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SMART HEALTH: 

EMPOWERING THE FUTURE OF MOBILE APPS 

HEARING 

BEFORE THE

SUBCOMMITTEE ON RESEARCH AND TECHNOLOGY 

COMMITTEE ON SCIENCE, SPACE, AND 

TECHNOLOGY 

HOUSE OF REPRESENTATIVES 

ONE HUNDRED FOURTEENTH CONGRESS 

SECOND SESSION 

March 2, 2016 

Serial No. 114–63 

Printed for the use of the Committee on Science, Space, and Technology 

( 

Available via the World Wide Web: http://science.house.gov 
(II) 

COMMITTEE ON SCIENCE, SPACE, AND TECHNOLOGY 

HON. LAMAR S. SMITH, Texas, Chair 

FRANK D. LUCAS, Oklahoma 

F. JAMES SENSENBRENNER, JR., 

Wisconsin 

DANA ROHRABACHER, California 

RANDY NEUGEBAUER, Texas 

MICHAEL T. MCCAUL, Texas 

MO BROOKS, Alabama 

RANDY HULTGREN, Illinois 

BILL POSEY, Florida 

THOMAS MASSIE, Kentucky 

JIM BRIDENSTINE, Oklahoma 

RANDY K. WEBER, Texas 

JOHN R. MOOLENAAR, Michigan 

STEVE KNIGHT, California 

BRIAN BABIN, Texas 

BRUCE WESTERMAN, Arkansas 

BARBARA COMSTOCK, Virginia 

GARY PALMER, Alabama 

BARRY LOUDERMILK, Georgia 

RALPH LEE ABRAHAM, Louisiana 

DARIN LAHOOD, Illinois 

EDDIE BERNICE JOHNSON, Texas 

ZOE LOFGREN, California 

DANIEL LIPINSKI, Illinois 

DONNA F. EDWARDS, Maryland 

SUZANNE BONAMICI, Oregon 

ERIC SWALWELL, California 

ALAN GRAYSON, Florida 

AMI BERA, California 

ELIZABETH H. ESTY, Connecticut 

MARC A. VEASEY, Texas 

KATHERINE M. CLARK, Massachusetts 

DON S. BEYER, JR., Virginia 

ED PERLMUTTER, Colorado 

PAUL TONKO, New York 

MARK TAKANO, California 

BILL FOSTER, Illinois 

SUBCOMMITTEE ON RESEARCH AND TECHNOLOGY

HON. BARBARA COMSTOCK, Virginia, Chair 

FRANK D. LUCAS, Oklahoma 

MICHAEL T. MCCAUL, Texas 

RANDY HULTGREN, Illinois 

JOHN R. MOOLENAAR, Michigan 

BRUCE WESTERMAN, Arkansas 

GARY PALMER, Alabama 

RALPH LEE ABRAHAM, Louisiana 

DARIN LAHOOD, Illinois 

LAMAR S. SMITH, Texas 

DANIEL LIPINSKI, Illinois 

ELIZABETH H. ESTY, Connecticut 

KATHERINE M. CLARK, Massachusetts 

PAUL TONKO, New York 

SUZANNE BONAMICI, Oregon 

ERIC SWALWELL, California 

EDDIE BERNICE JOHNSON, Texas 
(III) 

C O N T E N T S 

March 2, 2016 

Page 

Witness List ............................................................................................................. 2 

Hearing Charter ...................................................................................................... 3 

Opening Statements 

Statement by Representative Barbara Comstock, Chairwoman, Subcommittee 

on Research and Technology, Committee on Science, Space, and Technology, 

U.S. House of Representatives ............................................................................ 6 

Written Statement ............................................................................................ 8 

Statement by Representative Daniel Lipinski, Ranking Minority Member, 

Subcommittee on Research and Technology, Committee on Science, Space, 

and Technology, U.S. House of Representatives ............................................... 10 

Written Statement ............................................................................................ 12 

Witnesses: 

Mr. Morgan Reed, Executive Director, The App Association 

Oral Statement ................................................................................................. 15 

Written Statement ............................................................................................ 17 

Dr. Bryan F. Shaw, Assistant Professor, Department of Chemistry and Biochemistry, Baylor University 

Oral Statement ................................................................................................. 36 

Written Statement ............................................................................................ 38 

Mr. Howard Look, President, CEO and Founder, Tidepool 

Oral Statement ................................................................................................. 43 

Written Statement ............................................................................................ 46 

Dr. Gregory Krauss, Professor of Neurology, The Johns Hopkins Hospital 

Oral Statement ................................................................................................. 64 

Written Statement ............................................................................................ 66 

Mr. Jordan Epstein, CEO & Founder, Stroll Health 

Oral Statement ................................................................................................. 70 

Written Statement ............................................................................................ 72 

Discussion ................................................................................................................. 85 

Appendix I: Answers to Post-Hearing Questions 

Mr. Morgan Reed, Executive Director, The App Association ............................... 102 

Dr. Bryan F. Shaw, Assistant Professor, Department of Chemistry and Biochemistry, Baylor Univ ........................................................................................ 104 

Mr. Howard Look, President, CEO and Founder, Tidepool ................................. 106 

Dr. Gregory Krauss, Professor of Neurology, The Johns Hopkins Hospital ....... 109 

Mr. Jordan Epstein, CEO & Founder, Stroll Health ............................................ 111 

Appendix II: Additional Material for the Record 

Statement submitted by Representative Eddie Bernice Johnson, Ranking 

Member, Committee on Science, Space, and Technology, U.S. House of 

Representatives .................................................................................................... 116 

(1) 

SMART HEALTH: 

EMPOWERING THE FUTURE OF MOBILE APPS 

WEDNESDAY, MARCH 2, 2016 

HOUSE OF REPRESENTATIVES, 

SUBCOMMITTEE ON RESEARCH AND TECHNOLOGY, 

COMMITTEE ON SCIENCE, SPACE, AND TECHNOLOGY, 

Washington, D.C. 

The Subcommittee met, pursuant to call, at 10:07 a.m., in Room 

2318 of the Rayburn House Office Building, Hon. Barbara Comstock [Chairwoman of the Subcommittee] presiding. 
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Chairwoman COMSTOCK. Good morning. The Committee on 

Science, Space, and Technology will come to order. Without objection, the Chair is authorized to declare recesses of the Committee 

at any time. Welcome to today’s hearing, entitled ‘‘Smart Health: 

Empowering the Future of Mobile Apps’’. I now recognize myself 

for five minutes for an opening statement. 

There’s something we all have, not just us here in this country, 

but all around the world. The mobile penetration that is growing 

exponentially every day is very exciting, and it’s very exciting when 

you think about how it’s permeated all aspects of our life, but now 

has the opportunity to help so many aspects. And today we’re here 

to talk about how it can help with health care. 

There’s an app for just about anything we want to do, from finding the nearest and cheapest gas station to depositing a check, and 

also, of course, with health care. The rapid growth of this game 

changing technology, and the data, and how we can amass that, is 

a reflection of the ingenuity of app designers, and the market of 

consumers ready, willing, and able to take advantage of what technology has to offer in order to be more personally involved in our 

own health care, and that of our families. 

When it comes to our health, especially for the younger generation, you know, it might be easy to ignore different visits to the 

doctor, and we obviously want to make sure every does that, but 

we really want to put that power back in the hands of the consumers. And mobile apps are a really exciting way we can do that, 

particularly in the busy two-earner families, who run around with 

so many things going on, this is a great opportunity to really improve quality of life while making people’s life easier to get that 

health care. 

You know, it can be difficult to make an informed decision about 

your health, but with the abundance of health apps, and wearable 

technologies which cover a wide variety of diseases, and chronic 

diseases, we can now exercise more control by availing ourselves of 

that data. The data also benefits those who might suffer from an 

ailment or a chronic disease. Whether it’s cancer, epilepsy, or diabetes, the more data we have about ourselves that we are personally aware of, and how we are going to share and amass that data. 

I was just at the Milken Public Health Summit that’s being held 

in Washington today, and it was really exciting to see all aspects 

of health care, but the mobile technology, and what we are going 

to do there, and how we can amass data, and—for example, they 

talked about people who have cancer. They said 75 percent of them 

would be happy to share their information if it would allow them 

to access data, and get information, you know, for themselves, and 

for their doctors to see, you know, what they, you know, what they 

might have in common with other people in the same boat. 

So this new revolution in technology can, and should, open up a 

new revolution, and all of us being very personally engaged and responsible for our own health care, but also more knowledgeable. 

You know, it’s a great education tool, and we don’t have to just go 

in and see the doctor now. We can be a full participant. It may 

be—sometimes doctors may not like that, but—we had a witness 

here earlier this year, talked about a book, which I still have to 
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read yet, which is called ‘‘The Patient Will See You Now’’, turning 

the whole world upside down, which I think is kind of exciting. 

So our witnesses today are here to talk about technologies they 

have developed, or are developing, to help individuals take control 

of their own health care. Two of our witnesses, Dr. Bryan Shaw 

and Mr. Howard Look, have very personal reasons for their endeavors. Dr. Krauss and his colleagues have embarked on some important research using the Apple Watch and the Apple Research Kit, 

an open source software framework that may revolutionize medical 

studies. And Mr. Epstein’s technology helps people make informed 

decisions about receiving care at reduced cost. This ability to save 

a few or many dollars is something we can all support, both on the 

personal individual level, and obviously at the aggregate level, with 

the federal government, with that being one of the fastest growing 

costs in our budget. 

As with all new technologies, there are, of course, pros and cons. 

We’ll be discussing them also today. But this kind of research and 

technology is really exciting, and we want to make sure we in Congress have the kind of policies and help to make sure you could leverage and do this in the best way possible, and have faster cures, 

as the Milken Institute was talking about today. Faster cures is 

what we all want. Prevention is obviously another area where mobile apps have a great opportunity. 

[The prepared statement of Chairwoman Comstock follows:] 
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Chairwoman COMSTOCK. So I now recognize the Ranking Member of the Research and Technology Subcommittee, the gentleman 

from Illinois, Mr. Lipinski, for his opening statement. 

Mr. LIPINSKI. Thank you, Chairwoman Comstock, for holding this 

hearing, and to the witnesses for being here today. With well over 

100,000 health-related apps available through the Google and 

Apple app stores, and hundreds of millions of downloads, mobile 

health apps are increasingly becoming part of our daily lives. The 

phrase there’s an app for that is very applicable to the mobile 

health environment, and the number of apps is growing daily. 

Most of us are familiar with, and may even use, one of the popular fitness apps to track our steps and help us with fitness goals. 

But some people rely on mobile health apps to monitor serious 

health conditions. The CDC reports that, as of 2012, over half of 

all adults had one or more chronic diseases. The treatment of 

chronic conditions accounts for 86 percent of the nation’s health 

care costs. As people are taking a more active role in the management of their health, they’re turning to electronic and digital medial platforms for help. Diabetics can find apps that track their 

blood sugar levels, cardiac patients can find apps to track their 

blood pressure, and people that suffer from depression can find 

apps to monitor their mood. 

The great promise of these apps is that they have the potential 

to contribute to better health outcomes for their users. But whether 

this potential can be realized depends on the quality and reliability 

of the apps, and the information they contain. For mobile health 

apps not regulated by the FDA, there is much greater uncertainty. 

We don’t want to stifle innovation, but there are major concerns 

that must be considered, including the potential for an app to lead 

to harm. Inaccurate readings, for example, could lead to a life 

threatening situation. We also need to consider how to address 

ownership of data, given that information flows between patients 

and their app providers. Some of these regulatory questions fall 

outside our Committee’s jurisdiction. However, there are parts of 

this discussion that do fall within our purview, and, in fact, they’re 

very common themes before this Committee, including human factors research, privacy, and cybersecurity. 

The goal for users of many mobile health apps is to live a 

healthier life. They may be looking to increase their fitness, to eat 

healthier, or to quit smoking. Some users, as I have discussed previously, are using apps to monitor and respond to potentially serious chronic health conditions. In all of these cases, there is an implicit assumption that the app will influence behavior in a predictable way, and in some cases assist users in long term behavioral 

changes. But, as an engineer, I know that we—if we do not incorporate human factors into the design and evaluation of these apps, 

they may not function as intended, or may even cause harm. This 

is a very important area of research, one where the National 

Science Foundation has a role, possibly in collaboration with the 

NIH. 

In addition, privacy, and the security of a user’s personal information, must be a part of today’s conversation. Many mobile health 

app users trust the information within the app is secure. However, 

a recent study by a research team at the University of Illinois at 
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Urbana-Champagne found that many free apps use ad libraries as 

revenue sources, which many expose users’ data to these ad libraries. This is clearly a privacy issue, but it could also be a security 

issue if the app requires a user to enter personally identifying information and/or sensitive health data. Furthermore, in the case of 

high quality apps that health care providers incorporate into their 

patient care, we may also want to give the physicians and nurses 

access to data being recorded by the apps. This brings up more 

questions about how to keep the data secure. 

We all share the goals of promoting better health care outcomes 

and reducing health care costs. Mobile health apps have the potential to contribute to these ends, and so it’s very important that we 

continue down this road. As these apps are being developed, we— 

make sure we are looking at these apps, and make sure that, in 

the end, we are doing—at least not doing harm, and hopefully we 

can do a lot of good for people. So there are many important questions that need to be addressed as this technology continues to 

grow. I look forward to a good discussion with our witnesses, and 

I yield back the balance of my time. 

[The prepared statement of Mr. Lipinski follows:] 
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Chairwoman COMSTOCK. Thank you. And I’ll now recognize our 

witnesses. Our first witness today is Mr. Morgan Reed, Executive 

Director of The App Association. Mr. Reed specializes in issues involving application development relating to privacy, intellectual 

property, competition, and small business innovation. His expertise 

and knowledge has been sought by the House and Senate in multiple hearings, and his commentary and insight is a—has been featured on news networks. Mr. Reed received his undergraduate degree in Political Science and Chinese from Arizona State University, and a graduate degree in Chinese from the University of 

Utah. I am pleased to welcome you here today. 

Dr. Bryan Shaw is our second witness, and he is an Assistant 

Professor in the Department of Chemistry and Biochemistry at 

Baylor University in Waco, Texas. Dr. Shaw received his undergraduate degree in Biochemistry and Biophysics at Washington 

State University, and his Ph.D. in Inorganic Chemistry from the 

University of California, Los Angeles. In 2008 Dr. Shaw’s son Noah 

was diagnosed with bilateral retinoblastoma. While his doctors initially missed his eye cancer, Noah’s mother, Elizabeth, observed a 

white reflection in his eyes in pictures she took, which ultimately 

helped lead to his diagnosis. Noah is the inspiration behind the 

Cradle app created by Dr. Shaw and his colleagues at Baylor University, and I’d like to welcome both Dr. Shaw and his son Noah, 

who’s in the audience with us today. And I understand your—I did 

get to meet your wife, and your other—your younger son also, so 

it’s delightful to have you with us here today. 

Our third witness is Mr. Howard Look, President, CEO, and 

Founder of Tidepool, a Silicon Valley non-profit startup that has 

developed apps to help people reduce the burden of managing 

Type1 diabetes. Prior to Tidepool, Mr. Look held technology leadership positions at Amazon, Pixar Animation Studios—might come in 

handy with the kids here today, right—and as a founding team 

member at TiVo. In 2015, Mr. Look, who holds a Bachelor of 

Science degree in Computer Engineering from Carnegie Mellon 

University, received the White House Champions of Change Award 

for Precision Medicine on behalf of Tidepool’s work. And just last 

month Mr. Look shared the stage with President Obama during a 

panel discussion at the Precision Medicine Initiative Summit. Mr. 

Look’s motivation behind Tidepool comes from his daughter, Katie, 

who was diagnosed with Type1 diabetes five years ago, and I am 

pleased to welcome him here today. 

Our fourth witness is Dr. Gregory Krauss, a Professor of Neurology at The John Hopkins Medical Center in Baltimore. Dr. 

Krauss is a native of southern Oregon, and received undergraduate 

training at Harvard College, medical school training at Oregon 

Health Sciences University, and neurology residency and epilepsy 

fellowship training at Johns Hopkins. Dr. Krauss is the co-inventor 

of the EpiWatch app, along with his colleague, Dr. Nathan Crone, 

who is also a Professor of Neurology at Johns Hopkins. EpiWatch 

research uses a novel data management program integrated with 

the Apple Watch and iPhone operating systems called Research 

Kit. It is the first research app to use the Apple Watch. We welcome you, Dr. Krauss. 
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Mr. Jordan Epstein is our fifth witness, and he’s founder and 

CEO of Stroll Health, which makes software applications that help 

doctors and their patients find and follow through with lower cost, 

best value health care. Prior to Stroll Health, Mr. Epstein worked 

on a client services team of Merced Systems, sorry, a business intelligence startup. After their acquisition by NICE Systems, he led 

development of the small and medium-sized business performance 

management product line, which today is used by hundreds of 

thousands of people on five continents. Mr. Epstein’s clients have 

included Fortune 500 companies, such as United Healthcare, Kaiser, Delta Airlines, and Chase. Mr. Epstein holds a B.A. from 

Carlton College, and I am pleased to welcome him, and all of you, 

here today. 

So I now recognized Mr. Reed for five minutes to present his testimony. 

TESTIMONY OF MR. MORGAN REED, 

EXECUTIVE DIRECTOR, THE APP ASSOCIATION 

Mr. REED. Thank you. Subcommittee Chair Comstock, Ranking 

Member Lipinski, and distinguished Members of the Committee, 

my name is Morgan Reed, and I am the Executive Director of The 

App Association. I thank you for holding this important hearing on 

empowering the future of mobile health apps. The App Association 

represents more than 5,000 companies and technology firms 

around the globe, making the software that runs the devices that 

you wear, and the apps that you love. We are currently spearheading an effort, through our connected health initiative, to clarify 

outdated health regulations, incentivize the use of remote patient 

monitoring, and ensure the environment is one in which patients 

and consumers can see improvement in their health. This coalition 

of leading mobile health companies and key stakeholders needs 

Congress, HHS, and NIST to encourage mobile health innovation 

and support policies that keep sensitive health data private and secure. 

Now, traditionally this is the moment in my oral testimony 

where I would recite some interesting numbers about the industry, 

talk about jobs created and niches filled, but I’d like to break from 

tradition and instead tell you a story, one that is likely to be relevant to all of you, and is certainly relevant to a huge chunk of 

your constituents. Nearly everyone in this room is either caring for 

aging parents, or knows someone who is. Now, imagine your parents are fortunate and living at their own home, but significant 

medical challenges are beginning to face them. The questions 

begin, do I get a home health attendant? Do I pay as much as 

12,000 a month to move them to an assisted living facility? Do they 

move into my basement? And how do I deal with the fact that my 

parents don’t want to move into my basement? And a home nurse 

feels infantilizing. What do I do to help them stay at home and live 

with dignity? 

Well, most of you remember Life Alert. You know, the product 

with that tag line, help, I’ve fallen, and I can’t get up. That kind 

of device is commonly known as a personal emergency response 

system, or PERS. They’re great devices, but incredibly limited in 

what they can do. Now, imagine a far more sophisticated PERS, 
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packed with sensors that can track blood sugar, blood pressure, 

heart rate, biomarkers for medication adherence, geo-fencing for 

Alzheimer’s patients, and much more. Sensors small enough to fit 

into a watch, one that connects to the loved one’s phone, an alert 

device, alert service, a physician’s tablet, and a medical record. 

Suddenly, mom can stay at home, maybe another year, two, or 

three, all while managing her health. And if mom allows the data 

to be sent to you, you can be part of the solution, staying in touch, 

and on top of her needs. And, not insignificantly, your basement 

can keep its big screen TV. 

By 2050 there will be 83.7 million Americans over the age of 65, 

twice the number from 2012. 80 percent will have at least one 

chronic condition. Without question, this age group’s rapid growth 

will severely strain public and private health resources. Therefore, 

the picture I painted for you is not a pipe dream, but rather imperative to prevent a cataclysmic economic outcome for this boom in 

aging adults. Moreover, we’re already seeing near real time technology making a difference today. One example that we didn’t mention was Airstrip as a model of the potential for connected health 

care. Its apps and connectivity services allow physicians to remotely view live patient data. Emergency medical staff are able to 

send live waveform data from an ambulance to the emergency room 

so that a trauma center or cath lab can be readied by the time the 

patient arrives. The minutes, or even seconds, that are saved by 

this technology can make a critical difference in a patient’s life. 

So what’s standing in the way of this dream? What is needed to 

ensure everyone can benefit from these new innovations? Well, I 

have three messages for Congress. One, questions about privacy, 

security, and government regulation have met to create an environment where companies are worried about making devices more 

medically relevant. And physicians worry about the impact on their 

practice. The slow process by which HIPAA has been updated continues to delay uptake, and impede investment in innovation. 

Two, patients and care providers must know that their information is private and security. Industry best practices around the 

treatment of sensitive health data, as well as a commitment from 

government to support these practices, are important to establish 

trust, and push the industry forward. Moreover, clarifications on 

government access to data matter, and Congress should be pushing 

back on any government pressure to weaken encryption, and harm 

the protections that NIST are trying to establish. 

Finally, ensuring that doctors are reimbursed for the use of these 

technologies will be essential. Currently CMS is statutorily prevented from reimbursing for certain kinds of remote patient monitoring based on some absurd geographic restrictions and antiquated technological requirements that were state of the art 15 

years ago, but haven’t moved since. Success will come when the 

technology, trust, and means to pay for it all come together. I ask 

that Congress help ensure that that happens now, rather than see 

one more of our family members move out of the home they love 

because we failed to act. I look forward to your questions. 

[The prepared statement of Mr. Reed follows:] 
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Chairwoman COMSTOCK. Thank you. And I now recognize Dr. 

Shaw. 

TESTIMONY OF DR. BRYAN F. SHAW, 

ASSISTANT PROFESSOR, 

DEPARTMENT OF CHEMISTRY AND BIOCHEMISTRY, 

BAYLOR UNIVERSITY 

Dr. SHAW. Chairwoman Comstock, Ranking Member Lipinski, 

and distinguished Members of the Research and Technology Subcommittee, my name is Bryan Shaw, and I am a Professor of 

Chemistry at Baylor University in Waco, Texas. Thank you for inviting me today to testify on our health care app, Cradle. 

I want to tell you the story of Cradle, and show you how it 

works, because I believe doing so will help you continue to make 

wise policy. Cradle is an acronym for Computer Assisted Detector 

of Leukocoria. What is Leukocoria, and why would we want to detect it on a smartphone? Leukocoria is simply white eye. It is a 

white pupillary reflex. You can see an example of Leukocoria on 

your video monitor. White eye is a symptom of several pediatric eye 

diseases, including the aggressive childhood eye cancer 

retinoblastoma, and much more common, but less serious, conditions such as refractive error. One in 80 children will present with 

Leukocoria because of some type of eye disorder. This picture is of 

my son Noah at three months old. Noah’s Leukocoria was caused 

by a 9 millimeter tumor in the back of his eye. The Cradle app 

alerts a parent to the presence of this type of picture on their 

smartphone. The Cradle app also harnesses the phone’s digital 

camera and LED to convert the smartphone into a crude ophthalmoscope to help a doctor directly examine a child’s eye for a white 

pupillary reflex. 

Although the appearance of white eye might seem obvious in a 

picture of a child with eye disease, and although white eye can be 

observed by a doctor when shining a conventional ophthalmoscope 

into the eye, white eye often goes unnoticed and undetected for 

months, for years, by both doctor and parent. These delays can 

blind, and even kill, children. I know this fact from personal experience. My son Noah, who inspired my team and I to invent Cradle, 

was born with retinoblastoma tumors in both of his eyes. Noah’s 

pediatrician never caught the Leukocoria during any of his routine 

eye exams, but his mother did, using her digital camera. Tragically, 

it was too late to save Noah’s right eye, but doctors were able to 

salvage his left eye with external beam radiation and systemic 

chemotherapy. We later learned, to our horror, that Leukocoria had 

been showing up in our pictures for months, ever since Noah was 

12 days old, and had we noticed Leukocoria then, we likely 

would’ve saved both of Noah’s eyes. 

Unfortunately, our story is common, but Cradle is beginning to 

make it less common. Since its release for the iPhone in October 

of 2014, and for the Android in July of 2015, Cradle has prevented 

vision loss in other children all across the world, and it’s done so 

at zero cost. In two of my favorite cases, parents used the free Cradle app to catch retinoblastoma so quickly, so early in their children, that the children did not require chemotherapy, they did not 
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require radiation. They didn’t require removal of their eye, or eyes. 

They only required laser treatment, and they have good vision. 

Very quickly, I would like to do a little show and tell by showing 

you a video of me demonstrating the video ophthalmoscope mode 

of Cradle on my 7-year-old son, who’s in the audience today, and 

also as a control on my 3-year-old son, who does not have 

retinoblastoma. If we could see that video? 

[Video shown.] 

That’s the end of the video. 

In closing, the Cradle app demonstrates the humanitarian, entrepreneurial, and innovative potential of mobile medical apps. Cradle 

was created by basic scientists and students in their spare time, 

with no prior expertise in conventional health screening, other than 

witnessing its failures with Noah. We were able to provide Cradle 

to parents quickly because there were no regulatory or cost barriers 

in our way. Cradle cost under $20,000 to create. We provide it to 

the world freely. Cradle has already reduced health care costs 

around the globe. We are now pursuing funding for the clinical validation of Cradle, and plan to apply for regulatory approval. I 

would be happy to answer any of your questions on Cradle. Thank 

you. 

[The prepared statement of Dr. Shaw follows:] 
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Chairwoman COMSTOCK. Thank you so much, Dr. Shaw. And I 

think if that video is available for us to put up online, I think all 

of us would love to do that, and share that with everybody. And 

thank you so much. 

And Mr. Look, we’ll now hear from you. 

TESTIMONY OF MR. HOWARD LOOK, 

PRESIDENT, CEO AND FOUNDER, TIDEPOOL 

Mr. LOOK. Thank you. Chairwoman Comstock, Ranking Member 

Lipinski, and distinguished Members of the Subcommittee, thank 

you for inviting me today. My name’s Howard Look. I’m the founder and CEO of Tidepool, a non-profit open source startup from Silicon Valley. We’re building software to help people reduce the burden of managing Type1 diabetes. 

My story starts five years ago, on a family camping trip. Our 

daughter Katie had unzipped the tent three times in the middle of 

the night to go to the bathroom. The next morning she was throwing up and we thought that she might have the stomach flu. Two 

days later we were told that, along with weight loss, these are the 

classic symptoms of Type1 diabetes. Katie’s immune system had 

begun attacking her pancreas, the insulin producing cells in her 

pancreas, and without insulin, she simply couldn’t metabolize the 

energy that she needed to survive. My kids call me their geek dad. 

At the time my daughter was diagnosed, I was VP of Software at 

Amazon. Before that, I was VP of Software at Pixar, and I had 

been on the founding team at TiVo. I knew software and user experience, but I knew nothing about the challenges of health care. 

Our family quickly discovered what everyone who lives with 

Type1 diabetes knows. It’s a challenging and burdensome disease, 

requiring hundreds of decisions per day, and constant vigilance. 

Managing Type1 involves calculating precise doses of insulin, a 

deadly hormone, based on food, hormones, exercise, illness, and 

more. Not enough insulin, and you run the risk of ketoacidosis, or 

contributing to long term complications, like blindness and kidney 

failure. Even a little too much insulin and you risk severe hypoglycemia, or low blood sugar, which can lead to seizure, coma, or 

death. Said another way, effectively managing Type1 diabetes is all 

about meaningful, real time access to data to make the best dosing 

decision possible. 

The most popular insulin pump and continuous glucose monitor, 

these are two devices critical to successful diabetes therapy, come 

from different manufacturers, and they’re incompatible with each 

other. The software that comes with most diabetes devices is 

closed, proprietary, and hard to use. It’s a little bit like owning a 

digital camera and being forced to use the terrible software that 

came with it in order to view your pictures. To make a long story 

short, I found lots of other people who felt just like I did, and we 

founded a non-profit, open source startup called Tidepool. Our mission is simple, allow every patient to liberate their own health data 

from their devices, and in doing so, catalyze an ecosystem of applications to help them more meaningfully engage in their own care. 

It’s still early, but we’ve already made a tremendous impact. Nearly all device makers have made their data protocols available, and 

our free applications are currently the only way to visualize data 
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from the most popular insulin pump and most popular glucose 

monitor in one place at one time. 

This is our web application called Blip. It lets you see diabetes 

data from multiple devices. Here we have data from an insulin 

pump, continuous glucose monitor, and a finger stick meter, as well 

as contextual notes from your mobile phone. This is another mobile 

app called Nutshell. It lets you keep track of what you ate, along 

with the insulin dose that you used, and shows how your body reacted to it so that you can make an even better dosing decision the 

next time you eat the same thing. And this is a prototype of a mobile application that shows real time blood glucose values combined 

with location services, allowing parents to know that their child is 

safe no matter where they are. All of these are examples of a robust ecosystem of applications that can exist when health data is 

liberated, and the patient can choose how the data is used. 

Tidepool is not the only patient-led initiative using data to improve standards of care for people with Type1 diabetes. Our family 

also used Night Scout, an open source project that allowed us to 

keep—to see our daughter’s blood sugar remotely, keeping her safe 

when she was at a sleepover. And finally my daughter now uses 

a do-it-yourself system based on an open source project called Open 

APS, for Artificial Pancreas System. Her devices now work together 

to automatically deliver insulin based on a software algorithm, allowing her to receive safer and more effective therapy than the 

usual standard of care. 

This kind of innovation is only possible when patients have access to their own health data in real time. Real time is a far cry 

from requests for health data that are fulfilled within 30 days, or 

that come on paper, or by downloading PDF or Excel files. Medical 

device companies have the power and ability to publish their device 

data protocols now. Cloud data services can make that data available to users securely, using modern methods like OAuth and 

REST APIs. There are no technological, security, or privacy barriers. There are only barriers of fear and uncertainty. We’ve heard 

companies say, we’re worried about what people will do with the 

data, or we’re worried that people will present the data out of context. Positions like these serve to perpetuate existing standards of 

care, and limit what an open and vibrant ecosystem of liberated 

data can achieve. 

From a regulatory standpoint, the FDA has been extremely pragmatic with guidance documents like MMA and MDDS. They’ve 

been supportive of non-traditional quality systems that enable a 

lean and agile startup like Tidepool to iterate quickly, and we look 

forward to continuing conversations with the FDA to support nontraditional trials in n-of-1 studies based on distributed and patientled projects, and to discussing labelling requirements that would 

allow device companies to publish their data and control protocols 

without fear of added liability. 

To summarize, engaged patients should not need to outsmart the 

very companies that they depend on in order to achieve safer and 

more effective therapy. Their data should be readily available. The 

ability to foster and catalyze patient-led innovation and personalized engagement through mobile and web-based health care applications exists today. Thank you. 
45 

[The prepared statement of Mr. Look follows:] 
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Chairwoman COMSTOCK. Thank you very much. It was fascinating. It’s so inspiring to hear what you’re able to do, and—with 

your personal situation, how you’ve helped so many, so thank you. 

And now I will hear from Dr. Krauss. 

TESTIMONY OF DR. GREGORY KRAUSS, 

PROFESSOR OF NEUROLOGY, 

THE JOHNS HOPKINS HOSPITAL 

Dr. KRAUSS. Thank you for inviting me, Chairwoman Comstock, 

and Members—and for reviewing this important topic in the new 

era of using personal technology to support health care. I think it 

might be helpful to start with just illustrating the problem we deal 

with in supporting patients with epilepsy. So could we show a 

video, and then go to the next slide? And this is EpiWatch, which 

we’re using to detect seizures and alert caregivers when a seizure 

occurs to help their family members. And I’ll show you a typical patient during a seizure in our hospital. 

[Video shown.] 

So this is a 17-year-old boy who now—he feels the seizure. 40 

percent of people —as their seizure begins—activate a monitoring 

system. And now the seizure’s spreading across his brain. He becomes confused. Now, his father, who’s a physician, comes in. He 

knows something’s wrong. Now the seizure’s spreading across the 

brain, evolving into a—here’s the staff coming in—towards the end 

of the seizure—respiratory distress—and so this 17-year-old has 

seizures like this at school about every two weeks. and they often 

last up to 10 minutes. And so one need is to have a detector that 

can warn caregivers of a seizure, and allow emergency intervention 

to help a patient. An app such as this can also provide a lot of support activity for children. 

And so we are developing EpiWatch. It uses Research Kit, which 

is a novel data management program, that’s integrated with the 

Apple Watch. So the app lives on the watch, and when a patient 

has a seizure, it can be triggered by a caregiver or the participant, 

and then for ten minutes it collects data. And these watches have 

sensors, so it can detect heart rate changes, movement changes 

with an accelerometer, and it has a gyroscope that can detect 

changes in position. The advantage of the watch also is every 

minute we can query the patient to perform a tap test, and let us 

know if they’re alert, or if the seizure’s ended. And so we can measure the duration of the seizure, movements during the seizure, and 

heart rate changes associated with seizures, and with that we’re 

developing a seizure detector. 

Now, the question is, how do you collect data like that to make 

a seizure detector and do research? And so the advantage of Research Kit is that it’s a system that allows anonymized data collection from a national participant pool, and allows rapid research to 

be performed. So the Research Kit has an electronic consenting system where possible participants—they can read about the research 

on their iPhone. They can be screened based on their criteria, are 

they the appropriate age, if they have sufficient seizures. They 

then are tested for comprehension of the research on the iPhone, 

and then they sign the consent, and then they receive an e-mail 

with a PDF signed version of the consent. And so you’re able to do 
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mobile e-consenting in a national population very rapidly. And so 

this is very useful. Once they sign up for the research, they track 

seizures, and we collect data for ten minutes during seizures, and 

then encrypted data is transferred to a data system, and transferred to us in encrypted form. And so this Research Kit approach 

really allows, I think, an explosion of novel research to be performed. First, we’re able to study several hundred patients within 

a month, and capture thousands of seizures rapidly. We can capture seizures from all ages and demographics in the U.S., and we 

can quickly accumulate data to develop the seizure detector. 

And so we’re using this research to especially focus on serious 

seizure types, such as this boy’s. So, for example, one in 500 persons per year with epilepsy die suddenly, usually of a respiratory 

death of cardiac arrhythmia, and that’s called SUDEP, Sudden and 

Unexpected Death of Epilepsy. The majority of this occurs during 

nocturnal convulsions, and so we’re focusing initially on close detection of seizures associated with SUDEP. Could you show the slide? 

And so this is the data we’re collecting during a patient who’s having a convulsion at night. They’re shaking. You can see on the bottom right, that’s their heart rate, markedly increasing several minutes after the seizure, when they’re in cardiac distress. 

And so this app—the idea is that it would alert patients’ caregivers that they’re having a serious seizure type. They can then 

come in, reposition them, stimulate and arouse them to avoid respiratory dysfunction, and perhaps rescue them. And so this is the 

goal of the research, and we have the advantage that we can actually test prototypes of the detector on the system, and do a lot of 

research in a large pool of patients very quickly. So we’ve not 

moved on to commercialization of this product. That’s our—not our 

goal. The Research Kit is open source, non-commercial software. All 

our software will be open source, and so we will be able to migrate 

our seizure detector and app to other platforms once it’s developed. 

Other questions regarding types of research, and issues of regulation and data security, I think I’ll just leave to my written summary. Thank you. 

[The prepared statement of Dr. Krauss follows:] 
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Chairwoman COMSTOCK. All right. Thank you so much, Doctor. 

And now we will hear from our final witness, Mr. Epstein. 

TESTIMONY OF MR. JORDAN EPSTEIN, 

CEO & FOUNDER, STROLL HEALTH 

Mr. EPSTEIN. Great, thank you, Chairwoman Comstock, Ranking 

Member Lipinski, Members of the Subcommittee. Thanks for having me. My name is Jordan Epstein, and I’m the founder and CEO 

of Stroll Health, a startup based in San Francisco that helps doctors help their patients find better value health care. We started 

with the vision that when you go to your doctor, your doctor should 

do what’s best for you, not just what’s easy for them, or what they 

do for every patient, but what’s actually best for you based on your 

insurance, where you live, and how much you can pay. And that’s 

exactly what we do for 300 procedures. 

In radiology today, when a doctor orders it through the Stroll 

app, we can show a patient what’s in network, what’s nearby, what 

their out of pocket cost options are, and, together with their patient, decide the best place to go. On average we save 30 percent, 

and 86 percent of the time send patients to lower than average cost 

care. If Stroll, or a Stroll-like tool, could be used for all non-hospital-based health care decisions in this country, we would save the 

nation $500 to $700 billion a year. That’s a lot. So you would think 

that the National Science Foundation, or the Small Business Innovation Research Program would want to support this kind of research and development, but you’d be wrong. Stroll applied for, and 

did not receive, an SBIR grant. And when you look at the average 

age of an app developer versus the average age of a health related 

grantee, it’s almost double. Too many of my generation are spending their time building apps for ads for mobile and texting, and we 

need to support those of us who choose to dedicate our time to address some of the toughest problems our nation faces. 

In developing Stroll, we’ve come across a number of barriers. The 

first is we work with hundreds of insurance companies, and the 

protocols to do that are incredibly complex and arcane. Imagine for 

a moment if you’re on, you know, a U.S. highway, except for—there 

were no speed limits, and whatever vehicle you wanted to be on, 

you could. Bicycles, cars, tractors, you name it, right? Traffic would 

be a nightmare, and that’s exactly how the current U.S. architecture, you know, IT health care architecture works. 

The second sort of problems that Stroll faced were on the regulatory side. So there’s a number of regulations, including the Federal Anti-Kickback statute, that basically regulate how companies 

like mine, that try to improve efficiency and reduce the cost of care, 

can be compensated. So imagine again, for a moment, you wanted 

to buy an airline ticket, except there’s no Progressive, there’s no 

Kayak, there’s no Expedia, right? You have to call each individual 

airline, and ask for a price, and what’s available, and that’s exactly 

how our U.S. health care system works today, and it needs to 

change. 

The third sort of roadblock we’ve run into is just—as a small 

business that employs highly technical, highly skilled workers, we 

need to offer health insurance to stay competitive. What I don’t understand is why I have to choose those plans for my employees. So 
71 

imagine again—let’s say I wanted to offer a tax free transportation 

benefit. I could offer my employees a Lexus or a Ford, but only 

ones that had large cup holders and a V8 engine. That’s clearly not 

best for my employees, right, and it doesn’t foster innovation and 

competition in industry, but that’s exactly the sort of decision I 

have to choose every time I make a health care, you know, plan 

decision for my patients—or my employees. 

So, bringing it back to Stroll, we started with the vision that 

when you go to your doctor, your doctor can do what’s best for you, 

and five to ten years from now, when you go to your doctor, they’ll 

be able to tell you what’s in network, what’s covered, and you can 

leave knowing exactly how much it costs. 

I look forward to your questions, and thanks for having me. 

[The prepared statement of Mr. Epstein follows:] 
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Chairwoman COMSTOCK. Thank you so much. Boy, this is so exciting, to hear from all of you. I really appreciate your expertise, 

and all the things you’re working on. It strikes me, as I hear all 

of you speak, and certainly with your personal experiences, that 

this really is going to require some really different thinking. This 

is sort of the Uber economy and health care. How are, you know, 

and I have a number of doctors in my family, and I know oftentimes they’re like, well, we have to decide, so—the doctor knows 

best. And this is turning this on its head a little bit, where we’re 

going to use our knowledge and understanding, but also the technology, which is probably more precise in many cases. 

So what kind of resistance, if any, are you—I think—lot of resistance, so that’s very helpful. But what kind of resistance are you 

seeing, if any, hopefully not much, to this kind of thing, and what 

can we do to assuage that resistance that the medical field might 

have? Mr. Reed? 

Mr. REED. Yeah. I think one of the things we have to consider, 

it’s very easy for us in the technology industry to say, the doctor 

is wrong, and, you know, be disruptive, and welcome disruption in 

their lives. But what I’ve found is that physicians are as frustrated 

by the regulatory requirements, and the barriers, and the questions 

about reimbursement as anyone. The AMA had a recent study that 

showed a 30 percent decrease in efficiency due the way that the 

failure of EHRs to be interoperable had created, and, frankly, bad 

user interface design. 

So I think we have two real problems that’s we’re facing with 

physicians. One, physicians are uncertain about how to accept that 

data, and the accuracy of the data they might accept. And then, 

two, what are the liability that extends to them if they accept that 

data and they don’t act on it? And then the overarching question 

is, if they take the time to review the data, and engage with a patient in that way, how does that figure into their reimbursement? 

So I know this Committee’s jurisdiction touches on the edges, but 

we are all frustrated with the physicians, but I think I would speak 

for the—my meetings with the AMA and others in saying that 

they’re frustrated right along with us. 

Dr. SHAW. What I work on, retinoblastoma, it’s highly specialized. So pediatricians, ophthalmologists, they actually know peer 

reviewed studies have shown that mom, then grandma, then dad, 

are statistically the first people to catch the symptoms of 

retinoblastoma. And the primary test that the pediatrician uses, 

shining a light into the eye, this is called the red reflex test. It’s 

notoriously ineffective, and everybody knows it. 

So the doctors that we’re working with, I mean, they love it. I 

haven’t—— 

Chairwoman COMSTOCK. Yeah. 

Dr. SHAW. I haven’t encountered any resistance—— 

Chairwoman COMSTOCK. Great. 

Dr. SHAW. —from the practicing pediatric, or ophthalmology, or 

oncology community. 

Chairwoman COMSTOCK. That’s great news. 

Mr. LOOK. So Type1 diabetes I think is a great example of this. 

It’s one of the only diseases where you are literally prescribed a 

deadly hormone, right? If you take too much of it, it will kill you. 
85 

There’s a shortage of endocrinologists in this country. Most endos 

see their Type1 patients four times a year for maybe 15 or 20 minutes. The other 361 days a year, the patient is on their own. So 

most endos love engaged patients. Patients who engage with their 

data and understand what a fine line it is to deliver good insulin 

doses do better. 

Chairwoman COMSTOCK. And in terms of the data sharing that 

was mentioned earlier this morning, when we were talking about, 

you know, cancer patients wanting to share data and get to share 

that, I guess, you know, maybe we need to have some legal 

changes, liability changes, but do you think in that area, as we 

share that data, you’re going to see, like, well, this, you know, so 

this is the, you know, the person who’s done the best with Type1 

diabetes, not doing any damage, have done these things, so as 

you’re tracking through, you sort of have a goalpost of all these 

thousands before you that you can stay in the zone to get, you 

know, the A level of performance from something like this. 

Mr. LOOK. By and large, in the world of Type1 diabetes, there 

is not resistance to sharing data. People understand that by sharing their data, they’re doing better for the community. And when 

there’s a large pool of data, it means that not only doctors can see 

how patients are achieving effective therapy, but you can even 

start imagining effective ways of computing insulin doses. When 

my daughter walks into California Pizza Kitchen and orders the 

five cheese margherita pizza, she should be able to look on her 

phone and see how did other 16-year-old girls who ordered that 

same pizza dose for this effectively, and help to come up with a better insulin dose that way. So, by liberating the data, we allow for 

more engaged patients, and much more effective therapy. 

Chairwoman COMSTOCK. And I have to imagine, as a parent, that 

gives you a lot more peace of mind too. 

Mr. LOOK. That’s right. 

Chairwoman COMSTOCK. Yeah. All right. 

Dr. KRAUSS. One interesting thing we found is that, actually, patients want to control their own health data. So when we collect 

tracking data about their pill taking, or the number of seizures, 

they actually don’t want that to go directly to their doctor. They 

want to receive it, and then show it to their doctor, potentially, and 

they’re quite willing to come in for appointments and have their device optimized. 

But that’s an interesting feature, but it’s one that we use also, 

so we want to optimize our graphing, and show relationships between missed pills and seizures. We have a participant, like me, 

graph so they can see how other people with the same condition, 

same age are doing. But that was an interesting finding, yeah. 

Chairwoman COMSTOCK. Okay. 

Mr. EPSTEIN. Okay. So bringing it back to, you know, kind of doctors using apps, we actually make apps for doctors, right? So we’ve 

encountered lots of resistance. The first is, as Mr. Lipinski pointed 

out, there’s 100,000 apps, right? So are you really going to ask a 

doctor to use—no way, right? And so basically, you know, when we 

talk to doctors, we have our own app, but they’re like, put it in the 

EMR. And really kind of—if you think about the EMR as the sales 

force sort of model, where you basically stick a whole bunch of 
86 

apps—and the doctors don’t even know they’re separate apps. It’s 

just a widget within the app, right? And so you have, you know, 

one for blastoma, you have one for, you know, all these different 

things, right? So that’s kind of, I think, where the future is—— 

Chairwoman COMSTOCK. So we really need to make that just 

available directly for the patients, and not having any blocking 

things? Because the doctors can’t possibly know all the things. 

Mr. EPSTEIN. Or, right, make it easier, so HHS is just putting 

this interoperability thing, you know, freeing the data to allow doctors to be able to say, look, in my EMR I can control it how I want 

to control it, with whatever apps that I want, right? So that’s exciting. 

And then when you think about, again, this work flow problem— 

so, again, if you were trying to diagnose, or trying to use any of 

these things, you’re saying, I have to do a new thing, right, as a 

doctor. I used to do this, and now I have to do something else, 

right? And so that’s one of the biggest things that we’ve, you know, 

faced, is how do we reduce work flow for physicians, right? And so, 

I mean, that’s—— 

Chairwoman COMSTOCK. All right. Thank you very much, and 

I’m over my time, but I really appreciate it. I’m—— 

Mr. REED. If I could borrow some time from Mr. Lipinski really 

quickly, I think it’s interesting that Dr. Shaw, Mr. Look, and Dr. 

Krauss all talked about access to data. But one of the problems 

that we do see is that much of the guidance around remote patient 

access to data on HIPAA pre-dates the iPhone. 

Chairwoman COMSTOCK. Yeah. 

Mr. REED. Now, they’ve done some new stuff, but 2006, for the 

guidance, iPhone came out in 2007. So as you’re considering the 

places where there’s movement, there is room there. 

Chairwoman COMSTOCK. Thank you very much. Recognize Mr. 

Lipinski for five minutes. 

Mr. LIPINSKI. Thank you. I want to follow up on what Mr. Epstein had just mentioned about the—how the Office of the National 

Coordinator within HHS had recently released the final rule on expanding electronic health information, access, and exchange. Now, 

the rule requires that mobile health app vendors develop apps with 

an open application programming interface that allows the user to 

share data from her mobile health app with her electronic health 

record. 

So, Mr. Epstein, is there anything else that you wanted to add 

on that? Is there anything more that needs to be done on interoperability? I wanted to see if anyone else had any comments on that. 

Mr. EPSTEIN. Yeah, absolutely. So, on the app side, I think I can 

speak for all of us, but maybe not. We all use APIs, right? That’s 

the standard, right? But when you talk to the EMR vendors, when 

you’re talking about, like, Epic, and, you know, these guys, right, 

that’s really the problem. It’s not us, right? We want to get in with 

those guys, right? We want to integrate with the system, right? 

And it’s really, how can we get in? 

And so, you know, the current process today, there’s both these 

technical barriers, right, but then there’s also—I have to actually 

go first sell—there’s no easy way to do it, right? I have to go 

through this long contracting period. I usually have to get the doc-
87 

tor or the health system to vouch for me to get into these guys, 

right? There’s no standard process. And then on top of that, in 

terms of HIPAA regulations and data sharing, as Mr. Reed was, 

you know, pointing out, the standards are totally unclear for what 

we’re supposed to do. 

So, for example, we’re integrating with AllScripts and Athena, 

right, large publicly traded EMR vendors, right? For one of them 

I assigned a subcontractor, BAA, with one of them, which I think 

is the correct thing to do, and with the other one I literally have 

to go doctor by doctor to sign a new contract with every single one 

of them, which makes no sense at all, right? But it’s unclear what 

we’re supposed to do with how the laws are written, so—— 

Mr. REED. I would say that NIST has a role to play. We all believe that better user interface design is absolutely critical. They 

have some oversight in it. Originally NIST was powered in part to 

help with the interoperability. I think we all know there were some 

misaligned incentives for the EHRs, in terms of creating the interoperability that we all need. We’re all exploring open APIs, and 

there are projects underway to improve it, but realistically I believe 

that the motivation will have to come elsewhere. The major vendors recently signed a pledge about no data blocking. That’s a nice 

start. We want to see that continue to grow, and an acceptance of 

either open APIs or other systems that allow for better interoperability. 

Mr. LIPINSKI. Anyone else? Go ahead. Can you pull the mic a little closer? 

Mr. EPSTEIN. You know, turn it on. You know, basics. Yeah, 

sorry. So everyone is talking about interoperability between EMRs 

and apps, right, but there’s also another type of interoperability 

that’s not talked about very often, which is also incredibly important, which is interoperability with insurance companies. And there 

needs to be standards there. It’s a—literally that highway analogy 

that I told you is how it works today, and it—it’s almost—it’s so 

difficult for a company like mine, that’s trying to say, look, what 

is your benefit, where can you go, how can I help you, and the insurance companies don’t want to do that. 

And that—it’s the same interoperability problem, actually, for 

doctors talking to those insurance companies with a—what’s called 

a prior authorization process. You have to literally go—with phone 

calls, right, with—you have to get the nurses, you know, back and 

forth—you have to do a peer to peer with physicians, right? This 

is all just standards. This should be in the API connection. I should 

be able to ask you, and you should be able to tell me electronically, 

and we’re done. 

Mr. LIPINSKI. Thank you. I just—very quickly, before I get to my 

next question, I want—so here’s my blood glucose monitor, and 

here’s my pump PDA. So I’m looking forward to looking at and trying out Tidepool, although it’s a lot of information to put in there. 

And it’s a matter of actually getting myself to do that. The issue 

that is—you talked about—— 

Mr. LOOK. We try to make it easy, so—— 

Mr. LIPINSKI. Connect—— 

Mr. LOOK. —you know—— 
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Mr. LIPINSKI. But it still takes time. The issue with connecting 

these two, which you said you have done—the issue, as my 

endocrinologist has told me for a number of years, is a liability 

issue. There’s no technology issue whatsoever, so—but that’s something beyond where—what we can do here, but I just wanted to 

mention that. And—before I ask my last question on price transparency. Again, Mr. Epstein, you—it’s been, you know, I’ve been 

trying to do this for the 12 years I’ve been in Congress, is get to 

more price transparency. There’s been some work that’s been 

done—requirements that have been done at the federal level. How 

do you get the prices? The providers don’t want to provide the 

prices. And then you have—the insurance companies have their, 

you know, the rates that they negotiate. The insurance company 

has a different rate with the hospital. How’d you get at this? 

Mr. EPSTEIN. Yeah. So the long answer is talk to me afterward 

and look at my written testimony, but the short answer is it’s really not easy at all. We work directly with providers. We try to get 

fee schedules. We try to get claims data. Again, there’s, you know, 

gag clauses, and all sorts of, you know, most every nation clauses, 

all—and these contracts they sign with insurance companies, all of 

which, I think, should not be allowed. In California, for example, 

gag clauses are not allowed, so I think at a federal level there’s 

more that we can do there. 

But basically, you know, the way that you have to do this is 

you’ve got to get—first, what’s in and out of network, and there’s 

no standards on that right now for insurance companies. There 

need to be, right? Because, you know, just as an average patient, 

like, where do I go? Come on, guys, right? And even if you call your 

insurance company, they can’t tell you. So there needs to be standards there. And then when you get to the fee schedule component, 

you know, there’s lots of companies, like Castlight, like my company, that look at claims data that try to process these things, that 

write statistical models, but it’s just not easy. It’s really a complex 

problem. 

When you look at the—kind of the scope of what Stroll does, you 

know, for an individual doctor trying to make a decision, there’s 

more than a trillion options, with a T, trillion, when you’re trying 

to figure out where a patient can go that’s best for them. So it’s 

really not an easy question. 

Mr. LIPINSKI. Thank you. 

Chairwoman COMSTOCK. Thank you. And I now recognize Ms. 

Bonamici for five minutes. 

Ms. BONAMICI. Thank you very much, Chair Comstock, and 

Ranking Member Lipinski, for having this informative hearing. 

This topic is—in this Committee, we’re frequently reminded of the 

challenges of regulating and legislating around technology, because 

the technology advances so much faster than the policy. And the 

example about HIPAA, you know, it was back when we had 

landlines and pagers. You know, it’s really time to update a lot of 

these things. And there’s some great examples from my home state 

of Oregon. 

Dr. Krauss, I saw you spent some time at Oregon Health 

Sciences University. I, last fall, met with some entrepreneurs from 

OHSU. They developed Provata Health. They got a grant from 
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NIH, and it’s a wellness digital health program. And they’re using 

it with Oregon’s public employees, educators, and families, and seeing tremendous progress and improvements in nutrition and physical activity just through the digital health program. For example, 

the Portland Fire Bureau said they’re saving about $1,000 per firefighter just because of using this. So there’s a tremendous amount 

of potential. The director of the OHSU Knight Cancer Centers Institute on Melanoma Research, and a cancer biologist there, Dr. 

Sancy Leachman, and the biologist, Dan Webster, created an app 

to help users track moles for science in melanoma. So there’s just 

a tremendous amount of potential. And as we look at ways that we 

can help patients receive better care, and improve diagnoses, it’s 

really important for us to look at the potential here, and evaluate 

these tools. 

I really appreciate your innovation and, you know, Mr. Look, 

and, you know, your personal stories about—Dr. Shaw, how you 

stepped up and filled this need. I serve also on the Education Committee, and I have founded and co-chair the STEAM Caucus to talk 

about the importance of integrating arts and design into STEM so 

that we have an innovative work force, and creativity, and innovation. So this is yet another example of where design is important. 

I know that—I think the NSF, their Smart and Connected Health 

Program goal, is to help transform the health care system to one 

that’s more reactive. 

One of the largest, as you know, health information technology 

conferences is happening this week, and focusing on some of the 

behavioral aspects of these apps. So can you talk a little bit about 

the design, and how important it is that these apps be useable, and 

how has design played in your design—how has design played a 

role in your development of apps? Who wants to start? Mr. Reed? 

Mr. Epstein? 

Mr. REED. So, very quickly, I use an example of AirStrip. It is 

a vendor that actually puts live wait forms in the hands of physicians on a screen. Like, this—it is amazing in its ability for a physician to actually quickly go through, look at live wait forms, spin 

out, pick something in particular, look at the event, move it on, 

transfer it to another doctor, all on their iPad, while the patient 

is still in the ambulance. And so the design of that is critical. 

Notice what I didn’t say. I didn’t say pull down menu. I didn’t 

say a login screen, followed by a pull down menu, followed by a 

sidebar, followed by a pullover. It’s got to be touch sensitive—— 

Ms. BONAMICI. Right. 

Mr. REED. —obvious in its usefulness, and responsive in its design. 

Ms. BONAMICI. And, Mr. Epstein, I know you say something in 

your testimony about removing the complexity and decision fatigue, 

I think is what you said, and confusion facing the average patient 

in the U.S. health system. So can you expand on that, and how 

your app has changed a person’s management of their health care? 

Mr. EPSTEIN. Certainly. So if you look at—I was just talking to 

Providence Health Care. I was at that large conference in Las 

Vegas yesterday, right? And so if you look at the average number 

of clicks that would go through to ordering a radiology procedure, 

it used to be 20. 20 clicks, right? So now it’s four, with Scroll. And 
90 

so when you think about, you know, just, you know, what you have 

to do, it needs to be easier. And when you think about, like, login 

screens and things like that, that’s actually required by HIPAA. So, 

you know, we should think—and do you know what—the first thing 

that—when I go talk to hospitals, you know what they ask me? 

They say, can you make it an auto login? 

Ms. BONAMICI. And? Yes, Mr. Look? 

Mr. LOOK. So a lesson I learned working at TiVo, an easy to use 

consumer electronics device, is if you don’t make it simple, and approachable, and intuitive, it will fail. A lesson that Silicon Valley 

has taught us is you have to iterate. You have to try something, 

test it, try it again, test it, try it again, test it. We’ve tried to apply 

both of those to everything we do at Tidepool. Design is at the core 

of everything we do. Our UI design lead, Sarah Krugman, has been 

living with Type1 diabetes since she was six years old, so she has 

empathy for the people that she’s designing for, and then she gets 

to iterate, and try and try again. One of the challenges is the regulatory structure tends to be design up front, test, release, not 

iterate, try, iterate, try. So I do think we can do more. 

Ms. BONAMICI. Right. And, real quickly, I mean, we also talk on 

this Committee a lot about cybersecurity, and data breaches, so are 

you all convinced that we can do this, and protect people’s privacy, 

but still make everything more efficient, more usable? Because, you 

know, it’s not like we’re logging in to buy a plane ticket or something. You know, this—health issues are sometimes really urgent, 

and we need these things to be easy to use. Are you all convinced 

that we can do this and protect privacy? 

Mr. REED. Yes. 

Mr. LOOK. Yes. 

Mr. REED. Yes. 

Mr. LOOK. 100 percent. 

Dr. SHAW. Yes. 

Mr. REED. But I would point out that yesterday we had a hearing 

in the House Judiciary Committee where we had FBI Director 

Comey and Cyrus Vance basically take a swing at the idea of the 

kind of security that we’re all talking about. And we are all confronted with the reality that, on one hand, you have Comey saying, 

well, I don’t know about this encryption stuff, at a certain level. 

And yet NIST is telling us in order to protect the patient privacy 

and health that we must engage with high level cybersecurity elements, like encryption. So we asked Congress to make sure they’re 

giving us the right message, and make sure the solution makes 

some sense. 

Ms. BONAMICI. Well, I look forward to working with my colleagues in breaking down some of those barriers. I yield back. 

Thank you, Madam Chair. 

Chairwoman COMSTOCK. Thank you. And I now recognize Ms. 

Esty for five minutes. 

Ms. ESTY. Thank you, Chairwoman Comstock, Ranking Member 

Lipinski, for this really important hearing today. To Mr. Look, with 

a brother who has Type1 diabetes who’s also a triathlete, this 

would improve his life. I’m going to make sure he gets on board. 

As a mother who took many, many pictures, Dr. Shaw, I think empowering consumers, parents, to really use technology to look for 
91 

things—as the one who checks my husband’s moles—I mean, we 

are starting to take pictures. And we talk about this. Like, I should 

be taking pictures, because you’re only going to get in, you know, 

it takes you 2 months to get in and see the doctor. So, for all of 

you, it is critical that we do this, not just to save money, but to 

save lives, and to empower Americans to lead healthier lives. It 

can’t be about going to see your doctor and fixing the problem after 

the fact. How do we keep ourselves healthier for longer? And I 

think we’re all committed to that, because that’s the goal, not more 

health care. It is healthier lives. So I want to thank you all for your 

work. 

In Connecticut we’re doing a lot of work around stem cell research, personalized medicine, all of these things that are going to 

be so important. And when I think about the privacy issues, we’re 

using our fingerprint to open our phone. That kind of is a personal 

identifier that ought to be able to unlock these things pretty quickly. So it seems to me we should be able to solve that problem, I 

hope, in ways that meet the tests that we are being challenged 

with otherwise. 

Dr. Epstein, you had—in your testimony you talked about—Mr. 

Epstein. I know, I—as somebody who grew up in Minnesota, I figure, Carlton, I’m just going to elevate you to doctor. You’re—it’s the 

spillover effect of all the doctors around you. You talked about how 

when you applied—when Stroll applied for—to receive federal funding through SBIR you were turned down, and you went elsewhere. 

You went to the private sector. Now, these programs are up for reauthorization. Can you talk to us a little bit about—what should 

we be looking for? What should we, as Members of Congress, be 

doing about critical roles in federal funding, which we fight for 

every single day in this committee on basic research, and yet you 

are raising some really interesting and troubling questions about 

whether we’re going after it the right way. 

Mr. EPSTEIN. Great. Thank you. Yeah, so I’m all for those programs, and I think, you know, there’s two questions. One, is there, 

you know, enough money for those programs? And then the second 

is, you know, is the money going to the right places, right? You 

know, I think probably the answer is no to both of them, right? 

But, you know, I won’t talk about the absolute management of the 

money. But in terms of—especially, you know, for app developers, 

right, I think it’s great that we have, you know, a number of doctors, you know, that are here that have, you know, tens of years 

of experience. But there’s also, you know, people with, like, you 

know, a couple years out of college that really have great ideas that 

don’t, you know, need to make very much money, right, that really 

just want to make a difference. 

And when you look at, you know, what $150,000 can do for this 

country, like, you know, let’s say, you know Stroll is not successful, 

right? Let’s say there were 100 Strolls, right? That’s, what, $15 

million, right? We’re talking about $500 billion that, you know, 

how many bets do you want to make? And I think it’s worth taking 

those bets, so, you know, and I think it’s really, you know, how 

those programs are administered, and who is reading those applications, right, and who has the experience to say, like, is it—do we 

believe this person can do it, and is it a worthwhile endeavor? 
92 

Ms. ESTY. Thank you, and I may follow up more on that, because 

I think that’s exactly where there is a role for federal government. 

We have a market failure, because if you’re trying to save money, 

it’s not clear who’s going to collect that money, and the apps are 

designed for free, and you’re not going to charge people to use 

them. So we do have a real compensation issue, and incentive misalignment. So I think—the other issue I wanted to ask all of you 

about was this question about iteration. And we run into that all 

the time in this Committee. You know, the legislative process is designed to be slow, and yet technology is moving very, very fast. And 

so we have, you know, we’re dealing with agencies who are struggling who have 15-year-old systems, to say nothing of trying to deal 

with apps. 

Any of you want to talk to us a little bit about how, as responsible policymakers, how do we think about, you know, what can we 

responsibly look to do to vet ideas and technologies, and yet not be 

so far behind the curve by the time we approve them? So it looks— 

Dr. Krauss is getting ready to go. Please. 

Dr. KRAUSS. Well, yeah. The reason is is—one thing that’s very 

important to us is that there’s a real marketplace of these apps. 

And we do want very safe and effective apps to come out. And I 

don’t know that there’s enough focus on that in many of these 

areas, particularly with significant medical apps. And so we are 

very sort of engaged with this idea of using a research approach, 

using mobile devices to collect data, build prototype systems, test 

them, and only then release it, and we hope that that’s encouraged. 

And I think this sort of Research Kit approach is helpful in that 

regard. 

I think it would be very helpful if there were administrative addons to NIH grants for rare diseases to fund apps in those areas. 

That’d be very helpful. And general encouragement of app development with FTA, which, you know, they’ve been helpful, but everything’s in a preliminary stage. Thank you. 

Mr. REED. I’ll quickly explain what he—one of the things that he 

mentioned there at the end, which is a solution, or at least a— 

something that the FDA is trying, and that is the development of 

this risk triangle, where they came out with the guidance in 2013, 

and declared that apps that posed essentially no risk to patients, 

or something that would not require a 510(k), a review—regulatory 

review process, that applications that moved into the middle category, which they refer to as a regulatory discretion area, were 

ones that they felt had low likelihood of patient harm, but yet probably still fell under the purview of the FDA. 

And then, finally, the obvious ones, which is if you have an app 

that, either through marketing, or through the technology that 

you’re trying to do, creates a real risk to patients, then yes, this 

needs to go through a formal process. So far several applications 

have gone through the FDA, and have passed 510(k). At last 

count—I don’t believe anything has been pre-market approval. I 

don’t recall a single app that’s done full pre-market approval. Everything has been 510(k). If I’m wrong on that, I’ll correct it in my 

written. Thank you. 

Ms. ESTY. Thank you. Appreciate all of that. And did you have 

a comment? 
93 

Mr. LOOK. I was going to suggest, I do think we need to find a 

way to disconnect the riskier components of technology, where you 

would want to actually do a deeper testing release cycle from the 

parts of applications where you should be able to iterate quickly. 

Like, even—something that visualizes blood glucose data, I should 

be able to release software multiple times per day to help find the 

best way to present that to my user. So it’s a matter of where the 

risk is. 

Ms. ESTY. Thank you very much, and I think we’ll follow up to 

get a little more precision so we can pass that through to FDA, and 

we can look at it in our own legislation to try to provide some of 

that—your help, and that guidance. Thank you very much. 

Chairwoman COMSTOCK. Thank you. And I now recognize Ms. 

Clark for five minutes. 

Ms. CLARK. Thank you so much, Chairwoman Comstock, and 

Ranking Member Lipinski. And, really, what an incredible panel. 

Thank you for being here. Thank you for the work that you’re 

doing, and trying to help us help you. Last night I had a great 

privilege. I have three Weston, Massachusetts High School juniors 

who won the STEM app contest, and they—Dr. Krauss, you’d be 

interested—developed neurological testing that could be done on an 

app and give real time information, be able to be done remotely, 

and also measure things that couldn’t be measured on a paper test. 

So the speed, how many times, where did things sort of fall apart 

for patients. Really interesting stuff. 

And I was thinking about them, and, coming from Massachusetts, where we really have a hub of innovation, one of the things 

that I am hearing from companies in my district is that, as they 

are worried about technology and app development sort of falling 

into the regulatory no man’s land, they’re seeing the lack of clarity 

really causing the VC community and investors to pull back. They 

don’t trust the regulatory atmosphere, so they don’t know how to 

play in that field. And I wondered, to any of you, what were some 

of the questions that investors asked when your companies were 

getting started, and what were some of the biggest pushbacks? And 

what are you sort of hearing from the landscape around investors? 

Mr. EPSTEIN. So—I’m going through this process right now, so I, 

you know, I’ve had 80 conversations in the last 2 months, so I feel 

like I can speak pretty—so we’re not FDA regulated, so that’s not 

something what we’re worried about. And, in fact, on the regulatory side, that’s—the biggest sort of fear, like, just—like non-rational fear that investors, you know, talk to me about is really just 

about what is the future of this market, in the sense that, you 

know, are apps going to win, right, or are these big, you know, 

EMR vendors, right, basically going to, you know, rule the ship? 

Like, is there a role for a company like Stroll, that makes this very, 

very important, but very, very small, in terms of the big, you know, 

scheme of health care, right how do we fit into this, right? 

And basically, if it’s not going to be the case that we can integrate, and it’s not going to be the case that we can, you know, distribute through these channels, right, then we’re not going to win, 

right? Then an investor doesn’t want to invest. It doesn’t matter 

how great the idea is, right, and then they walk away. 

Ms. CLARK. Yeah. 
94 

Dr. KRAUSS. We have more of an academic model, where we’ve, 

like, aligned ourselves with Cure Epilepsy, that was founded by 

Susan Axelrod. And so we’re applying for grants, we’re collaborating with them and their scientists, in terms of patient experience, and what we want to include in the app, and then we will 

develop a non-profit kind of model for release of this app. 

Ms. CLARK. Yeah. So it just doesn’t come into your world, the private investor. 

Dr. KRAUSS. Well, it will eventually, probably—— 

Ms. CLARK. Yeah. 

Dr. KRAUSS. —but we basically want to get it right, and use Research Kit, do research, really optimize the system before then— 

we turn to commercialization. 

Mr. LOOK. So my company made a crazy decision to be non-profit, even though we’re in the middle of Silicon Valley, in part because of this, in part because we wanted to focus on the unique 

needs of Type1 diabetes, and not have to be pulled into the—a 

broader market that had to show a return. But one of my board 

members is one of the leading health care VCs in Silicon Valley. 

We spend a lot of time with the device makers that are trying to 

raise funds from VCs, and this is a real issue. Why would a VC 

give money to a medical device company that’s going to have an 18 

to 24 month PMA approval cycle, when they can give that same 

money to the next software only social network, and get them out 

the door quickly. So it is a real problem, and I do think it hinders 

innovation in this area. 

Ms. CLARK. Great. 

Dr. SHAW. In the case of retinoblastoma, you know, my vision is 

to get this app into—I can dream big. There’s nothing with dreaming big. But my vision is to get this app into every parent’s phone. 

There’s 4 million babies born a year in the U.S. I—you know, and 

every year it’s a new set of parents. And I can’t reach them, right? 

Ms. CLARK. Right. 

Dr. SHAW. But there’s only 30,000 pediatricians. I can reach 

them, and they don’t have low—they don’t have high turnover, 

right? So I actually want to be regulated. I want a pediatrician to 

feel comfortable with our app. And I think if I get some sort of regulatory approval, and we, you know, we put it through all the tests, 

that that will happen. 

It’s so cheap—what we’re doing is so inexpensive. I mean, I just 

don’t know if we would—this is probably bad to say, but I don’t 

know if we would need any more money, other than what an NIH 

R–1 could give us. 

Ms. CLARK. We won’t hold you to that. 

Dr. SHAW. And I, you know, it’s all free, open source, no ads, or 

anything like that. So—I haven’t got to the business side yet. I 

should get all your cards. 

Mr. REED. Well, I think, to try to given you some perspective, we 

have a connected health initiative, which engages with hundreds of 

these companies, and three things come to light. If you have to 

spend time in your pitch meeting explaining why the VC doesn’t 

understand HIPAA correctly, it’s a problem. 

Ms. CLARK. Yeah. 
95 

Mr. REED. HIPAA becomes one. And oftentimes HIPAA isn’t the 

problem. It’s the education around HIPAA. The number of HIPAA 

consultants that, frankly, have it wrong is remarkable. So HIPAA 

is the first. The second is the FDA questions, which—I think it’s 

important to give some credit where credit is due. The FDA, from 

2013 on, has really tried to step up their game. Now, they 

haven’t—there are still auditors in the field that seem to have not 

gotten the message from on top, but that’s a problem. 

And the third, and the most important, is reimbursement. The 

realize of anything where you’re selling to a physician or a health 

care system is if they don’t see the monetary tie back to it, then 

you don’t get the purchase. I see lots of companies that get angel 

investing, Series A financing, and then never get mezzanine. Because that’s the moment where you have to walk in to your funders 

and say, here’s my sales projection. 

Ms. CLARK. Yeah. 

Mr. REED. And the regulatory barriers, with no reimbursement 

model, with liability increased for physicians, how do you make 

that—how do you close that purchase when the other end of it isn’t 

sure, as we’ve pointed from Research Kit, is it going to be effective? 

Is it going to reduce cost? Is it going to actually increase liability? 

So there are multiple regulatory threads that form through this, 

and ultimately it creates a barrier, really at that mezzanine financing level that we see. 

Ms. CLARK. Great. Thank you. I’m well over my time. Thank you. 

Chairwoman COMSTOCK. All right. Thank you. And I now recognize Mr. Swalwell for five minutes. 

Mr. SWALWELL. Thank you, Madam Chair. Thank you to our 

panelists, and, Mr. Look and Mr. Epstein, I’m familiar with your 

landscape. I represent the East Bay out in California, where so 

many of these apps have been created, are being developed, and 

being used by my constituents, and other folks in the Bay Area. We 

are many of the early adopters. 

With these apps—one question I have, you know, speaking about 

just HIPAA, and privacy, is—it’s an exciting time. You know, people are experimenting with different ways to tackle many of the 

health conditions that plague us, or allow us to live more healthy 

lives with better preventative measures. But, you know, in—it’s— 

as we know, in the Valley, and the Bay Area, companies take off, 

companies crash. That’s just kind of the culture of our environment. 

But when an app company at least gets off the ground and starts 

to get some users, and then, say, it crashes, what happens right 

now with the data of the people who have, you know, hoped and 

trusted that that company’s going to be around, and that they’re 

going to have a relationship with the company? But now, you know 

for whatever reason, it just didn’t survive. Do we have laws around 

what happens with the data? And what is your experience in the 

community of what happens with the data? Is it destroyed, or is 

it still kind of out there on a server that is dormant? Open to anyone who wants to take—— 

Mr. LOOK. I can answer from the perspective of Tidepool. I think 

this is why it’s so important for end users, patients, to own their 

own data, and for the companies that house that data to be stew-
96 

ards of that data. And, finally, for those companies to say, here’s 

how you get access to your data at any time. Whether it’s by 

downloading it in a simple text format, or—JSON is the, you know, 

wonderful modern way of storing data, or providing APIs so that 

you can say, at any time, you may get your data from our system 

to someone else’s system. Companies do go away. We need to expect that that will happen, but it also needs to be possible for the 

end user to always have access to their own data so they can take 

it wherever they want. 

Mr. SWALWELL. Sure. And, Mr. Epstein, if you could address 

that, and also just tell me, in your statement, that private funding 

alone is not enough to drive innovation in mobile health technology. What could the federal government specifically do to help 

enable investment in mobile health technology? 

Mr. EPSTEIN. Great, thank you. I’m actually glad you asked that 

one, to address something that Ms. Clark said. But—so there’s a 

class of apps that you can develop for $20,000, which are very important, right? Then there’s a class of apps where you have to hire 

data scientists, right, you have to work with huge sets of data. It 

takes years of development, right, and you cannot do that with 

just, you know, my team, you know, working on their own. You 

need to have funding, right, and investors don’t want to invest in 

that, because they look at other apps that are, you know, texting 

or whatever, and say, look, I can deploy that in two months and 

see growth. And I’m saying it took us two years to develop Stroll. 

It took us two years, no product. two years, right? That’s not something that most investors want to invest in, especially when I don’t 

know how I’m going to make money, and I don’t know if it’ll work. 

And then—but—and then briefly, for the death of apps, just— 

again, this is where I may now be misinterpreting HIPAA, but 

there’s—you’re supposed to keep data for seven years. You—the— 

who you sign a HIPAA contract with, they can destroy that—you— 

they can request that you return and destroy that data. I have no 

idea what happens when a company dies. 

Mr. REED. He—Mr. Epstein is right. There are provisions of 

HIPAA, and the Office of Civil Rights, OCR, at HHS deals with 

these questions every day. It is an ongoing thing. It’s funny, Congressman Swalwell, we were just doing our sharing economy event 

together, and these same questions of what happens to data is 

something that rides throughout our new modern sharing economy. 

I think in the health care space—you’ve heard from all of us that— 

the idea that the patient owns their health data is a thematic element that I think we would all agree to. It’s different than where 

you traveled in your Uber or your Lyft. It has a certain level of— 

personal nature to it that I think is critical. 

Mr. SWALWELL. Thank you. Yield back. 

Chairwoman COMSTOCK. Thank you. And I now recognize Mr. 

Palmer for five minutes. 

Mr. PALMER. Thank you, Madam Chairman. Mr. Reed, according 

to a report from the Health Research Institute published in December, 32 percent of consumers reported having at least one health 

app on their mobile device, which is double from just a couple years 

ago. Given the increasing prevalence of health apps, what are developers doing to ensure that consumers don’t begin to see apps as 
97 

replacement for their physician? And I find this particularly interesting the context of, typical male that I am, I tend to self-diagnose. 

Mr. REED. First of all, you’re right. As a fellow male, I can tell 

you that we are a terrible species when it comes to my wife, when 

you go to the doctor, it says who’s your primary care physician? 

Most men before 40, and even after 40 in many cases, what a primary care physician? 

Mr. PALMER. Yeah. 

Mr. REED. I go to the doctor when I’m hurt, and that’s the primary care that I get, from that perspective. I worry less about people using apps to self-diagnose. I’m more concerned with them finding applications that actually engage them in a way that they don’t 

do what we, as typical males do, and then ignore it. You know, one 

of the Members of Congress who was here earlier spoke about 

checking her husband’s moles. That’s an interesting concept, but 

there it is, right? We look to others to engage with us in a way that 

gets us involved. 

And the reality is that my dad loves to watch World War II 

shows on the History Channel. If there was some way that an app 

engaged with him in the same way that the History Channel does 

on World War II, he might be better about monitoring his Type1I 

diabetes. So I think that we’re looking at the ways to make these 

more engaging, and from a user design perspective. 

But I think replacing the physician isn’t the problem. How do we 

get the person to the physician in a timely fashion so that they’re 

not as sick? 

Mr. PALMER. Anyone else want to say thing? I’ve got a comment 

on this, and I think where technology might lead us on this, is 

that—you do these EKGs, is there any possibility at some point 

that, instead of plugging in earphones, you plug in something that 

you’ve tapped on—you’re on the stationary bike or whatever, and— 

and in the context of self-diagnosis, actually—again, from a male 

perspective, well, that’s just heartburn, actually go see a doctor 

when you need to? Mr. Epstein? 

Mr. EPSTEIN. I’m not sure if I have anything intelligent to say 

on that. 

Dr. KRAUSS. I have a comment. One function we’re putting in our 

app is screening for risks for sudden death with epilepsy. And so 

you will get a red light, green light, yellow light kind of meter, 

based on your risk, based on assessment of your tracking of your 

seizures, and your pill-taking, and the type of seizures. And so that 

sort of feedback will go to the patient, and then it will guide them 

to go see their doctor. 

Mr. PALMER. I should’ve—— 

Dr. KRAUSS. But we don’t give that data to the doctor. 

Mr. PALMER. I should’ve give you a little more background on 

this, because I just visited a cardiovascular group a couple of weeks 

ago, and people who have pacemakers, they have the ability, on 

their phone, to have their heart monitored by their phone, that if 

they have an irregularity, not only does it inform the patient, but 

it communicates with the doctor’s office. So the technology is moving in a direction where, you know, to a—in a positive way. You 

could self-diagnose to get an alert that you need to seek care. 
98 

Also, it may also give us an opportunity to avoid over-diagnosis. 

Do you see any opportunity there? 

Mr. REED. You know, you’re jumping to my favorite topic, which 

is the world of wearables. We actually did a study of 99 days of— 

we looked at 25 different wearables. And you’re completely right. 

The reality is, starting with sports med, you see companies like 

Under Armor already beginning to look at it. But how do I turn 

the shirt that you wear into something that helps you keep track 

of your health? I think I see at least two Apple Watches here at 

the table. And if you look at the back of this watch, it’s exactly 

what you said. 

Mr. PALMER. Um-hum. 

Mr. REED. It’s a platform for sensors. The back of it is a whole 

row of sensors. And what you’re discussing, sir, is exactly where I 

think all of us will end up being, and that is how do we incorporate 

wearables into giving better diagnosis? We’re still on the road to 

that. There are regulatory barriers. But that is, I think, a big part 

of our vision. 

Mr. PALMER. Thank you, Madam Chairman. I yield back. 

Chairwoman COMSTOCK. All right. Thank you, and I just want to 

thank all of our witnesses for a great hearing. It’s so exciting, 

about the possibilities here, and what you all have created and are 

doing, and how we need to make sure we’re getting out of your 

way, in some cases, and in other cases figuring out how we can 

clear some of those roads for you. So I would invite the witnesses 

to continue to keep in touch with us, give us any thoughts or ideas 

that you might have for additional areas we can focus on. 

So the record will remain open for two weeks for additional written comments or questions from any of the Members. And so, 

again, thank you so much. And since there are—well, there’s only 

two of us left here, but since there are 435 of us, Dr. Shaw, I did 

want to say my dream is to get this in every parent’s phone. As 

the grandmother now of three children, I can tell you, three parents, I’m going to get it into their phones, but share it with my constituents. I think this is the kind of thing we can all start sharing. 

We can do this organically, virally, however we can do it, and help 

you share this mission. And God bless, it’s wonderful work. 

Dr. SHAW. Thank you. 

Chairwoman COMSTOCK. And this hearing is adjourned. 

[Whereupon, at 11:34 a.m., the Subcommittee was adjourned.] 
(99) 

Appendix I 

ANSWERS TO POST-HEARING QUESTIONS
100 

ANSWERS TO POST-HEARING QUESTIONS

Responses by Mr. Morgan Reed, questions submitted by Chairwoman Comstock 
101 
102 

Responses by Dr. Bryan F. Shaw 
103 
104 

Responses by Mr. Howard Look 
105 
106 
107 

Responses by Dr. Gregory Krauss 
108 
109 

Responses by Mr. Jordan Epstein 
110 
111 

(113) 

Appendix II 

ADDITIONAL MATERIAL FOR THE RECORD
114 

STATEMENT BY COMMITTEE RANKING MEMBER EDDIE BERNICE JOHSNON

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