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22–361 2017

THE DISRUPTER SERIES: HEALTH CARE APPS 

HEARING 

BEFORE THE

SUBCOMMITTEE ON COMMERCE, MANUFACTURING, 

AND TRADE 

OF THE

COMMITTEE ON ENERGY AND 

COMMERCE 

HOUSE OF REPRESENTATIVES 

ONE HUNDRED FOURTEENTH CONGRESS 

SECOND SESSION 

JULY 13, 2016 

Serial No. 114–163 

( 

Printed for the use of the Committee on Energy and Commerce 

energycommerce.house.gov 

(II) 

COMMITTEE ON ENERGY AND COMMERCE 

FRED UPTON, Michigan 

Chairman 

JOE BARTON, Texas 

Chairman Emeritus 

ED WHITFIELD, Kentucky 

JOHN SHIMKUS, Illinois 

JOSEPH R. PITTS, Pennsylvania 

GREG WALDEN, Oregon 

TIM MURPHY, Pennsylvania 

MICHAEL C. BURGESS, Texas 

MARSHA BLACKBURN, Tennessee 

Vice Chairman 

STEVE SCALISE, Louisiana 

ROBERT E. LATTA, Ohio 

CATHY MCMORRIS RODGERS, Washington 

GREGG HARPER, Mississippi 

LEONARD LANCE, New Jersey 

BRETT GUTHRIE, Kentucky 

PETE OLSON, Texas 

DAVID B. MCKINLEY, West Virginia 

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 

LARRY BUCSHON, Indiana 

BILL FLORES, Texas 

SUSAN W. BROOKS, Indiana 

MARKWAYNE MULLIN, Oklahoma 

RICHARD HUDSON, North Carolina 

CHRIS COLLINS, New York 

KEVIN CRAMER, North Dakota 

FRANK PALLONE, JR., New Jersey 

Ranking Member 

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 

G.K. BUTTERFIELD, North Carolina 

DORIS O. MATSUI, California 

KATHY CASTOR, Florida 

JOHN P. SARBANES, Maryland 

JERRY MCNERNEY, California 

PETER WELCH, Vermont 

BEN RAY LUJA ́ N, New Mexico 

PAUL TONKO, New York 

JOHN A. YARMUTH, Kentucky 

YVETTE D. CLARKE, New York 

DAVID LOEBSACK, Iowa 

KURT SCHRADER, Oregon 

JOSEPH P. KENNEDY, III, Massachusetts 

TONY CA ́ RDENAS, CaliforniaS5904 

SUBCOMMITTEE ON COMMERCE, MANUFACTURING, AND TRADE

MICHAEL C. BURGESS, Texas 

Chairman 

LEONARD LANCE, New Jersey 

Vice Chairman 

MARSHA BLACKBURN, Tennessee 

GREGG HARPER, Mississippi 

BRETT GUTHRIE, Kentucky 

PETE OLSON, Texas 

MIKE POMPEO, Kansas 

ADAM KINZINGER, Illinois 

GUS M. BILIRAKIS, Florida 

SUSAN W. BROOKS, Indiana 

MARKWAYNE MULLIN, Oklahoma 

FRED UPTON, Michigan (ex officio) 

JANICE D. SCHAKOWSKY, Illinois 

Ranking Member 

YVETTE D. CLARKE, New York 

JOSEPH P. KENNEDY, III, Massachusetts 

TONY CA ́ RDENAS, California 

BOBBY L. RUSH, Illinois 

G.K. BUTTERFIELD, North Carolina 

PETER WELCH, Vermont 

FRANK PALLONE, JR., New Jersey (ex 

officio) 

(III) 

C O N T E N T S 

Page 

Hon. Michael C. Burgess, a Representative in Congress from the State of 

Texas, opening statement .................................................................................... 1 

Prepared statement .......................................................................................... 3 

Hon. Janice D. Schakowsky, a Representative in Congress from the State 

of Illinois, opening statement .............................................................................. 4 

Hon. Marsha Blackburn, a Representative in Congress from the State of 

Tennessee, opening statement ............................................................................ 5 

Hon. Frank Pallone, Jr., a Representative in Congress from the State of 

New Jersey, opening statement .......................................................................... 6 

Hon. Fred Upton, a Representative in Congress from the State of Michigan, 

prepared statement .............................................................................................. 93 

WITNESSES

Bettina Experton, M.D., M.P.H., President and CEO, Humetrix ........................ 8 

Prepared statement .......................................................................................... 11 

Answers to submitted questions ......................................................................

Laura Ferris, M.D., Assistant Professor, University of Pittsburgh, Department 

of Dermatology ..................................................................................................... 26 

Prepared statement .......................................................................................... 28 

Answers to submitted questions ......................................................................

E. Ray Dorsey, M.D., M.B.A., Professor of Neurology and Director of the 

Center for Human Experimental Therapeutics, University of Rochester 

Medical Center ..................................................................................................... 35 

Prepared statement .......................................................................................... 37 

Answers to submitted questions ......................................................................

Diane Johnson, North America Regulatory Affairs Policy and Intelligence 

Medical Devices, Johnson & Johnson ................................................................. 45 

Prepared statement .......................................................................................... 47 

Answers to submitted questions ......................................................................

Nicolas P. Terry, Hall Render Professor of Law and Executive Director of 

The William S. and Christine S. Hall Center for Law and Health, Indiana 

University Robert H. McKinney School of Law ................................................. 50 

Prepared statement .......................................................................................... 52 

Answers to submitted questions ......................................................................

Matt Patterson, M.D., President, Airstrip ............................................................. 54 

Prepared statement .......................................................................................... 57 

Answers to submitted questions ......................................................................

SUBMITTED MATERIAL

Statement of Fitbit .................................................................................................. 95 

Statement of Competitive Carriers Association .................................................... 98 

Statement of the Consumer Technology Association ............................................ 100 

Statement of the American Medical Association ................................................... 101 

Statement of Opternative, Inc. ............................................................................... 108 

(1) 

THE DISRUPTER SERIES: HEALTH CARE APPS 

WEDNESDAY, JULY 13, 2016 

HOUSE OF REPRESENTATIVES, SUBCOMMITTEE ON COMMERCE, MANUFACTURING, AND

TRADE, COMMITTEE ON ENERGY AND COMMERCE, Washington, DC. 

The subcommittee met, pursuant to call, at 10:20 a.m., in room 

2322, Rayburn House Office Building, Hon. Michael C. Burgess, 

M.D., (chairman of the subcommittee) presiding. 

Present: Representatives Burgess, Lance, Blackburn, Harper, 

Olson, Kinzinger, Bilirakis, Brooks, Mullin, Schakowsky, Clarke, 

Kennedy, Butterfield, Welch, and Pallone (ex officio). 

Staff Present: Rebecca Card, Assistant Press Secretary; James 

Decker, Policy Coordinator, Commerce, Manufacturing, and Trade; 

Graham Dufault, Counsel, Commerce, Manufacturing, and Trade; 

Melissa Froelich, Counsel, Commerce, Manufacturing, and Trade; 

Giulia Giannangeli, Legislative Clerk, Commerce, Manufacturing, 

and Trade, Environment and the Economy; Paul Nagle, Chief 

Counsel, Commerce, Manufacturing, and Trade; Tim Torres, Deputy IT Director; Olivia Trusty, Professional Staff, Commerce, Manufacturing, and Trade; Michelle Ash, Minority Chief Counsel, Commerce, Manufacturing, and Trade; Jeff Carroll, Minority Staff Director; Lisa Goldman, Minority Counsel, Commerce, Manufacturing 

and Trade; Caroline Paris-Behr, Minority Policy Analyst; Matt 

Schumacher, Minority Press Assistant; and Ryan Skukowski, Minority Policy Analyst. 

Mr. BURGESS. The subcommittee on Commerce, Manufacturing, 

and Trade will come to order. The chair will recognize himself for 

5 minutes for an opening statement. 

OPENING STATEMENT OF HON. MICHAEL C. BURGESS, A 

REPRESENTATIVE IN CONGRESS FROM THE STATE OF TEXAS 

Mr. BURGESS. Good morning. Thanks to everyone for being here. 

It is a hearing I have been looking forward to for some time. This 

is part of our Disrupter Series, and the Disrupter Series this morning is going to be examining mobile health apps. 

With health care being 17 percent of the Nation’s economy, it 

seems appropriate for the Disrupter Series to be in this space. I 

will also tell you I am a physician. I served the people of north 

Texas for over 25 years. And I am encouraged by this emerging 

technology within the healthcare system, and I look forward this 

morning to examining how it is transforming the way in which docVerDate Nov 24 2008 13:49 Jan 17, 2017 Jkt 037690 PO 00000 Frm 00005 Fmt 6633 Sfmt 6633 F:\MY DOCS\HEARINGS 114\114-163 CHRIS
2 

tors, patients and consumers approach and manage the delivery of 

care. 

Health apps are powered by the deployment of advanced 

broadband Internet technology and the mere ubiquitous 

smartphone adoption. The draw of mobile healthcare tools and 

services and health apps particularly lies in their potential to radically improve health care. The potential comes in part from enabling both sides of the equation: doctors and patients. For 

healthcare providers, health apps enable constant, instant, and 

real-time access to patient data, helping to make streamlining of 

work flows and decisionmaking processes, so the data is both more 

complete and more accessible. Doctors are also able to remotely 

monitor patient healthcare conditions, collaborate, and implement 

care. 

The emergence of mobile apps within the healthcare system is 

particularly exciting because of how they empower patients to gain 

access to and manage aspects of their health. Patients are using 

apps to track symptoms, send vital sign information to doctors, and 

set up medication adherence reminders. Patients are also using the 

technology to gain faster access to more routine healthcare services 

that are often inconvenient or time-consuming. Apps available on 

the market today create virtual waiting rooms where users can receive their prescriptions, engage in face-to-face video consultations 

with physicians, compare prices for health care, and make payments to a healthcare provider. The last is obviously, to me, very 

important. By enabling physicians to remotely monitor a patient’s 

health condition or by empowering consumers with information to 

engage in healthier living, health apps are driving more robust 

healthcare management and oversight from both patients and doctors. This can help improve the continuum of care. 

There are important issues that need to be addressed as more individuals turn to healthcare apps. Some of these issues include understanding how health apps are impacting the overall quality of 

care compared to in-person visits, whether the proper financial incentives are in place to increase the adoption of health apps, what 

additional infrastructure is needed to support the development and 

the use of health apps, some of the legal and policy barriers to 

health app adoption, and how to adequately educate patients and 

consumers about the capabilities and limitations of health apps, 

and finally, whether the regulatory framework governing our 

healthcare system today is, in fact, able to keep pace with lifesaving innovations made available through these apps. 

So I look forward to examining each of these issues throughout 

our discussion today. In addition, as with all Internet-connected 

things, applications, and devices, adequately addressing the privacy 

and security implications associated with health apps will be essential to driving this market. 

We have seen that healthcare data has a growing appeal among 

identity thieves and bad actors. We only need to look at the recent 

data breaches and the increase in ransomeware attacks on hospitals. It is critical that every actor in this space start by addressing privacy and security. If industry fails to do this, then Congress 

will be forced to do this. And, unfortunately, whatever Congress 

would like to do could very likely limit the potential of development 

3 

of this space and limit the ultimate success of the health apps market. 

It is interesting this summer is the 20-year anniversary of the 

passage of the Kennedy-Kassebaum Act. Needless to say, I was not 

here when that bill passed. Since it contains HIPAA, there is a 

downside, but the plus side is the Kennedy-Kassebaum Act allowed 

for the first time a demonstration project where 750,000 medical 

savings accounts were permitted. I was one of the early adopters 

of the medical savings account. In fact, I was fearful after the bill 

was signed into law that I would not get there in time to be able 

to set up a medical savings account. It turns out I needn’t have 

worried. The 750,000 subscriptions were not filled. But then that 

led in 2004 to the development of health savings accounts. 

And here’s the thing: The Commonwealth Foundation has published information on what they call the activated patient. Consumer-directed health care also helps to activate a patient. We 

want patients to be involved in their care. We think they make better decisions. I think that is the opportunity to hold down the cost 

in health care. So it is the marriage of the Health Savings Act, the 

consumer-directed health plan, and the activated patient all 

brought together by this technology that I think holds great promise for our system. 

Throughout this Disrupter Series, we have explored how technology is changing business, creating jobs, and improving the quality of life for Americans everywhere. The breakthrough of mobile 

apps into the healthcare system opens a significant opportunity to 

improve patient care, reduce healthcare costs, and make health 

care more accessible. 

I will thank the witnesses in advance for their testimony. I would 

now like to recognize the gentlelady from Illinois, Ms. Schakowsky, 

5 minutes for an opening statement, please. 

[The prepared statement of Mr. Burgess follows:] 

PREPARED STATEMENT OF HON. MICHAEL C. BURGESS

Good morning and welcome to our Disrupters Series hearings on mobile health 

apps. As a doctor who has served the people of North Texas for over 25 years, I 

am particularly delighted to explore this emerging technology within the health care 

system and examine how it is transforming the way in which doctors, patients, and 

consumers approach and manage the delivery of care. 

Health apps are powered by the deployment of advanced broadband internet technology and nearubiquitous smartphone adoption. The draw of mobile health care 

tools and services, and health apps in particular, lies in their potential to radically 

improve health care. The potential comes in part from enabling both sides of the 

equation, Doctors and patients. 

For health care providers, health apps enable constant, instant and real-time access to patient data, helping to streamline workflows and decision-making processes. 

So the data is both more complete and more accessible. Doctors are also able to remotely monitor patient health care conditions, collaborate and implement care. 

The emergence of mobile apps within the health care system is particularly exciting because of how they empower patients to gain access to care and manage their 

health. Patients are using apps to track their symptoms, send vital sign information 

to doctors, and set-up medication adherence reminders. Patients are also using the 

technology to gain faster access to more routine health care services that are often 

inconvenient and time-consuming. Apps available on the market today create virtual 

waiting rooms where users can: 

• receive prescriptions; 

• engage in secure face-to-face video consultations with physicians; 

• compare prices for care; 

4 

• and make payments to a health care provider. 

By enabling physicians to remotely monitor a patient’s health condition or empowering consumers with information to engage in healthier living, health apps are 

driving more robust health care management and oversight from both patients and 

providers. This can help improve the quality and continuum of care. 

There are important issues that need to be addressed as more individuals turn 

to health care apps.Some of these issues include: 

• Understanding how health apps are impacting the overall quality of care compared to in-person visits; 

• Whether the proper financial incentives are in place to increase the adoption of 

health apps; 

• What additional infrastructure is needed to support the development and use of 

health apps; 

•Legal and policy barriers to health app adoption at both the federal and state 

level; 

• How to adequately educate patients and consumers about the capabilities and 

limitations of health apps; 

• And whether the regulatory framework governing our health care system today 

is keeping pace with the life-saving innovations made available through these apps. 

I look forward to examining each of these issues throughout our discussion today. 

In addition, as with all Internet-connected things, applications, and devices, adequately addressing the privacy and security implications associated with health 

apps will be essential to driving this market forward. We have seen that healthcare 

data has a growing appeal among identity thieves and other bad actors—just look 

at the recent data breaches and an increase in ransomware attacks. It is critical 

that every actor in this space start by addressing privacy and security. If industry 

fails to do this then Congress will be forced to address it. And unfortunately, whatever Congress would do would likely limit the potential in this space and limit the 

success of the health apps market. 

Throughout the disrupter series we have explored how technology is changing 

business, creating jobs and improving the quality of life for Americans everywhere. 

The breakthrough of mobile apps into the health care system opens a significant opportunity to improve patient care, reduce health care costs, and make health care 

more accessible and affordable to all Americans. 

I thank the witnesses for their testimonies and I look forward to a thoughtful discussion on this topic. 

OPENING STATEMENT OF HON. JANICE D. SCHAKOWSKY, A 

REPRESENTATIVE IN CONGRESS FROM THE STATE OF ILLINOIS 

Ms. SCHAKOWSKY. So, today, we are continuing this Disrupter 

Series with healthcare apps. We talked about these apps a little 

during our recent hearing on wearables. Consumers use apps to 

track their calories, their exercise, and their sleep. The technology 

is advancing far beyond that. Health apps may help in the treatment of chronic medical conditions like diabetes. 

From a consumer perspective, health apps seem to blur the line 

between your smartphone and a more traditional medical device. 

However, that distinction can have important ramifications for the 

protections that consumers have. The efficacy and privacy standards for apps depend on whether it is a medical device or it is associated with an entity covered by HIPAA. 

Generally speaking, the Food and Drug Administration only regulates health apps when they are an accessory to a medical device 

or perform the function of a regulated medical device. Apps that 

dispense information or simply store data are usually not reviewed 

by the FDA. 

Without FDA review, consumers face the threat of false claims, 

which can be very dangerous when a person’s health is at issue. 

Last year, the Federal Trade Commission took action against two 

5 

apps that claimed to detect symptoms of melanoma using a 

smartphone camera. But the apps did not have a scientific basis for 

their claims to detect or diagnose melanoma in users. 

This case is yet another example of the FTC’s critical work to 

protect consumers from deceptive claims. Later today, we will be 

marking up a bill to undermine the FTC’s authority by shortening 

consent decrees and bogging down the FTC by requiring unnecessary review and analysis when it takes action. 

Innovation is good and should be encouraged, but industry selfregulation does not work. Bad actors will continue to make potentially life-threatening claims about what their products can do. We 

need a strong FTC to go to bat for consumers and stop bad actors 

from falsely claiming to diagnose skin cancer, for example. America’s health is at stake. 

Consumers want to be sure that health apps that they install 

don’t give false information. They also want their personal information on those apps protected. If you download an app to track blood 

sugar, that download in and of itself tells the app that you probably might or do have diabetes. The app is able to and often does 

sell this information to advertisers. 

A recent study in the Journal of the American Medical Association found that 80 percent of diabetes apps have no privacy policy 

in place and half of those that did have privacy policies that shared 

user data with third parties. 

In many cases, apps are not connected with entities covered by 

HIPAA. Only apps tied to health plans and healthcare providers 

would have the responsibility to safeguard protected health information. If it is a random app you found in the app store, your information is probably not protected. 

As with other technologies we have discussed in this Disrupter 

Series, we need to make sure that innovation and consumer protection go hand in hand as health apps continue to develop. These 

apps need to be designed with the well-being and the security of 

consumers in mind. So I look forward to hearing from our witnesses about the exciting new technologies coming to the market, 

and I hope to hear how we can ensure that consumers receive accurate information and that their sensitive health information is protected. 

I yield back, unless anybody wants my remaining time. 

Seeing none, I yield back. 

Mr. BURGESS. The chair thanks the gentlelady. The gentlelady 

yields back. 

The chair would like to recognize the vice chairman of the full 

committee, Mrs. Blackburn, 5 minutes for an opening statement 

please. 

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

Mrs. BLACKBURN. I want to welcome all of our witnesses. We are 

appreciative that you are here. 

And, Mr. Chairman, I thank you for the attention to the issue. 

And I want to just bring up the SOFTWARE Act, which Mr. Green 

and I have put a lot of effort into over the past several years. It 

6 

has been included in the Cures legislation. We look forward to the 

Senate finishing that and moving Cures to the President’s desk. 

But the SOFTWARE Act really addresses much of what we are 

going to discuss today. And, as the chairman said, technological innovation around health informatics and health software and wireless platforms, such as smartphones and iPads, holds great promise 

for the healthcare system, both for patients and for providers. And 

we are excited about some of the innovation that can be there, 

whether it is Bluetoothing, pharmaceuticals, or home healthcare 

providers that are entering and transmitting and holding data on 

their patients. 

There are concerns about the regulatory framework that exists 

around this, and I will say simply, as we have worked on this issue 

through the years, we have to go back and look historically at what 

we did with the FDA. Congress said, in the 1930s, this is what is 

a pharmaceutical. In the 1970s, we defined a medical device. And 

now it is time for us to create a classification for healthcare technology and put the FDA on the right track. Should there be some 

regulatory flexibility there, because technology changes faster than 

Congress is going to change a statute? Absolutely, there should be 

that flexibility. But there should also be the awareness that most 

of the healthcare informatics components, the smartphone apps, 

whether they are used for providers or by patients, should be able 

to go directly to the marketplace. They shouldn’t be over to the 

FDA and shouldn’t have to have this subjective approach of, if we 

think it is necessary, then we will on a case-by-case basis decide 

how we regulate technology. We think that that is inappropriate in 

and of itself. We want some clarity and some certainty for 

innovators. Therefore, we are encouraging the completion of the 

SOFTWARE Act through 21st Century Cures. 

We know that it would be helpful to the delivery of health care, 

to the telemedicine concepts for meeting the healthcare needs of 

those in remote areas the more we utilize healthcare technology 

and informatics. 

And, Mr. Chairman, I thank you for your attention to the matter. 

We thank you all for being here today for the discussion, look forward to the conversation. And I will yield my time back to you or 

to anyone who is in search of time. 

[The prepared statement of Mrs. Blackburn follows:] 

Mr. BURGESS. Very well. The gentlelady yields back. The chair 

thanks the gentlelady. 

The chair recognizes the gentleman from New Jersey, Mr. Pallone, 5 minutes for an opening statement, please. 

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

Mr. PALLONE. Thank you, Mr. Chairman. 

Mobile devices have become an indispensable part of our daily 

lives, and apps are a major reason why. For millions of consumers, 

the smartphone has become more than just a means to call or text. 

It is now their personal scheduler, navigator, jukebox, television 

and much more, thanks to apps available for download online. 

7 

Health apps, which have risen in popularity in recent years, look 

to add physician, personal trainer, and dietician to that list as well. 

Many of these apps perform relatively simple tasks, such as helping users keep track of their calories or sending out a reminder to 

take a prescription. Other apps may actually analyze and diagnose 

a medical condition, effectively eliminating the need for a doctor’s 

appointment altogether in some cases. And consumers and physicians alike are embracing health apps as a way to better manage 

and administer care. A growing health app marketplace mirrors a 

rising health consciousness amongst Americans, and we should 

support technology that yields positive outcomes for consumers. 

Like many of the technologies this subcommittee has examined 

this Congress, however, we must also be aware of the potential 

risks to personal safety, privacy, and data security. The safety and 

effectiveness of these apps should be closely examined. An inaccurate calorie counting app may be an inconvenience, but an app 

that incorrectly diagnoses a cancerous skin condition could be fatal. 

It is, therefore, essential that consumers and physicians understand the limitations of each app and recognize when they cannot 

substitute for a doctor’s visit. 

Personal health information is a prime target for hackers, and 

breaches of this type of information in recent years have been devastating for consumers. In addition to these security gaps, I am 

also concerned with the lack of adequate privacy protections on a 

large percentage of these health apps. Healthcare data contains addresses, Social Security numbers, in addition to diagnosis and prescription history. The more apps that handle this information, the 

greater the risk of a privacy breach for consumers. And exacerbating the health privacy problems is consumer confusion and, 

frankly, confusion by many stakeholders. Most people believe 

health information to be especially personal, requiring a higher 

level of privacy and security, yet the law protecting a person’s personal health records, the Health Insurance Portability and Accountability Act, HIPAA, applies only to health plans, healthcare 

clearinghouses, mosthealthcare providers, and their business associations. Many, if not most, health apps available right now in the 

app store are not covered entities under HIPAA. So, even if these 

apps collect the same information as a healthcare provider, the 

same protections may not apply. 

So mobile health technology is where we are, where we are 

going. As the mobile app industry continues to grow, I believe that 

prioritizing privacy, security, and safety will benefit consumers and 

businesses alike. And so I look forward to learning more about the 

potential of health apps to improve health outcomes for consumers 

and the protections that these apps are putting in place. 

Unless someone on my side wants the time, I yield back. Thank 

you, Mr. Chairman. 

Mrs. BLACKBURN. If the gentleman would yield to me. 

I am thrilled that Mr. Pallone is revealing his age by using the 

term ‘‘jukebox.’’ 

I yield back. 

Mr. PALLONE. I’m sorry. I didn’t say ‘‘icebox,’’ at least. That is 

even worse. And I say that sometimes too. 

I yield back. 

8 

Mr. BURGESS. The gentleman yields back. 

We will await punching B17 on the jukebox. 

That concludes member opening statements. The chair would 

like to remind members that, pursuant to committee rules, all 

members’ opening statements will be made part of the record. 

Again, we do want to thank all of our witnesses for being here 

this morning, taking time to testify before the subcommittee. Today’s witnesses will have the opportunity to give opening statements, followed by a round of questions from members. 

Our witness panel for today’s hearing will include Dr. Matt Patterson, President at AirStrip; Dr. Bettina Experton, President and 

CEO of Humetrix; Dr. Laura Ferris, Assistant Professor, University of Pittsburgh, Department of Dermatology; Dr. Ray Dorsey, 

Professor of Neurology and Director of the Center for Human Experimental Therapeutics at the University of Rochester Medical 

Center; Ms. Diane Johnson, Senior Director, North America Regulatory Affairs Policy and Intelligence Medical Devices, at Johnson 

& Johnson; and Mr. Nicolas P. Terry, Professor of Law and Executive Director of the William S. and Christine S. Hall Center for 

Law and Health at Indiana University, Robert H. McKinney School 

of Law. 

We appreciate each of you being here today. Ordinarily, we 

would begin the panel with Dr. Patterson, but are we still waiting 

for some technical assistance? Yes. 

OK. I do this all the time. This is the premier predominant technological committee in the United States House of Representatives, 

the greatest deliberative body in the free world, and we frequently 

have trouble with our electronics here. 

So, Dr. Experton, let us begin with you, and we will come back 

to Dr. Patterson at the end. 

STATEMENTS OF BETTINA EXPERTON, M.D., M.P.H., PRESIDENT AND CEO, HUMETRIX; LAURA FERRIS, M.D., ASSISTANT 

PROFESSOR, UNIVERSITY OF PITTSBURGH, DEPARTMENT 

OF DERMATOLOGY; E. RAY DORSEY, M.D., M.B.A., PROFESSOR 

OF NEUROLOGY AND DIRECTOR OF THE CENTER FOR 

HUMAN EXPERIMENTAL THERAPEUTICS, UNIVERSITY OF 

ROCHESTER MEDICAL CENTER; DIANE JOHNSON, NORTH 

AMERICA REGULATORY AFFAIRS POLICY AND INTELLIGENCE MEDICAL DEVICES, JOHNSON & JOHNSON; NICOLAS P. TERRY, HALL RENDER PROFESSOR OF LAW AND EXECUTIVE DIRECTOR OF THE WILLIAM S. AND CHRISTINE S. 

HALL CENTER FOR LAW AND HEALTH, INDIANA UNIVERSITY 

ROBERT H. MCKINNEY SCHOOL OF LAW; AND MATT PATTERSON, M.D., PRESIDENT, AIRSTRIP 

STATEMENT OF BETTINA EXPERTON, M.D., M.P.H. 

Dr. EXPERTON. Chairman Burgess, and distinguished subcommittee members, thank you for the opportunity to appear before you today to discuss the disruptive role of mobile health applications in transforming the U.S. healthcare system. My name is 

Dr. Bettina Experton, and I am the founder and CEO of Humetrix, 

a mobile health technology company based in Del Mar, California. 

9 

As a member of the Consumer Technology Association’s, CTA, 

Health and Fitness Technology Board, Humetrix actively worked 

on the CT Guiding Principles on the Privacy and Security of Personal Wellness Data because it is important that consumers understand both the potential value of patient-facing technologies and 

the privacy options they have. We believe that this will help drive 

adoption of these important lifesaving apps. Humetrix’s mobile 

health apps address critical health needs and can literally save 

lives. 

One of our apps, SOS QR, recently won the prestigious FCC 

Chairman’s Award and was designed to help anyone in an emergency situation. Through the app, anyone can call for help, send 

their GPS location, and even if the user is incapacitated, his or her 

critical health information can be made immediately accessible to 

emergency responders. And when you travel abroad, this information can be displayed in the language of that emergency responder 

automatically. 

Another Humetrix app, TENSIO, can help more than 30 million 

Americans with uncontrolled high blood pressure, managing their 

hypertension in consultation with their physicians. 

But, today, I would like to focus on our iBlueButton app, which 

won multiple industry innovation awards, which can greatly improve patient safety and reduce healthcare costs by addressing the 

issue of the lack of interoperability of disparate electronic health 

record systems. 

The average Medicare beneficiary sees seven different doctors in 

a given year. Our veterans who access the VA healthcare system 

receive, in fact, more than 50 percent of their care outside the VA. 

Often they are transitioned from the DOD health system with complex medical needs. And the care transition is not optimum, as the 

exchange of VA and DOD records is complex to operate. In this environment, the potential of medical errors as a result of incomplete 

information is high. 

However, there is a cure: patient-facing mobile apps that put patients’ medical data in their own hands, securely and effectively. 

Randy Watson is a disabled Army veteran who served in Korea 

and Vietnam and is an active user of the Humetrix iBlueButton 

mobile app to assemble and annotate his health records from the 

VA, Medicare, and his private providers directly and securely on 

his own smartphone. Randy manages various service-connected 

health problems, survived multiple heart attacks and had several 

surgeries, some of which were performed by non-VA surgeons. Because the closest VA Medical Center is more than an hour away, 

in emergency situations, he often finds himself in a non-VA hospital closer to his home. He reports that having his VA and Medicare records on his mobile device has resulted in doctors quickly 

getting the information they need and, in many cases, avoiding repeating costly tests like MRIs. 

When Randy uses iBlueButton, the app will automatically get his 

Medicare claim data, translate billing codes and assemble these 

with his VA and private providers’ EHR data, automatically creating a usable and actionable summary record with all of his medications in one place, providers’ contact details, and the dates of his 

past tests and procedures on his mobile phone. This ensures that 

10 

his information is immediately accessible wherever he seeks care. 

And because all of his personal information resides on the device 

itself and all the computing is done in real time in the app, all personal data is safely and only stored on the user’s mobile device, 

encrypted under the user’s own control, rather than in the cloud or 

other servers, where it could be subject to hacking. 

With iBlueButton, more than 55 million Americans covered by 

Medicare, 10 million in the TRICARE program, and 9 million veterans using the VA system can securely download, understand, annotate, and share their medical history with any doctor to help ensure their own safety and control costs. Today, with the same 

goals, the State of New York is planning to provide next year a 

version of iBlueButton to their millions of Medicaid beneficiaries, 

who will be empowered with their own health information on their 

own phones wherever they receive care. 

In closing, I would like to thank you again for inviting me to testify today. At Humetrix, we believe that disruptive mobile technology, developed in the private sectors and placed in the consumer’s hands, can be the needed disrupter to change the face of 

health care. I look forward to answering any questions. Thank you. 

[The prepared statement of Dr. Experton follows:] 

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Mr. BURGESS. The chair thanks the gentlelady. The gentlelady 

yields back. 

Dr. Ferris, you are recognized for 5 minutes for an opening statement, please. 

STATEMENT OF LAURA FERRIS, M.D. 

Dr. FERRIS. Thank you. I appreciate the opportunity to testify 

today. I was invited here based on work that I have done showing 

the potential harm of mobile health technology, which both of you 

actually mentioned in your opening statements. However, I also do 

want to discuss how technology may improve patient care and access, particularly in my field of dermatology. 

The three points I would like to make and focus on are that direct-to-consumer apps that function as medical devices making unsubstantiated claims and that are not data-driven can put patients 

at a higher degree of risk, and regulatory oversight should reflect 

this. 

Telehealth applied to the field of dermatology does have the potential to improve patient access to high-quality care. And mobile 

health applications that aid in making a diagnosis really are most 

appropriately and safely used in the hands of physicians, and the 

regulatory path to developing such technologies should take into 

consideration the difference in risk posed by a medical device in the 

hands of a physician versus in the hands of a patient. 

So, because of the visual nature of my field of dermatology, we 

were really among the first fields to experience the breadth of applications that can be used in delivering mobile health care to patients. So I am going to talk a little bit about the good and the bad. 

So the first is my work as a researcher and clinician at the University of Pittsburgh. So I had many patients who came in and casually asked me about apps that they could download on their 

smartphone that allowed them to use their camera to take a picture of a mole and then the app would tell them ‘‘this looks good’’ 

or ‘‘this looks bad.’’ And so my research team and I thought this 

would be something interesting to study, because there really 

wasn’t data to back these up. 

So we decided to look at three different apps that were available 

in the app store that were automated, inexpensive or free, and gave 

an immediate response as to if that lesion was likely to be skin 

cancer or not, and then a fourth app that sent the image to a board 

certified dermatologist who then gave feedback on it. 

What we found is that these three automated apps missed a 

third to over 90 percent of the melanomas, which is our most deadly form of skin cancer, that we presented to them. The board certified dermatologist missed only one. Really, that was less than 2 

percent of the melanomas in our study. 

What does this mean? This means that if a patient had decided 

to save some time and money and used one of these apps, they 

could have been dissuaded at least a third of the time from seeking 

medical attention for something that is a curable disease when it 

is caught and treated early but fatal when it is caught late. 

However, they wouldn’t have been aware of this, because these 

apps didn’t provide them with data, and they didn’t provide an adequate warning of the risk of a missed melanoma. So mobile medical 

27 

apps that interact directly with the patient without physician input 

had the greatest potential for harm. 

Our findings did also show, however, that store-and-forward teledermatology can be an effective way to diagnose skin cancer. However, this must be done safely. In the apps that we used, the physician was not providing an extension of an existing relationship, and 

they were not able to do things such as arrange followup care. And 

there are several similar apps in dermatology that are currently 

available online, and many of these actually don’t even provide care 

from a physician who is licensed in the United States. 

So it is important to realize that it is easier to ignore an app 

than it is to ignore a physician. It is also important to realize that 

a physician can provide care remotely as long as it is done safely. 

Finally, it is important that we have access for our patients to 

dermatologic care. We do have an issue of limited availability, particularly of dermatologists, and we think that this is a way that we 

can provide access to patients who might not have it otherwise. 

Finally, in addition, although I have already pointed out some of 

the pitfalls of using technology, in my own work, in collaboration 

with Carnegie Mellon University, we have developed a system that 

allows us to take an image taken with a tool attached to a 

smartphone called a dermatoscope that can allow us to upload an 

image of a skin lesion to a classifier, which can then analyze that 

and give an idea, give a score that helps to predict if that lesion 

is malignant or not. In our own study, we found that we could accurately identify 97 percent of melanomas with this tool. 

Others have developed similar technologies. We have always 

seen this as a tool that would be helpful in the hands of another 

healthcare provider, such as a primary care provider who may be 

seeing a patient with a suspicious lesion. It would allow them to 

get a basic risk assessment and communicate back with us. We 

have not seen this as a tool that would be helpful directly placed 

in the hands of a patient. 

So, in summary, I would just like to say that we think that the 

oversight of such tools should reflect the risk and that the risk in 

the hands of a physician is much lower than the risk directly in 

the hands of a patient. In addition, privacy concerns are allayed, 

because physicians in healthcare systems are covered entities 

under HIPAA. Thank you. 

[The prepared statement of Dr. Ferris follows:] 

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Mr. BURGESS. The chair thanks the gentlelady. 

Dr. Dorsey, you are recognized for 5 minutes for an opening 

statement, please. 

STATEMENT OF E. RAY DORSEY, M.D., M.P.H. 

Dr. DORSEY. Chairman Burgess, Ranking Member Schakowsky, 

members of the Commerce, Manufacturing, and Trade subcommittee, today we have the means to enable anyone anywhere 

to receive care, to participate in research, and to benefit from those 

advances. Unfortunately, policy barriers limit adoption of these 

new tools. 

I am a neurologist at the University of Rochester Medical Center 

in Rochester, New York, and for the past decade, my colleagues 

and I have been applying technologies, including smartphones, 

wearable sensors, and video conferencing, to enhance research and 

improve care for individuals with Parkinson’s disease and Huntington’s disease. Currently, clinical trials are plagued by limited participation and insensitive outcome measures. For example, only 3 

percent of individuals with cancer participate in clinical trials, and 

today, we assess whether a new drug works for Parkinson’s disease 

with paper diaries and subjective assessments of finger tapping. 

We can progress faster with better tools, including smartphones. 

In March 2015, Apple created ResearchKit, an open-source platform for creating smartphone research applications, and released 

applications for asthma, breast cancer, cardiovascular disease, diabetes and Parkinson’s disease. Within a day, 2,000 individuals 

were participating in the Parkinson’s disease study. In 7 months, 

over 70,000 individuals from every State in the union had enrolled 

in the study. In 1 year, nearly 10,000 Parkinson’s disease study 

participants were sharing their data with researchers globally. Because of their potential, pharmaceutical companies are incorporating smartphones into clinical trials. Such use could help determine whether new therapies are efficacious in smaller, shorter, 

cheaper studies and accelerate our ability to find treatments for 

Parkinson’s disease and other neurological disorders that will affect 

almost all of us. 

In addition to smartphones, we use video conferencing to care for 

individuals with Parkinson’s disease. Because of distance and disability, over 40 percent of Medicare beneficiaries with Parkinson’s 

disease do not see a neurologist. Those that do not see one are 

more likely to fracture their hip, more likely to be placed in a 

skilled nursing facility, and more likely to die prematurely. Simple 

videoconferencing, like Skype, enables clinicians to reach patients 

in their homes. In a pilot study, these virtual house calls were feasible, provided comparable outcomes to in-person care, and saved 

patients and their caregivers 3 hours of time and 100 miles of travel. With 18 centers, including Baylor, Northwestern, University of 

Kansas, and the University of Florida, we are conducting the first 

national randomized controlled trial of virtual house calls for Parkinson’s disease. 

Demand for telehealth is high. Over 11,000 individuals from 80 

countries and all 50 states visited the study’s Web site, and nearly 

1,000 individuals with Parkinson’s disease wanted to participate in 

this 200-person study, which will complete this summer. 

36 

Despite the promise and potential of these new technologies, policy barriers, including State licensure laws and Medicare’s narrow 

coverage, limit adoption. In 2015, Medicare spent less than onehundredth of 1 percent of its budget on telehealth. Currently, 

Medicare pays neurologists $150 to see a patient with Parkinson’s 

disease in a hospital-based clinic, $80 for a visit in a communitybased clinic, and zero dollars to see a patient remotely in her home. 

In essence, Medicare subsidizes institution-based care and 

disincents patient-centered care. 

Fortunately, policy solutions are available. The Tele-Med Act 

would enable any Medicare provider to care for me Medicare beneficiary. The act mirrors how physicians in the Veterans Administration can care for any veteran anywhere in the U.S., and last 

year, the VA provided over 2 million telehealth visits. 

The Medicare Telehealth Parity Act would expand Medicare’s 

coverage of telehealth, which today reaches veterans, military personnel, Medicaid beneficiaries, and prisoners, but largely excludes 

50 million older Americans. 

Fifty-one years ago, a Texan signed legislation that guaranteed 

all older Americans healthcare coverage. Two generations later, 

Medicare is showing its age. However, this committee, led by a 

Texan, can help ensure that this generation’s tools fulfill Medicare’s founding vision and extend care to every American senior everywhere. 

Thank you very much for your time and service. 

[The prepared statement of Dr. Dorsey follows:] 

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Mr. BURGESS. Thank you, Dr. Dorsey. 

Ms. Johnson, you are recognized for 5 minutes for an opening 

statement, please. 

STATEMENT OF DIANE JOHNSON 

Ms. JOHNSON. Before I begin my testimony, I would first like to 

thank Chairman Burgess for his key leadership on this issue and 

others. He has been a longstanding advocate for patients, and we 

appreciate his tireless efforts. 

Distinguished members of the subcommittee, thank you for the 

opportunity to come before you today and to detail critical applications within development at the Johnson & Johnson family of companies that will enhance physician and patient interaction while 

delivering additional patient tools in innovative ways. In addition, 

my testimony will focus on how Congress can help support these 

ongoing activities. 

As part of the Johnson & Johnson credo, we believe our first responsibility is to the doctors, nurses and patients, mothers and fathers, and all others who use our products. The commitment to 

safety is part of our DNA, factoring into our decisions and development of our products and services. 

With that credo in mind, J&J has developed a number of apps 

to help individuals monitor their health or health of their family 

and support the doctor-patient relationship. I will describe a few 

key points, but there are many more. 

The goal of this suite of apps is to empower patients, reduce cost 

of care, and enhance patient outcomes. 

OneTouch Reveal allows patients to check blood sugar results on 

a mobile phone or tablet. The app provides overviews and a 365- 

day logbook with colorful visuals and simple navigation. It provides 

the patient with the ability to share ongoing information with his 

or her physician, allowing for enhanced care management for people with diabetes. 

Care4Today Mobile Health Manager is a mobile app and Web 

site designed to support and motivate people to stay on schedule 

with their medication and report adherence to their treatment plan 

as prescribed by their physician. The application helps ensure that 

the physician is aware of possible drug interactions or problems 

with medication adherence. 

The PATIENT ATHLETE Program is designed to help patients 

preparing for surgery to take their experience beyond merely reducing the pain. The program encourages patients to emerge 

stronger, healthier, and ready for the next chapter of life. Key components include a self-guided video-based training program led by 

a performance coach who had a bilateral knee replacement and 

uses the same concepts to enhance his own experience. Eight core 

lessons, two per week, to complete over a 4-week period prior to 

surgery and 11 refresher lessons to complete post surgery. 

The Johnson & Johnson 7 Minute Wellness for Expecting and 

New Moms App is a science-based wellness resource designed to 

help new moms manage and expand their energy during pregnancy 

and after giving birth. 

The Digital Health Scorecard helps one determine one’s health 

score and better understand the likelihood of developing common 

46 

chronic diseases such as diabetes, heart or respiratory disease, or 

cancer. 

HEALTHYDAY gathers data from the same trusted sources that 

doctors and hospitals use and cross-references information with 

local crowd-sourced data to determine what illnesses are trending 

nearby. This help informs the user to determine whether what they 

are feeling may be a cold, the flu, or pesky allergies. Then when 

you are feeling great, it lets you see what is going on around local 

and sends real-time alerts to help you know what to watch out for. 

With this demand for cutting-edge technologies and continuous 

innovation, we as manufacturers must remain diligent in ensuring 

that cyber security is an integral part of the process. We believe 

that patient safety, including security of their data, is the most important consideration. To that end, foundational to our approach to 

cyber security is the development of a formalized security framework for our products. From a policy perspective, we believe that, 

in order to ensure the continuous innovation, smart regulation is 

critical. 

Currently, the FDA has shown great flexibility in establishing 

the types of apps for which the agency intends to exercise enforcement discretion; that is, the FDA will not enforce the requirements 

of the act. FDA released a guidance document that provides examples. This guidance document is extremely useful, and J&J is supportive of this approach, but having specific criteria that determines what is and is not regulated is key. 

Johnson & Johnson worked extensively with the HELP committee and other stakeholders to craft the language of the SOFTWARE Act that would provide this clarity. While additional work 

may need to be done to reconcile the SOFTWARE Act with the 

MEDTECH Act, the goals are similar, and we would encourage 

Congress to complete the work and provide companies with the regulatory certainty that will foster innovation and encourage investment in this space. 

We think the following considerations are critical, that the 

functionality is what is critical, what the app does—not the platform it runs on—and that the findings should be applied regardless 

of whether the app developer is or is not considered a medical device manufacturer. 

The policy changes are similar to those raised in the wearable 

devices hearing, including device security, data ownership, and privacy laws. 

We hope you can ascertain that Johnson & Johnson strongly encourages and supports these activities, which enhance the doctorpatient relationship and improve patient empowerment and access 

to medical products. We look forward to continue working with 

Congress. Again, thank you for the opportunity. 

[The prepared statement of Ms. Johnson follows:] 

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Mr. BURGESS. The chair thanks the gentlelady. 

Mr. Terry, you are recognized for 5 minutes for an opening statement please. 

STATEMENT OF NICOLAS P. TERRY 

Mr. TERRY. Chairman Burgess, Vice Chairman Lance, Ranking 

Member Schakowsky, and members of the subcommittee, it is a 

privilege to share my thoughts and some of the legal and regulatory issues involving healthcare apps. I congratulate this committee on its Disrupter Series and its engagement on these forward-looking and exciting issues. 

I live in a small village just north of Indianapolis, where I receive particularly superior representation. My day job is serving as 

a professor at Indiana University Robert H. McKinney School of 

Law. There I teach and write about health law and policy, with a 

particular interest in information technologies and healthcare data 

protection. 

Some of my work is examining the question, why health information technology, such as electronic health records or clinical decision support systems, has failed to transform or disrupt health 

care. I concluded there were several overlapping explanations. 

These included typical healthcare market failure problems, overarching structural issues, the illiquidity of healthcare data, and 

underperforming technologies. 

Not surprisingly, Federal and State policymakers have turned toward subsidy and command-control models in an attempt to promote HIT adoption. Mobile health and healthcare apps potentially 

avoid these problems. They posit inexpensive care pulled by patients only when needed and delivered away from inconvenient, 

centralized locations. 

Obviously, many mobile health apps will be developed with regard to existing healthcare relationships, offering improved condition management, particularly for chronic diseases. Many of these 

apps will be subject to existing regulatory models. 

However, the most disruptive health apps are those that are patient-facing. These create or may create a direct app-patient relationship that lacks professional intermediation and, as a result, 

traditional regulation of safety, quality, and confidentiality. 

The regulatory framework for most of these apps is complicated 

and, in some cases, troubling. Here, the oversimplified binary of 

regulation versus innovation is a poor frame. Rather, we have a 

current technological space that is subject to both over-regulation 

and under-regulation. This is also a space I would suggest where 

overarching labels, such as health apps, mobile health, or digital 

health, are not always helpful. Different apps for different functions used in different contexts by different persons pose quite diverse policy questions. 

For present purposes, I restrict my comments to three issues: 

safety, effectiveness, and data protection. 

First, the Food and Drug Administration has used a subregulatory guidance to signal a light touch regarding most categories of 

apps. However, patient diagnosis and treatment-recommending 

apps, that arguably could be useful and stimulate innovation, remain subject to traditional device regulation. Arguably, this apVerDate Nov 24 2008 13:49 Jan 17, 2017 Jkt 037690 PO 00000 Frm 00054 Fmt 6633 Sfmt 6633 F:\MY DOCS\HEARINGS 114\114-163 CHRIS
51 

proach frightens off responsible innovators while the FDA lacks the 

bandwidth to deal with the many industry minnows selling apps on 

the app stores that seem to cross the regulatory line. Such a state 

suggests that additional regulatory clarity is required, together 

with some innovative regulatory models that is more attuned to the 

rapid iteration in the mobile industry. 

Second, there is the question of app efficacy or effectiveness. 

Even if they are safe, many health apps are simply ineffective. The 

structure of the app market and the absence of effective 

infomediaries create immense problems for consumers looking for 

quality apps, creating doubts as to whether the market will function effectively. This is a classic consumer protection problem, and 

in my opinion, the Federal Trade Commission has taken the correct 

approach in demanding competent and reliable scientific evidence 

in app cases involving, for example, claims of melanoma detection 

and vision improvement. However, sufficient regulatory resources 

must be deployed in this endeavor lest innovative apps are 

drowned out by mobile health snake oil. 

Third, data protection. This is an area of acute under-regulation. 

Most patient-facing apps existing exist in what I call a HIPAA-free 

zone, subject only to a small number of State laws or, in the most 

egregious cases, to the FTC’s unfairness jurisdiction. Here, our 

flawed sectoral downstream approaches to data protection are on 

full display. 

This country has enjoyed a deep-rooted cultural expectation of 

and professional commitment to health privacy, no doubt in part 

because healthcare data seems particularly susceptible to discriminatory and other harmful uses. Every day, doctors rightfully reassure their patients as to the legally enforced confidentiality of the 

information they share while their offices distribute mandated privacy notices. However, the same or similar data collected on mobile 

devices lack these protections. Most mobile health apps, particularly the more disruptive patient-facing ones, are not subject to 

HIPAA privacy and security rules, leaving patient wellness and 

health data woefully unprotected. In my opinion, Federal data protection law that obviates the gaps between our commercial sectors 

and protects health information wherever it happens to reside is 

overdue and is a necessary precondition for the full embrace of disruptive health apps by both medical professionals and consumers. 

Again, I express my thanks to the committee. 

[The prepared statement of Mr. Terry follows:] 

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Mr. BURGESS. The chair thanks the gentleman. 

The gentleman yields back. 

Dr. Patterson, we will come to you finally. Are we good? 

Dr. PATTERSON. I hope so, sir. 

Mr. BURGESS. I hope so too. Very well. You are recognized for 5 

minutes. Regardless of whether the technology works, we are 

happy you are here and look forward to what you have to say. 

STATEMENT OF MATT PATTERSON, M.D. 

Dr. PATTERSON. Chairman Burgess, Ranking Member Schakowsky, and members of the subcommittee, thank you for the opportunity to be here with you. 

I am excited to hopefully show a glimpse of the software that my 

firm, AirStrip, creates because I think that that is the best way to 

really demonstrate the opportunity for mobile health to improve 

healthcare outcomes as well as to set the platform to talk about 

some of the challenges. 

So, as a United States Navy physician, I got my first taste of the 

value of mobile technology in remote care. I left clinical practice to 

devote my career toward the improvement of healthcare access, 

quality, and cost efficiency at scale in the United States. Before I 

joined AirStrip, I consulted with major U.S. health firms around 

the country as they transitioned from fee-for-service based reimbursement to value-based reimbursement. And I saw firsthand 

that, after waves of cost-cutting, they finally realized that the only 

way to really move the needle further and get further gains is to 

bring about broad transformation in healthcare delivery, and that 

is shifting high-quality care to lower cost settings, using all the resources. So now, as president of AirStrip, I feel very fortunate to 

be creating solutions to address that challenge. 

I would like to show you what AirStrip created with the following 

scenario. So imagine I am a doctor, and I am in a value-based care 

program like the Medicare Shared Savings Program. I get a call 

from a patient from the call center on a patient, who was discharged 2 weeks ago with heart failure, now feeling short of breath 

at home and wondering what to do. The primary care doctor is a 

colleague, but let’s say I don’t know the patient very well. I get a 

name and phone number from the call service and that is it. 

So when I was in this situation as a doctor, I would try desperately to create some kind of objective context before I made that 

phone call. But, since that was usually impossible, most of those 

phone calls ended with: You should go to the emergency department. 

Today, we must do better. We must prevent avoidable escalations 

in care while improving outcomes, and we need the right tools to 

do that. So, hopefully, if all goes well, I can show you that. 

The eagle has landed. OK. So I would, of course, have to authenticate and log in, either with biometrics or a password, but once I 

am in and I find my patient, I get, in near real time, a longitudinal 

view of this patient’s data, multiple tiles populating on the fly from 

multiple disparate sources of information. 

So, if this patient had home monitors, I would be able to pull up 

home monitoring data, see trended vital signs, like weight and 

blood pressure, since the patient was discharged. Since I don’t 

55 

know the patient that well, I could then view documents that were 

logged by their primary care doctor. And since the patient was just 

recently discharged from the hospital, I could also take a look at 

a different electronic medical record note that came from the hospital setting. 

So, right there, with 10 seconds and three clicks, I can do what 

was previously impossible for doctors. I mean, I can’t explain the 

revelation that doctors have of being able to go to one place and 

not have to log in 20 different times in order to view this data. 

We can also accommodate FDA-regulated medical devices. In 

fact, we were pioneering the first medical software to be a Class 

II regulated medical device. So I can view at 12G ECG on this patient if they had a body sensor monitoring them at home, and I can 

view that side by side with an electrocardiogram that was done 

perhaps in the hospital. And the level of fidelity that I can pull up 

in real time using pinch and zoom and normal gestures that we all 

use on our smart devices, I can see very, very minute detail. 

Let’s say that I wanted to get a quick opinion from a cardiologist 

about this patient. I could send a HIPAA-compliant secure text to 

another doctor, and I could share in real time where I was in this 

exact link to this electrocardiogram. So text-based asynchronous 

work flows are the norm now in health care. It has totally replaced 

phone calls in many circumstances. 

So, as a recipient cardiologist, when I get this, I can then explore 

other places in the work flow, to include looking at other monitors 

that may be hooked up to the patient—in this case a cardiac monitor—that I can search through, or I can even look as if I am standing at the bedside in near real time, wherever I am, wherever the 

patient is, across the continuum of care. 

So, with a view like this, when I have all of the data in one 

place, it is much easier for me to come to a conclusion to tell this 

patient ‘‘you should come to my office, and I can see you immediately right now’’ or ‘‘come tomorrow morning,’’ and I will feel a 

lot more confident about that if that is the right decision. 

So if we are going to do anything when it comes to helping clinicians in a value-based reimbursement climate, we have to address 

work flow improvement. And by ‘‘work flow,’’ I mean, the way that 

people interact with data on devices. It is the clicks they have. It 

is the swipes of the screen that they do. And I think that that is 

the thing that is making the biggest difference in mobile health 

technology on the provider side and the physician side, is making 

it easier for them to interact with that data. 

I describe several challenges in my written testimony, but very, 

very briefly, I think mobile help applications require true interoperability with existing data sources. So, in technical terms, we need 

open, bidirectional, complete, and affordable outpatient programming interfaces. And the technology already exists to do that today. 

We don’t need future standards. 

Interoperability enforcement can be strengthened through seamless grant and incentive structures. On the regulatory front, there 

is an opportunity to improve and clarify mobile health technology 

classification by the FDA and to expedite real-time communication 

on submissions for innovative solutions that may not fit in previous 

categories. 

56 

Finally, updating telehealth definitions for HIPAA and other 

policies to reflect the current state of technology offerings would be 

very welcome. 

Thank you again for the opportunity. I apologize for taking a little bit of extra time, but I appreciate the opportunity to show our 

software to you. 

[The prepared statement of Dr. Patterson follows:] 

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Mr. BURGESS. The chair thanks the gentleman. 

So I want to thank all of our witnesses for their succinct presentations this morning. 

Dr. Patterson, it was worth the wait to see your mobile device 

up on the big screen. 

We are going to move to the question-and-answer portion of the 

hearing, and I would like to recognize the gentleman from New 

Jersey, Mr. Lance, to begin the questioning. 

Five minutes, please. 

Mr. LANCE. Thank you, Mr. Chairman. 

And good morning to the panel. 

To Ms. Johnson from J&J, the FDA issued mobile medical app 

guidance in 2015 to help stakeholders understand how the FDA 

plans to oversee healthcare apps that include medical device 

functionalities. In your judgment, is there a need for more regulatory clarity and certainty, particularly regarding the FDA’s enforcement discretion for healthcare apps that do not operate as 

medical devices? 

Ms. JOHNSON. Yes. We do support that legislative clarity is needed in this area. 

Mr. LANCE. Is regulatory uncertainty affecting investment and 

innovation in the healthcare apps market, not only regarding J&J 

but based upon your experience across the entire field? 

Ms. JOHNSON. At Johnson & Johnson, we are a very large company. We have very sophisticated regulatory departments and extensive law departments. And I think for us it is somewhat easier 

to navigate. Where we see the real struggle is with the smaller innovative app developers, the one-, two-, three-people companies 

that don’t have access to the level of expertise. Their level of comfort with enforcement discretion and the investor’s level of comfort 

with enforcement discretion is certainly, from my experience, quite 

a bit lower than it is with J&J. So I believe it is really impacting 

the small companies. 

Mr. LANCE. Are there other distinguished members of the panel 

who would like to comment on that? What would you propose is the 

right level of FDA and FTC oversight over apps that don’t meet the 

definition of a mobile medical app under the FDA’s guidance but 

may have health- and medical-related components, Ms. Johnson? 

Ms. JOHNSON. Well, the decision should be risk-based, as long as 

they don’t—they are not performing functions that meet the definition. The current regulatory environment is positive, but we do believe that the patient privacy aspects need to be better addressed 

and a patient’s ownership of the data and the ability of people to 

sell patient’s data should be more transparent. 

Mr. LANCE. And I think we are all of that view, that patients’ 

privacy should be foremost, and certainly that is something on 

which we should be working here in Washington. And I started 

with you because J&J is a great New Jersey company, and much 

of J&J is in the district I have the honor of serving. 

Dr. Patterson, from your perspective, what are the biggest legal 

and policy barriers preventing or obstructing the adoption of 

healthcare apps and other digital healthcare technologies for patients and for providers? 

77 

Dr. PATTERSON. I think some of the greatest challenges right now 

that we face on the policy and regulatory front have to do with both 

interoperability enforcement as well as to clarity from the FDA on 

classification of more innovative solutions. 

So, briefly, on the second point—and it feeds on what you were 

just talking about—I think that we have to consider situations 

where a platform can accommodate both data that is in the sophisticated medical device, medical grade world of sensors as well as 

be able to accommodate consumer-based data in one place, because 

the combination of those two data elements can lead to some very, 

very insightful analytics and predictive insights about patient behavior and outcomes. 

And so the concept that I would introduce is one of provenance, 

and provenance refers to knowing where a piece of data comes 

from. So getting clarity on data provenance and what the burden 

is of provenance, that when a consumer device or a medical device 

shares its data with something else, you know where that data element came from and what grade of data element that was. 

Mr. LANCE. And is provenance an area where, working together, 

we have to do a better job? 

Dr. PATTERSON. I would agree so, yes. 

Mr. LANCE. Thank you. 

I yield back 35 seconds, Mr. Chairman. 

Mr. BURGESS. The admonition to do a better job is so noted and 

will be taken under advisement by the chair. 

The chair recognizes the gentlelady from Illinois, Ms. Schakowsky, 5 minutes for questions, please. 

Ms. SCHAKOWSKY. Thank you, Mr. Chairman. 

Thank you, panel. 

There was an article this week in the New York Times that prescribed caution for consumers seeking medical advice from Web 

sites and apps instead of going directly to a doctor. 

The study, conducted by doctors at the Mayo Clinic, tested the 

quality of medical advice provided by health Web sites, and the 

doctors found that, ‘‘going online for health advice was more likely 

to result in getting no advice or incomplete advice than the right 

advice.’’ 

Now, Dr. Ferris, you conducted a similar study of apps meant to 

detect skin cancer. As you said in your testimony, you had similar 

results to the Mayo Clinic study. It seems that false negatives are 

a particular concern with these apps. What happens if an app 

falsely tells a person that a mole is benign? 

Dr. FERRIS. If an app falsely tells a person that their melanoma 

is benign and reassures them that they can save their time and 

money and not go see a physician, the consequence will be that 

that melanoma is going to progress. It is going to be deeper. And 

it goes from being what is, diagnosed early, a fairly surgically curable disease with a simple inexpensive procedure to a fatal cancer. 

Ms. SCHAKOWSKY. And were the apps that you tested intended 

to be used with physicians, or were they meant for consumer use? 

I guess you called that, Mr. Terry, consumer-facing, is that what 

you said? 

Mr. TERRY. Patient-facing. 

78 

Ms. SCHAKOWSKY [continuing]. Patient-facing apps and using 

that app instead of going to a doctor? 

Dr. FERRIS. In our study, we tested four apps. And the first three 

that were automated were intended to be patient-facing, and they 

were not used in conjunction with a physician. So it was to give 

the patient an assessment of the risk of their lesion being skin cancer, and it would say, looks OK, green light, things like that, or it 

would say, red light, caution, get this looked out. 

They all contain some sort of small disclaimer but really not significant or sufficient information about the risk of misdiagnosis. 

None of them had data saying how likely they were to be wrong 

or the risk of a false positive versus a false negative. 

Ms. SCHAKOWSKY. And none of them made a suggestion that they 

go see a physician if they have further questions? 

Dr. FERRIS. They generally somewhere in their warnings would 

say things like, you should see a physician if you have concerns. 

The problem is that that wasn’t highlighted in the output that they 

gave, and they still gave medical advice, they still gave an assessment of that lesion. 

Ms. SCHAKOWSKY. I am just wondering from the panel, should we 

be considering this in two different categories, those that deal with 

professional health providers and those that are just alone, patientfacing? Is there anyone who disagrees with that? 

Dr. FERRIS. So that is, I think, a very important distinction. 

So part of the reason—I have been interested in this idea of 

using technology to diagnosis skin cancer, and I think that there 

is potential that it can be helpful and safe. 

As I mentioned, sort of, at the end of my statement, I am working on a technology with computer scientists at Carnegie Mellon in 

Pittsburgh where, you know, we are doing validation studies. We 

are trying to understand how we can use technology to better understand melanoma. 

We have very promising early results. However, I would never 

put that out and make it available to my patients, because I feel 

that this is technology better used in the hands of a physician. We 

all know, all of us who are physicians up here know that sometimes your clinical judgment overrules what the tests that you ordered showed. 

And so, really, I am a proponent of having really a little more 

flexibility and regulations that respect the decreased risk when 

there is additional information provided to a physician and it is 

really physician-to-physician communication that is being impacted 

or data being provided to a physician who ultimately communicates 

that back to the patient and helps to make a decision about the 

course of the treatment of that patient. 

Ms. SCHAKOWSKY. Dr. Patterson, in the display that you had, the 

doctor that is looking at all the data is not the physician that the 

patient normally goes to. Is that true? 

Dr. PATTERSON. It can be a situation where it is a primary physician, or it could be a colleague or another member of the care team. 

Ms. SCHAKOWSKY. But on that care team. 

Dr. PATTERSON. Correct. 

Ms. SCHAKOWSKY. I see. 

79 

Again, is there anyone here who thinks that there ought not to 

be a distinction between those that are physician-driven, that are 

healthcare-provider-driven, and just the app? 

Did you want to answer that? 

Ms. JOHNSON. I think when we were working on the language 

around the SOFTWARE Act, we tried very hard to embody the concept that there is a big difference and that, if it is the patient trying to make a decision, that is a lot different than the physician. 

And the physician who is getting the information needs to understand the context around the information that they are receiving. 

And we do believe it makes a critical difference. 

Ms. SCHAKOWSKY. OK. 

Can Dr. Dorsey reply? 

Dr. DORSEY. The FDA guidance is around regulating apps that 

are used to diagnosis or treat a condition, and I think that is great 

guidance. Apps that empower consumers to give them more information on how they are sleeping, how they are eating, how they 

are exercising, potential medication interactions, those are all very 

valuable. 

I think the concern comes around when you are giving a diagnosis or a treatment recommendation. I think that would be the 

distinction that I would highlight. 

Ms. SCHAKOWSKY. Right. 

And that is your expertise, too, Mr. Terry. What did—— 

Mr. TERRY. I think, yes, the patient-facing-against-professionalfacing differentiation is important. But, equally, I think, as this 

moves forward with the pace that it is showing, we may end up 

with additional categories, including some sort of hybrid categories. 

I think it is also quite possible that we would want to get more 

granular and distinguish between some patient-facing apps and 

others. So, for example, the risk of a melanoma negative, a false 

negative, is such that we maybe wouldn’t want that. But, on the 

other hand, personally, I would find it quite useful if my watch 

would tell me when I am about to have a myocardial infarction and 

tell my car to pull over and also phone my spouse and tell her I 

am going to be late for dinner. 

Ms. SCHAKOWSKY. Thank you. 

Dr. EXPERTON. If I may add a point on this, Mr. Chairman, yes, 

those patient-facing mobile apps can also be extremely important 

in the physician-patient communication. 

We discussed, you know, how we want to avoid medical harm. 

Today, in America, the third-leading cause of deaths are medical 

errors. About one-fourth of them are caused by the fact that, at any 

given point in time, a physician doesn’t have the full picture of the 

history of that patient. 

So when a patient comes with a medical app which provides the 

key information that a physician needs to properly diagnosis and 

treat, we can address a dramatic public health issue. And so, with 

those apps, we are talking about enhancing the physician-patient 

communication, and then the patient provides that information the 

physician is seeking, which often lacks when that Medicare beneficiary comes alone or with a family caregiver and comes a critical 

question from that physician: What medication do you take? 

80 

And oftentimes it can be half a dozen of those. And at one point 

that patient may say, ‘‘I take a pink pill, but I don’t remember the 

name of it.’’ Then comes the additional prescription which can 

interfere with that list of multiple medications that Medicare beneficiary is taking. 

So those are the situations of life-and-death scenario, where more 

harm is being done with a lack of information. And arming the patient with tool to enhance their memory, to provide their physician 

with a list of medication which the physician can see, provided 

from that Medicare source it can trust, is lifesaving. So I would put 

that category of applications, of patient-facing applications, a hybrid indeed application, they are of critical use for the physician. 

I am a former adjunct professor of medicine at University of California, San Diego. I am a former public health officer; I am a data 

scientist. And, at one point, it came to me that a commonsense approach to the lack of information we have is to outfit patients with 

the critical information they need to present to their physician. Because we are still in a very fragmented healthcare system. We 

spend $35 million in the HITECH Act. The patient has to be part 

of that story to communicate information that their physician 

needs. 

Ms. SCHAKOWSKY. Thank you for your indulgence, Mr. Chairman. 

And thank you, panelists. 

Mr. BURGESS. Absolutely. You will pay for it later. 

The chair would like to recognize the gentleman from Mississippi, Mr. Harper, 5 minutes for questions, please. 

Mr. HARPER. Thank you, Mr. Chairman. 

And thanks to each of you for being here. This is such an important topic for our future and for today. 

Ms. Johnson, the Center for Telehealth at the University of Mississippi Medical Center in Jackson, Mississippi, is a leader in providing health care using telemedicine, especially to underserved 

populations. 

How do telemedicine and other mobile health technologies, including healthcare apps, affect patient engagement in the 

healthcare system? And what does this mean for the accessibility, 

affordability, and delivery of care? 

Ms. JOHNSON. Well, certainly, as the healthcare system as a 

whole becomes more interoperable and data-sharing is possible 

across the entire healthcare system and patients have access to all 

of their information, the patients will become more engaged. As the 

patients become more engaged, we believe this will help reduce 

healthcare costs, help them make more cost-conscious decisions. 

So, really, as the whole ecosystem grows to be as one and the patients have access to their data, we do think it will change the way 

the healthcare system operates. 

Mr. HARPER. Thank you. 

Dr. Dorsey, in your testimony, you talk about Medicare’s limited 

coverage of telehealth. How is Medicare’s current reimbursement 

scheme impacting clinicians’ adoption of telehealth and other mobile health technologies? Tell us your opinion on how that is working. 

Dr. DORSEY. Congressman Harper, thank you very much for the 

question. Thank you very much for your advocacy for telehealth. 

81 

It really impacts patients. So, as I mentioned, 40 percent of 

Medicare beneficiaries with Parkinson’s disease don’t see a neurologist. And that happens in Mississippi, that happens in Texas, that 

happens in Nevada, and it even happens in New York City. And 

the reason they can’t access it is because they are either an outsider—all of us in this room are healthcare insiders and we can 

readily access care, but many people can’t because of distance or 

disability. And, increasingly, we ask people who are disabled, have 

limited mobility and impaired driving ability, to drive to urban centers to receive care. We have it backwards. We should be providing 

care to individuals on their terms, in their environments, and not 

in institutions. 

And Medicare, which increasingly stands alone in its limited coverage of telehealth, is limiting access to care for Medicare beneficiaries, including 2 million homebound Medicare beneficiaries who 

can’t access care increasingly, except by either physicians and clinicians visiting them or through telehealth. 

Mr. HARPER. OK. So is there a role from Congress in addressing 

this issue? 

Dr. DORSEY. Absolutely. The VA covers telehealth, and 2 million 

telehealth visits were conducted last year. Increasing reimbursement for telehealth would be an outstanding start, including coverage of telehealth provided into the home, where it is most beneficial, most convenient, and most centered on the needs of patients. 

Medicare could stop incenting institution-based care by providing 

higher incentives to institutions for the same visits that could be 

conducted remotely that are centered on the needs of patients. 

Mr. HARPER. Thank you, Dr. Dorsey. 

Ms. Johnson, do you have specific examples of how your mobile 

healthcare technologies or these technologies generally have shown 

demonstrable changes in patients’ health status or in improved patient health outcomes? 

Ms. JOHNSON. Well, I can’t say that there is published statistically significant data available, but, certainly, with the diabetes 

care solutions, in particular, we do see, generally speaking, the appearance of less excursions of blood sugar, you know, being too 

high and too low. 

There is certainly literature to support that sort of improved control leads to a reduction in complications from the diabetes. But 

there is no published data to support that. But, certainly, with the 

diabetes, we see better control. 

Mr. HARPER. Thank you very much. 

And, Dr. Dorsey, the Congressional Budget Office, CBO, has 

raised concerns that expanding telehealth and remote patient monitoring, or RPM, services within Medicare will be costly to implement and sustain. The CBO scoring does not look at longer-term 

cost savings that could result from a healthier Medicare patient 

population. 

Could you share any insight on those cost savings that telehealth 

and RPM services have provided in other settings and how that 

might impact Medicare in the future? 

Dr. DORSEY. There is tremendous empirical evidence to get 

around this concern that increased reimbursement will lead to 

higher cost. Increased reimbursement will lead to increased utilizaVerDate Nov 24 2008 13:49 Jan 17, 2017 Jkt 037690 PO 00000 Frm 00085 Fmt 6633 Sfmt 6633 F:\MY DOCS\HEARINGS 114\114-163 CHRIS
82 

tion of services, but in the grand scheme of things, physician visits 

at $70 a visit are much less expensive than $1,000 emergency room 

visits and $17,000 hip replacements. 

The VA uses telehealth. They are under a fixed budget, and they 

view it as a cost-effective solution for providing patient-centered 

care to military veterans. 

Kaiser Permanente this year will have more virtual visits, in the 

form of phone, e-mail, video, than in-person visits. They are under 

a capitated environment, and they obviously view this as a means 

for enhancing care at lower cost. 

Bills like the Medicare Telehealth Parity Act are a step in that 

direction, and we are just scratching the surface of what is possible. Our chief areas right now are Medicare’s limited reimbursement and our arcane licensure laws. 

Mr. HARPER. Thank you, Dr. Dorsey. 

And thanks to each witness for being here and sharing your testimonies with us. 

And I yield back. 

Mr. BURGESS. The gentleman yields back. The chair thanks the 

gentleman. 

The chair recognizes the gentlelady from New York, Ms. Clarke, 

5 minutes for questions, please. 

Ms. CLARKE. I thank you, Mr. Chairman and our ranking member. 

I thank our experts for your testimony here today. It has been 

extremely edifying and certainly has raised a number of issues that 

I think we are all going to have to grapple with. It is something 

that I believe will advance us if done correctly. And I thank you 

once again for your testimony here today. 

Professor Terry, in your testimony, you mention that many apps 

are operating in a HIPAA-free zone. It is my understanding that, 

when HIPAA does not apply, the apps may be subject to FTC oversight. Is that correct? 

Mr. TERRY. That is correct. The FTC has some general oversight 

with regard to unfairness that could apply and has been applied 

outside of the app space to security violations, for example, by businesses. However, the FTC’s jurisdiction is very broad and therefore 

tends not to provide a lot of guidance for industry as a result, or 

certainty. And, of course, you have a major resource problem with 

regard to enforcement from that angle. 

Ms. CLARKE. And I was going to go directly to that. The FTC is 

an enforcement-only regime when it comes to privacy. So is it the 

case that the FTC’s privacy-related enforcement actions mostly 

have focused on companies’ failure to comply with their own privacy policies? 

Mr. TERRY. That is correct. And, as you point out, Congresswoman, it is an ex post facto regulation. 

Ms. CLARKE. Right. 

Mr. TERRY. The FTC has stated in a recent case that its jurisdiction does extend into the healthcare space as it tries to sort of 

break down one of the gaps between our privacy sectors. But there 

is a lot more that could be done, I think, in that way. 

Ms. CLARKE. Absolutely. 

83 

Professor Terry, if a health app that is not covered by HIPAA 

does not have a privacy policy at all or if the privacy policy permits 

the app to share or sell information, is there anything that prevents that company from selling or sharing personal information it 

collects? 

Mr. TERRY. It is very difficult to find any clear answer ‘‘yes’’ to 

that. Generally speaking, those apps are just going to be unregulated. 

Now, obviously, some jurisdictions, some states, like California, 

have state laws that require a privacy policy. If you are using the 

care framework or the health framework or the health kit framework from Apple, then the Apple store requires you to have a privacy policy. 

But the people that would comply with that are not our problem. 

It is the ones that don’t comply with that that are the—— 

Ms. CLARKE. And, certainly, when we all are talking about portability in health care as well, if you are in California, great, but 

if you move someplace else, quality control becomes an issue, right? 

How have the app developers, as relative newcomers to the technology space, affected data security practices in the industry? 

Mr. TERRY. Well, again, I think you have to recognize, particularly my copanelists, when we are looking at extremely responsible 

companies with lots of lawyers and lots of risk managers who are 

doing fine things. But our main concern is going to be the apps 

that are out there that simply have inadequate security. And there 

have been studies showing that that is the case. 

There have been studies shown, for example, in Canada that 

most wearable devices give off persistent tracking signals, creating 

privacy and security issues. And an English study showed that 

there were major security flaws even with apps that have been approved by the National Health Service for use there. 

Ms. CLARKE. So how can we ensure that new companies are up 

to speed and know what they are doing with respect to data security before their products reach consumers? 

Mr. TERRY. Well, I think I could have given my same presentation to any of the disrupter topics that you chose, and the reason 

for that is because we have this sectoral approach to privacy. And 

so my optimistic suggestion is that we move away from that and 

we have an overarching, comprehensive privacy law, data protection law, that would stop these gaps between these different industries or between the industries that are conventional and the 

disrupters, to stop those developing. 

In the absence of that, in a shorter term, I think the existing 

agencies probably need to maybe be given some additional powers. 

If I may give you one example, we know, for example, that the 

ONC, with its meaningful-use program, now has APIs, application 

programming interfaces, in order to improve the interoperability of 

data and share it with patients. And we all believe that that is a 

good thing. Yet the moment that data leaves the hospital or physician her, it merges into unprotected space. 

Ms. CLARKE. Yes. 

Mr. TERRY. So I think maybe we need sort of a version of the 

Pottery Barn rule, right? So if we give an agency the power to push 

84 

the data out, we should also give that agency the power to protect 

it as it emerges from that sort of protective cocoon. 

Ms. CLARKE. Dr. Experton, did you want to—— 

Dr. EXPERTON. Yes. Thank you for giving me the microphone. I 

think there is a very positive element in what technology can bring 

to that security question. 

We have all learned that phones can be highly secure, they cannot be broken down, with the FBI having to reach out to try to get 

information in an older iPhone series 5. The phone can be highly 

secure, and it is a personal device. So your phone can indeed store 

securely when the data is encrypted, which is the case for multiple 

applications—iBlueButton or Tensio for hypertension measurement. 

It is in your hands. It is under your control. You cannot break 

in. If hackers want to get to your data, they will have then to hack 

millions of phones instead of one server in a cloud. So I think technology has made incredible steps to give individual citizens control 

over their most personal and critical information, which is their 

health information. 

And I mentioned the iBlueButton app. At no point does 

Humetrix store or share that data. The data comes directly from 

the source, whether it is Medicare or TRICARE, VA or privatized 

care providers, directly to the user’s phone, where it is securely 

encrypted. 

So modern technology and mobile technology answer critical 

healthcare needs. It is immediate access to information me, the patient, or my doctor needs. It is in my hands, under my own control. 

And we oftentimes forget that, indeed, technology has evolved to 

solve the very problems we have. 

Ms. CLARKE. Thank you, Mr. Chairman. There is still an issue 

of quality control that we will all have to manage though. And I 

yield back, sir. 

Mr. BURGESS. The chair thanks the gentlelady. The gentlelady 

yields back. 

The chair recognizes the gentlelady from Indiana, Mrs. Brooks, 

5 minutes for questions, please. 

Mrs. BROOKS. Thank you, Mr. Chairman. 

And thank you to our panel. This has been fascinating, and really appreciate your expertise. 

We know that in the next year, I have been told, 500 million 

smartphone users worldwide will have a health app. So the apps 

are growing. We have to wrap our arms around what is the right 

way forward with respect to how we use these. 

And, in Indiana, Eskenazi Health in Indianapolis recently hosted 

what was called ‘‘Connectathon,’’ and it brought together software 

developers and innovators from across the state. And it was a competition, and the winning team built a medication adherence app 

that sends texts or mobile reminders to patients’ smartphones to 

take or refill their prescription medications—obviously something 

critically important in patient care. 

And so I am encouraged with all that is happening out there. 

And we need these creative app developers like the teams in Indianapolis and around the country, but we also need to protect 

health data. 

85 

And I must say, Professor Terry, welcome to Washington, D.C. 

You weren’t a professor when I was at the law school in which you 

teach, and I wish to thank you for your leadership at the Hall Law 

and Health Center. And I think we all would really enjoy your 

classes, but I am happy I am not in law school any longer. 

Mr. TERRY. You are always welcome. 

Mrs. BROOKS. But had you been there, I would have certainly 

looked forward to taking your class. 

But I want to talk to you a little bit about the issues of context 

and functionality of the apps in defining and properly classifying 

it for proper regulatory and policy purposes. And that is something 

you have studied actually far more than I have studied and maybe 

more than most of the panel has really given a lot of thought to. 

And I think that is very important. 

Can you talk to us a bit more about—you talked about whether 

it is patient-facing versus physician- or provider-facing. As we are 

crafting this important area of law that is growing and that is 

needed, what are, kind of, the classification tools and categories we 

should be looking at? Or should we not be looking at classification 

categories? 

It would be great also if you just gave us the proper privacy policy legislation that we could debate and discuss; we would welcome 

that. But what about with respect to the classifications in this 

space? 

Mr. TERRY. Well, I think with respect to the classifications, Congressman Lance, you referred to the 2015 subregulatory guidance. 

That is, in fact, a republication of one that was in 2012. And the 

way that this stuff is developing so fast, maybe that is worth a reexamination to see if we have more categories or categories that we 

can better define. 

I think that we probably know enough about this space now that 

there are some categories that have been proven to be risk-free, 

and we no longer need regulatory discretion; we just need to jettison now into the consumer electronic space and let them thrive 

as they can. 

So then the question is, can we actually be slightly cleverer with 

regard to how we categorize some of these products? Should we 

start maybe saying the condition-diagnosis type of app is a little bit 

different from the treatment type of app, so that we can get some 

space in there? 

And then I think the other thing that is a continual problem that 

high-tech disruptive industries face is that the timeframe for regulation is out of sync with the rapid iteration of these types of technologies. And I think it is going to take smarter people than myself 

to figure that piece out. But those will be the kind of pushes that 

I would throw out to the regulatory agencies to see if they could 

come up with something like that. 

Mrs. BROOKS. And thank you. We look forward to your help and 

your continued suggestions in this space. 

Dr. Experton, quick question with respect to the iBlueButton. Because I am on a Medicaid Task Force contemplating reforms to our 

Medicaid program, and I understand the iBlueButton is being contemplated for the millions of Medicaid beneficiaries as well. 

86 

And yet, can you please talk to us a little bit about what that 

app looks like, how it could help with cost containment, and, very 

briefly, how you have overcome with your products the HIPAA 

issues that Professor Terry brought up? 

And sorry, that is a lot. Mr. Chairman, if I might indulge. Thank 

you. 

Dr. EXPERTON. Thank you, Congresswoman, for this question. 

Yes, the iBlueButton app I mentioned is also available for State 

Medicaid programs. And the State of New York took a leadership 

role in choosing that application, to have patients participate in 

solving the critical safety but also cost-control issue any State Medicaid program has. 

So, with the iBlueButton app, we take the Medicaid claims the 

way we take the Medicare claims and, on the fly, on the app, decode financial information into clinical information in English for 

that Medicaid beneficiary to understand, review, annotate, research, and to share with their physician wherever they receive 

care. 

Medicaid beneficiaries are, more than anyone, subject to a problem of access and coordination of care. And, at most instances, any 

given patient doesn’t have the full history of their medical care. So 

they come with that information coming from their claims, turn 

into a longitudinal health record right there on their phone, securely encrypted, which they can present, whether it is in the 

emergency room, whether it is some specialist to the next. 

So that is the use of iBlueButton. So we white-label and customize our iBlueButton app for a State Medicaid program, which 

is going to query directly from the app in the user’s control that 

Medicaid database of claims and, in real-time, turn that claim data 

into a longitudinal record so that patient can say, ‘‘Here, Doctor, 

the medication that has been prescribed to me and the one I continue to take or do not take because of this side effect I discovered 

through the app. Here is a test I got. You don’t need to repeat.’’ 

Medicaid program represents about one-third of the State budgets. There is an issue of cost control, but there is also an issue of 

safety with the lack of coordination of care in those States. So this 

patient visit type of technology is critical on both fronts. 

Mrs. BROOKS. Thank you very much. 

And thank you, Mr. Chairman, for the extra time. I yield back. 

Mr. BURGESS. The chair thanks the gentlelady. 

The chair recognizes the gentleman from North Carolina, Mr. 

Butterfield, 5 minutes for questions, please. 

Mr. BUTTERFIELD. Thank you, Mr. Chairman. 

And good morning, one and all. Thank you to all of the witnesses 

for coming today. I have been watching some of your testimony on 

television, and at other times I have been moving around the Capitol, as most of the members have today, trying to complete our 

work before the August recess. And so thank you for your testimony. 

It is clear that for most Americans health information is so very 

personal, requiring a high degree of privacy and data security. But 

as Mr. Pallone said in his opening statement, I think there is some 

confusion for the average consumer when it comes to the privacy 

of their health information. 

87 

And so, Professor Terry, it is my understanding that, despite the 

fact that that is not true, most people assume that health information is generally protected by HIPAA. Do you have any of those 

same concerns? 

Mr. TERRY. I definitely do. Let me illustrate it by the simplestof-all type of exchange that could involve a smartphone app, which 

is that I use an app to access my electronic health record. We want 

that kind of sharing, right? 

Well, the moment that that data leaves the electronic health 

record of the provider and enters the smartphone app, there is considerable confusion as to the legal state of it. Now, if that app was 

provided by the hospital or the provider or a business associate, 

then the HIPAA shield would be all over it. If it was not, if it was 

an app that the patient just purchased from an app store, then it 

is highly likely HIPAA would not apply. 

Now you have two sets of data, identical data, one on the her, 

one on the phone, identical data. One bundle is subject to the most 

stringent privacy protection we have in this country; the other is 

basically unregulated. 

The patient then, for example, could add some wellness information from a Fitbit app or something to that electronic health record. 

Now the data is different. The patient could then send that back 

to the doctor, back across the threshold. Now you have two more 

sets of data, but, again, completely different protective systems applying to them. 

I considered that certainly beyond my ability to explain to any 

patient. 

Mr. BUTTERFIELD. I think I read in the material that there are 

160,000 apps that are out there. 

Mr. TERRY. I think that is about right, yes, and growing. 

Mr. BUTTERFIELD. And growing. 

Does HIPAA protect all health-related information? 

Mr. TERRY. No, it does not. So, for example, there is tons of data, 

probably more health-related data is being generated outside of the 

traditional healthcare environment than is being generated within 

it. So every time you use a supermarket loyalty card and you pick 

up, I don’t know, a diabetes testing kit or an over-the-counter pregnancy testing kit, that little piece of data goes up into the data 

broker cloud. 

You are all familiar with the Target story of early diagnosis of 

pregnancy by the use of preferences with regard to hand lotion; exhaust data that comes off online sites that sell products, online resellers. Social media sites and, more and more frequently, mobile 

devices are all building this sort of surrogate version of your health 

life completely outside of the regulation of HIPAA. And it is being 

sold back to insurers and employers as body scores or health 

scores, which are potentially extremely discriminatory. 

Mr. BUTTERFIELD. All right. 

I have 45 seconds remaining. Let me do this very quickly. Let’s 

say that an app that monitors blood pressure is offered by the patient’s primary care physician, who would be a HIPAA entity. Does 

HIPAA cover the information that is collected and stored by the 

physician? 

88 

Mr. TERRY. If that app was developed by the physician or the 

hospital or a business associate, then it is highly likely that it 

would be covered. 

Mr. BUTTERFIELD. Would be covered. Yes. 

Again, let’s say that a doctor recommends that a patient use a 

blood pressure monitoring app, but the doctor does not offer the 

app. If the patient shares the information collected with his or her 

doctor, is information held by the doctor covered by HIPAA? 

Mr. TERRY. That would be covered by HIPAA. Of course, there 

is the overarching question as to whether any sane physician would 

recommend an app without knowing it inside-out because of the liability issues that could well occur there. 

Mr. BUTTERFIELD. Thank you. You have been very kind. 

Thank you. I yield back. 

Mr. BURGESS. The chair thanks the gentleman. 

The chair would note to the members of the subcommittee that 

the chair has deferred his questions till the end. I did that on purpose so that I could accumulate all of the time that each of you 

went over, and I have now aggregated that, and I yield myself the 

next hour and a half. 

No, I do want to thank all of you for being here this morning. 

It has been terribly illuminating and illustrative. I have made a 

number of notes here. And I do, of course, as always, will have opportunities for questions for the record if time does not permit all 

the questions to be asked. 

But, Dr. Patterson, let me just ask you—you know, you gave 

such a wonderful demonstration. It really was worth the wait. I 

mean, I cannot tell you the times—look, we just had a big series 

on opiates within the full committee and Subcommittee on Health. 

And I will tell you, as a practicing physician, I think you just 

hated to realize that maybe you got scammed on that prescription. 

So, in order to avoid that, even though it was 3 o’clock in the morning, I would go back up to my office that was physically adjacent 

to the hospital. A patient would call in and say, look, your partner 

prescribed whatever because I had surgery, and the dog ate my 

homework, and could you just get me enough to get me through my 

3-week vacation that is coming up in just a few hours here? 

I would fall for it once, but next time—‘‘Well, meet me at the 

emergency room. I just want to check and make sure everything is 

OK, and I will be happy to write you a prescription.’’ I would go 

to my office and pull the record. The patient almost invariably did 

not show up in the emergency room. 

But, boy, how powerful to have what you demonstrated to us, 

where you could basically access that information at home. So, like, 

in a five- or six-physician practice, all of those records would be 

available to the physician on call for the practice. Is that correct? 

Dr. PATTERSON. That is correct, yes. 

Mr. BURGESS. Now, Mr. Terry pointed out that, once that data 

leaves the confines of the medical records department at the clinic 

or the hospital, now it is in a different world. But that is OK on 

your device? There is a proper protection on that device? 

Dr. PATTERSON. Yes. So everything that we provide in our platform is done under a business associate agreement with the proVerDate Nov 24 2008 13:49 Jan 17, 2017 Jkt 037690 PO 00000 Frm 00092 Fmt 6633 Sfmt 6633 F:\MY DOCS\HEARINGS 114\114-163 CHRIS
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vider side, so either the health system clients or the physician 

groups where our software is deployed. 

I think that the challenge that comes with a platform like ours 

is that we are positioned to incorporate device data from anywhere, 

so we are agnostic to the source. And so there is a host of consumer-facing applications and sensors out there where that data 

could be very useful for the broader context of caring for a patient. 

So, as a doctor, I don’t mean to be crass, but I really don’t care 

how many steps you take, and I don’t really care how many calories you have eaten on a day-to-day basis. That is not what I am 

going to be spending my time on and probably shouldn’t be, for 

that level of decisionmaker. But if I can see data that links how 

many steps somebody takes to their onset of depression because 

they are no longer taking their dog for a walk, and then that is 

linked to their medication noncompliance, and then that is linked 

to a rehospitalization, suddenly I might be very, very interested in 

having that being pulled together through machine learning or algorithms. 

And so we have to find a way to accommodate various disparate 

sources of data. So I liken it to recreational data versus professional-grade data. So in my mind, we have to set a very clear bar 

on what is recreational and what is professional-level. And I don’t 

necessarily think it is who is using it, but I do think it is more related to the level of risk and the safety involved. And that should 

be the primary criterion, is what is safe, what is not safe. 

And then, subsequent to that, there needs to be a crosswalk capability that allows recreational data to be drafted to the big 

leagues, so to speak, down the line. So there has to be some way 

that we can bridge the gap between these two and do that safely. 

And I feel that provenance is one of the most important things. 

You always have to be able to tell where a data element originated 

from. If that is lost in the little pieces of metadata that surround 

that data element—for example, if I have a glucose reading, I want 

to know where did that glucose reading come from on that diabetic, 

what type of device, how is that regulated, how much can I trust 

that. 

I think if we solve for some of those issues, we can probably clarify a lot of the classification issues that are coming up where we 

don’t have to have 20 different classifications. And the legislation 

would never be able to keep up with the innovation. 

Mr. BURGESS. One of the things that got me interested in this 

several years ago, I was able to download an app onto my phone 

that used the flash attachment to measure heart rate, so that was 

kind of neat. 

And then at a prayer breakfast, Dr. Collins, the head of the NIH, 

was seated next to me, and his iPhone had an EKG on it. Well, 

wait a minute, Dr. Collins, I want an EKG on my iPhone. So I figured out how to get it. It actually is an FDA-approved device. You 

do have to have a physician’s license in order to have that; you 

can’t just download that for regular consumer use. But now I have 

two ways to measure heart rate on my iPhone, one with the light 

sensor and one with the EKG app. 

But, Mr. Terry, your last comments about the blood pressure 

cuff—the other thing that made me interested in this, I used to 

90 

practice OB/GYN. Yes, it has been a few years since I have done 

so. But, invariably, the last patient at 4:45 on a Friday afternoon 

comes in for a routine prenatal check up at 36 or 37 weeks pregnancy, about a month away from delivery, and her diastolic blood 

pressure is 90 millimeters of mercury. Yikes. She has never had 

blood pressure that high before. But, is this the harbinger of something very bad that is about to happen, or is this a one-off because 

I didn’t provide adequate parking out in front of my office and she 

got mad at her husband because he had to drive around to drop 

her off? You don’t know that at 4:45 on a Friday afternoon. Sure, 

recheck the blood pressure, perhaps wait 15 minutes. 

But how empowering—you make one decision and say, ‘‘I am 

sorry. You have never had blood pressure this high before. Although you have no other symptoms and no other criteria, I am 

going to have to ask you to come into the hospital for observation.’’ 

Three days later, with no elevated blood pressure, rather sheepishly you are discharging that patient. She is angry because of having to arrange daycare for her other kids. Or, 3 o’clock on Sunday 

morning, that patient is back in the emergency room either having 

had an eclamptic seizure or a platelet count of 2,000 or something 

very bad has happened. 

So how great to be able to use that blood pressure now that is 

available in the home. I mean, you don’t even have to tell someone 

to go down to Walgreens and sit in the chair. A $40 peripheral and 

you can measure that blood pressure at home and have perhaps 

several blood pressures a day e-mailed to the doctor on call for that 

weekend. What is wrong with that? That seems like it is a way to 

extend the ability to give good care and make good decisions. 

Mr. TERRY. I completely agree. And, in fact, I would go further 

than Dr. Patterson, because I don’t think we are talking about just 

wellness or fitness data that could be valuably incorporated into 

this very professional environment that you are talking about. But, 

as we know from the Institute of Medicine and work that is being 

done elsewhere at HHS, we are really trying very hard to incorporate a lot more health-determinant information data into our 

records to push that environmental piece back into it. 

So not only would you be able to look at the blood pressure of 

that patient, but you would get a sense of the different environments that maybe have pushed or lowered that blood pressure, 

which would, again, I think, give you even more data. 

The problem is that, after a while, you wonder whether this really can stay on that encrypted device for that level of processing and 

whether, in fact, our desire for sharing and additional processing 

will in the end force this up into the cloud and, therefore, raise so 

many of the privacy and security risks that we have discussed. 

Mr. BURGESS. Very well. 

Let me ask you this, because you brought up the question of industry minnows. And although we don’t deal with endangered species on this committee, I couldn’t help but wonder about the delta 

smelt and if that was one of those industry minnows. But, seriously, that is—and Ms. Johnson referenced some of the difficulties 

that the FDA has. 

That potentially is an enormous task on the regulatory side. Industry minnows are turning out health apps. The regulatory body 

91 

that, oh, by the way, in addition to the 180,000 health apps that 

they are trying to regulate, they have also got 11,000 laboratorydeveloped tests that they now say they are going to regulate as 

medical devices—I mean, suddenly just the workflow through the 

agency becomes problematic. 

What do you foresee in that situation? 

Mr. TERRY. Well, I think unless there is tight regulation and enforcement, I think the minnows are going to get worse. You only 

have to do a brief search through app stores these days amongst 

health-related apps to find all sorts of apps that look like they are 

doing device-like things but are not approved medical devices. 

And, frequently, you will see when you click on the ‘‘more’’ button 

on that app site, it will proudly tell you that this is for informational or educational or game enjoyment only and should not be 

used for diagnosis. Yet, at the same time, they are selling these 

things for what looks like diagnosis. 

Unless that gets tightened up, I worry that the good companies 

will find themselves just sort of overwhelmed by the bad. Generally 

speaking, it is my belief, at least, that our finest corporations actually will embrace regulation because it brings certainty. And good 

enforcement might help that. 

Mr. BURGESS. Yes. This is the disrupter series, however, and I 

think the admonition to pay attention to the provenance of the data 

is—I mean, I think that is valid and I think that is wise. 

Dr. Ferris, let me just ask you, because not this subcommittee 

but another subcommittee of the Energy and Commerce Committee, in 2012, did a number of hearings leading up to the FDA 

user-fee agreement reauthorization, the FDA Safety and Improvement Act. And as part of those hearings leading up to that, we had 

a member who is no longer here in Congress but was very concerned. His daughter had a melanoma. He was interested in—it 

wasn’t a consumer app. It was something called the MelaFind camera. 

MelaFind had difficulty getting approval and then did. And then 

I don’t know what the difficulties were after the fact, but I think, 

if I understand correctly, it is back on. So it sort of speaks to some 

of the difficulty that you raised. 

And yet, at the same time, I am thinking back to the flip phone 

that I had when I started in the Congress. Yes, I could take a picture with it, and you could almost make out the images. The technology is getting a lot better literally every year. I rather expect, 

when we have the user-fee agreement reauthorizations, we are 

likely to have other devices that are talked about at that time because of the advance of the technology. 

So do you have a sense how the improvements in technology, 

how that may impact the ability to provide this type of information? And I am not even thinking so much at the consumer-level. 

I am thinking at the level of a primary care doctor, like I was. 

Basically, it is a binary choice for me. If a patient shows me a 

mole and asks me if she needs to be worried about it, I say, ‘‘You 

need to go to the dermatologist to get it biopsied.’’ Because if she’s 

worried about, I am worried about it, and we are all going to worry 

about it until you tell us it is OK. 

92 

Yes, if there were an intermediate step that dealt with a transmission of data on a—whether it was a consumer-driven app or an 

FDA-approved app, that just seems to me that that would increase 

utilization of trying to diagnose those lesions. 

Dr. FERRIS. Yes. Thank you. 

So I am familiar with MelaFind device and actually participated 

in the pivotal trials that resulted in, ultimately, FDA approval 

after a very long process of that. 

So there is a difference between a device like MelaFind—because 

it is truly on optical device. It is doing image capture. It is doing 

analysis within the app and giving a score. And part of the reason 

it needed approval was that it actually did initially give a binary 

output, a biopsy recommended or no biopsy recommended. So that 

is purely a recommendation. 

In the scenario that you are talking about, where you have a patient who has a mole and you just say, ‘‘Go see dermatology,’’ if you 

were doing that in western Pennsylvania, where I practice, if you 

were not within the city of Pittsburgh and didn’t have my cell 

phone number, you would potentially be telling that patient to either drive at least an hour to see a dermatologist or to call our office, where they would be told that our next available appointment 

may be up to 4 to 6 months later because of the access-to-care 

issues. 

So now we have better ways to do that. So one is you can take 

a photo, and, through a HIPAA-secure system, you can send that 

to a dermatologist, because we can very quickly triage. So, one, 

that should be more widely available. That is not a direct-to-consumer. That is physician-to-physician communication. 

Two, the technology that we are trying to work on is that we 

could outfit your office with an attachment to your iPhone that is 

maybe a couple hundred dollars that would give us an even more 

clear and analyzable image of that lesion, that you could either, 

one, get an even better opinion from us quickly through telemedicine, or, two, that we, by having a tool that can analyze that image, 

we could actually give you a score of risk. 

We are not giving that to the patient; we are giving that to you 

as a physician. We know how to set the bar. I can talk to you about 

sensitivity and specificity or positive and negative predictive value 

in a way that I can’t talk to a patient about it. We can set the bar 

such that, if it comes back high-risk, you don’t have to go through 

having your office call my office. We have a way to immediately get 

that patient triaged. And then if it comes back as very low-risk, 

that can go into perhaps a more cumbersome process of maybe having that image reviewed by a dermatologist. But this can really 

speed up the process. 

Again, I think that the bar for safety is lower when it is physician-to-physician or when it is data being provided to a physician. 

I can in real-time improve that app as I get more images. If I have 

to go through full-bore FDA approval every single time we tweak 

an algorithm to make it better, we are not going to make products 

better; we are going to come up with what we think we can get approved and not continue to develop and use technology to make 

health care better. 

Mr. BURGESS. Correct. That is the regulatory risk. 

93 

Dr. Patterson—but, really, just for the panel in general—I don’t 

think we can discount how the young physician—medical students, 

residents—are going to change how this is all viewed. I went and 

talked to either one of my medical schools or residency programs 

down in Fort Worth a couple of years ago. And the residency director opined—I guess they had a system like yours that they did defensively because it was impossible to keep the residents from taking a picture of something in the emergency room, sending it to 

their attending and saying, what do you think, can I close this here 

or does it have to go to the OR, that kind of question, which were 

the same questions that I asked as a resident to my faculty, but 

there we had a rotary dial phone, and now, of course, they have 

these very, very fancy smartphones with quite accurate cameras. 

So that hospital actually had to develop something like your system that was a secure system where, in a HIPAA-compliant way, 

data could be transferred. And the only reason I bring that up is 

the young physicians coming up are either going to demand or they 

are just going to drive in a direction that they want to go, whether 

or not we thought it was a great idea or not in a congressional 

hearing. 

This has been a very fascinating hearing. I have a number of 

questions for folks in writing, but I am way over time, and it always makes Ms. Schakowsky nervous when I do that. So, in deference to her—oh, well, I would yield to the gentlelady if she had 

a followup question she wanted to ask. 

Ms. SCHAKOWSKY. No, I don’t. Thank you. 

Mr. BURGESS. So, seeing that there are no further members 

wishing to ask questions for this panel, I will thank all of our witnesses for being here. 

Before we conclude, I need to submit the following documents for 

the record by unanimous consent: a letter from Fitbit that tells me 

to get busy—I am way behind; a letter from the Competitive Carriers Association; a letter from the Consumer Technology Association; a letter from the American Medical Association; a letter from 

Opternative, Incorporated. 

[The information appears at the conclusion of the hearing.] 

Mr. BURGESS. Pursuant to committee rules, I remind members 

they have 10 business days to submit additional questions for the 

record. I ask the witnesses to submit their responses witness 10 

business days upon the receipt of those questions. 

Without objection, the subcommittee is adjourned. 

[Whereupon, at 12:13 p.m., the subcommittee was adjourned.] 

[Material submitted for inclusion in the record follows:] 

PREPARED STATEMENT OF HON. FRED UPTON

Today we continue our Disrupter Series as we examine health care apps that are 

truly revolutionizing how folks in Michigan and across the country are managing 

their health. 

As the sponsor of the 21st Century Cures Act, with my good friend and colleague, 

Congresswoman Diana DeGette, it’s no secret that we have been fighting to modernize and personalize our health care system to find faster cures and better treatments for all Americans. 

And we face some of the same concerns with health apps in terms of ensuring 

that government is encouraging rather than hindering the development of new life 

saving technologies. Today, we will examine what it means for patients as mobile 

94 

apps have the potential to modernize, personalize, and improve the overall delivery 

of care. 

The development and proliferation of health apps is an essential part of our effort 

to cultivate a healthier population and save more lives. Because of remarkable advancements in technology, doctors and patients both receive information that is 

more accurate and timely, which accelerates better diagnoses and preventative 

treatment plans. This technology’s ability to seamlessly connect doctors and patients 

together through a smartphone or connected device opens the door to a wide range 

of medical discoveries, possibilities, and insights, not to mention the potential to 

prevent medical problems before they occur. 

An additional benefit of mobile health apps is that they help to drastically reduce 

skyrocketing health care costs. By integrating the Internet into practically everything we own, we have generated productivity and efficiency gains, and cost savings 

across multiple economic sectors. The health care sector is no different—if anything, 

there is no sector in greater need of this modernizing. Better care achieved more 

efficiently can lead to reduced doctor visits, decreased complications and risks, lower 

hospital readmissions, and much more. 

The potential stemming from this technology is undeniable and exciting. To ensure that these life-saving tools are accessible to folks in Michigan and every corner 

of the country, we need the right regulatory framework in place. A framework that 

encourages innovation, removes barriers to investment, and advances new opportunities for patients and providers to engage in the health care system. At the same 

time privacy and security are absolute musts. This is one of the most important 

policies that industry must show leadership on. 

As the world’s leader in medical innovation, the time to make these promising 

health care advances available to American families is now. 

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