[House Hearing, 114 Congress]
[From the U.S. Government Publishing Office]
THE DISRUPTER SERIES: HEALTH CARE APPS
=======================================================================
HEARING
BEFORE THE
SUBCOMMITTEE ON COMMERCE, MANUFACTURING, AND TRADE
OF THE
COMMITTEE ON ENERGY AND COMMERCE
HOUSE OF REPRESENTATIVES
ONE HUNDRED FOURTEENTH CONGRESS
SECOND SESSION
__________
JULY 13, 2016
__________
Serial No. 114-163
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Printed for the use of the Committee on Energy and Commerce
energycommerce.house.gov
______
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COMMITTEE ON ENERGY AND COMMERCE
FRED UPTON, Michigan
Chairman
JOE BARTON, Texas FRANK PALLONE, Jr., New Jersey
Chairman Emeritus Ranking Member
ED WHITFIELD, Kentucky BOBBY L. RUSH, Illinois
JOHN SHIMKUS, Illinois ANNA G. ESHOO, California
JOSEPH R. PITTS, Pennsylvania ELIOT L. ENGEL, New York
GREG WALDEN, Oregon GENE GREEN, Texas
TIM MURPHY, Pennsylvania DIANA DeGETTE, Colorado
MICHAEL C. BURGESS, Texas LOIS CAPPS, California
MARSHA BLACKBURN, Tennessee MICHAEL F. DOYLE, Pennsylvania
Vice Chairman JANICE D. SCHAKOWSKY, Illinois
STEVE SCALISE, Louisiana G.K. BUTTERFIELD, North Carolina
ROBERT E. LATTA, Ohio DORIS O. MATSUI, California
CATHY McMORRIS RODGERS, Washington KATHY CASTOR, Florida
GREGG HARPER, Mississippi JOHN P. SARBANES, Maryland
LEONARD LANCE, New Jersey JERRY McNERNEY, California
BRETT GUTHRIE, Kentucky PETER WELCH, Vermont
PETE OLSON, Texas BEN RAY LUJAN, New Mexico
DAVID B. McKINLEY, West Virginia PAUL TONKO, New York
MIKE POMPEO, Kansas JOHN A. YARMUTH, Kentucky
ADAM KINZINGER, Illinois YVETTE D. CLARKE, New York
H. MORGAN GRIFFITH, Virginia DAVID LOEBSACK, Iowa
GUS M. BILIRAKIS, Florida KURT SCHRADER, Oregon
BILL JOHNSON, Missouri JOSEPH P. KENNEDY, III,
BILLY LONG, Missouri Massachusetts
RENEE L. ELLMERS, North Carolina TONY CARDENAS, CaliforniaS5904
LARRY BUCSHON, Indiana
BILL FLORES, Texas
SUSAN W. BROOKS, Indiana
MARKWAYNE MULLIN, Oklahoma
RICHARD HUDSON, North Carolina
CHRIS COLLINS, New York
KEVIN CRAMER, North Dakota
Subcommittee on Commerce, Manufacturing, and Trade
MICHAEL C. BURGESS, Texas
Chairman
JANICE D. SCHAKOWSKY, Illinois
LEONARD LANCE, New Jersey Ranking Member
Vice Chairman YVETTE D. CLARKE, New York
MARSHA BLACKBURN, Tennessee JOSEPH P. KENNEDY, III,
GREGG HARPER, Mississippi Massachusetts
BRETT GUTHRIE, Kentucky TONY CARDENAS, California
PETE OLSON, Texas BOBBY L. RUSH, Illinois
MIKE POMPEO, Kansas G.K. BUTTERFIELD, North Carolina
ADAM KINZINGER, Illinois PETER WELCH, Vermont
GUS M. BILIRAKIS, Florida FRANK PALLONE, Jr., New Jersey (ex
SUSAN W. BROOKS, Indiana officio)
MARKWAYNE MULLIN, Oklahoma
FRED UPTON, Michigan (ex officio)
C O N T E N T S
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Page
Hon. Michael C. Burgess, a Representative in Congress from the
State of Texas, opening statement.............................. 1
Prepared statement........................................... 3
Hon. Janice D. Schakowsky, a Representative in Congress from the
State of Illinois, opening statement........................... 4
Hon. Marsha Blackburn, a Representative in Congress from the
State of Tennessee, opening statement.......................... 5
Hon. Frank Pallone, Jr., a Representative in Congress from the
State of New Jersey, opening statement......................... 6
Hon. Fred Upton, a Representative in Congress from the State of
Michigan, prepared statement................................... 93
Witnesses
Bettina Experton, M.D., M.P.H., President and CEO, Humetrix...... 8
Prepared statement........................................... 11
Answers to submitted questions...............................
Laura Ferris, M.D., Assistant Professor, University of
Pittsburgh, Department of Dermatology.......................... 26
Prepared statement........................................... 28
Answers to submitted questions...............................
E. Ray Dorsey, M.D., M.B.A., Professor of Neurology and Director
of the Center for Human Experimental Therapeutics, University
of Rochester Medical Center.................................... 35
Prepared statement........................................... 37
Answers to submitted questions...............................
Diane Johnson, North America Regulatory Affairs Policy and
Intelligence Medical Devices, Johnson & Johnson................ 45
Prepared statement........................................... 47
Answers to submitted questions...............................
Nicolas P. Terry, Hall Render Professor of Law and Executive
Director of The William S. and Christine S. Hall Center for Law
and Health, Indiana University Robert H. McKinney School of Law 50
Prepared statement........................................... 52
Answers to submitted questions...............................
Matt Patterson, M.D., President, Airstrip........................ 54
Prepared statement........................................... 57
Answers to submitted questions...............................
Submitted material
Statement of Fitbit.............................................. 95
Statement of Competitive Carriers Association.................... 98
Statement of the Consumer Technology Association................. 100
Statement of the American Medical Association.................... 101
Statement of Opternative, Inc.................................... 108
THE DISRUPTER SERIES: HEALTH CARE APPS
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WEDNESDAY, JULY 13, 2016
House of Representatives,
Subcommittee on Commerce, Manufacturing, and Trade,
Committee on Energy and Commerce,
Washington, DC.
The subcommittee met, pursuant to call, at 10:20 a.m., in
room 2322, Rayburn House Office Building, Hon. Michael C.
Burgess, M.D., (chairman of the subcommittee) presiding.
Present: Representatives Burgess, Lance, Blackburn, Harper,
Olson, Kinzinger, Bilirakis, Brooks, Mullin, Schakowsky,
Clarke, Kennedy, Butterfield, Welch, and Pallone (ex officio).
Staff Present: Rebecca Card, Assistant Press Secretary;
James Decker, Policy Coordinator, Commerce, Manufacturing, and
Trade; Graham Dufault, Counsel, Commerce, Manufacturing, and
Trade; Melissa Froelich, Counsel, Commerce, Manufacturing, and
Trade; Giulia Giannangeli, Legislative Clerk, Commerce,
Manufacturing, and Trade, Environment and the Economy; Paul
Nagle, Chief Counsel, Commerce, Manufacturing, and Trade; Tim
Torres, Deputy IT Director; Olivia Trusty, Professional Staff,
Commerce, Manufacturing, and Trade; Michelle Ash, Minority
Chief Counsel, Commerce, Manufacturing, and Trade; Jeff
Carroll, Minority Staff Director; Lisa Goldman, Minority
Counsel, Commerce, Manufacturing and Trade; Caroline Paris-
Behr, Minority Policy Analyst; Matt Schumacher, Minority Press
Assistant; and Ryan Skukowski, Minority Policy Analyst.
Mr. Burgess. The subcommittee on Commerce, Manufacturing,
and Trade will come to order. The chair will recognize himself
for 5 minutes for an opening statement.
OPENING STATEMENT OF HON. MICHAEL C. BURGESS, A REPRESENTATIVE
IN CONGRESS FROM THE STATE OF TEXAS
Mr. Burgess. Good morning. Thanks to everyone for being
here. It is a hearing I have been looking forward to for some
time. This is part of our Disrupter Series, and the Disrupter
Series this morning is going to be examining mobile health
apps.
With health care being 17 percent of the Nation's economy,
it seems appropriate for the Disrupter Series to be in this
space. I will also tell you I am a physician. I served the
people of north Texas for over 25 years. And I am encouraged by
this emerging technology within the healthcare system, and I
look forward this morning to examining how it is transforming
the way in which doctors, patients and consumers approach and
manage the delivery of care.
Health apps are powered by the deployment of advanced
broadband Internet technology and the mere ubiquitous
smartphone adoption. The draw of mobile healthcare tools and
services and health apps particularly lies in their potential
to radically improve health care. The potential comes in part
from enabling both sides of the equation: doctors and patients.
For healthcare providers, health apps enable constant, instant,
and real-time access to patient data, helping to make
streamlining of work flows and decisionmaking processes, so the
data is both more complete and more accessible. Doctors are
also able to remotely monitor patient healthcare conditions,
collaborate, and implement care.
The emergence of mobile apps within the healthcare system
is particularly exciting because of how they empower patients
to gain access to and manage aspects of their health. Patients
are using apps to track symptoms, send vital sign information
to doctors, and set up medication adherence reminders. Patients
are also using the technology to gain faster access to more
routine healthcare services that are often inconvenient or
time-consuming. Apps available on the market today create
virtual waiting rooms where users can receive their
prescriptions, engage in face-to-face video consultations with
physicians, compare prices for health care, and make payments
to a healthcare provider. The last is obviously, to me, very
important. By enabling physicians to remotely monitor a
patient's health condition or by empowering consumers with
information to engage in healthier living, health apps are
driving more robust healthcare management and oversight from
both patients and doctors. This can help improve the continuum
of care.
There are important issues that need to be addressed as
more individuals turn to healthcare apps. Some of these issues
include understanding how health apps are impacting the overall
quality of care compared to in-person visits, whether the
proper financial incentives are in place to increase the
adoption of health apps, what additional infrastructure is
needed to support the development and the use of health apps,
some of the legal and policy barriers to health app adoption,
and how to adequately educate patients and consumers about the
capabilities and limitations of health apps, and finally,
whether the regulatory framework governing our healthcare
system today is, in fact, able to keep pace with lifesaving
innovations made available through these apps.
So I look forward to examining each of these issues
throughout our discussion today. In addition, as with all
Internet-connected things, applications, and devices,
adequately addressing the privacy and security implications
associated with health apps will be essential to driving this
market.
We have seen that healthcare data has a growing appeal
among identity thieves and bad actors. We only need to look at
the recent data breaches and the increase in ransomeware
attacks on hospitals. It is critical that every actor in this
space start by addressing privacy and security. If industry
fails to do this, then Congress will be forced to do this. And,
unfortunately, whatever Congress would like to do could very
likely limit the potential of development of this space and
limit the ultimate success of the health apps market.
It is interesting this summer is the 20-year anniversary of
the passage of the Kennedy-Kassebaum Act. Needless to say, I
was not here when that bill passed. Since it contains HIPAA,
there is a downside, but the plus side is the Kennedy-Kassebaum
Act allowed for the first time a demonstration project where
750,000 medical savings accounts were permitted. I was one of
the early adopters of the medical savings account. In fact, I
was fearful after the bill was signed into law that I would not
get there in time to be able to set up a medical savings
account. It turns out I needn't have worried. The 750,000
subscriptions were not filled. But then that led in 2004 to the
development of health savings accounts.
And here's the thing: The Commonwealth Foundation has
published information on what they call the activated patient.
Consumer-directed health care also helps to activate a patient.
We want patients to be involved in their care. We think they
make better decisions. I think that is the opportunity to hold
down the cost in health care. So it is the marriage of the
Health Savings Act, the consumer-directed health plan, and the
activated patient all brought together by this technology that
I think holds great promise for our system.
Throughout this Disrupter Series, we have explored how
technology is changing business, creating jobs, and improving
the quality of life for Americans everywhere. The breakthrough
of mobile apps into the healthcare system opens a significant
opportunity to improve patient care, reduce healthcare costs,
and make health care more accessible.
I will thank the witnesses in advance for their testimony.
I would now like to recognize the gentlelady from Illinois, Ms.
Schakowsky, 5 minutes for an opening statement, please.
[The prepared statement of Mr. Burgess follows:]
Prepared statement of Hon. Michael C. Burgess
Good morning and welcome to our Disrupters Series hearings
on mobile health apps. As a doctor who has served the people of
North Texas for over 25 years, I am particularly delighted to
explore this emerging technology within the health care system
and examine how it is transforming the way in which doctors,
patients, and consumers approach and manage the delivery of
care.
Health apps are powered by the deployment of advanced
broadband internet technology and nearubiquitous smartphone
adoption. The draw of mobile health care tools and services,
and health apps in particular, lies in their potential to
radically improve health care. The potential comes in part from
enabling both sides of the equation, Doctors and patients.
For health care providers, health apps enable constant,
instant and real-time access to patient data, helping to
streamline workflows and decision-making processes. So the data
is both more complete and more accessible. Doctors are also
able to remotely monitor patient health care conditions,
collaborate and implement care.
The emergence of mobile apps within the health care system
is particularly exciting because of how they empower patients
to gain access to care and manage their health. Patients are
using apps to track their symptoms, send vital sign information
to doctors, and set-up medication adherence reminders. Patients
are also using the technology to gain faster access to more
routine health care services that are often inconvenient and
time-consuming. Apps available on the market today create
virtual waiting rooms where users can:
receive prescriptions;
engage in secure face-to-face video consultations
with physicians;
compare prices for care;
and make payments to a health care provider.
By enabling physicians to remotely monitor a patient's
health condition or empowering consumers with information to
engage in healthier living, health apps are driving more robust
health care management and oversight from both patients and
providers. This can help improve the quality and continuum of
care.
There are important issues that need to be addressed as
more individuals turn to health care apps.Some of these issues
include:
Understanding how health apps are impacting the
overall quality of care compared to in-person visits;
Whether the proper financial incentives are in
place to increase the adoption of health apps;
What additional infrastructure is needed to
support the development and use of health apps;
Legal and policy barriers to health app adoption
at both the federal and state level;
How to adequately educate patients and consumers
about the capabilities and limitations of health apps;
And whether the regulatory framework governing our
health care system today is keeping pace with the life-saving
innovations made available through these apps. I look forward
to examining each of these issues throughout our discussion
today.
In addition, as with all Internet-connected things,
applications, and devices, adequately addressing the privacy
and security implications associated with health apps will be
essential to driving this market forward. We have seen that
healthcare data has a growing appeal among identity thieves and
other bad actors--just look at the recent data breaches and an
increase in ransomware attacks. It is critical that every actor
in this space start by addressing privacy and security. If
industry fails to do this then Congress will be forced to
address it. And unfortunately, whatever Congress would do would
likely limit the potential in this space and limit the success
of the health apps market.
Throughout the disrupter series we have explored how
technology is changing business, creating jobs and improving
the quality of life for Americans everywhere. The breakthrough
of mobile apps into the health care system opens a significant
opportunity to improve patient care, reduce health care costs,
and make health care more accessible and affordable to all
Americans.
I thank the witnesses for their testimonies and I look
forward to a thoughtful discussion on this topic.
OPENING STATEMENT OF HON. JANICE D. SCHAKOWSKY, A
REPRESENTATIVE IN CONGRESS FROM THE STATE OF ILLINOIS
Ms. Schakowsky. So, today, we are continuing this Disrupter
Series with healthcare apps. We talked about these apps a
little during our recent hearing on wearables. Consumers use
apps to track their calories, their exercise, and their sleep.
The technology is advancing far beyond that. Health apps may
help in the treatment of chronic medical conditions like
diabetes.
From a consumer perspective, health apps seem to blur the
line between your smartphone and a more traditional medical
device. However, that distinction can have important
ramifications for the protections that consumers have. The
efficacy and privacy standards for apps depend on whether it is
a medical device or it is associated with an entity covered by
HIPAA.
Generally speaking, the Food and Drug Administration only
regulates health apps when they are an accessory to a medical
device or perform the function of a regulated medical device.
Apps that dispense information or simply store data are usually
not reviewed by the FDA.
Without FDA review, consumers face the threat of false
claims, which can be very dangerous when a person's health is
at issue. Last year, the Federal Trade Commission took action
against two apps that claimed to detect symptoms of melanoma
using a smartphone camera. But the apps did not have a
scientific basis for their claims to detect or diagnose
melanoma in users.
This case is yet another example of the FTC's critical work
to protect consumers from deceptive claims. Later today, we
will be marking up a bill to undermine the FTC's authority by
shortening consent decrees and bogging down the FTC by
requiring unnecessary review and analysis when it takes action.
Innovation is good and should be encouraged, but industry
self-regulation does not work. Bad actors will continue to make
potentially life-threatening claims about what their products
can do. We need a strong FTC to go to bat for consumers and
stop bad actors from falsely claiming to diagnose skin cancer,
for example. America's health is at stake.
Consumers want to be sure that health apps that they
install don't give false information. They also want their
personal information on those apps protected. If you download
an app to track blood sugar, that download in and of itself
tells the app that you probably might or do have diabetes. The
app is able to and often does sell this information to
advertisers.
A recent study in the Journal of the American Medical
Association found that 80 percent of diabetes apps have no
privacy policy in place and half of those that did have privacy
policies that shared user data with third parties.
In many cases, apps are not connected with entities covered
by HIPAA. Only apps tied to health plans and healthcare
providers would have the responsibility to safeguard protected
health information. If it is a random app you found in the app
store, your information is probably not protected.
As with other technologies we have discussed in this
Disrupter Series, we need to make sure that innovation and
consumer protection go hand in hand as health apps continue to
develop. These apps need to be designed with the well-being and
the security of consumers in mind. So I look forward to hearing
from our witnesses about the exciting new technologies coming
to the market, and I hope to hear how we can ensure that
consumers receive accurate information and that their sensitive
health information is protected.
I yield back, unless anybody wants my remaining time.
Seeing none, I yield back.
Mr. Burgess. The chair thanks the gentlelady. The
gentlelady yields back.
The chair would like to recognize the vice chairman of the
full committee, Mrs. Blackburn, 5 minutes for an opening
statement please.
OPENING STATEMENT OF HON. MARSHA BLACKBURN, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF TENNESSEE
Mrs. Blackburn. I want to welcome all of our witnesses. We
are appreciative that you are here.
And, Mr. Chairman, I thank you for the attention to the
issue. And I want to just bring up the SOFTWARE Act, which Mr.
Green and I have put a lot of effort into over the past several
years. It has been included in the Cures legislation. We look
forward to the Senate finishing that and moving Cures to the
President's desk. But the SOFTWARE Act really addresses much of
what we are going to discuss today. And, as the chairman said,
technological innovation around health informatics and health
software and wireless platforms, such as smartphones and iPads,
holds great promise for the healthcare system, both for
patients and for providers. And we are excited about some of
the innovation that can be there, whether it is Bluetoothing,
pharmaceuticals, or home healthcare providers that are entering
and transmitting and holding data on their patients.
There are concerns about the regulatory framework that
exists around this, and I will say simply, as we have worked on
this issue through the years, we have to go back and look
historically at what we did with the FDA. Congress said, in the
1930s, this is what is a pharmaceutical. In the 1970s, we
defined a medical device. And now it is time for us to create a
classification for healthcare technology and put the FDA on the
right track. Should there be some regulatory flexibility there,
because technology changes faster than Congress is going to
change a statute? Absolutely, there should be that flexibility.
But there should also be the awareness that most of the
healthcare informatics components, the smartphone apps, whether
they are used for providers or by patients, should be able to
go directly to the marketplace. They shouldn't be over to the
FDA and shouldn't have to have this subjective approach of, if
we think it is necessary, then we will on a case-by-case basis
decide how we regulate technology. We think that that is
inappropriate in and of itself. We want some clarity and some
certainty for innovators. Therefore, we are encouraging the
completion of the SOFTWARE Act through 21st Century Cures.
We know that it would be helpful to the delivery of health
care, to the telemedicine concepts for meeting the healthcare
needs of those in remote areas the more we utilize healthcare
technology and informatics.
And, Mr. Chairman, I thank you for your attention to the
matter. We thank you all for being here today for the
discussion, look forward to the conversation. And I will yield
my time back to you or to anyone who is in search of time.
[The prepared statement of Mrs. Blackburn follows:]
Mr. Burgess. Very well. The gentlelady yields back. The
chair thanks the gentlelady.
The chair recognizes the gentleman from New Jersey, Mr.
Pallone, 5 minutes for an opening statement, please.
OPENING STATEMENT OF HON. FRANK PALLONE, JR., A REPRESENTATIVE
IN CONGRESS FROM THE STATE OF NEW JERSEY
Mr. Pallone. Thank you, Mr. Chairman.
Mobile devices have become an indispensable part of our
daily lives, and apps are a major reason why. For millions of
consumers, the smartphone has become more than just a means to
call or text. It is now their personal scheduler, navigator,
jukebox, television and much more, thanks to apps available for
download online.
Health apps, which have risen in popularity in recent
years, look to add physician, personal trainer, and dietician
to that list as well. Many of these apps perform relatively
simple tasks, such as helping users keep track of their
calories or sending out a reminder to take a prescription.
Other apps may actually analyze and diagnose a medical
condition, effectively eliminating the need for a doctor's
appointment altogether in some cases. And consumers and
physicians alike are embracing health apps as a way to better
manage and administer care. A growing health app marketplace
mirrors a rising health consciousness amongst Americans, and we
should support technology that yields positive outcomes for
consumers.
Like many of the technologies this subcommittee has
examined this Congress, however, we must also be aware of the
potential risks to personal safety, privacy, and data security.
The safety and effectiveness of these apps should be closely
examined. An inaccurate calorie counting app may be an
inconvenience, but an app that incorrectly diagnoses a
cancerous skin condition could be fatal. It is, therefore,
essential that consumers and physicians understand the
limitations of each app and recognize when they cannot
substitute for a doctor's visit.
Personal health information is a prime target for hackers,
and breaches of this type of information in recent years have
been devastating for consumers. In addition to these security
gaps, I am also concerned with the lack of adequate privacy
protections on a large percentage of these health apps.
Healthcare data contains addresses, Social Security numbers, in
addition to diagnosis and prescription history. The more apps
that handle this information, the greater the risk of a privacy
breach for consumers. And exacerbating the health privacy
problems is consumer confusion and, frankly, confusion by many
stakeholders. Most people believe health information to be
especially personal, requiring a higher level of privacy and
security, yet the law protecting a person's personal health
records, the Health Insurance Portability and Accountability
Act, HIPAA, applies only to health plans, healthcare
clearinghouses, mosthealthcare providers, and their business
associations. Many, if not most, health apps available right
now in the app store are not covered entities under HIPAA. So,
even if these apps collect the same information as a healthcare
provider, the same protections may not apply.
So mobile health technology is where we are, where we are
going. As the mobile app industry continues to grow, I believe
that prioritizing privacy, security, and safety will benefit
consumers and businesses alike. And so I look forward to
learning more about the potential of health apps to improve
health outcomes for consumers and the protections that these
apps are putting in place.
Unless someone on my side wants the time, I yield back.
Thank you, Mr. Chairman.
Mrs. Blackburn. If the gentleman would yield to me.
I am thrilled that Mr. Pallone is revealing his age by
using the term ``jukebox.''
I yield back.
Mr. Pallone. I'm sorry. I didn't say ``icebox,'' at least.
That is even worse. And I say that sometimes too.
I yield back.
Mr. Burgess. The gentleman yields back.
We will await punching B17 on the jukebox.
That concludes member opening statements. The chair would
like to remind members that, pursuant to committee rules, all
members' opening statements will be made part of the record.
Again, we do want to thank all of our witnesses for being
here this morning, taking time to testify before the
subcommittee. Today's witnesses will have the opportunity to
give opening statements, followed by a round of questions from
members.
Our witness panel for today's hearing will include Dr. Matt
Patterson, President at AirStrip; Dr. Bettina Experton,
President and CEO of Humetrix; Dr. Laura Ferris, Assistant
Professor, University of Pittsburgh, Department of Dermatology;
Dr. Ray Dorsey, Professor of Neurology and Director of the
Center for Human Experimental Therapeutics at the University of
Rochester Medical Center; Ms. Diane Johnson, Senior Director,
North America Regulatory Affairs Policy and Intelligence
Medical Devices, at Johnson & Johnson; and Mr. Nicolas P.
Terry, Professor of Law and Executive Director of the William
S. and Christine S. Hall Center for Law and Health at Indiana
University, Robert H. McKinney School of Law.
We appreciate each of you being here today. Ordinarily, we
would begin the panel with Dr. Patterson, but are we still
waiting for some technical assistance? Yes.
OK. I do this all the time. This is the premier predominant
technological committee in the United States House of
Representatives, the greatest deliberative body in the free
world, and we frequently have trouble with our electronics
here.
So, Dr. Experton, let us begin with you, and we will come
back to Dr. Patterson at the end.
STATEMENTS OF BETTINA EXPERTON, M.D., M.P.H., PRESIDENT AND
CEO, HUMETRIX; LAURA FERRIS, M.D., ASSISTANT PROFESSOR,
UNIVERSITY OF PITTSBURGH, DEPARTMENT OF DERMATOLOGY; E. RAY
DORSEY, M.D., M.B.A., PROFESSOR OF NEUROLOGY AND DIRECTOR OF
THE CENTER FOR HUMAN EXPERIMENTAL THERAPEUTICS, UNIVERSITY OF
ROCHESTER MEDICAL CENTER; DIANE JOHNSON, NORTH AMERICA
REGULATORY AFFAIRS POLICY AND INTELLIGENCE MEDICAL DEVICES,
JOHNSON & JOHNSON; NICOLAS P. TERRY, HALL RENDER PROFESSOR OF
LAW AND EXECUTIVE DIRECTOR OF THE WILLIAM S. AND CHRISTINE S.
HALL CENTER FOR LAW AND HEALTH, INDIANA UNIVERSITY ROBERT H.
MCKINNEY SCHOOL OF LAW; AND MATT PATTERSON, M.D., PRESIDENT,
AIRSTRIP
STATEMENT OF BETTINA EXPERTON, M.D., M.P.H.
Dr. Experton. Chairman Burgess, and distinguished
subcommittee members, thank you for the opportunity to appear
before you today to discuss the disruptive role of mobile
health applications in transforming the U.S. healthcare system.
My name is Dr. Bettina Experton, and I am the founder and CEO
of Humetrix, a mobile health technology company based in Del
Mar, California.
As a member of the Consumer Technology Association's, CTA,
Health and Fitness Technology Board, Humetrix actively worked
on the CT Guiding Principles on the Privacy and Security of
Personal Wellness Data because it is important that consumers
understand both the potential value of patient-facing
technologies and the privacy options they have. We believe that
this will help drive adoption of these important lifesaving
apps. Humetrix's mobile health apps address critical health
needs and can literally save lives.
One of our apps, SOS QR, recently won the prestigious FCC
Chairman's Award and was designed to help anyone in an
emergency situation. Through the app, anyone can call for help,
send their GPS location, and even if the user is incapacitated,
his or her critical health information can be made immediately
accessible to emergency responders. And when you travel abroad,
this information can be displayed in the language of that
emergency responder automatically.
Another Humetrix app, TENSIO, can help more than 30 million
Americans with uncontrolled high blood pressure, managing their
hypertension in consultation with their physicians.
But, today, I would like to focus on our iBlueButton app,
which won multiple industry innovation awards, which can
greatly improve patient safety and reduce healthcare costs by
addressing the issue of the lack of interoperability of
disparate electronic health record systems.
The average Medicare beneficiary sees seven different
doctors in a given year. Our veterans who access the VA
healthcare system receive, in fact, more than 50 percent of
their care outside the VA. Often they are transitioned from the
DOD health system with complex medical needs. And the care
transition is not optimum, as the exchange of VA and DOD
records is complex to operate. In this environment, the
potential of medical errors as a result of incomplete
information is high.
However, there is a cure: patient-facing mobile apps that
put patients' medical data in their own hands, securely and
effectively.
Randy Watson is a disabled Army veteran who served in Korea
and Vietnam and is an active user of the Humetrix iBlueButton
mobile app to assemble and annotate his health records from the
VA, Medicare, and his private providers directly and securely
on his own smartphone. Randy manages various service-connected
health problems, survived multiple heart attacks and had
several surgeries, some of which were performed by non-VA
surgeons. Because the closest VA Medical Center is more than an
hour away, in emergency situations, he often finds himself in a
non-VA hospital closer to his home. He reports that having his
VA and Medicare records on his mobile device has resulted in
doctors quickly getting the information they need and, in many
cases, avoiding repeating costly tests like MRIs.
When Randy uses iBlueButton, the app will automatically get
his Medicare claim data, translate billing codes and assemble
these with his VA and private providers' EHR data,
automatically creating a usable and actionable summary record
with all of his medications in one place, providers' contact
details, and the dates of his past tests and procedures on his
mobile phone. This ensures that his information is immediately
accessible wherever he seeks care. And because all of his
personal information resides on the device itself and all the
computing is done in real time in the app, all personal data is
safely and only stored on the user's mobile device, encrypted
under the user's own control, rather than in the cloud or other
servers, where it could be subject to hacking.
With iBlueButton, more than 55 million Americans covered by
Medicare, 10 million in the TRICARE program, and 9 million
veterans using the VA system can securely download, understand,
annotate, and share their medical history with any doctor to
help ensure their own safety and control costs. Today, with the
same goals, the State of New York is planning to provide next
year a version of iBlueButton to their millions of Medicaid
beneficiaries, who will be empowered with their own health
information on their own phones wherever they receive care.
In closing, I would like to thank you again for inviting me
to testify today. At Humetrix, we believe that disruptive
mobile technology, developed in the private sectors and placed
in the consumer's hands, can be the needed disrupter to change
the face of health care. I look forward to answering any
questions. Thank you.
[The prepared statement of Dr. Experton follows:]
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Mr. Burgess. The chair thanks the gentlelady. The
gentlelady yields back.
Dr. Ferris, you are recognized for 5 minutes for an opening
statement, please.
STATEMENT OF LAURA FERRIS, M.D.
Dr. Ferris. Thank you. I appreciate the opportunity to
testify today. I was invited here based on work that I have
done showing the potential harm of mobile health technology,
which both of you actually mentioned in your opening
statements. However, I also do want to discuss how technology
may improve patient care and access, particularly in my field
of dermatology.
The three points I would like to make and focus on are that
direct-to-consumer apps that function as medical devices making
unsubstantiated claims and that are not data-driven can put
patients at a higher degree of risk, and regulatory oversight
should reflect this.
Telehealth applied to the field of dermatology does have
the potential to improve patient access to high-quality care.
And mobile health applications that aid in making a diagnosis
really are most appropriately and safely used in the hands of
physicians, and the regulatory path to developing such
technologies should take into consideration the difference in
risk posed by a medical device in the hands of a physician
versus in the hands of a patient.
So, because of the visual nature of my field of
dermatology, we were really among the first fields to
experience the breadth of applications that can be used in
delivering mobile health care to patients. So I am going to
talk a little bit about the good and the bad.
So the first is my work as a researcher and clinician at
the University of Pittsburgh. So I had many patients who came
in and casually asked me about apps that they could download on
their smartphone that allowed them to use their camera to take
a picture of a mole and then the app would tell them ``this
looks good'' or ``this looks bad.'' And so my research team and
I thought this would be something interesting to study, because
there really wasn't data to back these up.
So we decided to look at three different apps that were
available in the app store that were automated, inexpensive or
free, and gave an immediate response as to if that lesion was
likely to be skin cancer or not, and then a fourth app that
sent the image to a board certified dermatologist who then gave
feedback on it.
What we found is that these three automated apps missed a
third to over 90 percent of the melanomas, which is our most
deadly form of skin cancer, that we presented to them. The
board certified dermatologist missed only one. Really, that was
less than 2 percent of the melanomas in our study.
What does this mean? This means that if a patient had
decided to save some time and money and used one of these apps,
they could have been dissuaded at least a third of the time
from seeking medical attention for something that is a curable
disease when it is caught and treated early but fatal when it
is caught late.
However, they wouldn't have been aware of this, because
these apps didn't provide them with data, and they didn't
provide an adequate warning of the risk of a missed melanoma.
So mobile medical apps that interact directly with the patient
without physician input had the greatest potential for harm.
Our findings did also show, however, that store-and-forward
teledermatology can be an effective way to diagnose skin
cancer. However, this must be done safely. In the apps that we
used, the physician was not providing an extension of an
existing relationship, and they were not able to do things such
as arrange followup care. And there are several similar apps in
dermatology that are currently available online, and many of
these actually don't even provide care from a physician who is
licensed in the United States.
So it is important to realize that it is easier to ignore
an app than it is to ignore a physician. It is also important
to realize that a physician can provide care remotely as long
as it is done safely.
Finally, it is important that we have access for our
patients to dermatologic care. We do have an issue of limited
availability, particularly of dermatologists, and we think that
this is a way that we can provide access to patients who might
not have it otherwise.
Finally, in addition, although I have already pointed out
some of the pitfalls of using technology, in my own work, in
collaboration with Carnegie Mellon University, we have
developed a system that allows us to take an image taken with a
tool attached to a smartphone called a dermatoscope that can
allow us to upload an image of a skin lesion to a classifier,
which can then analyze that and give an idea, give a score that
helps to predict if that lesion is malignant or not. In our own
study, we found that we could accurately identify 97 percent of
melanomas with this tool.
Others have developed similar technologies. We have always
seen this as a tool that would be helpful in the hands of
another healthcare provider, such as a primary care provider
who may be seeing a patient with a suspicious lesion. It would
allow them to get a basic risk assessment and communicate back
with us. We have not seen this as a tool that would be helpful
directly placed in the hands of a patient.
So, in summary, I would just like to say that we think that
the oversight of such tools should reflect the risk and that
the risk in the hands of a physician is much lower than the
risk directly in the hands of a patient. In addition, privacy
concerns are allayed, because physicians in healthcare systems
are covered entities under HIPAA. Thank you.
[The prepared statement of Dr. Ferris follows:]
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Mr. Burgess. The chair thanks the gentlelady.
Dr. Dorsey, you are recognized for 5 minutes for an opening
statement, please.
STATEMENT OF E. RAY DORSEY, M.D., M.P.H.
Dr. Dorsey. Chairman Burgess, Ranking Member Schakowsky,
members of the Commerce, Manufacturing, and Trade subcommittee,
today we have the means to enable anyone anywhere to receive
care, to participate in research, and to benefit from those
advances. Unfortunately, policy barriers limit adoption of
these new tools.
I am a neurologist at the University of Rochester Medical
Center in Rochester, New York, and for the past decade, my
colleagues and I have been applying technologies, including
smartphones, wearable sensors, and video conferencing, to
enhance research and improve care for individuals with
Parkinson's disease and Huntington's disease. Currently,
clinical trials are plagued by limited participation and
insensitive outcome measures. For example, only 3 percent of
individuals with cancer participate in clinical trials, and
today, we assess whether a new drug works for Parkinson's
disease with paper diaries and subjective assessments of finger
tapping. We can progress faster with better tools, including
smartphones.
In March 2015, Apple created ResearchKit, an open-source
platform for creating smartphone research applications, and
released applications for asthma, breast cancer, cardiovascular
disease, diabetes and Parkinson's disease. Within a day, 2,000
individuals were participating in the Parkinson's disease
study. In 7 months, over 70,000 individuals from every State in
the union had enrolled in the study. In 1 year, nearly 10,000
Parkinson's disease study participants were sharing their data
with researchers globally. Because of their potential,
pharmaceutical companies are incorporating smartphones into
clinical trials. Such use could help determine whether new
therapies are efficacious in smaller, shorter, cheaper studies
and accelerate our ability to find treatments for Parkinson's
disease and other neurological disorders that will affect
almost all of us.
In addition to smartphones, we use video conferencing to
care for individuals with Parkinson's disease. Because of
distance and disability, over 40 percent of Medicare
beneficiaries with Parkinson's disease do not see a
neurologist. Those that do not see one are more likely to
fracture their hip, more likely to be placed in a skilled
nursing facility, and more likely to die prematurely. Simple
videoconferencing, like Skype, enables clinicians to reach
patients in their homes. In a pilot study, these virtual house
calls were feasible, provided comparable outcomes to in-person
care, and saved patients and their caregivers 3 hours of time
and 100 miles of travel. With 18 centers, including Baylor,
Northwestern, University of Kansas, and the University of
Florida, we are conducting the first national randomized
controlled trial of virtual house calls for Parkinson's
disease.
Demand for telehealth is high. Over 11,000 individuals from
80 countries and all 50 states visited the study's Web site,
and nearly 1,000 individuals with Parkinson's disease wanted to
participate in this 200-person study, which will complete this
summer.
Despite the promise and potential of these new
technologies, policy barriers, including State licensure laws
and Medicare's narrow coverage, limit adoption. In 2015,
Medicare spent less than one-hundredth of 1 percent of its
budget on telehealth. Currently, Medicare pays neurologists
$150 to see a patient with Parkinson's disease in a hospital-
based clinic, $80 for a visit in a community-based clinic, and
zero dollars to see a patient remotely in her home. In essence,
Medicare subsidizes institution-based care and disincents
patient-centered care.
Fortunately, policy solutions are available. The Tele-Med
Act would enable any Medicare provider to care for me Medicare
beneficiary. The act mirrors how physicians in the Veterans
Administration can care for any veteran anywhere in the U.S.,
and last year, the VA provided over 2 million telehealth
visits.
The Medicare Telehealth Parity Act would expand Medicare's
coverage of telehealth, which today reaches veterans, military
personnel, Medicaid beneficiaries, and prisoners, but largely
excludes 50 million older Americans.
Fifty-one years ago, a Texan signed legislation that
guaranteed all older Americans healthcare coverage. Two
generations later, Medicare is showing its age. However, this
committee, led by a Texan, can help ensure that this
generation's tools fulfill Medicare's founding vision and
extend care to every American senior everywhere.
Thank you very much for your time and service.
[The prepared statement of Dr. Dorsey follows:]
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Mr. Burgess. Thank you, Dr. Dorsey.
Ms. Johnson, you are recognized for 5 minutes for an
opening statement, please.
STATEMENT OF DIANE JOHNSON
Ms. Johnson. Before I begin my testimony, I would first
like to thank Chairman Burgess for his key leadership on this
issue and others. He has been a longstanding advocate for
patients, and we appreciate his tireless efforts.
Distinguished members of the subcommittee, thank you for
the opportunity to come before you today and to detail critical
applications within development at the Johnson & Johnson family
of companies that will enhance physician and patient
interaction while delivering additional patient tools in
innovative ways. In addition, my testimony will focus on how
Congress can help support these ongoing activities.
As part of the Johnson & Johnson credo, we believe our
first responsibility is to the doctors, nurses and patients,
mothers and fathers, and all others who use our products. The
commitment to safety is part of our DNA, factoring into our
decisions and development of our products and services.
With that credo in mind, J&J has developed a number of apps
to help individuals monitor their health or health of their
family and support the doctor-patient relationship. I will
describe a few key points, but there are many more.
The goal of this suite of apps is to empower patients,
reduce cost of care, and enhance patient outcomes.
OneTouch Reveal allows patients to check blood sugar
results on a mobile phone or tablet. The app provides overviews
and a 365-day logbook with colorful visuals and simple
navigation. It provides the patient with the ability to share
ongoing information with his or her physician, allowing for
enhanced care management for people with diabetes.
Care4Today Mobile Health Manager is a mobile app and Web
site designed to support and motivate people to stay on
schedule with their medication and report adherence to their
treatment plan as prescribed by their physician. The
application helps ensure that the physician is aware of
possible drug interactions or problems with medication
adherence.
The PATIENT ATHLETE Program is designed to help patients
preparing for surgery to take their experience beyond merely
reducing the pain. The program encourages patients to emerge
stronger, healthier, and ready for the next chapter of life.
Key components include a self-guided video-based training
program led by a performance coach who had a bilateral knee
replacement and uses the same concepts to enhance his own
experience. Eight core lessons, two per week, to complete over
a 4-week period prior to surgery and 11 refresher lessons to
complete post surgery.
The Johnson & Johnson 7 Minute Wellness for Expecting and
New Moms App is a science-based wellness resource designed to
help new moms manage and expand their energy during pregnancy
and after giving birth.
The Digital Health Scorecard helps one determine one's
health score and better understand the likelihood of developing
common chronic diseases such as diabetes, heart or respiratory
disease, or cancer.
HEALTHYDAY gathers data from the same trusted sources that
doctors and hospitals use and cross-references information with
local crowd-sourced data to determine what illnesses are
trending nearby. This help informs the user to determine
whether what they are feeling may be a cold, the flu, or pesky
allergies. Then when you are feeling great, it lets you see
what is going on around local and sends real-time alerts to
help you know what to watch out for.
With this demand for cutting-edge technologies and
continuous innovation, we as manufacturers must remain diligent
in ensuring that cyber security is an integral part of the
process. We believe that patient safety, including security of
their data, is the most important consideration. To that end,
foundational to our approach to cyber security is the
development of a formalized security framework for our
products. From a policy perspective, we believe that, in order
to ensure the continuous innovation, smart regulation is
critical.
Currently, the FDA has shown great flexibility in
establishing the types of apps for which the agency intends to
exercise enforcement discretion; that is, the FDA will not
enforce the requirements of the act. FDA released a guidance
document that provides examples. This guidance document is
extremely useful, and J&J is supportive of this approach, but
having specific criteria that determines what is and is not
regulated is key.
Johnson & Johnson worked extensively with the HELP
committee and other stakeholders to craft the language of the
SOFTWARE Act that would provide this clarity. While additional
work may need to be done to reconcile the SOFTWARE Act with the
MEDTECH Act, the goals are similar, and we would encourage
Congress to complete the work and provide companies with the
regulatory certainty that will foster innovation and encourage
investment in this space.
We think the following considerations are critical, that
the functionality is what is critical, what the app does--not
the platform it runs on--and that the findings should be
applied regardless of whether the app developer is or is not
considered a medical device manufacturer.
The policy changes are similar to those raised in the
wearable devices hearing, including device security, data
ownership, and privacy laws.
We hope you can ascertain that Johnson & Johnson strongly
encourages and supports these activities, which enhance the
doctor-patient relationship and improve patient empowerment and
access to medical products. We look forward to continue working
with Congress. Again, thank you for the opportunity.
[The prepared statement of Ms. Johnson follows:]
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Mr. Burgess. The chair thanks the gentlelady.
Mr. Terry, you are recognized for 5 minutes for an opening
statement please.
STATEMENT OF NICOLAS P. TERRY
Mr. Terry. Chairman Burgess, Vice Chairman Lance, Ranking
Member Schakowsky, and members of the subcommittee, it is a
privilege to share my thoughts and some of the legal and
regulatory issues involving healthcare apps. I congratulate
this committee on its Disrupter Series and its engagement on
these forward-looking and exciting issues.
I live in a small village just north of Indianapolis, where
I receive particularly superior representation. My day job is
serving as a professor at Indiana University Robert H. McKinney
School of Law. There I teach and write about health law and
policy, with a particular interest in information technologies
and healthcare data protection.
Some of my work is examining the question, why health
information technology, such as electronic health records or
clinical decision support systems, has failed to transform or
disrupt health care. I concluded there were several overlapping
explanations. These included typical healthcare market failure
problems, overarching structural issues, the illiquidity of
healthcare data, and underperforming technologies.
Not surprisingly, Federal and State policymakers have
turned toward subsidy and command-control models in an attempt
to promote HIT adoption. Mobile health and healthcare apps
potentially avoid these problems. They posit inexpensive care
pulled by patients only when needed and delivered away from
inconvenient, centralized locations.
Obviously, many mobile health apps will be developed with
regard to existing healthcare relationships, offering improved
condition management, particularly for chronic diseases. Many
of these apps will be subject to existing regulatory models.
However, the most disruptive health apps are those that are
patient-facing. These create or may create a direct app-patient
relationship that lacks professional intermediation and, as a
result, traditional regulation of safety, quality, and
confidentiality.
The regulatory framework for most of these apps is
complicated and, in some cases, troubling. Here, the
oversimplified binary of regulation versus innovation is a poor
frame. Rather, we have a current technological space that is
subject to both over-regulation and under-regulation. This is
also a space I would suggest where overarching labels, such as
health apps, mobile health, or digital health, are not always
helpful. Different apps for different functions used in
different contexts by different persons pose quite diverse
policy questions.
For present purposes, I restrict my comments to three
issues: safety, effectiveness, and data protection.
First, the Food and Drug Administration has used a
subregulatory guidance to signal a light touch regarding most
categories of apps. However, patient diagnosis and treatment-
recommending apps, that arguably could be useful and stimulate
innovation, remain subject to traditional device regulation.
Arguably, this approach frightens off responsible innovators
while the FDA lacks the bandwidth to deal with the many
industry minnows selling apps on the app stores that seem to
cross the regulatory line. Such a state suggests that
additional regulatory clarity is required, together with some
innovative regulatory models that is more attuned to the rapid
iteration in the mobile industry.
Second, there is the question of app efficacy or
effectiveness. Even if they are safe, many health apps are
simply ineffective. The structure of the app market and the
absence of effective infomediaries create immense problems for
consumers looking for quality apps, creating doubts as to
whether the market will function effectively. This is a classic
consumer protection problem, and in my opinion, the Federal
Trade Commission has taken the correct approach in demanding
competent and reliable scientific evidence in app cases
involving, for example, claims of melanoma detection and vision
improvement. However, sufficient regulatory resources must be
deployed in this endeavor lest innovative apps are drowned out
by mobile health snake oil.
Third, data protection. This is an area of acute under-
regulation. Most patient-facing apps existing exist in what I
call a HIPAA-free zone, subject only to a small number of State
laws or, in the most egregious cases, to the FTC's unfairness
jurisdiction. Here, our flawed sectoral downstream approaches
to data protection are on full display.
This country has enjoyed a deep-rooted cultural expectation
of and professional commitment to health privacy, no doubt in
part because healthcare data seems particularly susceptible to
discriminatory and other harmful uses. Every day, doctors
rightfully reassure their patients as to the legally enforced
confidentiality of the information they share while their
offices distribute mandated privacy notices. However, the same
or similar data collected on mobile devices lack these
protections. Most mobile health apps, particularly the more
disruptive patient-facing ones, are not subject to HIPAA
privacy and security rules, leaving patient wellness and health
data woefully unprotected. In my opinion, Federal data
protection law that obviates the gaps between our commercial
sectors and protects health information wherever it happens to
reside is overdue and is a necessary precondition for the full
embrace of disruptive health apps by both medical professionals
and consumers.
Again, I express my thanks to the committee.
[The prepared statement of Mr. Terry follows:]
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Mr. Burgess. The chair thanks the gentleman.
The gentleman yields back.
Dr. Patterson, we will come to you finally. Are we good?
Dr. Patterson. I hope so, sir.
Mr. Burgess. I hope so too. Very well. You are recognized
for 5 minutes. Regardless of whether the technology works, we
are happy you are here and look forward to what you have to
say.
STATEMENT OF MATT PATTERSON, M.D.
Dr. Patterson. Chairman Burgess, Ranking Member Schakowsky,
and members of the subcommittee, thank you for the opportunity
to be here with you.
I am excited to hopefully show a glimpse of the software
that my firm, AirStrip, creates because I think that that is
the best way to really demonstrate the opportunity for mobile
health to improve healthcare outcomes as well as to set the
platform to talk about some of the challenges.
So, as a United States Navy physician, I got my first taste
of the value of mobile technology in remote care. I left
clinical practice to devote my career toward the improvement of
healthcare access, quality, and cost efficiency at scale in the
United States. Before I joined AirStrip, I consulted with major
U.S. health firms around the country as they transitioned from
fee-for-service based reimbursement to value-based
reimbursement. And I saw firsthand that, after waves of cost-
cutting, they finally realized that the only way to really move
the needle further and get further gains is to bring about
broad transformation in healthcare delivery, and that is
shifting high-quality care to lower cost settings, using all
the resources. So now, as president of AirStrip, I feel very
fortunate to be creating solutions to address that challenge.
I would like to show you what AirStrip created with the
following scenario. So imagine I am a doctor, and I am in a
value-based care program like the Medicare Shared Savings
Program. I get a call from a patient from the call center on a
patient, who was discharged 2 weeks ago with heart failure, now
feeling short of breath at home and wondering what to do. The
primary care doctor is a colleague, but let's say I don't know
the patient very well. I get a name and phone number from the
call service and that is it.
So when I was in this situation as a doctor, I would try
desperately to create some kind of objective context before I
made that phone call. But, since that was usually impossible,
most of those phone calls ended with: You should go to the
emergency department.
Today, we must do better. We must prevent avoidable
escalations in care while improving outcomes, and we need the
right tools to do that. So, hopefully, if all goes well, I can
show you that.
The eagle has landed. OK. So I would, of course, have to
authenticate and log in, either with biometrics or a password,
but once I am in and I find my patient, I get, in near real
time, a longitudinal view of this patient's data, multiple
tiles populating on the fly from multiple disparate sources of
information.
So, if this patient had home monitors, I would be able to
pull up home monitoring data, see trended vital signs, like
weight and blood pressure, since the patient was discharged.
Since I don't know the patient that well, I could then view
documents that were logged by their primary care doctor. And
since the patient was just recently discharged from the
hospital, I could also take a look at a different electronic
medical record note that came from the hospital setting.
So, right there, with 10 seconds and three clicks, I can do
what was previously impossible for doctors. I mean, I can't
explain the revelation that doctors have of being able to go to
one place and not have to log in 20 different times in order to
view this data.
We can also accommodate FDA-regulated medical devices. In
fact, we were pioneering the first medical software to be a
Class II regulated medical device. So I can view at 12G ECG on
this patient if they had a body sensor monitoring them at home,
and I can view that side by side with an electrocardiogram that
was done perhaps in the hospital. And the level of fidelity
that I can pull up in real time using pinch and zoom and normal
gestures that we all use on our smart devices, I can see very,
very minute detail.
Let's say that I wanted to get a quick opinion from a
cardiologist about this patient. I could send a HIPAA-compliant
secure text to another doctor, and I could share in real time
where I was in this exact link to this electrocardiogram. So
text-based asynchronous work flows are the norm now in health
care. It has totally replaced phone calls in many
circumstances.
So, as a recipient cardiologist, when I get this, I can
then explore other places in the work flow, to include looking
at other monitors that may be hooked up to the patient--in this
case a cardiac monitor--that I can search through, or I can
even look as if I am standing at the bedside in near real time,
wherever I am, wherever the patient is, across the continuum of
care.
So, with a view like this, when I have all of the data in
one place, it is much easier for me to come to a conclusion to
tell this patient ``you should come to my office, and I can see
you immediately right now'' or ``come tomorrow morning,'' and I
will feel a lot more confident about that if that is the right
decision.
So if we are going to do anything when it comes to helping
clinicians in a value-based reimbursement climate, we have to
address work flow improvement. And by ``work flow,'' I mean,
the way that people interact with data on devices. It is the
clicks they have. It is the swipes of the screen that they do.
And I think that that is the thing that is making the biggest
difference in mobile health technology on the provider side and
the physician side, is making it easier for them to interact
with that data.
I describe several challenges in my written testimony, but
very, very briefly, I think mobile help applications require
true interoperability with existing data sources. So, in
technical terms, we need open, bidirectional, complete, and
affordable outpatient programming interfaces. And the
technology already exists to do that today. We don't need
future standards.
Interoperability enforcement can be strengthened through
seamless grant and incentive structures. On the regulatory
front, there is an opportunity to improve and clarify mobile
health technology classification by the FDA and to expedite
real-time communication on submissions for innovative solutions
that may not fit in previous categories.
Finally, updating telehealth definitions for HIPAA and
other policies to reflect the current state of technology
offerings would be very welcome.
Thank you again for the opportunity. I apologize for taking
a little bit of extra time, but I appreciate the opportunity to
show our software to you.
[The prepared statement of Dr. Patterson follows:]
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Mr. Burgess. The chair thanks the gentleman.
So I want to thank all of our witnesses for their succinct
presentations this morning.
Dr. Patterson, it was worth the wait to see your mobile
device up on the big screen.
We are going to move to the question-and-answer portion of
the hearing, and I would like to recognize the gentleman from
New Jersey, Mr. Lance, to begin the questioning.
Five minutes, please.
Mr. Lance. Thank you, Mr. Chairman.
And good morning to the panel.
To Ms. Johnson from J&J, the FDA issued mobile medical app
guidance in 2015 to help stakeholders understand how the FDA
plans to oversee healthcare apps that include medical device
functionalities. In your judgment, is there a need for more
regulatory clarity and certainty, particularly regarding the
FDA's enforcement discretion for healthcare apps that do not
operate as medical devices?
Ms. Johnson. Yes. We do support that legislative clarity is
needed in this area.
Mr. Lance. Is regulatory uncertainty affecting investment
and innovation in the healthcare apps market, not only
regarding J&J but based upon your experience across the entire
field?
Ms. Johnson. At Johnson & Johnson, we are a very large
company. We have very sophisticated regulatory departments and
extensive law departments. And I think for us it is somewhat
easier to navigate. Where we see the real struggle is with the
smaller innovative app developers, the one-, two-, three-people
companies that don't have access to the level of expertise.
Their level of comfort with enforcement discretion and the
investor's level of comfort with enforcement discretion is
certainly, from my experience, quite a bit lower than it is
with J&J. So I believe it is really impacting the small
companies.
Mr. Lance. Are there other distinguished members of the
panel who would like to comment on that? What would you propose
is the right level of FDA and FTC oversight over apps that
don't meet the definition of a mobile medical app under the
FDA's guidance but may have health- and medical-related
components, Ms. Johnson?
Ms. Johnson. Well, the decision should be risk-based, as
long as they don't--they are not performing functions that meet
the definition. The current regulatory environment is positive,
but we do believe that the patient privacy aspects need to be
better addressed and a patient's ownership of the data and the
ability of people to sell patient's data should be more
transparent.
Mr. Lance. And I think we are all of that view, that
patients' privacy should be foremost, and certainly that is
something on which we should be working here in Washington. And
I started with you because J&J is a great New Jersey company,
and much of J&J is in the district I have the honor of serving.
Dr. Patterson, from your perspective, what are the biggest
legal and policy barriers preventing or obstructing the
adoption of healthcare apps and other digital healthcare
technologies for patients and for providers?
Dr. Patterson. I think some of the greatest challenges
right now that we face on the policy and regulatory front have
to do with both interoperability enforcement as well as to
clarity from the FDA on classification of more innovative
solutions.
So, briefly, on the second point--and it feeds on what you
were just talking about--I think that we have to consider
situations where a platform can accommodate both data that is
in the sophisticated medical device, medical grade world of
sensors as well as be able to accommodate consumer-based data
in one place, because the combination of those two data
elements can lead to some very, very insightful analytics and
predictive insights about patient behavior and outcomes.
And so the concept that I would introduce is one of
provenance, and provenance refers to knowing where a piece of
data comes from. So getting clarity on data provenance and what
the burden is of provenance, that when a consumer device or a
medical device shares its data with something else, you know
where that data element came from and what grade of data
element that was.
Mr. Lance. And is provenance an area where, working
together, we have to do a better job?
Dr. Patterson. I would agree so, yes.
Mr. Lance. Thank you.
I yield back 35 seconds, Mr. Chairman.
Mr. Burgess. The admonition to do a better job is so noted
and will be taken under advisement by the chair.
The chair recognizes the gentlelady from Illinois, Ms.
Schakowsky, 5 minutes for questions, please.
Ms. Schakowsky. Thank you, Mr. Chairman.
Thank you, panel.
There was an article this week in the New York Times that
prescribed caution for consumers seeking medical advice from
Web sites and apps instead of going directly to a doctor.
The study, conducted by doctors at the Mayo Clinic, tested
the quality of medical advice provided by health Web sites, and
the doctors found that, ``going online for health advice was
more likely to result in getting no advice or incomplete advice
than the right advice.''
Now, Dr. Ferris, you conducted a similar study of apps
meant to detect skin cancer. As you said in your testimony, you
had similar results to the Mayo Clinic study. It seems that
false negatives are a particular concern with these apps. What
happens if an app falsely tells a person that a mole is benign?
Dr. Ferris. If an app falsely tells a person that their
melanoma is benign and reassures them that they can save their
time and money and not go see a physician, the consequence will
be that that melanoma is going to progress. It is going to be
deeper. And it goes from being what is, diagnosed early, a
fairly surgically curable disease with a simple inexpensive
procedure to a fatal cancer.
Ms. Schakowsky. And were the apps that you tested intended
to be used with physicians, or were they meant for consumer
use? I guess you called that, Mr. Terry, consumer-facing, is
that what you said?
Mr. Terry. Patient-facing.
Ms. Schakowsky [continuing]. Patient-facing apps and using
that app instead of going to a doctor?
Dr. Ferris. In our study, we tested four apps. And the
first three that were automated were intended to be patient-
facing, and they were not used in conjunction with a physician.
So it was to give the patient an assessment of the risk of
their lesion being skin cancer, and it would say, looks OK,
green light, things like that, or it would say, red light,
caution, get this looked out.
They all contain some sort of small disclaimer but really
not significant or sufficient information about the risk of
misdiagnosis. None of them had data saying how likely they were
to be wrong or the risk of a false positive versus a false
negative.
Ms. Schakowsky. And none of them made a suggestion that
they go see a physician if they have further questions?
Dr. Ferris. They generally somewhere in their warnings
would say things like, you should see a physician if you have
concerns. The problem is that that wasn't highlighted in the
output that they gave, and they still gave medical advice, they
still gave an assessment of that lesion.
Ms. Schakowsky. I am just wondering from the panel, should
we be considering this in two different categories, those that
deal with professional health providers and those that are just
alone, patient-facing? Is there anyone who disagrees with that?
Dr. Ferris. So that is, I think, a very important
distinction.
So part of the reason--I have been interested in this idea
of using technology to diagnosis skin cancer, and I think that
there is potential that it can be helpful and safe.
As I mentioned, sort of, at the end of my statement, I am
working on a technology with computer scientists at Carnegie
Mellon in Pittsburgh where, you know, we are doing validation
studies. We are trying to understand how we can use technology
to better understand melanoma.
We have very promising early results. However, I would
never put that out and make it available to my patients,
because I feel that this is technology better used in the hands
of a physician. We all know, all of us who are physicians up
here know that sometimes your clinical judgment overrules what
the tests that you ordered showed.
And so, really, I am a proponent of having really a little
more flexibility and regulations that respect the decreased
risk when there is additional information provided to a
physician and it is really physician-to-physician communication
that is being impacted or data being provided to a physician
who ultimately communicates that back to the patient and helps
to make a decision about the course of the treatment of that
patient.
Ms. Schakowsky. Dr. Patterson, in the display that you had,
the doctor that is looking at all the data is not the physician
that the patient normally goes to. Is that true?
Dr. Patterson. It can be a situation where it is a primary
physician, or it could be a colleague or another member of the
care team.
Ms. Schakowsky. But on that care team.
Dr. Patterson. Correct.
Ms. Schakowsky. I see.
Again, is there anyone here who thinks that there ought not
to be a distinction between those that are physician-driven,
that are healthcare-provider-driven, and just the app?
Did you want to answer that?
Ms. Johnson. I think when we were working on the language
around the SOFTWARE Act, we tried very hard to embody the
concept that there is a big difference and that, if it is the
patient trying to make a decision, that is a lot different than
the physician. And the physician who is getting the information
needs to understand the context around the information that
they are receiving. And we do believe it makes a critical
difference.
Ms. Schakowsky. OK.
Can Dr. Dorsey reply?
Dr. Dorsey. The FDA guidance is around regulating apps that
are used to diagnosis or treat a condition, and I think that is
great guidance. Apps that empower consumers to give them more
information on how they are sleeping, how they are eating, how
they are exercising, potential medication interactions, those
are all very valuable.
I think the concern comes around when you are giving a
diagnosis or a treatment recommendation. I think that would be
the distinction that I would highlight.
Ms. Schakowsky. Right.
And that is your expertise, too, Mr. Terry. What did----
Mr. Terry. I think, yes, the patient-facing-against-
professional-facing differentiation is important. But, equally,
I think, as this moves forward with the pace that it is
showing, we may end up with additional categories, including
some sort of hybrid categories.
I think it is also quite possible that we would want to get
more granular and distinguish between some patient-facing apps
and others. So, for example, the risk of a melanoma negative, a
false negative, is such that we maybe wouldn't want that. But,
on the other hand, personally, I would find it quite useful if
my watch would tell me when I am about to have a myocardial
infarction and tell my car to pull over and also phone my
spouse and tell her I am going to be late for dinner.
Ms. Schakowsky. Thank you.
Dr. Experton. If I may add a point on this, Mr. Chairman,
yes, those patient-facing mobile apps can also be extremely
important in the physician-patient communication.
We discussed, you know, how we want to avoid medical harm.
Today, in America, the third-leading cause of deaths are
medical errors. About one-fourth of them are caused by the fact
that, at any given point in time, a physician doesn't have the
full picture of the history of that patient.
So when a patient comes with a medical app which provides
the key information that a physician needs to properly
diagnosis and treat, we can address a dramatic public health
issue. And so, with those apps, we are talking about enhancing
the physician-patient communication, and then the patient
provides that information the physician is seeking, which often
lacks when that Medicare beneficiary comes alone or with a
family caregiver and comes a critical question from that
physician: What medication do you take?
And oftentimes it can be half a dozen of those. And at one
point that patient may say, ``I take a pink pill, but I don't
remember the name of it.'' Then comes the additional
prescription which can interfere with that list of multiple
medications that Medicare beneficiary is taking.
So those are the situations of life-and-death scenario,
where more harm is being done with a lack of information. And
arming the patient with tool to enhance their memory, to
provide their physician with a list of medication which the
physician can see, provided from that Medicare source it can
trust, is lifesaving. So I would put that category of
applications, of patient-facing applications, a hybrid indeed
application, they are of critical use for the physician.
I am a former adjunct professor of medicine at University
of California, San Diego. I am a former public health officer;
I am a data scientist. And, at one point, it came to me that a
commonsense approach to the lack of information we have is to
outfit patients with the critical information they need to
present to their physician. Because we are still in a very
fragmented healthcare system. We spend $35 million in the
HITECH Act. The patient has to be part of that story to
communicate information that their physician needs.
Ms. Schakowsky. Thank you for your indulgence, Mr.
Chairman.
And thank you, panelists.
Mr. Burgess. Absolutely. You will pay for it later.
The chair would like to recognize the gentleman from
Mississippi, Mr. Harper, 5 minutes for questions, please.
Mr. Harper. Thank you, Mr. Chairman.
And thanks to each of you for being here. This is such an
important topic for our future and for today.
Ms. Johnson, the Center for Telehealth at the University of
Mississippi Medical Center in Jackson, Mississippi, is a leader
in providing health care using telemedicine, especially to
underserved populations.
How do telemedicine and other mobile health technologies,
including healthcare apps, affect patient engagement in the
healthcare system? And what does this mean for the
accessibility, affordability, and delivery of care?
Ms. Johnson. Well, certainly, as the healthcare system as a
whole becomes more interoperable and data-sharing is possible
across the entire healthcare system and patients have access to
all of their information, the patients will become more
engaged. As the patients become more engaged, we believe this
will help reduce healthcare costs, help them make more cost-
conscious decisions.
So, really, as the whole ecosystem grows to be as one and
the patients have access to their data, we do think it will
change the way the healthcare system operates.
Mr. Harper. Thank you.
Dr. Dorsey, in your testimony, you talk about Medicare's
limited coverage of telehealth. How is Medicare's current
reimbursement scheme impacting clinicians' adoption of
telehealth and other mobile health technologies? Tell us your
opinion on how that is working.
Dr. Dorsey. Congressman Harper, thank you very much for the
question. Thank you very much for your advocacy for telehealth.
It really impacts patients. So, as I mentioned, 40 percent
of Medicare beneficiaries with Parkinson's disease don't see a
neurologist. And that happens in Mississippi, that happens in
Texas, that happens in Nevada, and it even happens in New York
City. And the reason they can't access it is because they are
either an outsider--all of us in this room are healthcare
insiders and we can readily access care, but many people can't
because of distance or disability. And, increasingly, we ask
people who are disabled, have limited mobility and impaired
driving ability, to drive to urban centers to receive care. We
have it backwards. We should be providing care to individuals
on their terms, in their environments, and not in institutions.
And Medicare, which increasingly stands alone in its
limited coverage of telehealth, is limiting access to care for
Medicare beneficiaries, including 2 million homebound Medicare
beneficiaries who can't access care increasingly, except by
either physicians and clinicians visiting them or through
telehealth.
Mr. Harper. OK. So is there a role from Congress in
addressing this issue?
Dr. Dorsey. Absolutely. The VA covers telehealth, and 2
million telehealth visits were conducted last year. Increasing
reimbursement for telehealth would be an outstanding start,
including coverage of telehealth provided into the home, where
it is most beneficial, most convenient, and most centered on
the needs of patients.
Medicare could stop incenting institution-based care by
providing higher incentives to institutions for the same visits
that could be conducted remotely that are centered on the needs
of patients.
Mr. Harper. Thank you, Dr. Dorsey.
Ms. Johnson, do you have specific examples of how your
mobile healthcare technologies or these technologies generally
have shown demonstrable changes in patients' health status or
in improved patient health outcomes?
Ms. Johnson. Well, I can't say that there is published
statistically significant data available, but, certainly, with
the diabetes care solutions, in particular, we do see,
generally speaking, the appearance of less excursions of blood
sugar, you know, being too high and too low.
There is certainly literature to support that sort of
improved control leads to a reduction in complications from the
diabetes. But there is no published data to support that. But,
certainly, with the diabetes, we see better control.
Mr. Harper. Thank you very much.
And, Dr. Dorsey, the Congressional Budget Office, CBO, has
raised concerns that expanding telehealth and remote patient
monitoring, or RPM, services within Medicare will be costly to
implement and sustain. The CBO scoring does not look at longer-
term cost savings that could result from a healthier Medicare
patient population.
Could you share any insight on those cost savings that
telehealth and RPM services have provided in other settings and
how that might impact Medicare in the future?
Dr. Dorsey. There is tremendous empirical evidence to get
around this concern that increased reimbursement will lead to
higher cost. Increased reimbursement will lead to increased
utilization of services, but in the grand scheme of things,
physician visits at $70 a visit are much less expensive than
$1,000 emergency room visits and $17,000 hip replacements.
The VA uses telehealth. They are under a fixed budget, and
they view it as a cost-effective solution for providing
patient-centered care to military veterans.
Kaiser Permanente this year will have more virtual visits,
in the form of phone, e-mail, video, than in-person visits.
They are under a capitated environment, and they obviously view
this as a means for enhancing care at lower cost.
Bills like the Medicare Telehealth Parity Act are a step in
that direction, and we are just scratching the surface of what
is possible. Our chief areas right now are Medicare's limited
reimbursement and our arcane licensure laws.
Mr. Harper. Thank you, Dr. Dorsey.
And thanks to each witness for being here and sharing your
testimonies with us.
And I yield back.
Mr. Burgess. The gentleman yields back. The chair thanks
the gentleman.
The chair recognizes the gentlelady from New York, Ms.
Clarke, 5 minutes for questions, please.
Ms. Clarke. I thank you, Mr. Chairman and our ranking
member.
I thank our experts for your testimony here today. It has
been extremely edifying and certainly has raised a number of
issues that I think we are all going to have to grapple with.
It is something that I believe will advance us if done
correctly. And I thank you once again for your testimony here
today.
Professor Terry, in your testimony, you mention that many
apps are operating in a HIPAA-free zone. It is my understanding
that, when HIPAA does not apply, the apps may be subject to FTC
oversight. Is that correct?
Mr. Terry. That is correct. The FTC has some general
oversight with regard to unfairness that could apply and has
been applied outside of the app space to security violations,
for example, by businesses. However, the FTC's jurisdiction is
very broad and therefore tends not to provide a lot of guidance
for industry as a result, or certainty. And, of course, you
have a major resource problem with regard to enforcement from
that angle.
Ms. Clarke. And I was going to go directly to that. The FTC
is an enforcement-only regime when it comes to privacy. So is
it the case that the FTC's privacy-related enforcement actions
mostly have focused on companies' failure to comply with their
own privacy policies?
Mr. Terry. That is correct. And, as you point out,
Congresswoman, it is an ex post facto regulation.
Ms. Clarke. Right.
Mr. Terry. The FTC has stated in a recent case that its
jurisdiction does extend into the healthcare space as it tries
to sort of break down one of the gaps between our privacy
sectors. But there is a lot more that could be done, I think,
in that way.
Ms. Clarke. Absolutely.
Professor Terry, if a health app that is not covered by
HIPAA does not have a privacy policy at all or if the privacy
policy permits the app to share or sell information, is there
anything that prevents that company from selling or sharing
personal information it collects?
Mr. Terry. It is very difficult to find any clear answer
``yes'' to that. Generally speaking, those apps are just going
to be unregulated.
Now, obviously, some jurisdictions, some states, like
California, have state laws that require a privacy policy. If
you are using the care framework or the health framework or the
health kit framework from Apple, then the Apple store requires
you to have a privacy policy.
But the people that would comply with that are not our
problem. It is the ones that don't comply with that that are
the----
Ms. Clarke. And, certainly, when we all are talking about
portability in health care as well, if you are in California,
great, but if you move someplace else, quality control becomes
an issue, right?
How have the app developers, as relative newcomers to the
technology space, affected data security practices in the
industry?
Mr. Terry. Well, again, I think you have to recognize,
particularly my copanelists, when we are looking at extremely
responsible companies with lots of lawyers and lots of risk
managers who are doing fine things. But our main concern is
going to be the apps that are out there that simply have
inadequate security. And there have been studies showing that
that is the case.
There have been studies shown, for example, in Canada that
most wearable devices give off persistent tracking signals,
creating privacy and security issues. And an English study
showed that there were major security flaws even with apps that
have been approved by the National Health Service for use
there.
Ms. Clarke. So how can we ensure that new companies are up
to speed and know what they are doing with respect to data
security before their products reach consumers?
Mr. Terry. Well, I think I could have given my same
presentation to any of the disrupter topics that you chose, and
the reason for that is because we have this sectoral approach
to privacy. And so my optimistic suggestion is that we move
away from that and we have an overarching, comprehensive
privacy law, data protection law, that would stop these gaps
between these different industries or between the industries
that are conventional and the disrupters, to stop those
developing.
In the absence of that, in a shorter term, I think the
existing agencies probably need to maybe be given some
additional powers. If I may give you one example, we know, for
example, that the ONC, with its meaningful-use program, now has
APIs, application programming interfaces, in order to improve
the interoperability of data and share it with patients. And we
all believe that that is a good thing. Yet the moment that data
leaves the hospital or physician her, it merges into
unprotected space.
Ms. Clarke. Yes.
Mr. Terry. So I think maybe we need sort of a version of
the Pottery Barn rule, right? So if we give an agency the power
to push the data out, we should also give that agency the power
to protect it as it emerges from that sort of protective
cocoon.
Ms. Clarke. Dr. Experton, did you want to----
Dr. Experton. Yes. Thank you for giving me the microphone.
I think there is a very positive element in what technology can
bring to that security question.
We have all learned that phones can be highly secure, they
cannot be broken down, with the FBI having to reach out to try
to get information in an older iPhone series 5. The phone can
be highly secure, and it is a personal device. So your phone
can indeed store securely when the data is encrypted, which is
the case for multiple applications--iBlueButton or Tensio for
hypertension measurement.
It is in your hands. It is under your control. You cannot
break in. If hackers want to get to your data, they will have
then to hack millions of phones instead of one server in a
cloud. So I think technology has made incredible steps to give
individual citizens control over their most personal and
critical information, which is their health information.
And I mentioned the iBlueButton app. At no point does
Humetrix store or share that data. The data comes directly from
the source, whether it is Medicare or TRICARE, VA or privatized
care providers, directly to the user's phone, where it is
securely encrypted.
So modern technology and mobile technology answer critical
healthcare needs. It is immediate access to information me, the
patient, or my doctor needs. It is in my hands, under my own
control. And we oftentimes forget that, indeed, technology has
evolved to solve the very problems we have.
Ms. Clarke. Thank you, Mr. Chairman. There is still an
issue of quality control that we will all have to manage
though. And I yield back, sir.
Mr. Burgess. The chair thanks the gentlelady. The
gentlelady yields back.
The chair recognizes the gentlelady from Indiana, Mrs.
Brooks, 5 minutes for questions, please.
Mrs. Brooks. Thank you, Mr. Chairman.
And thank you to our panel. This has been fascinating, and
really appreciate your expertise.
We know that in the next year, I have been told, 500
million smartphone users worldwide will have a health app. So
the apps are growing. We have to wrap our arms around what is
the right way forward with respect to how we use these.
And, in Indiana, Eskenazi Health in Indianapolis recently
hosted what was called ``Connectathon,'' and it brought
together software developers and innovators from across the
state. And it was a competition, and the winning team built a
medication adherence app that sends texts or mobile reminders
to patients' smartphones to take or refill their prescription
medications--obviously something critically important in
patient care.
And so I am encouraged with all that is happening out
there. And we need these creative app developers like the teams
in Indianapolis and around the country, but we also need to
protect health data.
And I must say, Professor Terry, welcome to Washington,
D.C. You weren't a professor when I was at the law school in
which you teach, and I wish to thank you for your leadership at
the Hall Law and Health Center. And I think we all would really
enjoy your classes, but I am happy I am not in law school any
longer.
Mr. Terry. You are always welcome.
Mrs. Brooks. But had you been there, I would have certainly
looked forward to taking your class.
But I want to talk to you a little bit about the issues of
context and functionality of the apps in defining and properly
classifying it for proper regulatory and policy purposes. And
that is something you have studied actually far more than I
have studied and maybe more than most of the panel has really
given a lot of thought to. And I think that is very important.
Can you talk to us a bit more about--you talked about
whether it is patient-facing versus physician- or provider-
facing. As we are crafting this important area of law that is
growing and that is needed, what are, kind of, the
classification tools and categories we should be looking at? Or
should we not be looking at classification categories?
It would be great also if you just gave us the proper
privacy policy legislation that we could debate and discuss; we
would welcome that. But what about with respect to the
classifications in this space?
Mr. Terry. Well, I think with respect to the
classifications, Congressman Lance, you referred to the 2015
subregulatory guidance. That is, in fact, a republication of
one that was in 2012. And the way that this stuff is developing
so fast, maybe that is worth a reexamination to see if we have
more categories or categories that we can better define.
I think that we probably know enough about this space now
that there are some categories that have been proven to be
risk-free, and we no longer need regulatory discretion; we just
need to jettison now into the consumer electronic space and let
them thrive as they can.
So then the question is, can we actually be slightly
cleverer with regard to how we categorize some of these
products? Should we start maybe saying the condition-diagnosis
type of app is a little bit different from the treatment type
of app, so that we can get some space in there?
And then I think the other thing that is a continual
problem that high-tech disruptive industries face is that the
timeframe for regulation is out of sync with the rapid
iteration of these types of technologies. And I think it is
going to take smarter people than myself to figure that piece
out. But those will be the kind of pushes that I would throw
out to the regulatory agencies to see if they could come up
with something like that.
Mrs. Brooks. And thank you. We look forward to your help
and your continued suggestions in this space.
Dr. Experton, quick question with respect to the
iBlueButton. Because I am on a Medicaid Task Force
contemplating reforms to our Medicaid program, and I understand
the iBlueButton is being contemplated for the millions of
Medicaid beneficiaries as well.
And yet, can you please talk to us a little bit about what
that app looks like, how it could help with cost containment,
and, very briefly, how you have overcome with your products the
HIPAA issues that Professor Terry brought up?
And sorry, that is a lot. Mr. Chairman, if I might indulge.
Thank you.
Dr. Experton. Thank you, Congresswoman, for this question.
Yes, the iBlueButton app I mentioned is also available for
State Medicaid programs. And the State of New York took a
leadership role in choosing that application, to have patients
participate in solving the critical safety but also cost-
control issue any State Medicaid program has.
So, with the iBlueButton app, we take the Medicaid claims
the way we take the Medicare claims and, on the fly, on the
app, decode financial information into clinical information in
English for that Medicaid beneficiary to understand, review,
annotate, research, and to share with their physician wherever
they receive care.
Medicaid beneficiaries are, more than anyone, subject to a
problem of access and coordination of care. And, at most
instances, any given patient doesn't have the full history of
their medical care. So they come with that information coming
from their claims, turn into a longitudinal health record right
there on their phone, securely encrypted, which they can
present, whether it is in the emergency room, whether it is
some specialist to the next.
So that is the use of iBlueButton. So we white-label and
customize our iBlueButton app for a State Medicaid program,
which is going to query directly from the app in the user's
control that Medicaid database of claims and, in real-time,
turn that claim data into a longitudinal record so that patient
can say, ``Here, Doctor, the medication that has been
prescribed to me and the one I continue to take or do not take
because of this side effect I discovered through the app. Here
is a test I got. You don't need to repeat.''
Medicaid program represents about one-third of the State
budgets. There is an issue of cost control, but there is also
an issue of safety with the lack of coordination of care in
those States. So this patient visit type of technology is
critical on both fronts.
Mrs. Brooks. Thank you very much.
And thank you, Mr. Chairman, for the extra time. I yield
back.
Mr. Burgess. The chair thanks the gentlelady.
The chair recognizes the gentleman from North Carolina, Mr.
Butterfield, 5 minutes for questions, please.
Mr. Butterfield. Thank you, Mr. Chairman.
And good morning, one and all. Thank you to all of the
witnesses for coming today. I have been watching some of your
testimony on television, and at other times I have been moving
around the Capitol, as most of the members have today, trying
to complete our work before the August recess. And so thank you
for your testimony.
It is clear that for most Americans health information is
so very personal, requiring a high degree of privacy and data
security. But as Mr. Pallone said in his opening statement, I
think there is some confusion for the average consumer when it
comes to the privacy of their health information.
And so, Professor Terry, it is my understanding that,
despite the fact that that is not true, most people assume that
health information is generally protected by HIPAA. Do you have
any of those same concerns?
Mr. Terry. I definitely do. Let me illustrate it by the
simplest-of-all type of exchange that could involve a
smartphone app, which is that I use an app to access my
electronic health record. We want that kind of sharing, right?
Well, the moment that that data leaves the electronic
health record of the provider and enters the smartphone app,
there is considerable confusion as to the legal state of it.
Now, if that app was provided by the hospital or the provider
or a business associate, then the HIPAA shield would be all
over it. If it was not, if it was an app that the patient just
purchased from an app store, then it is highly likely HIPAA
would not apply.
Now you have two sets of data, identical data, one on the
her, one on the phone, identical data. One bundle is subject to
the most stringent privacy protection we have in this country;
the other is basically unregulated.
The patient then, for example, could add some wellness
information from a Fitbit app or something to that electronic
health record. Now the data is different. The patient could
then send that back to the doctor, back across the threshold.
Now you have two more sets of data, but, again, completely
different protective systems applying to them.
I considered that certainly beyond my ability to explain to
any patient.
Mr. Butterfield. I think I read in the material that there
are 160,000 apps that are out there.
Mr. Terry. I think that is about right, yes, and growing.
Mr. Butterfield. And growing.
Does HIPAA protect all health-related information?
Mr. Terry. No, it does not. So, for example, there is tons
of data, probably more health-related data is being generated
outside of the traditional healthcare environment than is being
generated within it. So every time you use a supermarket
loyalty card and you pick up, I don't know, a diabetes testing
kit or an over-the-counter pregnancy testing kit, that little
piece of data goes up into the data broker cloud.
You are all familiar with the Target story of early
diagnosis of pregnancy by the use of preferences with regard to
hand lotion; exhaust data that comes off online sites that sell
products, online resellers. Social media sites and, more and
more frequently, mobile devices are all building this sort of
surrogate version of your health life completely outside of the
regulation of HIPAA. And it is being sold back to insurers and
employers as body scores or health scores, which are
potentially extremely discriminatory.
Mr. Butterfield. All right.
I have 45 seconds remaining. Let me do this very quickly.
Let's say that an app that monitors blood pressure is offered
by the patient's primary care physician, who would be a HIPAA
entity. Does HIPAA cover the information that is collected and
stored by the physician?
Mr. Terry. If that app was developed by the physician or
the hospital or a business associate, then it is highly likely
that it would be covered.
Mr. Butterfield. Would be covered. Yes.
Again, let's say that a doctor recommends that a patient
use a blood pressure monitoring app, but the doctor does not
offer the app. If the patient shares the information collected
with his or her doctor, is information held by the doctor
covered by HIPAA?
Mr. Terry. That would be covered by HIPAA. Of course, there
is the overarching question as to whether any sane physician
would recommend an app without knowing it inside-out because of
the liability issues that could well occur there.
Mr. Butterfield. Thank you. You have been very kind.
Thank you. I yield back.
Mr. Burgess. The chair thanks the gentleman.
The chair would note to the members of the subcommittee
that the chair has deferred his questions till the end. I did
that on purpose so that I could accumulate all of the time that
each of you went over, and I have now aggregated that, and I
yield myself the next hour and a half.
No, I do want to thank all of you for being here this
morning. It has been terribly illuminating and illustrative. I
have made a number of notes here. And I do, of course, as
always, will have opportunities for questions for the record if
time does not permit all the questions to be asked.
But, Dr. Patterson, let me just ask you--you know, you gave
such a wonderful demonstration. It really was worth the wait. I
mean, I cannot tell you the times--look, we just had a big
series on opiates within the full committee and Subcommittee on
Health.
And I will tell you, as a practicing physician, I think you
just hated to realize that maybe you got scammed on that
prescription. So, in order to avoid that, even though it was 3
o'clock in the morning, I would go back up to my office that
was physically adjacent to the hospital. A patient would call
in and say, look, your partner prescribed whatever because I
had surgery, and the dog ate my homework, and could you just
get me enough to get me through my 3-week vacation that is
coming up in just a few hours here?
I would fall for it once, but next time--``Well, meet me at
the emergency room. I just want to check and make sure
everything is OK, and I will be happy to write you a
prescription.'' I would go to my office and pull the record.
The patient almost invariably did not show up in the emergency
room.
But, boy, how powerful to have what you demonstrated to us,
where you could basically access that information at home. So,
like, in a five- or six-physician practice, all of those
records would be available to the physician on call for the
practice. Is that correct?
Dr. Patterson. That is correct, yes.
Mr. Burgess. Now, Mr. Terry pointed out that, once that
data leaves the confines of the medical records department at
the clinic or the hospital, now it is in a different world. But
that is OK on your device? There is a proper protection on that
device?
Dr. Patterson. Yes. So everything that we provide in our
platform is done under a business associate agreement with the
provider side, so either the health system clients or the
physician groups where our software is deployed.
I think that the challenge that comes with a platform like
ours is that we are positioned to incorporate device data from
anywhere, so we are agnostic to the source. And so there is a
host of consumer-facing applications and sensors out there
where that data could be very useful for the broader context of
caring for a patient.
So, as a doctor, I don't mean to be crass, but I really
don't care how many steps you take, and I don't really care how
many calories you have eaten on a day-to-day basis. That is not
what I am going to be spending my time on and probably
shouldn't be, for that level of decisionmaker. But if I can see
data that links how many steps somebody takes to their onset of
depression because they are no longer taking their dog for a
walk, and then that is linked to their medication
noncompliance, and then that is linked to a rehospitalization,
suddenly I might be very, very interested in having that being
pulled together through machine learning or algorithms.
And so we have to find a way to accommodate various
disparate sources of data. So I liken it to recreational data
versus professional-grade data. So in my mind, we have to set a
very clear bar on what is recreational and what is
professional-level. And I don't necessarily think it is who is
using it, but I do think it is more related to the level of
risk and the safety involved. And that should be the primary
criterion, is what is safe, what is not safe.
And then, subsequent to that, there needs to be a crosswalk
capability that allows recreational data to be drafted to the
big leagues, so to speak, down the line. So there has to be
some way that we can bridge the gap between these two and do
that safely.
And I feel that provenance is one of the most important
things. You always have to be able to tell where a data element
originated from. If that is lost in the little pieces of
metadata that surround that data element--for example, if I
have a glucose reading, I want to know where did that glucose
reading come from on that diabetic, what type of device, how is
that regulated, how much can I trust that.
I think if we solve for some of those issues, we can
probably clarify a lot of the classification issues that are
coming up where we don't have to have 20 different
classifications. And the legislation would never be able to
keep up with the innovation.
Mr. Burgess. One of the things that got me interested in
this several years ago, I was able to download an app onto my
phone that used the flash attachment to measure heart rate, so
that was kind of neat.
And then at a prayer breakfast, Dr. Collins, the head of
the NIH, was seated next to me, and his iPhone had an EKG on
it. Well, wait a minute, Dr. Collins, I want an EKG on my
iPhone. So I figured out how to get it. It actually is an FDA-
approved device. You do have to have a physician's license in
order to have that; you can't just download that for regular
consumer use. But now I have two ways to measure heart rate on
my iPhone, one with the light sensor and one with the EKG app.
But, Mr. Terry, your last comments about the blood pressure
cuff--the other thing that made me interested in this, I used
to practice OB/GYN. Yes, it has been a few years since I have
done so. But, invariably, the last patient at 4:45 on a Friday
afternoon comes in for a routine prenatal check up at 36 or 37
weeks pregnancy, about a month away from delivery, and her
diastolic blood pressure is 90 millimeters of mercury. Yikes.
She has never had blood pressure that high before. But, is this
the harbinger of something very bad that is about to happen, or
is this a one-off because I didn't provide adequate parking out
in front of my office and she got mad at her husband because he
had to drive around to drop her off? You don't know that at
4:45 on a Friday afternoon. Sure, recheck the blood pressure,
perhaps wait 15 minutes.
But how empowering--you make one decision and say, ``I am
sorry. You have never had blood pressure this high before.
Although you have no other symptoms and no other criteria, I am
going to have to ask you to come into the hospital for
observation.'' Three days later, with no elevated blood
pressure, rather sheepishly you are discharging that patient.
She is angry because of having to arrange daycare for her other
kids. Or, 3 o'clock on Sunday morning, that patient is back in
the emergency room either having had an eclamptic seizure or a
platelet count of 2,000 or something very bad has happened.
So how great to be able to use that blood pressure now that
is available in the home. I mean, you don't even have to tell
someone to go down to Walgreens and sit in the chair. A $40
peripheral and you can measure that blood pressure at home and
have perhaps several blood pressures a day e-mailed to the
doctor on call for that weekend. What is wrong with that? That
seems like it is a way to extend the ability to give good care
and make good decisions.
Mr. Terry. I completely agree. And, in fact, I would go
further than Dr. Patterson, because I don't think we are
talking about just wellness or fitness data that could be
valuably incorporated into this very professional environment
that you are talking about. But, as we know from the Institute
of Medicine and work that is being done elsewhere at HHS, we
are really trying very hard to incorporate a lot more health-
determinant information data into our records to push that
environmental piece back into it.
So not only would you be able to look at the blood pressure
of that patient, but you would get a sense of the different
environments that maybe have pushed or lowered that blood
pressure, which would, again, I think, give you even more data.
The problem is that, after a while, you wonder whether this
really can stay on that encrypted device for that level of
processing and whether, in fact, our desire for sharing and
additional processing will in the end force this up into the
cloud and, therefore, raise so many of the privacy and security
risks that we have discussed.
Mr. Burgess. Very well.
Let me ask you this, because you brought up the question of
industry minnows. And although we don't deal with endangered
species on this committee, I couldn't help but wonder about the
delta smelt and if that was one of those industry minnows. But,
seriously, that is--and Ms. Johnson referenced some of the
difficulties that the FDA has.
That potentially is an enormous task on the regulatory
side. Industry minnows are turning out health apps. The
regulatory body that, oh, by the way, in addition to the
180,000 health apps that they are trying to regulate, they have
also got 11,000 laboratory-developed tests that they now say
they are going to regulate as medical devices--I mean, suddenly
just the workflow through the agency becomes problematic.
What do you foresee in that situation?
Mr. Terry. Well, I think unless there is tight regulation
and enforcement, I think the minnows are going to get worse.
You only have to do a brief search through app stores these
days amongst health-related apps to find all sorts of apps that
look like they are doing device-like things but are not
approved medical devices.
And, frequently, you will see when you click on the
``more'' button on that app site, it will proudly tell you that
this is for informational or educational or game enjoyment only
and should not be used for diagnosis. Yet, at the same time,
they are selling these things for what looks like diagnosis.
Unless that gets tightened up, I worry that the good
companies will find themselves just sort of overwhelmed by the
bad. Generally speaking, it is my belief, at least, that our
finest corporations actually will embrace regulation because it
brings certainty. And good enforcement might help that.
Mr. Burgess. Yes. This is the disrupter series, however,
and I think the admonition to pay attention to the provenance
of the data is--I mean, I think that is valid and I think that
is wise.
Dr. Ferris, let me just ask you, because not this
subcommittee but another subcommittee of the Energy and
Commerce Committee, in 2012, did a number of hearings leading
up to the FDA user-fee agreement reauthorization, the FDA
Safety and Improvement Act. And as part of those hearings
leading up to that, we had a member who is no longer here in
Congress but was very concerned. His daughter had a melanoma.
He was interested in--it wasn't a consumer app. It was
something called the MelaFind camera.
MelaFind had difficulty getting approval and then did. And
then I don't know what the difficulties were after the fact,
but I think, if I understand correctly, it is back on. So it
sort of speaks to some of the difficulty that you raised.
And yet, at the same time, I am thinking back to the flip
phone that I had when I started in the Congress. Yes, I could
take a picture with it, and you could almost make out the
images. The technology is getting a lot better literally every
year. I rather expect, when we have the user-fee agreement
reauthorizations, we are likely to have other devices that are
talked about at that time because of the advance of the
technology.
So do you have a sense how the improvements in technology,
how that may impact the ability to provide this type of
information? And I am not even thinking so much at the
consumer-level. I am thinking at the level of a primary care
doctor, like I was.
Basically, it is a binary choice for me. If a patient shows
me a mole and asks me if she needs to be worried about it, I
say, ``You need to go to the dermatologist to get it
biopsied.'' Because if she's worried about, I am worried about
it, and we are all going to worry about it until you tell us it
is OK.
Yes, if there were an intermediate step that dealt with a
transmission of data on a--whether it was a consumer-driven app
or an FDA-approved app, that just seems to me that that would
increase utilization of trying to diagnose those lesions.
Dr. Ferris. Yes. Thank you.
So I am familiar with MelaFind device and actually
participated in the pivotal trials that resulted in,
ultimately, FDA approval after a very long process of that.
So there is a difference between a device like MelaFind--
because it is truly on optical device. It is doing image
capture. It is doing analysis within the app and giving a
score. And part of the reason it needed approval was that it
actually did initially give a binary output, a biopsy
recommended or no biopsy recommended. So that is purely a
recommendation.
In the scenario that you are talking about, where you have
a patient who has a mole and you just say, ``Go see
dermatology,'' if you were doing that in western Pennsylvania,
where I practice, if you were not within the city of Pittsburgh
and didn't have my cell phone number, you would potentially be
telling that patient to either drive at least an hour to see a
dermatologist or to call our office, where they would be told
that our next available appointment may be up to 4 to 6 months
later because of the access-to-care issues.
So now we have better ways to do that. So one is you can
take a photo, and, through a HIPAA-secure system, you can send
that to a dermatologist, because we can very quickly triage.
So, one, that should be more widely available. That is not a
direct-to-consumer. That is physician-to-physician
communication.
Two, the technology that we are trying to work on is that
we could outfit your office with an attachment to your iPhone
that is maybe a couple hundred dollars that would give us an
even more clear and analyzable image of that lesion, that you
could either, one, get an even better opinion from us quickly
through telemedicine, or, two, that we, by having a tool that
can analyze that image, we could actually give you a score of
risk.
We are not giving that to the patient; we are giving that
to you as a physician. We know how to set the bar. I can talk
to you about sensitivity and specificity or positive and
negative predictive value in a way that I can't talk to a
patient about it. We can set the bar such that, if it comes
back high-risk, you don't have to go through having your office
call my office. We have a way to immediately get that patient
triaged. And then if it comes back as very low-risk, that can
go into perhaps a more cumbersome process of maybe having that
image reviewed by a dermatologist. But this can really speed up
the process.
Again, I think that the bar for safety is lower when it is
physician-to-physician or when it is data being provided to a
physician. I can in real-time improve that app as I get more
images. If I have to go through full-bore FDA approval every
single time we tweak an algorithm to make it better, we are not
going to make products better; we are going to come up with
what we think we can get approved and not continue to develop
and use technology to make health care better.
Mr. Burgess. Correct. That is the regulatory risk.
Dr. Patterson--but, really, just for the panel in general--
I don't think we can discount how the young physician--medical
students, residents--are going to change how this is all
viewed. I went and talked to either one of my medical schools
or residency programs down in Fort Worth a couple of years ago.
And the residency director opined--I guess they had a system
like yours that they did defensively because it was impossible
to keep the residents from taking a picture of something in the
emergency room, sending it to their attending and saying, what
do you think, can I close this here or does it have to go to
the OR, that kind of question, which were the same questions
that I asked as a resident to my faculty, but there we had a
rotary dial phone, and now, of course, they have these very,
very fancy smartphones with quite accurate cameras.
So that hospital actually had to develop something like
your system that was a secure system where, in a HIPAA-
compliant way, data could be transferred. And the only reason I
bring that up is the young physicians coming up are either
going to demand or they are just going to drive in a direction
that they want to go, whether or not we thought it was a great
idea or not in a congressional hearing.
This has been a very fascinating hearing. I have a number
of questions for folks in writing, but I am way over time, and
it always makes Ms. Schakowsky nervous when I do that. So, in
deference to her--oh, well, I would yield to the gentlelady if
she had a followup question she wanted to ask.
Ms. Schakowsky. No, I don't. Thank you.
Mr. Burgess. So, seeing that there are no further members
wishing to ask questions for this panel, I will thank all of
our witnesses for being here.
Before we conclude, I need to submit the following
documents for the record by unanimous consent: a letter from
Fitbit that tells me to get busy--I am way behind; a letter
from the Competitive Carriers Association; a letter from the
Consumer Technology Association; a letter from the American
Medical Association; a letter from Opternative, Incorporated.
[The information appears at the conclusion of the hearing.]
Mr. Burgess. Pursuant to committee rules, I remind members
they have 10 business days to submit additional questions for
the record. I ask the witnesses to submit their responses
witness 10 business days upon the receipt of those questions.
Without objection, the subcommittee is adjourned.
[Whereupon, at 12:13 p.m., the subcommittee was adjourned.]
[Material submitted for inclusion in the record follows:]
Prepared statement of Hon. Fred Upton
Today we continue our Disrupter Series as we examine health
care apps that are truly revolutionizing how folks in Michigan
and across the country are managing their health.
As the sponsor of the 21st Century Cures Act, with my good
friend and colleague, Congresswoman Diana DeGette, it's no
secret that we have been fighting to modernize and personalize
our health care system to find faster cures and better
treatments for all Americans.
And we face some of the same concerns with health apps in
terms of ensuring that government is encouraging rather than
hindering the development of new life saving technologies.
Today, we will examine what it means for patients as mobile
apps have the potential to modernize, personalize, and improve
the overall delivery of care.
The development and proliferation of health apps is an
essential part of our effort to cultivate a healthier
population and save more lives. Because of remarkable
advancements in technology, doctors and patients both receive
information that is more accurate and timely, which accelerates
better diagnoses and preventative treatment plans. This
technology's ability to seamlessly connect doctors and patients
together through a smartphone or connected device opens the
door to a wide range of medical discoveries, possibilities, and
insights, not to mention the potential to prevent medical
problems before they occur.
An additional benefit of mobile health apps is that they
help to drastically reduce skyrocketing health care costs. By
integrating the Internet into practically everything we own, we
have generated productivity and efficiency gains, and cost
savings across multiple economic sectors. The health care
sector is no different--if anything, there is no sector in
greater need of this modernizing. Better care achieved more
efficiently can lead to reduced doctor visits, decreased
complications and risks, lower hospital readmissions, and much
more.
The potential stemming from this technology is undeniable
and exciting. To ensure that these life-saving tools are
accessible to folks in Michigan and every corner of the
country, we need the right regulatory framework in place. A
framework that encourages innovation, removes barriers to
investment, and advances new opportunities for patients and
providers to engage in the health care system. At the same time
privacy and security are absolute musts. This is one of the
most important policies that industry must show leadership on.
As the world's leader in medical innovation, the time to
make these promising health care advances available to American
families is now.
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