[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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