[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

                              ----------                              
                                                                   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.
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                 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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