[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
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COMMITTEE ON ENERGY AND COMMERCE
FRED UPTON, Michigan
Chairman
RALPH M. HALL, Texas HENRY A. WAXMAN, California
JOE BARTON, Texas Ranking Member
Chairman Emeritus JOHN D. DINGELL, Michigan
ED WHITFIELD, Kentucky Chairman Emeritus
JOHN SHIMKUS, Illinois EDWARD J. MARKEY, Massachusetts
JOSEPH R. PITTS, Pennsylvania FRANK PALLONE, Jr., New Jersey
GREG WALDEN, Oregon BOBBY L. RUSH, Illinois
LEE TERRY, Nebraska ANNA G. ESHOO, California
MIKE ROGERS, Michigan ELIOT L. ENGEL, New York
TIM MURPHY, Pennsylvania GENE GREEN, Texas
MICHAEL C. BURGESS, Texas DIANA DeGETTE, Colorado
MARSHA BLACKBURN, Tennessee LOIS CAPPS, California
Vice Chairman MICHAEL F. DOYLE, Pennsylvania
PHIL GINGREY, Georgia JANICE D. SCHAKOWSKY, Illinois
STEVE SCALISE, Louisiana 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
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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
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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.
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\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.]
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