[House Hearing, 113 Congress]
[From the U.S. Government Publishing Office]
21ST CENTURY TECHNOLOGY FOR 21ST CENTURY
CURES
=======================================================================
JOINT HEARING
BEFORE THE
SUBCOMMITTEE ON COMMUNICATIONS AND TECHNOLOGY
AND THE
SUBCOMMITTEE ON HEALTH
OF THE
COMMITTEE ON ENERGY AND COMMERCE
HOUSE OF REPRESENTATIVES
ONE HUNDRED THIRTEENTH CONGRESS
SECOND SESSION
__________
JULY 17, 2014
__________
Serial No. 113-162
[GRAPHIC NOT AVAILABLE IN TIFF FORMAT]
Printed for the use of the Committee on Energy and Commerce
energycommerce.house.gov
___________
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95-732 PDF WASHINGTON : 2015
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COMMITTEE ON ENERGY AND COMMERCE
FRED UPTON, Michigan
Chairman
RALPH M. HALL, Texas HENRY A. WAXMAN, California
JOE BARTON, Texas Ranking Member
Chairman Emeritus JOHN D. DINGELL, Michigan
ED WHITFIELD, Kentucky FRANK PALLONE, Jr., New Jersey
JOHN SHIMKUS, Illinois BOBBY L. RUSH, Illinois
JOSEPH R. PITTS, Pennsylvania ANNA G. ESHOO, California
GREG WALDEN, Oregon ELIOT L. ENGEL, New York
LEE TERRY, Nebraska GENE GREEN, Texas
MIKE ROGERS, Michigan DIANA DeGETTE, Colorado
TIM MURPHY, Pennsylvania LOIS CAPPS, California
MICHAEL C. BURGESS, Texas MICHAEL F. DOYLE, Pennsylvania
MARSHA BLACKBURN, Tennessee JANICE D. SCHAKOWSKY, Illinois
Vice Chairman JIM MATHESON, Utah
PHIL GINGREY, Georgia G.K. BUTTERFIELD, North Carolina
STEVE SCALISE, Louisiana JOHN BARROW, Georgia
ROBERT E. LATTA, Ohio DORIS O. MATSUI, California
CATHY McMORRIS RODGERS, Washington DONNA M. CHRISTENSEN, Virgin
GREGG HARPER, Mississippi Islands
LEONARD LANCE, New Jersey KATHY CASTOR, Florida
BILL CASSIDY, Louisiana JOHN P. SARBANES, Maryland
BRETT GUTHRIE, Kentucky JERRY McNERNEY, California
PETE OLSON, Texas BRUCE L. BRALEY, Iowa
DAVID B. McKINLEY, West Virginia PETER WELCH, Vermont
CORY GARDNER, Colorado BEN RAY LUJAN, New Mexico
MIKE POMPEO, Kansas PAUL TONKO, New York
ADAM KINZINGER, Illinois JOHN A. YARMUTH, Kentucky
H. MORGAN GRIFFITH, Virginia
GUS M. BILIRAKIS, Florida
BILL JOHNSON, Ohio
BILLY LONG, Missouri
RENEE L. ELLMERS, North Carolina
(ii)
Subcommittee on Communications and Technology
GREG WALDEN, Oregon
Chairman
ROBERT E. LATTA, Ohio ANNA G. ESHOO, California
Vice Chairman Ranking Member
JOHN SHIMKUS, Illinois MICHAEL F. DOYLE, Pennsylvania
LEE TERRY, Nebraska DORIS O. MATSUI, California
MIKE ROGERS, Michigan BRUCE L. BRALEY, Iowa
MARSHA BLACKBURN, Tennessee PETER WELCH, Vermont
STEVE SCALISE, Louisiana BEN RAY LUJAN, New Mexico
LEONARD LANCE, New Jersey JOHN D. DINGELL, Michigan
BRETT GUTHRIE, Kentucky FRANK PALLONE, Jr., New Jersey
CORY GARDNER, Colorado BOBBY L. RUSH, Illinois
MIKE POMPEO, Kansas DIANA DeGETTE, Colorado
ADAM KINZINGER, Illinois JIM MATHESON, Utah
BILLY LONG, Missouri G.K. BUTTERFIELD, North Carolina
RENEE L. ELLMERS, North Carolina HENRY A. WAXMAN, California (ex
JOE BARTON, Texas officio)
FRED UPTON, Michigan (ex officio)
------
Subcommittee on Health
JOSEPH R. PITTS, Pennsylvania
Chairman
MICHAEL C. BURGESS, Texas FRANK PALLONE, Jr., New Jersey
Vice Chairman Ranking Member
ED WHITFIELD, Kentucky JOHN D. DINGELL, Michigan
JOHN SHIMKUS, Illinois ELIOT L. ENGEL, New York
MIKE ROGERS, Michigan LOIS CAPPS, California
TIM MURPHY, Pennsylvania JANICE D. SCHAKOWSKY, Illinois
MARSHA BLACKBURN, Tennessee JIM MATHESON, Utah
PHIL GINGREY, Georgia GENE GREEN, Texas
CATHY McMORRIS RODGERS, Washington G.K. BUTTERFIELD, North Carolina
LEONARD LANCE, New Jersey JOHN BARROW, Georgia
BILL CASSIDY, Louisiana DONNA M. CHRISTENSEN, Virgin
BRETT GUTHRIE, Kentucky Islands
H. MORGAN GRIFFITH, Virginia KATHY CASTOR, Florida
GUS M. BILIRAKIS, Florida JOHN P. SARBANES, Maryland
RENEE L. ELLMERS, North Carolina HENRY A. WAXMAN, California (ex
JOE BARTON, Texas officio)
FRED UPTON, Michigan (ex officio)
C O N T E N T S
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Page
Hon. Greg Walden, a Representative in Congress from the State of
Oregon, opening statement...................................... 1
Prepared statement........................................... 3
Hon. Frank Pallone, Jr., a Representative in Congress from the
State of New Jersey, opening statement......................... 3
Hon. Joseph R. Pitts, a Representative in Congress from the
Commonwealth of Pennsylvania, opening statement................ 5
Prepared statement........................................... 5
Hon. Anna G. Eshoo, a Representative in Congress from the State
of California, opening statement............................... 9
Hon. Fred Upton, a Representative in Congress from the State of
Michigan, opening statement.................................... 10
Prepared statement........................................... 11
Hon. Henry A. Waxman, a Representative in Congress from the State
of California, opening statement............................... 11
Witnesses
Dave Vockell, Chief Executive Officer, Lyfechannel, Inc.......... 12
Prepared statement........................................... 15
Answers to submitted questions \1\........................... 94
Dan Riskin, Founder, Health Fidelity............................. 21
Prepared statement........................................... 23
Answers to submitted questions............................... 95
Paul Misener, Vice President, Global Public Policy, Amazon....... 29
Prepared statement........................................... 31
Answers to submitted questions............................... 109
Robert Jarrin, Senior Director, Government Affairs, Qualcomm
Incorporated................................................... 40
Prepared statement........................................... 42
Answers to submitted questions............................... 114
Jonathan M. Niloff, Vice President and Chief Medical Officer,
McKesson Connected Care & Analytics............................ 56
Prepared statement........................................... 58
Answers to submitted questions............................... 120
Submitted Material
Letter of July 16, 2014, from Grant Seiffert, President,
Telecommunications Industry Association, to subcommittee
leadership, submitted by Mr. Pitts............................. 7
Article of June 17, 2014, ``Coalition Calls for Action Against
EHRs That Block Interoperability,'' iHealthBeat, submitted by
Mr. Gingrey.................................................... 78
----------
\1\ Mr. Vockell did not answer submitted questions for the record by
the time of printing.
21ST CENTURY TECHNOLOGY FOR 21ST CENTURY CURES
----------
THURSDAY, JULY 17, 2014
House of Representatives,
Subcommittee on Communications and Technology,
joint with the
Subcommittee on Health,
Committee on Energy and Commerce,
Washington, DC.
The subcommittees met, pursuant to notice, at 9:33 a.m., in
room 2123, Rayburn House Office Building, Hon. Greg Walden
(chairman of the subcommittee of Communications and Technology)
presiding.
Members present: Representatives Walden, Upton, Barton,
Shimkus, Pitts, Terry, Burgess, Blackburn, Gingrey, Scalise,
Latta, Lance, Cassidy, Guthrie, Gardner, Kinzinger, Griffith,
Bilirakis, Long, Ellmers, Waxman, Pallone, Eshoo, Green,
DeGette, Butterfield, Barrow, Matsui, and Braley.
Staff present: Clay Alspach, Chief Counsel, Health; Gary
Andres, Staff Director; Ray Baum, Senior Policy Advisor/
Director of Coalitions; Sean Bonyun, Communications Director;
Matt Bravo, Professional Staff Member; Leighton Brown, Press
Assistant; Noelle Clemente, Press Secretary; Andy Duberstein,
Deputy Press Secretary; Paul Edattel, Professional Staff
Member, Health; Gene Fullano, FCC Detailee; Kelsey Guyselman,
Counsel, Communications and Technology; Sydne Harwick,
Legislative Clerk; Robert Horne, Professional Staff Member,
Health; Grace Koh, Counsel, Communications and Technology;
Carly McWilliams, Professional Staff Member, Health; David
Redl, Chief Counsel, Communications and Technology; Charlotte
Savercool, Executive Assistant, Legislative Clerk; Heidi
Stirrup, Policy Coordinator, Health; John Stone, Counsel,
Health; Jean Woodrow, Director of Information Technology; Ziky
Ababiya, Democratic Staff Assistant; Eric Flamm, Democratic FDA
Detailee; Karen Lightfoot, Democratic Communications Director
and Senior Policy Advisor; Margaret McCarthy, Democratic
Professional Staff Member; Rachel Sher, Democratic Senior
Counsel; Matt Siegler, Democratic Counsel; and Ryan Skukowski,
Democratic Policy Analyst.
OPENING STATEMENT OF HON. GREG WALDEN, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF OREGON
Mr. Walden. We are going to call the hearing to order.
Thank you all for being here this morning. Good morning and
welcome. Today, the Subcommittee on Communications and
Technology and Subcommittee on Health joint hearing on the
``21st Century Technologies for 21st Century Cures.'' I would
like to thank all of our witnesses for testifying today. Your
testimony is extraordinary and most helpful in our endeavors.
When Chairman Upton and I announced that we would begin the
process in updating the Communications Act, we knew it would be
a difficult but much-needed process. So I am pleased today to
be joining the Communications Act update with another important
Energy and Commerce Committee initiative, 21st century cures,
the communications and technology sectors that are an enormous
boost to our Nation's struggling economy due in part to the
high investment and innovation in wireless technology and other
devices.
As we craft the legislation to update our laws, it is
essential to hear from a wide variety of people who are on the
front lines of developing and using these types of technologies
in all spaces. Their unique viewpoints and expertise will help
inform our consideration as we move forward, as well as
underscore exactly why we have undertaken these challenging
efforts to revamp existing laws.
It makes sense to unite these two initiatives, as they are
both critically important not only to industries that are
crucial to the economy, but also for every person here. This is
an opportunity to recognize the benefits wireless smartphones
and devices can provide to improve an individual's health and
the healthcare community.
We have seen examples of this intersection already from
wearable devices that track activity, to the use of mobile apps
reminding users of their individual health needs, to a
patient's ability to easily and remotely communicate with their
doctor through a telehealth device. The growth in this area has
been remarkable. There is a technological revolution happening
in the healthcare space.
In the communications and technology world, there has been
a good deal of focus on the so-called virtuous cycle of
technology; that is, the investment in devices and networks
creates opportunities for app developers to create new and
innovative uses for these devices, driving demand for
consumers, which then spurs further investment. The healthcare
technology field the perfect setting for this engine of
invention and development.
As healthcare technologies proliferate, patients, doctors
and researchers will realize the potential for the technology,
and as a result, demand will increase. Increased demand means
even greater incentive for investors to place their bets on the
technology, which, in turn, spurs the cycle even further.
In reading the testimony submitted by our witnesses in
advance of today's hearing, I was impressed by what they can
already do in the healthcare field using technology that exists
and what the potential is as we develop. In Mr. Misener's
written testimony, he describes how leveraging cloud technology
allowed scientists to conduct an experiment at a cost that was
orders of magnitude less than it would have been using
traditional data center and infrastructure. And I believe it
was 39 years compressed into 9 hours. This is exactly what we
are hoping to learn about today in more detail and how we can
take advantage of these opportunities.
With that, again, thank you for being here.
[The prepared statement of Mr. Walden follows:]
Prepared statement of Hon. Greg Walden
Good morning and welcome to today's Subcommittee on
Communications and Technology and Subcommittee on Health joint
hearing, ``21st Century Technology for 21st Century Cures.'' I
would like to thank all of our witnesses for testifying today
on this timely topic.
When Chairman Upton and I announced that we would begin the
process of updating the Communications Act, we knew it would be
a difficult, but much-needed, process. I am pleased today to be
joining the Communications Act Update with another important
Energy and Commerce Committee initiative, 21st Century Cures.
The communications and technology sector has been an enormous
boost to our Nation's struggling economy, due in part to the
high investment and innovation in wireless technology and other
devices. As we craft the legislation to update our laws, it is
essential to hear from a wide variety of people who are on the
front lines of developing and using these types of technologies
in all spaces. Their unique viewpoints and expertise will help
inform our consideration as we move forward, as well as
underscore exactly why we have undertaken these challenging
efforts to revamp existing laws.
It makes sense to unite these two initiatives, as they are
both critically important not only to industries that are
crucial to the economy, but also for every person here. This is
an opportunity to recognize the benefits wireless smartphones
and devices can provide to improve an individual's health and
the health care community. We have seen examples of this
intersection already, from wearable devices that track
activity, to the use of mobile apps reminding users of their
individual health needs, to a patient's ability to easily and
remotely communicate with their doctor through a telehealth
device. The growth in this area has been remarkable; there is a
technological revolution happening in the health space.
In the communications and technology world, there has been
a good deal of focus on the so-called virtuous cycle of
technology; investment in devices and networks creates
opportunities for app developers to create new and innovative
uses for those services, driving demand from consumers, which
then spurs further investment. The health technology field is
the perfect setting for this engine of invention and
development. As health care technologies proliferate, patients,
doctors, and researchers will realize the potential for the
technology, and as a result, demand will increase. Increased
demand means even greater incentive for investors to place
their bets on the technology, which in turn spurs the cycle
even further.
In reading the testimony submitted by our witnesses in
advance of today's hearing, I was impressed by what can already
be done in the healthcare field using the technology that
exists, and what the potential is as we developed. In Mr.
Misener's written testimony, he describes how leveraging cloud
technology allowed scientists to conduct an experiment at a
cost that was orders of magnitude less than it would have been
using traditional datacenters and infrastructure. This is
exactly what we are hoping to learn more about today--how we
can take advantage of what these companies are already experts
at doing, be it technology or healthcare, and benefit everyone.
I hope that our diverse panel of witnesses today will take
this opportunity to expand on the specific ways in which their
particular organizations are contributing to this space and
what opportunities they see for the future. While there are
undoubtedly obstacles that remain before some of these
technologies come to bear, this conversation is a good starting
point and a way to highlight why it's worth working through the
issues that arise. I would like to thank you all for being here
today and I look forward to your testimony.
Mr. Walden. And I now recognize Mr. Pallone for 3 minutes.
OPENING STATEMENT OF HON. FRANK PALLONE, JR., A REPRESENTATIVE
IN CONGRESS FROM THE STATE OF NEW JERSEY
Mr. Pallone. Thank you. Thank you, Chairman Pitts and
Chairman Walden.
We are here today to discuss the ways in which promising
new technologies may be harnessed by the healthcare industry to
provide better quality care, inform healthcare research, and
empower Americans to better maintain their own health. The
Subcommittee on Health has explored this issue in a number of
different hearings this Congress, most recently in April, when
we examined how 21st century technology can benefit patients.
And what we have learned today and what I hope we will hear
more about today is that these technologies may not just
improve patient outcomes, but also have the potential to bring
down the cost of care for everyday Americans and for the
Nation.
Many health systems are responding to the Affordable Care
Act's call to reduce costs and improve quality by adopting the
use of technologies like electronic health records, health
analytics, telemedicine and mobile health applications. By
monitoring patient progress in real time, providers will limit
costly readmissions and prevent the onset of advanced stages of
disease. In fact, declining readmission rates played a
significant role in slowing the growth of our Nation's health
spending in the years following passage of the ACA, and in the
long-term budget outlook published Tuesday, the CBO found that
the decline in our health spending will allow the Medicare
trust fund to remain solvent for an additional 6 years.
And this testifies to how the law is pushing providers to
improve the quality of care, but also to the potential of
health technology like telemedicine and patient tracking
systems to relieve the financial burden of preventable
conditions on the entire healthcare system.
In keeping with the ACA's embrace of preventive care, many
of these technologies will help keep people healthy and enable
patients with chronic disease to better manage their conditions
on their own. The CDC estimates that 133 million Americans live
with at least one chronic illness disease like diabetes, heart
disease and cancer, and the treatment of chronic illness
accounts for more than 75 percent of all health spending, so it
should be clear that keeping Americans healthy must be a
national priority. Additionally, with access to quality data,
health researchers at the NIH and throughout the country will
be better able to study the range of conditions which afflict
Americans, research that can be used to develop more effective
treatments and inform the practice of evidence-based medicine.
Meanwhile, health analytics will allow insurers to design
value-based benefit plans which will reimburse providers for
the quality and not the quantity of care they render. And with
this monetary incentive, providers will more often invest in an
ounce of prevention than wait to deliver a pound of care.
Many of the technologies discussed today can improve
Americans' health, yet we must remember that the adoption of
technology for its own sake does little good and can contribute
to the escalating cost of medicine. We have to work to ensure
that advances in health technologies serve to improve all
Americans' health, stopping the onset of preventable conditions
while not exacerbating health disparities along socioeconomic
lines. And further, we must make certain that the transfer of
these data and doctor-patient communications complies with
Federal regulations and that Federal law ensures the
confidentiality of patient data.
Our witnesses today represent firms developing these
technologies, and I thank them for their testimony as well as
their efforts to improve Americans' health.
And Mr. Chairman, I am looking forward to hearing what is
now in the field and how this further contributes to the past
work of our committee. Thank you.
Mr. Walden. Thank you, Mr. Pallone. Appreciate that.
Now we go to the chairman of the Health Subcommittee, Mr.
Pitts, for an opening statement.
OPENING STATEMENT OF HON. JOSEPH R. PITTS, A REPRESENTATIVE IN
CONGRESS FROM THE COMMONWEALTH OF PENNSYLVANIA
Mr. Pitts. Thank the chairman for this joint hearing of the
Subcommittees on Communications and Technology and Health, and
welcome all of our witnesses here this morning.
As part of our committee's 21st Century Cures Initiative,
we are examining the discovery, development and delivery
process to speed new treatments and cures to patients. One of
the most promising avenues to facilitate this goal is new
technology, and we are witnessing the impact of that
technological innovation that it has played in every aspect of
our economy. Technology has the potential to transform health
care as well, and in doing so, address many of the challenges
that we currently face. The question before us is, How do we
ensure that our healthcare system can take advantage of the
innovation going on in the tech world?
We now have mobile medical apps that can make health care
more personalized, if we don't over regulate them. We have
electronic health records that can be shared among various
providers to help better coordinate the care we receive, if we
can ensure they are interoperable. These and other technologies
hold great potential for the future of health care and
personalized medicine. In order to realize this potential,
however, we are going to have to address barriers that
currently make full integration difficult.
Our witnesses are here today to help us think through these
technologies and the role they can play in a 21st century
healthcare system. So I thank all of the witnesses for being
here today.
[The prepared statement of Mr. Pitts follows:]
Prepared statement of Hon. Joseph R. Pitts
As part of our committee's 21st Century Cures Initiative,
we are examining the discovery, development, and delivery
process to speed new treatments and cures to patients.
One of the most promising avenues to facilitate this goal
is new technology. We are witnessing the impact that
technological innovation has played in every aspect of our
economy.
Technology has the potential to transform health care as
well, and in doing so address many of the challenges that we
currently face.
The question before us: How do we ensure that our health
care system can take advantage of the innovation going on in
the tech world?
We now have mobile medical apps that can make health care
more personalized if we don't overregulate them.
We have electronic health records that can be shared among
various providers to help better coordinate the care we
receive, if we can ensure they are interoperable.
These and other technologies hold great potential for the
future of health care and personalized medicine. In order to
realize this potential, however, we are going to have to
address barriers that currently make full integration
difficult.
Our witnesses are here today to help us think through these
technologies and the role they can play in a 21st century
health care system.
Mr. Pitts. And as I yield back, I ask for unanimous consent
to submit for the record a letter from the Telecommunications
Industry Association.
Mr. Walden. Without objection, so ordered.
[The letter follows:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Mr. Walden. We now turn to the gentlelady, my friend from
California, Ms. Eshoo, for opening comments.
OPENING STATEMENT OF HON. ANNA G. ESHOO, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF CALIFORNIA
Ms. Eshoo. Thank you, Mr. Chairman. And welcome to the
witnesses. And I want to thank the leaders of the two
subcommittees for having this joint hearing. I think it is a
terrific idea and an important one, to talk about the
combination, the intersection of technology and medicine. And I
think that in both areas, it represents American genius, and
that is why I find it so exciting.
My Silicon Valley District is the home of modern-day
innovation. It really is the innovation capital of our country,
of the world. It embodies an entrepreneurial spirit, and it
attracts those who identify challenges and turn them into
opportunities. They drive new technologies, expand education,
and find creative ways to build a better world and to improve
humankind.
The valley has a long history of pioneering technological
advancements. After World War II, the development of the
semiconductor industry, which is really the foundation of
Silicon Valley, led the way to the desktop computer and then to
the explosion of the Internet, which continues to flourish. And
I could tick off a whole list of honor roll names of companies
that are identified with the Valley.
What is equally important, in my view, in Silicon Valley,
and it is not always widely recognized, are the parallel
advancements in health care. My district is the birthplace of
biotechnology in our country, and we have more biotechnology
companies there than any other place in the country and in the
world. So it is an eloquent statement about the region and what
takes place.
There are hundreds of young companies developing the latest
therapeutics, medical devices, diagnostics, genomic tests and
wireless healthcare technologies. And the ability for these two
industries, high technology and health care, to mature side by
side has really yielded, I think, unparalleled advancements for
patients and dramatically improved healthcare outcomes. So that
the whole issue of the power of broadband and wireless
connectivity, it is the intersection of technology and health
care, I think is more dynamic than ever.
In Mountain View in my district, iHealth's blood pressure
monitor is empowering individuals to take charge of their
health care by wirelessly connecting this data to a smart
phone. That used to be for James Bond. Now it is for the
average person.
Similarly, Proteus, a Redwood City-based company is
improving patient health care through an ingestible sensor
which wirelessly sends information using blue tooth technology.
I mean, this--it really is--it is not only cutting-edge, it is
exciting and it is important.
I am very proud to have Dr. Dan Riskin here today from my
district testifying. Thank you for coming across the country to
do so. He is a serial entrepreneur. He is the founder of Health
Fidelity and consulting faculty at Stanford University School
of Medicine. So thank you, Dr. Riskin. And he serves on the
eHealth Initiative Leadership Council and collaborated with the
Bipartisan Policy Center on their oversight framework for
assuring patient safety and health information technology.
Jeez, I thought only in Government did we have long titles like
this, but I guess it is in academia as well.
So want to welcome all the distinguished witnesses here
today. And, again, I thank the leadership of both of the
subcommittees for putting this important hearing together.
Mr. Walden. Thank you.
Ms. Eshoo. And I yield back.
Mr. Walden. Thank the gentlelady.
We now turn to the chairman of the full committee, the
gentleman from Michigan, Mr. Upton, for opening comments.
OPENING STATEMENT OF HON. FRED UPTON, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF MICHIGAN
Mr. Upton. Well, thank you, Mr. Chairman.
With this hearing, we are going to continue our commitment
to modernizing laws and regulations to keep pace with the
breakneck speed of the innovation era. Two leading initiatives
have been our Comm Act update, which seeks to update the 80-
year-old laws governing the communications and technology
sectors, and obviously 21st Century Cures, which aims to
accelerate the pace of cures in treatments.
Today we have the unique opportunity to bring together two
of our subcommittees and look at the intersection of these
efforts and the ways in which new technology is enabling
remarkable advances in medical care and treatment and research.
Our witnesses include established tech companies that are
hoping to bring their expertise to bear on the challenges of
modern health care as well as startups that are focused solely
on tech solutions for patients and clinicians, from electronic
health records, to cloud storage of genome research and apps
that identify preventative health strategies, we are looking at
the future of medicine. Technology is supporting proactive
solutions, collaborative research, and improved communications
between patients and their physicians.
Our committee has gone great lengths to encourage
investment in innovation in the U.S. Tech sector, and there are
few applications of that work more important than the health of
all Americans. We have the opportunity to not only enable new
cures, but accelerate the pace at which they are realized. By
taking full advantage of available technology, the
possibilities for the future of health care indeed gives us
hope.
In June we held a round table to explore the opportunities
and obstacles surrounding digital health care, and I look
forward to continuing that conversation. It is my hope that
this hearing, like the round table, will help us identify ways
in which this committee and the Congress can support the
adoption of lifesaving technologies in the healthcare sector. I
thank you all for being here, and I yield back the balance of
my time.
[The prepared statement of Mr. Upton follows:]
Prepared statement of Hon. Fred Upton
With this hearing we continue our commitment to modernizing
laws and regulations to keep pace with thebreakneck speed of
the innovation era. Two leading initiatives have been our
CommActUpdate, which seeks to update the 80-year-old laws
governing the communications and technology sectors, and 21st
Century Cures, which aims to accelerate the pace of cures and
treatments. Today, we have the unique opportunity to bring
together two of our subcommittees and look at the intersection
of these efforts and the ways in which new technology is
enabling remarkable advances in medical care and research.
Our witnesses include established tech companies that are
bringing their expertise to bear on the challenges of modern
health care as well as startups that are focused solely on tech
solutions for patients and clinicians. From electronic health
records to cloud storage of genome research and apps that
identify preventive health strategies, we are looking at the
future of medicine. Technology is supporting proactive
solutions, collaborative research, and improved communications
between patients and their doctors.
Our committee has gone great lengths to encourage
investment and innovation in the U.S. technology sector, and
there are few applications of that work more important than the
health of all Americans. We have the opportunity to not only
enable new cures, but accelerate the pace at which they are
realized. By taking full advantage of available technology, the
possibilities for the future of health care gives us hope. In
June, we held a roundtable to explore the opportunities and
obstacles surrounding digital health care, and I look forward
to continuing that conversation today. It is my hope that this
hearing, like the roundtable, will help us identify ways in
which this committee and Congress can support the adoption of
life-saving technologies in the health care sector.
I thank the witnesses for being here with us today and
sharing their experiences as health tech innovators.
Mr. Walden. The gentleman yields back the balance of his
time.
The Chair now recognizes the distinguished gentleman and
former chairman of the committee, Mr. Waxman, for 3 minutes.
OPENING STATEMENT OF HON. HENRY A. WAXMAN, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF CALIFORNIA
Mr. Waxman. Thank you very much, Mr. Chairman.
This joint subcommittee hearing is a chance for members to
learn more about the technological innovation taking place in
our healthcare system. Technology can play an important role in
expanding access to care, improving the quality of care,
improving health outcomes, and reducing costs.
In recent years, we have witnessed incredible innovation in
our healthcare system, venture capital funding for digital
health companies is at a record level, new innovators are
entering the industry every day. And it is not a coincidence
that all of this innovation has occurred in the years since we
passed the Affordable Care Act. As a managing director of a
major startup incubator put it, ``We are seeing a lot of
tailwinds from the healthcare reform. It has put a lot of
pressure on existing stakeholders to reduce costs.''
It is also not a coincidence that this innovation is
occurring following our unprecedented investment in expanding
the use of health information technology through the Recovery
Act. The number of doctors using these technologies has
quadrupled in just 3 years. The percentage of hospitals using
them has grown from 16 percent to 94 percent.
It is not a coincidence that we have seen all of this
innovation with FDA and the FCC offering important guidance and
using their enforcement discretion wisely. And it is not a
coincidence that we have seen this innovation at the same time
that HHS has opened up vast amounts of data to the public while
recognizing innovation with awards and grants to help startups
shake up the health system.
I mention these important ways the Federal Government has
helped foster a climate of innovation, because this hearing and
the committee's 21st century cures initiative should focus on
these successes.
I look forward to hearing from today's witnesses about what
needs to be done to continue these trends that are improving
our healthcare system every day. We should legislate only where
appropriate and necessary, otherwise, we risk jeopardizing the
integrity of a system that is already functioning quite well.
Thank you, Mr. Chairman. I yield back the balance of my
time.
Mr. Walden. Thank the gentleman for his opening comments.
And now we go directly to the witnesses.
Thank you all again for submitting your testimony in
advance. We appreciate that. And we will open up with Mr. Dave
Vockell. Is that right? Did I say that correctly?
Mr. Vockell. Close enough.
Mr. Walden. And turn on that microphone.
Chief executive officer of Lyfechannel. We are delighted to
have you here. Please proceed.
STATEMENTS OF DAVE VOCKELL, CHIEF EXECUTIVE OFFICER,
LYFECHANNEL, INC.; DAN RISKIN, FOUNDER, HEALTH FIDELITY; PAUL
MISENER, VICE PRESIDENT, GLOBAL PUBLIC POLICY, AMAZON; ROBERT
JARRIN, SENIOR DIRECTOR, GOVERNMENT AFFAIRS, QUALCOMM
INCORPORATED; AND JONATHAN M. NILOFF, VICE PRESIDENT AND CHIEF
MEDICAL OFFICER, MCKESSON CONNECTED CARE & ANALYTICS
STATEMENT OF DAVE VOCKELL
Mr. Vockell. Good morning, Chairman Walden and Pitts. I am
Dave Vockell, the CEO and founder of Lyfechannel, Inc. It is a
great honor for me to be here today, and I want to thank you
for the opportunity to testify on this very important topic of
innovative technology and the current and potential impacts to
population health.
I would like to briefly cover three topics today: first, a
short overview of Lyfechannel to give you some context as to
the role that startups can play in the rapidly evolving
healthcare delivery landscape; second. I will cover three
lessons learned and the ``so what'' that might inform how you
evaluate health technology opportunities; and third, I am going
to share a list of large insiders who I think are forward
thinkers and innovators in working with new technology, and to
try to discover what is next for healthcare delivery.
Lyfechannel, Inc., builds mobile patient programs that
translate physician instruction into patient action, which help
patients new to diabetes, pre-diabetes, COPD, heart health and
smoking cessation begin to build basic good habits to support
their chronic conditions. We also operate a preventive health
program targeting the chief health officer of a household. We
create programs that connect the patient and their personal
support team and their care providers through integration
across mobile experiences and the provider's electronic health
record.
Over the past 3 years, we have worked closely with
patients, pharma companies, Government agencies, payers, EHR's,
providers and other technology companies to translate changes
in technology and consumer behavior into opportunities to
impact long-term health. We have learned three important
lessons relevant to consumer facing health. First, if you are
not integrated into the existing patient flow, whether it would
be the physician or the provider or payer, it is almost
impossible to become part of a patient's health journey.
Consumer health actions are not only the behaviors that new
technology companies need to engage, but they are also hospital
procedures, billing protocols, prescribing habits, hundreds of
habits within the system that we need to be a part of.
Number two, technology doesn't change behavior, it just
potentially creates a new access point to things that do change
patient behavior. A cool app on your phone doesn't make you
take your meds by reminding you or making a game out of it. You
don't skip your Lipitor because it wasn't fun or because you
forgot; you skip it for the basic human behavior that you feel
great and you are not connecting your current health behavior
to long-term health. Technology experiences that reinforce the
drivers of good health behavior create patient-led, not
technology-led solutions.
And finally, there remains a strong economic incentive not
to release the data that will drive patient insights and
recommendations for the next 10 years. Many payers do not
release claims data that could fuel incredible insights into
pinpointing health intervention opportunities, because they
have a large business selling that data to pharma companies.
Electronic health record companies don't make it simple to
exchange data with other EHR's, because it reduces switching
costs of moving to a different HR for a hospital.
There are a handful of innovative large institutions that
unleashed great innovative momentum through aggressive piloting
and partnership with third parties, and the pattern of their
innovation is similar. They make public a problem they are
trying to solve, they make data available to support solving
that problem, and then they find a pathway to engaging
technology innovators to solve that problem.
Here are a couple examples of those leading innovators. The
Office of Disease Prevention and Health Promotion, under the
guidance of Linda Harris, Ellen Langhans and Silje Lier of the
ODPHP are pioneers in co-design of digital experiences
incorporating health literacy principles. They not only engaged
third-party technology companies against the goal of the ODPHP,
but also systematically share their learnings with other
Government and public sector groups to advance best practices
and patient literacy around preventive health. Their Myfamily
mobile program has been a pilot for the past 10 months and is
about to release version 2, which includes EHR integration and
connectivity with the new Apple Healthkit platform.
Boehringer-Ingelheim, under the guidance of Jon Doniger in
their new business model group, aggressively engages new
technology companies to help his organization understand the
role that pharma could play in healthcare delivery in 10 years.
The Allscripts EHR platform under the leadership of Tina
Joros has also embraced third-party developers and platform
openness to tap into the power of technology innovators.
Johnson & Johnson, Robert J. Wood Hospital System, Box and
CMS have also been aggressive in identifying problems, making
data available to entrepreneurs and helping them try to solve
their hardest problems.
In summary, we believe that technology companies that
partner with large insiders and lead with patient behavior
versus cool technology have the greatest opportunity to impact
health outcomes in the next 10 years. There are some great
innovators that should serve as a model, and no shortage of
technology innovators with limitless energy and caffeine to try
to impact population health.
Thank you again to the chairpersons and members of the
subcommittee for your time today and the opportunity to
participate in this hearing. I would love to answer any
questions you have. Thank you.
[The prepared statement of Mr. Vockell follows:]
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Mr. Walden. Thank you very much, Mr. Vockell. We appreciate
your testimony as well.
And now we are going to go to Mr. Riskin. We appreciate
your being here. And founder of Health Fidelity. Thank you for
being here, Dan. And turn that microphone on, pull it close.
And we look forward to your comments.
STATEMENT OF DAN RISKIN
Mr. Riskin. Good morning, Chairman Walden, Chairman Pitts,
Ranking Member Eshoo, Ranking Member Pallone and members of the
subcommittees. It is an honor to testify.
I am a serial entrepreneur, founder of Health Fidelity, a
leading big data analytics company, and consulting faculty at
Stanford University School of Medicine. In addition, I am a
practicing physician, board certified in surgery, critical
care, palliative care, and clinical informatics. I serve on
eHealth Initiative Leadership Council and collaborated with
Bipartisan Policy Center on their efforts toward patient safety
and healthcare IT.
I have been fortunate to succeed as an entrepreneur,
educator and surgeon, and I am grateful to the Federal
Government for contributing to my success. I have been awarded
multiple grants from the NIH and National Science Foundation,
each grant resulting in creation of multiple longstanding,
long-term, high-paying skilled jobs. Every Federal dollar
received has resulted in $15 of follow-on private sector
investment. These efforts have led to companies and products
used at Harvard, Stanford and other leading institutions to
benefit patients and enhance medical knowledge. My background
has afforded me unique insight into healthcare innovation and
practice.
21st century technology in health care includes devices,
data, information-enabled work flow. This newly emerging data-
driven health care not only offers the right information at the
right time for the right patient, but also provides a needed
pathway for population health, analytics and patient
engagement. The goal is a more efficient, effective and
approachable healthcare system. Collaboration and innovation
are required, and Government has a critical role to play.
Today I will focus on three actionable recommendations to
promote safe and meaningful innovation in health care. These
include re-defining interoperability to share the information
that is needed for clinical analytics and population health;
revising our approach to quality to better align with improved
outcomes and reduced costs, and research to better understand
safety and healthcare IT.
I recently cared for a very nice woman who was failed by
our healthcare system. A heart murmur had been noted during
physical exam years earlier. Unfortunately, on changing her
insurance, the information was buried and lost in medical
documentation. Her failing heart valve was only discovered
years later when she presented to the emergency department
unable to breathe. She required an emergency operation, leading
to an extended ICU stay and millions of dollars at taxpayer
expense. If her condition had been recognized early and treated
electively, the likely costs would have been far lower, and she
and her family would have been spared a month-long stay in the
hospital. I will discuss recommendations in the context of her
case.
The first actionable recommendation is a better definition
of interoperability. Current efforts and proposed regulations
focus on sharing patient's summaries only. Unfortunately, there
is simply not enough information in these summaries for
innovative analytics companies like mine to promote data-driven
health care. In this clinical case, an exam finding was
documented in the physician narrative, but did not show up on
the problem list and would not be present in an interoperable
summary. To support interoperability of summaries only, as is
proposed in current regulation is to ignore critically
important information such as home environment, medication
compliance, exam findings and hospital course. Innovation and
care improvement will be hobbled for years to come by this
arbitrary limitation.
Through the Meaningful Use program, our country has
subsidized electronic capture of clinical data. Why wouldn't we
require that all data we paid to capture be available for use
by innovative companies and technologies to actually improve
care.
The second actionable recommendation is an enhanced
definition of quality. This patient's care met all process
measures required, she had routine tests, documented
counseling, weight documented, but did she receive great care?
Quality measures and increasingly selected for feasibility,
meaning we often select for what is easy to measure rather than
what really influences outcomes. In this case, a relevant
measure of quality would be whether the patient received
appropriate follow-up for her heart murmur. If quality measures
are our national target, this is the time to refine our
approach and require accurate and meaningful quality measures
in health care.
Finally, my patient's information was exposed to many
healthcare software systems. Were these systems safe and
effective? While the country defines a first-pass approach to
healthcare IT safety, we must acknowledge these IT systems are
new, innovative and rapidly evolving. To refine our regulatory
approach over time, we will need information on how and when
healthcare software is safe versus potentially dangerous.
Supportive academic and clinical research in healthcare IT
benefits and risks would go a long way to help us refine
regulation over time.
We are going in the right direction. Health systems, payers
and vendors are collaborating through new financing models and
newly available data with new enthusiasm, but there is a great
deal of work left to do if we are to bridge the gap from
electronic information to better and more efficient care.
I look forward to continuing to work with you to leverage
our national HIT investment to create data-driven health care.
The U.S. is well poised to revolutionize health care and to
benefit our people and economy at home while showing global
leadership in this critical industry.
[The prepared statement of Mr. Riskin follows:]
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Mr. Walden. Thank you very much, Mr. Riskin. We appreciate
your testimony.
We will go now to Mr. Misener, vice president, Global
Public Policy at Amazon. Paul, please go ahead. Thanks for
being here.
STATEMENT OF PAUL MISENER
Mr. Misener. Thank you, Chairman. Good morning, Chairman
Walden, Chairman Pitts, and Ranking Members Eshoo and Pallone.
My name is Paul Misener, and I am the vice president of Global
Public Policy at Amazon.com. On behalf of Amazon and our
customers, thank you for inviting me to testify today on how
21st century technology enables 21st century cures.
After briefly describing cloud computing technology, my
testimony will illustrate how innovative healthcare
organizations, both large and small, established and startup,
public and private already use cloud computing to foster the
innovation cycle of discovery, development and delivery of new
biomedical treatments and cures. I will conclude by suggesting
three ways that Congress could help accelerate this cycle by
adopting policies to facilitate use of cloud computing for
health care.
With cloud computing, information technology users,
including healthcare enterprises now can acquire technology
resources such as compute power and storage on an as-needed
basis instead of buying, owning and maintaining their own data
centers and servers.
In 2006, Amazon's cloud computing business, Amazon Web
Services, or AWS, began offering developer customers access to
in-the-cloud infrastructure services. AWS now has hundreds of
thousands of customers, including over 3,000 academic
institutions and 800 Government agencies.
In the healthcare sector, enterprises of all sizes and
types are beginning to use cloud computing technology for the
discovery of new biomedical treatment and cures. As the
chairman mentioned earlier, in 2013, Novartis scientists
discovered a large molecule involved in the disease mechanism
for a particular type of cancer. The scientists wanted to
virtually screen 10 million compounds against the large
molecule. Such a large number of screenings is extremely
computationally intensive. Novartis did not have the capacity
in their existing data center to do this type of test, and
building new infrastructure would have cost an estimated $40
million. Instead, using AWS, they built a virtual high
performance computing center in the cloud and were able to
perform the equivalent of 39 years of science in less than half
a day and for under $5,000.
Enterprises are also beginning to use cloud computing for
the development of new biomedical treatments and cures. For
example, in the summer of 2012, Merck was noticing higher than
usual discard rates for certain vaccines. The high discard
rates could result from many factors. Evaluating these factors
for every vaccine produced was extremely challenging using a
traditional spreadsheet approach, so instead, Merck worked with
a partner to implement a cloud-based solution using AWS, and
over a 3-month period, they were able to combine all of their
data sources and perform over 15 billion calculations and more
than 5.5 million vaccine batch-to-batch comparisons, and thus
they were able to precisely identify how characteristics of
fermentation had direct impact on vaccine discard rates.
Lastly, enterprises are beginning to use cloud computing
for the delivery of new biomedical treatments and cures. For
example, the USFDA, which receives 900,000 handwritten reports
of adverse drug effects each year, needed a way to make the
data entry process more efficient and reduce costs. Using AWS
cloud computing, the FDA and Captricity quickly turned manual
reports into machine readable information, reducing costs from
$29 per page to $0.25 per page.
Chairman Walden and Chairman Pitts, please allow me to
suggest three ways that Congress could help accelerate the
innovation cycle of discovery, development and delivery of new
biomedical treatments and cures by facilitating the use of
cloud computing for health care. First, to help accelerate the
discovery of new biomedical treatments and cures, Congress
could work with NIH to establish and operate cloud-based data
management platforms to which federally funded researchers
could upload their research data along with any relevant
software resources required to reproduce their analysis of the
data. Other researchers in the field could then access the data
in software in order to reproduce the results, re-analyze
previously collected data in novel ways, or even automate the
analysis of new data using the same approach as the original
experiment.
Second, to accelerate the discovery and development of new
biomedical treatments and cures, Congress could enact both H.R.
967 and H.R. 1232. These are bills that would assess and
facilitate the use of cloud computing by Federal science
agencies.
And third, to help accelerate the delivery of new
biomedical treatments and cures, Congress could work with HHS
to modernize implementation of HIPAA so that healthcare
providers could readily employ the benefits of cloud computing.
By narrowing the application of HIPAA to situations where cloud
services providers have access to and knowledge of health
information, time and money won't be wasted on contracts that
are mostly inapplicable, and cloud services providers can more
reasonably comply with HIPAA by focusing on areas where they
actually have access and knowledge of health information.
Chairman Walden and Chairman Pitts, thank you again for
holding today's hearing and for inviting me to testify. I look
forward to your questions.
[The prepared statement of Mr. Misener follows:]
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Mr. Walden. Those are wonderful recommendations. Thanks for
your testimony. It is always impressive to see what is
happening out there.
For the members' benefit, we have about 10 minutes to go in
the first vote, but we always know that takes a little longer,
so we will try and get through the witnesses if we can.
We will go now to Mr. Robert Jarrin, Senior Director,
Government Affairs, Qualcomm Incorporated. Thank you for being
here. We look forward to your testimony.
STATEMENT OF ROBERT JARRIN
Mr. Jarrin. Thank you, Chairman. Good morning, Chairman
Walden and Chairman Pitts, Ranking Members Eshoo and Pallone,
and members of the subcommittees. On behalf of Qualcomm, an
American company and the world's largest wireless chipset
supplier and largest licensor of mobile technology, it is an
honor to be here again. Thank you for inviting me.
Mobile technology, Qualcomm's specialty, has become the
largest communications platform in the history of the world,
and it continues to grow. Currently, there are 355 million
connections in the U.S. and over 7 billion globally.
We forget how quickly mobile technology has proliferated.
The Android OS and Apple's iPhone were launched in 2007, the
iPad in 2010. You wouldn't know it, the way consumers rely upon
these services and devices. Qualcomm can't make this happen by
itself, which is why we work with many partners. I am pleased
to be here today with one of them, Amazon.com. Their leading-
edge Kindle Fire HDX tablet, Fire smartphone and Fire TV media
player all incorporate Qualcomm's innovative Snapdragon
chipsets.
Qualcomm's technologies are found in products that touch
every aspect of society, including health care, which is why in
2011, we launched Qualcomm Life, a wholly owned subsidiary
focused on medical device connectivity and management of health
data. At Qualcomm, we understand that nothing can transform a
sector like mobile 3G and 4G technologies. Health care is a
good example, one in which I have personal experience.
On August 16th, 2006, my mother was diagnosed with Stage
III-C late term ovarian cancer. She was 65, a widow, with
limited English proficiency. From the start of her odyssey, I
discovered that doctors, clinics and hospitals were not sharing
her healthcare information. I was struck by the lack of
continuity of care. When she left the care provider or
facility, there was no mechanism to remotely monitor her basic
physiological status. This seemed dangerous in light of
countless doses of chemotherapy, protein inhibitors, and toxic
serums she endured, which caused horrible side-effects,
including extreme high blood pressure and edema.
In the years since my mom's initial diagnosis, mobile
computing devices have helped personalize health care. Remote
patient monitoring is now helping drive systemic changes in
healthcare networks. Platforms, such as Qualcomm Life's
HealthyCircles, facilitate the management and sharing of
medical information between stakeholders across the patient's
healthcare community.
Qualcomm Life and its partners produce novel commercially
available 21st century mobile medical solutions, such as mobile
ECG recorders, wireless telemetry sensors, mobile glucose
monitors, software systems that deliver live patient data to a
doctor's smartphone, smart inhalers, and radiological imaging
viewers for mobile devices, and implantable pulmonary sensors
that communicate wirelessly with bedside monitors.
The future is even more exciting. The X PRIZE Foundation
and Qualcomm developed a $10 million competition, the Qualcomm
Tricorder X PRIZE, to produce a device that diagnose 15
distinct diseases in a group of 15 to 30 people within 3 days
by a consumer, independently of a healthcare worker or
facility.
If investments are any sign of the future, the first half
of this year shows 143 companies having raised $2.3 billion
year to date, thus eclipsing the 2013 total of $2 billion.
Those investments include some by the Qualcomm Life Fund, which
was formed in 2011 and is now considered one of the most
prolific investors in wireless health.
However, challenges do persist. Lack of reimbursement is a
major barrier to telehealth and remote patient monitoring
technologies. Medicare telehealth provisions in the Social
Security Act are overly restrictive and exclude the majority of
these technological innovations, and that needs to be changed.
Another is the Center for Medicare and Medicaid Services EHR
incentive payment program, popularly referred to Meaningful Use
rules, which do not include the ability to upload patient-
generated health data into certified EHRs. Future stages of the
program should specify the incorporation of patient-generated
health data from home use medical devices into EHRs.
Another important issue is spectrum, the lifeblood of our
wireless networks. Qualcomm commends this committee and
Congress for all the work it is doing to make additional mobile
broadband spectrum available. This work is critically
important.
In closing, the speed of innovation should never come at
the expense of patient safety. Health IT software and mobile
medical apps developers should support data collection and
quality mechanisms to foster patient safety and create a
learning environment.
Nearly 8 years after my mom's diagnosis, I am thankful to
her healthcare team that she is continuing to live an enjoyable
life. I am also grateful for the advancements in 21st century
medical technologies are helping society as a whole. Qualcomm
has played a significant role in mobilizing health care, to
improve lives and advance digital medicine, and it will
continue to do so.
Thank you. I look forward to your questions.
[The prepared statement of Mr. Jarrin follows:]
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Mr. Walden. Mr. Jarrin, thank you. And that is good news on
your mother. Having lost a mother to ovarian cancer, I know how
awful that----
Mr. Jarrin. I am sorry to hear that.
Mr. Walden [continuing]. Diagnosis is and the treatments
can be. So I am glad to hear your mother is doing well.
We will now go to Dr. Jonathan Niloff, Chief Medical
Officer and Vice President, McKesson Connected Care &
Analytics, McKesson Corporation.
And for our members, the Whip's office will keep the vote
open until we get there, so we can conclude with our final
witness this morning.
So Mr. Niloff, thank you.
STATEMENT OF JONATHAN M. NILOFF
Mr. Niloff. Thank you. Good morning, Chairman Walden and
Pitts, Ranking Members Pallone and Eshoo, and distinguished
members of the subcommittees. I appreciate the opportunity to
appear before you today.
Throughout my career as a gynecologic oncologist in Boston,
faculty member at Harvard Medical School, and founder of a
small health IT company, I have seen firsthand the power of IT
to improve outcomes, reduce costs, and accelerate the pace of
change in our healthcare system.
As the largest health IT company in the world, McKesson is
focused on the transformation of health care from a system
burdened by paper to one empowered by interoperable electronic
solutions.
There is a significant opportunity to improve our
healthcare system, but to do so, we must fundamentally
transform how care is delivered. We need to move from a
fragmented model of care, where each patient visit is
disconnected, to a model where care is coordinated across the
entire continuum. Interoperable health IT is foundational to
this transformation.
I would like to share today two recommendations which will
advance health care in the 21st century. First, we must align
payment and coordinated care models in order to create an
environment that fosters interoperability; and second, we need
a new risk-based regulatory framework that is specific to
health IT.
We don't today have an easy, uniform way to move patient
data between care settings. The interoperability we need
requires collaboration among all stakeholders to develop
uniform standards, coordinated policies, and the necessary
infrastructure to promote interoperability and assure
coordination of care.
ONC has provided an important role in providing common
guardrails for the exchange of health information. It is
important that we maintain flexibility within those guardrails
to allow for industry innovation. One example of innovation and
interoperability is the CommonWell Health Alliance. CommonWell
was founded by McKesson in partnership with our competitors to
develop a software solution that will share patients' data,
with their consent, across multiple settings of care. We have
made significant progress in endeavor over the last 18 months.
It is essential that we are able to share the right patient
data in the right place and the right time. This solution is
imperative to creating a new model of coordinating care.
Fostering innovation in the private sector is critical, but
there is also a role for Congress to play. Policy changes are
needed to reflect current advances in technology and promote
ongoing innovation. A 21st century health system demands 21st
century policies. We support a new regulatory framework that
would establish three categories of health IT. Oversight of
each category would vary according to potential risk to
patients and the role of the clinician.
The FDA should continue its important role in regulating
software with the highest potential risk; however, we believe
Congress should amend the Food, Drug and Cosmetic Act to define
each of these categories of health IT and provide clarity that
clinical and administrative software should not be regulated as
medical devices.
To realize a true 21st century healthcare system, we need
fundamental change in our healthcare delivery model. We need to
replace our fragmented system with patient-centric coordinated
care. This transformation has begun, but we need to accelerate
the pace of change, and to do this, we must harness the power
of technology. Specifically, we must align reimbursement and
payment models to promote the adoption and also the
interoperability of health IT, and Congress must update the law
to codify how health IT is regulated in a way that, while
assuring patient safety, is predictable and fosters innovation.
The result will be better outcomes, better access, better cost
efficiency, and better experiences for patients and their
families.
Thank you for the opportunity to testify today.
[The prepared statement of Mr. Niloff follows:]
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Mr. Walden. Dr. Niloff, thank you for your testimony.
Thanks to all our witnesses.
We will go vote and then members will come back and ask
questions. We are probably going to be gone at least a half an
hour, I would assume, so if you need to take a break, it is a
good time. We will reconvene immediately after votes. Thank you
very much.
We stand in recess.
[Recess.]
Mr. Walden. I will call the subcommittee back to order and
appreciate again the testimony of our extraordinarily
distinguished panel of witnesses. Thank you very much.
And don't think you are off the hook because I think what
you have given us here is very important, and we will be
following up, I am sure, over the months and years ahead to
dive deeper with you on how we can all get this right.
I am going to start off with questions, and the first one
goes to Mr. Misener. Are there any laws or regulations that
have impacted the development of the cloud that we should take
a look at deeply, change that hinder what we are trying to
accomplish here, what you are trying to accomplish here?
And obviously we have got to protect data and privacy and
security and all that, but are there other things we should be
aware of that would facilitate advancements in the sectors we
are talking about today?
Mr. Misener. First of all, thank you for the question, Mr.
Chairman. There are areas in which Government could lead,
provide an example to private industry, and one particular
roadblock we have run up against over the years trying to serve
Government institutions including the U.S. Federal Government
and its agencies, is that there is oftentimes money set aside
for agencies to buy computers, to buy software, to invest
capital essentially which is highly inefficient when instead
money could be allocated for purchasing service, making it an
operational cost rather than a capital investment.
And the Government could not only be able to be much more
flexible that way, in other words, only purchase what is needed
and then discard it if it is not needed, but also it allows
Government to scale up and scale down as necessary. But we have
also often run into problems where agencies are only given
authority to buy specific things like hardware or software when
actually they should be able to have the freedom to obtain
services instead.
Mr. Walden. Got it. So on another issue, and back to you,
Mr. Misener, and if others want to weigh in on these subjects,
please feel free to do so. But, how can we modernize HIPAA to
ensure that patient information is protected but that we can
still utilize data? There are other countries that have laws
that protect patients but also facilitate data sharing and
leveraging the research being done.
I know in our round table that Chairman Upton convened
recently, Dr. Brian Druker who heads the Knight Cancer Research
Center in Oregon, talked about I think it is 65 petabytes--did
I say that right?--of data, just involving cancer patients that
could be harnessed to do an analytic work and all and research.
Are there some issues with HIPAA; are there things we should be
looking at in that respect?
Mr. Misener. There are, Mr. Chairman. It is not a huge
barrier at this point, but what we would like to be able do is
recognize that there are sometimes when information is stored
in the cloud where it is known to be health information and it
is accessible to the cloud service provider. But most of the
time that is not the case. We don't know what information is
stored there, and it is also encrypted, so we can't get at it;
and yet we still have to go through HIPAA hoops as if we had
access to the information.
Mr. Walden. So what would that mean in real laymen's terms?
Mr. Misener. It means the health care enterprise that is
storing data on our servers, has HIPAA requirements placed upon
it, but those requirements are also placed on a cloud services
provider, even though it is entirely unnecessary. We can't see
that data, and usually we don't even know it is there.
Mr. Walden. But from a practical standpoint, what does that
mean in your company you have to do?
Mr. Misener. I think it means asking NIH not to interpret
the rules so broadly as to require a cloud services provider to
comply with HIPAA where it is not necessary. But of course we
do comply with HIPAA, Amazon Web Services does, when it is
necessary.
Mr. Walden. OK.
Dr. Niloff, what are the technical challenges your company
is facing as you work to innovate in health care that we might
need to take a look at, besides what you outlined in your
testimony?
Mr. Niloff. Sure. So, I think the major technical
challenges involve interoperability, and the typical
environment in the health care system is very heterogeneous
with multiple different EMRs and multiple different other
systems that we need to connect to.
Mr. Walden. EMRs being electronic medical records?
Mr. Niloff. That is correct, sir. And solving that
challenge, the technical challenge of connecting such
heterogeneous environments, is a big barrier today.
Mr. Walden. All right, anybody else want to weigh in on
these topics.
Mr. Vockell. I would say the HIPAA question initially, the
inability of patients to give up their right to privacy, like
the HIPAA requirements are kind of universal whether it is I
have a cold or whether I have HIV. And there are some
conditions where let's say I had celiac disease, I would love
to tell everyone on earth that I have it because most likely
that is how I am going to find out better ways to take care of
myself. But because of HIPAA, I can't even email my doctor.
And so I think if there were additionalopportunities, let's
make it super simple. I want to email my doctor; he wants to
email me back, but we don't because it is against HIPAA for him
to send me health information, but both of us would agree that
it is OK for me to talk about my kid's fever through email. So
I think what that kind of example we have around regulation is
that when the FDA kind of took their very vague some mobile
stuff might be good, some mobile stuff might not be good and
made it we are all hanging around.
And they said, all right, you guys can leave the room; you
guys come in, we want to talk some more, and you guys stay
close, that changing very gray to more black and white allowed
a lot of people to innovate and build something and do stuff.
Mr. Walden. Yes. We did an oversight hearing on that very
issue about a year ago because nobody was getting clarity
whether your iPad was a medical device or not, and we got them
to admit some of those things.
Mr. Vockell. I would have stood up and applauded. But I
think similarly with HIPAA, if there could be another layer of,
this is what is covered, and this is what isn't; it is OK to
email your doctor about your kid's flu, that would do a lot to
create innovation points for better care.
Mr. Walden. All right. Thank you.
I have overextended my time. I will now turn to the
gentleman from New Jersey, the ranking member on the Health
Subcommittee, Mr. Pallone, for 5 minutes.
Mr. Pallone. Thank you.
Reading the testimony today, I was impressed by how much
progress we are making towards a more technologically advanced
health care system, and one important step the Federal
Government is taking to encourage this innovation is to open up
much of the data it collects to the public. That allows
developers, programmers, and academics to dig into this data
and develop new tools to help improve our system.
I wanted to ask Mr. Vockell, can you talk more about how
you have put this open data to use and the potential benefits
of this increased transparency over the long-term?
Mr. Vockell. Yes, thank you very much. Lyfechannel--about
six months ago, CMS released the big data set around exactly
what every provider for Medicare charges for every protocol.
And a couple weeks ago at the Health Datapalooza, which is a
lovely name that I think Todd Park came up with, that
Government and public agencies come together to talk about the
incredibly exciting topic of health data. They had a
competition to say for this big data set, who can make it into
something super interesting.
And Lyfechannel 1, largely based on some research that we
did at the International House of Pancakes, the good example
that CMS sets is they release data before it is totally
perfect. The CMS data was 50 percent actionable. But we said
early and they give entrepreneurs or any great data analytics
house a chance to churn through it and pull out what they can
and then make recommendations on what the next version of the
data should look like.
I think the more that holders of that health data are
encouraged to kind of release it when it is excellent, not when
it is perfect, will allow entrepreneurs to get up on it like a
shark and reveal if there is something inside or help identify
what the next round of it should look like.
Mr. Pallone. Thank you. I think the steps that CMS and the
other Federal agencies have taken in this area are really
important. I wanted to ask Dr. Riskin, in your testimony you
state that health quality measures are often selected because
they are easy to track. Could you elaborate on your
recommendation that we need more accurate and meaningful
quality measures in health care?
Mr. Riskin. Yes. Thank you for your question, Mr. Pallone.
The challenge is whether we try to develop measures for
what is easy to do today or whether we create a target for what
we need to do to improve health care. If we create a target for
what we need to do to improve health care, we won't be able to
hit it today. The technology doesn't exist. If we don't, if we
pick what is easy, then we won't actually meaningfully reduce
costs in health care in a short term.
So to give an example, an easy quality measure would be,
are you counseling people for smoking cessation, and a hospital
might meet that measure by on every discharge summary writing,
you should not smoke. That doesn't do a lot of good if it is
buried five pages down and mostly put in for non-smokers
anyway.
On the other hand if the measure is, do you smoke and that
ties to an outcome like reduced costs and improved quality of
care, that is the kind of measure that is meaningful. We don't
do a lot of that because it is so hard to measure, but over
time the really robust analytics companies will figure out a
way to hit that target if the Government makes that known that
that is the target to hit.
Mr. Pallone. Thanks. And, Mr. Jarrin, in September last
year, FDA issued a final guidance on mobile medical
applications. It provides a long list of applications that FDA
does not intend to regulate at all. Basically I just wanted to
get your views on this guidance. I mean, do you think that the
FDA struck a proper balance between protecting patients safety
on the one hand and allowing innovation to flourish on the
other? And do you see any risks in trying to legislate in this
area?
Mr. Jarrin. I think FDA did a good job by issuing the final
guidance on mobile medical applications. It was definitely very
different from the original draft. The original draft basically
just restated the law without any clarity and without any vivid
example.
In the final draft guidance, they provided numerous
examples of what they were putting under enforcement
discretion, enforcement discretion being the ability for the
agency to state publicly we are not going to obligate
regulatory requirements on certain medical devices. Even though
by definition they are medical devices, we are not going to
require regulatory obligations. So I think that was very
helpful to the industry.
Mr. Pallone. What about the risk though in trying to
legislate in this area?
Mr. Jarrin. I am not sure I would say that there is a risk
in legislating the area. I think that that was the next
evolution to what Congress had originally intended through
FDAISA. Through FDAISA they had asked for a risk-based
regulatory framework. The agencies then came out with that
through the FDAISA draft report that they are contemplating
currently. I think it is now the next step for Congress to
decide whether it would like to go in and make those
recommendations, you know, codify them. That is a higher pay
grade than me.
Mr. Pallone. Thank you.
Thank you, Mr. Chairman.
Mr. Pitts. [presiding]. The Chair thanks the gentleman.
I will recognize myself 5 minutes for questions.
Mr. Misener, in your testimony you suggest that Congress
work with NIH to establish and support the cloud-based
management platforms. Can you expound a little bit more on why
you think this is so important? What are some of the benefits
cloud-based platforms might lend to 21st century cures?
Mr. Misener. Thank you, Chairman Pitts.
Modern biomedical research is a highly collaborative
process. All scientific research these days is collaborative.
The days of a major breakthrough coming from a sole, an
individual working with a Bunsen burner and a test tube, it is
over. You only need to look at some of the scientific journals
and see the lists of authors. It is no longer unusual to see
hundreds of authors listed in a major scientific paper, even
over a thousand.
And so that kind of co-research requires collaboration. And
if the Federal Government can establish a way for federally
funded researchers to share their information, even outside
their normal channels of collaboration, it will become far more
efficient and more productive.
Mr. Pitts. And you mentioned one other concrete step that
you recommended as we decide, if we decide to support this
endeavor. List some other concrete steps that Congress can
take. One was clarifying HIPAA. What are others?
Mr. Misener. Well, there are two bills that the House has
already addressed--and hopefully they will be addressed in the
Senate, as well--that actually would assess the Government's
provision or accommodation of cloud computing for scientific
agencies, and another would clarify Government agency's ability
to obtain cloud services in lieu of hardware and software. Both
of those are important pieces of legislation, not only on their
own merits or on their own rights of what is going on within
the U.S. Federal Government, but as setting an example to State
and local Governments, to private industry, to Governments in
other countries, that there is a great deal of efficiency that
can be gleaned from the cloud in dealing with collaboration
that I mentioned and also just the massive amounts of data that
now go into any form of scientific research, including
biomedical research.
So Government setting an example, I think, is something
that Congress can be part of right now.
Mr. Pitts. You mentioned Amazon worked with FDA to turn
900,000 handwritten reports of adverse drug effects each year
into machine-readable information with 99.7 percent accuracy,
reducing the cost from $29 per page to 25 cents per page. This
Cures Initiative is in part focused on using technology to
relieve administrative burdens for agencies such as FDA, so
they can use the resources to invest in more researchers and
new development methods such as biomarkers. Do you have other
suggestions for other ways we can increase efficiency at FDA or
other agencies?
Mr. Misener. Yes, Mr. Chairman. There is a model of
scientists doing things that they don't need to be doing.
One would be for example, I don't know, producing their own
electricity for their laboratories. You don't want them out in
the back of the laboratory working on a diesel generator just
so their labs have lights. Likewise, you don't want them to
have to be tinkering with computing equipment, either for
storage or for computation, in a way that that could easily be
provided like a utility, like electricity. So let's figure out
ways to allow our scientists to be scientists, our doctors to
be doctors, and not have to have them be information
technologists at the same time, even though as part of the
collaboration and the data-intensive work that they are doing,
computation is absolutely necessary. It is just that they don't
need to be the ones doing it.
Mr. Pitts. Now, we talked a little bit about HIPAA. Are
there other countries that have laws that protect patients but
also facilitate data sharing, leveraging the research being
done? Any of you who would like to----
Mr. Vockell. Yes, I am not familiar with other countries'
details.
Mr. Pitts. Anyone familiar with other models?
All right, let me just go finally--one common
recommendation was for fully harnessing the potential of
interoperable technology. Are we talking about just electronic
health records, or do you think that medical devices, other
health care sources of data should be interoperable, if you
will elaborate on that any of you?
Dr. Niloff?
Mr. Niloff. Yes. Thank you. I think that the
interoperability has to extend beyond just electronic health
records. There are multiple sources of both clinical and non-
clinical data that are important to aggregate together with the
clinical data in electronic health records, and that
interoperability should exist.
There are also a variety of an analytic solutions which are
important to improving population health. So solutions that
identify patients that are likely to be hospitalized, patients
who have progressing illnesses, and the ability to link
clinical and claims data with those type of systems to allow
the early proactive intervention in the care of those patients,
is a very valuable intervention to driving improved health,
decreasing hospitalizations, and decreasing emergency room
visits.
Mr. Pitts. Chair thanks the gentleman.
Now recognize the gentlelady from California, Ms. Eshoo, 5
minutes for questions.
Ms. Eshoo. Thank you, Mr. Chairman.
I want to say to each of you, ``Bravo.'' I think every
single one of you have been terrific witnesses, and you have
given us--which is so important in a hearing, instead of
starting with Adam and Eve, you have gone right into the meat
of the subject matter to make recommendations for us, and that
really is so helpful. So thank you to you.
On this issue of interoperability, obviously there is more
than one part of it, and what I wanted to ask you, Dr. Niloff
is, is there anything that the Government is doing today that
stands in the way of interoperability, as you just described
it; i.e., in patient's record, is a physician prohibited from
putting in the last line these are the most important things to
track with this patient? I am not a doctor, so I am probably
not stating it, you know, as beautifully as I should.
But I am trying to figure out where we have regulations
that need to be written, where we have regulations that don't
make any sense anymore, or what we need to write and put on the
books, and all of these areas are really important. So can you
answer my question?
Mr. Niloff. Sure. Thank you. So, electronic medical records
typically have a lot of flexibility but we are----
Ms. Eshoo. Thank you. I helped write the legislation on it,
so it is nice to hear.
Mr. Niloff. But, you know, I think that with electronic
health records and the rest of healthcare technology, we are at
the beginning of a journey, and it is a journey that is going
to take us many years to get to both to the level of
sophistication in the solutions and in the level----
Ms. Eshoo. But specifically, though, when it comes to
interoperability and electronic health records, are there
regulations that you think don't make sense, or are you calling
for something that will help advance interoperability? We deal
with interoperability all the time at communications and
technology relative to the telecommunications industry. This is
a different deal. That is why I am probing here.
Mr. Niloff. Sure. I think that the thing that will drive
interoperability the most and where the Government can have the
greatest influence, is in making the business case for
interoperability for those who are going to pay for it and what
that means is that we need to align the payment models.
Ms. Eshoo. I think that for the most part now is private
sector though, because there were initial grants or whatever to
get the electronic records going. I think that money has been
spent. So I don't think we are players in it.
Mr. Niloff. If I may, I am not talking about direct
incentives. What I am referring to is that----
Ms. Eshoo. We need to speed it up. I have 1 minute and 20
seconds left. You have had 4 of my minutes almost.
Mr. Niloff. OK. I apologize.
Ms. Eshoo. That is all right. Go ahead.
Mr. Niloff. How we pay for medicine and what I mean by that
is if we are doing global payments, if we incent the delivery
model to do a coordinated care model and the payment is aligned
with the delivery model----
Ms. Eshoo. I understand that part of it.
Mr. Niloff. We will drive the adoption of this type of
technology.
Ms. Eshoo. Well, thank you very much.
To Dr. Riskin, I see you nodding, and I think you want to
say something.
Mr. Riskin. So to the same question, there are choices that
are being made right now that could be better. So the choice
for interoperability right now is we only share information out
of the electronic health record that is perfectly structured,
meaning only information----
Ms. Eshoo. So how do we make this more robust and
meaningful so that the right information is extracted because
that feeds through the whole system?
Mr. Riskin. Sure. So if a doctor wrote right now what is
really important here is these three things, that would be
ignored and never shared. What is needed is----
Ms. Eshoo. But the Federal Government shouldn't be
instructing doctors how to write something.
Mr. Riskin. It doesn't matter how--the doctors will write
what they write, but the Federal Government is instructing what
needs to be shared in interoperability format.
Ms. Eshoo. So share is the operative word?
Mr. Riskin. That is right. And if we share all of the
information, then the analytics companies can pick up the
useful information.
Ms. Eshoo. I just have so many questions, but my time has
run out. I think what I will do is to submit questions to you
both about the cloud, software, hardware; that is another whole
thing. I am so thrilled that your mother, that you told a
beautiful story, and it means a lot, I think, to all of us.
Certainly to you.
Thank you, Mr. Chairman.
Mr. Pitts. The Chair thanks the gentlelady.
Now recognize the gentleman from Illinois, Mr. Shimkus, for
5 minutes of questions.
Mr. Shimkus. Thank you, Mr. Chairman. It is great to have
you all here, and I am going to try to be quick, too.
But I am going to just segue right after my colleague
Congresswoman Eshoo's question, is getting out of order the way
I wanted to go.
But, Mr. Riskin, this data information is really the crux,
and so I am concerned that, or the question is, if you are
going into the genomics debate and personalized medicine, the
data, are we in the way because of HIPAA or some other rules
and regs that we are afraid to put the data available to a
larger field because of the rules and regs we have in place?
Mr. Riskin. Yes. Thank you for the question. Yes, certainly
the privacy and security policies make it tougher to share
data. With that said, I am one of the biggest proponents of
keeping data safe. We are asked as a big data company to use
genomic data and combine that with phenotypic data, the
clinical information, and figure out what it means. Keeping it
safe is critically important. That doesn't mean that you
shouldn't share it safely. So if the private sector can keep it
safe and follow regulations to do that but there is also a
requirement that the information come out in certain formats so
it can actually be used, that is a very powerful setup, so all
of the data we have paid to collect can be used to do
meaningful things.
Mr. Shimkus. So let me move to Mr. Misener on kind of the
same talk. A lot of folks are afraid to go into this field
because they have done a business analysis. They don't know if
there is a return on investment. You guys have decided to try
and move in this, and so data storage and computation is the
area that you think obviously can get you a business model plus
improve.
You know, I am a market capitalist, so we don't get these
investments unless there is a return on investment. We don't
get that unless there is improved health access and the like.
So is that the model, the business model that you think that
you all can do is this big data storage and computation while
keeping that data safe and secure.
Mr. Misener. Yes, Mr. Shimkus. We very much believe in this
business. We are very passionate about it as well. We kind of
backed into it as a retail company online. We figured out at
one point that, gee, we have a business in keeping data safe
and organizing it and storing it and being very efficient about
it. So we started making it just kind of a service available to
developer customers. We think in the medical field, the medical
sector, there are many opportunities for the storage and
sharing of data in a way that is highly secure.
We not only believe that security is incredibly important
to our business, but it is actually much easier to do at scale.
We have the ability to provide security measures in the cloud
that just aren't available for local storage of information and
so we are passionate about it, and I think we are an enabler of
the genius that you see at the table here.
Mr. Shimkus. Just because I want to get the last two in. In
the mid 1970's, Congress defined medical devices, which I think
for the most part people thought at that time was good and
helpful. The question is, is it time for us to look at
codifying terminologies to help us through these processes? I
mean a lot of us talk about FDA and how do we expedite, but
don't you think it might be time to look at some new words and
definitions and define them in the law so that we can get some
application speedily and I just kind of throw that up as a
comment. Anyone want to jump in real quick? I got one more
question so if you can be brief.
Dr. Niloff?
Mr. Niloff. Yes, so I believe that, that is very important.
You know, when I went to medical school, we didn't have
computers. This is all new stuff, and that is the era the law
was developed, and I think that we need sort of new law that
conforms with the state of the world as it exists today. I
think that is really essential to driving investment.
Mr. Shimkus. Let me follow up because your testimony, you
really talk about developing a new risk-based regulatory
framework that is specific to health information technology.
With my remaining time do you want to talk about that a little
bit?
Mr. Niloff. Sure. So you know, I think it is essential. I
go back to you know, when I started my company. I raised four
rounds of venture capital, and the process was very similar
every time. Once you figured out the business model with the
investors, they wanted to know two things. What's the IP issues
or the patent problems, and what is the regulatory environment
and how is that going to affect their investment and the risk
of their investment, and it happened every time.
And also predictability, a stable environment where
everything is codified and predictable is critical, and it has
to be over the long-term. I thought one round was going to do
it, and I was all set, but we ended up with four rounds. And it
is a long process, you need a stable environment for it to
drive technology and innovation.
Mr. Shimkus. Thank you.
Mr. Pitts. The Chair thanks the gentleman.
Now recognize the gentleman from Texas, Mr. Green. Five
minutes for questions.
Mr. Green. Thank you, Mr. Chairman. Again, thank you for
calling the hearing on joint telecomm and health care.
In a July 4th article in Forbes the co-founders of Google
were asked if they would imagine Google becoming a health
company. Their response was no. To quote Mr. Page, ``generally
health is so heavily regulated, it is a painful business to be
in. Even though we do have some health projects, we will be
doing that in a certain extent, but I think the regulatory
burden of the U.S. is so high I think it would dissuade a lot
of entrepreneurs. In my experience this is not an isolated
sentiment from the tech community.''
Doctor, now in your experience, is Google's view of
innovation in the health care sector a common one?
Mr. Niloff. Yes, sir. You know, I think as I have had you
know, sort of lots of opportunities over the years when I was
running my company to meet with other entrepreneurs and largely
through forums through our investors, and this was a common
topic of discussion. You know, overregulation is an inhibition
to investment and an inhibition to innovation.
So having, as I just stated, a stable environment that is
predictable and where we are not prohibiting investment and
therefore innovation is important and I believe widespread.
Mr. Green. Well, just from what some of us know, and this
is such a good coordination of these two subcommittees because
of what we can do with the combination of the high tech and the
health care, it literally could open up so many avenues for
folks. I know there are some supporters of the current
regulatory approach of health care that suggest that the
regulatory uncertainty under the FDA is a proper approach,
which I don't obviously agree with that.
However, my constituents are concerned when leaders in the
tech space like Google suggest health sector is an unwelcome
place for innovators. Frankly if that is true, millions of
patients will be harmed, and this is a huge problem.
Dr. Niloff, what can we do to attract more tech innovators
into the health care space, and can Congress play a role in
helping to create more certainty for innovators in the health
care space?
Mr. Niloff. Yes, thank you. So, I think that there are two
things. I think that the first thing reflects on my previous
comment, is we need an environment that from a regulatory point
of view that drives investment, and that is all around
certainty about the future so that that doesn't become a
barrier, we don't have, if you will, a risk premium on
investments related to health IT.
I think the second area is certainty or greater certainty
about what the environment is going to be, the delivery
environment is going to be, and how we are going to pay for
health care in that environment, so that there is greater
certainty around what the market is going to be for these
innovations.
And specifically I am referring to, from a congressional
perspective, is that CMS with respect to the various programs
that it promulgates defines the payment model, and the private
sector commonly follows what is promulgated by CMS. Providers
are challenged when they have to work in part fee for service
world and part accountable care world, and you need to reach a
tipping point where enough of your business is in the
accountable care world, and I called it the coordinated care
world, so it is worth making the investments in the technology
to support that care model.
To the extent that collaboratively between the private
sector and the public sector we can drive past a tipping point,
where investments in technology make sense and are economically
sound, we will both help our healthcare delivery systems be
more viable and successful while at the same time driving
better access, better quality, better patient safety, and more
cost effective care.
Mr. Green. Thank you.
My colleagues, we have legislation called the Software Act
to establish a commonsense approach to regulating mobile apps
and other health information technologies under the FDA and our
work is a work in progress, and our office has worked with Ms.
Blackburn, Mr. Butterfield, Chairman Walden and others that
takes into account the feedback we have received from various
stakeholders over the last few months.
And I would commend my colleagues on their leadership but
also the important issue we could urge the chairman to address
this in the 21st Century Cures, and that is what you just said
is something I keep hearing. We need to have a payment system
that reflects, are we going to go to the outcomes-based, or are
we just going to continuing with the same pay for procedure,
and maybe we need to provide leadership from that.
Mr. Chairman, thank you for having this hearing.
Mr. Pitts. The Chair thanks the gentleman.
Now recognizes the gentleman from Georgia, Dr. Gingrey, 5
minutes for questions.
Mr. Gingrey. Mr. Chairman, thank you, Chairmen Walden and
Pitts, and thank you for holding today's joint hearing on an
important nexus within the jurisdiction of the full committee.
I would like to focus my line of questioning on a topic
that has been the focus of the committee for a long time. Ms.
Eshoo was getting to that point as well. Innovation and health
information technology, HIT. Dr. Niloff, you state in your
testimony, and I quote, interoperable health IT is foundational
to health care transformation. We cannot change the health care
delivery model without it. Do you believe that we are on the
path to interoperability, or are there changes to the law that
we should consider as part of the 21st Century Cures
Initiative?
Mr. Niloff. Thank you, sir. I believe that we are on the
path. I think it is a challenging and long journey. I think we
can help accelerate that path with some of the suggestions I
made in the response to my last question.
I think a good example of that is the work that we have
accomplished with the Commonwealth Alliance where we have
brought together essentially competitors to collaborate and
work together to be able to move patients' health information
with their consent around a health care system. We have pilots
in place today. It is working. We have tremendously positive
feedback from both patients and providers, so I think, sir,
that we are, indeed, on the path.
Mr. Gingrey. Well, I agree with what you said, and I hope
we are, but I am very concerned, the Rand Corporation report
that was published last month found that the main electronic
health record vendor, with over half of the stimulus dollars
paid out to medical providers going to their customers, was
operating a closed platform which in essence means that they
cannot be interoperable.
And Congress has spent, as we all know, something like $24
billion over the past 6 years buying products to facilitate
interoperability only to have the main vendor under the
program, Epic, sell closed platforms. Do you believe that the
Federal Government and the taxpayers are getting their money's
worth subsidizing products that are supposed to be
interoperable but they are not? And I will ask any of the panel
if they want to weigh in on that. Yes, Mr. Jarrin.
Mr. Jarrin. If I may Congressman, thank you.
One of the aspects that we have been pushing for when we
discuss interoperability is medical device interoperability,
and I mean very specifically home use medical devices because
interoperability can be many things. Health information data
exchange between electronic health records, that is one aspect,
systems-wide within a hospital, and that would include high
acute medical devices. That is another kind of
interoperability.
But when you leave a care facility, the electric health
records incentive payment program right now that is run by CMS
and the ONC which you have quoted, the $24 billion, I believe
it goes all the way up to $27 billion, not really much of that
really engages patients and families in their care.
As part of the meaningful use stages, stage one, stage two,
and stage three, in stage one they described that they were
looking at potentially including uploading patient-generated
health data into the electronic health record. That would be a
way of interoperability. That happens right now because there
are many companies that are actually doing that and allowing
medical device that is are used at home, like wireless
glucometers for example, wireless sensors on inhalers, et
cetera. That information can go straight into a portal. It can
easily go into an electronic health record, but that is not
something that is happening at all and part of that is because
the meaningful use stages have not actually stated that very
directly. They should.
Mr. Gingrey. Well Mr. Chairman, this committee has primary
jurisdiction over the Office of the National Coordinator, ONC,
and the HITECH Act that is responsible for the tens of billions
of dollars being spent on non-interoperable products, if the
June 2014 Rand report is true, we have been subsidizing systems
that block information instead of allowing for information
transfers, which was never the intent of the statute. It may be
time that this committee take a closer look at the practices of
vendor companies in this space, given the possibility that
fraud may be perpetrated on the American taxpayer.
Furthermore, Mr. Chairman, as I see my time is elapsed, I
would like to ask unanimous consent to include in the record an
article from June 17, 2014, from iHealthBeat entitled,
``Coalition Calls for Action Against EHRs That Block
Interoperability.'' That gets, I think, Mr. Chairman, to the
very point I am talking about. With that I yield back, Mr.
Chairman.
Mr. Pitts. Without objection, so ordered.
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Mr. Gingrey. And with that I yield back. Mr. Chairman,
thank you.
Mr. Pitts. The Chair thanks the gentleman.
I now recognize the gentlelady from California, Mrs.
Matsui, for 5 minutes for questions.
Ms. Matsui. Thank you, Mr. Chairman. Thank you for holding
today's hearing. It is been very, very interesting listening to
all of you.
American innovation is transforming health care,
integrating science, medicine and technology, to provide
individuals with real-time access to vital health information,
much of which was previously unavailable outside of a hospital
or a doctor's office. Smart phones are really creating pathways
for virtual interactions between doctors and patients. Texting
between doctors and patients is becoming more common.
Now, telehealth is really at a critical juncture and
increasingly becoming an integral component of the country's
healthcare system. But one of the challenges of implementing
telehealth is that there is no consistent standard. What we
have is an inconsistent and often dated patchwork of State
laws. States are currently considering passing legislation
addressing telehealth policies which means there is a wide
variation in how telehealth is defined and this inconsistency
hinders the national deployment of telehealth, hurting those
who need care the most.
And that is why I along with my colleague here on the
committee, Representative Bill Johnson, introduced the
Telehealth Modernization Act to create a workable definition
for telehealth services. It provides a strong incentive for
States to adopt consistent standards to remove the regulatory
barriers to telehealth.
Now, you know, we move forward with all this, too, I am
listening to all of this, and I want to ask the question here
of Mr. Misener. You talked about some of the ways that cloud
computing is enabling medical research, and I think that cloud
technologies are useful to foster innovation and research.
And if we think really broadly, and I think about Amazon
and all the data you have and all the information that you have
and what you are doing now in the cloud, how can big data
impact the healthcare sector and be expansive? And I would like
to hear comments from the others, too.
Mr. Misener. Thank you, Ms. Matsui. I think there are a
dozen or so examples that I offered in my written testimony,
but generally I think you are right on point that cloud
services are an enabler of the biomedical field both in
discovery and development but also in delivery, so I have tried
to give you examples in each. But one way to think about this
is a researcher today is typically constrained to thinking
about questions that he or she may address only with the
computing power that they have available in their laboratory,
and so they can't think about big questions because they don't
have much computing capacity.
But, if all of a sudden available to them on a temporary
basis, however much or little they need, is computing power,
they now can think about questions that are far beyond what
their laboratory constraints impose upon them today. And so it
really is an enabler of that discovery side of things, and it
does again enable researchers, scientists, doctors, to focus on
what they are best at and not have to worry about the
technology that enables them.
Ms. Matsui. OK.
And Dr. Riskin, I would like your comments, too.
Mr. Riskin. Sure. We are a big data company, so we see a
lot of data.
Ms. Matsui. Right.
Mr. Riskin. One of our partners, a large health system sent
us a million longitudinal records at one point recently and
said we want to understand the association of concepts.
If you have a disease, diabetes, and you take a drug, is
there any correlation with an adverse event there. We didn't
have the processing power locally certainly to do that kind of
effort. Fortunately we do work with Amazon and we have a good
relationship with them, and we asked them can you spin up 100
servers and 20 threads per server, and can we have massive
processing power, and we crunched away at the numbers for a
day.
Ms. Matsui. For a day.
Mr. Riskin. Cross referencing every concept with every
other concept. There is a challenge here, it is powerful. You
get information that you may not want to have, and we work
closely with the large academic centers to understand what
information is useful and what information is not and put
useful information out into the community. But there is a great
responsibility behind that kind of work.
Ms. Matsui. Absolutely. And would you be analyzing a lot of
this data yourself, or are you going to, as you contract out
with the other institutions, have them take that
responsibility?
Mr. Riskin. In terms of what gets published, we think it is
best for the health systems, the large academic centers, to
create protocols and publish, so we can crunch numbers and
support them in their protocol. In terms of internal
development, we certainly use information to develop the next
products to influence patient care.
Ms. Matsui. Do you see big data assisting in as far as the
implementation as you get into the healthcare practices
themselves down to the very ground level?
Mr. Riskin. I hope so. I don't see that happening in the
short term, a year or two, but I sure hope that happens in the
long-term. It is one of the best approaches to reduce costs and
improve outcomes in health care.
Ms. Matsui. OK. I thank you, and I went over my time.
Thank you. I yield back.
Mr. Pitts. The Chair thanks the gentlelady.
Now recognize the gentleman from Ohio, Mr. Latta, 5 minutes
for questions.
Mr. Latta. Well thank you, Mr. Chairman, and thanks so much
to the panel for being here. It is been a very enlightening
discussion that you have all given us today.
And if I could start with Mr. Jarrin, in your written
testimony, you stated that another important component of any
21st century technology for 21st century cures is spectrum,
which is the lifeblood of our wireless networks. Mobile health
solutions are part and parcel of an enormous surge in wireless
data usage which is causing the spectrum crunch we are all now
facing.
Now in this committee we have had many hearings, we have
heard about the spectrum side and what is happening out there.
One was that worldwide, by 2017, there would be 1.4 mobile
devices per person across the globe. Well, that is not really
going to happen because we know that in some areas of the globe
of the technological challenges.
But I was also in another meeting the other day where they
thought by 2017 in the United States alone there would be seven
per person. So when you look at the numbers that are happening
out there and also what you want to be doing with this whole
technology, what can Congress be doing to help on this whole
spectrum crunch to make sure that the technologies can advance
in the future on your end?
Mr. Jarrin. Thank you. More spectrum is the lifeblood--
spectrum is the lifeblood of mobile technologies and modern
communications, modern wireless communications, and this
committee and Congress in particular have actually shown a lot
of leadership in trying to make more spectrum available. And
when I mean spectrum, I mean licensed spectrum, shared
spectrum, and unlicensed spectrum.
I believe recently there was a bill introduced to help make
more sense of the five gigahertz spectrum. We welcome that. M
health is not unique to any particular band of spectrum. It is
just going to add to the spectrum crunch. There was a task
force that was put together by the former chairman of the FCC a
few years ago which I helped be a part of, and one of the
findings of the task force was that through radiological
imaging and videoconferencing, spectrum is going to be really
even taxed more within the next couple of years because this is
what is expected out of some of the systems and some of the
services that we are discussing.
So the more that we have available spectrum, the better it
is for the user because we are face a spectrum crunch. The FCC
has been very honest about that. So it is something that we at
Qualcomm take very seriously. We actually have an internal
challenge where we are trying to maximize the use of spectrum
1,000-fold what we can today. Called the 1,000 X challenge, so
I believe that Congress is really taking steps to do that, and
thank you.
Mr. Latta. Thank you.
Dr. Niloff, in the 21st Century Cures Initiative, the
clinical trials process is one of the main focuses for the
area, and, in my home State of Ohio, I have toured many of the
premier research institutions across the State, and I have seen
firsthand the important work that these individuals are doing
to find cures for many different life-threatening diseases. Can
you give us some examples of how these new technologies will
assist with the clinical trial process and make it more
effective and efficient?
Mr. Niloff. Sure. So I think that the first thing that is
sort of the lifeblood of any trial is the identification of
appropriate patients who would meet the criteria, specifically
have the disease that is to be studied, and by having patient
registries, having patients' diseases codified as structured
data in these electronic systems allows for the easy or more
facile and rapid identification of the large populations of
patients that you need as candidates for these trials. So I
think having that data available will expedite and increase the
number of patients available for clinical trials.
The second part in clinical trials, is the ability to
follow patients longitudinally and have good reliable
structured data about the course of their disease and the
different parameters of their disease to understand if the
treatment under study is effective or not effective and by
having an electronic source of that data that captures the
patients clinical status and the response to the treatment
under study in a repeatable, standard way, is very helpful in
assessing the outcomes of the study and the conduct of the
trials.
Mr. Latta. Well thank you very much.
And, Mr. Chairman, I see my time is about to expire, and I
yield back.
Mr. Pitts. The Chair thanks the gentleman.
I now recognize the gentlelady from California, Ms.
DeGette, 5 minutes for questions.
Ms. DeGette. Thank you very much, Mr. Chairman.
I really want to thank the panel for this excellent
presentation this morning.
You might know that I am co-chairing this initiative with
Chairman Upton, and oftentimes we have people come in and sort
of talk vaguely about how great it would be to have a revision
of the system, but you really came in with some specific
suggestions, and we appreciate that as we look later this fall
towards actually drafting legislation.
I just want to follow-up with whoever wants to answer this
on some discussion we have been having about interoperability.
Everybody agrees interoperability is important, and we are
striving for that even now under the system that we have. We
are making some progress, but I frequently meet with smaller
companies as well as individual physicians who are talking
about electronic medical records, and the concern that smaller
companies have is that they really don't have the resources to
work with patient data and to get that interoperability.
And I am wondering, Dr. Niloff, Dr. Riskin, and also Mr.
Vockell, if you can sort of address what we can do to
incentivize this kind of interoperability throughout the
system, not just with the larger players who can afford to do
it?
Mr. Niloff. So I think that the solution to that is through
collaboration, and it is not necessary for each individual
company to reinvent the wheel multiple times, but through for
instance the Commonwealth Collaboration that I referred to
earlier is a mechanism where companies who might otherwise
compete, be they large or small, can collaborate together and
pool resources to develop technologies for interoperability
that can then be broadly adopted.
Ms. DeGette. Do you think there is any governmental role in
making those things happen, Doctor?
Mr. Niloff. I think the Government role, again, at the end
these solutions need to be paid for, and it all harkens back,
if you will, to creating the economic environment and payment
environment where the ultimate purchasers of the technology and
the interoperability have a business case for purchasing it,
which means aligning around a payment model, where having that
technology makes the providers successful in the payment model
or care delivery model that they are operating under.
Ms. DeGette. Dr. Riskin, do you have a perspective on this?
Mr. Riskin. Yes. Thank you. The question is a great one.
There is a boundary between the electronic health record and
the analytics system.
Ms. DeGette. Right.
Mr. Riskin. When I work in the venture community in Silicon
Valley, we look at opportunities, and there is very little
coming through of new electronic health records. It is not
where the new value is. The new value is in analytics and
population health and patient engagement and we say for those
companies to be successful, they need the data, so we will see
company after company come in and say we are just going to have
the data, and here is what we are going to do and we say that
is not fundable because you can't get the data. It is too
expensive.
So today, very expensive to get the data out. People are
building custom interfaces into these electronic health records
that is stifling innovation. There is a Government role here to
say we paid for the data in the electronic health record, and
here is the information we want out. Today's approaches have
very limited information for analytics and population health,
ignoring the compliance issues and social issues and other
things, so actually requiring broad data to be brought out
would be powerful to promoting innovation.
Ms. DeGette. Thank you. And Mr. Vockell, what about you? Do
you have a view on this?
Mr. Vockell. Yes. Earlier Mr. Gingrey talked about Epic and
their slow path to making their information available and at
the other end of the spectrum is Allscripts which has made a
lot of their data available to third-party developers and the
challenge has been that I believe Allscripts and some of the
other providers have been told here is the format and the type
of data you need to make available.
And they look at their own system and they built it in an
era that didn't anticipate making that data available and so it
is hard work for them to build to this outside set standard,
and it makes them not include stuff that Dr. Riskin would find
very valuable.
A different approach could be you have to make your data in
whatever format you currently have it available, and if you do,
entrepreneurs will be all over building Rosetta Stones to
translate it between the services. But since you are telling
the slowest moving, ingrained, less hungry technology group to
build to something, it is slow, and you know, Epic started a
year and a half ago to build a public API, and it is barely out
the door.
Ms. DeGette. Thank you.
Thank you, Mr. Chairman.
Mr. Pitts. The Chair thanks the gentlelady.
And I now recognize the vice chair of the full committee,
Ms. Blackburn, 5 minutes for questions.
Mrs. Blackburn. Thank you, Mr. Chairman.
And thank you all for being here. We do appreciate the
panel.
The 21st Century Cures Initiative, the impact of technology
in that is something that is incredibly important to our
committee and as you have seen from the questioning, we are
working in a bipartisan way to address the needs that you all
have, that patients have, and that the industry also needs.
And being from Tennessee, we have appreciated the
convergence and the impact of technology on health care
delivery and do feel like that some of the answers for not only
health care delivery, but patient quality of life, are going to
be achieved through these devices. And I know Mr. Green
mentioned to you all the software act that he and I are working
on. Ms. DeGette has joined us in this effort, and we feel is
part of the backbone and that is necessary.
We are short on time. Votes are going to come up soon, so
Dr. Niloff, I want to come to you and just have a couple of
questions for you. The April 2014 FDAISA health IT report, are
you familiar with that?
Mr. Niloff. Yes, I am.
Mrs. Blackburn. OK. They have a framework that the ONC
would among other things create a health IT safety working
center. Are you familiar with that plan for regulating some
forms of software and health IT?
Mr. Niloff. Yes, I am.
Mrs. Blackburn. OK. All right, recently Chairman Upton and
a couple of our colleagues and I wrote over to ONC to see where
they think they are going to get this authority. And, have you
seen that letter? Are you familiar with that?
Mr. Niloff. I am familiar with it----
Mrs. Blackburn. We got a response recently, and we felt
like that they really don't know where they have that
authority, and like so many times agencies get into mission
creep, and it concerns us.
We feel like the FDA wants to regulate our medical app
products as medical devices, and they are not. And Congress in
its infinite wisdom decided in 1996 to update the FDA statute
by creating the definition of a medical device in order to
differentiate it from drugs. Before that time there was no
statutory difference between the two. So just like drugs,
software is not a medical device. Medical devices are not
drugs, and we think it is necessary to put some clarity in this
structure.
So do you believe that Congress needs to get involved in
the fix? Should we leave it to the FDA? Should we leave it to
the ONC? Because it is beginning to us to look like a misguided
system of regulation, and we don't want this to run off the
rails. So I would like to know what your guidance and your
thoughts would be on this.
Mr. Niloff. So, when the Act was last updated, if you will,
technology as we know it today did not exist, and I think could
not even have been contemplated, so we live in a completely
different technology environment today than when that Act was
written. And I believe that the Act should be updated with the
framework as described, a risk-based framework, so that we have
clarity for the community, both today and clarity for the
development community and the investment community going
forward so we are in a stable environment that will allow for
innovation and us to make good progress.
Ms. Blackburn. I thank you for that.
Mr. Chairman, I think it is just vitally important that the
FDA and the ONC work with Congressman Green and I as we work
with the committee to come up with what a structure is going to
be so that all of our low and moderate risk items can proceed
to the marketplace, and things that are invasive and high risk
have the oversight of the FDA, and that clarity is provided for
this Nation's innovators.
With that, I yield back my time.
Mr. Pitts. The Chair thanks the gentlelady. Now recognizes
the gentleman from Louisiana, Dr. Cassidy, 5 minutes for
questions.
Mr. Cassidy. Dr. Riskin, I have got some weird experiences
here, man. I go to a banker's office or a lawyer's office, and
they have fewer clerical workers because of computers. I go to
a physician's office, and they are hiring a data enterer and
someone to train the data enterer because of computers. Clearly
this is socking productivity.
Now, both of you, Mr. Vockell and Dr. Riskin, suggested
that there is minimal investment and little incentive on the
interface side of it, whereas there is a heck of a lot on the
back side. That is wrong.
Now, when I speak to people, they wonder if the High Tech
Act is not the problem; that by defining standards, we have
stuck in amber certain systems, but as a doc, and I speak to
docs whose productivity is down 25 percent, some of whom are
taking the penalty. They are tired of looking at a computer
screen instead of looking in a patient's eyes.
Do you agree with that assessment, that how the High Tech
Act has been implemented is the--so to speak, we have met the
enemy, it is us?
Mr. Riskin. Thank you, Dr. Cassidy. I appreciate the
question. Mixed agreement, in that the----
Mr. Cassidy. Speak quickly, please, because I have only got
3 minutes now.
Mr. Riskin. The High Tech Act was powerful in terms of
getting initial information in electronically, that is
definitely needed, but the current processes of requiring
information in certain ways has been excruciating for doctors.
Mr. Cassidy. So how do we unravel that?
Mr. Riskin. Probably the way to unravel is through
usability.
Mr. Cassidy. Now, that is a little bit code for me.
Mr. Riskin. Yes.
Mr. Cassidy. When you say ``usability,'' what do you mean?
Mr. Riskin. The challenges, the doctor who is entering data
right now, or their proxy, finds they are putting in
information that isn't that useful, or they are being forced to
put in information around billing that isn't clinically
relevant. More of a focus on how can the systems be useable and
how can we get the information----
Mr. Cassidy. I get that. So there is an incentive
apparently right now, I spoke of I am told it is stuck in
amber. Entrepreneurs don't have any incentive to go in this
space. Mr. Vockell just kind of suggested that. So what I am
really asking is how do we once more incentivize these
entrepreneurs to begin to do this as oppose--you know, get rid
of the amber, so to speak.
Mr. Riskin. So to solve the data usability problem, the
data entry problem, the incentive would require that EHR's be
usable and the EHR's would then need to work with companies to
create usability. Right now there is----
Mr. Cassidy. I accept that, but you can't just mandate from
on high, Washington likes to think it can do so, make it
useable. There has to be some penalty not doing so and there
has to be some reward for doing so, not upon the doc, because
the doc's already being penalized.
Mr. Riskin. Agreed. And the physician community is less and
less capable to push for useable systems.
Mr. Cassidy. So, Mr. Vockell, what would you say to that,
because you are nodding your head you are in agreement, but I
am not sure I have understood yet how we get back to the
entrepreneur in caring about this area.
Mr. Vockell. I think you have hit on what is the economic
incentive. And right now there is no way for a doctor to
translate, I could free up 25 percent of my time and see more
patients or deliver a higher quality of care. And so if the
payments that the physician were able to receive or the way
that they were compensated was linked to the quality outcomes
like----
Mr. Cassidy. No. But, see, I am not making my point. The
doc is willing to do this. The doc has taken the 25 percent
hit. The doc is hiring the scribe at $12 an hour plus benefits.
So I actually don't think it is the doc's problem; I think it
is the vendor, if you will, who is not creating the interface,
because they are either not required to or there is no reward.
Why not just foist it off upon the doc as opposed to us taking
the lumps. I mean, do you see my point?
Mr. Vockell. Yep. And I think they don't have the
incentive, because there is such high switching costs to go
from one system to another that----
Mr. Cassidy. So how do we create that incentive?
Mr. Vockell. I think it is--I don't know how you will get
an EHR to require to make their data interoperable, because
that is the barrier to switching.
Mr. Cassidy. Do you agree with the critic that says the way
that ONR has instituted this program does stick in amber so
that the companies like Epic can get high market share, but
they have little incentive in order to create that better user
interface?
Mr. Vockell. Yes. It makes them work towards the data
center, yes.
Mr. Cassidy. You agree with that?
Mr. Vockell. Yes.
Mr. Cassidy. Let me ask one more thing. I read your
testimony and didn't quite gather. You said there are strong
economic disincentives for people to share data, but I didn't
see you amplify that. What are those economic disincentives?
Mr. Vockell. So if you ask Humana to give you a data set
around linked co-morbidities or protocols, it will cost you
$500,000, because that is what they charged Pfizer for it. And
so if you are a startup, or even a data analytics company who
is trying to add a relevant data set that only payers have, you
can only do it if you have got a half a million bucks.
Mr. Cassidy. Gotcha. Thank you. I am out of time. I
appreciate it.
Mr. Pitts. The Chair thanks the gentleman. Now recognizes
the gentlelady from North Carolina, Mrs. Ellmers, 5 minutes for
questions.
Mrs. Ellmers. Thank you, Mr. Chairman. And thank you to our
panel.
Dr. Niloff, I am going to direct my question to you in the
interest of time. We were just discussing--you know, kind of
following up on some of the discussion, we were talking--I
certainly see all the benefits to patients on health IT. You
know, this really is an area that--of obviously much needed
into the future, but there again, keeping in mind that we know
that there are all the positives, what are the barriers? And I
think we were just talking about some cost issues here for
integrating the systems. Do you see this as an issue too, and
are there other barriers that we need to be aware of?
Mr. Niloff. Sure. So I think that the main barrier and the
main challenge today as we have discussed is interoperability
and continued innovation. And I think that we need to have the
right payment model in place to drive the purchase of these
systems. We need our delivery systems to have sufficient
alignment of their different contracts that they are operating
under so they are doing population health, coordinating care on
a significant portion of their population, that they can make
the investment both programmatically and technologically in
these type of things, because that will drive innovation as the
market grows.
Mrs. Ellmers. And when you say ``they,'' are you talking
about the physician themselves or are you talking about----
Mr. Niloff. I am really talking about at the health system
level.
Mrs. Ellmers. OK.
Mr. Niloff. I think much of this technology, because
physicians are now working in organized systems of care where
they are part of an integrated network, and we are really
driving to coordinate care from the in-patient arena to the
outpatient arena, to long-term care, that really what we are
talking about is health systems making purchases of technology,
and not just electronic medical record technology, but
enterprise registries to drive preventive care and manage
patients with chronic illnesses, care management systems, where
they use technology to identify high-risk patients and then
have skilled nurses manage those patients, that those are the
types of technologies and related programs that are ultimately
really going to drive us to a delivery system which is going to
drive real improvements in health.
Mrs. Ellmers. So that would be, too--you know, just
actually playing into another question, so I am just assuming
that that is kind of the path that you see us taking as we are
looking for the 21st century cures, and how we as legislators
and here how we in Congress can help that effort, obviously you
see that as an effort, too, when we are moving towards
advancements in medical technology and curing disease and
moving forward that way? Is that----
Mr. Niloff. Yes. You know, I think that it would be helpful
if, as Congress considers sort of health care for the 21st
century, that they think about health care in the context of
not how we are delivering care today, but in a framework that
thinks about the context of how we are going to deliver care in
the future in a more optimal model; think about how we are
going to have systems of care where everybody talks to each
other, where when a patient moves from the hospital to a
skilled nursing facility, their record moves with them, and it
is not, you know--it is not--I am thinking about a family
instance, but where, you know, an 80-some-year-old mother ends
up having to be the major coordinator of care for her 93-year-
old husband, because it is not happening electronically and the
health system can't manage it.
And I think that what we have to think to is what sort of
care model system of care that we are going to move to that
makes it not just better care, but better experience for
patients and families, and how Congress can modify the law to
drive that type of system of care, which will benefit all
Americans.
Mrs. Ellmers. Thank you, Dr. Niloff.
And thank you, Mr. Chairman. I yield back the remainder of
my time.
Mr. Pitts. The Chair thanks the gentlelady. And now
recognizes Mr. Butterfield, 5 minutes for questions.
Mr. Butterfield. Thank you very much, Mr. Chairman. And
thank all of the witnesses for their testimony today. I want to
commend you, Mr. Chairman, for the subject for the hearing
today, 21st century technology for 21st century cures. I like
that, and I hope that as the session that moves along this
year, we can continue to develop some ideas.
To all of the witnesses, and I can't call on each one of
you, but whoever feels the most comfortable, I would ask that
you respond. We know that certain population segments,
including seniors and Americans with disabilities, are less
likely, less likely to adopt broadband at home. Do the
broadband enabled innovations that we have discussed today help
these Americans get online and receive all the benefits of the
applications we are discussing today?
That is not fair to you. I guess I should have called on
one or two, but let's do it this way, and then I will call on
someone next.
Mr. Jarrin. Sure. So the answer to big data, you know, when
we are talking about big data, and I hear the theme coming up
quite a bit today, part of that is connectivity. Without
connectivity, there is no real big data, whether it is wired,
wireless or mobile. Increasingly, it is becoming mobile, and
that is obviously represented in the figures I gave at the
beginning, 355 million users in the U.S., 7 billion in the
world.
So I believe that through, you know, products like those of
Amazon, products like the chipsets that Qualcomm produces and
go into those products, those consumer facing devices, et
cetera, they are getting out there. I believe the FCC quoted
that over 95 percent of the country is now covered by at least
one mobile broadband provider. More needs to be done, both on
spectrum. Also I know that the FCC is working hard towards
reaching disparate populations through their rollup broadband
program, but I believe that we are getting there. We are
getting there.
Mr. Butterfield. All right. We have a buzzer to go to the
floor, so I will just ask one more, Mr. Chairman.
Telehealth programs are critical to communities in rural
areas like my district in eastern North Carolina. East Carolina
University, for example, has set up a telehealth opportunity at
clinics throughout many rural communities that enable
constituents to receive specialized medical care without
traveling long distances. And I know all of you are familiar
with this and you are looking forward to the next generation of
technology.
What are the major challenges, such as broadband access,
that rural communities face in fully utilizing telehealth
opportunities? If each one of you could just do a couple of
sentences, starting with Mr. Vockell.
Mr. Vockell. Well, I think probably they are more qualified
down there, but I think mobile devices are beginning to take
over what that capacity is. It is less, you know, cables into
the home and it is what used to be wired is now wireless. So as
the Qualcomm guys continue to do their good work and 1000X the
bandwidth.
Mr. Misener. If you wanted me to answer, Mr. Butterfield.
Mr. Butterfield. Sure.
Mr. Misener. Mr. Jarrin is exactly right. Connectivity is
the key. And we have always heard, at least for the past two
decades, that telehealth was going to be a major driver of the
need for connectivity in rural areas, and now it is here. So I
think the concept of ensuring broadband deployment nationwide,
including in rural areas is extremely important, not just for
telehealth, but especially for it.
Mr. Riskin. The answer, from my perspective, I actually
have an appointment in a safety net hospital. I am very
familiar with the access issues that occur. And I would say
connectivity is critical, but patient engagement is just as
difficult. Whatever modality you are using to reach your
provider, if the patient isn't engaged in their care, and
typically rural or safety net communities are more difficult to
engage, they won't be able to work with that modality.
Mr. Jarrin. And I know that we are almost out of time, but
one thing that I would like to mention: So Qualcomm sponsors
many things. We have a program called Wireless Reach. One of
our recent projects was delivering care in a Native American
area near Flagstaff, Arizona. And there were issues with being
able to get mobile broadband in those areas. There was no
connectivity whatsoever, but there were--there was one operator
in particular that actually was able to reach this population.
And what we did was we provided telephones, mobile, smart
phones that connected with home use medical devices such as
medical grade weight scales and blood pressure cuff monitors.
And what happened was that a person with congestive heart
failure would use these devices, it would connect with the
smartphone, go into the hospital, and then a series of nurses
and other care providers would actually develop a work flow and
be able to inform the patient of when things were going badly.
We were able to reduce hospital readmissions through that very
well.
Mr. Butterfield. The chairman is tapping on his microphone.
That is our----
Mr. Jarrin. Unlimited broadband is a very important thing
for----
Mr. Butterfield. I get it. Thank you.
Mr. Pitts. The gentleman has time expired. We are in the
middle of a vote. We have got 10 minutes left. We are going to
try to finish here. Mr. Griffith, you are recognized 5 minutes
for questions.
Mr. Griffith. Thank you very much, Mr. Chairman.
Thank you all. This have been a very educational hearing.
As you can hear, there is bipartisan support for trying to
figure out how we go forward. I have heard all kinds of things.
You know, figuring out the payment model when we are using new
devices that you may not even have to go in to see the doctor
on and electronic health records.
My concerns parallel those of Ms. Blackburn when she talked
about devices. It was sometime a year, a little over a year
ago, we had an FDA representative in here, and I asked them
about this $8 hack that had been used in Africa to send
photographs to a hospital in the United States. You had a team
of Canadian and I think Swiss doctors working on it, and they
were able to identify a parasite out of the stool of children
and get a diagnostic fix figuring out which parasite it was and
do the treatment the next day. I said, would this be a medical
device? And the answer was, yes. If it is diagnostic, it is a
medical device, even though all they were doing was taking a
picture on a smartphone with an $8 hack. Because it was being
used diagnostically, the FDA thinks it is a medical device.
So I think it is very important that we pass language that
we can approve in a bipartisan way that clears that up so that,
as she said in her statement earlier today, if it is a truly--
you know, something that is invasive, we want FDA making sure
it is safe, if it is just diagnostic, we want to make sure that
we get it to the market.
And, Mr. Jarrin, I noticed, and it is in your written
testimony and in your oral testimony, you mentioned like 15
devices that you could use that would give you some diagnostic
capabilities without the healthcare provider being present. Are
you all finding that FDA's worried about that or spending a lot
of time on that?
Mr. Jarrin. Well, actually the X PRIZE included the FDA
originally, so that way we wouldn't land into those issues and
lack that clarity, because that was definitely an issue that we
were considering, whether or not this would be obviously a
medical device. So the FDA joined the project early on. I
believe that Dr. Shuran, who may have been the person that you
were referring to, actually even put a video on the FDA Web
site about their involvement with the X PRIZE. So I am hoping
that when everything is said and done, you know, we will all be
on the same page.
One thing that I would mention, you have an excellent
example of the kind of clarity that was needed and still
needs--there is never enough, right?
Mr. Griffith. Right.
Mr. Jarrin. Because that exact example is something that
they actually ended up putting into the draft--the final
guidance by saying that those mobile apps that can be used to
visually augment, you know, whatever a provider is dealing with
in a diagnosis would not be regulated under their enforcement
discretion. So, you know, it was very helpful. Again, Congress
was very helpful, because when you ask those questions, I
believe the agencies really do pay attention and listen, and
the FDA in that very specific instance did exactly that. You
know, they did release the mobile medical apps guidance
document. I believe that FDASIA tries to deregulate 95 percent
of what they--what they say very specifically, most CDS
products and mobile medical apps and health IT software, but
now it needs to be codified.
Mr. Griffith. I might need to cut you short, because I have
got to leave a little bit of time for Mr. Bilirakis to get a
question or two in.
I would say that not only is that important, I am glad that
they were listening, but the telemedicine is going to be very
important. I represent a rural district, and it is going to be
extremely important in the rural parts of this country.
Thank you so much. With that, Mr. Chairman, I yield back.
Mr. Pitts. The Chair thanks the gentleman. Now recognize
Mr. Bilirakis. 5 minutes for questions.
Mr. Bilirakis. Thank you. I appreciate it, Mr. Chairman.
And thank you, Mr. Griffith, for keeping it short. I really
appreciate it. I want to go quickly, too.
With regard to the cloud, unfortunately, 10 percent of the
agencies who adopt the cloud in the Federal Government, so it
hasn't really been a success on the Federal level,
unfortunately, but in the private sector, the private sector
has rapidly adopted cloud-based solutions. And I know
Representative Matsui actually touched upon this, but I have a
couple questions.
What are some of the barriers to the adoption and expanded
use of cloud-based computing and cloud-based storage in the
medical space, and how can we facilitate the expanded use of
cloud? What are some of the laws that need to be examined,
because of the way they interact with the cloud computing?
And anyone on the panel can respond. Doctor?
Mr. Vockell. The cloud expert to start, probably.
Mr. Misener. Well, thank you, Mr. Bilirakis. I appreciate
that. In our experience with Amazon Web Services, the take rate
isn't as great as we would like it to be with Government
agencies, but it is changing, and as I mentioned in my
testimony, we already serve many around the world, but in the
Federal Government, there are areas where Congress could lead
by example, either through legislation or working in their
oversight role over agencies to ensure that agencies do use
cloud when it makes sense to.
Right now, sometimes agencies feel constrained to buy only
traditional hardware and software and pay their own in-house
people to run it, and that turns out to be highly inefficient,
and so hopefully Congress, through the two acts that I
mentioned in my testimony, including FITARA, could encourage
the Government use of cloud, to the benefit of our taxpayers,
of course. Thank you.
Mr. Bilirakis. Anyone else on the panel? OK. I will get on
to the next question.
With regard to the medical devices in the dialysis world,
they have remained largely unchanged, you will agree with that.
If you were to need kidney dialysis, you would basically be
using the same devices your parents were using. There have not
been any large innovations in that space. However, in the world
of consumer electronics, there have been continued innovations
in this space. Televisions today are radically different from
televisions in the 1990s, cell phones today are different than
they were, the ones in the 1990s, tablet PCs are different than
the laptops and notebooks from the past decade.
So my question is, How is it that we can have rapid
innovation in consumer electronics with lower costs for
consumers, but slower innovation with higher costs in the
medical space? Is it the cost of the excessive regulation? Is
it the higher barrier to entry? How do we encourage shaking up
the status quo?
And whoever would like to begin, please.
Mr. Jarrin. I actually will take it only because I am aware
of a pilot project that is actually part of the Center for
Medicare and Medicaid innovation challenge grants which is
being conducted at the George Washington University Hospital in
consult with a company named DeLier and a company named Baxter
and a number of other partners, and it deals with kidney
dialysis in one way or another. So I believe that that
community is definitely listening. They are really looking into
things like remote patient monitoring, et cetera.
But if I step back for a moment, I think one of the largest
barriers to adoption for this entire field are the outdated
rules that we have governing reimbursement for services,
particularly when we talk about remote patient monitoring, it
automatically gets lumped into something called telehealth
reimbursement, and it is not necessarily the same thing. Under
the telehealth rules, you have to start off from an originating
set of care that CMS stipulates; it has to be a specific
disease condition, there is only about 20 or 25 of them; and it
can't happen in a metropolitan statistical area, it has to
happen in a health shortage area; it has to be live voice and
video, which removes automatically all the stuff that we are
working on. It is incredibly restrictive.
So according to the American Telemedicine Association,
doctors are only able to access between 5 and $8 million--with
an M--worth of reimbursements for telehealth consults. You
know, the CMS budget is near $800 billion, so I would pause to
think that some of that could by targeted towards incentivizing
the uses of these types of equipment and services, because the
issue is this: If I am a hospital or I am a health plan, if I
am not being reimbursed by my largest population, which happens
to be Medicare, I am not going to be incentivized to adopt
those technologies that I am not being paid to use, or to
provide services that I am not going to be paid to provide.
So I think that is a real huge barrier to adoption. And
then that folds into, of course, the incentive payment program,
which has done a good job of incentivizing the use of
electronic health records, but there is no aspect that actually
allows for patient-generated health data to go into that
electronic health record, so the patient is really literally
cut out, except when he walks into the facility, and then you
have got the situation that your colleague was mentioning where
we have the scribe, you know, typing stuff in while the doctor
and the patient discuss their care. So it is a real complex
issue, but I think that I those are barriers to adoption.
Mr. Bilirakis. Thank you very much. Thank you, gentlemen,
for your testimony.
I yield back, Mr. Chairman.
Mr. Pitts. Thank you.
Thank you again to the witnesses for sharing your
expertise. This has been a very informative hearing. I am sure
members will have a lot of follow-up questions. We will submit
those to you in writing. We ask that you please respond
promptly.
I remind members that they have 10 business days to submit
questions for the record. Members should submit their questions
by the close of business on Thursday, July 31st.
Another very important, informative hearing. Thank you very
much. Without objection, this subcommittee is adjourned.
[Whereupon, at 12:21 p.m., the subcommittee was adjourned.]
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