingrey. Sure, thank you. Mr. Bialick. I 100 percent agree with that, absolutely agree with that. Dr. Mitus. I support the comments of my colleagues. Dr. Classen. And I would agree. Mr. Gingrey. All right. Excuse me, I didn't realize my phone was alive. I apologize for that, panelists. Dr. Smith, who makes mobile apps? It is sophisticated, big developers or are we talking about the little developer working out of the garage, the entrepreneur types, or is it both engaged in this activity? Dr. Smith. So over the last 3 years, I have probably met with 1,000 companies that are interested in this space, all small, all largely unaware or incompletely aware of the regulatory framework that they are kind of naively entering, and find a bit of frustration as they realize that there is this other burden that they are not yet aware of. It is not enough to solve the problem; one must then engage a system with its own set of rules. And so it is often a fresh graduate out of graduate school, or even an undergrad who identified a problem in his family, the health care that they see, and are trying to figure out a way to solve it. Mr. Gingrey. The next question is for Mr. Bialick. Today, there are roughly 97,000--I can't believe that, but this is a statistic that I have. Today, there are roughly 97,000 medical apps in the Apple app store, 97,000. These apps have generated more than three million free downloads. If the FDA regulates medical apps as medical devices and these products have to go through regulatory review at the agency and then they become subject to the 2.3 percent medical device tax, how likely do you believe it is that these apps will remain free to the public? Mr. Bialick. I would just say that any additional costs added to the development process is going to change the marketing approach for them. This is a very capitalist market that we have created in health care apps. I would say that if you are going to increase the startup cost, if you are going to recoup that cost within a reasonable amount of time, you are likely going to have to change how money is coming in, and so that is either going to be to stop offering them for free, or require that end users pay for additional functionality within the app itself. Mr. Gingrey. Well sure, exactly, and I will stay with you, Mr. Bialick. The death toll for chronic conditions is a staggering number. More than 10,000 people die every day because of chronic conditions. Not only is the human toll large, but of course, the economics behind it are driving up health care costs, they are harming our household and national finances, and as these costs for health care go up, more money is diverted from other programs. It is diverted from job creation, indeed, from consumers' pockets. How can health information technologies such as medical apps or electronic health records, if not classified by the FDA as medical devices, how can they address these problems and how do we accelerate their use? Mr. Bialick. So to address the--let's look at a really high cost problem specifically to get to your question, which would be something like dually eligible beneficiaries between Medicare and Medicaid programs. Even if you target a specific issue like using these mobile apps to provide very high touch care, so we are not talking about managed care, but rather, we are talking about a direct way for the patient to be reminded for something, like imagine, taking their medication, some of these issues that could avoid the number of costly returns to the hospital. That is a very direct and tangible way that people can interact with their health care. That is what should be accelerated. Mr. Gingrey. Well, and that is the point I wanted to make to the witnesses and to my colleagues on the subcommittee. These devices, these medical apps, they don't draw blood. They don't take a biopsy. They are not invasive. They are just giving information to people in a timely fashion, and if permitted, to members of their family so that they know what is going on with mom or dad who 5,000 miles away and maybe very elderly, or maybe even in a nursing home. I mean, this is a hugely important subject and I commend the chairman for assembling this panel of witnesses and discussing this subject. So Mr. Chairman, I thank you for letting me go over a little bit, but I appreciate it and I yield back. Mr. Pitts. Chair thanks the gentleman, and now recognizes the gentleman from Florida, Mr. Bilirakis, for 5 minutes for questions. Mr. Bilirakis. Thank you, Mr. Chairman. I appreciate it very much. Thank you to the panel for their testimony. I was over in VA. I apologize, but that is very important as well. I want to--question to Mr. Smith. You mentioned in your testimony the potential cost savings benefits of telehealth. Do you believe it is feasible to expand the use of telehealth to Medicare to effectively lower its costs? Dr. Smith. It is a simple word, absolutely. I could go on, but we have seen the impact of telehealth and telemedicine--New England, the Health Care Institute, the VA program, there is a rich history of information, some of which I provided in my written testimony, about the beneficial impacts not only on outcome but also on costs. And so it seems obvious that we can extend that to patients struggling with chronic disease, independent of how their health care bills are paid. Mr. Bilirakis. Very good, thank you. Follow up again to Mr. Smith. With doctors showing an increase of reluctance to accept new Medicare patients, for obvious reasons, do you believe that allowing doctors to use telehealth will enable them to expand their reach in not only treating existing patients, but also increase access by enabling them to treat new beneficiaries? If you could elaborate a little bit. Dr. Smith. Sure. I think the technology obviously enables that notion of care at a distance in ways that are much more efficient than, say, in addition to the costs associated with travel, say, many of the costs associated with--in unnecessary or untimely ER visits or doctor's office visits. But I think it is not enough to have the technology enabled, we also have to have payment mechanisms that provide appropriate incentives for use. And so I was talking to a colleague who is a dermatologist and I asked about this--the world of teledermatology. And he says, it is never going to take off because I don't get paid for it. I think that is an unfortunate, but rational, statement. Mr. Bilirakis. Very good. Anyone else on the panel wish to comment? Mr. Bialick. I would like to just specifically on that point about taking on more Medicare providers. I think that when we talk about telemedicine, we think about it in a traditionally rural setting, so it is the idea of someone that lives in the country that doesn't have access to advanced care facility that is using telemedicine to connect to that. But especially from what we have learned from the VA around telestroke interventions as well as a number of other occupational therapy style interventions that you are able to do via telemedicine, this is absolutely something that can be leveraged to not only increase--improve outcomes, but save money in the urban setting as well. So we shouldn't be thinking about this as a purely rural situation, but this is also something that can be done in an urban situation as well, and still much like we are talking about with the idea of regulation of apps, there are major regulatory barriers in place that are limiting the amount that Medicare providers are able to do that. Mr. Bilirakis. Thank you. Anyone else? Thank you very much. I yield back, Mr. Chairman. I appreciate it. Mr. Pitts. Chair thanks the gentleman. That concludes the questioning. At this time, I would like unanimous consent to place two documents into the record. The first is a letter from Kevin McCarthy, the second is a statement from the Bipartisan Policy Center. I think you have seen these. So without objection, so ordered. [The information appears at the conclusion of the hearing.] Mr. Pitts. This has been a very interesting hearing, very important issue, very informative. We would like to thank all the witnesses for taking time and presenting testimony and answering all the questions. Members may have follow-up questions. I will remind members they have 10 business days to submit questions for the record, and I ask the witnesses to respond to the questions promptly. With that--and members should submit their questions by the close of business on Wednesday, April 3. With that, thank you very much. Without objection, the subcommittee is adjourned. [Whereupon, at 12:00 p.m., the subcommittee was adjourned.] [Material submitted for inclusion in the record follows:] Prepared statement of Hon. Phil Gingrey Mr. Chairman, Thank you for calling this hearing today, and I commend the committee looking at the benefits that health information technologies can provide to the practice of medicine. The possibility that these emerging technologies may encourage higher patient engagement and ultimately better health outcome is impossible to ignore. An impediment to innovation continues to be the uncertainty regarding the regulation of these technologies. We must seek a balance between patient safety and innovation. An overly restrictive regulatory process will stifle innovation and ultimately lead to erosion in the quality of care that a patient may receive. We need to work together to develop a framework that minimizes risk to a patient, but limits the regulatory hurdles so that future innovation will continue to change health care delivery and a patient's access to their health information. Mr. Chairman, I look forward to working with the Committee to develop this framework. I still believe in the amazing potential that health information technologies will have on the practice of medicine, and I will continue to work to allow the market to develop breakthroughs to the benefit of patients. Thank you and I yield back. [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]