[House Hearing, 113 Congress]
[From the U.S. Government Publishing Office]





    HEALTH INFORMATION TECHNOLOGIES: ADMINISTRATION PERSPECTIVES ON 
                       INNOVATION AND REGULATION

=======================================================================

                                HEARING

                               BEFORE THE

              SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS

                                 OF THE

                    COMMITTEE ON ENERGY AND COMMERCE
                        HOUSE OF REPRESENTATIVES

                    ONE HUNDRED THIRTEENTH CONGRESS

                             FIRST SESSION

                               __________

                             MARCH 21, 2013

                               __________

                           Serial No. 113-22



[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]






      Printed for the use of the Committee on Energy and Commerce

                        energycommerce.house.gov
                                _____

                  U.S. GOVERNMENT PRINTING OFFICE

80-807                    WASHINGTON : 2013
-----------------------------------------------------------------------
For sale by the Superintendent of Documents, U.S. Government Printing 
Office Internet: bookstore.gpo.gov Phone: toll free (866) 512-1800; DC 
area (202) 512-1800 Fax: (202) 512-2104  Mail: Stop IDCC, Washington, DC 
20402-0001









                    COMMITTEE ON ENERGY AND COMMERCE

                          FRED UPTON, Michigan
                                 Chairman
RALPH M. HALL, Texas                 HENRY A. WAXMAN, California
JOE BARTON, Texas                      Ranking Member
  Chairman Emeritus                  JOHN D. DINGELL, Michigan
ED WHITFIELD, Kentucky                 Chairman Emeritus
JOHN SHIMKUS, Illinois               EDWARD J. MARKEY, Massachusetts
JOSEPH R. PITTS, Pennsylvania        FRANK PALLONE, Jr., New Jersey
GREG WALDEN, Oregon                  BOBBY L. RUSH, Illinois
LEE TERRY, Nebraska                  ANNA G. ESHOO, California
MIKE ROGERS, Michigan                ELIOT L. ENGEL, New York
TIM MURPHY, Pennsylvania             GENE GREEN, Texas
MICHAEL C. BURGESS, Texas            DIANA DeGETTE, Colorado
MARSHA BLACKBURN, Tennessee          LOIS CAPPS, California
  Vice Chairman                      MICHAEL F. DOYLE, Pennsylvania
PHIL GINGREY, Georgia                JANICE D. SCHAKOWSKY, Illinois
STEVE SCALISE, Louisiana             ANTHONY D. WEINER, New York
ROBERT E. LATTA, Ohio                JIM MATHESON, Utah
CATHY McMORRIS RODGERS, Washington   G.K. BUTTERFIELD, North Carolina
GREGG HARPER, Mississippi            JOHN BARROW, Georgia
LEONARD LANCE, New Jersey            DORIS O. MATSUI, California
BILL CASSIDY, Louisiana              DONNA M. CHRISTENSEN, Virgin 
BRETT GUTHRIE, Kentucky                  Islands
PETE OLSON, Texas                    KATHY CASTOR, Florida
DAVID B. McKINLEY, West Virginia     JOHN P. SARBANES, Maryland
CORY GARDNER, Colorado               JERRY McNERNEY, California
MIKE POMPEO, Kansas                  BRUCE L. BRALEY, Iowa
ADAM KINZINGER, Illinois             PETER WELCH, Vermont
H. MORGAN GRIFFITH, Virginia         BEN RAY LUJAN, New Mexico
GUS M. BILIRAKIS, Florida            PAUL TONKO, New York
BILL JOHNSON, Missouri
BILLY LONG, Missouri
RENEE L. ELLMERS, North Carolina
              Subcommittee on Oversight and Investigations

                        TIM MURPHY, Pennsylvania
                                 Chairman
MICHAEL C. BURGESS, Texas            DIANA DeGETTE, Colorado
  Vice Chairman                        Ranking Member
MARSHA BLACKBURN, Tennessee          BRUCE L. BRALEY, Iowa
PHIL GINGREY, Georgia                BEN RAY LUJAN, New Mexico
STEVE SCALISE, Louisiana             EDWARD J. MARKEY, Massachusetts
GREGG HARPER, Mississippi            JANICE D. SCHAKOWSKY, Illinois
PETE OLSON, Texas                    G.K. BUTTERFIELD, North Carolina
CORY GARDNER, Colorado               KATHY CASTOR, Florida
H. MORGAN GRIFFITH, Virginia         PETER WELCH, Vermont
BILL JOHNSON, Ohio                   PAUL TONKO, New York
BILLY LONG, Missouri                 GENE GREEN, Texas
RENEE L. ELLMERS, North Carolina     JOHN D. DINGELL, Michigan
JOE BARTON, Texas                    HENRY A. WAXMAN, California (ex 
FRED UPTON, Michigan (ex officio)        officio)












                             C O N T E N T S

                              ----------                              
                                                                   Page
Hon. Tim Murphy, a Representative in Congress from the 
  Commonwealth of Pennsylvania opening statement.................     1
    Prepared statement...........................................     3
Hon. Diana DeGette, a Representative in Congress from the state 
  of Colorado, opening statement.................................     4
Hon. Michael C. Burgess, a Representative in Congress from the 
  State of Texas, opening statement..............................     6
Hon. Marsha Blackburn, a Representative in Congress from the 
  State of Tennessee.............................................     6
Hon. Henry A. Waxman, a Representative in Congress from the State 
  of California, opening statement...............................     7

                               Witnesses

Christy Foreman, Director, Office of Device Evaluation, Center 
  for Devices and Radiological Health, Food and Drug 
  Administration.................................................     9
    Prepared statement...........................................    12
    Answers to submitted questions...............................    61
Farzad Mostashari, National Coordinator, Health Information 
  Technology, U.S. Department of Health and Human Services.......    21
    Prepared statement...........................................    23
    Answers to submitted questions...............................    66

                           Submitted Material

Letter of March 20, 2013, from the FDA to the Committee, 
  submitted by Ms. DeGette.......................................    57

 
                    HEALTH INFORMATION TECHNOLOGIES:
        ADMINISTRATION PERSPECTIVES ON INNOVATION AND REGULATION

                              ----------                              


                        THURSDAY, MARCH 21, 2013

                  House of Representatives,
      Subcommittee on Oversight and Investigations,
                          Committee on Energy and Commerce,
                                                    Washington, DC.
    The subcommittee met, pursuant to call, at 9:08 a.m., in 
room 2322 of the Rayburn House Office Building, Hon. Tim Murphy 
(chairman of the subcommittee) presiding.
    Present: Representatives Murphy, Burgess, Blackburn, 
Harper, Olson, Griffith, Johnson, Long, Ellmers, Barton, 
DeGette, Butterfield, Tonko, and Waxman (ex officio).
    Staff present: Mike Bloomquist, General Counsel; Matt 
Bravo, Professional Staff Member; Karen Christian, Chief 
Counsel, Oversight; Andy Duberstein, Deputy Press Secretary; 
Julie Goon, Health Policy Advisor; Debbee Hancock, Press 
Secretary; Brittany Havens, Staff Assistant; Sean Hayes, 
Counsel, O&I Robert Horne, Professional Staff Member, Health; 
Peter Kielty, Deputy General Counsel; Katie Novaria, 
Legislative Clerk; John O'Shea, Professional Staff Member, 
Health; David Redl, Counsel, Telecom; Alan Slobodin, Deputy 
Chief Counsel, Oversight; Jean Woodrow, Director, Information 
Technology; Tiffany Benjamin, Democratic Senior Counsel; Brian 
Cohen, Democratic Staff Director, Oversight & Investigations, 
Senior Policy Advisor; Eric Flamm, FDA Detailee; Elizabeth 
Letter, Democratic Assistant Press Secretary; Stephen Salsbury, 
Democratic Special Assistant; Rachel Sher, Democratic Senior 
Counsel; and Matt Siegler, Democratic Counsel.

   OPENING STATEMENT OF HON. TIM MURPHY, A REPRESENTATIVE IN 
         CONGRESS FROM THE COMMONWEALTH OF PENNSYLVANIA

    Mr. Murphy. All right. Good morning, everyone, and welcome 
to our hearing today on ``Health Information Technologies: 
Administrative Perspectives on Innovation and Regulation.'' 
Thank you for being here. Today, we convene the Subcommittee on 
Oversight and Investigations to discuss development and 
innovation and these technologies, particularly mobile medical 
applications or ``apps,'' and how federal regulations may 
impact this growing industry.
    We are joined by two witnesses from the Administration, Dr. 
Farzad Mostashari, who is the head of the Office of the 
National Coordinator with HHS; and Christy Foreman, who is the 
director of the Office of Device Evaluation in the Center for 
Devices and Radiological Health at the FDA. Both of these 
agencies have been leading the government's response to the 
rapid changes that new technologies are making to our Nation's 
healthcare system.
    On March 4, this committee sent a letter to the FDA on its 
approach to regulating the rapidly growing market applications 
used on smartphones and tablets. With this explosive growth, 
the use of those apps to monitor health information is growing, 
as well as increasing in accuracy and technological 
sophistication. News reports indicate that there are as many as 
40,000 medical applications on the market for smartphones and 
tablets.
    We are here today to discuss the discretion FDA has an 
regulating these apps as devices under the Food, Drug, and 
Cosmetic Act, and over the last few days, we have heard a 
number of examples of medical apps and concerns from apps 
companies about whether these apps are devices. For example, 
where does an app that transmits photos of potential skin 
cancer or the healing of surgical scars cross the line to FDA 
scrutiny? If an app that turns a smartphone into an ultrasound 
can be regulated, what about apps that let you review images 
from ultrasound or x-rays?
    You know, there has been incredible advances in all these 
things and we expect to see more in not only areas of 
dermatology in the use of photos, endocrinology with monitoring 
blood glucose levels, x-rays with radiology and orthopedics, 
heart monitors with cardiology, mental status tests with 
neurology. The list goes on and on.
    In 2011 the FDA issued Draft Guidance on how the Agency 
planned to regulate mobile medical applications. The FDA has 
not yet issued Final Guidance. To our witnesses from the FDA, 
over the last 2 days we have heard from a variety of witnesses 
and members of both sides of the aisle, and the message was 
clear: we need Final Guidance. The developers of these apps and 
the healthcare industry need certainty.
    That certainty is also needed because of the tax on medical 
devices put in place by the new healthcare law. As we have 
heard this week, a tax on medical devices can make capital 
needed to develop these apps and new breakthrough technologies 
more scarce. This can slow innovation. And we are caught in its 
cycle of the snake eating its own tail whereby we raise taxes 
on medical devices, thus increasing the costs, and then use 
those taxes to subsidize increased costs and offer tax 
incentives to cover R&D. It doesn't quite make sense but we 
want to make sure we are not slowing innovation.
    So this isn't about scaring people into thinking this tax 
will apply to their iPhones, Blackberries, or iPads, but this 
tax could absolutely halt the development of new apps to run on 
those devices. Everyone here recognizes the need to balance 
patient safety and innovation. I hope that today's hearing will 
provide some certainty that regard.
    We will also hear from Dr. Mostashari on the efforts that 
have been made by the Department of Health and Human Services 
to encourage the utilization of health information technology, 
and particularly, the incentive payments that have been made to 
providers to adapt to new healthcare technologies. Recently, 
HHS announced that for this year they hope to have 50 percent 
of physicians' offices using electronic health records with 80 
percent of eligible hospitals receiving incentive payments by 
the end of this year.
    While the movement to increased use of electronic health 
records may seem like an obvious choice as doctors and hospital 
employees become more comfortable with new technologies, as a 
supporter of health IT, I am concerned that the promised 
benefits of electronic medical records have yet to arrive. I 
have personally heard from physicians in my district who have 
struggled to adapt or received unclear Guidance from the 
Agency. Of particular concern are complaints that systems in 
place aren't able to share information with other systems. I 
hope our witnesses today will be able to address these concerns 
over interoperability.
    I am encouraged by the work this committee has done this 
week. We have had a great dialogue on these issues and today I 
hope we will be able to hear the Administration's view on its 
approach to innovation and regulation of healthcare 
technologies.
    I also want to apologize ahead of time. I have another 
hearing that I have to testify, and I will be leaving in a 
little bit, but it will be taken over by the capable hands of 
the vice chairman, Dr. Mike Burgess.
    [The prepared statement of Mr. Murphy follows:]

                 Prepared statement of Hon. Tim Murphy

    Today we convene the Subcommittee on Oversight and 
Investigations to discuss development and innovation in health 
care technologies, particularly mobile medical applications or 
``apps,'' and how federal regulations may impact this growing 
industry.
    Today we are joined by two witnesses from the 
administration: Dr. Farzad Mostashari is the head of the Office 
of the National Coordinator within HHS. Christy Foreman is the 
Director of the Office of Device Evaluation within the Center 
for Devices and Radiological Health at FDA.
    Both of these agencies have been leading the government's 
response to the rapid changes being made to the health care 
industry by new technologies.
    On March 4, this Committee sent a letter to the FDA on its 
approach to regulating the rapidly growing market for 
applications used on smartphones and tablets. With this 
explosive growth, the use of those apps to monitor health 
information is growing as well. News reports indicate that 
there are as many as 40,000 medical applications on the market 
for smartphones and tablets, and it is expected to grow.
    We are here today to discuss the discretion FDA has to 
regulate these apps as devices under the Food, Drug, and 
Cosmetic Act. I have seen that in today's testimony the FDA is 
now definitely saying: NO, we will not regulate the general 
sale of smartphones or tablets-I thank the FDA for providing 
certainty on this matter.
    Yet, over the last few days we have heard a number of 
examples of medical apps and concerns from apps companies about 
whether these apps are devices. For example, where does an app 
that transmits photos of potential skin cancer cross the line 
to FDA scrutiny? If an app that turns a smartphone into an 
ultrasound can be regulated, what about apps that let you view 
images from an ultrasound or xray?
    In 2011, the FDA issued draft guidance on how the agency 
planned to regulate mobile medical applications. FDA has not 
yet issued final guidance. To our witness from the FDA, over 
the last two days we have heard from a variety of witnesses and 
members of both sides of the aisle-the message is clear: we 
need final guidance. The developers of these apps and the 
health care industry needs certainty.
    That certainty is also needed because of the tax on medical 
devices put in place by the new healthcare law. As we have 
heard this week, a tax on medical devices can cause money for 
the development of these apps and the advancement of medical 
technology to become more scarce. It can slow innovation. I've 
heard a lot from my Democrat colleagues about how we're trying 
to scare people into thinking this tax will apply to their 
iPhones, Blackberries or iPads, but they don't seem to be 
concerned that the problem is that it could halt the 
development of new apps to run on those devices.
    Everyone here recognizes the need to balance patient safety 
and innovation. I hope that today's hearing will provide some 
certainty on that balance.
    We will also hear from Dr. Mostashari on the efforts that 
have been made by the Department of Health and Human Services 
to encourage the utilization of health information technology, 
and particularly the incentive payments that have been made to 
providers to adapt to new health care technologies. Recently 
HHS announced that for this year they hope to have 50 percent 
of physician offices using electronic health records, with 80 
percent of eligible hospitals receiving incentive payments by 
the end of the year. 1A\1\
    While the movement to increased use of electronic health 
records may seem like an obvious choice as doctors and hospital 
employees become more comfortable with new technologies, this 
Committee is concerned whether their effectiveness has been 
oversold. In the last few months we have seen reports 
indicating that the savings promised by electronic health 
records may have yet to materialize while doctors struggle to 
adapt. Of particular concern are complaints that some of the 
systems being utilized may not be able to share information 
with other systems--and I hope our witness today will be able 
to address these concerns over interoperability.
    I am proud of the work this Committee has done this week--
we have had a great dialogue on these issues and today I hope 
we'll be able to hear the administration's views on its 
approach to innovation and regulation of health care 
technologies.
---------------------------------------------------------------------------
    \1\ 1 http://www.hhs.gov/news/press/2013pres/03/20130306a.html

    Mr. Murphy. And now, I would like to recognize Ms. DeGette 
for her opening statement.

 OPENING STATEMENT OF HON. DIANA DEGETTE, A REPRESENTATIVE IN 
              CONGRESS FROM THE STATE OF COLORADO

    Ms. DeGette. Thank you very much, Mr. Chairman.
    Mobile medical apps and electronic health records are 
developing at a rapid pace and they have the capacity to 
transform the patient-doctor relationship, improve healthcare 
quality, and also to save billions of dollars. And I am looking 
forward to hearing from the FDA and HHS about the efforts to 
integrate these new technologies into the healthcare sector.
    Dr. Mostashari, I want to welcome you, the national 
coordinator for Health Information Technology.
    The 2009 stimulus bill contained billions of dollars to 
help incentivize doctors and hospitals to implement meaningful 
use of electronic medical records. That investment has already 
made a big difference. Since 2009, the use of electronic health 
records by physicians has doubled from 20 to 40 percent in the 
hospital adoption of electronic health records has more than 
tripled. More than 230,000 healthcare providers have qualified 
for payments for implementing the use of electronic health 
records. Ultimately, the adoption of these records will reduce 
medical errors, save money, and most importantly, improve the 
quality of care.
    Earlier this week, the Premier Healthcare Alliance reported 
that 333 hospitals in their network had, since 2008, save $9.1 
billion and avoided 92,000 deaths by implementing a set of 
patient-centered quality improvement reforms that was made 
possible in part by enhanced data-sharing and use of health 
information technology. But the transition to electronic health 
records is not without challenges, and Dr. Mostashari, I am 
glad you are here to address questions about the Agency's 
roadmap to help us fully implement health IT.
    Ms. Foreman, I also want to welcome you to talk about the 
FDA's role in regulating and improving mobile medical apps.
    Mr. Chairman, I have got to admit the discussion of FDA's 
role in regulating medical apps seems a little redundant. This 
is the third hearing that is focused on these issues. As we 
heard during the first two hearings, the other subcommittee 
heard from 11 different nongovernment witnesses about how the 
Administration is balancing the need to promote innovation in 
this field against the need to ensure patient safety. Those 
witnesses thankfully already debunked some of the biggest myths 
that we have heard from the outside about the FDA's role. Thank 
goodness the myth of the iPhone tax has now been put to rest.
    We also learned from the witnesses that smartphones and 
tablets are exempt from the Affordable Care Act medical device 
tax. We learned that the FDA is not currently and does not 
intend in the future to regulate smartphones or tablets as part 
of its regulation of mobile medical apps. We also learned that 
the FDA does not intend to regulate calorie counters or 
pedometers or other kinds of similar apps as medical devices. 
But we also learned about how the Agency has a role in ensuring 
that other medical devices like monitoring blood glucose or 
providing other vital medical information are accurate and work 
the way they are supposed to do, which is exactly what the FDA 
is therefore.
    But the Committee also heard from some industry witnesses 
expressing concerns about the FDA's regulatory efforts and 
worrying that they could overreach and limit innovation. These 
concerns are not new and they are not specific to mobile 
medical apps. FDA, and frankly this committee, has to 
constantly address this balance, whether the Agency is 
regulating food, drugs, traditional medical devices, or these 
apps. That is part of what we have to do.
    The FDA addressed all of these concerns in a letter that 
was sent to the Committee yesterday and, Mr. Chairman, I would 
like to ask that the letter be made part of the hearing record. 
The letter makes it abundantly clear that the FDA will not tax 
your iPhone and it provides new information that shows for the 
mobile medical apps FDA has reviewed, those reviews are moving 
quickly, taking an average of only 67 days. So to me that 
sounds pretty much like an agency that is trying to foster 
innovation while at the same time ensuring that patients are 
safe.
    And so, Mr. Chairman, I don't think that the debate over 
how to balance patient safety and innovation will end any time 
soon, but I am hopeful that at least we can have a common 
understanding of the facts with regard to electronic health 
records and mobile medical apps, and we can continue in our 
joint effort with the agencies to make sure we balance 
innovation and safety.
    And with that, Mr. Chairman, I yield back and thank you.
    Mr. Murphy. Thank you. And we do have a copy of this letter 
for the record, but I thank the ranking member for bringing 
that up again.
    I now yield to 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. And certainly we have 
heard from a number of qualified and distinguished scientists 
and specialists in medical technology and the communications 
industries for the past two hearings, and today, we are going 
to hear the perspectives of the agencies that wrote the 
proposed regulations guiding these industries.
    The emergence of mobile medical technology does hold great 
promise not only for lowering the care cost, but most 
importantly, for improving health outcomes. The increasing 
availability of these technologies has revolutionized how 
providers interact with patients. We are at a point now where 
the number of providers using these devices has increased, 
almost doubled, from a year ago such that nearly 2/3 of 
providers are using some type of device. The rapid 
proliferation of these new technologies also raises legitimate 
concerns about patient safety, but we also want to encourage 
important advancements that can improve patients' quality of 
life. And it is not just the overregulation by the government 
but it is the uncertainty of pending regulation that also 
drives some of this discussion.
    The FDA struggles to maintain their current regulatory 
charge, but we need to be assured that they have the 
experience, that they have the expertise to handle the 
additional responsibilities of an emerging market.
    Ms. Foreman, I would like to thank you and your agency for 
the rapid response to the letter earlier this week. I hope that 
sets a new benchmark in the Administration. We are accustomed 
to waiting years for a response, and this was indeed refreshing 
that it was only a few weeks in turnaround. And certainly, we 
look forward to similar quick turnaround for the final 
regulations of the Draft Guidance, which was issued in July 
2011.
    And Dr. Mostashari, I have enjoyed visiting with you in the 
past, and I thank you for being with us as well.
    As a provider, I have direct experience using health 
information technology and seeing the benefits as well as some 
of the downfalls that it brings to both patients and providers. 
Artificial barriers do nothing for care coordination, for 
patient safety, or for provider communication. As a physician, 
my primary concern is the health and safety of the patient. 
Inaction is not an option on this issue. However, we must do so 
in a way that encourages the development of innovative 
technologies, and we certainly do not want to push them outside 
of our borders.
    I will now yield the balance of the opening statement time 
to the gentlelady from Tennessee, Mrs. Blackburn.

OPENING STATEMENT OF HON. MARSHA BLACKBURN, A REPRESENTATIVE IN 
              CONGRESS FROM THE STATE OF TENNESSEE

    Mrs. Blackburn. And I thank the gentleman for yielding. And 
thank you, Mr. Chairman, for the hearing. And to our witnesses, 
Ms. Foreman, Dr. Mostashari, we thank you for being here with 
us.
    The hearings that we have done this week I think are 
essential. I don't think they are redundant. I do think they 
are essential to getting our arms around an issue that we are 
going to have to deal with on mobile medical apps. And I would 
say that one of the things that has come forward through the 
testimony we have received is that a 40-year-old FDA statute is 
not nimble enough to address the needs that are in front of us 
with this new innovation sector.
    I do think that ONC has a unique perspective on these HIT 
issues, and along with input from the FDA and from stakeholders 
that Congress can find a path forward on what a framework would 
look like. One of the things we have heard from the innovators 
is the uncertainty that is there within FDA. This big gray area 
of whether you will or will not be regulated, that is stifling 
innovation. And as we heard in the hearing on Tuesday, it also 
does not do anything to provide certainty to investors who are 
going to be there. So that is of concern to us.
    Now, Dr. Burgess mentioned yesterday that these are the 
tools of today's doctors and future doctors, and 15 percent of 
these apps that are out there, the 97,000 apps, the mobile 
medical apps, 15 percent are used by physicians. This is a way 
for us to achieve efficiency. It is a way for us to expand 
access, and what we want to be certain is that our innovators 
know with certainty what their classification would be, how 
they would be dealt with as an industry.
    So we thank you all for the testimony and for being here 
and we look forward to concluding our series and finding a way 
forward on the issue.
    And I yield back.
    Mr. Murphy. Thank you.
    I now recognize the ranking member of the full committee 
for an opening statement, 5 minutes, Mr. Waxman.

OPENING STATEMENT OF HON. HENRY A. WAXMAN, A REPRESENTATIVE IN 
             CONGRESS FROM THE STATE OF CALIFORNIA

    Mr. Waxman. Mr. Chairman, we are here today for the third 
day in a row to discuss electronic health records and FDA's 
regulation of mobile medical apps, and I am surprised at the 
amount of time and attention given to this issue.
    I have attended the last 2 days of hearings, and from what 
I have heard, the members on your side of the aisle seek to 
answer two basic questions: question one, whether the FDA is 
regulating mobile medical apps with too heavy a hand; is the 
Agency impeding innovation and harming this market by 
regulating too aggressively or approving mobile medical apps 
too slowly?
    This is not a new responsibility for FDA. For over 100 
years the Agency has been balancing patient and consumer safety 
with the need for innovation. In the case of mobile medical 
apps, the answers that we heard in the first 2 days of hearings 
indicate little by way of concern. The witnesses told us that 
they understood the role of FDA and the need for agency 
regulation and were unable to point out any legitimate examples 
of apps that FDA was improperly regulating under its Draft 
Guidance. Although they had some anxiety about it, they had 
nothing to point to.
    Question two is whether FDA will impose a new tax, the 
Affordable Care Act medical device tax, on your cell phone. The 
answer to this question is as plain as day. The answer is no. 
The Affordable Care Act itself contains a clear retail 
exemption. Even if a cell phone was designated to be a medical 
device, the Act says that any device that is ``generally 
purchased by the general public at retail for individual use'' 
is not subject to the tax. That exemption would apply to any 
cell phone you can buy at a retail store. And FDA has been 
clear that the Agency is not currently regulating and does not 
intend in the future to regulate smartphones or tablets as part 
of its regulation of mobile medical apps. The IRS has provided 
similar indications.
    Mr. Chairman, this issue is a non-issue. We did not need to 
spend 1 day of hearings on this, let alone 3. This committee 
could have used this time more wisely. I have asked you to hold 
hearings on the abuse of tax and regulatory loopholes by the 
tobacco industry and their efforts to undermine the Tobacco 
Control Act. Ranking Member DeGette and I have asked for 
hearings on the impacts of sequestration on the agencies of our 
committee's jurisdiction. We have asked for hearings on the 
risks associated with antibiotic-resistant bacteria, a very 
serious and growing public health threat. We have asked for you 
to hold hearings on Lifeline, the Universal Service Fund's low 
income phone program. These hearings could examine the 
expenditure of billions of dollars of consumer funds.
    In the last 2 years, I have sent over 20 letters asking for 
hearings on the impacts of climate change. And we have not held 
a hearing on a single one of these important issues. Mr. 
Chairman, I hope you can understand our concern. I don't mean 
to discount the importance of mobile medical apps and the 
electronic health records. This is an industry that, thanks to 
the investment we made in the 2009 Obama stimulus bill, is 
growing, is creating jobs, and has the potential to 
dramatically improve healthcare quality and save billions of 
dollars in healthcare costs.
    But there are too many pressing issues before us for this 
committee and this Congress to get bogged down for 3 days in 
what amounts to an inaccurate talking point about FDA 
overregulation and the nonexistent iPhone tax. I hope that in 
the future this subcommittee can use its time more wisely. I 
must say, Mr. Chairman, for this particular subcommittee, I 
thought that the first hearings we have held under your 
leadership have been very worthwhile and that we can go back to 
doing things that are constructive and not just talking points 
for political purposes, which is all these 3 days have been 
about.
    I yield back the balance of my time.
    Mr. Murphy. Thank you very much, Mr. Waxman. I would now 
like to recognize Christy Foreman. She is currently the 
director of the Office of Device Evaluation for the Center for 
Devices and Radiological Health for the FDA. Before being named 
to the director position, she served as the deputy director for 
Science and Regulatory Policy in the Office of Device 
Evaluation.
    I would also like to introduce Farzad Mostashari. He 
currently serves as national coordinator for Health Information 
Technology within the Office of the National Coordinator for 
Health Information Technology at the U.S. Department of Health 
and Human Services. Farzad joined ONC in July of 2009.
    You are aware that the Committee is holding an 
investigative hearing, and when doing so, has had the practice 
of taking testimony under oath. Do you have any objections to 
testifying under oath?
    Both witnesses have said they do not.
    The chair then advises you that under the rules of the 
House and the rules of the Committee, you are entitled to be 
advised by counsel. Do you desire to be advised by counsel 
during your testimony today?
    Both witnesses have said no.
    In that case, if you please rise and raise your right hand, 
I will swear you in.
    [Witnesses sworn.]
    Mr. Murphy. And if someone could work on the volume, I 
would appreciate that, too.
    You are now under oath and subject to the penalties set 
forth in Title XVIII, Section 1001 of the United States Code. 
You may now give a 5-minute summary of your written statements. 
Ms. Foreman, if you would like to begin.

   TESTIMONY OF CHRISTY FOREMAN, DIRECTOR, OFFICE OF DEVICE 
 EVALUATION, CENTER FOR DEVICES AND RADIOLOGICAL HEALTH, FOOD 
   AND DRUG ADMINISTRATION; AND FARZAD MOSTASHARI, NATIONAL 
COORDINATOR, HEALTH INFORMATION TECHNOLOGY, U.S. DEPARTMENT OF 
                   HEALTH AND HUMAN SERVICES

                  TESTIMONY OF CHRISTY FOREMAN

    Ms. Foreman. Mr. Chairman, Ranking Member DeGette, and 
members of the subcommittee, I am Christy Foreman, Director of 
the Office of Device Evaluation in the Center for Devices and 
Radiological Health, or CDRH, at the Food and Drug 
Administration. Thank you for the opportunity to testify today. 
I am pleased to be here to discuss issues related to health IT 
and to talk specifically about the actions FDA is taking to 
foster innovation in the field of mobile medical applications, 
also referred to as mobile medical apps.
    The widespread adoption and use of mobile technologies is 
opening new and innovative ways to improve health and 
healthcare delivery. Mobile apps, which are software programs 
that run on smartphones and other mobile devices, can help 
consumers and patients manage their own health and wellness, 
promote healthy living, and gain access to useful information 
when and where they need it.
    FDA believes it is important to adopt a balanced approach 
to mobile medical apps that supports continued innovation while 
assuring appropriate patient protections. We also recognize 
that mobile health application developers need a clear, 
predictable, and reasonable understanding of the Agency's 
expectations.
    While many mobile apps carry minimal risk, others can pose 
significant risk to patients if they don't operate correctly. 
In some cases, those risks are identical to the risks 
associated with an already marketed medical device. For 
example, a mobile app that affects the programming of a drug 
infusion pump or a Computed Tomography scanner could lead to a 
drug or radiation overdose. And an inaccurate or malfunctioning 
mobile medical app designed to diagnose skin cancer could delay 
life-saving diagnosis and treatment.
    In July 2011, FDA issued a Draft Guidance announcing our 
intention to exercise enforcement discretion for most mobile 
apps. The Guidance also clarifies that the focus of our 
oversight will be a small subset of mobile apps, which we refer 
to as ``mobile medical apps.'' These are apps that meet the 
definition of a device in the Federal Food, Drug, and Cosmetic 
Act and that are either intended to be used as an accessory to 
a regulated medical device or transform a mobile platform into 
a regulated medical device.
    What our policy proposes is equally important as what our 
policy does not propose. It would not regulate the sale or 
general consumer use of smartphones or tablets. It would not 
consider entities that exclusively distribute mobile medical 
apps, such as the iTunes App Store or the Android Market, to be 
medical device manufacturers. It would not consider mobile 
platform manufacturers to be medical device manufacturers just 
because their mobile platform could be used to run a mobile 
medical app regulated by FDA. It would not require mobile 
medical app developers to seek agency reevaluation for minor 
iterative product changes. And it would not apply to mobile 
apps that perform the functionality of an electronic health 
record, an EHR system, or personal health record system.
    We have received more than 130 written comments on our 
Draft Guidance. The comment have been overwhelmingly supportive 
of our narrow, tailored, risk-based approach, and we continue 
to receive many inquiries from industry stakeholders who are 
eager to see this Guidance finalized. Some commenters have 
sought additional clarity on the types of mobile apps that 
would fall within the scope of enforcement discretion. Our 
Final Guidance will provide that additional clarity and 
examples.
    Pursuant to Section 618 of the Food and Drug Administration 
Safety and Improvement Act (FDASIA), the FDA, the Office of the 
National Coordinator, and the Federal Communications Commission 
have established a FDASIA workgroup which will provide expert 
input from a wide range of stakeholders to develop 
recommendations on an appropriate, risk-based regulatory 
framework pertaining to health information technology, 
including mobile medical apps.
    It is important to note that FDA has been regulating 
medical device software for decades, and medical device 
software on mobile platforms for more than 10 years. We have 
reviewed approximately 100 mobile medical apps, including 
remote blood pressure, heart rhythm, and patient monitor apps 
in addition to smartphone-based ultrasound and glucose meters.
    We recognize the importance of using a balanced, 
transparent approach that fosters the development of innovative 
mobile medical apps while ensuring appropriate patient 
protections. We intend to strike the right balance by providing 
a risk-based, focused approach to the oversight of a small 
subset of mobile medical apps that present a serious potential 
risk to patients if they do not work as intended. We believe 
that focusing the Agency's oversight will encourage the 
development of new products while also providing appropriate 
patient protections.
    Thank you for the opportunity to testify today about issues 
related to health IT, including mobile medical apps, and about 
the actions FDA is taking to foster innovation.
    Mr. Chairman, I commend the Subcommittee's efforts and am 
pleased to answer any questions the Subcommittee may have.
    [The prepared statement of Ms. Foreman follows:]

[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]


    Mr. Burgess [presiding]. The chair thanks the witness. I 
recognize Dr. Mostashari, 5 minutes for your opening statement, 
sir.

                 TESTIMONY OF FARZAD MOSTASHARI

    Dr. Mostashari. Dr. Burgess, Ranking Member DeGette, 
distinguished subcommittee members, thank you for the 
opportunity to appear today on behalf of the Department of 
Health and Human Services. My name is Dr. Farzad Mostashari. I 
am the National Coordinator for Health Information Technology.
    In 2009, HITECH was enacted as part of the American 
Recovery and Reinvestment Act. HITECH provided the resources 
and infrastructure needed to stimulate the rapid, nationwide 
adoption and use of health IT, especially electronic health 
records, or EHRs. HITECH is working. The CMS Medicare and 
Medicaid EHR Incentive Program, the ONC-led Certification 
Program for EHRs, as well as the hands-on technical assistance 
provided by 62 regional extension centers, or RECs, across the 
country are critical in facilitating unprecedented progress in 
EHR development, adoption, and use.
    There are now over 1,700 unique products produced by nearly 
1,000 EHR developers and certified by 1 of 5 ONC-accredited 
private sector certification bodies. Adoption of EHRs has 
doubled among providers and more than tripled in hospitals. 
Electronic prescribing has increased sevenfold. RECs have 
signed up more than 130,000 primary care providers in over 
30,000 practices. As of February 2013, more than 230,000 
providers, nearly 43 percent of the Nation's eligible 
professionals, and over 75 percent of eligible hospitals have 
earned payments for meeting the initial requirements of EHR 
Incentive Program.
    Recognizing the need to strike a balance between the 
urgency of modernizing our healthcare system and the pace of 
change that can be safely absorbed, CMS and ONC have developed 
the Incentive Program in stages. Each stage is designed to add 
increasingly advanced concepts. Published in July 2010, the 
Stage 1 final rules focused on functionality that support the 
electronic capture of data and its use to improve patient care, 
enhance care coordination in population health management, and 
increase patient and family engagement. The final rules for 
Stage 2 were published in September 2012 and represent an 
important next step with a focus on increasing standards-based 
health information exchange between providers and with 
patients.
    Even as we work to bring data and data tools to doctors and 
hospitals, we have also been encouraged by the pace of progress 
in the domain of consumer e-health tools. Increasingly, people 
are literally taking their health into their own hands. Mobile 
phones can be an incredible tool for empowering consumers to 
take control of their health, their care, their healthcare 
finances. And as we all know, more engaged consumers get better 
outcomes.
    ONC's strategy in consumer e-health is to work with 
partners to increase patients' ability to access their own 
health data, to increase the use of this data for actionable 
apps and services, and to shift attitudes around patient 
empowerment. However, we recognize there are risks as well as 
benefits to any technology. We must carefully balance the need 
for the widest possible innovation with protection of patient 
privacy, security, and safety.
    Over the past 4 years, we have worked with FDA and other 
departmental agencies on a risk-based approach to health IT 
that promotes innovation and avoids regulatory duplication. ONC 
advised FDA on the Draft Guidance for mobile medical apps. 
Where it concerns EHR technologies, FDA has advised us on a 
health IT patient safety action and surveillance plan, the 
draft of which was released on December 21, 2012. The draft 
plan prescribes actions that all stakeholders can take within 
their existing authorities and resources, including safety 
requirements related to user-centered design quality management 
systems and easier reporting of adverse events in ONC 
regulations, use of ONC-authorized testing and certification 
bodies to collect complaints and conduct surveillance, working 
with developers to establish a code of conduct, working with 
AHRQ and patient safety organizations to improve aggregation 
and analysis of reported events and working with CMS to train 
surveyors and use health IT to assist investigations. ONC has 
received public comments on the draft plan, and those comments 
have been generally favorable.
    On February 20, ONC, FDA, and FCC announced the formation 
of the Food and Drug Administration's Safety Innovation Act 
Work Group under ONC's Health IT Policy Committee to provide 
expertise for the development of a congressionally mandated 
report on an appropriate risk-based regulatory framework 
pertaining to health IT broadly, including mobile medical 
applications that will further promote innovation, protect 
patient safety, and avoid regulatory duplication. We are now in 
the process of reviewing nominations.
    New technologies, including health IT and mobile 
applications, offer great promise to improve the quality of 
care and bring down healthcare costs. This doesn't happen 
overnight. To truly transform delivery, healthcare providers 
must also redesigned workflows and reengineer care. Payments 
must promote value over volume and care that is better 
coordinated and safe. Implementation of any program of this 
scale and complexity will inevitably include challenges, but by 
working within an open and transparent process and in 
partnership with our public and private sector stakeholders, we 
can build on this strong start in bringing better care to all 
Americans.
    Thank you.
    [The prepared statement of Dr. Mostashari follows:]

[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]


    Mr. Burgess. I thank the gentleman for his testimony.
    Before we start members' questioning, I do want to stress 
the importance of the members' questions and the importance of 
getting direct answers from all of you all. The importance of 
this questioning is reflected in the fact that the Committee 
recently changed rules to limit member opening statements to 
provide more time for testimony and questioning. In order to 
make the question-and-answer period as productive as possible, 
I ask that you answer the questions in as a director manner as 
possible. Some members will ask yes-or-no questions and I ask 
that you limit yourself to a yes-or-no answer. I thank you in 
advance for your understanding.
    I will now yield myself 5 minutes for the purposes of 
questions.
    Ms. DeGette. That is not part of the rules.
    Mr. Butterfield. Will the chairman allow a question at this 
point? Is that part of our committee rules?
    Mr. Burgess. Stop the clock.
    Mr. Butterfield. Yes.
    Mr. Burgess. Yes, the committee rules as adopted and the 
Committee was to limit the opening statements.
    Mr. Butterfield. Dr. Burgess----
    Ms. DeGette. Yes, but not the whole rest of the stuff you 
said.
    Mr. Butterfield. Dr. Burgess, I have been in this Congress 
for 8\1/2\ years--not as long as you have--but I have never, 
ever, ever heard of a rule such as that.
    Ms. DeGette. It is not a rule.
    Mr. Butterfield. Thank you.
    Mr. Burgess. Well, let me direct it as a courtesy then to 
the members of the committee that we keep our answers direct 
and to the questions at hand.
    I yield myself 5 minutes for questions.
    Now, we are here today of course to discuss the issue of 
the guidance that was produced in July of 2011. Ms. Foreman, 
the FDA proposed its mobile medical apps policy would not 
regulate the sale of the general consumer or the use of 
smartphones or tablets. And certainly, today, we thank you for 
the certainty. Will the Final Guidance definitively say that 
the sale or general consumer use of smartphones or tablets will 
not be regulated by the Food and Drug Administration?
    Ms. Foreman. No, it is not the Agency's intent to change 
that position in the Final Guidance.
    Mr. Burgess. But, as everything, there is that possibility. 
And that is where the uncertainty comes from. And really, one 
of the things that the last 2 days and today are all about is 
trying to provide some certainty for the people who work into 
this space and are making significant investments of dollars 
and time, and they are doing so because they think they have 
ideas that are ultimately going to help people. And we would 
like to provide them that certainty. I think that is one of the 
reasons these committee hearings have been so important.
    Some of the uncertainty we have heard this week relates to 
the fact that the Guidance issued in July of 2011 is a draft. 
When can we look for the final draft, the Final Guidance? When 
can that be released?
    Ms. Foreman. We have prioritized that Guidance for 
publication this year. It should be coming soon with the intent 
of providing clarity to the----
    Mr. Burgess. Is your microphone working?
    Ms. Foreman. It is on.
    Mr. Burgess. OK. Pull it a little closer then.
    Ms. Foreman. We intend to finalize that Guidance this year. 
It is a priority for the Agency. It should be coming out within 
the next few months. And the point of the Final Guidance will 
be to seek to provide clarity by addressing the questions 
received during the comment period, and provide additional 
examples to clarify the Agency's policy.
    Mr. Burgess. Did you say it will be coming out in the final 
month of this year?
    Ms. Foreman. No, it will be coming out in the coming 
months.
    Mr. Burgess. In the coming months. And when you say this 
year, you are talking about the calendar year and not the 
fiscal year?
    Ms. Foreman. It should be out before the end of the fiscal 
year, yes.
    Mr. Burgess. OK. The fiscal year. Well, then let's make a 
note of that.
    Some of the statements made by the FDA either in the 
Guidance or were made by you today, is the Guidance going to be 
binding on the Food and Drug Administration? Are there 
situations where the Food and Drug Administration has deviated 
from its Guidance when exercising its enforcement discretion?
    Ms. Foreman. Guidance is not binding. Guidance represents 
agency thinking, but it is not a regulation. It is not statute. 
It is on a lower level that represents agency thinking to 
provide clarity both to staff and to industry.
    Mr. Burgess. And again, I do want to just for the record 
thank you for your rapid response to that letter. Again, I do 
hope that sets a new standard for the Administration in 
replying to letters from this committee. Historically, it can 
take some time to get questions answered, but these are 
important questions. These are questions not asked in a 
partisan manner in any way, shape, or form, and really trying 
to advance the science of the knowledge.
    Dr. Mostashari, I will tell you, again, I do get to travel 
to a lot of places in the country. I talked to a lot of 
provider groups. And I will just say there is some concern. You 
know, the FDA always looks to whether things are safe and 
effective, well, with the exception of tobacco, but always 
looks to whether things are safe and effective under its 
regulatory jurisdiction. I can't recall if we ever saw the 
randomized clinical trials for electronic health records. Are 
those trials in existence? Were they done? Do we have that 
data?
    Dr. Mostashari. Dr. Burgess, thank you for your question. 
There are many, many studies that have looked at whether when 
you try to improve quality, whether having information helps. 
And it is not something that perhaps is well-suited to a 
randomized trial at the policy level, but the overwhelming 
evidence--and we have commissioned a study of--that looks at 
every published study on this--and while some of the negative 
studies, the ones that are counterintuitive, get a lot of 
press, the preponderance of the evidence is absolutely that 
when implemented appropriately, health IT is going to improve 
quality, safety, and efficiency.
    Mr. Burgess. And yet, I just noticed from your testimony--I 
mean it was the end of last year, December of 2012, when your 
safety guidelines were published. Our stimulus bill was passed 
4 years ago. The implementation began June of 2011 as I recall, 
and December of 2012 is when you were providing the safety 
guidelines. And you have stipulated such things as privacy and 
patient protections.
    Dr. Mostashari. We have been--you know, our belief is 
that--and I think the evidence is that the best thing we can do 
for safety in general is to get off of paper. And the evidence 
around computerized order entry, for example, reducing 
medication errors by 48 percent, is clear. And we have seen an 
increase in e-prescribing that gets away from my handwriting 
and perhaps yours, which is a good thing in terms of improving 
the safety of prescribing.
    We just heard from the Premier System just this week about 
how they have saved $9 billion and 91,000 lives by implementing 
data-driven processes to improve care that can't be done in a 
paper-based world. So we believe that really getting healthcare 
into the data age is critical for improving safety.
    Now, as I mentioned, any technology----
    Mr. Burgess. Sir, I am actually going to stop you because 
my time has expired. In the interest of getting everyone heard, 
I will yield to the ranking member of the subcommittee.
    Ms. DeGette. Thank you, Mr. Chairman.
    I just have a few questions. Over the last 2 days of 
hearings before today there was a lot of testimony and claims 
that app developers face a threat from the FDA and that the 
Agency is planning to regulate mobile phones on a wide range of 
apps and then impose a medical device tax on phones. In the 
chairman's opening statement, I think he implied that he 
understands that the Agency is not planning to put the medical 
device tax on phones, but I just want to clarify exactly what 
the Agency is planning to do, Ms. Foreman. So I want to ask you 
a couple questions.
    Is it within the Agency's jurisdiction to regulate mobile 
medical apps?
    Ms. Foreman. Yes, it is.
    Ms. DeGette. If you can pull that microphone even closer, I 
think you are a very soft-spoken person. Can you give us some 
examples of the types of apps that the FDA is trying to 
regulate?
    Ms. Foreman. The apps that we are trying to regulate and 
that we have been regulating for a decade, are similar to what 
is regulated through other medical device technology, such as a 
central monitoring station for a nurse that transmits patient 
data, heart rate, SpO2, other critical parameters for patient 
care that need to be monitored. We have seen ultrasound 
technology where there is an app and a transducer that can plug 
into a smartphone to allow ultrasounds to take place. Those are 
the types of technology that we are regulating.
    Ms. DeGette. And why are you trying to regulate those types 
of technology, Ms. Foreman?
    Ms. Foreman. Those types of technology pose patient risk. 
If the device does not perform as intended, there is a 
potential for patient risk. Additionally, it is the same as 
other medical devices we regulate. We regulate based on 
intended use, not based on platform. Just because a device 
moves to a mobile platform, it would not be the Agency's 
intention that that would make it deregulated.
    Ms. DeGette. So you are not looking at how the app is used; 
you are looking at what the purpose is, right?
    Ms. Foreman. Exactly.
    Ms. DeGette. And this is an ability that the Agency has had 
for some years; it is just not new under the Affordable Care 
Act or under the stimulus, correct?
    Ms. Foreman. That is correct. Our first clearance of a 
mobile app product goes back to 1997.
    Ms. DeGette. 1997, oK. And can you tell me what types of 
apps the Agency will not be regulating and why?
    Ms. Foreman. There are apps that do not meet the definition 
of a medical device. The Agency would not regulate those. Those 
would be, for example, an app that takes an electronic version 
of a printed textbook. We have said that is not a medical 
device.
    Ms. DeGette. OK.
    Ms. Foreman. There are mobile medical devices that meets 
the definition of a device, but the risk is low. The Agency 
would rather focus its regulatory priorities on the higher-risk 
products. So devices for maintaining a healthy lifestyle that 
help with----
    Ms. DeGette. Pedometers----
    Ms. Foreman. Exactly. We would not put regulatory oversight 
priorities into those products.
    Ms. DeGette. OK. Now, in a different subcommittee the other 
day, members of the industry also agreed with what you are 
saying. Qualcomm's representative testified at that hearing 
``the FDA is squarely within its jurisdiction and we took a lot 
of their initial actions as a very promising indication to the 
industry at large that they were willing to work with all of 
us.'' So Ms. Foreman, I want to ask you, what are you doing to 
make sure that the Agency doesn't overreach when regulating 
these devices and using the standards that you have set forth?
    Ms. Foreman. As I mentioned, for FDA to regulate the 
product, it must first meet the definition of a medical device. 
That is what gives the Agency its authority. But for all of the 
products that technically meet the definition of a medical 
device, we have narrowed our focus to a smaller subset of those 
based on risk. We are actually refining our regulatory approach 
rather than overreaching.
    Ms. DeGette. OK. So that is good that you are narrowing it 
down, looking at things that affect patient safety and so on, 
but we are still hearing concerns about the impact of 
uncertainty on the mobile medical device market. Can you tell 
me what the Agency is doing to eliminate this uncertainty for 
investors and developers?
    Ms. Foreman. We believe finalizing the mobile medical apps 
Guidance is the first step in eliminating that uncertainty. 
That Guidance will provide clear, transparent, and predictable 
messaging regarding FDA oversight of mobile medical apps.
    Ms. DeGette. And that is the Guidance that you told Mr. 
Burgess that you are planning to issue by the end of the fiscal 
year, right?
    Ms. Foreman. Correct.
    Ms. DeGette. Now, also, we have heard concerns about the 
effects of FDA-induced delays on the mobile medical device 
market. Now, how do you respond to those?
    Ms. Foreman. We looked at our performance over the last 3 
years, which we believe is a contemporary sample of 
performance. On average, it takes the FDA 67 days to review a 
mobile medical app. That is well within our statutory time 
frame of 90 days for the 510(k) process. All mobile apps we 
have seen thus far have been in the 510(k) process on----
    Ms. DeGette. And you are going to continue that----
    Ms. Foreman. For the most part, yes.
    Ms. DeGette. Thank you. Mr. Chairman, I had referenced the 
letter from the FDA in my opening statement and asked for 
inclusion in the record, and the chairman said he had received 
it but I don't believe he agreed to my unanimous consent 
request to put it into the record, so I would renew that 
request.
    Mr. Burgess. I also received it and I accept your unanimous 
consent request. So ordered.
    [The information appears at the conclusion of the hearing.]
    Ms. DeGette. Thank you so much.
    Mr. Burgess. The chair recognizes Mr. Johnson from Ohio, 5 
minutes, for the purposes of questions, sir.
    Mr. Johnson. Thanks to our panelists for coming today.
    The Meaningful Use Program has made good progress in 
automating the current system. The first stage was to encourage 
adoption of current technology and gain automation 
efficiencies. Of course, Stage 2 addressed connectivity and 
sharing of information, and Stage 3, the final stage, is where 
providers and patients have accurate, real-time information in 
the systems and devices that provide care anywhere.
    As an IT professional myself for nearly 30 years, 
architecture and a roadmap of where you are going is vitally 
important because, as they say, if you don't know where you are 
going, any road will get you there. And you can pump millions, 
billions into these projects. And in today's environment, our 
healthcare providers simply don't have millions and billions to 
pump into something that is not working for them.
    So what is the gap between today's technology and the 
architecture of tomorrow to achieve an integrated, coordinated 
care system? How are we making sure that the data that is being 
collected people can use? I call it decisional information. How 
are we making sure that we are connecting the dots?
    Dr. Mostashari. That is a terrific question and you are 
absolutely right that it is the use of data not just the data 
itself that improves care. And as we found in other IT 
endeavors, it--particularly--IT becomes particularly important 
when you redesign the processes to take advantage of the 
information technology instead of merely digitizing the paper-
based or former processes.
    Mr. Johnson. And I would certainly agree with you. You 
know, over my 30 years in IT, one of the cardinal lessons is 
just because something can be automated doesn't mean that it 
should be automated. It is an issue of business process 
reengineering, and if you don't do that, you don't have a 
complete solution or certainly you don't have a solution that 
is connected.
    So who is developing the architecture that tells our 
healthcare providers in our system how this is all going to fit 
together?
    Dr. Mostashari. We have developed that roadmap that you 
speak of, and it is an incremental roadmap, as you mentioned, 
through the stages. And it begins with making sure that we have 
data because until you have data, you really can't see what you 
are doing. You can't have accountable care if you can't count. 
And that is where paper-based systems are today. So in Stage 1, 
the idea is let's collect the information in a structured way 
because--yes.
    Mr. Johnson. Well, that goes back to what I said earlier, 
and I think this is a discussion between two IT professionals 
here that everybody else may get bored with. That goes back to 
the ``if you don't know where you are going, any road will get 
you there.'' I don't think you know what data you need until 
you have an architecture and you know what the end stage looks 
like. You know, in the many, many software and technology 
programs that I managed throughout my 30-year career, if you 
don't start with an idea of what the end state looks like, then 
you waste a lot of money; you waste a lot of time.
    Dr. Mostashari. That is right.
    Mr. Johnson. So I am not sure data collection up front 
without knowing what data you want to collect makes a whole lot 
of sense.
    Dr. Mostashari. Let me clarify my response.
    Mr. Johnson. Sure. Because we start with data. Data doesn't 
become information until it is relevant and until it can be 
used. And data just for the sake of data, as you know, is----
    Dr. Mostashari. That is right.
    Mr. Johnson. So go ahead. I am sorry.
    Dr. Mostashari. Sorry about that. So we start with--in the 
framework, we actually start with the end in mind. So we said 
what is it about the use of technology that can--we can expect 
to improve safety, improve the quality of care, patient 
engagement, public health. And then we work backwards to say, 
oK, if we want to reduce deaths--unnecessary deaths, those are 
associated with better decision support at the point of care, 
it is associated with quality measurement, and being able to 
make a list of patients by certain criteria, oK, and taking 
that a step back, you need to be able to have a list of 
medications for patients. That is pretty clear. We need to have 
a list of their problems and diagnoses. You need to know their 
allergies. You need to know their laboratory values. You need 
to know their blood pressure and smoking status. And it was 
those data elements recognizing that as the system evolves, 
there would need to be flexibility and the ability to extend 
that framework and add in the next iteration devices, for 
example.
    Mr. Johnson. Like I said, people are probably going to get 
bored. You and I can----
    Dr. Mostashari. We would----
    Mr. Johnson. But how many physicians have been involved in 
the development of this roadmap and the kind of data that we 
need to----
    Dr. Mostashari. We have one of the, I think, hardest-
working and most respected Federal Advisory Committees in 
government. We--it--there--it is--there are certain statutory 
representations on that. The house majority and minority 
leaders appoint members to the Policy Committee. The Senate 
minority, majority leaders, the Comptroller General----
    Mr. Johnson. My time is expired.
    Dr. Mostashari. Sorry.
    Mr. Johnson. The chairman is making that known, so I thank 
you for your answers. I would love to talk to you more 
sometime.
    Mr. Burgess. And the gentleman may request the answer in 
writing, and I hope that he will.
    The chair recognizes----
    Dr. Mostashari. Will do.
    Mr. Burgess [continuing]. Now Mr. Waxman, the ranking 
member of the full committee.
    Mr. Waxman. Thank you, Mr. Chairman.
    Ms. Foreman, we have heard a lot of allegations over the 
last few days that FDA is intending to regulate everything and 
anything digital or online that has any relation to healthcare. 
But the facts seem to be very different. I know you have 
attempted in your testimony, as well as in the 2011 Draft 
Guidance, to allay concerns about the scope of what FDA intends 
to regulate. But I would like for the record to go over some of 
the examples we heard in testimony yesterday or the day before. 
Is FDA currently proposing or does it intend in the future to 
regulate ordinary smartphones and tablets?
    Ms. Foreman. No, it does not.
    Mr. Waxman. What about mobile platforms in general such as 
the iPhone, Blackberry, Android phones, tablet computers, or 
other computers that are typically used as smartphones or 
personal digital assistants?
    Ms. Foreman. No.
    Mr. Waxman. What about the entire mobile network?
    Ms. Foreman. No.
    Mr. Waxman. Each new mobile device released on the market?
    Ms. Foreman. No.
    Mr. Waxman. All health IT?
    Ms. Foreman. No.
    Mr. Waxman. An iPad application to help track the number of 
steps walked per day?
    Ms. Foreman. No.
    Mr. Waxman. An iPad application that reminds one that it is 
time to refill a prescription?
    Ms. Foreman. No.
    Mr. Waxman. Software that enables a physician to search a 
medical textbook?
    Ms. Foreman. No.
    Mr. Waxman. Apps to allow parents to access online services 
such as personal health records to document procedures that a 
baby has undergone and drugs their baby was given?
    Ms. Foreman. No.
    Mr. Waxman. I don't think you can be any clearer. FDA has 
established limits on what it can and cannot regulate in the 
mobile device market, and I appreciate you walking through 
these limits.
    While I know that IRS, not FDA, implements the tax code, I 
would like to ask you a bit about the recent claims that mobile 
platforms will be taxed under the Medical Device Act. Under the 
new medical device tax, will smartphones and iPads now be taxed 
as medical devices?
    Ms. Foreman. The FDA is a public health agency, not a 
taxation agency.
    Mr. Waxman. I understand.
    Ms. Foreman. These questions would probably be best 
answered by IRS or the Treasury, but my understanding is no.
    Mr. Waxman. These type of products are exempt from the 
medical device tax, isn't that correct? Can you explain a 
little bit about this exemption?
    Ms. Foreman. As I said, we are public health agency----
    Mr. Waxman. Yes.
    Ms. Foreman [continuing]. Not a taxation agency, but they 
would not be regulated as medical devices, therefore, not 
subject to the medical device tax.
    Mr. Waxman. OK. As I understand it, they will be exempt 
because FDA will not define them as a medical device, and even 
if you did define them as a medical device, they won't be tax 
because they will qualify for the retail exemption. The law 
says that items sold to consumers by way of retail cannot be 
taxed. Isn't that your understanding as well?
    Ms. Foreman. That is my understanding.
    Mr. Waxman. Although we don't rely on you for tax 
information.
    Ms. Foreman. You really should not.
    Mr. Waxman. But we are interested in this issue because it 
has been brought up so many times, and this committee is not a 
committee that has jurisdiction over tax.
    I thank you very much. It is clear that fears that iPhones 
and other smartphones are going to be regulated by FDA and 
taxed as medical devices are unfounded and we can put this myth 
to rest.
    OK. Well, Mr. Chairman, my staff informs me the next 
question is not for me to pursue and I have asked the questions 
that I think are important and I think they are good way to end 
the third day of hearings to allay a lot of the fears that have 
been raised in the other two. And so unless anybody wants my 
minute, I will yield it back.
    Mr. Burgess. And the chair thanks the ranking member. It is 
forever in his debt.
    Now yields for 5 minutes to Ms. Ellmers from North 
Carolina.
    Mrs. Ellmers. Thank you, Mr. Chairman.
    Thank you. Thank you. And Dr. Mostashari, good to see you 
again. We have worked together many times on this issue and 
there again thank you for coming. Thank both of you for coming 
to testify today.
    You know, one of the things--and I know we have discussed 
this in the past--is really the cost to physicians who are 
small business owners, and as important as we all know health 
information technology is, the cost being passed on to them, 
you know, there are estimations of 15,000 to $70,000 for the 
cost of implementing IT. And also, there is the issue of the 
physician really being taken away from the patient at the 
bedside to implement the information. And there is of course 
that learning curve that everyone has to go under.
    Now, one of the points that is being made is how this is 
helping eliminate errors and actually thereby improving 
healthcare. However, when limited time is given to the patient 
directly, hands-on, and eye-to-eye contact with that patient, 
don't you think that subsequently it could actually have a 
bearing on the ultimate outcome of the patient, maybe something 
being missed, possibly tests being over-ordered as a result of 
not an adequate time with the patient?
    Dr. Mostashari. Overall, the--we actually have data from 
the National Center for Health Statistics where providers 
report that EHRs have, in their estimation, produced clinical 
benefit for their patients. It is 79 percent. And if you look 
at those who are using the modern systems and who have been 
using it for more than 2 years--and this is important because 
it takes time----
    Mrs. Ellmers. Yes. Yes. Sure. Sure.
    Dr. Mostashari [continuing]. To get used to the systems, 
that rises to 92 percent. Now, providers believe that in their 
practice the electronic health records are providing clinical 
benefit to their patients.
    Mrs. Ellmers. OK. Now, that leads me to my next question 
because a lot of the software is incompatible with other 
facilities, so software that one physician may be using may not 
be the same software another physician or the physician in the 
hospital not using the same. So getting back to again 
considering errors, considering the possibility of information 
not being exchanged adequately, but also considering cost, 
which of course ultimately gets passed on to the patient, and 
we are always looking for good quality of care, what is going 
to happen when we are trying to integrate all those systems? Is 
this cost then going to be passed on to the physician again 
and, you know, having to bear the brunt of that expense?
    Dr. Mostashari. Making sure that the patient information is 
available when and where it is needed is one of our top 
priorities. And we could have, as some countries have done, 
have said we are going to solve that problem by the government 
is going to buy the EHR system for the whole country. That is 
not the way we do things----
    Mrs. Ellmers. Yes. Yes.
    Dr. Mostashari [continuing]. Right? We said the people who 
are best suited to make those purchasing decisions are the 
hospitals and doctors who have to live with the systems. But in 
order to make sure that they can talk with each other, then we 
need to have some standards. We need to have a certification 
program and to evolve that certification program and to create 
consensus, industry consensus----
    Mrs. Ellmers. Yes.
    Dr. Mostashari [continuing]. Private sector consensus 
around how we can have one doctor choosing one system, the 
other choosing a different system that meets their needs but 
having those systems----
    Mrs. Ellmers. Be able to communicate.
    Dr. Mostashari [continuing]. Be able to talk to each other. 
That is the approach we have taken, and the certification 
criteria for 2014 put a big step up in those requirements.
    Mrs. Ellmers. OK. Thank you.
    Ms. Foreman, I do have a couple questions. I know we 
continuously are talking about, one, the FDA regulation issue, 
which is very important, but also the tax on the medical 
devices. Has the FDA looked at this as an issue that it might 
actually be stifling some of the innovation moving forward with 
having the tax on medical devices?
    Ms. Foreman. As I said, we are public health agency. Our 
decisions are governed by public health. Our decision-making is 
based on balancing innovation and public health.
    Mrs. Ellmers. Yes. Yes.
    Ms. Foreman. We identified a large subset of devices that 
could be under enforcement discretion without our regulatory 
oversight.
    Mrs. Ellmers. Yes. Yes.
    Ms. Foreman. As it happens, those devices may not be 
subject to the device tax.
    Mrs. Ellmers. OK.
    Ms. Foreman. As was mentioned, there is a retail exemption 
as well----
    Mrs. Ellmers. Right.
    Ms. Foreman [continuing]. Meaning products available for 
retail--even declared to be a medical device--is exempt from 
the tax--FDA does is a public health organization, not a 
taxation agency.
    Mrs. Ellmers. Thank you. Thank you. My time is expired. 
Thank you both.
    Mr. Burgess. The chair recognizes the gentleman from North 
Carolina 5 minutes for purposes of questions, sir.
    Mr. Butterfield. I thank you, Mr. Chairman.
    And I thank both of you for your testimony here today.
    Over the course of the last 2 days of hearings, and 
actually in Ms. Foreman's testimony here today, we have learned 
that FDA has proposed regulating only a very small subset of 
mobile applications. FDA's Draft Guidance states that the 
Agency will only look at those mobile apps that are essentially 
acting as a medical device or as part of one. The Guidance also 
explicitly exempts many of the apps that my colleagues on the 
other side have been trying to scare people into thinking FDA 
was going to take over, things like electronic PDRs and 
electronic health records. That seems like a very reasonable 
approach to me.
    But I want to learn more about exactly what kind of 
regulatory burden we are talking about even with this small 
subset of applications that will be regulated as devices. I 
know that an FDA-regulated medical device may fall into one of 
three tiers. We have heard about that. Class 1 devices are the 
least risky devices while Class 3 devices are the most risky.
    And so let me start with Ms. Foreman. Ms. Foreman, can you 
briefly elaborate on these three levels of device oversight and 
explain what responsibilities a device manufacturer has under 
each of these levels?
    Ms. Foreman. Certainly. I will start at the bottom and work 
up. If the device is a Class 1 device, and this small subset 
could include devices that would meet the Class 1 definition of 
a medical device, they are not subject to agency premarket 
review. They are subject to meeting registration and listing 
requirements, as well as the quality system regulation, which 
ensures that the devices are manufactured properly.
    Moving up to Class 2 devices, these must meet those same 
criteria--registration, listing, quality system--but they also 
need what is called a 510(k) or a premarket notification. That 
application would allow the Agency to review and clear the 
device as equivalent to another device on the market. There is 
a user fee associated with that. It is just under $5,000. 
However, if it is a small business, it is half of that. If the 
sponsor makes significant modifications to the device, they 
would need a new 510(k), but as I mentioned, we planned many of 
those iterative changes to not require new submissions of 
510(k)s.
    If we move up to the next level, Class 3, those devices 
require a premarket approval application. To date, we have not 
found a mobile app that would fit into that category. I am not 
saying that in the future it wouldn't be possible, but we have 
not seen one yet.
    Mr. Butterfield. So essentially, what you are saying is 
that a Class 1 or 2 device doesn't have to do all that much in 
terms of premarket clearance, while Class 3, if there is one, 
sounds like it may be subject to more stringent requirements if 
one evolves----
    Ms. Foreman. Correct.
    Mr. Butterfield [continuing]. Is that correct?
    Ms. Foreman. Correct.
    Mr. Butterfield. OK. Now, which level of regulatory 
oversight will most of these medical applications fall under?
    Ms. Foreman. Class 1 or Class 2.
    Mr. Butterfield. Class 1 or Class 2. And you don't know of 
any Class 3 existing at this moment?
    Ms. Foreman. I do not.
    Mr. Butterfield. All right. Now Ms. Foreman, there were 
also some assertions yesterday that FDA lacked the expertise to 
regulate mobile applications. Your testimony states that you 
have regulated medical device software for decades and mobile 
apps for more than 10 years. Can you elaborate on FDA's 
experience regulating in this area?
    Ms. Foreman. Absolutely. This is not a new area for the 
FDA. We have been regulating software and mobile apps for some 
time. When we do our review, we actually bring together two 
different sets of expertise. There is the software expertise, 
we have software engineers who will review the software 
information to make sure that it was developed properly, 
coupled with a clinical review because the app is intended for 
a medical application. For example, if you take an app to view 
a radiology image on a smartphone, the software reviewer can 
make sure that all of the technical specifications happen 
properly on the smartphone. And we will ask the clinical 
reviewer for an evaluation to determine if, for example, we 
view an image on a smartphone, can we actually detect cancer 
with the same level of sensitivity and specificity that we 
would on the large view station? You can zoom the image, you 
can pan, you can look at it that way, but is there a difference 
between looking at the whole image versus pieces of the image 
to make sure that patient safety is not compromised? Because 
you don't want somebody to have undergone radiation for a 
diagnostic purpose and then--realize there is a false negative 
or a false positive.
    Mr. Butterfield. Can you finally address how you plan to 
keep up with the world in which so many apps are already on the 
market and so many new ones are coming out every day? How are 
you going to keep up with all this stuff?
    Ms. Foreman. As I mentioned, part of keeping up with it is 
prioritizing our focus, and we are prioritizing our focus on 
the small subset; within that subset we receive about 20 
applications a year. Right now, we are getting less than 20 a 
year. That is actually in our 510(k) inventory. That is about 
.5 percent of the medical device applications that we review. 
And keeping up with technology is something that we are always 
faced with, so that is why we add on competent staff and we 
make sure to provide training opportunities for those staff so 
that they can continue to stay abreast of the latest 
technology.
    Mr. Butterfield. Thank you. My time is expired.
    Mr. Burgess. The gentleman's time is expired.
    I am advised that votes have been called. We will try to go 
over and get through as many of the panel as we can.
    I recognize the gentleman from Missouri 5 minutes for 
questions.
    Mr. Long. Thank you, Mr. Chairman. And thank you all for 
being here today.
    Director Foreman, I have a question for you. As far as 
current FDA Risk Evaluation and Mitigation Strategy, REMS for 
short, their Guidance requires, doesn't it, that medication 
guides upon first dispensing of the medication and then for 
every subsequent refill you have to have the medication guides 
printed out. Is that correct?
    Ms. Foreman. So I am going to apologize because REMS is a 
provision implemented by CDER, or Center for Drug Evaluation 
and Research. So that is really outside of my area of expertise 
in the Center for Devices and Radiological Health.
    Mr. Long. OK. Who should I go to to answer that question? 
Who should I----
    Ms. Foreman. CDER is headed by Dr. Janet Woodcock.
    Mr. Long. OK. OK. Because that was my intent was to ask if 
on a refill prescription if that could be able to be handled 
through a mobile device as opposed to trying to mail a stack of 
how to retake your medicine every time that it is prescribed. 
So with that--and I know we are short on time--Mr. Chairman, I 
yield back.
    Mr. Burgess. The gentleman yields back.
    The gentleman from New York is recognized for 5 minutes for 
questions.
    Mr. Tonko. Thank you, Mr. Chair.
    Dr. Mostashari, there is a broad consensus that the 
increased use of electronic health records and health 
information technology ultimately leads to better patient care 
and a bending of that cost curve and savings, but there is also 
a concern that the adoption of these EHRs also provide an 
increased opportunity for fraud by exaggerating the intensity 
of care or severity of patients' conditions on their Medicare 
claims. We have, I guess, labeled this as up-coding and it is 
often facilitated by software programs that prompt billing for 
additional services that were not provided and maybe only 
tangentially related to the care received. Many of our health 
IT vendors are developing these systems to promote their 
products as a way to increase the bottom line.
    So my question is can you discuss what your office is doing 
to develop guidance and technological standards in electronic 
health records software that will help to prevent this type of 
fraud?
    Dr. Mostashari. Yes, thank you for the question. I want to 
make one thing very clear, which is that if there is 
documentation of care that did not occur, that is fraud. And 
CMS and the Attorney General and the Secretary of Health have 
made it very clear that we will not tolerate fraud. And the 
electronic health records provide increased tools also on our 
side to be able to better investigate and prosecute fraud 
should it occur. There are always those who will attempt to 
defraud the system and I think this Administration in 
particular has been very successful and has had record 
prosecutions and recoveries under that.
    But I think your question gets to also issues where it is 
not explicit fraud, and those are more complicated situations. 
I think some of the analysis has been done looked at patterns 
of coding intensity over the past decade. Before the first 
meaningful use payment check ever went out, for a decade there 
has been this creep towards higher intensity codes. CMS--this 
is not a new issue for CMS and they have ways of dealing with 
shifts in these patterns. But the electronic health records 
that were formally predominantly used for documentation and 
billing purposes before meaningful use, that may have been part 
of the business case for them. I think that our challenge is 
twofold. First, to make sure that we get the broadest possible 
input on ways that we can mitigate any possibility of the 
records systems themselves inducing inadvertent violations.
    The second is to make sure that the systems meet the needs 
of the future, which is, as I think there is broad consensus, 
means moving away from paying fee-for-service based on 
documentation and more towards outcomes and value.
    Mr. Tonko. Thank you. And what lessons can be drawn from 
the implementation of EHRs nationwide from the VA's long 
successful track record with VISTA, their Veterans Health 
Information Systems and Technology Architecture program, 
specifically in terms of interoperability and usability of 
records?
    Dr. Mostashari. It is interesting, following on your 
previous question, one of the groups that had the most 
experience with the perils of copy-and-paste was the VA, which, 
even though there was no billing incentive, it was convenient 
to carry forward notes from before, and it resulted in not--it 
is not a billing issue. It is a clinical documentation issue 
where it wasn't easy to understand. If you practiced at the VA, 
sometimes you saw notes that were copied forward and forward 
and forward, and it wasn't good for clinical care. You couldn't 
understand what was really going on with the patient in this 
visit. And the VA has done a lot working with clinical 
leadership to say how can we improve the quality of the 
clinical documentation and the usability of the systems?
    The VA--there is very strong evidence that they have saved 
billions of dollars by implementing IT and by continually 
improving the systems that they have. And if there is one 
lesson I would take from the VA it is that, that no system is 
perfect the day it is implemented. And it becomes improved over 
time through the polishing of that stone to the application of 
clinical judgment, improved usability, improved 
interoperability, and that is what we are engaged with here. 
This is not a, you know, one-and-done process. This is going to 
be a continual process of refinement, optimization, 
improvement, and redesign.
    Mr. Tonko. Thank you, Dr. Mostashari and Ms. Foreman, for 
appearing before us.
    And Mr. Chair, with that, I yield back.
    Mr. Burgess. The gentleman's time is expired.
    The chair now recognizes Mr. Griffith for 5 minutes for 
questions, sir.
    Mr. Griffith. Thank you.
    And I apologize to the witnesses in advance. I have to move 
fairly quickly so I am cutting through a lot of the explanation 
because I think you all know where we are heading with the 
questions as we get to it. But if you need further, let me 
know.
    Ms. Foreman, your testimony notes that questions about 
medical device tax should be directed to the IRS, but clearly, 
they are going to need help in figuring out what is a medical 
device at what you are regulating as a medical device if it is 
the purpose of it and not the platform. And so I would ask, 
have you had any discussions with the IRS about this tax, if 
they have asked for your input on that?
    Ms. Foreman. We provided technical input to the IRS on the 
interpretations of our laws. The way it was implemented is that 
if a medical device lists, it would be subject to the tax.
    Mr. Griffith. And can you provide us with a copy of what 
you gave the IRS so we can take a look at that to the 
committee? Not today, but subsequently?
    Ms. Foreman. I can look into that.
    Mr. Griffith. OK. Thank you. And has the FDA done any 
analysis on the impact of the tax either in dollar figures or 
the number of manufacturers it will have an impact on?
    Ms. Foreman. FDA is a public health agency. We are not 
involved in the taxation. We receive no direct benefits.
    Mr. Griffith. In regard to the questions, the list of 
examples that Mr. Waxman listed out, while the FDA does not 
currently have any plans, do you believe that the FDA could if 
it so chose to do so regulate those examples down the road if 
it had a change of heart?
    Ms. Foreman. If the device meets the definition of a device 
as defined in the Food, Drug, and Cosmetic Act, we could. We 
have no intent to. The only thing that would change our mind is 
if there was a strong safety signal that we became aware of 
related to a device that we were not regulating appropriately 
under enforcement discretion. By not regulating it, that would 
cause us to reconsider our position. But absent strong safety 
signals, no, we would not change our mind.
    Mr. Griffith. All right. And then the practical question 
that I would have is if somebody is currently developing an app 
of a medical nature, how does anybody know if they are supposed 
to be contacting the FDA? And, you know, I am just an old 
country lawyer and I got on my tablet here--it is an Android--
and found an article yesterday and there was lots of; I just 
chose this one because it sounded interesting--that the iPhone 
is now a handy tool for detecting and diagnosing parasites, and 
the article says ``using little more than an iPhone, strips of 
double-sided tape, a cheap ball lens, and a battery-powered 
flashlight, a workable model was assembly to determine whether 
or not a child had parasites.'' Are you all regulating that or 
not?
    Ms. Foreman. To my knowledge, we have not regulated that. 
It has not come before us. A diagnostic device, though, would 
meet the definition. That would----
    Mr. Griffith. So if the Canadians, the Bostonians, and the 
Swiss who worked this up to help in other countries decided 
that it might be helpful in rural parts of the United States, 
they would have to come to you first, and instead of costing 
$8, it would cost what? Hundreds of thousands?
    Ms. Foreman. We are not involved in the pricing of medical 
devices.
    Mr. Griffith. No, no, no, I am not talking about with the 
price is. I am talking about how much it costs to get it 
approved.
    Ms. Foreman. So, as I say, a 510(k) fee is just under 
$5,000. If it is a small business, it would be half of that.
    Mr. Griffith. OK.
    Ms. Foreman. So $2,500.
    Mr. Griffith. But you would want all kinds of tests and 
studies, not the fact that they have been out in the field and 
made it work with double-sided tape, am I not correct?
    Ms. Foreman. I am not inherently opposed to double-sided 
tape but----
    Mr. Griffith. I understand. I think I have made my point, 
and I yield back my time, Mr. Chairman.
    Mr. Burgess. I thank the chair. The chair yields to the 
gentleman from Texas, Mr. Barton, for questions.
    Mr. Barton. Mr. Chairman, I appreciate the time. I want to 
yield it to you to use as you so decide.
    Mr. Burgess. Well, I thank the chairman emeritus.
    Dr. Mostashari, I just have to ask you here as we conclude 
today, I hear a lot of stuff about interoperability. I mean you 
are the head. Why don't you just fix that? Why don't you just 
make that happen?
    Dr. Mostashari. We are using every lever at our disposal to 
increase the sharing of information, and that includes not just 
the data standards and getting industry together to help us. We 
don't want to be the ones to say, you know, we will choose the 
standards. We really want to work with industry to get 
consensus and to accelerate this.
    Mr. Burgess. But, you know, in the interest of time, we do 
hear about this a lot. Even anecdotally, hospital systems in 
the same city that have the same operating system aren't 
talking to each other. It seems like you could make that 
happen.
    Dr. Mostashari. We--the 2014 certification criteria, Dr. 
Burgess, I--we--I would be happy to go into great detail with 
you, but they are a big step forward, and I believe that 
hospitals and doctors around the country will see a palpable 
difference once those certification criteria are in place.
    Mr. Burgess. Well, I want to thank both of our witnesses 
for being here today and for bearing with us. I apologize about 
votes cutting the hearing short. Dr. Mostashari, I look forward 
to having you back at either the Health Subcommittee or this 
subcommittee in the future. You are a fascinating witness. We 
have learned a lot this morning from both of you, and I 
appreciate your time.
    I want to thank the members for their devotion to the 
hearing today.
    The committee rules provide that members have 10 days to 
submit additional questions for the record to the witnesses. I 
also failed to ask for unanimous consent that all members' 
statements that wish to be entered in the record be entered.
    Hearing no objection, so ordered.
    The hearing stands adjourned.
    [Whereupon, at 10:25 a.m., the subcommittee was adjourned.]
    [Material submitted for inclusion in the record follows:]

[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]



                                 
