    [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

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                        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:]

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        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:]

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        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:]

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        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:]

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        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:]

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        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.

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