[House Hearing, 114 Congress]
[From the U.S. Government Publishing Office]
OPPORTUNITIES AND CHALLENGES IN ADVANCING HEALTH INFORMATION TECHNOLOGY
=======================================================================
JOINT HEARING
BEFORE THE
SUBCOMMITTEE ON
INFORMATION TECHNOLOGY
AND THE
SUBCOMMITTEE ON HEALTH CARE,
BENEFITS AND ADMINISTRATIVE RULES
OF THE
COMMITTEE ON OVERSIGHT
AND GOVERNMENT REFORM
HOUSE OF REPRESENTATIVES
ONE HUNDRED FOURTEENTH CONGRESS
SECOND SESSION
__________
MARCH 22, 2016
__________
Serial No. 114-109
__________
Printed for the use of the Committee on Oversight and Government Reform
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COMMITTEE ON OVERSIGHT AND GOVERNMENT REFORM
JASON CHAFFETZ, Utah, Chairman
JOHN L. MICA, Florida ELIJAH E. CUMMINGS, Maryland,
MICHAEL R. TURNER, Ohio Ranking Minority Member
JOHN J. DUNCAN, Jr., Tennessee CAROLYN B. MALONEY, New York
JIM JORDAN, Ohio ELEANOR HOLMES NORTON, District of
TIM WALBERG, Michigan Columbia
JUSTIN AMASH, Michigan WM. LACY CLAY, Missouri
PAUL A. GOSAR, Arizona STEPHEN F. LYNCH, Massachusetts
SCOTT DesJARLAIS, Tennessee JIM COOPER, Tennessee
TREY GOWDY, South Carolina GERALD E. CONNOLLY, Virginia
BLAKE FARENTHOLD, Texas MATT CARTWRIGHT, Pennsylvania
CYNTHIA M. LUMMIS, Wyoming TAMMY DUCKWORTH, Illinois
THOMAS MASSIE, Kentucky ROBIN L. KELLY, Illinois
MARK MEADOWS, North Carolina BRENDA L. LAWRENCE, Michigan
RON DeSANTIS, Florida TED LIEU, California
MICK, MULVANEY, South Carolina BONNIE WATSON COLEMAN, New Jersey
KEN BUCK, Colorado STACEY E. PLASKETT, Virgin Islands
MARK WALKER, North Carolina MARK DeSAULNIER, California
ROD BLUM, Iowa BRENDAN F. BOYLE, Pennsylvania
JODY B. HICE, Georgia PETER WELCH, Vermont
STEVE RUSSELL, Oklahoma MICHELLE LUJAN GRISHAM, New Mexico
EARL L. ``BUDDY'' CARTER, Georgia
GLENN GROTHMAN, Wisconsin
WILL HURD, Texas
GARY J. PALMER, Alabama
Jennifer Hemingway, Staff Director
David Rapallo, Minority Staff Director
Troy Stock, Subcommittee on Information Technology Staff Director
Christina Hinkle, Counsel
Willie Marx, Clerk
Subcommittee on Information Technology
WILL HURD, Texas, Chairman
BLAKE FARENTHOLD, Texas, Vice Chair ROBIN L. KELLY, Illinois, Ranking
MARK WALKER, North Carolina Member
ROD BLUM, Iowa GERALD E. CONNOLLY, Virginia
PAUL A. GOSAR, Arizona TAMMY DUCKWORTH, Illinois
TED LIEU, California
----------
Subcommittee on Health Care, Benefits and Administrative Rules
JIM JORDAN, Ohio, Chairman
TIM WALBERG, Michigan MATT CARTWRIGHT, Pennsylvania,
SCOTT DesJARLAIS, Tennessee Ranking Member
TREY GOWDY, South Carolina ELEANOR HOLMES NORTON, Distict of
CYNTHIA M. LUMMIS, Wyoming Columbia
MARK MEADOWS, North Carolina BONNIE WATSON COLEMAN, New Jersey
RON DeSANTIS, Florida MARK DeSAULNIER, California
MICK MULVANEY, South Carolina, Vice BRENDAN F. BOYLE, Pennsylvania
Chair JIM COOPER, Tennessee
MARK WALKER, North Carolina MICHELLE LUJAN GRISHAM, New Mexico
JODY B, HICE, Georgia Vacancy
EARL L. ``BUDDY'' CARTER, Georgia
C O N T E N T S
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Page
Hearing held on March 22, 2016................................... 1
WITNESSES
Karen DeSalvo, M.D., National Coordinator for Health Information
Technology, U.S. Department of Health and Human Services
Oral Statement............................................... 5
Written Statement............................................ 8
Ms. Jessica Rich, Director, Bureau of Consumer Protection, U.S.
Federal Trade Commission
Oral Statement............................................... 13
Written Statement............................................ 15
Mr. Matthew Quinn, Federal Managing Director, Intel Healthcare
and Life Sciences
Oral Statement............................................... 24
Written Statement............................................ 27
Mr. Neil DeCrescenzo, Member, Executive Committee, Healthcare
Leadership Council
Oral Statement............................................... 44
Written Statement............................................ 46
Mr. Mark Savage, Director of Health IT Policy and Programs,
National Partnership for Women and Families
Oral Statement............................................... 126
Written Statement............................................ 128
APPENDIX
An April 1, 2016 letter from the National Partnership for Women &
Families to Chairman Will Hurd, Chairman Jim Jordan, Ranking
Member Robin Kelly, and Ranking Member Matthew Cartwright,
Entered by Chairman Will Hurd.................................. 152
A December 2014 report from the National Partnership for Women &
Families titled, ``Engaging Patients and Families: How
Consumers Value and Use Health IT'', Entered by Representative
Matt Cartwright. A copy of the report can be found online here:
http//www.nationalpartnership.org/research-library/health-care/
HIT/engaging-patients-and-families.pdf
OPPORTUNITIES AND CHALLENGES IN ADVANCING HEALTH INFORMATION TECHNOLOGY
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Tuesday, March 22, 2016
House of Representatives,
Subcommittee on Information Technology, joint with
the Subcommittee on Health Care, Benefits, and
Administrative Rules,
Committee on Oversight and Government Reform,
Washington, D.C.
The subcommittees met, pursuant to call, at 2:06 p.m., in
Room 2154, Rayburn House Office Building, Hon. William Hurd
[chairman of the Subcommittee on Information Technology]
presiding.
Present from Subcommittee on Information Technology:
Representatives Hurd, Walker, Blum, Connolly, and Lieu.
Present from Subcommittee on Health Care, Benefits, and
Administrative Rules: Representatives Walberg, Gowdy, DeSantis,
DeSaulnier, Cartwright, and Lujan Grisham.
Mr. Hurd. The Subcommittee on Information Technology and
the Subcommittee on Health Care, Benefits, and Administrative
Rules will come to order. Without objection, the chair is
authorized to declare a recess at any time.
We are expecting votes fairly soon, so I am hoping we can
get through opening remarks, go do our vote series, and come
back and finish the hearing.
Good afternoon. I appreciate your being here today. You all
know that heart disease is a leading cause of death in the
United States, according to the CDC. More than 600,000
Americans die from heart disease each year.
The American Medical Association recommends walking as the
simplest positive change you can make to improve your heart
health. Walking 30 minutes day, or around 10,000 steps, lowers
blood pressure, improves movement and mobility, and increases
energy. Simply increasing the number of steps you take per day
can significantly reduce your risk of coronary heart disease
and stroke.
Many of you could glance right now at your smart phones,
wearables, or other devices and report your number of steps and
calories burned for the same period of time. For most of us, I
will bet that number is probably higher than before we had the
app or device and we were tracking our steps.
It would not be an extreme exaggeration to say that the
proliferation of wearable devices and smart phone apps that
track steps and the accompanying increases in the number of
steps some people are taking on a daily basis has saved lives.
This is just one example of the benefits technology has
brought to health and health care, and we have barely scratched
the surface. We are on the cusp of being able to use technology
to truly revolutionize health care and health care delivery.
Leveraging the power of the cloud will enable us to move
more health care tasks online, including consultations and data
storage and retrieval.
Sensors will make it easier for people to take care of
themselves before they get sick. Constituents in rural parts of
Texas 23rd, my district, will be able to speak directly with
their primary care providers instead of commuting hours each
way.
As more devices are connected and more data is generated,
medicine will become customized and personalized. Preventative
medicine and healthy living practices will increase, costs will
decline, and the prevalence of chronic diseases will decrease
substantially.
But this will only happen if researchers, hospitals,
entrepreneurs, regulators, health care professionals, patient
advocates, and lawmakers come together to update antiquated
laws and reform outdated institutions.
Right now, old and unclear privacy laws hinder
interoperability between health IT systems and devices. Right
now, the sheer number of Federal agencies, and often
conflicting rules one must navigate to invest in the space,
chills investment and entrepreneurship. And right now, a
fragmented and bureaucratic system places the patient at the
fringe of the process, rather than at the center.
In today's hearing, I hope to hear specifically what laws
or regulations need to be changed or updated, and how they
should be changed or updated or abandoned.
Health IT is an exciting, innovative field, but to get this
right, we must collaborate. We must destroy silos. I am
committed to doing so. I know my friend and ranking member, Ms.
Kelly, and Ted Lieu are as well.
And I want to thank the witnesses for being here today, and
I look forward to their testimony.
Now I would like to recognize Mr. Cartwright for his
opening statement.
Mr. Cartwright. Thank you, Chairman Hurd. I would like to
thank you both for calling this hearing so we can hear about
how the Federal Government and private industry are working
together, and for your interest and efforts at creating the
next generation of health information technology.
I represent largely a rural district in northeastern
Pennsylvania, and I know quite well how health IT can bring
affordable medical care to those who might not otherwise be
able to receive it.
In fact, that is why I cosponsored the Medicare Telehealth
Parity Act of 2015, the 21st Century Cures Act, and also the
TELE-MED Act. Bills like these help medical professionals
provide patients with the best health care available anywhere
and at any time.
But even with the undeniable benefits technology brings,
patient safety must remain our foremost consideration.
Technology brings opportunity, but it can also bring unforeseen
challenges, and I hope we can talk about that a little today.
As a career courtroom attorney, I have seen too many
medical malpractice lawsuits where carelessness caused injuries
and death, and where doctors have made grave and avoidable
mistakes. Too often these mistakes were due to failures in
communication that left physicians and nurses without all of
the patient's information that they needed to complete proper
assessment and treatment.
We worry that different computer system standards and
methods of tracking medical history often mean doctors, nurses,
lab technicians, and others involved in the treatment process
cannot get a complete understanding of the illness in front of
them and the treatment that is needed.
That is why it is so important that technologies like
electronic health records, which contain the complete medical
and treatment history of a patient quickly and efficiently give
providers insight and a comprehensive view into what is going
on and all the facts of the case. Standardized, industry-
accepted technologies can make that happen, in my view.
In the field of health IT, private industry has a critical
role in the process doing what it does best: drive innovation
and keep America at the leading edge in medical technology.
The Federal Government also has a role to play, making sure
these new technologies meet health care needs without
compromising patient safety.
I am looking forward to today's hearing, to the testimony
of all of you. I am glad that industry and government are
working together to bring about the kinds of technological
advances that will improve health care in this country, make it
safer, and make it more available to people in all corners and
all pockets of this Nation.
I thank you again, Chairman Hurd, and I yield back.
Mr. Hurd. Thank you.
I am going to hold the record open for 5 legislative days
for any members who would like to submit a written statement.
Ranking Member Lieu is here, and if he is ready, we will
have him give his opening remarks.
Mr. Lieu from California is recognized for 5 minutes.
Mr. Lieu. Thank you, Mr. Chairman.
Thank you to the witnesses who will be presenting today.
Today, we are here to learn more about how to make the
primary health technology laws work smarter and better. Laws
and regulations should be there to protect the public, but done
incorrectly, they can hinder innovation, and the same holds
true in the health IT space.
The Health Insurance Portability and Accountability Act,
HIPAA, contains provisions to create universal electronic
medical records and protect patient privacy. The Health
Information Technology for Economic and Clinical Health,
HITECH, contains provisions to protect consumer privacy and
give notice in case of data breach. The Affordable Care Act
also contains provisions to improve the quality and efficiency
of patient care with EHRs.
However, these laws and regulations were enacted before key
technological advances that we now take for granted. HIPAA was
passed in 1996 before broad adoption of the mobile revolution.
HITECH was passed in 2009, before much of cloud computing
existed.
Some might suggest that rolling back regulations is the
answer. While I agree that government regulation is not as
nimble as technology, we still need some combination of
regulations and enforceable guidance to protect the public.
For instance, last month, the IT system at Hollywood
Presbyterian Hospital in Southern California was held hostage
by ransomware denying patients and providers access to their
medical records. The HITECH law has cybersecurity requirements
that require notifications for data breaches, but the law says
nothing about notification for data that was frozen or held
hostage where it is stored.
I note that today the press reports that two more hospitals
in Southern California were hit with malware attacks.
Technology is moving very quickly. Telemedicine and text
messaging and mobile smart phone exposure requires that HHS and
FTC keep up with technology changes, update guidance reliably,
and keep rules and regulations flexible to encourage
innovation.
Regulation done wrong or too little regulation makes it
difficult to protect the public and ensure that data flows
freely. Regulation done right spurs innovation and improves
quality of care and protects the public.
I look forward to hearing from the witnesses today about
what we can do to encourage innovation and cooperation, and
continue to bring government health care into a more modern era
of service.
With that, I yield back.
Mr. Hurd. Thank you, Mr. Lieu.
If Chairman Jordan joins us and is interested in giving
opening remarks, we will let him do that as he arrives.
Again, I would like to thank the witnesses. I would like to
recognize you all now. I am pleased to welcome Dr. Karen
DeSalvo, national coordinator for health information technology
at the U.S. Department of Health and Human Services. Thank you
for being here. Ms. Jessica Rich, director of the Bureau of
Consumer Protection at the U.S. at the Federal Trade
Commission; Mr. Matthew Quinn, Federal managing director at
Intel Healthcare and Life Sciences; Mr. Neil DeCrescenzo,
member of the executive committee at the Healthcare Leadership
Council; and Mr. Mark Savage, director of health IT policy and
programs at the National Partnership for Women and Families.
Welcome to you all. Pursuant to committee rules, all
witnesses will be sworn in before you testify.
Please rise and raise your right hands.
Do you solemnly swear or affirm that the testimony you are
about to give will be the truth, the whole truth, and nothing
but the truth?
Thank you. Please be seated.
Let the record reflect that the witnesses answered in the
affirmative.
In order to allow time for discussion, please limit your
testimony to 5 minutes. Your entire written statement will be
part of the record.
We are going to go through as many opening remarks as we
can before we get called to votes. If the bells go off while
you are in your remarks, go ahead and continue. We will finish
after your remarks.
Now I would like to recognize Ms. DeSalvo for your opening
remarks.
WITNESS STATEMENTS
STATEMENT OF KAREN DeSALVO, M.D.
Dr. DeSalvo. Thank you, Chairman Hurd, and Ranking Members
Lieu and Cartwright, and distinguished members of the
subcommittees. Thank you all for the opportunity to appear here
today.
I am Dr. Karen DeSalvo, and I have the honor of serving as
the national coordinator for health information technology at
the U.S. Department of Health and Human Services for the past 2
years. I'm proud to be here today representing the remarkable
team at the Office of National Coordinator and share with you
the current State of health information technology in our
Nation and how we are working with others to see that these
systems realize their full potential.
The Office of the National Coordinator for Health
Information Technology has a strong, bipartisan history. It was
established in 2004 by executive order and charged with the
mission of giving every American access to their electronic
health information. In 2009, it was statutorily established by
the Health Information Technology for Economic and Clinical
Health Act, or HITECH, which provided the resources and
infrastructure needed to foster the rapid nationwide adoption
and use of health IT.
In the 7 years since HITECH was enacted, we have seen
dramatic progress. Today, nearly all hospitals and more than
three-quarters of physicians report using a certified
electronic health record. This tripling in rates of adoption
puts us as a Nation well ahead of our peer countries, giving us
a significant competitive advantage in health care innovation
and scientific advancement. And it is working in so many
communities across this country.
But I also note that we haven't realized the full potential
of health IT for every person in this country.
And this is not just an abstract policy idea to me. It is
personal. It is why I came to ONC 2 years ago, because I knew
as a doctor the promise of health IT, of having information
available for me when I was on call in the evening not at the
hospital, such a leap from the days in the early 1990s when I
was a medical school student at Charity Hospital and had to
physically go up to a lab and pull a lab slip with handwritten
results from a wooden box, so that I would understand more
about my patients and how to care for them.
Today, that is all available electronically to me and other
doctors, and not just to us but to our patients, to really see
that they can be empowered and have the information they need
to self-care. It is a rapid and remarkable transformation in a
very short period of time. But the pace has come with
challenges.
Like others, I have been frustrated by the lack of
interoperability, by the usability of the systems, and by how
hard it can be to select the right system to buy. I hear about
these challenges from my colleagues whether at listening
sessions but also from consumers and other stakeholders.
We all want to move ahead with technology, but we want it
to work better. That is what I came to Washington to do.
Since I've been the national coordinator, we have been
focused on fixing those challenges in an urgent fashion to meet
the expectations of the people that I serve, the American
people. ONC does this in a variety of ways.
For example, we can leverage our electronic health record
certification program. We also serve as a coordinator across
the Federal Government to see that agencies have shared policy
and technology approaches and will send clear signals to the
private sector.
We have also worked with the private sector on setting a
clear path ahead for our nationwide interoperability. This
roadmap that we produced last year lays out who should do what
by when to achieve interoperability in the near term to see
that electronic health information is available when and where
it matters to consumers and clinicians.
ONC and others have been meeting our deliverables from this
plan and are advancing drivers of interoperability like payment
reform, publishing clear standards, working with States and
others on harmonizing privacy and security expectations. The
plan has been publicly endorsed by our Federal partners, by the
private sector, and we have been so pleased with everyone's
willingness to step up and lead where appropriate, to see that
we can innovate and accelerate interoperability. Indeed,
working with the private sector is how ONC operates.
As another example, we recently convened stakeholders to
ask them to make a series of commitments to ensure that
electronic health information works better for patients and
providers. It is a really tremendous opportunity for the
private sector to lead.
So last month, we were able to announce that companies that
provide electronic health records for 90 percent of hospitals
in this country, and health care systems with facilities in 46
States, including the States for all the members of these two
subcommittees, and over a dozen professional associations and
stakeholder groups like the AMA and the American Hospital
Association, all have agreed to implement three commitments
that will help make sure health information flows.
The commitments are that consumers will have access to
their electronic health information, that entities will not
engage in health information-blocking, and that we will move to
federally recognized national standards so that all these
different systems will speak the same language.
ONC and our partners in the Federal space and the private
sector are working together each and every day to see that we
can move this future vision to an immediate reality. And
Congress has been one of the great partners in health IT, and I
look forward to continuing to work with you all to realize the
full potential of health IT for this country.
Thank you for having me here today, and I look forward to
your questions.
[Prepared statement of Dr. DeSalvo follows:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Mr. Hurd. Thank you, Dr. DeSalvo.
Now, Ms. Rich, you are recognized for 5 minutes.
STATEMENT OF JESSICA RICH
Ms. Rich. Chairman Hurd, Ranking Members Lieu and
Cartwright, and members of the subcommittees, I am Jessica
Rich, director of the Bureau of Consumer Protection at the
Federal Trade Commission. I appreciate this opportunity to
present the commission's testimony.
Consumers are increasingly taking an active role in
managing their health data, and there has been an explosion of
new products and services to help them. These range from
wearable fitness devices like Fitbit or Jawbone, to dieting
apps like My Fitness Pal and Calorie Counter, and to Web sites
like WebMD where consumers can get health advice and
information.
These products and services offer enormous benefits to
consumers, but they raise privacy and security concerns, too.
Who has access to all of this data? And is it being stored
securely?
Much of this activity now happens outside of the doctor's
office and other traditional health care contexts. As a result,
it is not protected under HIPAA, which only applies to health
data held or generated by covered entities, such as health care
providers and health plans. In most instances, however, this
activity is covered by the Federal Trade Commission Act, which
prohibits unfair or deceptive practices across the marketplace,
including in the area of health privacy.
As the primary Federal agency charged with protecting
consumer privacy, the FTC has made it a priority to protect
consumer-sensitive health information. Our efforts include
civil law enforcement, policy initiatives, and consumer and
business education.
Three recent FTC cases illustrate the challenges we face in
protecting consumer health data and how the FTC is addressing
them.
PaymentsMD is a medical billing company that offered an
online portal where consumers could pay their bills. The FTC
charged that the company misled thousands of consumers who
signed up by failing to tell them that it would also seek their
highly detailed medical data from pharmacies, medical labs, and
insurance companies.
Henry Schein provided office equipment software for dental
practices. We charged this company with misrepresenting to
clients that its software provided industry-standard encryption
of sensitive patient information as required by HIPAA. In fact,
we alleged the software used a weaker method of data masking
that didn't meet HIPAA standards.
A third example is our settlement with GMR, a medical
transcription service. We charged that GMR assured its clients
that its services were secure but outsourced them to a third-
party service provider without adequately checking its security
measures. As a result, consumers found doctors' notes of their
physical examinations freely available on the Internet.
Besides enforcement, the commission engages in policy
initiatives to encourage stronger protection for health
information. Last year, we hosted a public workshop on consumer
health data to examine the products and services consumers are
using to generate and control their data and how this data is
protected.
We also released a staff report on the Internet of Things,
which, among other topics, examined the privacy and security
issues raised by connected medical devices and health and
fitness products. Of greatest concern, panelists discussed the
unique risks if health devices like pacemakers and insulin
pumps are not secure and are vulnerable to hackers.
Finally, the commission promotes stronger data protections
through consumer education and business guidance. For example,
our new IdentityTheft.gov Web site provides customized advice
to consumers who have been victims of medical identity theft.
And last year, the FTC launched its Start with Security
campaign to educate small businesses around the country about
how to develop an effective data security program.
In addition, working with HHS and with FDA, the FTC is
currently developing business guidance for health app
developers to help them understand which legal requirements
apply to them.
The FTC shares the subcommittees' concerns about the need
to protect the privacy and security of consumer health data.
Although we now use a variety of tools to protect consumers in
this area, additional tools would enhance our ability to do so.
To this end, the commission reiterates its longstanding
bipartisan call for Federal data security and breach
legislation that would allow us to seek civil penalties to
deter unlawful conduct and give us jurisdiction over nonprofit
entities.
In closing, the FTC remains committed to protecting
consumer health data and looks forward to our continued work
with Congress on this critical issue. Thanks again for the
opportunity to provide the commission's views today.
[Prepared statement of Ms. Rich follows:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Mr. Hurd. Thank you, Ms. Rich.
Mr. Quinn, you are recognized now for 5 minutes.
STATEMENT OF MATTHEW QUINN
Mr. Quinn. Good afternoon, Chairman Hurd and other esteemed
members of the House Oversight and Government Reform Committee.
Thank you for the opportunity to testify today on behalf of
Intel Corporation.
In my written testimony, I provide some tangible examples
of how Intel is working to make good on the promise of today's
health technologies and to pave the way toward tomorrow's.
Today, I would like to frame my comments in the context of
recent personal experiences.
Two Fridays ago, I received a call that no one wants. My
sister in Ohio said that dad had just taken a bad fall. He had
just left his doctor's office where he was in for a checkup
after a recent hospitalization.
Things had gone well, and they stopped by a favorite
restaurant for breakfast. As my dad climbed the curb, he became
lightheaded, fell to the ground, and tumbled back into the
parking lot. As we soon found out, he broke his clavicle,
pelvis, and deeply cut his elbow.
To say that my dad is a complex patient would be an
understatement. He is the poster child for needing all of his
providers and caregivers to be on the same sheet of music and
have the whole picture of his health and health care.
Let's begin by thinking of the constellation of my dad's
health data. Most familiar are the clinical and claims data
captured at clinics, hospitals, and the like. Secondly, there
is diagnostic data captured by medical devices and imaging.
Adding to this is consumer-generated data. And finally, there
is 'omics, vast amounts of information in his genome.
Personal precision medicine in the 21st century will need
to make sense of all of this.
The U.S. has made great strides to ensure that each person
has an electronic health record. Yet the goal of point-of-care
and personal access to comprehensive health information has not
yet been achieved.
There are three recurring barriers that often limit data-
sharing. First, medical institutions using privacy and security
policies and laws like HIPAA as excuses for why they can't
share; next, medical professionals lacking easy, affordable
tools to share data, especially because vendors fail to use or
consistently implement standards; and finally, payment reforms
that don't reimburse for new care models like telehealth.
Back to my dad's experience, when he arrived at the ER, the
same hospital where he had received his most recent treatment,
they pieced together his health history, partly from the EHR
and partly from my parents.
I fear that if he was brought to a different hospital, it
would've been basically starting from scratch. There exists a
local health information exchange, but evidently, this hospital
and my dad's nephrologist don't participate. My mom is our de
facto health information exchange.
My dad would definitely enjoy the kind of secure,
standards-based data-sharing that Intel's own Connected Care
program makes available for over 33,000 of its employees. As we
have shown, it is all quite possible today, just not as
widespread as it could be.
We need to think about interoperability in much broader
terms than merely exchange of electronic health record data.
That will change as the Internet of Things takes hold and we
connect smart devices to the Internet in ways that generate
data that can be turned into valuable insights.
How would this affect my dad? Well, first of all, it would
allow him to get some sleep. Because the devices monitoring him
in the ICU don't talk to each other and his vitals tend to
bounce around, there are endless, nearly always false alarms.
What if devices even from different vendors could talk to
each other? Innovators could create smart alarms from the new
combined data streams and save countless hours of nursing time,
countless lives, and just let my dad sleep. The data from all
the medical devices could automatically feed the EHR, millions
more nursing hours saved.
But let's think bigger. What if when my dad was discharged
that he was outfitted with sensors or an app that constantly
detected whether his gait was making him prone to falls? Or
what if instead of having to drive across town to visit his
doctor, he could do so from his home via telemedicine, and his
blood and vitals could be automatically analyzed via his home
dialysis unit? What if his caregivers could track his progress
in getting back up on his feet as he rehabs?
I think we have come up with a half-dozen ideas for new
businesses, but all of this relies on there being a solid
foundation for the Internet of Things to blossom: security from
the sensor to the cloud; connectivity, allowing devices to
communicate their status to the system; data normalization to
allow devices to speak the same language; and actionable
analytics.
So to close, how do we believe Congress can help seize the
opportunities and overcome the challenges?
First, sustain momentum toward standards and
interoperability for today and for tomorrow. As Intel's
Connected Care program demonstrates, a rigorous standard-based
approach enables quicker and more rapid efficient deployments
today. And to rapidly move forward toward the Internet of
Things, Intel invites active Federal participation in industry-
led initiatives such as the IIC, OCF, ICE alliance, and
Continua.
Second, encourage patient engagement by removing obstacles
for patients to access and share their data. Intel invites
policymakers to partner with industry to pursue a standardized,
machine-readable consent form to allow patients to easily
donate their data to ongoing research.
And last but not least, continue to push towards value-
based care. We support the HHS goal to move half of care to
alternative payment models by 2018. When incentives are aligned
to value-based care, the demand for information-sharing goes
up. Congress can further drive innovation by providing
reimbursement for remote patient monitoring and other promising
technologies.
Thank you, and I look forward to your questions.
[Prepared statement of Mr. Quinn follows:]
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Mr. Hurd. Mr. Quinn, I appreciate your opening remarks.
Now Mr. DeCrescenzo is recognized for 5 minutes.
STATEMENT OF NEIL DeCRESCENZO
Mr. DeCrescenzo. Thank you. Mr. Chairman, members of the
committee, it is a privilege to be here today.
My name is Neil DeCrescenzo. I am the president and CEO of
Change Healthcare. Perhaps our name says it all.
Change Healthcare is headquartered in Nashville, Tennessee,
provides its services in all 50 States, and has over 50 offices
nationwide. We are a leading provider of software and
analytics, network solutions, and technology-enabled services
that optimize communications, payments, actionable insights
that enable smarter health care.
By leveraging our Intelligent Healthcare Network, which is
one of the largest financial and administrative networks in the
United States health care system, payers, providers, and
pharmacies are able to more effectively manage complex
workflows that support value-based health care.
While I am proud to represent the nearly 7,000 people of
Change Healthcare, I am testifying today in my role as a member
of the executive committee of the Healthcare Leadership
Council, a coalition of leading companies and organizations
from virtually every sector of American health care. In that
role, I would like to share a few thoughts on the role and
capability of health information technology to transform our
Nation's health care system for the better.
As increasingly is the case in most fields, health care
improvement today is driven by data. If our health care system
is not improving at the pace any of us would like, this is in
large part due to barriers standing in the way of access to
data, the ability to share information, and the utility of this
information for consumers, providers, payers across the health
care continuum.
Our HLC member companies know from firsthand experience
that data interoperability can strengthen care coordination,
enabling providers, payers, pharmacists, laboratories, and
others, to be on the same page when treating a patient. It can
boost progress toward an outcome-driven, value-based payment
system to replace the outdated and inefficient fee-for-service
status quo while also improving our quality measurement
capabilities.
With interoperability and access to clinical and claims
data, we can accelerate medical research and give hospitals and
physician offices real-time access to comparative effectiveness
findings. An interoperable system can improve care to rural and
underserved areas of the country through improved telehealth
and remote patient monitoring. Wellness and prevention will
also be enhanced through the better use of patient-generated
data.
This future is promising, exciting, and imminently
obtainable, once we address some of the obstacles standing in
our way.
Last year, HLC, under the auspices of its National Dialogue
for Healthcare Innovation initiative, brought together leaders
from over 70 organizations representing government, industry,
patients, employers, and academia. There we built consensus on
how we can move closer to this desirable data-driven future.
Last month, we announced the consensus recommendations
emerging from this effort, a number of which are relevant to
today's discussion.
On data interoperability, we believe that a firm date of
December 31, 2018, should be established by which health
information is widely shared among electronic health record
systems nationwide. We have the capability to reach this goal
in the near term, not a decade from now. Progress toward this
nationwide data infrastructure should be driven by private
sector innovation, with emphasis placed on secure data-sharing
to protect patient privacy, common standards and governance,
and a ban on data-blocking.
In addition, we believe that Congress and the
administration must address physician health referral laws and
Federal anti-kickback statutes, as well as civil monetary
penalty laws.
These fraud and abuse protections were built for a fee-for-
service world, but today, they often stand as barriers to the
kind of collaboration and information-sharing that is essential
for value-based health care approaches and for improving
patient care.
Another barrier to data-sharing is the multitude of diverse
and often contradictory Federal and State laws regulating
health information that exist alongside the Federal HIPAA
regulations. We believe these national and State privacy laws
and regulations should be harmonized to facilitate greater
information-sharing for the benefit of patients while still
protecting their confidentiality.
Members of the committee, I would like to close by
applauding you for conducting this hearing and your focus on
the issues that can genuinely transform and improve health care
for every American.
We can move faster. We can move more collaboratively across
the spectrum of U.S. health care. And we can help more
Americans maintain or improve their health better than we do
today through data, information, and insights.
We look forward to working with you toward our shared
goals, and I will be happy to take your questions. Thank you.
[Prepared statement of Mr. DeCrescenzo follows:]
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Mr. Hurd. Thank you, sir.
Mr. Savage, you are recognized for 5 minutes.
STATEMENT OF MARK SAVAGE
Mr. Savage. Good afternoon, Chairman Hurd, Ranking Members
Lieu and Cartwright, and distinguished committee members. Thank
you for the opportunity to testify today.
I am Mark Savage, director of health IT at the National
Partnership for Women and Families, a nonprofit, nonpartisan
organization that for 45 years has worked to improve the lives
of women and families. We are deeply invested in improving the
value and experience of health care and ensuring that new
models of delivery and payment help make consumers partners in
their care with access to the right care at the right time.
I am delighted to be able to share today the values,
experiences, and needs of patients and consumers who are using
health information technology, such as online access and
electronic data-sharing with doctors to improve their health
and care.
The national partnership leads the Consumer Partnership for
eHealth coalition and can speak broadly to the great
opportunities that health IT presents and the obstacles that
still make it difficult to realize its full potential.
Health IT is the essential infrastructure for improving
quality, care coordination, and value in our health care system
today.
It is a critical tool for engaging consumers who clearly
recognize its value, according to a national survey we
commissioned in 2014. We found that nearly 9 in 10 patients
with online access to their health information use it. Notably,
people who use online access frequently are much more likely
than infrequent users to report that health IT motivates them
to improve their health.
Patients recognize that health IT is essential to improving
their access to care, as well as their access to their health
information. They know what we know, that health IT helps
patients and family caregivers communicate with their health
care providers, share information and manage their care;
improves patients' knowledge of their health and empowers them
to take charge of their care plans; allows patients to correct
errors or outdated information in their medical records, such
as a missing drug allergy; enables patients to share treatment
outcomes, such as pain levels, functional status, and whether
their health improved after the office visit; helps health care
providers answer questions from patients by secure email and
provide care with telehealth and see the patients who need the
most; gives patients more control over how much personal
medical information is shared and how it is used; and much,
much more.
Like electronic access in so many other parts of our lives,
such as banking and retail, health IT enables real-time access
to care and information, and provides individuals with the
convenience and control they need and expect in the 21st
century. Health IT can also enhance patient trust and the
privacy and security of patient data through encryption and
other means.
The country has seen a rapid increase in health care
providers' adoption and use of health IT in recent years, but
much work remains before the potential benefits reach all
patients. We have an urgent imperative to break down barriers
and continue the progress.
First, that begins with removing barriers to health
information. The national partnership runs the Get My Health
Data campaign, and, through it, we have learned that many
patients continue to face astonishing barriers to getting their
digital health records from their health care providers. We
need to change that by advancing policies and programs that
promote patients' online access to and use of their health
information.
Second, we need to clarify privacy and security
requirements for sharing health data, because confusion
persists about patient access rights. That means, for example,
adding proactive education initiatives about what HIPAA
requires and what it does not, and encouraging mobile app
developers and technology vendors to post their privacy
policies and data-sharing practices in standardized ways.
Third, we need to enhance the usability of health
information so that when patients access their medical data,
they can understand and use it. For example, innovative apps
could help patients organize their health information in ways
that they find most useful.
And fourth, we need to bridge existing digital divides to
help identify and reduce disparities in care. That means, for
example, promoting online access to health information across
diverse communities, and innovation in mobile apps can help.
In sum, patients and consumers applaud the progress to date
and they need more. Patients have a unique vantage point for
they are at the center of the health care and information-
sharing we are all working to improve.
Our goal must be to leverage health IT so it helps patients
become real partners in their care and health. Only if we do
that will we realize the full promise of health information
technology. Thank you very much.
[Prepared statement of Mr. Savage follows:]
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Mr. Hurd. Thank you, Mr. Savage.
We are going to keep going. We are expecting votes in about
10 to 15 minutes, so we will try to get through as many
members' questions as we can.
To kick us off this afternoon is the distinguished
gentleman from North Carolina, Mr. Walker.
Mr. Walker. I thank you, Mr. Chairman.
I appreciate the panel being here today and taking your
time and being really a valuable resource for us.
I married into the medical community. My wife is a family
nurse practitioner at Wake Forest Baptist Medical Health
Center. Every time I feel like I have, by osmosis, learned more
medical knowledge, after 23 years, she reminds me that I don't
really have a good base of understanding.
But this is something that concerns. I remember even as a
minister for 2 decades sometimes trying to get information
about a patient to family members or to others, and trying to
figure out how we can meet those needs. Sometimes there were
problems to do that, even good laws.
I also want to paint a picture here of some friends. I
recently tagged along with a surgeon there in Moses Cone
Hospital in Greensboro that has been so burdened with some of
the software and some of the regulation. It has impacted him
negatively, as well as other physicians who have talked about
this.
So I want to address a couple of these issues. Maybe, Mr.
DeCrescenzo, if I could start with you, you both mentioned in
your testimony obstacles. You also mentioned the word
``barriers.'' Talk to me for just a minute, if you would, about
what specifically are the obstacles and barriers to getting
where this needs to go.
Mr. DeCrescenzo. I think some of the barriers and
obstacles, Representative, are some of the things that I
mentioned and some of the other folks here on the panel.
First of all, there is a lot of activity underway around
collaboration in the industry, but it is one that we think
needs to be supported broadly. We have both private sector and
combined private sector and government initiatives, things like
the CommonWell Alliance, the Sequoia Project. There are
technical standards from committees like HL7 that are trying to
push the ball forward to make these systems talk to themselves,
to each other, a lot more adeptly and easily than they have
historically.
I think support for that, as exhibited by the ONC report
that came out last year, to push us down a roadmap where those
efforts can be channeled into a way that they ultimately come
to a harmonized approach between the State regulations and laws
and standards, Federal, State, Federal laws, regulations, and
standards, and private sector initiative, really is one of the
ways that we can make the most against some of the obstacles
and barriers that exist today where the systems don't have
those standards to make it easier for them to talk to one
another.
Mr. Walker. Thank you for responding to that. Are you
familiar with the Press Ganey scores?
Mr. DeCrescenzo. The patient satisfaction scores.
Mr. Walker. Exactly right. I want to make sure that we are
also being an advocate for the health care providers, that we
don't put these guys in a bind. In fact, earlier this morning,
we had a very passionate hearing--compassionate, I should say
as well--as far as the heroin and opioids. And we know
sometimes patients can be very manipulative in this process.
Can you take a moment, Dr. DeSalvo, and speak to that to
make sure, as we move forward with this, we are not putting our
providers in a more vulnerable position?
Dr. DeSalvo. Thank you for the question, Congressman.
As a doctor, I know full well the challenges of making sure
that you are being compassionate but also being evidence-based
in the practice of medicine.
I wanted to touch on the patient access piece, because you
mentioned it, and it is so critically important. The electronic
health information is theirs. They have the right to access it.
And we have worked with the private sector to see that we are
creating innovative ways that they have more ready access to
that information, so they can make their own care decisions,
but also it can be available in the care setting.
As an example, just in the last few months, working with
the Office of Civil Rights, who has the primary responsibility
for HIPAA access, put out some guidance directed at consumers,
so that they would know what they have the right to access.
This is a common refrain that we hear from consumers but also
from docs who want to make sure that the information is getting
out.
In the space of opioids, as an example, we certainly want
to make sure that we are doing everything to support clinicians
on the frontlines.
My husband is an emergency medicine doctor, so this is a
very everyday occurrence for him. The tools like PDMPs, the
prescription drug monitoring programs that are electronic in
many States and have really made it easier for us to access
information to make sure that we are appropriately giving
opioids to people who have pain, are needed, but also trying to
help folks stay out of trouble.
We have been working with SAMHSA and with States and with
the industry to see that those become more aligned within
electronic health records, so you don't have to go to another
place and sign on. That's an added burden.
Mr. Walker. Before my time expires, let me also look at
this. Health care certainly is very important as we move
forward in having the right perspective. As a Member of
Congress, we also have a financial fiscal responsibility as
well. We spend more than $2,000 per patient than any other
country in the world.
Can we make a case out of this that is something that can
drive us to be more health care cost conscience as well?
Mr. Quinn or Ms. Rich, would one of you like to address
that?
Mr. Quinn. I will use as an example Intel's Connected Care
program. Where Intel, as a large purchaser of health care on
behalf of its 53,000 employees in the U.S., said how can we
make our employees the healthiest in the country, retain them,
and also try to save some money doing it?
We have been very successful in the first two. The third
has been more challenging, although there has been a great
progress there.
The key to it, I would say, and this is also the key
potentially for driving data-sharing and information-sharing in
our broader health care system, is focusing on value-based
care, rather than fee-for-service. That was the engine that
drove this, and we have seen a massive amount of actual use of
this health information exchange because, of course, the
technical pieces are there with the Sequoia Project and
building this, but also the incentives for using it are there
for the health care providers.
Mr. Walker. Thank you, Mr. Quinn.
I yield back, Mr. Chairman.
Mr. Hurd. The plan is to go to Mr. Connolly, and then we
will go into recess to get to votes.
I now recognize the gentleman from Virginia, Mr. Connolly,
for 5 minutes.
Mr. Connolly. I thank the chair.
And I thank Mr. Lieu and Mr. Cartwright for their gracious
consideration. Thank you so much. I have seven hearings in a
day and half, so I'm running back and forth.
Mr. Quinn, thank you for sharing your story. Boy, could I
relate to that. Both of my parents are in their 80s, and I have
witnessed scenes where one is in the hospital in the emergency
room, and the other one is being asked to give the history, the
medical history. I'm thinking, what could go wrong with this
scenario? Thank God they are both alert and have mental acuity,
but you know, memory sometimes fails us in moments of stress.
It is hardly an ideal system, and surely technology exists
that would allow us to have a comprehensive picture of the
patient in question without relying on human memory and such.
So I really related to what you had to say, and I hope your
dad is doing well.
Dr. DeSalvo, picking up on Mr. Quinn's narrative, according
to HHS's 2016 report to Congress on the adoption of health IT,
your agency found that 97 percent of hospitals and 74 percent
of physicians possessed a certified electronic health record
system. But only 76 percent of hospitals and 42 percent of
physicians with electronic health record systems were sharing
the information for the coordination of care. Why that big gap?
Dr. DeSalvo. Well, thank you for the question. I certainly
identified with Mr. Quinn also, both as a doctor who takes care
of those kinds of patients but also because of family members
as well. So as I said in my opening, it is pretty personal to
all of us to see that the data is moving.
The good news story in the data that you present is that,
over the course of the last many years, we have dramatically
increased not just adoption but the opportunity to move and
share data. So those are snapshot numbers. But if you look back
at the trajectory, every year it improves both for doctor
offices and hospitals. We are not where we want to be yet, but
we are making progress.
There are areas like the national capital region where
health information exchanges like CRISP make that data
available, such that if somebody arrives in an emergency room,
their primary care doc will get a ping and be able to have the
opportunity to send that med list or problem list, so that we
will actually know more about the person in the ER.
There are even more exciting advances happening, like in
Mississippi, where the State of Mississippi has been working
with local vendors to see that all of long-term data from their
Medicaid program is available to the doctors in the University
of Mississippi Medical Center, so that when somebody arrives,
you have a picture like you mentioned.
Mr. Connolly. You mentioned CRISP, but doesn't that require
a voluntary decision to participate?
Dr. DeSalvo. You are touching on the challenge that has
emerged since we have been adopting electronic health records
and moving to a digitized system, and that is that State laws
vary, and so there is a need to harmonize that.
Mr. Connolly. Right. That is a particular challenge here in
the national capital region, since we have three jurisdictions
with three different political cultures and sets of laws and so
forth.
I have actually encountered that, where Maryland has one
set of standards on this kind of communication and Virginia has
another, and we are not always talking, which what could go
wrong with that for someone's health? I mean, you could
jeopardize someone's health without intending to.
Now, do we need, from your point of view, and I welcome Ms.
Rich as well, or anyone else, but is this a case where,
frankly, we do need to look at some Federal legislation?
We regulate blood supply for safety. Well, electronic
recordkeeping is not just a nice thing to have. In the digital
age, it may be very critical to someone's health and the care
they get, especially in an emergent situation.
Dr. DeSalvo. In the short run, we have been working, the
Office of National Coordinator, with the National Governors
Association on developing a toolkit so States themselves can
harmonize their privacy expectations, so that won't be an
unnatural impediment to information flow.
Over the long term, clearly, the health IT landscape has
changed a lot since HITECH was passed in 2009. We were on iOS 3
then and now we are up to 6, just as one example. But apps and
cloud computing have really evolved.
So we certainly are leveraging all the opportunities that
we have at ONC and our partners, the Office of Civil Rights and
other agencies, to see that we are protecting consumers and
that data is going to flow. But there are areas where we know
that there may be some opportunity, like information-blocking,
where we would need some additional support.
Mr. Connolly. Thank you so much for this fascinating
conversation.
Again, Mr. Chairman, thank you.
Mr. Hurd. Sure.
Votes have been called. The committee stands in recess
until immediately following votes.
[Recess.]
Mr. Hurd. The Committee on Oversight and Government Reform
Subcommittees on Information Technology and Health Care,
Benefits, and Administrative Rules will get started again.
I appreciate our witnesses' and guests' patience as we went
to go vote. We shouldn't be interrupted.
To get us restarted is my friend from California, Mr. Lieu.
You are recognized for 5 minutes.
Mr. Lieu. Thank you, Mr. Chair.
Dr. DeSalvo, in your opening statement, you mentioned data-
blocking. Can you explain what that is and how it works?
Dr. DeSalvo. Yes, certainly, Mr. Lieu. Thank you for the
question.
Congress asked us to provide a report on health
information-blocking, which we did last April. We thank you for
that, because it generated a national conversation and set into
motion some actions that we have been taking in partnership,
for example, with the Office of Inspector General, also with
the Office of Civil Rights, to see that we unblock data that
has been collected in electronic health records.
This is a new challenge we wouldn't have had years ago when
we did not have a digitized system. It has emerged since 2009
when the HITECH Act put ONC and our authorities into place.
An example of it would be that I'm in a health system and
my patient records have been collected or digitized, and a
patient ends up in the emergency room at another hospital
across the street, and for whatever reason I'm not sure I can
share it, because I don't understand HIPAA, or maybe I don't
have a business associate degree that I think you need to have
to share data. And so when that patient shows up across the
street literally, the data is not moving. And it is just
because of a lack of understanding.
So that would be sort of an unknowing example. And by
educating about HIPAA, which is something we have been actively
doing, we hope to unblock that sort of data.
Sometimes it is more around business practices. People want
to hold onto patients or hold onto data and don't share it.
So we have asked and gotten pledges from the health IT
industry to say they won't block data. Now we are acting on
making sure that we can put some teeth to it.
But if I may, Congressman, it is an area where, since 2009,
the world has really evolved. That is why in our budget
request, we did put forward a proposal asking for some more
opportunities for us to be able to address blocking, and to see
that, where data could move, that it would.
We really welcome the chance to talk with you more about
the ways that we think we could have more opportunities to
address it.
Mr. Lieu. Just so I understand, sometimes you have data-
blocking because the doctor or hospital may not have
interpreted HIPAA correctly. Are there times where, in your
opinion, they are intentionally doing it to gain a competitive
advantage?
Dr. DeSalvo. We certainly heard plenty of reports about the
use of it to gain a competitive advantage.
Mr. Lieu. What about vendors? Do vendors sometimes do that
as well?
Dr. DeSalvo. Occasionally. The way that will occur with
vendors is they will require added fees, unexpected fees, to
create the interfaces, and that is a form of lack of
transparency but can also be a form of blocking.
Mr. Lieu. And in the HITECH law, do you believe there are
gaps that could address this? What can this committee or
Congress do to help on data-blocking?
Dr. DeSalvo. Yes, sir.
What we have asked for as part of our budget request are
some additional opportunities around defining it and giving us
an opportunity to require that vendors, for example, can't use
gag clauses to prevent providers from talking about some of the
contractual elements. Those are just a couple of the examples
that we've asked for.
So, yes, we do believe that, since the world has evolved,
there is a new need for us to have some additional
opportunities to protect the people who are using the systems
and, more importantly, to protect the data of the consumers.
Mr. Lieu. Let me switch to cybersecurity.
Hollywood Presbyterian Hospital in Southern California had
been attacked with malware. They had to give a ransom to get
their data essentially unencrypted, unblocked. Two more
hospitals, it was disclosed, were recently attacked in Southern
California.
What do you think we can do to help prevent those attacks?
And my understanding is that it is the Office of Civil
Rights that does cybersecurity?
Dr. DeSalvo. That's correct.
Mr. Lieu. And do you think that would be the appropriate
office or not?
Dr. DeSalvo. The Office of Civil Rights does have the
primary responsibility for privacy and security, and for
security breach investigations. We work with them in a variety
of ways to see that we are educating providers, clinicians, and
others to make sure that the functionalities, the capabilities
in electronic health records that we require to keep the data
secure, are actually used in the field.
We all know that there is a mix of both physical and
cybersecurity expectations, so tools like our security risk
assessment tool is a way that we educate providers to know in a
simple way how they can protect the data that is in there. So
there are some opportunities that we leverage, but we work
largely in partnership with the Office of Civil Rights.
Mr. Lieu. And does that office have a team of computer
folks that deal with cybersecurity issues?
Dr. DeSalvo. It is very tight partnership. They certainly
have experts in the area of HIPAA and cybersecurity and
privacy, and we work very hand in hand with them.
We, for example, recently released some additional guidance
for providers but also for consumers about access and security,
and have posted a series of joint blogs to make sure there is a
shared understanding of what security expectations there are.
You all, for example, asked the department to put together
a cybersecurity task force, and we have been working along with
others across the department to see that we put together that
task force. It just met for the first time last week, so we
thank you guys for raising that issue.
Mr. Lieu. Thank you. I yield back.
Mr. Hurd. I would like to pick up where Mr. Lieu left off.
So in OCR, they have lawyers so they understand HIPAA. Do they
have technical folks that can actually help with a breach or
the next ransomware attack?
Dr. DeSalvo. Congressman, I would not want to speak
specifically to the skill sets of their staff. What I can share
with you is that the Office of the National Coordinator, which
has technical staff, partners very tightly with the Office of
Civil Rights, just like we do with other agencies, to make sure
that we are bringing that talent to the table if it is
necessary.
Part of this task force as an example, which is with the
private sector, is to bring together the best minds in
cybersecurity and to work with not only ONC but OCR to see that
we are helping to advance the health care marketplace to adjust
to any new changes they need to in cybersecurity.
Mr. Hurd. Ms. Rich, why is there so much confusion around
HIPAA?
Ms. Rich. I can't speak to why there is confusion around
HIPAA, but I do know that there are many entities that are
outside of HIPAA that are under our jurisdiction, and that
includes all the health apps and the Web sites that take in
consumer-generated information, and that consumers may be
confused about whether there is a regulation that protects
their privacy in those areas, which is one of the reasons why
we think there ought to be a regulation that protects the
privacy and data security for the information collected by
those entities directly from consumers.
Mr. Hurd. Does FDA have responsibility in some type of
regulation in this space?
Ms. Rich. The FDA regulates medical devices, and that
includes some health apps. But generally, they are looking at
safety issues surrounding whether the app does what it says it
does. The privacy and data security issues of such entities is
generally in our care. And we have been working in this area
for over 15 years, and we have an extensive program to look at
the data security of these entities and take action--well,
educate them to start with and then also take action in
appropriate instances.
Mr. Hurd. So if it is a HIPAA violation, that is OCR's
jurisdiction. If it is generally something else, it may be you,
it may be FDA, it may be SAMHSA, or the PPACA. There are so
many of these different regulatory bodies, and my fear is that
it is hurting innovation. It is hurting the proverbial two guys
or two gals in a garage from creating something that can change
the way that we deliver health care.
Ms. Rich, I will get back to you on another question.
I wanted to ask Messrs. Quinn, DeCrescenzo, and Savage, and
then, Ms. DeSalvo, you answer after them, meaningful use, this
is a term that I have been hearing a lot over the last 16
months that I have been in Congress and how it was originally
designed to kind of spur companies from participating in EHR
programs. But what I am hearing is that it is actually getting
in the way of innovation.
I would like for you three gentlemen to comment on your
opinions on meaningful use. And, Ms. DeSalvo, I will let you be
the cleanup batter.
Mr. Quinn?
Mr. Quinn. So meaningful use was quite successful in
driving adoption of electronic health records. Without
meaningful use, we wouldn't have the rates of adoption today
that we see.
As is the case with my dad's example, that each individual
health care organization has an electronic health record and
may be beginning to exchange data doesn't mean that the net
result of it is the coordinated care, the shared health
information, that we all need. And the prescriptiveness of this
led some vendors and health care organizations to play to the
test.
What we need is to think ahead about the next generation of
technology that is needed to embrace, for example, the Internet
of Things, consumer-generated health data, the data that is
being unearthed with the genome, and these other sources, and
incorporate them into this so that we are not just thinking
about this program as an end unto itself, but as an enabler of
new technologies, new care models, et cetera.
Mr. Hurd. Thank you.
Mr. DeCrescenzo. Thank you, Mr. Chairman. I would certainly
second Mr. Quinn's opinion that meaningful use as it has been
affected in the last few years to dramatically increase use of
the EHRs, as Dr. DeSalvo mentioned earlier, in addition to some
of the new technologies that you mentioned, need now to be
considered, and also suggest that over the last 4 or 5 years
under meaningful use, we have learned a lot about how
technology is used and what are some of the other process and
incentive issues, including things like reimbursement
mechanisms that may or may not incent further use of electronic
medical records and other types of electronic digitization of
health information in a sharing around that.
So going forward, we believe that we need to be thoughtful
about what we have learned over the last 4 or 5 years, as we
look at additional regulation or requirements for expanding the
use of electronic medical records and allied technologies.
Mr. Hurd. Mr. Savage?
Mr. Savage. We agree that the meaningful use program has
been a major catalyst for improved adoption and use of health
IT. Patients have been seeing a lot of the benefit of that. As
I said in my testimony, there are still obstacles to overcome,
and more needs to be done.
But with the meaningful use program in our surveys, we saw
a doubling of online access from 2011 to 2014, from 26 percent
of patients with online access to 50 percent.
We see them using it for the kinds of things that are
really critical for delivery system reform that is coming. So
the access is important, but the meaningful use program is also
in 2017 to 2018 to provide much more robust functions around
patients sharing data with their providers, nonclinical data
that is nonetheless relevant to care, better correction of
errors, wearables, remote monitoring. And it will, indeed,
stimulate the kind of innovation that we are all looking for.
The version that is coming up also has APIs. We have tech
developers who are writing apps for using those APIs.
So important catalyst. Critical things are coming for
patients and family caregivers to help them with their care
planning.
Dr. DeSalvo. Thanks to these folks, I'm just going to talk
about going forward, because the health IT landscape and health
care has absolutely been changing and evolving. We are looking
to go forward after listening to providers, after seeing where
the health IT landscape is, to take the opportunity that was
made from the doc fix or the MACRA legislation and make this
program going forward more flexible, much more focused on
clinical outcomes and on interoperability.
Mr. Hurd. Thank you.
Mr. Cartwright, you are recognized for 5 minutes.
Mr. Cartwright. Thank you, Chairman Hurd.
I want to follow up that discussion with Mr. Savage a
little bit. I think a cornerstone of the health IT field are
the electronic health records, the digital version of a
patient's paper chart containing not just the patient's current
condition but also his or her medical history.
I have here, it looks like a Harris poll that NPWF
commissioned. Is that correct, Mr. Savage?
Mr. Savage. That is correct.
Mr. Cartwright. So this is entitled, ``Engaging Patients
and Families: How Consumers Value and Use Health IT.''
I will ask that this be made a part of the record, Mr.
Chairman.
Mr. Hurd. So moved.
Mr. Cartwright. It is a result of the Harris poll. I cannot
imagine how long this poll went, Mr. Savage, but it's pretty
hefty.
It was done in the spring of 2014, correct?
Mr. Savage. Correct.
Mr. Cartwright. Toward the end of it, there is a global
summary. And it showed that more than 50 percent of patients
want the ability to review their treatment plans, right?
Mr. Savage. Correct.
Mr. Cartwright. And that nearly 60 percent wanted to see
their doctors' notes, and that fully 75 percent of patients
wanted access to their test results electronically.
Have I got that correct, Mr. Savage?
Mr. Savage. Yes, we found great interest in all of those.
Mr. Cartwright. So that is the sort of information that
would be available in an electronic health record, correct?
Mr. Savage. Yes.
Mr. Cartwright. Okay. Is it easy for patients to get access
to their electronic health records right now?
Mr. Savage. The survey that you are referencing does
identify increased numbers of access, doubling from 26 percent
to 50 percent. For those who have it, it has become easier, but
the national partnership has also done work with the Get My
Health Data campaign, which has found that there are also
people without the access that they need and that there are
some barriers.
So I can either talk about on the survey side, or I can
share with you some of the barriers we found with the Get My
Health Data side.
Mr. Cartwright. The barriers I'm interested in.
Mr. Savage. We have tracers, volunteers who report to us
their experience with trying to get data, and everybody's story
is unique. But we do find some commonalities among those
stories.
So some of the significant barriers are a very complex,
time-consuming process in order to get access. So you and I, in
order to get access to our banking records, we just go down to
an ATM or access it through the Internet. That is not a time-
consuming process, for the norm.
But for access to health records, yes, it has been very
time-consuming for these individuals.
Records provided in a format that is not useful. You may
ask for it in an electronic format. You get a piece of paper by
snail mail.
Misunderstanding of what patient's rights to access are.
And perhaps one of the things that we've discovered most
recently is the use of unreasonable fees in order to--before
you can get access to your records. That may take the form of
you have asked for your information and, sure, here's the copy
and here's the bill, and it is a bill that you never expected.
Surprise. Or you are charged a per page fee when it is an
electronic record.
So there's actually been--the Get My Health Data campaign
has recommended that there be some comprehensive education
initiatives to try to help providers and patients alike
understand the requirements better.
And the OCR guidance that recently came out provides some
examples of the kind of innovative education efforts that we
really do need to see.
Mr. Cartwright. Dr. DeSalvo, pick up from there. What kind
of examples?
Dr. DeSalvo. So consumers have more access to their
information than they did previously, though it is not where we
think it needs to be. And as Mr. Savage mentioned in his
earlier comments, we have been pushing through the meaningful
use program and through other ways to get increased consumer
access.
We, in fact, just put out a challenge grant through the
Office of National Coordinator calling on the private sector to
take advantage of this API expectation that we put in
electronic health records to create very consumer-friendly apps
that would be on a smart phone and allow somebody, any patient,
to be able to access their health information and have more
opportunity to control it. So we are really excited to see what
the private sector is going to develop in the next few months
to make it easier to get more access.
The kinds of examples that get in the way of that,
technology certainly Mr. Savage mentioned, but they are
sometimes just a misunderstanding of HIPAA. The Congressman had
asked earlier why doctors don't understand HIPAA, and part of
it is we are not really well-trained in it in medical school.
This is, I think, a really important opportunity that the
medical education field has along the way to see that we
understand what HIPAA is and is not, and do not let it get in
the way. Also, the way sometimes it is enacted gets in the way
of consumers having access to their information.
It is, in essence, a form of blocking.
So, again, back to this comment of, the world has really
evolved and now there is data to be free, data to move. And the
primary concern is to see that it is there for that clinical
moment when you need it.
There are also many other important uses, so we are
leveraging all the tools we have, whether that is education or
clarity on rules and regs, but there's probably also some
additional needed attention and maybe some additional support
to see that blocking is never a reason that people do not get
their data.
Mr. Cartwright. So last question, my sense of it is that
the better access patients have to their medical records, the
better we all are in terms of patient safety.
Does anybody disagree with that? Let the record reflect
they are all shaking their head no, Mr. Chairman, and I yield
back.
Mr. Hurd. Thank you, sir.
I would now like to recognize Ms. Lujan Grisham for 5
minutes.
Ms. Lujan Grisham. Thank you, Mr. Chairman. I think I
probably want to take off from where my colleague was leading
you all, Mr. Cartwright.
I actually think in addition to the blocking and
misunderstanding that we have seen two principles in HIPAA be
determined--and as an attorney, I feel bad about this--but sort
of a legal opinion that you have two mutually exclusive
premises. One, patient protection, and the other would be the
portability of that information, and they err on the side they
are absolutely in their minds mutually exclusive, so they go to
privacy.
I just had this happen with a very large, very recently,
health care provider who argued with me--and HIPAA, I spent a
lot of time dealing with HIPAA, so it wasn't--I won, because
the CEO of the health care company refused to provide the
patient information from provider to provider.
Actually, I was trying to do them a favor, right? I have
labs that are 45 days out. I get a patient who calls my office
as a constituent and says I have to have them because my
specialist can't do what they need to do without the records
from this other provider. I said, let me just call, because I
know I don't need really anything else, provider to provider,
just do it. And basically I'm helping you, because God forbid
we find something in those labs that indicate to your lawyers
that you have a real liability.
And then second, they wouldn't do it, because HIPAA
prevents that, as you all know it absolutely does not. For the
audience, it does not prevent that. It explicitly provides for
that.
Then in addition, to make it easy for them, I was willing
to get the patient on the phone, with plenty of patient
identifiers. And HIPAA, according to this provider, also
explicitly prohibits not having someone where you have really
restrictive proof that that is the patient. I said that is
nowhere in there. That is your own system, which gets to that
it is proprietary, it is not interoperable, and that while we
are to doing I think great strides to make this information
available, that unless we deal with that, you can't really
create a patient record.
I have to have apps for, right now, let's see, I'm old,
that would work with about 47 different providers. Now that I
am lucky enough to have this job, I have to have to add all the
providers that are in D.C. that I guarantee you do not speak to
any of my providers in Albuquerque.
So that was a typical-for-me, long-winded statement that
our intentions here and meaningful use and all the incentives
and including many of the accountability mechanisms really
haven't gotten us to what we really want, which is very
effective patient records, because if we want patients to be
part of problem-solving, and you do. If I get access to my
record, I find all kinds of stuff that my docs didn't see
because they are busy. I feel bad about that. I love them. They
are my docs, so I really like them, or my practitioners.
But they do not have the time to search through stuff,
which is why every time you go, they have to do a whole new
history because they have to ask me, because it is much faster.
But what happens when about 20 years from now, I can't remember
for a whole variety of reasons?
So what additional incentives can we use? And you sort of
floated around many, right?
But I also want a milestone check, because I have also been
working on telehealth for more than 2 decades. Quite frankly,
the reimbursement issues and the other barriers really simply
have not made it available in the places where the technology,
not only in juxtaposition to physician consultations or
physician-to-patient consultations, but now you have the
ability to do incredible online diagnostics. And yet, we aren't
really doing it.
So what are some really great milestones and mechanisms
that this committee can help you achieve, to that end?
Anyone? All of you? Everyone?
Ms. Rich. I would just like to comment that I do think an
obstacle to uptake on the part of consumers is concern about
privacy, an obstacle to uptake of use of electronic records.
Regardless of what a lot of consumers think about privacy
in other contexts, we do know that they care a lot about
privacy when it comes to their health records, which can reveal
truly personal information. So from the perspective of somebody
that is talking about privacy, we would like to see stronger
protections that make sense. Yes, it is a balance. Stronger
protections for data ----
Ms. Lujan Grisham. Where do you see the balance? And nobody
I think on this committee is making any sort of statement that
we should reduce privacy protections. But when they become an
obstacle--that does not diminish the protection of privacy, we
have a really big problem here.
I gave you one illustration. There are many. But what is a
milestone to not diminish the protections that we are all
interested in, but to get us to real patient records, serious
interoperability, not just provider to provider because of
proprietary, but as you mentioned in an earlier meeting, within
our hospital equipment, which creates huge patient outcome
issues, that is not a privacy issue, and gets us to telehealth,
all the different kinds of things I know that you all are
promoting?
I don't know if the chairman is going to let me keep going.
What a good guy.
Mr. Hurd. Mr. Quinn can answer that question.
Mr. Quinn. I would say a wonderful milestone is getting to
50 percent alternate payment models by 2018, as HHS has
proposed, and that Intel, eating our own dog food or, as my
colleague says, drinking our own champagne, including in
Albuquerque, where we have a huge facility ----
Ms. Lujan Grisham. We would like that to be bigger.
Mr. Quinn. Thirty-three-thousand employees are today
participating in our Connected Care program. The real enabler
of this is, of course, that there is something called the
Sequoia Project that makes interoperability possible in
connecting 150 different EHRs, but more importantly, that we
are directly contracting with the providers in that area and we
have purchasing power.
We are doing this in Albuquerque. We are doing it in
Portland. We are doing it in Arizona.
Intel is a big purchaser, and we said you are going to
participate as part of this, and we are going to collect these
metrics.
The same is happening on this national basis, this 50
percent. Fifty percent I think is a real tipping point, because
you can't live in two different worlds. You can't live in the
fee-for-service world and the alternate-payment world.
The sooner we can get there, the better. We can't let up on
the accelerator.
Ms. Lujan Grisham. Okay, thank you.
Mr. Hurd. Thank you, Mr. Quinn.
Raise your hand if you have suggestions on how to harmonize
privacy laws, and which privacy laws and regulations need to be
harmonized?
Mr. Savage, your organizations don't have opinions?
Mr. Savage. We do. We don't look at them as harmonization.
We look at them as protecting privacy for patients in all the
different States.
Mr. Hurd. So I would like all of you all to submit those
ideas, those white papers, to the committee for the record, so
we can review those and see if that can be an area that we look
at.
I would be remiss if I don't ask a cybersecurity question.
Ms. Rich, this is for you, and I am not interested in any
particular company or something like that. What do you think is
the biggest threat right now to health information and our
citizens' health data?
Ms. Rich. There are a few. One is failure by companies
still to take this as seriously as they should. There has been
a lot of progress in recent years, but we are still seeing not
enough attention focused on this issue.
Congressman Lieu also mentioned ransomware, which is
something that is on the rise and is particularly on the rise
when sensitive information is collected, because of the great
interest in protecting that information, so the ransomware
tactics are more likely to succeed.
We are seeing that more and more in our cases, and we are
looking at this issue ourselves, and maybe doing something
publicly on that.
But the number one issue is still the failure to pay enough
attention to this issue, among many, many companies.
Mr. Hurd. Mr. DeCrescenzo?
Mr. DeCrescenzo. Obviously, Ms. Rich has her perspective,
what I think at the HLC, we are taking this very seriously. And
we see across providers, payers, pharmacies, everybody who is
part of HLC, an enormous amount of investment and forward-
thinking on what to do about the problems that you described,
for example, at Hollywood.
I think one of the challenges everyone needs to recognize
is that we are also trying to constrain costs as much as
practicable in the U.S. health care system. And all these
things come at a cost. And there is not necessarily as much
freedom, or maybe should there be, to be able to capture
reimbursement in order to reflect those costs.
So I think it is a very difficult barrier when you think of
the resources that are applied anywhere from telecommunications
to banking to other industries around cybersecurity, the fact
that we have all described the importance of personal health
information, and recognizing that many of these institutions,
including many hospitals I'm sure in your districts, are
already struggling to deal with a number of other aspects of
successfully providing patient care.
So I think we certainly see people taking it very
seriously. As I'm sure you're aware, many people go into the
medical profession because they have that commitment to
patients, their data, and privacy.
So I think one of the things we need to consider is how
well is reimbursement reflecting the cost of doing a good job
at it.
Mr. Hurd. Ms. Rich, what has been the biggest fine that FTC
has issued on a private company for violating our privacy? We
don't need to know the situation, just what is the dollar
amount? And can you describe the situation?
Ms. Rich. We actually, in the initial instance, don't have
fining authority in the data security area in general. We do
when it involves kids' information or consumer credit data. But
in the general data security work we do, we do not have the
authority to obtain any penalties.
That is, I think, something that we seriously need in order
to create different incentives here.
Mr. Hurd. If a private company would have lost the
information on 23 million records, what would FTC have done?
Ms. Rich. In the abstract, it is hard to say. Each
violation, if we had civil penalty authority, just borrowing
from the authority that we have in other areas, every violation
could amount to a $16,000 penalty. So if you add that up over
millions of consumers, it's potentially infinite. But, of
course, we take the ability to pay, et cetera, into account.
But the fines could be quite high for a company that had
very serious violations and injured a lot of consumers.
Mr. Hurd. Thank you.
Now to close this out, Mr. Blum, you are recognized for 5
minutes.
Mr. Blum. Thank you, Chairman Hurd, for holding this most
important hearing.
And thank you to all the panelists today for your insights.
I appreciate it very much.
Telehealth, telemedicine, has absolutely intrigued me since
I have been in office the last 15 months. When we talk about
rising health care costs in the country, I know many citizens
want a silver bullet, one answer, one thing that is going to
solve the increasing health care costs.
I kind of believe, pardon my pun, I believe it has been
death by 1,000 cuts, the increase in health care costs. It has
been a lot of small things. And I think one piece of the
puzzle, the solution to keeping health care costs in line, is
telehealth or telemedicine, and particularly in our veterans'
care system with the psychiatric care, PTSD.
I know in Iowa, it is rural, so we don't have a lot--in all
the outpatient clinics for vets, we don't have a psychologist
or psychiatrist on staff. So telemedicine is a great
application there.
I would like to ask all the panelists, what policy changes
do you think are necessary so there is 100 percent--100
percent--telehealth participation by providers and by
hospitals? I see it as critically important to saving the
government money and also improving the outcomes of our
patients.
So whoever would like to take that, jump on it, please.
Dr. DeSalvo. Congressman, perhaps I will begin and say that
I share your enthusiasm for telehealth. As a doctor, I have had
the opportunity to use that, particularly for access to
psychiatric care in my home community of New Orleans after
Katrina, when we had really a lack of services. As a rural
State, we have been able to leverage that as well.
So as a care delivery model, very well-received, and can
also save people money, because they don't have to take off of
work and find health care, et cetera, to go to the sites. It is
less of a technology issue and more of, I think, an opportunity
as we move to alternative payment models.
So as the VA has been able to show and the private sector,
and certainly through some of the work that the department has
done with these models in the Center for Medicare and Medicaid
Services, we have been working to advance that as an
administration, in partnership with the private sector.
I think it is something that we see as a department an
opportunity in the delivery system reform work that is moving
to alternative payment models, such as in the MACRA legislation
that is required for docs. It is going to give us a lot of
opportunity to really enable and support new kinds of care
models.
So from our standpoint, we believe that, with the
department, we really believe that we are moving forward into
this world and that the MACRA legislation for docs, in
particular, is going to be helpful.
Mr. Blum. You are a medical doctor, correct?
Dr. DeSalvo. Yes.
Mr. Blum. I know you cannot speak for the medical
community, but what is your impression or your opinion of the
medical community's opinion of telemedicine? Is it a good one?
Or do they say this isn't that good?
Dr. DeSalvo. So I can't speak for the medical community, so
I will speak for myself and my peers, that there are some real
benefits to it.
Speaking purely as a doctor, I think one of the challenges
is there is a lot that you gain from being in the room with a
patient, you can touch them, you can listen to them in a way
you can't necessarily through technology. So a mix of kinds of
interaction is typically what we want. We wouldn't want it to
all to be remote, because you also gain something from that
touch in that exam room.
Mr. Blum. Absolutely.
Others? Yes, sir?
Mr. DeCrescenzo. Congressman, one other thing I would
mention is harmonization of standards across the States.
Obviously, with telemedicine, as you described, it is
something that brings the ability to provide care across
distance. And, of course, many of the States are quite large,
so it is urban to rural and various other ways. It certainly
would facilitate the growth of telemedicine in a very important
fashion.
But in addition, there is quite a patchwork of regulations
and standards on a State basis across the country, so the
ability to leverage perhaps highly specialized care outside the
State is often more difficult for somebody looking to put
together a national network or even nationally focused
providers like Cleveland Clinic and others who have a very
large footprint across the country.
Mr. Blum. And what would the solution to that be? Is there
an easy one? I like easy solutions.
Mr. DeCrescenzo. Well, we have 50 States, so I doubt there
is an easy one.
But I think there is increasing, I would say, similarity
between the regulations of different States as they become more
familiar with this. And perhaps like a lot of the work ONC and
others have done around harmonization of technology standards,
we would hope there would also be a similar effort to harmonize
the standards and regulations around telemedicine.
Mr. Blum. Yes, ma'am?
Ms. Rich. The FTC in the competition area, which I don't
personally work, but we have done a good deal of work on
breaking down barriers to competition that may hold back
certain alternative forms of medicine.
For example, we have commented to States that may have laws
that favor certain medical techniques over others in a way that
interferes with competition through State laws. So competition
is very important in this area.
Mr. Blum. Do I have time for one more question, Mr.
Chairman?
Mr. Hurd. Thirty-nine seconds.
Mr. Blum. One of the major barriers preventing a focus on
home-based health care versus expensive hospitalization--
another area I am very interested in, is keeping that person in
their home as long as we possibly can or getting them back to
their home as quick as we can. Thoughts on that?
Mr. Savage. I would jump in and say that is a good
illustration of perhaps an interoperability issue. We want to
make sure that the patient's home is connected with the system.
So you want access. You want the patient to be able to send
remote monitoring information to the doctor's clinical record.
These are things that are actually in the process of being
developed on a national level.
That kind of two-way communication between the home and the
doctor's system also contributes to care planning, so that you
actually have working together to manage the care and to move
from care to health.
Mr. Blum. This could apply to nursing homes as well,
correct?
Mr. Savage. That's correct.
Mr. Quinn. I would say that one of the things that really
is lacking today is ensuring that those home-based applications
have a market. So today without the reimbursement for many of
those things, the market hasn't blossomed the way that it
could. Many of the applications and the tools aren't
necessarily designed for a 78-year-old or maybe somebody with
disabilities who is at home.
Ensuring that that, frankly, consumer marketplace with the
technology that is rigorous enough to be trusted and
incorporated into the health care system is built and that
there is a marketplace for it, because there is reimbursement,
there is a path for investors to say there is something here.
Mr. Blum. That's a good point. Thank you very much for your
input. I appreciate very much.
With that, I yield the time that I do not have.
Mr. Hurd. I would like to thank Mr. Lieu and Mr. Cartwright
for the bipartisan nature in working on this topic. It is
important for an exchange of information.
And I appreciate our witnesses taking the time to appear
before us today and for your patience.
If there's no further business, without objection, the
subcommittees stand adjourned.
[Whereupon, at 4:22 p.m., the subcommittees were
adjourned.]
APPENDIX
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