- EXAMINING FEDERAL REGULATION OF MOBILE MEDICAL APPS AND OTHER HEALTH SOFTWARE

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

EXAMINING FEDERAL REGULATION OF MOBILE MEDICAL APPS AND OTHER HEALTH
SOFTWARE

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

HEARING

BEFORE THE

SUBCOMMITTEE ON HEALTH

OF THE

COMMITTEE ON ENERGY AND COMMERCE
HOUSE OF REPRESENTATIVES

ONE HUNDRED THIRTEENTH CONGRESS

FIRST SESSION

__________

NOVEMBER 19, 2013

__________

Serial No. 113-99

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

JOSEPH R. PITTS, Pennsylvania
Chairman
MICHAEL C. BURGESS, Texas FRANK PALLONE, Jr., New Jersey
Vice Chairman Ranking Member
ED WHITFIELD, Kentucky JOHN D. DINGELL, Michigan
JOHN SHIMKUS, Illinois ELIOT L. ENGEL, New York
MIKE ROGERS, Michigan LOIS CAPPS, California
TIM MURPHY, Pennsylvania JANICE D. SCHAKOWSKY, Illinois
MARSHA BLACKBURN, Tennessee JIM MATHESON, Utah
PHIL GINGREY, Georgia GENE GREEN, Texas
CATHY McMORRIS RODGERS, Washington G.K. BUTTERFIELD, North Carolina
LEONARD LANCE, New Jersey JOHN BARROW, Georgia
BILL CASSIDY, Louisiana DONNA M. CHRISTENSEN, Virgin
BRETT GUTHRIE, Kentucky Islands
H. MORGAN GRIFFITH, Virginia KATHY CASTOR, Florida
GUS M. BILIRAKIS, Florida JOHN P. SARBANES, Maryland
RENEE L. ELLMERS, North Carolina HENRY A. WAXMAN, California (ex
JOE BARTON, Texas officio)
FRED UPTON, Michigan (ex officio)

C O N T E N T S

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Page
Hon. Joseph R. Pitts, a Representative in Congress from the
Commonwealth of Pennsylvania, opening statement................ 1
Prepared statement........................................... 2
Hon. Frank Pallone, Jr., a Representative in Congress from the
State of New Jersey, opening statement......................... 3
Hon. Marsha Blackburn, a Representative in Congress from the
State of Tennessee, opening statement.......................... 5
Hon. Henry A. Waxman, a Representative in Congress from the State
of California, opening statement............................... 6
Hon. Fred Upton, a Representative in Congress from the State of
Michigan, prepared statement................................... 106
Hon. Lois Capps, a Representative in Congress from the State of
California, prepared statement................................. 107

Witnesses

Jeffrey E. Shuren, M.D., J.D., Director, Center for Devices and
Radiological Health, United States Food and Drug Administration 8
Prepared statement........................................... 10
Mike Marchlik, Vice President, Quality Assurance and Regulatory
Affairs, McKesson Technology Solutions......................... 43
Prepared statement........................................... 45
Jim Bialick, Executive Director, Newborn Coalition............... 54
Prepared statement........................................... 56
Hon. Zachary J. Lemnios, Vice President, Research Strategy, IBM
Research....................................................... 67
Prepared statement........................................... 69
Answers to submitted questions............................... 116
Robert Jarrin, Senior Director, Government Affairs, Qualcomm
Incorporated................................................... 78
Prepared statement........................................... 80
J. Leonard Lichtenfeld, Deputy Chief Medical Officer, American
Cancer Society, Inc............................................ 93
Prepared statement........................................... 95
Answers to submitted questions............................... 118

Submitted Material

Six letters of support for the SOFTWARE Act, submitted by Mr.
Butterfield.................................................... 108
Letter of July 16, 2013, from the Advanced Medical Technology
Association to the subcommittee, submitted by Mrs. Blackburn... 114

EXAMINING FEDERAL REGULATION OF MOBILE MEDICAL APPS AND OTHER HEALTH
SOFTWARE

----------

TUESDAY, NOVEMBER 19, 2013

House of Representatives,
Subcommittee on Health,
Committee on Energy and Commerce,
Washington, DC.
The subcommittee met, pursuant to call, at 10:01 p.m., in
room 2322, Rayburn House Office Building, Hon. Joseph R. Pitts
(chairman of the subcommittee) presiding.
Present: Representatives Pitts, Burgess, Blackburn,
Gingrey, Lance, Guthrie, Griffith, Bilirakis, Ellmers, Pallone,
Capps, Matheson, Green, Butterfield, Barrow, Christensen,
Castor, Sarbanes, and Waxman (ex officio).
Staff Present: Clay Alspach, Counsel, Health; Sydne
Harwick, Legislative Clerk; Robert Horne, Professional Staff
Member, Health; Carly McWilliams, Professional Staff Member,
Health; Andrew Powaleny, Deputy Press Secretary; Chris Sarley,
Policy Coordinator, Environment and Economy; Heidi Stirrup,
Health Policy Coordinator; John Stone, Counsel, Oversight; Ziky
Abablya, Minority Staff Assistant; Eric Flamm, Minority FDA
Detailee; Elizabeth Letter, Minority Assistant Press Secretary;
Karen Nelson, Minority Deputy Committee Staff Director For
Health; and Rachel Sher, Minority Senior Counsel.

OPENING STATEMENT OF HON. JOSEPH R. PITTS, A REPRESENTATIVE IN
CONGRESS FROM THE COMMONWEALTH OF PENNSYLVANIA

Mr. Pitts. The subcommittee will come to order. The chair
will recognize himself for an opening statement. In the last
few years, health information technologies including mobile
medical apps, or applications, electronic health records,
personal health records, computerized health care provider
order entry systems, and clinical decisions support have
transformed the provision of health care in this country.
In September of this year, the FDA put forward a proposal
in the form of final guidance indicating that software was a
medical device for the purposes of regulation, except that
software is not a medical device. To regulate it as such, the
FDA has said it will use discretion to decide which software to
regulate. Except that no matter what Dr. Shuren may tell this
committee here today, there is no guarantee that its successor
won't go back on this guidance tomorrow.
While guidance is a valuable tool for the FDA, there is a
significant limitation, certainty. What stands today could
change tomorrow. Patients and industry have told us that the
FDA's involvement and guidance was a good thing. There was much
too much ambiguity around the issue and companies needed to
know what the FDA intended to do. In addition, many believe the
FDA acted to the best of its ability with the only tool
available to them: its medical device definition. But they also
are telling Congress that we need to give FDA new tools that
create regulatory certainty, not just today, but also tomorrow.
That certainty can start with properly defining what these
technologies are for the purposes of regulation.
Representative Blackburn and her colleagues on both sides
of the aisle have outlined an approach that would give the FDA
a new tool, a 21st century definition to regulate a 21st
century technology. The SOFTWARE Act is a starting place and an
opportunity to begin a dialogue with thought leaders like the
FDA. Representative Blackburn and five of her colleagues,
Democrats and Republicans, have put forward one way to
modernize the FDA so that it is ready to meet the challenge it
has so far recognized it needs to meet.
I commend her in her thoughtful approach to this issue, and
for her leadership. Dr. Shuren, I stand ready to pledge this
committee's support to help you modernize the agency in a way
that makes sense for patients, for industry, and for the
agency. And I hope you take this offer seriously, and will
agree to work with us toward a goal we all share.
And to all of the witnesses on both panels here today, I
thank you for your testimony. And I yield the balance of my
time to the gentleman from Illinois, Mr. Shimkus.
[The prepared statement of Mr. Pitts follows:]

Prepared statement of Hon. Joseph R. Pitts

The Subcommittee will come to order.
The Chair will recognize himself for an opening statement.
In the last few years, health information technologies,
including mobile medical applications (apps), electronic health
records, personal health records, computerized health care
provider order entry systems, and clinical decision support,
have transformed the provision of health care in this country.
In September of this year, the Food and Drug Administration
(FDA) put forward a proposal, in the form of final guidance,
indicating that software was a medical device for the purposes
of regulation.
Except that software is not a medical device.
To regulate it as such, the FDA has said it will use
discretion to decide which software to regulate. Except that no
matter what Dr. Shuren tells this committee here today, there
is no guarantee that his successor won't go back on this
guidance tomorrow.
While guidance is a valuable tool for the FDA, there is a
significant limitation: certainty. What stands today, could
change tomorrow.
Patients and industry have told us that the FDA's
involvement and guidance was a good thing--there was too much
ambiguity around the issue and companies needed to know what
the FDA intended to do. In addition, many believe the FDA acted
to the best of its ability with the only tool available to
them--its medical device definition.
But they also are telling Congress that we need to give FDA
new tools that create regulatory certainty not just today but
also tomorrow. That certainty can start with properly defining
what these technologies are for the purposes of regulation.
Rep. Blackburn and her colleagues on both sides of the
aisle have outlined an approach that would give the FDA a new
tool--a 21st century definition--to regulate a 21st century
technology.
The SOFTWARE Act is a starting place and an opportunity to
begin a dialogue with thought leaders like the FDA. Rep.
Blackburn and five of her colleagues--Democrats and
Republicans--have put forward one way to modernize the FDA so
that it is ready to meet the challenge it has so far recognized
it needs to meet. I commend her for her thoughtful approach to
this issue and for her leadership.
Dr. Shuren, I stand ready to pledge this Committee's
support to help you modernize the agency in a way that makes
sense for patients, for industry, and for the Agency. I hope
you take this offer seriously, and will agree to work with us
toward a goal we all share.
To all of the witnesses here today, thank you for your
testimony and for being here today.
Thank you, and I yield the remainder of my time to Rep. --
--------------------------------.

Mr. Shimkus. Thank you, Mr. Chairman. I applaud the calling
of this hearing and I, too, want to mention Congressman
Blackburn and her bill. I am not a sponsor yet but we are
looking at it seriously. It is bipartisan, and the issues we
need to--we need a new tool to help us continue to modernize.
Software is not a medical device, and what you call something
matters, especially as we have our tech companies trying to go
through a process. So I wanted to use this time to thank my
colleague for her work. I look forward to you coming back, Dr.
Shuren, and discussing how we can maybe give you some help and
some tools so that we can label devices, devices, and label
software, software. With that, Mr. Chairman, I thank you. I
yield back.
Mr. Pitts. The chair thanks the gentleman. I now recognize
the ranking member of the subcommittee, Mr. Pallone, for 5-
minute opening statement.

OPENING STATEMENT OF HON. FRANK PALLONE, JR., A REPRESENTATIVE
IN CONGRESS FROM THE STATE OF NEW JERSEY

Mr. Pallone. Thank you, Mr. Chairman. The possibilities for
mobile health technologies are promising and exciting and there
are so many functions that mobile health applications can be
designed for, from diet logs and medication reminders, to
medical textbooks reference tools to ECG monitors, and they
play an increasingly important role in getting health
information into the hands of consumers and helping patients
take control of their health. They may also help doctors
improve and facilitate patient care by, for example, providing
instant mobile access to standards of care, or helping to
streamline their business processes.
I think it is fair to say that we all want to encourage
continued innovation, but it is also important that we shepherd
these emerging technologies and make sure that they are safe
and effective for patients. As with traditional medical
devices, some mobile apps that operate in the health sphere
could pose a risk to patient safety if they don't work as they
are supposed to, and we want to make sure consumers can have
confidence in the products they use. When we last had a hearing
6 months ago on health information technologies, we heard from
stakeholders a desire for clarity on FDA's regulatory approach
to mobile health applications and support for risk-based
strategy that protects patients, ensures product quality, and
at the same time, fosters innovation. The FDA has since
finalized its guidance and laid out examples of the types of
mobile applications, what it calls mobile medical applications
that the agency will apply its regulatory authority to.
To me, and from what I have heard from industry, FDA's
guidance is very measured and risk-based. We had heard concerns
before the final guidance was out that FDA was going to
regulate smartphones and tablets as medical devices and stifle
innovations through regulation. In fact, as we see now, FDA's
guidance clearly states that it would not regulate the sale or
general use of smartphones or tablets and will not consider the
manufactures of these products to be medical device
manufacturers. Rather, the agency directs its oversight to
those apps that are medical devices, as defined in existing
statutes, and that could pose a risk to patient safety.
For certain mobile apps such as those that purport to
diagnose cancer or that recommend a dosage plan for radiation
therapy, there should be a role for FDA to play to ensure they
are safe and effective. And these are the kinds of apps FDA has
said it will direct its oversight to. I appreciate that we have
the opportunity today to discuss the SOFTWARE Act, a bill
introduced by my colleagues on our committee, Ms. Blackburn,
Mr. Green, Ms. DeGette, Mr. Butterfield, and Mr. Gingrey.
However, I have several concerns about this bill starting with
the timing. FDA's guidance was released barely 2 months ago,
and we have not had the opportunity to see how it works in
practice, or to hear from industry whether it poses any
barriers to innovation.
In addition, a small but important provision was passed as
part of the user fee law last summer which required FDA, along
with other Federal agencies, to recommend an appropriate
regulatory framework that ensures patient safety, but also
promotes innovation. These recommendations are not due until
January of 2014. And I think it would be prudent for this
committee to analyze and examine that report before moving any
legislation.
And that leads to my second concern, which is whether
legislation is even necessary and whether it is the right
approach to take. As we all know, the legislative process is
slow, and in an environment where technologies are changing so
rapidly, I question whether it makes sense to enshrine in
statute something that may not work for an ever-evolving
industry. Regarding the content of the bill itself, I also have
concerns about what it seeks to achieve, whether it meets those
goals as written, and what the consequences down the road would
be if we were to permanently carve out certain types of mobile
health apps from FDA's oversight.
So in closing, I look forward to learning more today about
FDA's regulatory approach to mobile health apps and the
potential impact of the SOFTWARE Act. And again, thank you, and
of course, I thank Dr. Shuren for being here.
Mr. Green, I will yield the remainder of the time to my
colleague from Texas.
Mr. Green. Thank you, Ranking Member Pallone, for yielding
time and I appreciate the majority holding the hearing on the
SOFTWARE Act which I cosponsored. I understand that there are
concerns, but this proposal is a work in progress. It is
important that we take time to get this right. A few weeks ago
the FDA issued guidance on mobile medical apps and other
software and I commend them for their thoughtfulness and
leadership. Medical software and other health-related software
is a quickly growing sector with unbelievable potential. The
FDA has done all it can through enforcement discretion to
implement commonsense steps to foster innovation and protect
patient safety. Enforcement discretion is not the right tool,
but it is all they have. It is Congress' obligation to give the
FDA the tools necessary to properly protect patient safety, and
also to encourage innovation and create regulatory certainty.
That is why the SOFTWARE Act is important, and it is a work in
progress.
And I guess this is the first time the Senate passed our
compounding bill, and we learned with our effort on compounding
that the FDA didn't have the authority or didn't think they had
the authority, so we needed to deal with that. And I would hope
we could get in front of the curve on software instead of
behind the curve like we were on compounding. And I yield back
my time.
Mr. Pitts. The chair thanks the gentleman. I now recognize
the gentlelady from Tennessee, Ms. Blackburn 5 minutes for an
opening statement.

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

Mrs. Blackburn. Thank you, Mr. Chairman. I think it goes
without saying that I am very pleased that we are holding the
hearing today. Tennessee is home to hundreds of health IT
innovators and they are grateful that we are turning our
attention to this issue. They feel like it is needed and so,
Dr. Shuren, I thank you for being with us. To the other
witnesses that we have today, we welcome you. We look forward
to hearing from you, and I do want to thank my colleagues here
on the committee, Dr. Gingrey, Mr. Green, Mr. Butterfield, of
course, Ms. DeGette, who have worked on the legislation. We
appreciate the efforts that they have put into this.
The health informatics industry is innovating at a pace
that I think is startling to everyone who is watching. I am
constantly amazed as I visit with these innovators and hear of
their plans, and look at their research, and view the platforms
that they are working with. Every day the use of technology
becomes more engrained in how health care is delivered in the
U.S. As such, Congress has a very important role to play to
ensure that our agencies tasked with ensuring the safety and
efficacy of these technologies has the proper tools necessary
to do the job to understand their mission, and not to overstep.
Unfortunately, the FDA is stuck trying to use a 1970s
definition of a medical device to regulate mobile medical apps
and other health care-related software. We can all agree that
there is certainly a role for the FDA to play as we go about
determining the regulatory playing field for this growing
sector and trying to funnel these products into existing
outdated definitions is just not going to make any sense and it
will not work.
The SOFTWARE Act would give the agency a needed tool for
emerging technologies where necessary, while allowing moderate
to low risk technology developers the certainty necessary to
proceed with development, knowing full well what the regulatory
playing field is going to be.
It would provide certainty for our innovators who are
constantly working to deliver health care in a more efficient
manner. With their decisions and the September 2013 mobile apps
guidance to use, enforcement discretion to regulate only a
subset of mobile medical apps, the FDA took an important step
to acknowledge where their focus should be. Congress has the
opportunity to go a bit further and codify this intent to
ensure that our innovators have the clarity and certainty they
need to continue to invest in this area, and develop tools that
will help make us healthier.
At this time, I yield the balance of my time to Dr.
Burgess, vice chair of the subcommittee.
Mr. Burgess. I thank the vice chair for yielding, and Dr.
Shuren thank you for being here. It is always good to see you
in our subcommittee. Don't make yourself so scarce now that you
know where we are.
I do want to emphasize the point that providing that
certainty for software developers, providing clarity for
industry is one of the things that we seek to accomplish today.
We want predictability for our providers. There are areas of,
emerging area of clinical decision support has the ability to
transform practice of medicine in the realm of continuing
medical education, always a challenge for clinicians to meet
the requirements that are imposed, generally at a State level,
but now you also have the new Sunshine Laws that perhaps may
make it harder to keep up with these programs that otherwise we
would have the ability to support our doctors.
The issue is that the lack of careful regulation could end
many of these programs before they even begin, and it is a
bright future ahead of us, and we want to be certain we do
everything to provide that predictability and clarity for our
providers and for industry alike. And I yield back the balance
of my time.
Mr. Pitts. The chair thanks the gentleman. And now
recognize the ranking member of the full committee, Mr. Waxman,
for 5 minutes for an opening statement.

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

Mr. Waxman. Thank you very much, Mr. Chairman. Mobile
medical applications hold incredible promise for patients and
health care provider, potentially reducing cost, improving
health care delivery, and saving lives. We should all want to
see this exciting innovation continue. At the same time, we
must be cognizant of the need to protect patient safety, so
just as we do when it comes to all types of medical devices, we
logically look to the FDA to oversee the safety of these
cutting-edge technologies. FDA has been regulating software
under its medical device regulatory scheme for decades. At the
end of September FDA issued final guidance regarding mobile
medical applications, and I think it struck the right balance.
It ensures that patients are not placed in harm's way by these
medical apps, and they do not apply undue regulatory restraints
in the way of innovation.
As the FDA says in its guidance something like a dietary
tracking app which reminds you of a medical appointment, or
some dietary information, help you follow a diet. That kind of
app purports to--that kind of app is certainly one that we
don't want FDA to regulate. But an app that tells you whether
you have cancer or not, well, that deserves a lot of scrutiny.
Because let me give you an example. A group of
dermatologists recently published a study of four apps that
claim to be able to diagnose melanomas. That is a very serious
skin cancer. The dermatologists found that three of the four
apps incorrectly classified 30 percent or more of melanomas as
benign when they were actually malignant. Well, that is a kind
of device where you want FDA to take a look at. We don't want
you to just say you don't have to be involved, FDA, we are
going to let people get access to it. We can't tell the
American people buyer beware when potentially life and death
care decisions are at stake.
FDA's final guidance should put to rest any concerns that
this agency is interested in a regulatory overreach now or in
the future. FDA, very reasonably and clearly, sets forth the
types of mobile medical applications that the agency intends to
oversee, as well as those it does not. For instance, FDA's
guidance says that it intends to look at only those apps that
could impact patients' safety. At the same time, the guidance
specifically states that the agency does not intend to regulate
distributors of mobile medical apps like iTunes store or the
makers of smartphones or tablets like Apple.
Today we have before us a bill. It is called the SOFTWARE
Act and it attempts to codify, put in law some of what FDA has
set forth in this guidance. And I appreciate the offer of the
sponsors of this bill to work on that legislation, and talk
more about it. But I am skeptical of the need for legislation
in this area at this point in time for a number of reasons.
First of all, FDA's guidance was just issued at the end of
September. We barely had an opportunity to see how it is
working out, whether there are instances of burdensome
requirements stifling innovation in this area. It is not
appropriate to legislate based on unfounded fears of what might
happen in the future.
Second, by almost all of the accounts I have heard, the
guidance has been favorably received by most of the industry.
It is written in a clear and concise manner, including a litany
of specific examples that provide the regulatory certainty so
many in the industry were seeking.
And third, as I mentioned, FDA's guidance strikes the right
balance between protecting patient safety on the one hand, and
promoting innovation on the other. As I think we will hear
today, the current draft of the SOFTWARE Act does not strike
that balance. This bill upsets that balance. I think there are
several examples of mobile medical apps that I think we all
would agree should not be permanently removed from FDA's
oversight, but that is exactly what the current draft does.
I am not suggesting this was the intent of the sponsors,
but it does illustrate a major concern I have whether the blunt
instrument of legislation is the appropriate tool for
regulation of mobile medical apps given the rapidly changing
nature of technology in this area. As we all know, once the law
is in place, it is very difficult to change it, and it is
exceedingly difficult to craft the perfect legislative language
that would preserve FDA's ability to oversee appropriate
subsets of these changing technologies now and in the years in
the future. Thank you, Mr. Chairman.
Mr. Pitts. The chair thanks the gentleman. That concludes
the opening statements of the members. We have two panels
today. On our first panel we have Dr. Jeffrey Shuren, director
of the Center for Devices and Radiological Health at the U.S.
Food and Drug Administration. Thank you for coming today, Dr.
Shuren. Your written testimony will be entered into the record.
You will have 5 minutes to summarize your testimony. And at
this time, you are recognized for 5 minutes.

STATEMENT OF JEFFREY E. SHUREN, M.D., J.D., DIRECTOR, CENTER
FOR DEVICES AND RADIOLOGICAL HEALTH, UNITED STATES FOOD AND
DRUG ADMINISTRATION

Dr. Shuren. Thank you, Mr. Chairman, and members of the
subcommittee for the opportunity to testify today. The use of
mobile apps is revolutionizing health care delivery and has the
potential for transforming health care by allowing doctors to
diagnose patients outside of traditional health care settings,
and help consumers manage their own health and wellness. We are
excited about these technologies, and have been taking steps to
facilitate their development and safe use. Developers of mobile
apps have been asking for guidance about which mobile apps are
subject to FDA oversight and not. Such clarity is critical for
tracking investment in accelerating innovation.
Recently we provided that clarity by issuing final
guidance. The gist of that guidance is the following: Although
many mobile apps pertain to health, of which many may be
medical devices we are only overseeing a very small subset of
those mobile apps that are medical devices. We have called that
subset mobile medical apps. We believe this pragmatic,
narrowly-tailored approach will promote innovation while
protecting patient safety by focusing on those mobile apps that
pose greater risks to patients. Our regulation of software as a
medical device, and a mobile app is software, is based on risk
and function, their intended use. A foundational principle is
that we treat devices that perform the same function for a
patient the same regardless of the platform on which it is
used.
For example, an electrocardiography device, an ECG machine
that measures heart rhythms to help doctors diagnose patients,
is still an ECG machine regardless of whether it is the size of
a bread box or the size of a smartphone. The risk it poses to
patients and the importance of assuring for practitioners and
patients that it is safe and effective is essentially the same.
That is what our guidance does. It makes clear that if a mobile
app is a medical device, specifically, it transforms a mobile
platform into a medical device, like an ECG machine, and we
have cleared apps for that, or it is an accessory to a medical
device, such as an app that acts as a remote control for a CAT
scanner and is the kind of function we already regulate so we
have approved it, cleared it, or classified such a device, we
would continue to regulate that kind of technology if it is on
a mobile platform rather than on a non-mobile platform. A
mobile medical app is simply a mobile app that is a medical
device and a kind of device we have approved cleared or
classified.
Again, it is not about the platform. It is about the
function. An ECG is an ECG. And regulating mobile apps is
nothing new for us. In the past 15 years, we have cleared over
75 mobile apps, roughly 20 in the past year. For all other
types of mobile apps that meet the regulatory definition of
medical device, we will exercise a policy known as enforcement
discretion. This means we do not intend to enforce requirements
under the law. In addition, we will exercise enforcement
discretion for some functions we have been actively regulating;
for example, medication reminders, and drug-drug interactions.
Taken together, we have focused our priorities and taken a
big deregulatory action, the biggest we have taken in over a
decade. We received about 130 comments in a draft guidance,
which were generally supportive of the approach we propose, but
wanted even more clarity; therefore, the final guidance keeps
the same core policy, but provides clearer explanations and
more examples. Also, we clarify that at the request of some of
our stakeholders, this guidance does not apply to what has been
called clinical decision support software; software to aid a
practitioner or patient in making a decision.
Instead, we have been asked to and will address clinical
decision support software as part of the ongoing effort we have
with the Office of the National Coordinator of Health
Information Technology, and the FCC, to post a proposed
strategy and recommendations on a risk-based regulatory
framework pertaining to health IT as required by FDASIA. As
part of this effort, we established a multi-stakeholder working
group to provide us some recommendations on what to consider
when proposing a framework. The working group gave their final
recommendations in September. They recommended the FDA explain
which forms of clinical decision support software it regulates.
They also highlighted the importance of treating function the
same across platforms, what we are doing, and recommended that
we expedite our guidance on mobile medical apps because of its
critical importance in providing clarity.
We will provide ongoing clarity to mobile app providers
through a new Web site to which we will continually pose new
examples of apps that we are not actively regulating. App
developers who have questions can contact us through several
means, including a new email address. Queries will be handled
by a special team under the guidance of CDRH senior managers.
Smart regulation by FDA can help promote innovation in mobile
apps, and protect patient safety.
Mr. Chairman, I thank the subcommittee for its efforts. I
am pleased to answer any questions you may have.
[The prepared statement of Dr. Shuren follows:]

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Mr. Pitts. The chair thanks the gentleman, and we will now
begin questioning. I will recognize myself 5 minutes for that
purpose.
Dr. Shuren, the FDASIA working group produced a report on
the issue of regulation of mobile medical apps and other
software. Included in the FDASIA report are problems associated
with the challenges faced by FDA related to wellness and
disease, accessory issues, post-market requirements for
networks, enforcement, interoperability of medical devices,
regulatory jurisdiction on converged medical devices, and
resource constraints among other issues. Is that correct?
Dr. Shuren. Yes, they did make recommendations pertaining
to all of those.
Mr. Pitts. And isn't it true that the FDASIA working group
stated there are issues in each area that I just mentioned that
are ``broken at the written law level.''
Dr. Shuren. They did say that. In reality, from our
perspective many of the things we need to do are about
providing clarity in those areas, which is something we intend
to do.
Mr. Pitts. Now, Dr. Shuren, as the opening statements here
today suggest, and in light of reports like the FDASIA working
group report, there is a strong role for Congress to modernize
the FDA to regulate software and other forms of health
information technology because the written law is antiquated
and did not take into account such technologies when it was
written 30 years ago. Understanding this, did your office reach
out to my office or other offices of members on the health
subcommittee with an offer to work together on this issue
before you released the proposed or final guidance?
Dr. Shuren. Not to my understanding, but we have certainly
gotten lots of input from the stakeholder committee. It is
something we have been working on for roughly 2 years.
Mr. Pitts. Can you tell me why your office did not reach
out to offer collaboration on this issue when you knew the
important role Congress needs to play in this space?
Dr. Shuren. I think in this space we were trying to provide
clarity regarding our current authorities, which is what we
did. I will tell you that if we certainly felt that at the time
there was a need for legislation, we would absolutely have
reached out to you, and you have had hearings on this matter
before, and we have stated the same previously. But we
certainly welcome opportunities to work with you, and I will
say it is Congress' prerogative to pass legislation. That is
certainly your choice to make. We would hope, though, that we
have an opportunity to engage and certainly point out
implications of any legislative path that may be under
consideration.
Mr. Pitts. Now, Dr. Shuren, you have publicly intimated in
the past that the FDA could regulate electronic health records
as medical devices. Can the FDA regulate electronic health
records as medical devices?
Dr. Shuren. Arguably, yes, but we have stated on the record
and we have put into formal policy that that is not what we are
doing. And that is now official policy of the agency.
Mr. Pitts. Now, in her testimony on behalf of the FDA to
this committee on March 21st, 2013. Christy Foreman said that
the FDA could change its mind tomorrow and regulate items and
products not described in its final guidance, products like
electronic health records, or clinical decision support
programs.
Dr. Shuren, do you agree with Christy Foreman that the FDA
could change its mind and regulate beyond the FDA guidance it
published in September 2013?
Dr. Shuren. So I don't know what Christy actually said, but
we have now put in place a final policy. I can't change that
overnight. There are statutory requirements that we have to
comply with to change any such policy which requires extensive
public input on proposal, and there is congressional oversight.
Changing policies like that, if there is disagreement within
the community, is exceptionally difficult to do.
The value, though, of such policies and guidance, and I
will tell you that we have had extensive conversations during
FDASIA about the invaluable nature of guidances to provide both
predictability, and flexibility, both are critical to industry,
particularly an industry like health care IT that is rapidly
innovating. So our guidance, we spent 2 years with extensive
input with a public meeting, a proposal, public comment, then
final guidance, and that is about 40 pages long with extensive
explanations and examples, and answering questions. And it
gives us the ability that if the health care IT community--and
it gives them the flexibility that if they, over time, as their
technologies evolve, they feel, you know what FDA, we want you
to make certain changes, we have the ability to do that. The
challenge with statute, and it is your call whether or not to
do that, is to take what is a 40-page document, and hone it
down into a few sentences of statute, is not only very
challenging, it becomes difficult to make changes to because
statute is so much inflexible compared to----
Mr. Pitts. My time is expired. I just want to clarify your
answer. Can FDA change it, a guidance at any time--its guidance
at any time?
Dr. Shuren. Not overnight. Not overnight. We have to go
through a long process.
Mr. Pitts. All right, the chair recognizes the ranking
member, Mr. Pallone, 5 minutes for questions.
Mr. Pallone. I wanted to thank Dr. Shuren for being here
again. As you know, Representative Blackburn has introduced a
bill, H.R. 3303, that would create an entirely new regulatory
framework for medical software. It creates three new
categories, medical software, clinical software, and health
software. The effect of the bill is to remove entirely from
FDA's jurisdiction clinical and health software, and if I read
the bill correctly, FDA could still regulate so-called medical
software, but the bill says the medical software would no
longer be considered a medical device even though FDA could
continue to use all of its device authorities to regulate it.
Now, supporters of this bill assert that it is essentially
an effort to codify FDA's mobile medical apps guidance. So I
wanted to ask you briefly, is that what this bill does and do
the two cover the same policies? Quickly, though, because I've
got a lot of questions for you.
Dr. Shuren. No, this doesn't codify our policy. It takes
out from our authority the ability to assure the safety and
effectiveness of devices that we currently regulate, including
some high-risk devices.
Mr. Pallone. All right. Now focusing on the medical
software, it appears this category is intended to describe
software that is marketed directly to consumers and would make
clinical recommendations that could result in the consumer
taking some health action in response to that recommendation,
but without actually seeing a doctor. And that certainly is a
type of software I would want FDA to look at too, but I am
concerned about the way it is drafted and what the actual
effect would be. So the question is, are there examples of
software FDA currently regulates, or would be interested in
overseeing, that would be excluded by this definition?
Dr. Shuren. Yes. And our read of it, this is not just
limited to software for consumers. So our read is we would no
longer be able to assure safety and effectiveness of blood
glucose meters, which measures sugar in the blood and is used
by diabetic patients and doctors to determine if they need
insulin and how much insulin. We have cleared an app for it. We
wouldn't be able to assure the safety and effectiveness of
software that is used to analyze the Pap smear slides, and
highlight the fields that the health care provider should look
at to then screen for cervical cancer. And if we can't assure
it is accurate, then those providers may be missing cervical
cancer.
Mr. Pallone. All right, let me move on. I am also concerned
about what the impact would be of giving this broad set of
software a new definition and excluding it from the device
definition. Is there any question, is there any precedent for
that kind of legislation, and what would the effect of saying
something is not a device but authorizing FDA to use all of its
device regulatory authorities?
Dr. Shuren. I am not aware, and I have asked my agency. We
are not aware of any similar case. And it is very confusing to
us what this actually accomplishes.
Mr. Pallone. Yes, I would agree with that. Lastly, I am not
going to have enough time to explore the other two categories
in the bill with you, but hopefully somebody else will. But let
me ask you a more general question. The reason we are even
talking about legislation today on the heels of the release of
FDA's guidance is that some are apparently concerned that the
guidance leaves too much room for chance and it is
unpredictable. But in the face of what I know is a rapidly
changing marketplace, I am concerned about using legislation as
a tool here at all.
So do you think it is appropriate to be looking at
legislation at this point, and can you say anything to
alleviate fears that FDA is going to stray far from this final
guidance in the future and begin regulating every mobile app on
the market? I think that is the concern.
Dr. Shuren. Right. Like I said for legislation, it is your
prerogative. We want to make sure you understand from our
perspective the implications, at least for the bill as
currently drafted. We think at the present time, it may be
premature for legislation. If we are going to talk about things
that suddenly are not regulated and go into a new framework,
what is that framework? What is being put in place? And once
you draw lines, and it is chiseled in stone, we are sort of
locked in for a long period of time. Are those the lines then
on which you develop a framework around? Now, we are not saying
there isn't going to be a need for legislation at some point.
There may well be. But we think at the present time, this is
just simply premature.
Mr. Pallone. What about my last thing, Dr. Shuren, the fear
that FDA is going to stray from its final guidance and regulate
every mobile app?
Dr. Shuren. Yes. No, we are not going to do that. There are
a lot of hoops and hurdles for us if we ever go there, and
quite frankly, let me put a sensitive topic on the table,
laboratory developed tests, I think people know we have been
trying to change an enforcement policy. While I have been at
the agency we have been trying to change that policy for 15
years.
Mr. Pallone. All right. I don't know if you answered my
last question, but I guess that is the best I am going to get,
right?
Dr. Shuren. The answer is no, we are not going to be going
after a whole bunch of other mobile apps.
Mr. Pallone. All right, thank you Mr. Chairman.
Mr. Pitts. The chair thanks the gentleman and now
recognizes the gentlelady from Tennessee, Ms. Blackburn, 5
minutes for questions.
Mrs. Blackburn. Thank you, Dr. Shuren, and we do appreciate
that you are here, and look forward to working with you as we
continue to go through this process. Let me stay with the
framework, and of course, FDASIA requires your working group
deliver a framework, regulatory framework, what it would look
like, the various agencies, where the responsibility would lie,
and when do you expect that we are going to be able to see
that?
Dr. Shuren. So I am expecting that it won't be our call to
make because it will go through administration review. I think
it is more reasonable to expect that more in the February time
frame. But again, I am not the one to make that decision.
Mrs. Blackburn. Do you think we are safe saying first
quarter next year?
Dr. Shuren. Yes, I think that is realistic.
Mrs. Blackburn. OK, that is great. And then do you know
what the report is expected to say about strengths and
weaknesses of the FDA regulating in this space?
Dr. Shuren. Excuse me, the report----
Mrs. Blackburn. You are excused.
Dr. Shuren. Thank you. I had a teenage moment right there.
The report isn't done so it is hard to comment on what is in
there, but you can anticipate what we are focusing more on are
the things where FDA isn't dealing with technologies than what
is the framework that should be in place? And where are the
areas where there are additional clarity between what the
different agencies do? That is, and that should be in place.
And I will tell you, the report will give thinking. It will
give proposals. We will be seeking public comment on that
before proceeding to even do anything on the framework. So that
framework isn't going to say here is the proposed policy, give
us comment, and we move to final. It is a step before even
getting to trying to put formal proposals in place for a
framework. So there are lots of opportunity for input. In fact,
we believe it is essential that we are working closely and
collaboratively with the stakeholder community in trying to put
in place what best meets the needs of the entire stakeholder
community, the innovators, and patients, and practitioners.
Mrs. Blackburn. OK, do you think that your framework would
require the FDA to modify its approach if it identifies FDA's--
some regulatory weaknesses, we will say it like that, and then
would you expect those changes to be big or small?
Dr. Shuren. So right now there is nothing written in stone.
What we will do is we will put out ideas. We will get feedback
on that. Things may change based upon what we hear back from
stakeholders as we move forward. And there are particular areas
where there is still need for greater clarity that we are going
to take the time and attention to work with stakeholders on
what final policy should look like. We are not rushing to
judgment. We think we need to give it the time and we need to
give it the collaboration that is absolutely essential to try
to get it right. But also, to give flexibility to this
community, and allow the marketplace to evolve. What we worry
about is locking ourselves into such a great degree, we end up
stifling innovation because we really haven't thought through
what will happen in the future. We don't know what is going to
happen in the future. Do we have the flexibility to account for
it as times change, and as technology evolved?
Mrs. Blackburn. I think that one thing we can all agree on
is we do not want to stifle innovation, and I would appreciate
if we can say that is a shared goal, and something that we
would seek to do. For those of us that have rural areas that
are dependent many times upon expanding access to certain
health care concepts, this, the mobile medical apps plays a
tremendously important position in that delivery.
So I like hearing you say let's not stifle innovation. I
think that our community of innovators would appreciate hearing
that also. I do think it is important that you conduct impact
analysis, not only on the industry, but on patients, and as you
all have worked through this process, are you conducting that
type of impact analysis and looking at the expectation of what
that innovation can have on the industry and on individuals, on
patients?
Dr. Shuren. So we certainly take into account what the
impact when we are looking at regulating, or on the flip side I
would say not regulating, particular technologies. We do take
that into account. For the framework that everyone has been
talking about that we need a new framework for some of these
technologies, we are early on for kind of considering what does
that look like, and what the impact will be, which is why we
think it is so critical to have those collaborative efforts
with the stakeholders, to figure out what to do and understand
what the implications are.
Mrs. Blackburn. Thank you, I yield back.
Mr. Pitts. The chair thanks the gentlelady. I now recognize
the ranking member of the full committee, Mr. Waxman, 5 minutes
for questions.
Mr. Waxman. Thank you, Mr. Chairman, I want to follow up,
Dr. Shuren, with the questions that Mr. Pallone asked you about
the effect of the SOFTWARE Act, the proposed bill, that
proposed new law. I am still concerned about the notion that we
could successfully use legislation to effectively give FDA the
tools it needs to assure patient safety when they use these
apps. You know, this is a balance. We don't want to stifle
innovation but we don't want patient safety to be at risk. So
let me ask you about the two categories that are defined in
this bill. One says there is clinical software, and the other
part of the bill says there is health software. The bill would
completely remove FDA's jurisdiction to even look at both of
these newly defined types of software.
Now, clinical software is clinical decision support
software that captures, analyzes, changes, or presents patients
or population clinical data, but does not directly change the
structure or function of the body and is intended only for the
use by health care providers. Health software is software that
can also capture, analyze, change, or present patient or
population clinical data. It can support administrative or
operational aspects of health care, but is not used in the
direct delivery of patient care. So that is what defined in the
bill.
First, let me ask you an overarching question about both of
these categories before I get into the specifics about each. Do
you see any problems with your existing authority over the apps
that these provisions would cover, such that there could be an
advantage in putting them into a newly defined categories of
unregulated products for which some future regulation would be
contemplated?
Dr. Shuren. We think one of the challenges with suddenly
carving out areas, writing them down in statute for the moment,
is that in trying to figure out what a new framework looks
like, you are stuck with those definitions. You are stuck with
those categories, and you have to build a framework around
those, and it is unclear at this point if those lines are drawn
in the best possible way for the most appropriate regulatory
framework that facilitates innovation, while also protecting
patients.
Mr. Waxman. Well, they define these categories and say you
can't even look at them anymore. Let's look at this clinical
software category. As I read it, it would seem to cover a large
swath of software that the guidance that FDA issued
specifically says warrants FDA oversight. For example, it seems
to cover mobile apps that perform patient-specific analysis and
provide patient-specific diagnosis or treatment
recommendations.
I want to know if that is your interpretation. Are there
examples of software that the bill would explicitly exempt FDA
regulation, but that FDA believes raise patient safety issues
warranting oversight?
Dr. Shuren. Yes, it does. And some of those examples we
included in our guidance. So for example, computer-assisted
diagnostics, or computer-assisted detection devices analyze
radiological images for highlighting what may be cancer so they
can be used on mammograms to help a radiologist determine if
there is cancer or not. And if it is inaccurate, if don't make
sure it is safe and effective, radiologists may miss cancers or
they may send women for inappropriate biopsies.
Radiation therapy planning which takes patient information
and analyzes their imagining studies to come up with what dose
of radiation should be given for their cancer. Very complicated
analysis that usually took weeks, several experts, including a
physicist, now done by software, and then that is uploaded to a
machine that can deliver the radiation. If that is not safe and
effective, then cancer patients don't get the right radiation
to their cancer, or they get radiation to their healthy tissue.
Mr. Waxman. Let me ask you because I have a limited time.
There is a category called health software. This seems aimed at
excluding software such as electronic health records, which the
FDA guidance already describes is not warranting oversight.
Let's assume we all agree that FDA should not have authority
over electronic health records. But putting aside for a moment
whether you think that is a good or bad idea, could you
describe the factors one would have to take into account so as
not to inadvertently capture things that truly warrant FDA
oversight because of patient safety concerns?
Dr. Shuren. Well, certainly in any category, let's say we
do talk about electronic health records, I will put it on the
table. You have to be very clear about what are we talking
about? Are we talking about electronic version of medical
records, or are we talking about more, because software is
software. You can combine function in a variety of different
functions, so can you take what you could call an electronic
health record, but I just mentioned computer-assisted
diagnostics. That can actually be included. It is software,
with any other compilation of functions. So you can call up
radiological images and apply that analytical software to it.
So are we saying that computer-assisted diagnostics,
because if FDA were to assure it is safe and effective when it
sits as standalone program on a computer, if I combine it with
other functions suddenly, you don't assure it is safe and
effective.
That doesn't make sense. It is the same risk to patients.
Why would we do that? Why would we create arbitrary categories
like that? That would be a concern.
Mr. Waxman. There can be real complexities of what look
like simple definitions.
Dr. Shuren. Right.
Mr. Waxman. Thank you, Mr. Chairman.
Mr. Pitts. The chair thanks the gentleman. I now recognizes
the gentleman from Illinois, Mr. Shimkus, 5 minutes for
questions.
Mr. Shimkus. Thank you, Mr. Chairman, and I appreciate the
ranking member of the full committee and the subcommittee in
this line of questions. But I also was listening to the
chairman talk about a question about when was the first time
you provided some technical assistance on legislation--on this
piece of legislation, and my understanding was, following up
with staff, was late last night was the first time they had any
of these discussions. So I would ask my colleagues to hear,
Congresswoman Blackburn, are you willing to work with the FDA
to try to clean up some of this language that might be of
concern?
Mrs. Blackburn. Absolutely, and that is why we had
contacted them in July and continued to seek to work with them.
It is about making certain we do not stifle innovation
providing certainty and clarity.
Mr. Shimkus. And Dr. Shuren, would you then work with
Congresswoman Blackburn and the bipartisan group cosponsoring
this legislation, to see if they can reconcile some of these
language differences?
Dr. Shuren. We certainly would be more than happy to work
with you, and I will say in terms of request for feedback on
legislation, we did provide some feedback within the agency in
July. I don't know whatever came back to you all. And I was on
the first version of the bill. The new version of the bill. To
my understanding, we were first asked for any kind of feedback
late last week. And we did take a look at the bill, and we
spoke, I think, with one of your staffers.
Mr. Shimkus. Just reclaiming my time, I think the point
being made is, I think you have the author of the legislation,
and we have, I think, your commitment to work together because
there are issues raised by the ranking member, I think are
credible, but it is a good piece of bipartisan legislation that
they worked on. Mr. Waxman, would you like to comment?
Mr. Waxman. I thank you for yielding. I am always open to
discussing the matters, but it seems to me there is a threshold
question of whether we need legislation at all, and I am not
convinced of that. But I would certainly be happy to talk to--
--
Mr. Shimkus. Reclaiming my time, I am going to raise one of
those issues of why we might need legislation, and it goes back
to Mr. Pitts' other question, based upon this issue of Christy
Foreman's testimony, where she basically said that that
guidance could change.
Now, Mr. Pitts' question to you was, can that guidance
change at any time? And in good bureaucratic form, Dr. Shuren,
you said, well, not immediately. Well, that wasn't the question
of whether it could change immediately. The question was, could
that guidance change?
Dr. Shuren. Yes, it could change.
Mr. Shimkus. OK, that is the answer we are trying to get
out. But I do know that in her testimony, she said could change
its mind tomorrow, and I think that is probably where you
talked about no immediate response. But the point being that
guidance could change, and the importance of codifying is that
then the law would have to change, which brings us to the point
of why the legislation might be important, and because in the
tech industry, they need--just like any other business--they
need some certainty. And because of the two additional points
that I have would be with this, is what would you tell
companies who fear the FDA regulation with an imprecise tool
like an medical device regulatory tool who fear that regulatory
confusion and delay are sure to follow the September 2013 final
guidance. You are saying there is none. Is that correct?
Dr. Shuren. Well, I am just saying that we did provide a
lot of clarity in the guidance, and we have a mechanism to
continue to build on that. So companies who say you know what,
I am doing this specifically, I would like to get feedback from
the agency, we will look at and quite frankly, no, we shouldn't
be dealing with that. We will put that on the Web site so
everyone learns.
Mr. Shimkus. Let me reclaim my time. I have got a minute
left. There are really small companies, and this is how these
folks start as we all know, who are being--maybe the excitement
is being diminished based upon the FDA regulatory regime and so
larger companies, not that there is any here in this crowd,
might be trying to purchase smaller apps, or proposals, or
inventions because of the bureaucratic challenge of getting
through the FDA and this process. I only put that on the table
because we represent constituents, and this is what has been
raised to us.
So I put that just as one of the reasons why certainty
might be helpful, more certainty might be helpful than less.
And with that, Mr. Chairman, I yield back my time.
Mr. Pitts. The chair thanks the gentleman. I now recognize
the gentleman, Mr. Butterfield, 5 minutes for questions.
Mr. Butterfield. Thank you very much, Mr. Chairman, and I
won't take the full 5 minutes. I think my colleagues have
covered some of the territory that I intended to cover. But
thank you, Mr. Chairman, for holding this hearing. I am one of
the six individuals who have been referenced here as sponsors
for this bill. I think it is important. I have listened very
carefully to this conversation, and certainly, I understand the
concerns that Mr. Waxman and Mr. Pallone have raised, and I
think it is--they are legitimate concerns and I think we need
to work through this as we go forward.
But the reason I have signed on to this bill is just
because of the explosion of software in this space. These
applications have just exploded over the last 12 to 18 months,
and we have got to get some type of regulatory framework to
make sure that it does not have unintended consequences. I
don't want to discourage innovation. Innovation is the future.
And I want to keep us on the cutting edge, and we can do that.
And so I pledge to you, to all of you who are stakeholders in
this, that I will work with you to try to come up with a
framework that we can all agree on.
Speaking of stakeholders, I have in my possession, six
letters that I received. Mr. Chairman, I am going to ask
unanimous consent to submit these six letters of support for
the SOFTWARE Act that we have received from health care
industry.
Mr. Pitts. Without objection. So ordered.
[The information appears at the conclusion of the hearing.]
Mr. Butterfield. And if I may state for the record, these
letters are from Aetna Health, Healthcare Leadership Council,
Health IT Now Coalition, Verizon, and IBM, and Applications
Developers Alliance. Thank you, Mr. Chairman. I yield back.
Mr. Pitts. The chair thanks the gentleman. I now recognize
the gentleman from New Jersey, Mr. Lance, 5 minutes for
questions.
Mr. Lance. I thank you, Mr. Chairman, and I will not take
my full 5 minutes. It is always a pleasure to be with you,
Doctor. Do you know, does the FDA currently have reciprocity
agreements with the agencies with which it is working? I know
that the Congress has decided that there will be a regulatory
framework where no one agency would prevail in all matters. Do
you currently have reciprocity agreements?
Dr. Shuren. We do have MOUs in place.
Mr. Lance. MOUs, you will have to tell me what that is.
Dr. Shuren. Oh, I am sorry, Memorandums of Understanding.
Mr. Lance. Memorandums of Understanding.
Dr. Shuren. And Office of the National Coordinator is part
of Health and Human Services so that is actually part of, if
you will, one happy family.
Mr. Lance. One happy family. Rather like Congress, one
happy family. As an example, if an app developer finds a bug in
its software that causes a potential patient safety risk, as I
understand it, it will typically issue a patch as quickly as
possible to fix the functionality. Since the threshold for
submitting a change is whether the change could significantly
affect the safety or effectiveness of the device, wouldn't the
FDA require that it review the patch before the developer could
release it? And if that is correct, wouldn't that mean that a
change that actually improves the safety of the app might be
held back for months until approval is received?
Dr. Shuren. Yes, we actually don't generally ask to see
those security patches before they may--in fact, most of the
changes in software, we don't look at beforehand. But it is a
great point about what you do with software, and you should
know that there is currently an international effort underway
under the International Medical Device Regulators Forum that
you encourage us to be a part of under FDASIA, to develop an
international harmonized framework for software as a medical
device, because all of these other countries, they have been
regulating software medical devices for years. And now it is
about do we have a common appropriate framework in place? We
have been asked by industry to do that and we are actually
working with industry on that.
In fact, the U.S. is chairing that effort, and it deals
with what do you do when there are changes in software, and how
best to accommodate the business models of companies that make
software, but also assure proper patient safety, and that is
underway right now.
Mr. Lance. Thank you, Dr. Shuren, and Mr. Chairman. I yield
back the balance of my time.
Mr. Pitts. The chair thanks the gentleman and now
recognizes the gentleman from Texas, Mr. Green, 5 minutes for
questions.
Mr. Green. Thank you, Mr. Chairman. I am proud of the
efforts of the group of original co-sponsors of the SOFTWARE
Act, and this bill has been supported by the Healthcare
Leadership Council, the Bipartisan Policy Center, Information,
Technology and Innovation Foundation and several others. It is
an important first step toward Congress fulfilling our
obligation to provide the FDA the tools necessary to do our
jobs.
Dr. Shuren, thank you for being here today. And I am
pleased with the guidance issued by the FDA, and I appreciate
all your hard work and leadership. Under this guidance, are
most electronic records regulated?
Dr. Shuren. Under this guidance, we are not regulating
electronic health records.
Mr. Green. OK. Under this guidance, would mobile apps aimed
at diagnosing and prescribing medical care be regulated?
Dr. Shuren. Certain diagnostic apps, but the ones that are,
you know, just certain treatment recommendations, no, but
certain diagnostics ones, yes.
Mr. Green. Can you distinguish between those for those of
us who are not physicians?
Dr. Shuren. Yes. So what we have said is the kind of
functions we have been regulating all along, we have already
approved. We have approved devices for that or cleared. Just
because they moved to a mobile platform, we would treat them
the same. So I mentioned the ECG machine. We have a mobile app
for an ECG that doctors can use a smaller smartphone to use to
diagnosis patients in their office and help determine if
someone is having a heart attack. We want to make sure it is
safe and effective. Whether it is a box this big or it is a box
that big, it is still the same function.
Mr. Green. OK. The FDA is using enforcement discretion to
establish a risk-based framework for regulating these products.
Is that correct?
Dr. Shuren. We are using--we are actually just using
enforcement discretion to clarify the kinds of mobile apps that
we are not enforcing any requirements. That is it. It is not
creating any new framework at all.
Mr. Green. So future administrations could make different
decisions?
Dr. Shuren. So in order to do that, the good guidance
practice, the way it works is that there is a very extensive
public process to make any changes in it. It is not easily
done, it is not done overnight, but the value of it is that
things change over time. People sometimes come back and say you
know what, we tried this policy for a while, we need new
clarity, because things have changed. Guidance lets us do that.
When we have statute, we can't do that. We don't have that
flexibility. Guidance does.
And one of the things about changes here, what would
change? Well, we also said there are certain things we used to
regulate it, we are not regulating anymore. We anticipate over
time and more input from the community and more experience,
there will be more things we say we used to regulate, we don't
regulate. We can do that through guidance. That is what
enforcement discretion allows us to do. Statute provides
limitations.
Mr. Green. OK. It appears, though, that virtually all
software used in the health setting could be regulated under
some administrations and could not under others. I know that
discretion helps, but somewhere along the way there needs to be
certainty, regulatory certainty, but mostly important could
endanger the patient safety in the future.
Dr. Shuren, I commend you and your agency for recognizing
your need for clarity and certainty. If clarity and certainty
are the goals, why shouldn't we work on legislation?
Dr. Shuren. So as I said before, it is certainly your all
prerogative to do so. And if you all want to do that, we are
very happy to work with you. I just simply put out, put in
place what some of the challenges are with statute. There is a
desire for predictability and flexibility. Statute, it can give
you predictability, it doesn't give you that flexibility to be
able to adapt as technologies adapt, as the marketplace evolves
and, as stakeholders say, you know what? We need to see some
changes. We are able to better accommodate our stakeholders
through a guidance mechanism in many cases than we have with
statute. And I am not saying that legislation may not be
necessary in the future. All we are saying is it is premature
at this point, particularly in not even figuring out what does
a new framework look like?
And in that respect, maybe the line's drawn going different
places. Maybe at that point there is a need to put something in
legislation, or maybe we want something out there and get
experience with it first before we have decided whether or not
we got it right, because we got it wrong, it is much harder to
change statute than it is to change guidance if necessary, but
it is not easy to change guidance either.
Mr. Green. Believe me, we understand that, but the concern
I have is that we need to have both, we need to have some
flexibility with the FDA, but also certainty to industry and
everyone else that they know what the FDA's doing. And if FDA
should want certainty that comes from updated regular authority
through legislation, and if not the right time, how will we
know when the right time is to start? After a public health
crisis? And, again, our committee just dealt with compounding,
because--and the first hearing did not show very good on the
local pharmacy agency in Massachusetts or the FDA, and so we
have put together a bill that, again, nothing's perfect we do,
but that actually gave the FDA that authority, discretion, but
certainty in the authority of it.
Mr. Chairman, thank you. I know I am out of time.
Mr. Pitts. The chair thanks the gentleman and now
recognizes the gentleman from Florida, Mr. Bilirakis, 5 minutes
for questions.
Mr. Bilirakis. Thank you. Thank you, Mr. Chairman. I
appreciate it very much. Thanks for holding this hearing as
well. Thank you, Doctor, for your testimony.
The first question, Dr. Shuren, under the rules you issued,
FDA said it would have enforcement discretion on many commonly-
used applications, for example, apps that serve as video
conferencing portals specifically intended for medical use and
to enhance communications between patients and caregivers;
also, apps specifically intended for medical uses that utilize
a mobile device, built-in camera or a connected camera for
purposes of documenting or transmitting pictures to supplement
or augment what would otherwise be a verbal description.
This sounds like FDA reserves a right to regulate Skype,
Web cams, iPhones and tablet PC's. There are many off-the-shelf
software solutions that can be used or adopted into
telemedicine, as you know. How do you draw the delineation of a
program specifically intended for medical use?
Dr. Shuren. Yes. So actually the tablets, the tablets
themselves and the video cameras and all that, those aren't
even medical devices. I don't even view them as medical
devices. The issue has come up when someone develops software
and they use the smartphone, let's say, the person developing
the software that suddenly gives it a medical function. So I
mentioned the ECG. Another one is ultrasound. People use sound
waves to look at abnormalities in the body, so we have cleared
an app that is an ultrasound. It takes kind of a mobile
platform and it turns it into a medical device. The maker of
that platform is not a manufacturer of medical devices; no
responsibility on their part.
The software, though, is the issue. And the challenge there
is, and as this bill is currently drafted, the problem for us
is we wouldn't be able to assure that that software is safe and
effective. And it is used by, sorry Dr. Burgess isn't here, an
obstetrician to use on women who are pregnant to look for fetal
abnormalities. And in this case, we wouldn't be able to assure
that this is going to be accurate technology when a doctor uses
it to make sure the fetus is healthy or not healthy. Those are
the things that we are talking about, but a basic tablet by
itself is not even a medical device.
Mr. Bilirakis. Even if it is used for medical purposes?
Dr. Shuren. No. That itself isn't. The software maker,
then, is actually taking that tablet and as part of it is now
using it as a medical device. The software maker, then, whoever
is putting that together, they are the ones who have now put
out a medical device through their software. The person who
made the tablet, Apple, is not a device manufacturer, and that
is what we have said.
Mr. Bilirakis. OK. And in the mobile medical app guidance,
mobile platforms are defined to include smartphones, again,
tablet computers or other portable computers. Is a laptop
considered a portable computer?
Dr. Shuren. It is a portable computer. And we don't
regulate laptops.
Mr. Bilirakis. What about----
Dr. Shuren. And I have got to tell you, I don't want
someone regulating my iPad. I like my iPad.
Mr. Bilirakis. What about a desktop?
Dr. Shuren. A desktop is a computer, right.
Mr. Bilirakis. Not considered a portable computer?
Dr. Shuren. No.
Mr. Bilirakis. OK.
Dr. Shuren. And what you are highlighting is what has
changed over time is that you have a lot of the same functions,
but you didn't have the capability to make tiny computers. That
is the way the world changed. I had things years ago that are
on a desktop, and then the laptop came along, we had the PCs,
and now they can be on small smartphones. They are computers.
And the value is that they can play a variety of different
software. Manufacturers don't have to make the hardware
anymore, because they now have ubiquitous hardware that a
software maker can simply take advantage of.
That is the way the world has changed. And all we are
saying is the functions, when they stay the same, treat them
the same, because the impact and the risk to patients are the
same. Simply because it got smaller and I can pick it up and
walk out of the room with it doesn't change the risk for
patients. Why, for that reason alone, would we simply treat it
differently?
Mr. Bilirakis. OK. I have heard some, including staff at
the FDA, suggest that the FDA move to regulate mobile medical
apps, will give industry and patients more certainty. Can we
really say that enforcement discretion gives health IT
developers and investors any certainty or clarity if the FDA
can indicate that it may, that it may have the discretion to
change its policy? Is that the case? In other words, can we--
instead of--because the FDA has the discretion, how does that
give the industry or developers any certainty?
Dr. Shuren. Because there are safeguards in place to
actually change that discretion. As I mentioned, there are a
lot of statutory requirements for us to go through under good
guidance practices with putting out proposals, public comment,
and congressional oversight before we can make any kind of
changes. So it is not a simple thing for us to do, particularly
when there is disagreement on it, but a number of cases, we
have our constituents come and ask us to change guidance
because the times change and they want updates, and the
guidance lets us do that. That is the value of it. And we hear
time and time again from our industry how much they want
guidance, because it gives them both predictability and
flexibility. That is why we have been increasing our guidance
production, because we have been asked to do that by our
industry. They find it of tremendous value.
Mr. Bilirakis. OK. Thank you. I yield back the balance of
my time. Thank you, Mr. Chairman.
Mr. Pitts. The chair thanks the gentlemen and now
recognizes the gentlelady from Florida, Ms. Castor, 5 minutes
for questions.
Ms. Castor. Well, thank you, Mr. Chairman. And thank you,
Dr. Shuren, very much. I think this is a very exciting area,
all of the advances in health information technology. I have
seen it help boost small businesses back home and create
business opportunities across my community in the Tampa Bay
area. I think that the mobile apps hold great promise in
improving people's health, also empowering consumers and
individuals and providing more efficient tools for medical
professionals.
Now, the 2012 FDA Safety and Innovation Act, FDASIA,
directed FDA to work with the Office of the National
Coordinator of Health IT and the FCC to propose a strategy and
recommendations on an appropriate risk-based regulatory
framework pertaining to health information technology,
including mobile medical applications that promote innovation,
protects patient safety and avoids regulatory duplication.
FDASIA requires the working group of the three agencies to
report to Congress by January of 2014.
Dr. Shuren, can you tell us what steps the three agencies
have taken so far in developing that report and the extent to
which outside stakeholders have had an opportunity to provide
input into the development of that report?
Dr. Shuren. Well, certainly. We constituted a multi-
stakeholder working group, so representatives from all
different parts of the ecosystem under the Office of National
Coordinators Health IT Policy Committee, and they spent time
and they got a lot of public input along the way, they put out
draft recommendations, they got public input on that, and
provided it to us. We have gotten a lot of input from the
stakeholder community, both from that working group and from
other meetings and venues in which we have participated, and
that is helping to inform the report that we will make
available to Congress and we will make available to the public.
And as I had mentioned, we will get public comment on that
before even proceeding to put out proposals for anything that
would go into a regulatory framework. So trying to have a very
thoughtful process moving forward.
Ms. Castor. And are you satisfied that the participation
has been very diverse? Are small businesses adequately
represented, are academics represented, the larger
corporations? Has everyone had an opportunity? Is there enough
balance in what you have heard so far?
Dr. Shuren. We think there has been. I am sure you can
always hear from people who said, wow, I wish I am in the room
and I am part of a committee. Then you have a committee of
thousands. So it is always challenging, but in spite of that,
there are publicly available dockets where people provide
information, there are meetings where any member of the public
could come and to talk, and of course, people can always
request to talk to us directly. We talk to lots of people who
want to have those conversations, and we do so.
Ms. Castor. So are you still on track for January 2014?
Dr. Shuren. I am anticipating it is going to be a little
bit later, in all fairness. We have the recommendations from
the working group came in September, and we had the government
shutdown, so some people were not around working on things, it
adds a little bit more time, that is why I say more likely
February, certainly the first quarter, but the final decision
after it goes up to review will be made by others, but our goal
is to get it as close to that line as we can.
Ms. Castor. And do you think it is important for the
Congress to have the benefit of those recommendations before we
consider whether or not to legislate in this area?
Dr. Shuren. We do, because we have got a wealth of
information to provide back. And like I said, Congress can
decide at any moment if you all want to pass legislation, it is
your discretion to do so. We would like to make sure that any
decisions made are with full information, and then I think
there will be value coming from the report. In fact, may even
feel that at that point if additional comment, we think there
will be need for a lot more input from stakeholders before even
sort of figuring out exactly what a framework looks like and
what the pieces are, and even then, delving a little bit deeper
into the specific aspects of it, because this is complicated.
It was hard enough even drawing the lines that we did in
guidance that is 40 pages long that is just simply about things
that are in or out for FDA, nothing about stuff that is about
how you treat them, and we knew that was a 2-year process, but
how important stakeholders felt it was to have the opportunity
to provide input and really think it through.
And all we are asking is sometimes moving quickly to
judgment leads to unintended consequences that can be very hard
to undo once they are done, and that is all we are really
trying to put on the table. We share your desire to promote
innovation, and we share your desire to protect patients. We
want to see this field flourish. We are jazzed up about a lot
of the technology. We want it to happen. We want it to happen
right. And that is why we are moving about it in the way that
we are doing it and trying to do it in a very collaborative
fashion.
Ms. Castor. Good. I look forward to reading your report
early next year. Thank you.
Mr. Pitts. The chair thanks the gentlelady and now
recognizes the gentleman from Kentucky, Mr. Guthrie, 5 minutes
for questions.
Mr. Guthrie. Thank you. Hey, thank you for coming back
today. I appreciate you being here. As I have talked to
different people who provide apps, and I know you said we do
not intend to regulate iPads, it is the apps that go on the
iPads, and depends on what that app is that goes in the iPad.
And I am not an attorney, but I had one law school class and I
know the exams were always not black or white, it is always
somewhere in the middle, that is the questions they always
asked and where does the gray intersect each other. And so just
kind of--and they would give you scenarios. I was just looking
through a scenario that people have brought to my attention.
And I will be slow so you can follow, but it says, among the
mobile apps for the FDA intends to exercise enforcement
discretion are mobile apps that perform simple calculations
routinely used in clinical practice. It says, according to the
FDA, these apps are intended to provide a convenient way for
clinicians to perform various simple medical calculations
taught in medical schools or routinely used in clinical
practice.
And so the question is, while dosing calculators are not
listed among the examples, if a specialist routinely prescribes
a certain drug patients, would an app that calculates the
proper dose be considered not regulated, or would that app be
considered one that performs sophisticated analysis and
therefore is regulated?
Dr. Shuren. So we think a lot of those actually would not
be regulated. And this is why we ask and why we created this
mechanism for people who then have questions, say, well, here
is what we are looking to do. Is this the kind of thing that
you approve clearcut or something you are not exercising new
enforcement discretion to? Because in the past, we regulated
that as a medical device. We had a classification for it and
now we are saying we are no longer doing it. And those are the
cases where, particularly as we expand and enforce the
discretion, clarity around it, we want people to ask us and we
will put those examples on our Web site. But there are other
kinds of----
Mr. Guthrie. So they have pre-clearance if they are going--
because it makes a decision on your investment according to
where you think the time is going to take to be approved.
Dr. Shuren. Oh, yes. And we have actually provided that for
developers for years. They have always had the opportunity to
come and ask. Here we are trying to have a much more
streamlined mechanism to get feedback to developers very
quickly and let them know, and give them the kind of certainty
they look for. But when you draw a line, think about even
statute, in a few sentences, that is still very broad. The
question is, what does it mean? And then even with a bill, we
are going to have to move forward and interpret that and
provide clarity around that, and then there will be additional
questions about, well, what did that mean? And we will go
through the same kind of exercise. It will always be these
issues of, does this mean I am in or I am out, and we will
always be in a position of having to provide that kind of
clarity.
Mr. Guthrie. Because that would be very helpful that you
are going down that path. And actually I was going to kind of
continue that application, but I think that the answer will be
the same. You will have to get pre-clearance when you move
forward down that path, so----
Dr. Shuren. Yes. And you don't need pre-clearance, because
if you went out there on the market and we strongly said, yes,
you are the kind of stuff we are not touching, that is fine,
you don't have do come to us.
Mr. Guthrie. Right.
Dr. Shuren. We offer it as a service. If you want to and
ask us, we can do that. We provide even an email address to
send it in. And I will tell you, for these that are coming in,
where there is any kind of question about it, it actually--it
comes up to a group, I sit on that group. We are actually
meeting this week. And we have questions that come in, and we
are answering them.
Mr. Guthrie. Yes. I guess I--I understand on pre-clearance.
So I just have an app on my phone that calculates how far--if I
walk to the Washington Monument, it calculates my heart beat
and whatever, that type of thing, or if I have an app on my
phone that--I don't have diabetes, but if I have a diabetic
pump and it regulates that, that obviously clearly would have
to be regulated.
And I guess the question when people start getting, the
example, one I had is--I was going to go through, maybe I
should, like, look, you wouldn't regulate it if it was just
downloading the Physician's Desk Reference, and I just had that
on my phone instead of in a book, because you don't regulate
the book--but I will go through an example, I have about a
minute, then. I have an example of Coumadin, a blood thinner
that could cause major or fatal bleeding. The full prescribing
information in the Physician's Desk Reference gives the list of
patient-specific factors that impact the proper dosing of
Coumadin. And since this information is being used in the
mitigation, treatment or prescription by a facilitating
professional assessment of the specific patient, should it be
in a different category of apps? And MMA guidance is
inconsistent on how the FDA intends to oversee dosing
information. So that can kind of blur the lines----
Dr. Shuren. Yes. And what----
Mr. Guthrie [continuing]. In dosing calculators.
Dr. Shuren. We are moving toward a place where a lot of the
dosing information is taking a step back and letting a lot of
that happen. We are already doing that. I am anticipating we
wouldn't do more. But then we talked about dosing for radiation
and how complex a calculation that is, and that is one where it
is not so simple. Someone can't figure it out very--themselves
with paper and pencil, if you will, very quickly. That can take
weeks. You got a physicist, radiation oncologist. That is the
kind of dosing. So if you just blanket any kind of dosing, you
would sweep that in. Those are the kinds of challenges.
But I would say even with statute, you will always have the
issues on boundary lines and seeking for clarity, because I
will tell you, with the law we have today, on any of a variety
of different areas, we are always providing a different clarity
to people. It is just a question of do you draw a line that
locks you in and still have to provide the clarity, or do you
give flexibility to a community that itself is evolving, and we
don't know what the future will look like. Shall we tell
people, your future is locked in today or do we want to let the
community have the ability to let the marketplace evolve. And
we would like to see the marketplace evolve.
Mr. Guthrie. Thank you. I yield back.
Mr. Pitts. The chair thanks the gentleman. Now recognize
the gentlelady from the Virgin Islands, Dr. Christensen, for 5
minutes for questions.
Mrs. Christensen. Thank you. Thank you, Mr. Chairman.
Welcome, Dr. Shuren. So we have heard a lot so far about the
substance of the guidance FDA recently issued, all that went in
to developing it and how you are working with the developers,
and that has really been helpful, but I think it would be
useful to have some more context. And sort of to follow up on
my colleague's last set of questions, I would like to ask you
about the background and history of FDA's oversight on software
generally.
Your testimony mentions the fact that FDA has been
regulating medical device software for decades and medical
device software on mobile platforms for more than 10 years.
This would, I am sure, surprise many people, because software
is not typically thought of as being a medical device. So could
you explain to us how software can be a medical device again
under the Food and Drug Cosmetic Act? Obviously you don't
regulate all software. It would also be helpful if you could
give us--you gave us some examples of where you have exerted
regulatory oversight, but some examples of software that you
might have begun with decades ago and things you are looking at
today.
Dr. Shuren. Yes. Certainly. So, the device definition was
written broad, with the idea that it is in place to allow for
changes in technology over time. So how it becomes a device is
because it is intended for use in diagnosis of disease or
conditions or treatment-cure mitigation of disease, and not
doing so primarily by chemical action. If it is chemical
action, it is a drug, not chemical action. It can be a device.
And it is the same approach, by the way, other countries also
have that broad definition which allows them to handle new
technologies as they come up.
We have technologies now that are moving to mobile
platforms. So another one is fetal monitoring. We have now an
app for that. And this is typically used on women who have a
fragile pregnancy to monitor for uterine contractions, fetal
heart rate and determine is the fetus is in distress. It is
used in hospitals for that purpose. Our concern is under the
bill as currently drafted, we wouldn't be able to assure that
is safe and effective.
What is on the horizon? Diagnostics, lots of diagnostics.
They are all going to be on mobile platforms. The XPRIZE just
put out a challenge to develop a Tricorder. Now, I am a
Trekkie. Remember Dr. McCoy had what was probably the first
mobile medical app in history. He had a Tricorder, and he would
wave this little handheld thing over the body and he would make
a diagnosis.
Well, the XPRIZE Foundation put out a challenge for that,
to actually have technology to diagnose diabetes and stroke and
heart disease. And guess what? Today that technology is going
to become a reality, because there are ways of measuring things
in the blood without taking your blood.
Mrs. Christensen. Right.
Dr. Shuren. And they approached us, because they said,
these are medical devices. We have got to make sure it is safe
and effective. Will you work with us to provide guidance to
these developers, and we are doing this. This is a partnership.
I would love to see a Tricorder. Can you imagine ``Star Trek''
in reality? It is like a kid's dream come true. That is the
future. But we want to be there to help the future, and we
would be concerned on anything in legislation that doesn't
provide those assurances for patients.
Mrs. Christensen. And so would I. So obviously FDA has had
a lot of experience in this space, and that is really very
reassuring. And medical devices, they fall into different
tiers, Tier I, Tier II and Tier III. Of course, Class I devices
are the least risky and III are the riskiest.
Can you briefly elaborate on these three levels of device
oversight and the responsibilities the device manufacturer has
under each of these levels?
Dr. Shuren. Certainly. So Class I is our lowest. That is
low risk. We don't review those going on the market. And about
50 percent of devices on the market today are probably Class I.
And they have to have labeling, they have to report certain
serious problems to us or, we have some surveillance, and they
have to do something called quality systems. Some people call
it good manufacturing practices, but in engineering, we call it
quality systems, and it is having the practices and procedures
in place to assure you make a quality product. And this is
actually a linchpin in making good products.
And we believe the future, by the way, in software really
focuses much more on quality systems and a post-market approach
to many things, and that is what is under discussion in this
international effort.
Class II are moderate risk. And in addition to what I
talked about for requirements, we do see them beforehand. And
that case, we do a comparison of a substantially equivalent to
other technologies on the market. That is a 510K.
And the very high risk, Class III, we then ask for studies
to show are they, in fact, safe and effective? So we have a
very risk-based approach.
As I mentioned, though, all of this is looking at being
modified for purposes of software. Exactly. And that is the
same we are doing with Europe, Canada, Australia, Japan, China,
Russia, and we have the Asian Harmonization Working Party,
which if they agree too, will bring in other countries in Asia,
the Middle East, and Africa into one harmonized framework.
Mrs. Christensen. Thank you.
Mr. Pitts. The chair thanks the gentlelady, now recognizes
the gentleman from Virginia, Mr. Griffith, for 5 minutes of
questions.
Mr. Griffith. Thank you so much, Mr. Chairman. And I
apologize that I was not here earlier. I am working in another
committee as--or subcommittee as well.
Doctor, I understand your hesitation about setting things
in stone, especially considering how quickly this industry is
evolving. However, the medical industry as a whole is evolving
quickly, as you know. Your comments beg the question whether
Congress should ever legislate in this space. Our goal here is
to carefully craft legislation that sets your authority in
stone, but does so in a flexible manner that provides you the
authority for effective regulation of the industry.
My colleague, Mr. Green, in his opening statement mentioned
the issues that arose during the meningitis outbreak.
Throughout the investigation and legislative process that
followed that outbreak, we learned that the FDA felt it lacked
regulatory clarity and authority. We all want to make sure that
the FDA is in a position to regulate effectively and
confidently. I appreciate Mr. Green bringing up this
comparison, because it is an incredible lesson we learned about
the importance of FDA authority and making sure that the FDA
understands what its authority is.
Throughout the hearing, we have heard from everyone the
promise of health IT technology. We know this industry is
growing and holds enormous potential. You would agree, wouldn't
you, that we have an opportunity to set a sound regulatory
foundation for such pivotal technology?
Dr. Shuren. For Congress to do that, it is always
Congress's discretion to pass legislation, absolutely.
Mr. Griffith. And one of the concerns that I have had, and
I am so glad that we have this bill as a vehicle to work on
these areas, is that when we had a previous witness in
testifying, I brought out my cell phone. I have now got a newer
version that does more things by about five-fold than my old
one did. And I brought out my cell phone and I said, hey, here
is the problem. A group of scientists in Africa working with
people in Canada and the United States and Switzerland, I
believe, came up with an $8 hack onto a cell phone that allowed
them to take high resolution pictures of fecal material, and
folks in the United States were then telling them what parasite
was affecting the village in Africa.
I said, is that going to be considered a--if we were to try
to use something like that in the United States, would that be
a medical device? And the lady said, yes, I believe it would
be, because it is diagnostic. An $8 hack on a cell phone is a
way that we can bring a lot of innovation into diagnostics, et
cetera, and particularly when--and I am representing a largely
rural district in Virginia, and I had one of my hospitals
recently close down, and we are hoping that we can rectify
that, but now I have got folks who have to travel 45 minutes to
get cardiac care.
It sure would be nice if we had some high tech fixes, and
they are on the verge of being there, where my folks could hook
up directly with the doctor, if that technology were readily
available. And I am just afraid the FDA may slow it down by
having too much. So don't you think something like this bill is
necessary?
Dr. Shuren. So in all honesty, we don't believe such a bill
is necessary, or certainly at this time. And part of the issue,
the difference with compounding, in the compounding case, FDA
came back and said there is not clarity, to my understanding,
clarity in the law, we needed clarity.
Here we think we have the authority. We are using
enforcement discretion, if you will, to adapt to changing
technology.
I will say that example with stool, no, we wouldn't be
regulating that. We just had that with melanoma. If you take a
picture of skin and you are sending it to a doctor, no, we are
not touching that, but software that is analyzing that
melanoma, we just ran into it with an app developer who sold it
to consumers and said, look, use this on your skin lesion, you
have a concern, we will tell you if it is high risk or moderate
risk or low risk, and if it is high risk, we will recommend you
go see a doctor, and if it is moderate or low risk, you just
monitor it; not go and see your doctor, monitor it.
And guess what? When researchers at the University of North
Carolina looked at it, it was accurate in finding melanoma one
out of 10 times. Nine out of ten times it missed it. It was
telling patients, don't go see your doctor, monitor it. That is
a diagnostic and that is the kind of stuff we should be
concerned about.
Mr. Griffith. Well, and I understand that, but I also
risk--there is also the risk that if we don't get things out
there onto the marketplace, that people may miss something,
because those people who got that test, even with its low
accuracy rate, may not have been planning to go see a doctor
anyway, and some of them, one out of 10 at least, did go see
the doctor. Now, I would prefer it if obviously they didn't
have a false read, and that is an issue that has to be taken
up.
Dr. Shuren. Yes. And those folks obviously downloaded the
app because they were interested in looking at some suspicious
skin lesion. Again, we are not looking to hold up technology.
I will say of the feedback we have gotten on the guidance
is, for the most part, you know, you have got the line in a
good place. I mean, and we were trying to get to that point of
providing the clarity that people are seeking. It is not easy.
Whichever way we do it, statute, guidance or whatever, it is
not easy to draw perfectly clear lines, and that is why it took
2 years to even get to where we were.
Mr. Griffith. But 2 years is a long time. I do appreciate
it.
And I am hearing the signal that my time is up, and
therefore, Mr. Chairman, I yield back.
Mr. Pitts. The chair thanks the gentleman. I now recognize
the vice chair of the subcommittee, Dr. Burgess, 5 minutes for
questions.
Mr. Burgess. Thank you, Mr. Chairman. And again, Dr.
Shuren, thank you for being with us today. Back in my opening
statement, I talked a little bit about clinical decision
support. Back in my day, that meant the Merck manual in the
pocket of your white coat as you went down to the emergency
room, but now it can be so much more real-time and it can be
up-to-date. And it really, in my opinion, is one of those
things that could really transform the way doctors practice. Do
you agree with that observation?
Dr. Shuren. I do agree with that. And we actually think for
clinical decision port, and this is why we have been asked to
provide clarity in that area, but we were asked to give more
time and do it as part of this other process on a regulatory
framework, we do think a lot of those things are not the stuff
that FDA would be touching. Even things--IBM, I am glad they
are here, things they are doing with WatsonPaths we have seen
and they are going through data import, those are not the stuff
that we are touching. We think that is terrific. But the way
the people start--then the question is, how do you define?
So even the bill today which, again, as drafted, draws a
line that actually cuts out things like the computer-assisted
diagnostics that even the same groups that have said, oh, maybe
we would like statute, those are exactly the examples of what
they say FDA should regulate. And that is what we kind of mean
about we are drawing the lines on this. We want to make sure
the kinds of things that we should be looking at, we at least
have the ability to do that to assure for doctors and patients
are safe and effective, and the other things we are not going
to touch. That is our idea.
Mr. Burgess. Well, do you see where there is a concern that
as long as there is some ambiguity as to whether or not you
might regulate it in the future, it leaves them with the
ambiguity of not knowing how to proceed on the development
side?
Dr. Shuren. I would say typically for folks who have dealt
with us, and understand how we use our policies----
Mr. Burgess. Be careful. I have dealt with you.
Dr. Shuren. I know you have. I know. See, you even caught
me off guard right there. Thank you so much.
That being able to make those changes is not something that
can be done on a dime. And that is why for folks who have dealt
with us understand that, yes, we actually do have a level of
certainty. In fact, what they tend to ask for is more guidance
and more clarity as opposed to, please don't use guidance to
clarify for us.
Mr. Burgess. But, I mean, it is a little bit of a different
world than the typical drug device world in which you have
historically regulated. Is that a fair statement?
Dr. Shuren. Yes, but one of the things that has happened
here in terms of where we are looking, we didn't move out into
someone else's space and say, you know what, we are coming out
to reach new stuff. What has happened is developers, who
weren't making things in the health care space and FDA, typical
kind of FDA regulated functions started to say, well, now we
are going to go do that. And what they did is they kind of
moved into a world we have been dealing with, and for them it
became, ooh, we don't know the FDA. We hear of things. We are
concerned.
So we didn't reach out to actually expand our universe of
anything in our guidance. We have been contracting it. But we
have new players. And this has happened before in other times.
New people come in, they have uncertainty about us, and that is
why we are going through this extensive effort to engage with
folks and provide the clarity so that we think over time, the
people who aren't used to dealing with us will realize, oh, now
we get it, we are good, but that will take time.
Mr. Burgess. That is exactly the point. The developers who
have uncertainty about dealing with you, how can we provide
them the stable footing they need to proceed with their--and we
want them to proceed with their developments. I mean, this is
the golden age of medicine that stretches in front of us, so we
want them to proceed. How do we give them the certainty that
they can be surefooted in traveling down that road?
Dr. Shuren. By doing what the health IT working group, the
multi-stakeholder groups asked us to do: to continue to provide
that clarity through guidance in other areas, like clinical
decision support, in accessories, on certain claims, and that
is what you are likely to see in the report we send up to you
all, is saying these are the things that we should do. We
should follow up on those recommendations and put out that
clarity through guidance as we have been asked to do.
Mr. Burgess. Well, I apologize I wasn't here, but
apparently Representative Lance asked you about the updates to
apps, that the apps that the FDA does regulate, the up--it
seems like my iPad or iPhone is always telling me I have got to
update my apps. So everyone's familiar with the facts that apps
have to be updated. Are you regulating the updates to the apps
as well?
Dr. Shuren. Yes. So most of the kinds of updates, we see
the software, we don't even look at coming in the door. And I
mentioned, too, there is an international effort underway for
international harmonization on how software as medical devices
approach and that includes modifications. And this is a
collaborative effort between government and industry.
So all of this is included. This is an evolving area. It is
another reason why, too, some of these things we are not
locking in at all because it is evolving. Those discussions are
happening. And we want to get to a place where we and Europe
and Canada and Australia, China, Russia, Japan and elsewhere
are acting in that same way, have harmonized approaches,
because we think that ultimately is in the best interests of
everybody. That means a technology treated--a software in the
U.S. Gets treated the same in Europe. We would love to see that
happen and that is what we are working on, and that includes
modifications.
Mr. Burgess. All right. I wish I shared your certainty. But
thank you, Mr. Chairman. You have been kind. I will yield back.
Dr. Shuren. Well, consider it enthusiasm rather than
certainty at the moment.
Mr. Pitts. OK. The chair thanks the gentleman. That
concludes the questions from the members. The members may have
follow-up questions. We will get them to you in writing. Ask
you to please respond promptly.
To confirm what I heard from you today, Dr. Shuren, you
have committed to work with Representative Blackburn and her
colleagues, and I would ask that your assistance, collaboration
be responsive and timely.
And before I introduce our second panel, thank you, Dr.
Shuren, for all of your responses, your testimony.
I ask unanimous consent to include in today's hearing
record a letter from AdvaMed, which includes their comments on
H.R. 3303 and issues related to regulation and health
information technology. Without objection, so ordered.
[The information appears at the conclusion of the hearing.]
Mr. Pitts. With that, you are dismissed, and I will call
the second panel to the table. We have five witnesses, and I
will introduce them as they come and the staff sets up.
First, Mr. Mike Marchlik, vice president, Quality Assurance
and Regulatory Affairs, McKesson Technology Solutions; Mr. Jim
Bialick, Executive Director of Newborn Coalition; thirdly, the
Honorable Zachary Lemnios, vice president Research Strategy,
IBM Research; fourth, Mr. Robert Jarrin, senior director of
Government Affairs, Qualcomm Incorporated; and finally, Dr. J.
Leonard Lichtenfeld, deputy chief medical officer of the
American Cancer Society.
Thank you all for coming. Your written testimony will be
entered into the record. You will each be given 5 minutes to
summarize your testimony. And Mr. Marchlik, we will start with
you. You are recognized for 5 minutes to summarize.

STATEMENTS OF MIKE MARCHLIK, VICE PRESIDENT, QUALITY ASSURANCE
AND REGULATORY AFFAIRS, MCKESSON TECHNOLOGY SOLUTIONS; JIM
BIALICK, EXECUTIVE DIRECTOR, NEWBORN COALITION; HON. ZACHARY J.
LEMNIOS, VICE PRESIDENT, RESEARCH STRATEGY, IBM RESEARCH;
ROBERT JARRIN, SENIOR DIRECTOR, GOVERNMENT AFFAIRS, QUALCOMM
INCORPORATED; AND J. LEONARD LICHTENFELD, DEPUTY CHIEF MEDICAL
OFFICER, AMERICAN CANCER SOCIETY, INC.

STATEMENT OF MIKE MARCHLIK

Mr. Marchlik. Good morning, Mr. Chairman and distinguished
members of the subcommittee. My name is Michael Marchlik. I am
vice president of Quality Assurance and Regulatory Affairs for
McKesson Technology Solutions.
Today I am speaking on behalf of more than 15,000
technology employees. Together, we are transforming health care
from a paper-based system to one empowered by interoperable
electronic solutions. Our focus is to improve patient safety,
reduce the cost and variability of care, and advance health
care efficiency.
McKesson strongly supports H.R. 3303, the SOFTWARE Act.
This bipartisan legislation recognizes that a 40-year-old
statute should be updated to reflect innovation and the
importance of health IT.
Prior to joining McKesson, I spent 30 years as a quality
and regulatory professional in the medical device and nuclear
industries. This experience gave me a unique perspective on
effective risk-based regulatory frameworks as well as how
traditional medical device manufacturing differs from health IT
development.
At McKesson, I have faced the challenge of applying a 40-
year-old law to technology that did not even exist 4 years ago.
FDA rules are designed for physical devices, which undergo
slower incremental changes and longer development cycles, where
a focus on manufacturing processes makes sense. That
environment is markedly different from software, where
improvements, updates and patches are made available in a
matter of days.
The SOFTWARE Act creates a regulatory framework that
acknowledges the difference between medical devices and health
IT, recognizes the different categories of health IT, and
focuses FDA oversight on the technology that poses a greater
potential risk to patient safety. This legislation is the
culmination of many efforts to address how health IT should be
regulated in the 21st century. Under the auspices of the
Bipartisan Policy Center, BPC, I represented McKesson in
working with more than 100 hospital, physician and patient
organizations to develop recommendations for a new risk-based
regulatory framework for health IT.
In a March hearing before this subcommittee, my colleague,
Dr. Jackie Midas, testified that health IT is foundational to
improving the quality, safety and affordability of health care.
She emphasized that a new risk-based regulatory framework
distinct from medical device regulation and specific to health
IT is necessary. We believe that the SOFTWARE Act is a critical
step forward to achieving that vision.
The SOFTWARE Act establishes three distinct categories of
health IT: medical software, clinical software and health
software. Medical software acts directly on a patient without
the ability of a clinician to intervene. Clinical software, by
contrast, does not act directly on the patient, but rather
informs the clinician's treatment of the patient. Health
software is used by clinicians not to treat patients, but
rather to schedule appointments, process claims and analyze
data.
Under the SOFTWARE Act, medical software would continue to
be regulated by the FDA, clinical software would be subject to
a new oversight framework developed by Congress and the
administration, and health software would not be subject to
additional patient safety regulation.
These three software categories are consistent with both
the principles described in the BPC report as well as historic
FDA software guidance. FDA has little expertise in clinical
software development and implementation and does not regulate
the practice of medicine, nursing or pharmacy, where software
is ultimately customized and used. That is why we believe that
clinical software requires a new regulatory framework that
reflects first the dynamic nature and rapid innovation of
health IT; second, the shared responsibility among health IT
vendors and providers who developed, configure and use the
systems.
The SOFTWARE Act will update current law to provide clarity
on how best to ensure patient safety while promoting innovation
and broad adoption of health IT. It replaces non-binding FDA
guidance and enforcement discretion with the certainty needed
by the highly innovative health IT industry.
In conclusion, we urge Congress first to pass the SOFTWARE
Act, which is critically important to setting the guideposts
for a new policy; second, to provide oversight to the
administration when implementing this policy; and third, to
continue to work with stakeholders to establish the effective
risk-based framework to appropriately regulate cutting-edge
health IT.
On behalf of McKesson, I appreciate the opportunity to
testify in support this legislation and commend the sponsors
for your leadership. I am happy to answer your questions.
[The prepared statement of Mr. Marchlik follows:]

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Mr. Pitts. The chair thanks the gentleman and now
recognizes the gentleman, Mr. Bialick, 5 minutes for your
summary.

STATEMENT OF JIM BIALICK

Mr. Bialick. Chairman Pitts, Ranking Member Pallone and
members of the subcommittee, thank you for the opportunity to
testify today on this very important issue. My name is Jim
Bialick. I am the executive director and co-founder of the
Newborn Coalition.
The Newborn Coalition is an all volunteer organization that
works domestically and internationally to promote the
development and safe and effective use of health technologies
for newborns.
This hearing is very timely and it is appropriate that
Congress takes a deeper look into the many complexities of our
regulatory system, identifies the limits of what can be
improved administratively, and determines where legislative
action is necessary. To argue that Congress does not have a
role in reforming the way technology is regulated is to say
that regulators already have all of the tools they need to be
effective in fulfilling their statutory mandates.
While I recognize that some have come to know the existing
regulatory process better than others, the agencies themselves
have identified that there are a number of barriers to
effectively regulating health information technology that are
broken at the level of the written law. This means that even if
the agencies wanted to fix the problem, legally they could not,
and Congress has to intervene. To me, there is little certainty
in doing nothing, especially when doing nothing means not
addressing problems that the regulators themselves say they
have, and especially when doing nothing is at the expense of
those regulators fulfilling their statutory mandate of
protecting patient safety, including the stakeholders I
represent, which are our newest and most vulnerable citizens.
Technology, such as mobile apps, are playing a central role
in transforming our health care system, but their impact will
be muted unless there is a concerted effort to clarify how
products will be regulated. Efforts across regulators must be
coordinated and shift the way we think about medical devices
away from discrete products to a focus on the highest risk
components of integrated networks and medical devices and
consumer products. The line between medical and consumer
devices has been blurred by the evolution of this dynamic
marketplace, and only Congress can bring the needed clarity to
the process.
In my written testimony, I lay out seven recommendations
from the Newborn Coalition perspective on action Congress and
the administration can now put in place a framework that will
scale the needs of the marketplace while keeping patient safety
paramount. Among those recommendations are the following: First
we recommend that Congress should create a bright line that
defines FDA's authority over high-risk medical devices.
Enforcement by definition, is discretionary, and will need to
be constantly updated to address emerging technologies.
Our disagreement with those who believe regulation by
guidance, such as the FDA guidance on mobile medical
applications creates certainty, is we believe that that
certainty will evaporate as technologies evolve and the process
will have to begin anew.
Six members of this committee have sought to address this
issue head on with a SOFTWARE Act. We support these efforts for
being among the first to recognize that technology regulation
should shift away from the assumption that novel use of medical
device data constitutes a new device, acknowledge that
technology will continue to evolve, and focus on evaluating the
components of a system or network that pose the greatest
threats to patient safety.
I would argue that the authors recognize placing today's
definitions around future medical devices means our sights are
lowered rather than focused on the horizon and the innovative
technologies we cannot yet begin to imagine.
Second, we recommend Congress require HHS to contract with
independent private certification bodies that would certify
non-FDA technologies as safe and effective. Newborns are not
little adults, but facing limited treatment options, doctors
often use the smallest available version of an adult device on
babies to fill gaps where newborn-specific products do not
exist. We believe, however, that these medical devices can be
made more valuable by health information software that supports
these tools. Newborn-specific medical devices should continue
to be regulated by the FDA and be subject to significant pre-
and post-market evaluation.
We do, however, support an alternative certification
process for companion health information software. We are
engaged in this issue because we have seen health information
technology save the lives of newborns, and because in the
absence of devices designed for specifically for newborns, data
created by adult-focused medical devices will be of only
limited utility unless they are paired with health information
software that can curate the data to make it more relevant to
newborn care.
Health information software is not meant to replace
clinicians. Software will enhance the value of the device data,
and if it does not adversely impact the function or usability
of the clear device it interoperates with, then the software
should not be considered a new medical device in and of itself.
I would stress that data is not a medical device and does not
fit within statutory mandate of FDA. A public-private
certification process is a more appropriate means for reviewing
these technologies as they come to market.
In summation, there is no magic bullet, but with a level of
interest from Congress, the administration and a diversity of
stakeholders, it would be a shame to miss this opportunity to
reform the system in a way that will foster innovation and
improve patient safety for this generation and the next.
I thank you very much for the opportunity to testify and I
stand ready to help the committee in any way possible, and I am
happy to answer any questions.
[The prepared statement of Mr. Bialick follows:]

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Mr. Pitts. The chairs thanks the gentleman. I now recognize
the gentleman, Mr. Lemnios, 5 minutes to summarize his
testimony.

STATEMENT OF HON. ZACHARY J. LEMNIOS

Mr. Lemnios. Good morning, Chairman Pitts, Ranking Member
Pallone and distinguished members of the Health Subcommittee.
Thank you for the opportunity to speak with you today. My name
is Zachary Lemnios and I am the vice president of research
strategy at IBM Research.
I joined IBM last December and have served in the Obama
administration as the Assistant Secretary of Defense for
research and engineering. Off script, I will tell you it is a
delight to be back before Congress and testifying.
This morning I am going to talk about the innovations in
the private sector, but I will tell you that in the defense
sector, we saw remarkable progress for our wounded warriors,
the technology and innovations that 5 years ago were really
just in the research stage, and we should all be very proud of
that.
My comments this morning are with respect to technical
innovation regarding the private sector and the potential to
improve health care, and how Congress and the administration
can best work together to promote innovation.
IBM invests billions each year in research and development
from the first continuous blood separator that led to the
treatment of leukemia, to the first heart-lung machine used to
keep patients alive during surgery, to the excimer laser that
opened up LASIK surgery that many of us use today.
IBM research has a rich legacy of addressing health care's
most pressing needs. Today we are collaborating with
universities and with medical institutions to help children
with--universities and with medical institutions to help
children who would not otherwise have access to intensive care,
to simulating the human heart to better understand how genetic
variations predispose some patients to arhythmias, and to
transform EMR clinical data into user-friendly formats so that
patients can better understand and participate with their
health care management.
The victory of IBM's Watson on the television quiz show
``Jeopardy'' revealed how scientists and engineers at IBM and
elsewhere are pushing the boundaries of science and technology
to create the machines that interact with people in very new
ways. This new cognitive era promises a significant shift in
the ability of people and organizations to quickly analyze,
understand, and unlock the insights contained in a torrent of
data that is around us.
As this subcommittee knows, health care is one of the most
data-rich environments today, yet physicians are often working
with limited information and shortened timelines. The results
can be fragmented care, errors that raise the cost and threaten
the quality of health care.
Consider this: Primary care doctors spend on an average of
somewhere between 10 and 19 minutes face to face with each
patient per visit. An estimated 15 percent of diagnoses are
inaccurate or incomplete. Medical information is doubling every
5 years, but 81 percent of physicians spent less than 5 hours a
week reading medical journals.
Advanced analytics, combined with cognitive computing,
natural language processing, can help doctors efficiently
assess and make use of this ocean of information to achieve
individualized evidence-supported medicine. In addition,
advances in technology could help address disparities of access
across our Nation.
Congress can contribute to these advancements by assuring
that there is a regulatory environment that encourages
innovation while protecting the safety of individuals.
Innovation and improved safety are not inconsistent goals. In
fact, innovation can enable better tools to continuously
promote learning and possibly improve care, to reducing these
adverse effects.
The current regulatory framework, largely developed during
the decades before the rise of today's sophisticated IT
technology, focuses on traditional discrete devices,
manufacturing in a single site, and physically shifted
distributors and users. While some have embedded software,
these are frequently physical articles placed into the
commercial environment, modified relatively infrequently, and
often do not interact with multiple other devices provided by
parties.
With the rise of network ecosystems, and even more
sophisticated software, this paradigm simply doesn't encourage
tomorrow's innovation. The medical technology field is
populated with multiple players who are interconnected through
technology that can be rapidly and integrally improved through
deep collaboration and through IT partnerships with the
clinical end users.
Further, clarity is needed to enable a vibrant marketplace
where the paths of bringing collaboratives to market is known.
Clarity is really what we are after in this environment, and
one area that calls out for clarity is clinical decision
support software. This is intended to aid clinicians in making
decisions rather than making those decisions directly for
patients. It is one of the resources that clinicians can use,
not solely rely upon, but use in their decisionmaking process.
Currently it is unclear whether and how CDS would be
regulated, and we urge Congress and the administration to work
together to clarify this, recognize that in all health care, in
all software in this arena, it is not the--software is simply
not the same. One size fits all is not the right equation.
Using the current medical device regulatory framework to
determine if and how regulation of the diversity of potential
health care software would be used is something that needs to
be clarified. Without this, we will quash innovation, we will
delay the adoption of supporting tools that can help clinicians
better provide health care.
Mr. Pitts. The gentleman's time's expired.
[The prepared statement of Mr. Lemnios follows:]

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Mr. Pitts. The gentleman's time is expired.
Thank you, the chair recognizes Mr. Jarrin 5 minutes to
summarize his testimony.
Make sure your mic is up. We had a little trouble hearing
the last witness.

STATEMENT OF ROBERT JARRIN

Mr. Jarrin. Good morning, Chairman Pitts, Ranking Member
Pallone, and members of the subcommittee, earlier this year the
Subcommittee on Communications and Technology----
Mr. Pitts. Is your light on?
Mr. Jarrin. Yes. There we go. I thought it was on, my
apologies. Good morning, Chairman Pitts, Ranking Member
Pallone, and members of the subcommittee. Earlier this year,
the Subcommittee on Communications and Technology held hearings
during the third week of March on health information
technologies and innovations, including mobile medical apps. I
was honored to have been invited to participate in the first of
those hearings, and I am honored to be here today. Qualcomm
Incorporated is number one global supplier of wireless chips
and the leading inventor of 3G and 4G next generation wireless
technologies. To date, Qualcomm's chip shipments surpass 11
billion. If a person is using a 3G or 4G device, Qualcomm's
technology and ingenuity are being used.
Mobile technology continues to be the largest platform in
history. Innovation continues to personalize health care as
health apps are more available than ever via sophisticated
smartphones and tablets that rely on powerful, ubiquitous 3G
and 4G mobile broadband networks. In fact, according to
MobiHealthNews Research, unique health apps now number over
33,000 in the U.S. After 2 years, the FDA delivered on its
promise: A deregulatory and practical roadmap for the mobile
health industry. This is significant for solo developers,
garage entrepreneurs and established medical device
manufacturers, such as Qualcomm's wholly-owned medical device
subsidiary, Qualcomm Life. FDA has raised the bar and
demonstrated how it can work with industry, be progressive,
help speed innovation, and ensure public safety. But more is
yet to come as broader issues linger which require the same
light touch and flexible approach FDA has now demonstrated it
is capable of adopting.
Additionally, the final Food and Drug Administration Safety
Innovations Act, or FDASIA report due at year's end by FDA,
ONC, and FCC should contain a proposed strategy and
recommendations on an appropriate risk-based regulatory
framework pertaining to health IT, including mobile medical
applications. Qualcomm offers the following recommendations for
consideration. Number one, as recommended by the FDASIA
external working group report, FDA should utilize current
program mechanisms that could enable innovations such as
assessing exemption from good manufacturing practices for lower
risk health IT, expediting guidance on health IT software and
related matters, particularly FDA's 2014 proposed guidance
development B list that includes medical device decision
support software, medical device accessories, and general
wellness products; continue to improve internal coordination on
health IT software, and its regulatory treatment; and continue
to utilize external facing resources to proactively educate the
public about how policies and regulation impact health IT and
mobile medical apps.
Number two, FDA, ONC, and FCC should address policy and
regulatory deficiencies, ambiguity, and duplication in the
final FDASIA report.
Number three, FDA should continue its commitment to
consistency, predictability, and transparency by coordinating
internal and external efforts through a single dedicated office
of mobile health within FDA.
Number four, interoperability is a critical concern for
reliable data exchange and secured health communications to and
from mobile devices.
The FDA should collaborate closely with ONC in supporting
the direct messaging exchange standards and the direct trust
security and trust framework.
Number five, privacy data use rights and identity
management issues have unique concerns in relation to mobile
health devices. Close collaboration between the FDA, ONC, and
FTC are essential to the establishment of consistent standards
and requirements for industry health care providers and the
public.
Qualcomm underscores the importance of FDASIA's work and
encourages the involved agencies to utilize existing program
mechanisms to enable innovation immediately. While they explore
how to improve and modify existing frameworks, or if needed,
develop recommendations for Congress to consider a new risk-
based regulatory framework, what the public and industry don't
need is a situation where innovation suffers as a result of
regulatory confusion on health IT software, which is why
existing program mechanisms are vital policy tools that can be
employed promptly.
The end goal should be for a regulatory framework that
allows new technology to flourish, promotes innovation, avoids
regulatory duplication, and above all, protects patient safety.
Thank you. I look forward to your questions.
[The prepared statement of Mr. Jarrin follows:]

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Mr. Pitts. The chair thanks the gentleman and I any
recognize Dr. Lichtenfeld, 5 minutes for opening summary.

STATEMENT OF J. LEONARD LICHTENFELD

Dr. Lichtenfeld. Thank you, Chairman Pitts, Ranking Member
Pallone, and members of the subcommittee. I am Dr. Len
Lichtenfeld. I am Deputy Chief Medical Officer for the American
Cancer Society, and I thank you all for the opportunity to
testify before you today.
Software applications play an increasingly integral role in
the care of patients, including and especially patients with
cancer. So I applaud this committee's bipartisan attention to
providing a proper level of oversight for these products.
As we all know, cancer care has changed significantly in
the past 40 years when it might have been enough for a
physician to manually assess a tumor size, determine the
appropriate diagnosis, and the recommended treatment for a
patient with cancer. We are now moving into an era where
everything from sending patient appointment reminder emails to
analyzing genetic tests are all done using software, and
software applications have increased our ability to quickly and
accurately diagnose patients and develop the most effective
treatment plans as mentioned earlier today.
Continued innovation in this space is an urgent priority
for cancer patients, survivors, their families, loved ones, and
of course, their health care professionals. At the same time,
the power of software applications to improve patient care must
be tempered by potential dangers that come with any new medical
intervention. We consider it unethical to administer new drugs
as part of a patient's treatment without first understanding
both the safety and the efficacy of those medications, and
similarly, we need to understand the safety and efficacy of
integrating software applications directly into patient care.
In terms of the appropriate calibration of oversight for
software applications, you will find nearly universal
agreement, the lowest products do not merit FDA oversight,
while high risk ones do. The real challenge lies in how to
create oversight for the space in between that may include
clinical software, mobile apps, similar products.
Rather than commenting on specific proposals, I would like
to offer several broad design criteria for your consideration.
First, and foremost, patient safety and privacy are paramount
to all of us. It is the first duty of medical professionals,
the relevant oversight agencies and policymakers to ensure that
patients are not subjected to dangerous, ineffective, or
misleading treatment and that their information is secure.
Second, any information oversight system should be fluid.
Technology is advancing at a speed challenging our ability to
provide effective oversight. And some technology in use today
was, as we know, almost unheard of 5 years ago, and so any new
oversight structure should not be so rigid that it cannot
quickly adapt to new realities.
Third, details matter. The changes are enacted to create
new categories of medical software applications with differing
levels of oversight, then the definitions of those categories
must be very clear and not create loopholes, ambiguities, or
unintended consequences.
Fourth, focus the solution on the actual problem.
Innovation software mobile apps can be promoted through
regulatory certainty and the relief of regulatory burden on
software sectors where it is not appropriate. This may be
possible with narrower policy changes aimed at targeted sets of
software rather than the full spectrum of software and mobile
apps.
In closing, let me reiterate. The innovative new software
will be crucial to making progress against cancer, and ensuring
patient safety. We need a risk-based oversight paradigm for
this software that does not impose a heavy regulatory hand that
might otherwise stifle innovation. But we must never allow the
pursuit of innovation to displace patient safety and privacy as
our primary considerations. Wherever software is involved
directly in patient health, oversight is not only appropriate,
but it is necessary. I thank you again for the opportunity to
share our views and I look forward to your questions. Thank
you.
[The prepared statement of Dr. Lichtenfeld follows:]

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Mr. Pitts. The chair thanks the gentleman. That concludes
the opening summaries. We will now begin questioning. I will
recognize myself 5 minutes for that purpose.
Mr. Lemnios, so why, in your opinion, is it important that
Congress address regulating medical apps?
Mr. Lemnios. I am sorry?
Mr. Pitts. Why is it important that Congress address
regulating medical apps in your opinion.
Mr. Lemnios. We think the key issue here is one of clarity
and it goes back to comments that several Members made in their
questions in the opening statements. For the private sector to
make investments in developing new technologies and transition
those technologies, that involves decisions on partnerships, it
involves strategic decisions on where we will make those
investments, all of which must be framed----
Mr. Pitts. Pull the mic a little closer, sir. They say they
are having trouble hearing.
Mr. Lemnios. Let's try this.
Mr. Pitts. There you go, that is good.
Mr. Lemnios. You know, you guys really ought to get an IBM
mike. This doesn't say IBM.
Mr. Pitts. All right. We will start over.
Mr. Lemnios. The question was why should Congress, why
should this committee make a recommendation and pursue this?
Look, I think it is an issue of clarity, and in fact, that will
help our business decisions, and I think it will help decisions
of small innovators as well. And that is really what we want.
Not to compromise patient safety. But to build that environment
that encourages innovation in this field.
Mr. Pitts. Thank you. Mr. Marchlik, do you think the FDA
has the regulatory structure to appropriately regulate medical
apps?
Mr. Marchlik. I believe that they have certain structures
that they have been able to use for embedded software very
effectively. Where we have questions is around clinical
software, where implementation and use of the software is just
as important as the development, and there what we see is that
FDA doesn't have the oversight models necessary to ensure
patient safety across that continuum.
Mr. Pitts. Mr. Bialick, do you think that the regulation of
medical devices is best addressed through agency guidance,
legislation, or a combination of both?
Mr. Bialick. I think it is most likely a combination of
both. I think in hearing Dr. Shuren's testimony that there is--
it is quite clear that there is an effort within FDA to do the
right thing, to figure out how to fix the process. But I also
think that it is important to note that through the FDASIA
working group that he mentioned and so did Mr. Jarrin mention,
the external working group as well as those that will make the
report, I guess, in the first quarter of next year, there were
a number of issues that were identified by not only
stakeholders that were part of that external group, but
actually representatives from the agencies, FDA, FCC and ONC
that identified that there were some issues that got, like we
said before, broken at the level of the written law. And if
that is the case, then you are very well going to need a hybrid
of both.
Mr. Pitts. Mr. Lemnios, one of the main themes in this
hearing is how quickly technology is evolving. Some may argue
that because the industry is changing so much so quickly, we
should just continue to release guidances. Why do you think we
should address this legislatively, and how do you suggest we
incorporate enough flexibility to make sure the agency is
equipped with the flexibility to adapt to this evolving
industry?
Mr. Lemnios. So that is a tension in the dialogue. The
tension is how much flexibility and how much certainty will
there be in this environment? And I think what the bill has
done, and I would compliment the Congressman, the
Representative for drafting this--what the bill has done it has
laid out three imperatives that, in our view, sort of lay the
structure. Whether there is direct change in function, or
structure of the body, whether there is an involvement of a
health care provider, and whether the software is marketed to
individuals or to health care providers. I think those are
three key elements that you could build on.
Now, there is going to be a lot of discussion about each,
there will be a lot of discussion, does this particular
software fit under this category or that? But I think the basic
structure that was put in place really provides a way to build
on this.
Mr. Pitts. Let me ask each of you to respond to this
question. We will start at the other end. Dr. Lichtenfeld, can
you discuss the impact health IT can have on the
personalization of medicine as well as the potential to lower
medical cost?
Dr. Lichtenfeld. Obviously, it is a world that I live in in
a lot of different ways, and there is no question whatsoever
that health information technology is going to have a huge
impact on patient care, is going to have a huge impact on
directing personalized medicine, precision medicine, and making
sure that it works right is critically important. We have to
have the certainty that we need not only as health
professionals, as patients. We need to make certain just as we
do with our medications, that what people say something is
going to do, is, in fact, going to do it.
Mr. Pitts. OK.
Dr. Lichtenfeld. We are adjourning a discussion with the
early part of that discussion as we are here today with
obviously much more to come in the not too distant future.
Mr. Pitts. Mr. Jarrin.
Mr. Jarrin. Health IT has and will continue to have a huge
impact on America, especially things like cost savings. I would
only point out that 330 million subscriptions in America right
now for mobile devices, yet one out of two adults according to
the CDC--one out of almost--one out of two adults in America,
has at least one chronic illness and chronic disease is about
75 percent of our health care cost. I think will you start to
see that go down as the ubiquity of health IT continues.
Mr. Pitts. Briefly, Mr. Lemnios.
Mr. Lemnios. Again, I view the impact both from the
private--on the patient side, but also on the provider side. If
I look at the enormous growth in information that a health care
provider can access, a doctor can access, software that
translates that complexity into something that provides some
insight is going to have a significant value. So in fact, it
will, I think in both cases, there will be a significant
improvement.
Mr. Pitts. Mr. Bialick.
Mr. Bialick. I absolutely do believe health IT will have a
huge impact on the personalization of medicine. We often talk
about personalized medicine like it is a single thing, like we
can go buy personalized medicine, but personalized medicine is
the consequence of a health technology-enabled health care
system where we are able to communicate between devices,
between providers, between patients, and have that information
created in a way that it is valuable to the individual at the
point of care.
Mr. Pitts. Mr. Marchlik.
Mr. Marchlik. Yes, I would agree that the will and the data
is there and the opportunities to find applications which
actually can unlock that data and help with personalization.
Mr. Pitts. Thank you. My time is expired. The chair
recognizes the ranking member, Mr. Pallone, 5 minutes for
questions.
Mr. Pallone. Thank you, Mr. Chairman. My questions are of
Dr. Lichtenfeld. You note in your testimony that it is
necessary to ensure that any new definitions enacted into
statute be very clear and not create loopholes, ambiguities or
unintended consequences. You also note that many software
applications contain multiple functions and each individual
function in isolation could conceivably fit into a different
regulatory category. So clarity is needed about where in the
regulatory scheme these multifunctional applications fit. Those
points argue, at least for me, that this is not an area that
could be easily addressed through legislation. In FDA's
recently issued guidance, it appears to me to have been well
received by many stakeholders who have indicated that it
provide the necessary clarity to allow innovations to flourish.
As you say in your testimony, any oversight structure should
not be so rigid that it can't quickly adapt to new realities.
So my questions are: Are you concerned that legislation
will not provide the requisite flexibility here? Do you agree
that guidance is an appropriate way to oversee this kind of
technology?
Dr. Lichtenfeld. Far be it for me to say to Congress
whether or not you are able to legislate something. That is in
your purview, and I understand that the America Cancer Society
understands that. I mentioned a moment ago there are
substantial conversations that are currently ongoing, and I
believe that this legislation begins the process within the
legislative branch, but certainly within the private sector and
within the advocacy sector, and with interested parties, we
have had a lot of discussions surrounding these issues.
So our concern is that the FDA guidance meets a need at the
present time that listening to the testimony today reinforces,
in my opinion, that they have the flexibility and the direction
that we need today. But we are going to be having a different
conversation even within the next several months. And that
definitions do matter, not that they are not appropriate, not
that they are not important, but they do matter. And putting
something into legislative language today to codify something
when even in a couple of months we may be having a different
discussion, or a more informed discussion among all of the
parties, both governmental, legislative, private sector,
advocacy, this may not be the right time for us to do that as
opposed to, number one, seeing how the FDA guidance works, and
number two, listening to the reports and discussions that we
are going to be having as I mentioned in the not too distant
future, hopefully.
Mr. Pallone. Well, thank you. Let me also say, FDA
indicated on the first panel that the Blackburn bill would
exempt from all FDA oversight such apps as radiation therapy
planning software, and mammography detection software, to name
a couple. I have no doubt that the sponsors of the bill had no
intention of exempting such apps from oversight, but these
examples generally illustrate the difficulty deriving the
perfect language for legislation. Would you be concerned about
legislation that permanently removed FDA's jurisdiction over
certain types of software that might ultimately pose patient
safety risks?
Dr. Lichtenfeld. Well, it is not a question so much of
opposing the legislation, but making sure that we understand
the potential risk of unintended consequences and definitions,
as I mentioned, definitions matter. Getting those definitions
right in legislative language is an art. It is difficult. It
has to be done properly. If we don't do it properly, we do run
the risk of having--we do believe we have issues of oversight
difficulties and what we would call unintended consequences so
the definitions are critically important.
Mr. Pallone. You make another important point in your
testimony that we are still awaiting the report that Congress
requested in last year's FDASIA legislation from FDA, from the
Office of the National Coordinator for Health Info Technology
and the FCC. So do you agree that any legislation that we
consider here should be informed by that report?
Dr. Lichtenfeld. I do. As you are well--as you are probably
aware, there have been several reports, one from the Bipartisan
Policy Center that came out recently, another one from the
Office of National Coordinator. We are awaiting the report from
the working group as was mentioned. And I think that in the--
what I think is an appropriate place, is to say we need to have
that information. We need to be able to understand that
information. We need to have the input of all of the relevant
stakeholders before we advance a legislative remedy--before we
advance the legislative remedy, I should say.
Mr. Pallone. All right. Thanks a lot. And Mr. Chairman, I
am not convinced there is a problem that needs to be fixed
here, and if there is, that it should be addressed by such a
broad piece of legislation that virtually rewrites FDA's
oversight of what is a fast-moving technology. But I think it
is important that we had this hearing today. Thank you, Mr.
Chairman.
Mr. Pitts. The chair thanks the gentleman. I now recognize
the gentlelady from Tennessee, Ms. Blackburn, for 5 minutes of
questions.
Mrs. Blackburn. Thank you, Mr. Chairman. You all have been
very patient with us, and I hope I don't take my whole 5
minutes. How is that for starters?
Mr. Marchlik, three quick questions, and thank you for your
testimony. I want you to just kind of give a brief concise
overview, the difference between health IT, and medical
devices, why they need to be approached differently. You argued
in your testimony that the FDA is not well-suited for
regulating the software. I want you to expand a bit on why, and
then going back to the FDASIA work group recommendations that
were presented to the ONC policy committee earlier this fall, I
want to know what you thought about that.
Mr. Marchlik. Thank you. I think it is important that we
believe that the legislation and we agree that the FDA would
still be well-suited to regulating certain types of software.
Some of the applications that we expect would still be
regulated would be, for example, are perinatal care monitoring
type of software. Some of our cardiology products would meet
those definitions, would still be regulated by the FDA.
What I testified to and what we believe is that in a
clinical software space, it is not just a development. And it
is not just a manufacturer, which has standard, is regulated by
the FDA, but it is implementation and use. We deliver products
that actually require input, and configuration of the practice
of medicine for it to actually be fully functional. And the FDA
oversight doesn't extend that far. What we would be looking for
is the new oversight model which would be able to expand and
address that whole segment of that.
On the FDASIA report, I believe that a lot of the findings
that came out of FDASIA report were consistent with the BPC
report. Maybe, I think it is interesting is that we talk about
the need for legislation or not. Partly, I think what happened
is that in parts of the report, they were constrained because
the only oversight was FDA oversight, and therefore, if there
was a need for oversight it pointed to FDA versus nothing else.
And there is a gap there and that is where we think the bill
was very good about laying out that there should be an
alternative for type of clinical software.
Mrs. Blackburn. Excellent. Thank you, for that. Mr.
Bialick, does the FDA currently require changes to existing
drugs or devices on the market to go through an FDA review
process before they go to the patients?
Mr. Bialick. So you are asking if there are changes to
existing devices?
Mrs. Blackburn. Yes.
Mr. Bialick. As someone who has never put a device through
the process, I unfortunately can't answer that.
Mrs. Blackburn. All right. OK, let me move on then. I was
asking that in relation, Dr. Shuren, during his answer to
Congressman Lance said that patches, or updates, to the apps
that could improve or harm patient safety would not have to go
through the FDA approval process. So does that concern you?
Mr. Bialick. The question in my mind is really how those
errors or how those bugs are coming to people's attention. I
think that what really we should be trying to do here is foster
an environment where there is a transparent nature, a
combination of punitive and non-punitive mechanisms and levers
that would allow both vendors, maybe through the protections of
something like patient safety organizations as well as
providers, and really patients to have a way to redress their
grievances to say there is a problem. We want to figure out
what it is, and fix it as fast as possible. Now, depending on
if this is the world of the SOFTWARE Act or if this is the
world of FDA now, whether that goes through the FDA, whether
that goes back through a certification process, whatever it is,
I think just the real take-away there is that we need to have a
system of transparency so if there are patches we know why they
were needed.
Mrs. Blackburn. OK, so I guess what you are saying that
enforcement discretion rather than certainty, could have some
unintended consequences on patient safety, especially with the
very delicate patients that you all focus upon, is that fair?
Mr. Bialick. I think in certain circumstances, absolutely.
Mrs. Blackburn. OK, thank you. I yield back.
Mr. Pitts. The chair thanks the gentlelady. I now recognize
the gentleman from Florida, Mr. Bilirakis, 5 minutes for
questions.
Mr. Bilirakis. Thank you, Mr. Chairman, I appreciate it
very much. In the 1970s, Congress wrote the statute giving the
FDA the authority to regulate medical devices. As is often the
case, technology will outrace the law, and government is forced
to use outdated laws to deal with emerging situations. When the
Medical Device Statute was created, we did not have personal
computers, cell phones, the Internet, or cloud computing. Yet,
these things are part of our daily lives. We need to modernize
the law in my opinion, to provide clarity to the FDA, and the
medical software industry, on the regulatory framework for
their respective industries. And I want to ask Mr. Marchlik, a
question, Mr. Marchlik. You have suggested in your testimony
that different types of health IT should be regulated
differently. Isn't that exactly what the FDA is doing using
their discretion?
Mr. Marchlik. I believe that what they have attempted to do
within the boundaries of the current legislation is to use
enforcement discretion to carve out those products which they
are not going to actively enforce. I think that what is needed
is actually to take a fresh look at that, and also to expand
that, like I have been, you know, like I have discussed, is
expand that across the platform including clinicians, including
the way we implement and use, we need to have a framework that
works across and that is why we support the legislation is it
calls for that, which would be in addition to what the FDA is
doing with the higher-risk products.
Mr. Bilirakis. Thank you, I appreciate that. Mr. Lemnios,
IBM has proposed that Watson, your supercomputer, could provide
medical assistance to doctors. That is very exciting. It has
the ability to review medical records, the latest in medical
research, and provide recommendations or options to physicians
during the diagnosis process. Would this be regulated like a
medical device by the FDA in your opinion?
Mr. Lemnios. Well, Congressman, I can't comment on Watson
as a particular product. The discussion here I think is a much
bigger issue than that, and that is really about how decision
support software would be regulated. And I will come back to
the comments that I made earlier. I think in framing the
arguments, in framing how this regulation could be structured,
the distinction between whether that software is provided to
the patient, or the clinician is a key one; the distinction of
whether that software is used to support a decision, or to make
a decision, is a clear one; and the distinction of whether that
is--whether the result of that software, the conclusions are
interpreted by an individual or interpreted by a clinician is a
key thing. I think those are the key, as we view it, those are
the key structural elements of how to think about this. And I
think the bill clearly outlines that.
Now, Watson is a technology that we are developing. We are
training it. We are training it in many fields. It is in the
financial sector. We are training it in the medical community.
We have other areas that we will train systems like that, but I
will simply tell you that the field of analytics, and the field
of cognitive computing, where humans interact with data in a
very natural way, that field is exploding. We see that across
the VC community. We see that in other areas. And I think that
will be a key element of this field going forward.
Mr. Bilirakis. OK, if it were regulated by the FDA, why
don't you tell me, maybe you can elaborate a little bit. What
kind of implications would that have? Would it raise the cost
of the computer system? Would it make it slower to provide
updates and improve the system?
Mr. Lemnios. So updates, updates on any software is a key
cost issue, it is a risk issue, and it is a delivery timeline
issue. I mean, we really need to see the clarity and the reason
we support the bill is because we need clarity in this space.
Mr. Bilirakis. Thank you very much. I appreciate it. I
yield back, Mr. Chairman.
Mr. Pitts. The chair thanks the gentleman. That concludes
the questions of the members here. We have two hearings going
on at the same time, so I am sure some of the Members will have
follow-up questions. We will send them to you. We ask that you
please respond promptly, if you would. This is very, very
important hearing. Thank you very much for the information, for
coming today. I remind the members they have 10 business days
to submit questions for the record, and members should submit
those questions by the close of business on Thursday, December
5th.
Without objection, this subcommittee is adjourned.
[Whereupon, at 12:25 p.m., the subcommittee was adjourned.]
[Material submitted for inclusion in the record follows:]

Prepared statement of Hon. Fred Upton

Mr. Chairman, thank you for holding today's hearing on the
federal regulation of mobile medical apps, software, and other
health technologies as medical devices. We began this work last
Congress as part of the enactment of the Food and Drug
Administration Safety and Innovation Act. Innovation in this
sphere must be protected, which is why we included a provision
in the law on the regulation of these technologies, including
medical apps.
In March, three Energy and Commerce subcommittees,
including Health, held hearings on this important topic. At the
hearings, we heard from a broad spectrum of witnesses,
including a patient group and the Food and Drug Administration.
The witnesses believed that these technologies have the
potential to transform health care and help millions of
patients, adding that in order to continue that progress,
patients, doctors, innovators, and Congress must work together
to ensure that any regulation of health information
technologies protects innovation and patients.
In recent months, the FDA has taken significant action in
this area. The FDA's decision to step in and regulate some of
these technologies--by their own admission not all but some--is
something I think most people view positively. The issue for
this committee is how the FDA seeks to regulate in this space
and what that means to patients and innovators both now and in
the future.
I commend the FDA for its recognition that it needed to act
in this space. However, I also recognize that the FDA today is
ill-equipped with its current regulatory tools to manage such
an undertaking. Therefore, I promise to work with the FDA to
modernize these tools and regulations moving forward.
Vice-Chairman Blackburn, along with a bipartisan group of
colleagues from this committee, has put forward one such
proposal. It would give the FDA new and updated tools to
regulate medical apps and other technology as software rather
than as medical devices. It is my hope that FDA takes this
offer of support seriously and will commit to working with this
committee on the bipartisan, commonsense proposal we will
examine today.
----------

Prepared statement of Hon. Lois Capps

I think the evolution of medical apps-and the important
balance that must be struck between patient safety and
encouraging innovation. And clearly any regulatory framework
must be clear and predictable for all the parties involved and
resources targeted on only those products that provide risk,
while allowing for the flexibility of new technologies that we
have not yet dreamed of.
The FDA guidance put out to date strikes this balance and I
am eager to see the health IT regulatory strategy report when
it is released. I also appreciate my colleagues working on the
SOFTWARE Act to keep us focused on this important issue. I hope
today's hearing-and the forthcoming report-can be used to
further inform that legislation before we move to any sort of
markup here in committee.
I also encourage the Chairman to look at complementary
legislation-the Medical Checklist Act-that Mr. Holt and I have
introduced again this Congress. Checklists-whether on paper or,
increasingly, included in medical apps or electronic health
records are simple, yet effective ways to reduce medical errors
and improve patient outcomes, and I would appreciate the
opportunity to have that discussion here on the subcommittee at
a future hearing.
----------

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