[House Hearing, 114 Congress]
[From the U.S. Government Publishing Office]
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
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Available via the World Wide Web: http://science.house.gov
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COMMITTEE ON SCIENCE, SPACE, AND TECHNOLOGY
HON. LAMAR S. SMITH, Texas, Chair
FRANK D. LUCAS, Oklahoma EDDIE BERNICE JOHNSON, Texas
F. JAMES SENSENBRENNER, JR., ZOE LOFGREN, California
Wisconsin DANIEL LIPINSKI, Illinois
DANA ROHRABACHER, California DONNA F. EDWARDS, Maryland
RANDY NEUGEBAUER, Texas SUZANNE BONAMICI, Oregon
MICHAEL T. McCAUL, Texas ERIC SWALWELL, California
MO BROOKS, Alabama ALAN GRAYSON, Florida
RANDY HULTGREN, Illinois AMI BERA, California
BILL POSEY, Florida ELIZABETH H. ESTY, Connecticut
THOMAS MASSIE, Kentucky MARC A. VEASEY, Texas
JIM BRIDENSTINE, Oklahoma KATHERINE M. CLARK, Massachusetts
RANDY K. WEBER, Texas DON S. BEYER, JR., Virginia
JOHN R. MOOLENAAR, Michigan ED PERLMUTTER, Colorado
STEVE KNIGHT, California PAUL TONKO, New York
BRIAN BABIN, Texas MARK TAKANO, California
BRUCE WESTERMAN, Arkansas BILL FOSTER, Illinois
BARBARA COMSTOCK, Virginia
GARY PALMER, Alabama
BARRY LOUDERMILK, Georgia
RALPH LEE ABRAHAM, Louisiana
DARIN LaHOOD, Illinois
------
Subcommittee on Research and Technology
HON. BARBARA COMSTOCK, Virginia, Chair
FRANK D. LUCAS, Oklahoma DANIEL LIPINSKI, Illinois
MICHAEL T. MCCAUL, Texas ELIZABETH H. ESTY, Connecticut
RANDY HULTGREN, Illinois KATHERINE M. CLARK, Massachusetts
JOHN R. MOOLENAAR, Michigan PAUL TONKO, New York
BRUCE WESTERMAN, Arkansas SUZANNE BONAMICI, Oregon
GARY PALMER, Alabama ERIC SWALWELL, California
RALPH LEE ABRAHAM, Louisiana EDDIE BERNICE JOHNSON, Texas
DARIN LaHOOD, Illinois
LAMAR S. SMITH, Texas
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
SMART HEALTH:
EMPOWERING THE FUTURE OF MOBILE APPS
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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 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 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.
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, 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 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:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
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 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 non-traditional trials in n-of-1 studies based on
distributed and patient-led 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.
[The prepared statement of Mr. Look follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
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 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:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
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 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:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
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. 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 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 doctor 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----
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
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 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 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?
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 add-ons 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?
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.
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.
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 stewards 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 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.
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.]
Appendix I
----------
Answers to Post-Hearing Questions
Responses by Mr. Morgan Reed, questions submitted by Chairwoman
Comstock
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Responses by Dr. Bryan F. Shaw
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Responses by Mr. Howard Look
Responses by Dr. Gregory Krauss
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Responses by Mr. Jordan Epstein
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Appendix II
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Additional Material for the Record
Statement by Committee Ranking Member Eddie Bernice Johsnon
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[all]