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88–114 2014

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 

(II) 

COMMITTEE ON ENERGY AND COMMERCE 

FRED UPTON, Michigan 

Chairman 

RALPH M. HALL, Texas 

JOE BARTON, Texas 

Chairman Emeritus 

ED WHITFIELD, Kentucky 

JOHN SHIMKUS, Illinois 

JOSEPH R. PITTS, Pennsylvania 

GREG WALDEN, Oregon 

LEE TERRY, Nebraska 

MIKE ROGERS, Michigan 

TIM MURPHY, Pennsylvania 

MICHAEL C. BURGESS, Texas 

MARSHA BLACKBURN, Tennessee 

Vice Chairman 

PHIL GINGREY, Georgia 

STEVE SCALISE, Louisiana 

ROBERT E. LATTA, Ohio 

CATHY MCMORRIS RODGERS, Washington 

GREGG HARPER, Mississippi 

LEONARD LANCE, New Jersey 

BILL CASSIDY, Louisiana 

BRETT GUTHRIE, Kentucky 

PETE OLSON, Texas 

DAVID B. MCKINLEY, West Virginia 

CORY GARDNER, Colorado 

MIKE POMPEO, Kansas 

ADAM KINZINGER, Illinois 

H. MORGAN GRIFFITH, Virginia 

GUS M. BILIRAKIS, Florida 

BILL JOHNSON, Missouri 

BILLY LONG, Missouri 

RENEE L. ELLMERS, North Carolina 

HENRY A. WAXMAN, California 

Ranking Member 

JOHN D. DINGELL, Michigan 

Chairman Emeritus 

FRANK PALLONE, JR., New Jersey 

BOBBY L. RUSH, Illinois 

ANNA G. ESHOO, California 

ELIOT L. ENGEL, New York 

GENE GREEN, Texas 

DIANA DEGETTE, Colorado 

LOIS CAPPS, California 

MICHAEL F. DOYLE, Pennsylvania 

JANICE D. SCHAKOWSKY, Illinois 

JIM MATHESON, Utah 

G.K. BUTTERFIELD, North Carolina 

JOHN BARROW, Georgia 

DORIS O. MATSUI, California 

DONNA M. CHRISTENSEN, Virgin Islands 

KATHY CASTOR, Florida 

JOHN P. SARBANES, Maryland 

JERRY MCNERNEY, California 

BRUCE L. BRALEY, Iowa 

PETER WELCH, Vermont 

BEN RAY LUJAN, New Mexico 

PAUL TONKO, New York 

JOHN A. YARMUTH, Kentucky 

(III) 

SUBCOMMITTEE ON HEALTH

JOSEPH R. PITTS, Pennsylvania 

Chairman 

MICHAEL C. BURGESS, Texas 

Vice Chairman 

ED WHITFIELD, Kentucky 

JOHN SHIMKUS, Illinois 

MIKE ROGERS, Michigan 

TIM MURPHY, Pennsylvania 

MARSHA BLACKBURN, Tennessee 

PHIL GINGREY, Georgia 

CATHY MCMORRIS RODGERS, Washington 

LEONARD LANCE, New Jersey 

BILL CASSIDY, Louisiana 

BRETT GUTHRIE, Kentucky 

H. MORGAN GRIFFITH, Virginia 

GUS M. BILIRAKIS, Florida 

RENEE L. ELLMERS, North Carolina 

JOE BARTON, Texas 

FRED UPTON, Michigan (ex officio) 

FRANK PALLONE, JR., New Jersey 

Ranking Member 

JOHN D. DINGELL, Michigan 

ELIOT L. ENGEL, New York 

LOIS CAPPS, California 

JANICE D. SCHAKOWSKY, Illinois 

JIM MATHESON, Utah 

GENE GREEN, Texas 

G.K. BUTTERFIELD, North Carolina 

JOHN BARROW, Georgia 

DONNA M. CHRISTENSEN, Virgin Islands 

KATHY CASTOR, Florida 

JOHN P. SARBANES, Maryland 

HENRY A. WAXMAN, California (ex officio) 

(V) 

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 

(1) 

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 

2 

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. 

3 

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 

4 

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 

5 

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 

6 

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 

7 

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. 

8 

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 reVerDate Nov 24 2008 15:06 Jun 09, 2014 Jkt 037690 PO 00000 Frm 00014 Fmt 6633 Sfmt 6633 F:\MY DOCS\HEARINGS 113\113-99 CHRIS
9 

mote 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 multistakeholder 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. 

21 

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. 

22 

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 

23 

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 

24 

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 

25 

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 raVerDate Nov 24 2008 15:06 Jun 09, 2014 Jkt 037690 PO 00000 Frm 00031 Fmt 6633 Sfmt 6633 F:\MY DOCS\HEARINGS 113\113-99 CHRIS
26 

diation 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. 

27 

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. 

28 

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. 

29 

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. 

30 

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 

31 

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. 

32 

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 

33 

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 

34 

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. 

35 

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. 

36 

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 

37 

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 treatmentcure 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 

38 

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. 

39 

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. 

40 

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. 

41 

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 

42 

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 followup 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 ReVerDate Nov 24 2008 15:06 Jun 09, 2014 Jkt 037690 PO 00000 Frm 00048 Fmt 6633 Sfmt 6633 F:\MY DOCS\HEARINGS 113\113-99 CHRIS
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search; 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 riskbased 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-yearold 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, physiVerDate Nov 24 2008 15:06 Jun 09, 2014 Jkt 037690 PO 00000 Frm 00049 Fmt 6633 Sfmt 6633 F:\MY DOCS\HEARINGS 113\113-99 CHRIS
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cian 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 

55 

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 userfriendly 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 datarich 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 

68 

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 evidencesupported 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 exVerDate Nov 24 2008 15:06 Jun 09, 2014 Jkt 037690 PO 00000 Frm 00084 Fmt 6633 Sfmt 6633 F:\MY DOCS\HEARINGS 113\113-99 CHRIS
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ternal 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 

94 

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. 

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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 

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nificant 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, legVerDate Nov 24 2008 15:06 Jun 09, 2014 Jkt 037690 PO 00000 Frm 00108 Fmt 6633 Sfmt 6633 F:\MY DOCS\HEARINGS 113\113-99 CHRIS
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islative, 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 fastmoving 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 

104 

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, 

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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 

106 

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 followup 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. 

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I commend the FDA for its recognition that it needed to act in this space. However, I also recognize that the FDA today is ill-equipped with its current regulatory 

tools to manage such an undertaking. Therefore, I promise to work with the FDA 

to modernize these tools and regulations moving forward. 

Vice-Chairman Blackburn, along with a bipartisan group of colleagues from this 

committee, has put forward one such proposal. It would give the FDA new and updated tools to regulate medical apps and other technology as software rather than 

as medical devices. It is my hope that FDA takes this offer of support seriously and 

will commit to working with this committee on the bipartisan, commonsense proposal we will examine today. 

PREPARED STATEMENT OF HON. LOIS CAPPS

I think the evolution of medical apps-and the important balance that must be 

struck between patient safety and encouraging innovation. And clearly any regulatory framework must be clear and predictable for all the parties involved and resources targeted on only those products that provide risk, while allowing for the 

flexibility of new technologies that we have not yet dreamed of. 

The FDA guidance put out to date strikes this balance and I am eager to see the 

health IT regulatory strategy report when it is released. I also appreciate my colleagues working on the SOFTWARE Act to keep us focused on this important issue. 

I hope today’s hearing-and the forthcoming report-can be used to further inform that 

legislation before we move to any sort of markup here in committee. 

I also encourage the Chairman to look at complementary legislation-the Medical 

Checklist Act-that Mr. Holt and I have introduced again this Congress. Checklistswhether 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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