[Senate Hearing 114-697]
[From the U.S. Government Publishing Office]
S. Hrg. 114-697
ACHIEVING THE PROMISE OF HEALTH INFORMATION TECHNOLOGY: IMPROVING CARE
THROUGH PATIENT ACCESS TO THEIR RECORDS
=======================================================================
HEARING
OF THE
COMMITTEE ON HEALTH, EDUCATION,
LABOR, AND PENSIONS
UNITED STATES SENATE
ONE HUNDRED FOURTEENTH CONGRESS
FIRST SESSION
ON
EXAMINING ACHIEVING THE PROMISE OF HEALTH INFORMATION TECHNOLOGY,
FOCUSING ON IMPROVING CARE THROUGH PATIENT ACCESS TO THEIR RECORDS
__________
SEPTEMBER 16, 2015
__________
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Pensions
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COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS
LAMAR ALEXANDER, Tennessee, Chairman
MICHAEL B. ENZI, Wyoming PATTY MURRAY, Washington
RICHARD BURR, North Carolina BARBARA A. MIKULSKI, Maryland
JOHNNY ISAKSON, Georgia BERNARD SANDERS (I), Vermont
RAND PAUL, Kentucky ROBERT P. CASEY, JR., Pennsylvania
SUSAN COLLINS, Maine AL FRANKEN, Minnesota
LISA MURKOWSKI, Alaska MICHAEL F. BENNET, Colorado
MARK KIRK, Illinois SHELDON WHITEHOUSE, Rhode Island
TIM SCOTT, South Carolina TAMMY BALDWIN, Wisconsin
ORRIN G. HATCH, Utah CHRISTOPHER S. MURPHY, Connecticut
PAT ROBERTS, Kansas ELIZABETH WARREN, Massachusetts
BILL CASSIDY, M.D., Louisiana
David P. Cleary, Republican Staff Director
Evan Schatz, Minority Staff Director
John Righter, Minority Deputy Staff Director
(ii)
C O N T E N T S
__________
STATEMENTS
WEDNESDAY, SEPTEMBER 16, 2015
Page
Committee Members
Collins, Hon. Susan M., a U.S. Senator from the State of Maine,
opening statement.............................................. 1
Warren, Hon. Elizabeth, a U.S. Senator from the State of
Massachusetts, opening statement............................... 2
Murphy, Hon. Christopher, a U.S. Senator from the State of
Connecticut.................................................... 4
Alexander, Hon. Lamar, Chairman, Committee on Health, Education,
Labor, and Pensions............................................ 27
Franken, Hon. Al, a U.S. Senator from the State of Minnesota..... 28
Isakson, Hon. Johnny, a U.S. Senator from the State of Georgia... 30
Murray, Hon. Patty, a U.S. Senator from the State of Washington.. 31
Cassidy, Hon. Bill, a U.S. Senator from the State of Louisiana... 33
Baldwin, Hon. Tammy, a U.S. Senator from the State of Wisconsin.. 36
Whitehouse, Hon. Sheldon, a U.S. Senator from the State of Rhode
Island......................................................... 37
Witnesses
Ratwani, Raj, Ph.D., Scientific Director, National Center for
Human Factors in Healthcare, MedStar Health; Assistant
Professor of Emergency Medicine, Georgetown University School
of Medicine, Washington, DC.................................... 3
Prepared statement........................................... 6
Giusti, Kathy, MBA, Founder and Executive Chairman, Multiple
Myeloma Research Foundation, Norwalk, CT....................... 11
Prepared statement........................................... 13
Dishman, Eric, Intel Fellow, General Manager for Health and Life
Sciences, Intel Corporation, Hillsboro, OR..................... 15
Prepared statement........................................... 17
(iii)
ACHIEVING THE PROMISE OF HEALTH INFORMATION TECHNOLOGY: IMPROVING CARE
THROUGH PATIENT ACCESS TO THEIR RECORDS
----------
WEDNESDAY, SEPTEMBER 16, 2015
U.S. Senate,
Committee on Health, Education, Labor, and Pensions,
Washington, DC.
The committee met, pursuant to notice, at 10 a.m., in room
SD-430, Dirksen Senate Office Building, Hon. Susan Collins
presiding.
Present: Senators Collins, Alexander, Isakson, Kirk,
Cassidy, Warren, Murray, Franken, Bennet, Whitehouse, Baldwin,
and Murphy.
Opening Statement of Senator Collins
Senator Collins. Good morning. The Senate Committee on
Health, Education, Labor, and Pensions will please come to
order.
First, let me express my appreciation to our committee
chairman, Senator Lamar Alexander, for asking me to chair this
hearing. Also, let me welcome Senator Warren, who will be
serving as the Ranking Member today.
Today's hearing is the fifth in a series of hearings that
this committee has held on health information technology. We
have heard about the problems with the HITECH Act, particularly
regarding the ability of electronic health record systems to
exchange and use electronic health information. Either systems
are not talking at all, or they are doing so in a way that is
not particularly helpful. We have also heard about the
significant burdens posed by what is known as the meaningful
use standards.
This committee has formed a Health IT Working Group to help
identify ways that the Congress and the administration can work
together to improve the exchange of health information, which
continues to hold such great promise. But there remains a great
deal of frustration to many physicians and other healthcare
professionals, to hospitals and clinics, and, most of all, to
patients.
Today, the committee is seeking the advice of our expert
panel of witnesses on how to improve care through patient
access to their own health records. We also want to get the
insights of our panel into the challenges patients and
providers currently face. Our fundamental question is this: How
can electronic health records be improved to better serve
patients?
With health IT, we have the potential to improve the
patient experience and involvement in their own care, to
strengthen care coordination, to improve outcomes for patients,
and to empower patients, if they so choose, to share their
information with researchers to help drive the discovery,
development, and delivery of new treatments and cures.
Yet, according to the Office of the National Coordinator
for health IT's consumer survey, only 28 percent of Americans
were offered access to online medical records in 2013, 54
percent didn't access their records, and 21 percent viewed them
only once or twice. We're going to try to better understand why
that is so.
Many patients are still filling out paper forms every time
they visit the same doctor, and collecting their information in
piecemeal fashion from each individual doctor visit and trip to
the hospital, making monitoring health, sharing information
with a family member, enrolling in a clinical trial, or
requesting a correction an unnecessarily burdensome process.
For those with chronic conditions and seeing multiple providers
on a regular basis or for those facing a sudden and life-
threatening illness, this can be particularly exhausting and
frustrating and have consequences for the care that a patient
receives.
An interoperable, patient-centered system could alleviate
these frustrations. In the State of Maine, the health
information exchange operated by HealthInfoNet is completing a
pilot project on patient engagement. InfoNet has found that
patients want access to all their information, not just static
downloading of summaries, and that current data standards limit
the types of information that can be accessed by patients.
They have also highlighted that the meaningful use
provision that requires individual providers to have their own
patient portals has led to fragmentation, patient frustration
with having to access multiple portals, and a lack of
incentives for investment in patient access capabilities that
extend beyond a single provider.
To better serve patients, we need systems and flows of
information and data that allow better communication and that
have better utility for clinicians and for their patients. At
the same time, the security and the privacy of patients'
personal health information must be assured in an age where at
least two major insurers, as well as government agencies
storing sensitive personal information, have had their computer
networks hacked.
I look forward to hearing from all of our witnesses and
again want to thank the chairman for allowing me to chair this
important hearing today.
I am now pleased to turn to Senator Warren for her opening
statement before introducing our prestigious panel.
Senator Warren.
Opening Statement of Senator Warren
Senator Warren. Thank you, Senator Collins, and thank you,
Senator Alexander and Senator Murray, for calling this hearing
and for asking us to preside here. I am very much looking
forward to this.
This hearing is part of an ongoing series on health
information technology. We've previously discussed the views of
doctors, of hospitals, and of electronic health record vendors.
Today, we're going to talk about how health IT can work for
patients.
Patients want access to their own health data, and they
should have an easy way to do that. Making sure that patients
have access to their own information is also the best way to
engage patients in their own healthcare and to improve
outcomes.
We've come a long way from the time when doctors wrote all
of their notes in paper charts and then filed them away until
the next visit. But we still have ways to go before we have the
kind of interoperable, consumer-friendly system that will make
sure that patients can actually see their own information and
that will give access to that information to different doctors,
hospitals, and other healthcare providers.
In 1996, when Congress passed the Health Insurance
Portability and Accountability Act, or HIPAA, it set important
privacy standards, and it made clear that patients have a right
to see their own medical records and a right to send their
medical records to other physicians. In 2009, Congress expanded
those rights with the HITECH Act, encouraging hospitals and
doctors to set up electronic health record systems.
Today, after a Federal investment of more than $30 billion,
most medical records are digital. But there is a huge problem.
The systems still don't talk to each other very well. That
means that too many patients who try to access their records or
who try to transfer from one doctor to another can't do so
electronically. This lack of interoperability imposes other
costs: wasted medical tests, wasted time, and wasted money.
A 2014 study from the University of Michigan found that
emergency rooms that shared electronic health records through a
regional information exchange ordered fewer duplicate medical
tests. Patients in these ERs were 59 percent less likely to
have a redundant CT scan, 44 percent less likely to get a
duplicate ultrasound, and 67 percent less likely to have a
duplicated chest x-ray than patients who visited unconnected
hospitals. That's better care at lower costs.
We know that interoperability works. Individual health
plans, hospitals, regional networks, and even big private
companies like Intel have done it. The Federal electronic
health records programs have taken us part of the way toward
making sure that all patients and providers around the country
have access to an interoperable system.
There's more work to be done, and here's what I think we
still need to do. We need a standard format for recording and
sending test results and other medical information. We need a
way to accurately identify which records belong to which
patient. We need incentives to encourage doctors and electronic
health vendors to share information.
The Federal Government has invested billions of dollars in
health information. It is now time to implement policies that
create a system that works across the board.
I appreciate our witnesses being here today, and I'm
looking forward to a discussion about how we can make sure that
health information systems are efficient and that they work for
patients.
Thank you, Madam Chair.
Senator Collins. Thank you very much for your excellent
statement.
We're now going to hear from our panel of witnesses. I
would note that we have excellent attendance today at our
hearing, and to each Senator will be allocated 5 minutes for
questioning of our panel.
First, we're going to hear from Dr. Raj Ratwani, the
scientific director for Human Factors in Healthcare at MedStar
Health. Dr. Ratwani has studied electronic health records and
has significant expertise in the usability and usefulness of
health information technology in meeting the needs of patients
and clinicians.
Our second witness I am going to defer to Senator Murphy to
introduce at this point, and then I will introduce our third
witness.
Statement of Senator Murphy
Senator Murphy. Thank you very much, Madam Chair. We're
really excited to have with us a fantastic leader on behalf of
patients, Kathy Giusti. She's not only the founder and
executive chairwoman of the Multiple Myeloma Research
Foundation, which is based in Norwalk, CT, but she's also a
multiple myeloma patient. The foundation has a really unique
end-to-end system in precision medicine and is accelerating new
treatments for patients.
Quite justifiably, she serves on the White House Precision
Medicine Initiative Working Group and also serves at Harvard
Business School as part of their Health Advisory Board. I'm
really excited to have Kathy with us today.
Thank you, Madam Chair.
Senator Collins. Thank you.
Finally, we will hear from Eric Dishman, the general
manager for Health and Life Sciences at Intel Corporation. Mr.
Dishman, a cancer survivor, has been driving healthcare
innovation in California companies for 25 years. He and his
team are focused on developing pioneering technologies to
enhance the patient experience.
I want to thank all of you for joining us today and ask
that you try to summarize your statements in 5 minutes. We will
put your full statements in the hearing record. If you go over
a little bit, that's OK. People are chomping at the bit to ask
you questions.
Dr. Ratwani, we will start with you.
STATEMENT OF RAJ RATWANI, Ph.D., SCIENTIFIC DIRECTOR, NATIONAL
CENTER FOR HUMAN FACTORS IN HEALTHCARE, MEDSTAR HEALTH;
ASSISTANT PROFESSOR OF EMERGENCY MEDICINE, GEORGETOWN
UNIVERSITY SCHOOL OF MEDICINE, WASHINGTON, DC
Mr. Ratwani. Good morning, Madam Chair Collins, Ranking
Member Warren, Senators Alexander and Murray, and distinguished
members of the committee. Thank you for the opportunity to
speak with you today. I am Raj Ratwani, scientific director for
MedStar Health's National Center for Human Factors in
Healthcare, part of the MedStar Institute for Innovation, and
Assistant Professor of Emergency Medicine at Georgetown
University.
Our center is a unique collaboration between human factors
experts and clinicians who focus on applying human factors
principles to the Nation's most challenging healthcare issues.
Human factors engineering is the science of designing systems
to meet human capabilities, and the pressing issue of patient
access to health information that we're discussing today can
benefit tremendously from a human factors approach.
Patients should have access to their own health information
to improve health outcomes, facilitate patient and family
engagement in care, and to reduce safety risks. The
digitization of health information offers a tremendous
opportunity. However, the usability of electronic health
records, patient portals, and personal health records remains
subpar, but is a challenge that can be overcome.
Usability of health IT systems impacts patient safety and
is crucial to adoption and effective use. In most cases,
patient portals and other health IT have not been designed to
support patient needs and does not present information in a
manner that is understandable and useful. Consequently, these
technologies are underutilized by the public.
A more sophisticated approach to the design of this
technology should be undertaken to realize the full potential
of health IT. The application of user-centered design uses
established iterative design methods to develop an
understanding of the characteristics of the people who use
technology. This includes what their information needs are, how
they process the information, and how they'll use the
information to make decisions.
A common misunderstanding is to think that usability is
only about basic screen design, such as font size, color, and
layout. A more critical aspect to good usability is the degree
to which the functionality and design of the system supports
the decisions and actions that are critical to the typical
needs of patients and clinicians. Patients and clinicians are
able to comprehend, reason, and gain insight from health
information only when the systems work in concert with the way
patients and clinicians think.
Three critical factors that have a tremendous impact on
patient use of health IT are access, functionality, and
information quality. All three are directly impacted by
usability.
The first critical factor is access. Patients should be
able to easily access all of their health information securely
and in one place. Interoperability will be important for
improving access as long as the information is integrated in a
way that is meaningful for patients.
The second is functionality. The information and
capabilities of the system must be useful for the patient. The
design of system capabilities, such as patient-provider
communication, should be intelligently integrated with the
workflow processes of the clinician so the clinician can
respond to patients in a timely manner.
The third is quality of information. Information must be
accurate and presented in a manner that can be easily
understood. This requires an in-depth understanding of how
patients use their health information, recognizing that a
diverse population with varying levels of health literacy may
use this technology.
These examples are a brief snapshot of the usability
challenges that require attention.
It's important to recognize user-centered design is a well-
established method for developing effective software systems.
Other high-risk industries, such as aviation and defense, have
embraced human factors and user-centered design. Regulatory
bodies in these industries closely inspect usability processes
before any technology is implemented. It should be noted that
no technology enters the cockpit of an airplane before the
usability is inspected and found to meet detailed standards.
It is promising that the Office of the National Coordinator
has initiated efforts to mirror this in health IT with safety
enhanced design. However, our research has shown that few
health IT vendors have embraced this approach.
This represents a huge opportunity. In order to achieve the
promise of health IT and advance health, the recommendations to
the committee are, No. 1, to refocus certification requirements
to implement clear standards and guidelines to ensure
usability; No. 2, to encourage clear and transparent indicators
of the usability of health IT systems to better inform the
public, critically, providers, patients, and clinicians; and
No. 3, to review barriers and identify opportunities to promote
innovation that improves usability.
Thank you, and I look forward to questions.
[The prepared statement of Dr. Ratwani follows:]
Prepared Statement of Raj M. Ratwani, Ph.D.
summary
Patients must have easy access to their health information to
improve health outcomes, facilitate patient and family engagement in
care, and to reduce safety risks. Critically, this information must be
presented in a manner that is both understandable and useful. One of
the biggest barriers to patient access to their health information is
the usability of current health information technology (patient
portals, personal health records, and electronic health records).
Usability is not only about basic screen design such as font size,
color, and layout, but its functionality and design to support the
decisions and actions that are critical to the typical needs of
patients and clinicians. Understanding the needs of patients and
clinicians is a difficult process that many vendors do not properly
engage in. A more sophisticated approach to the design of this
technology must be undertaken to realize the full potential of health
IT. Health IT vendors must embrace user-centered design, a process that
focuses on understanding the characteristics of the people intended to
use the technology, what their information needs are, how they process
this information, and how they will use the information to make
decisions.
Shortcomings of current patient use of health IT include Access,
Functionality, and Information Quality. All three are directly impacted
by usability.
Access. Patients should be able to easily access all of
their health information, securely, and in one place. Interoperability
is crucial in achieving access.
Functionality. The information and capabilities of the
system must be useful for the patient. The design of system
capabilities, such as patient-provider communication, should be
intelligently integrated with the workflow processes of the clinician
so that the clinicians are able to support the patient in a timely
manner.
Quality of information. Information must be accurate and
meaningful to the patient, presented in a manner that can be easily
understood, and that will help them gain insights. This requires an in-
depth understanding of how patients use their health information and
recognition that patient portals serve a diverse population with
varying levels of health literacy.
There are ONC certification requirements in place to promote
usability under Safety Enhanced Design. However, many vendors have not
embraced this approach and are not adhering to the certification
requirements. Further, there are no formal guidelines for the design
and development of patient portals as part of the EHR.
To make advancements we must (1) refocus certification requirements
to promote true usability in design, development and implementation,
with an understanding of industry constraints, (2) increase
transparency around the usability of health IT systems, and (3) spur
competition and innovation in the marketplace by making it easier for
new vendors to develop products.
______
Good morning Chairman Alexander, Ranking Member Murray and
distinguished members of the committee. Thank you for the opportunity
to speak with you today.
I am Raj Ratwani, scientific director of MedStar Health's National
Center for Human Factors in Healthcare, part of the MedStar Institute
for Innovation, and assistant professor of emergency medicine at
Georgetown University. Our Center benefits from a unique collaboration
between clinicians and human factors experts who focus on applying the
science of human factors to the Nation's most challenging healthcare
issues. One of those issues is patient access to health information.
Patients must have easy access to their health information to
improve health outcomes, facilitate patient and family engagement in
care, and to reduce safety risks. Critically, this information must be
presented in a manner that is both understandable and useful. The
digitization of health information offers a tremendous opportunity to
improve care, however, the usability of electronic health records,
patient portals, and personal health records remains subpar and is a
significant challenge that we must overcome immediately. While some
have suggested that the low utilization rate of patient portals is from
a lack of interest, we know that it is because in most cases the
portals have not been designed using methods to optimize the system's
responsiveness to patient needs. There is overwhelming evidence that
usability of health IT systems impacts patient safety and that it is
crucial to adoption and effective use. It takes a very deliberate and
robust effort by specialized staff to develop health IT systems with
good usability, and this fact is not always fully appreciated in the
industry.
A more sophisticated approach to the design of this technology must
be undertaken to realize the full potential of health IT. The
application of user-centered design, in the development of health IT,
uses established iterative design methods to develop an understanding
of the characteristics of the people who use technology, what their
information needs are, how they process this information, and how they
will use the information to make decisions.
Other complex high risk industries invest heavily in this human
factors approach, including aviation, defense, and nuclear energy.
Healthcare has been slow to adopt the human factors approach and slow
to make advancements that would facilitate a more aggressive adoption
of this approach to optimize the safety, usefulness, and efficiency of
health IT.
A common misunderstanding is to think that usability is only about
basic screen design such as font size, color, and layout, the more
critical aspect of good usability is the degree to which the
functionality and design of the system supports the decisions and
actions that are critical to the typical needs of patients and
clinicians. Patients and clinicians are able to comprehend, reason, and
gain insight from health information only when the systems work in
concert with the way patients and clinicians think.
Three critical factors that have a tremendous impact on patient use
of health IT are: Access, Functionality, and Information Quality. All
three are directly impacted by usability. Without robust user-centered
design processes that are led by trained professionals, naive, clunky
systems are developed that don't serve patients needs, and are
therefore underutilized by the public.
The first critical factor is Access. Patients should be able to
easily access all of their health information, securely, and in one
place. Interoperability is crucial for patient access.
The second is Functionality. The information and capabilities of
the system must be useful for the patient. The design of system
capabilities, such as patient-provider communication, should be
intelligently integrated with the workflow processes of the clinician
so that the clinicians are able to support the patient in a timely
manner.
The third is Quality of information. Information must be accurate
and meaningful to the patient, presented in a manner that can be easily
understood, and that will help them gain insights. This requires an in-
depth understanding of how patients use their health information and
recognition that a diverse population with varying levels of health
literacy may use this technology.
For example, when a patient references their medication
list in today's typical patient portal, the medications are listed in
clinical jargon, and this fails to effectively communicate what the
patient needs to know--which medicines to take at what time and for
what conditions.
These examples are a brief snapshot of the usability challenges
that require our immediate attention. There are well-established
methods for developing usable software systems, and as a whole the
health IT industry has not yet embraced them.
It is important to note that this is not just a theory. User-
centered design is an established standard in other high-risk
industries, and regulatory bodies in these industries closely inspect
the usability processes used in development before any technology is
implemented. No technology enters the cockpit of an airplane before the
usability is inspected and found to meet detailed standards. The
Federal Government has initiated efforts to mirror this in health IT,
with the implementation of what the ONC has termed Safety Enhanced
Design. However, as described in studies from our Center, few vendors
in the health IT industry have demonstrated evidence that they have
embraced this approach. This represents a huge opportunity.
To make advancements we must: (1) refocus certification
requirements to promote true usability in the design, development and
implementation of health IT, with an understanding of industry
constraints, (2) increase transparency around usability, and (3) spur
competition in the marketplace by making it easier for new vendors to
develop products.
The National Center for Human Factors in Healthcare has conducted
research into both provider and vendor environments, reviewed existing
literature, and analyzed current policies to make the following
recommendations for improving the usability of electronic health
records (EHR), patient portals and personal health records:
1. Spur innovation in EHRs, patient portals and PHRs to foster
improved usability.
a. Many new vendors want to enter the marketplace of EHRs, patient
portals and PHRs but are not able to because of the daunting
certification requirements. This is inhibiting innovation and is
limiting the ability for usability to be driven by a competitive
market.
b. Poor interoperability and the lack of application program
interfaces (APIs) is limiting the sharing of health information and
preventing new vendors from entering the marketplace since they are not
able to access existing patient health information for their products.
Recommendation: Reduce the barriers for new vendors to enter the
marketplace so that vendors with better user-centered design (UCD)
processes, which typically result in designs with better usability can
innovative and bring new products to the market. This will shift the
paradigm to a market that competes on usability.
2. Refocus Safety Enhanced Design (SED) certification requirements.
Currently the Office of the National Coordinator (ONC) has
certification requirements in place to promote EHR vendor usability in
eight high-risk EHR capabilities. The requirements stipulate that
vendors must attest to a user-centered design process and conduct
formal summative usability testing on the final product. Our research
and analysis suggests:\1\ \2\
a. Many vendors are not adhering to the certification requirements
and are not following industry testing standards, yet their products
are still being certified.
b. The current summative testing requirements occur at the end of
development of the product and any design flaws that are identified are
unlikely to be addressed since the product has already been fully
developed. Consequently, this requirement is unlikely to be effective
at improving the usability of that product being released.
c. The summative testing requirement is overly burdensome for some
vendors, particularly if a rigorous UCD process is employed with
formative usability testing (i.e., iterative usability testing during
the development phase). Over 90 percent of the design challenges are
likely to be identified with the UCD process and formative testing
before the summative testing stage. Requiring summative usability
testing for vendors that have a rigorous UCD process can result in an
unnecessary expenditure of limited vendor usability resources and may
detract from the design of other aspects of the EHR. Our ONC-funded
evaluation of a cross section of vendors and their UCD processes found
that approximately \1/3\ of vendors might meet this condition.\1\ \2\
d. EHRs undergo a customization process during implementation at
each provider sight which often involves extensive changes, resulting
in an EHR product that is vastly different from the product that was
tested during summative usability testing. Consequently, the testing
results may no longer be valid for the customized product.
Recommendation: It is our recommendation that the certification
requirements be modified to provide two certification avenues: The
first would require the vendor to show evidence of their UCD process
and formative testing, which vendors should already be conducting given
current certification standards which require vendors to attest to
employing a UCD process. Vendors that are able to demonstrate a
rigorous UCD process should be exempt from having to conduct summative
usability testing. The second avenue would require that the final
product undergo summative usability testing with no safety-critical use
errors identified. For the vendors that do conduct summative usability
testing, the ONC certification requirements should be more explicit
about testing methodology requirements such as number of participants
and background of participants.
EHR vendors should be required to demonstrate evidence of their UCD
process beyond the eight capabilities that are currently stipulated by
the ONC so that broader usability coverage of the EHR products can be
captured.
3. Encourage more rigorous usability practices for patient portals
and PHRs.
a. There is little patient involvement in the design and
development of patient portals and PHRs. Patients are the intended
users of this technology and without involvement during design and
development it is difficult to develop a product that meets the needs
of patients in a meaningful way.
b. There are currently no usability certification requirements for
patient portals. In the existing health information technology
literature there are studies that identify the information needs of
patients and recommendations for improving usability and usefulness.\3\
\4\ \5\ \6\ \7\ \8\
Recommendation: Leverage our existing knowledge on how patients
think about their health information to develop guidelines that can
promote the usability of patient portals and personal health records.
Invest in applied research to expand the knowledge base around patient
health information needs to improve future products. Consider requiring
vendors to demonstrate evidence of a user-centered design process in
the development and optimization of their patient portal products.
4. Increase transparency of vendor usability.
a. The Safety Enhanced Design (SED) certification reports for each
vendor product that is certified must be made publicly available on the
ONC's consumer health product list website. However, the information is
difficult to access, difficult to digest, and not conducive for non-
usability experts to consume. The format of the reports prevents direct
comparison across different EHR products.
b. There are few, if any, formal usability evaluations of EHR
products conducted by independent organizations. Consequently,
purchasers cannot directly compare products based on metrics that
measure the usability of the actual product.
Recommendation: The SED certification reports should be adjusted to
present information in a standard format that can be easily consumed by
all audiences to allow more informed purchasing decisions. Methods
should be developed to foster independent usability evaluations of EHR
products so that purchasers have more usability insight prior to
purchase.
5. Improve the vendor access to usability resources.
A good UCD process includes detailed data on the cognitive tasks,
environments, and information needs of all potential user groups in
different environments. Studies to generate this knowledge are resource
intensive. Our analysis has demonstrated that many vendors do not have
the necessary resources to employ a sophisticated UCD process and to
conduct appropriate formative and summative usability testing.\1\ \2\
This includes access to rigorous clinical use cases, clinician
participants, and knowledge of how to conduct UCD given rigorous
software development timelines.
Recommendation: Develop standard testing use cases for all vendors
to utilize. Incentives may need to be developed for clinicians to
engage with EHR vendors during the UCD process. In addition, detailed
best practices around UCD and usability testing should be widely
disseminated to all EHR vendors.
medstar researchers find large number of ehrs do not meet
usability standards
A report by MedStar Health's National Center for Human Factors in
Healthcare finds that a significant percentage of electronic health
record (EHR) vendors failed to meet federally mandated user-centered
design requirements and did not conform to usability testing standards
for their EHRs, yet their products were certified as having met all the
requirements of the government's meaningful use program for EHRs. The
findings, reported in the September 8, 2015, issue of the Journal of
the American Medical Association, are based on publicly available
information supplied by the EHR vendors to the Office of the National
Coordinator for Health Information Technology (ONC) between April 2013
and November 2014.
The investigators studied official reports submitted by the EHR
vendors to the Federal Government attesting to the user-centered design
(UCD) process they had followed to develop their products and providing
results of usability testing they had conducted. Specifically, the
study focuses on the computerized order entry function, since it is
primarily used by clinicians and presents significant safety hazards
when not designed well. The authors conclude that enforcement of
existing standards and oversight of usability processes are necessary
to meet usability and safety goals for the next generation of EHRs.
The MedStar Health study found that among the problems were failure
to adequately test the usability of an EHR and failure to document that
an EHR was developed with a UCD process. Among the specific findings:
Sixty-three percent of the vendors whose reported results
were analyzed failed to enroll the recommended number of users--at
least 15--in tests on their EHRs.
Seventeen percent used no physician participants in
testing systems intended for physician use.
Twelve percent of reports lacked enough detail to
determine whether physicians participated.
Thirty-four percent of the vendors did not state, as
required, the UCD process they had followed.
Researchers compiled their study by examining available reports
from the top 50 EHR vendors, as measured by the number of meaningful
use attestations made between April 1, 2013, and November 30, 2014.
medstar researchers show tremendous variability in ehr vendor
usability practices
A report by MedStar Health's National Center for Human Factors in
Healthcare finds that many EHR vendors do not have a rigorous user-
centered design process in place. The findings, reported in the June,
2015 issue of the Journal of the American Medical Informatics
Association, are based on the research team visiting 11 different EHR
vendors to better understand their usability processes and barriers to
usability.
The MedStar study found that one third of vendors have a
misunderstanding of usability and user-centered design, one third of
vendors have a basic user centered design process in place and only
one-third of the vendors have a sophisticated process. Among the
specific findings:
Some of the largest EHR vendors (total revenue over $1b)
do not employ usability staff and do not have rigorous user-centered
design processes in place.
Many vendors only have a basic user-centered design
process in place and require additional knowledge and resources to
improve their process.
The vendors that do have a rigorous process in place have
developed methods to integrate user-centered design with their
aggressive software development timelines.
The research identifies targeted ways to improve the usability
processes of EHR vendors including: sharing of best practices,
improving vendor access to clinicians to better inform their products,
and developing standard use cases for testing.
about medstar health
MedStar Health is an academic health system which includes 10-
hospitals, 20 diversified healthcare organizations, 250 outpatient
sites, an air and ground EMS provider, and a population health
insurance provider. MedStar Health is the largest healthcare provider
in the Baltimore and Washington, DC region, and is a microcosm of the
American healthcare system, representing the broadest possible spectrum
of hospitals and patient populations. The 10 hospitals include large
tertiary care/academic medical center hospitals, small community
hospitals, and a university hospital (MedStar Georgetown University
Hospital); inner city, suburban, and rural hospitals; teaching
hospitals and hospitals staffed only by private attending physicians;
and large, medium, and small-sized hospitals. MedStar Health has $5
billion annual net operating revenues, and our resources total 3,300
licensed beds, 5,600 affiliated physicians, 166,000 annual inpatient
admissions, and 2 million annual outpatient visits. MedStar's six
teaching hospitals, including MedStar Georgetown University Hospital,
have a total of 1,100 resident physicians (the 11th largest GME
organization in the United States).
National Center for Human Factors in Healthcare's mission is to
apply human factors research methods and concepts to the medical
domain, with a focus on information technology, device design, and
systems design. The Center is involved in patient safety, risk
management, and systems engineering research sponsored by National
Institutes for Health/National Institute of Biomedical Imaging and
Bioengineering, Agency for Healthcare Research and Quality, Latham
Foundation, Robert Wood Johnson Foundation, Emergency Medicine
Foundation, American Diabetes Association, American Society for
Healthcare Risk Management, Office of the National Coordinator, and
other sources. With 20 people including Ph.D. human factors scientists,
clinical researchers, usability specialists, physicians, nurses, and
support staff, the Center is the largest hospital-based human factors
engineering center in the United States. The National Center for Human
Factors in Healthcare is part of the MedStar Institute for Innovation.
The MedStar Institute for Innovation is a systemwide initiative to
foster and catalyze innovation at MedStar Health, and is lead by
MedStar Health's Chief Innovation Officer Mark Smith, M.D., who also
serves as professor and chair of Emergency Medicine at the Georgetown
University School of Medicine. Dr. Smith is the co-creator of MedStar
Health's innovative Azzyxi clinical information system which is
considered to be a highly innovative health IT application, as
evidenced by its purchase by Microsoft, Inc.
MedStar Health Research Institute (MHRI) is the research center of
MedStar Health, and provides a robust research support infrastructure,
including a centralized IRB, grants management, biostatisticians, and
other research support services. MHRI is in the top 20 percent of all
U.S. institutions in total funding received from the National
Institutes of Health, with over $35M in sponsored work per year. There
currently are over 500 externally funded projects, from 175 principal
investigators, and 325 MHRI employees in support roles.
Reference List
1. Ratwani, R.M., Fairbanks, R.J., Hettinger, A.Z., & Benda, N.
Electronic Health Record Usability: Analysis of the User Centered
Design Processes of Eleven Electronic Health Record Vendors. 2015 Jun
6. doi: 10.1093/jamia/ocv050. PMID: 26049532
2. Ratwani, R.M., Benda, N.C., Hettinger, A.Z., & Fairbanks R.F.
Electronic Health Record Vendor Adherence to Usability Certification
Requirements and Testing Standards. JAMA. 2015;314(10):1070-71.
doi:10.1001/jama.2015.8372.
3. Hassol, A., Walker, J. M., Kidder, D., Rokita, K., Young, D.,
Pierdon, S., . . . & Ortiz, E. (2004). Patient experiences and
attitudes about access to a patient electronic health care record and
linked web messaging. Journal of the American Medical Informatics
Association, 11(6), 505-13.
4. Ralston, J. D., Carrell, D., Reid, R., Anderson, M., Moran, M.,
& Hereford, J. (2007). Patient web services integrated with a shared
medical record: patient use and satisfaction. Journal of the American
Medical Informatics Association, 14(6), 798-806.
5. Haggstrom, D. A., Saleem, J. J., Russ, A. L., Jones, J.,
Russell, S. A., & Chumbler, N. R. (2011). Lessons learned from
usability testing of the VA's personal health record. Journal of the
American Medical Informatics Association, 18(Supple-
ment 1), i13-i17.
6. Marchionini, G., Rimer, B. K., & Wildemuth, B. (2007). Evidence
base for personal health record usability: Final report to the National
Cancer Institute. University of North Carolina at Chapel Hill.
7. Archer, N., Fevrier-Thomas, U., Lokker, C., McKibbon, K. A., &
Straus, S. E. (2011). Personal health records: a scoping review.
Journal of the American Medical Informatics Association, 18(4), 515-22.
8. Kahn, J. S., Aulakh, V., & Bosworth, A. (2009). What it takes:
characteristics of the ideal personal health record. Health Affairs,
28(2), 369-76.
Senator Collins. Thank you very much for your testimony.
Ms. Giusti.
STATEMENT OF KATHY GIUSTI, MBA, FOUNDER AND EXECUTIVE CHAIRMAN,
MULTIPLE MYELOMA RESEARCH FOUNDATION, NORWALK, CT
Ms. Giusti. Good morning, Chairman Collins, Ranking Member
Warren, Senator Alexander and Senator Murray, and distinguished
committee members. My name is Kathy Giusti, and I'm the founder
and chairwoman of the MMRF. It's an honor for me to be here
today and represent all patients.
In 1996, at the age of 37, I was diagnosed with multiple
myeloma. Hearing the word, cancer--yes, that's devastating.
Hearing the words, 100 percent fatal, just 3 years to live--
that's crushing. Since my disease was uncommon, had no
awareness or funding and no drugs in the pipeline, there was
little room for hope.
As a patient, I could see the problems, and, as a business
woman, I could see there were ways to solve them. I founded the
MMRF so we could build business models that would advance
scientific solutions quickly. Working with academia,
government, industry, and technology, we did create an end-to-
end system in precision medicine.
We built our own data bank to capture the genetic changes
in patients. We made our data publicly available to every
scientist. We built our own clinical network that conducted 60
trials of 30 drugs. We educate our patients on which trials to
enroll in.
The results of this are unprecedented. We have seen seven
drugs approved in multiple myeloma, with three more at the FDA
right now. We have tripled the life span of the patients with
this very uncommon disease because we were sharing data.
But myeloma remains fatal, and in today's world, health IT
must accelerate new treatments and cures. So I'll discuss
health IT from the patient's perspective in three ways.
No. 1, engaging patients. Access to health IT allows every
patient to collaborate with their doctor and make the best
decisions. We can review our test results, our lab tests. We
can identify important trends that we see in the data. We can
learn at our own pace when it's quiet, not when we're sitting
in the doctor's office or the infusion room.
But the promise is so clear and the utilization so low. In
another recent study, only 36 percent of Americans online were
using portals. Thirty-five percent of those that weren't using
them didn't even know they had one.
Let me contrast this for you with the data that we have
from the MMRF, where our newly diagnosed patients--85 percent
of them know they have a portal. Ninety-five percent of those
patients are using their portal. They're looking at their
electronic health records, because they know from us the
importance of their data and their knowledge.
No. 2, integrating data. As a patient, I now have six
electronic health records scattered from Dana Farber in Boston
to the Mayo Clinic in Minneapolis, and I have no central place
to integrate them. I can't make this information available to
my healthcare team, and I can't possibly make it available to
the researchers that desperately want to see my genome, my
information that I want them to have.
To prove the point, I was just recently battling
osteonecrosis of the jaw. The oral surgeons needed to see my
treatment history. There was no way to possibly get it to them.
The greatest efficiency in our healthcare system is going to
come from integrating EHRs across the vast specialists that we
all see.
No. 3, accelerating cures. The MMRF recently launched its
own genomic initiative and CoMMpass trial. We are sequencing
1,000 myeloma patients from the moment of diagnosis and every
single time they relapse. Our genetic studies have already
identified a really important target in myeloma that nobody
knew was there. It's also a melanoma target. We are already
spearheading new trials next year for BRAF positive patients
that we can find through our own studies.
This is the world of precision medicine. This is where we
all need to go. But the ability to understand, integrate,
aggregate, and analyze EHRs is sitting on the critical path to
research. It could make things happen so much faster and so
much more efficiently.
The MMRF has shown the impact of sharing data in one
uncommon, very fatal disease. But it's time for all of us to
work together and do this across all diseases. We owe it to the
patients we serve.
I thank you for the honor of speaking with all of you
today.
[The prepared statement of Ms. Giusti follows:]
Prepared Statement of Kathy Giusti, MBA
summary
Good morning Chairman Collins, Ranking Member Warren, and
distinguished committee members. My name is Kathy Giusti. I am the
founder and chairwoman of the Multiple Myeloma Research Foundation
(MMRF). In 1996, at the age of 37, I was diagnosed with the blood
cancer multiple myeloma. My cancer was uncommon, had no funding, no
awareness, and no pipeline of drugs. As a patient, I could see the
problems. As a business woman, I saw ways to fix them. I founded the
MMRF to put those ideas into practice.
Working with academia, government, industry, and technology
partners, the MMRF created an end-to-end system in precision medicine.
We built our own data bank to capture the genetic changes in myeloma
patients and their responses to treatment. We made this data publicly
available to all scientists. We built a clinical network that has
conducted 60 trials of 30 compounds. We educate our patients so they
enroll in the right trial for them. Our community has seen seven new
drugs win FDA approval, with three more expected in the next year. Our
patients have benefited, nearly tripling survival from the 3 years when
I was diagnosed to 9 years today. Myeloma, however, remains fatal. In
today's world, health IT can and should accelerate new treatments and
cures. So today, I would like to discuss the importance of health IT
from the patient's perspective.
no. 1: engaging patients
Access to digital health information allows us to collaborate with
our doctors and health-care providers and make better decisions. The
promise is so clear, but the percentage of patients taking advantage of
these technologies is too low. According to a recent survey, only 36
percent of Americans online were using patient portals. Thirty-five
percent of Americans did not know they had a patient portal.
In contrast, when we looked at MMRF data, we found that 85 percent
of our newly diagnosed patients know they have a portal, and over 95
percent use their portal. This shows the importance of trusted third
parties in raising awareness and education amongst our patients.
Physicians, hospitals, advocacy organizations, and the government must
ensure that patients are educated on how best to use the technology.
no. 2: integrating data
As a patient, I now have six electronic health records (EHRs)
scattered from Dana Farber in Boston to the Mayo Clinic in Minneapolis.
I have no central repository where I can aggregate, store, and access
this information. The greatest efficiency will come from our ability to
integrate EHRs across the vast number of specialized doctors and
centers that patients now see. That data must be integrated into a
centralized portal that we as patients feel like we own, share, update,
and provide.
no. 3: accelerating cures
The MMRF recently launched its own genomic initiative and our
CoMMpass trial which sequences 1,000 patients at diagnosis and at every
relapse to understand our disease heterogeneity. We have already
identified a significant genetic mutation--BRAF--in myeloma patients.
But there are many more targets to uncover, more efficient trials to
run and new drugs to develop. The ability to understand, integrate,
aggregate and analyze EHRs is on the critical path to improving
outcomes and accelerating cures. We have shown the impact of data
sharing in one uncommon, fatal disease. Let's work together and improve
patient outcomes in all diseases. Thank you for the honor of speaking
today.
______
Good morning Chairman Collins, Ranking Member Warren, and
distinguished committee members. My name is Kathy Giusti. I am the
founder and chairwoman of the Multiple Myeloma Research Foundation
(MMRF). It's an honor to be here today to provide a patient's
perspective on the importance of health information technology (IT).
In 1996, at the age of 37, I was diagnosed with the blood cancer
multiple myeloma. Hearing the word ``cancer'' was devastating. Hearing
the words ``fatal, 100 percent fatal'', took me completely off guard. I
realized my cancer was uncommon, had no funding, no awareness, and no
pipeline of drugs.
As a patient, I could see the problems. As a business woman, I saw
ways to fix them. I founded the MMRF to put those ideas into practice.
Working with academia, government, industry, and technology partners,
the MMRF created an end-to-end system in precision medicine.
We built our own data bank to capture the genetic changes in
myeloma patients and their responses to treatment. We made this data
publicly available to all scientists. We built a clinical network that
has conducted 60 trials of 30 compounds. We educate our patients so
they enroll in the right trial for them. Our community has seen seven
new drugs win FDA approval, with three more expected in the next year.
Our patients have benefited, nearly tripling survival from the 3 years
when I was diagnosed to 9 years today.
Myeloma, however, remains fatal. In today's world, health IT can
and should accelerate new treatments and cures. So today, I would like
to discuss the importance of health IT from the patient's perspective.
no. 1: engaging patients
Access to digital health information allows us to collaborate with
our doctors and health-care providers and make better decisions. We
review our test results and lab reports on line, and identify and act
on important trends. We can learn at our own pace--when it is quiet and
convenient--not when we are stressed in the doctor's office or in the
infusion room.
The promise is so clear, but the percentage of patients taking
advantage of these technologies is too low. According to a recent
survey, only 36 percent of Americans online were using patient portals.
Thirty-five percent of Americans did not know they had a patient
portal.
In contrast, when we looked at MMRF data, we found that 85 percent
of our newly diagnosed patients know they have a portal, and over 95
percent use their portal. This shows the importance of trusted third
parties in raising awareness and education amongst our patients.
Physicians, hospitals, advocacy organizations, and the government must
ensure that patients are educated on how best to use the technology.
no. 2: integrating data
As a patient, I now have six electronic health records (EHRs)
scattered from Dana Farber in Boston to the Mayo Clinic in Minneapolis.
I have no central repository where I can aggregate, store, and access
this information. And, I cannot make this information available to my
healthcare team or scientific researchers. To prove the point, when I
recently developed osteonecrosis, my surgeon needed my treatment
history. There was no easy way to find it.
The greatest efficiency will come from our ability to integrate
EHRs across the vast number of specialized doctors and centers that
patients now see. That data must be integrated into a centralized
portal that we as patients feel like we own, share, update, and
provide.
no. 3: accelerating cures
The MMRF recently launched its own genomic initiative and our
CoMMpass trial which sequences 1,000 patients at diagnosis and at every
relapse to understand our disease heterogeneity. We have already
identified a significant genetic mutation--BRAF--in myeloma patients.
And we are pushing drugs that target this cancer causing mutation into
clinical trials. But there are many more targets to uncover, more
efficient trials to run and new drugs to develop. The ability to
understand, integrate, aggregate and analyze EHRs is on the critical
path to improving outcomes and accelerating cures. We have shown the
impact of data sharing in one uncommon, fatal disease. Let's work
together and improve patient outcomes in all diseases. Thank you for
the honor of speaking today.
Senator Collins. Thank you very much for sharing your
experience and for your eloquent testimony.
Mr. Dishman.
STATEMENT OF ERIC DISHMAN, INTEL FELLOW, GENERAL MANAGER FOR
HEALTH AND LIFE SCIENCES, INTEL CORPORATION, HILLSBORO, OR
Mr. Dishman. Chairwoman Collins, Chairman Alexander,
Senator Warren, Senator Murray, and our esteemed committee
members here, I am honored to testify today as a data-grabbing,
hyper-engaged cancer survivor, as a patient advocate for more
than 1,200 families, myself, and as the leader of Intel's
Global Health and Life Sciences business.
I can tell you that wearing all of these hats, I am quite
confident in saying that we will not achieve sustainable
healthcare by any name that you want to call it--the triple
aim, personalized healthcare, N-equals-1 medicine, precision
medicine--without two key foundations: deep patient engagement
and full data interoperability.
I have spent my life trying to build these foundations for
myself and others out of medical necessity, and I have spent my
career doing the same out of business necessity. For the past
16 years, that career has been with Intel, where our way of
life as a company is driving interoperability and standards
into broad platforms that the world can innovate on top of,
whether it's institutions or whether it's enterprising
individuals.
In my own case, I was treated incorrectly for a rare kidney
cancer for 23 years across six employers and health plans, 17
main hospitals and clinics, 38 specialty ones, and 67 different
diagnosis codes. It was often as much a fight to get my own
data and to be treated as part of my own care team as it was to
fight the cancer.
When lack of data about my complex medications led to a
near-death cardiac event because my four specialists were not
paying attention and coordinating what off-label uses they had
given to me, I fought to own all of my medication data from
then on out. When I failed to be eligible for the first
clinical trial ever for the rare cancer that they thought that
I had because I nor an attorney on my behalf could get all of
my paper and EHR data in time, I fought to own all of my
clinical data from then on out.
When my cross-country oncology team worked with me recently
to gather the terabytes of clinical, imaging, and diagnostic
data over 4 long months while I was suffering in kidney failure
to make sense of my whole genome sequence, I fought to get
access to the tools to help me understand these new data types
myself.
The end result: evidence now that 92 percent of the drugs I
had ever been put on were biologically destined never to have
worked, but one new round of individually targeted chemotherapy
did. I am a lucky, living prototype of a proactive precision
medicine patient who is cancer-free with 100 percent kidney
function, and I'll be celebrating my 3-year transplant
anniversary next week.
Across these personal and professional experiences, I've
seen four main barriers to patients' accessing our data that
the law says we have a right to. First, organizations are
hiding behind HIPAA as an excuse not to give us our data.
Second, clinicians are lacking truly interoperable affordable
tools to securely share our data even when they want to.
Third, skeptical paternalistic attitudes about patients
having their own data are keeping us from getting it. And,
fourth, increasingly these days everyone from providers to
research organizations to software and device vendors are all
hoarding patient data to try to monetize it for themselves.
The laws that are supposed to protect patients' privacy and
access to our health information should not be the very ones
that are used to block that access. Patients should not have to
become practically hackers to access our own data, nor should
clinicians have to become health IT experts or pay health IT
experts to share data with each other and their patients.
Strangers shouldn't get their returns from our data without us
having the chance to use our own data, too. We must do better.
I know from numerous Intel employee and business programs
that we have underway that we can do better, because we are
making interoperability and patient engagement work. Our
Connected Care employer ACO in New Mexico and Oregon has
delivered true interoperability for our providers and our
employees. Our collaboration with the Michael J. Fox Foundation
has Parkinson's patients collecting their own wearable and
clinical and other data to drive new discoveries.
Our YOU.24x7 Study of cardiovascular health is helping
participants bring together wearable, clinical, and lab data
for wellness applications for themselves as well as to donate
to cardio researchers. Our Collaborative Cancer Cloud work with
Oregon Health and Science University is showing ways to even
securely share large genomic data sets.
I believe we can improve the standards of care to expect
and assume that patients and families will be part of the care
team and in the information loop, and I believe that we can
improve the standards of data to expect and assume that
interoperability is scalable and the norm is out-of-the-box for
new software, hardware, and device tools that clinicians and
consumers use.
In conclusion, I survived not only cancer, but an era of
well-
intentioned but data-poor imprecision medicine that didn't know
what to do with me as a proactive patient who demanded my own
data. Admittedly, patient engagement and data interoperability
are two buzzwords that are easy to put on paper and Power Point
but hard to put in practice. Thanks to ARRA and ACA and MACRA
and ONC, NIH, MU, PMI, and an alphabet soup that I struggle to
keep track of, I know that we can actually do this because
there's early progress and momentum.
I look forward to your questions to explore specifics on
how we can go faster so that N-equals-1 medical care that I was
so lucky to receive can scale to N-equals-everyone.
Thank you.
[The prepared statement of Mr. Dishman follows:]
Prepared Statement of Eric Dishman
summary
Introduction: As a cancer survivor, a cancer patient advocate, a
healthcare researcher, and an Intel executive, Eric is a lucky early
prototype for the lifesaving potential of accessing your own health
data and genome-based precision medicine. Whether to qualify for
clinical trials or identify rare diseases based on genome sequencing or
track daily vital signs for trending and medication management, he--
like all of us--needs access to his/our own health information that's
convenient, timely, affordable, electronic, and secure. To achieve
precision medicine for all Americans, the two pillars of full data
interoperability and deep patient engagement are vital.
Barriers: Across Intel's global research on patient & family member
engagement, we see four primary barriers to accessing one's own data:
(1) Institutions hiding behind HIPAA & other privacy regulations/
policies; (2) Clinicians lacking affordable, interoperable tools to
share patient data due to inadequate or poorly implemented standards;
(3) Widespread beliefs that patients don't have the abilities to use
their data safely; and last, (4) Institutions and companies trying to
control patient data because they want to monetize it.
Principle 1: Start with patient engagement by design: The
healthcare system today rarely considers how to include a proactive
patient when designing software, quality metrics, expectations and
training. We need to change the social contract for how an engaged
patient interacts with the system to achieve two-way data exchange and
two-way responsibility for care. The healthcare systems needs to
improve the tools, data, and workflow--and first and foremost the
mindset--to allow and eventually assume--that we patients own our
health.
Principle 2: Precision medicine's foundation is secure shareability
of diverse data types: Four major data categories must be brought
together to deliver an individualized, precise treatment or prevention
plan: (1) clinical/claims data; (2) diagnostic/device data; (3) omic
data; and (4) consumer generated/mHealth data. Securing the ability for
individuals and institutions to safely, affordably decide who gets
access to their information is crucial. We must use common data models
and standards-based protocols for exchanging health IT data that extend
beyond clinical data to include imaging, genomic, and consumer
electronic device and smart phone data. With these new data types
scaling now, we should start with commitments to--and validation of--
interoperability standards from the outset so we do not recreate the
problems seen with traditional EHR data.
Intel Case Studies: For our employees and our business, we are
demonstrating that Big Data analytics for precision medicine depends on
patient and clinical access to comprehensive health records of diverse
data:
YOU.24x7 Study, an early pilot using patient-generated
data for research into health trends and behaviors to analyze
cardiovascular risk factors. A Basis smart watch tracks sleep and
activity, plus wireless blood pressure and weight scales in the home
combined with EHR data, labs, and other key metrics give a more
holistic view of the population and correlation insights, as well as
insight into an individual's cardiovascular wellness through 24x7
secure access to all of her or his information.
Intel's Connected Care, an employer ACO, demonstrates the
value of interoperability to improve Intel employees' and families'
healthcare experiences, outcomes, and reduce costs over time. This
program has achieved EHR interoperability for our employees and their
clinicians.
Intel and Oregon Health & Science University (OHSU)
Collaborative Cancer Cloud, a precision medicine analytics platform
that allows medical institutions to securely share access to their
private patient genomic & clinical data for potentially lifesaving
discoveries, without giving up control of that data or violating
privacy policies. This CCC program is part of our All In One Day by
2020 campaign to challenge the computing and life science industries to
work together to accelerate precision medicine analytics.
______
Chairman Alexander, Ranking Member Murray, Senator Collins, Senator
Warren and members of the Senate Health, Education, Labor, and Pension
(HELP) Committee, I appreciate the opportunity to testify today on
behalf of Intel Corporation. I thank you for your leadership and
appreciate the opportunity to speak today about the enormous--mostly
untapped--potential of individuals to own their health and contribute
positively toward national health transformation. This is a vital topic
you have chosen for today. If we are to achieve the ``triple aim'' in
America, then two foundational principles must be delivered upon: full
data interoperability and deep patient engagement.
I am a 23-year cancer survivor, a cancer patient advocate, an
executive at one of the world's most innovative technology companies, a
member of the President's Precision Medicine Initiative Working Group,
and a lucky early prototype myself for the lifesaving potential of
accessing your own health data and genome-based precision medicine.
Wearing each of these hats, I have thought a lot about what must be
done to make health care more customized, more connected and more
coordinated. Because of demographic trends toward an aging population,
it's not optional to take up this challenge of personal, precision
healthcare. It is an imperative of our times, global in scale, complex
in scope, and--at its very roots--it should be viewed as an opportunity
for every individual.
Across all of my different roles, and backed up by 15 years of
Intel's social science research worldwide, I have concluded that each
of us must have better tools to participate in our own health and
contribute to the well-being of others. Each of us needs access to our
own health information that's convenient, timely, affordable,
electronic, and secure. Each of us needs to work with our care teams to
build care plans, with goals and accurate tracking. Each of us needs to
own our health--but the healthcare systems needs to do a much better
job of giving us the tools, data, and responsibility to do so.
Let's think of the constellation of our health data over the course
of a lifetime. Most familiar are the clinical and claims data captured
at clinics, hospitals, pharmacies, insurers, etc., including such
information as diagnosis codes, prescriptions, program notes, claims,
vital signs, and test results. Second, there is diagnostic data
captured by medical devices and imaging equipment. Adding to this now
are two new data streams that are rapidly increasing in importance and
opportunity: consumer-generated health data, captured outside the
traditional health system and including such information as patient
diaries, observations of daily living, vital sign monitors, fitness
wearables, online and smartphone apps, social media and gaming. And
finally, there is ``omics''--vast amounts of information contained in
each person's genome (and proteome, metabolome) that will increasingly
be used to attack disease at its molecular roots. By their very nature,
these diverse data (coming from what we at Intel call the ``Four Circle
Model'' depicted below) are collected at multiple sites, across long
spans of time, and in a vast array of structured and unstructured
formats.
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
The reality is that personal, precision health in the 21st century
will need to make sense of all of this information for deeper insights
into population health and individual treatment. These data tell us
critical things about one of the most important aspects of anyone's
life--our very health and well-being. To me, it's just unthinkable that
we would architect a health system--a whole health economy--without
facilitating each person's access to one's own data, as well as the
ability to contribute meaningful data about oneself back to researchers
and data scientists to gain insights into population health and
wellness. Sharing of interoperable data must be the foundation of
targeted, individual care.
My own life events--from the beginning of my battle with rare and
unidentifiable forms of kidney cancer to the happy conclusion 23 years
later--have shaped the passion I have for accurate, affordable,
comprehensive and timely access to one's own health information. In the
summer of 1989 before my junior year at UNC Chapel Hill, I was first
diagnosed with a rare form of cancer, hurling me into more than two
decades of chemo, immune, and radiation therapy across 8 States, 6
employers and health plans, and 17 hospitals and clinics. To survive, I
had to know my own history, carry my latest data with me, understand
the latest clinical trials research, and be on top of promising new
treatment options, oftentimes better than many of my oncologists and
other specialists. But accessing my own data could be as challenging as
surviving the cancer at times.
Five years into this journey, my first near-death experience came
because four different specialists--none of whom had a complete view of
my complex medication regimen--over prescribed off-label treatments
that put my heart at risk. Luckily, a nurse and I finally figured out
that the drug cocktail--really, a lack of sharing data--was the real
culprit, not anything wrong with my heart. Fifteen years into it, the
first clinical trial ever for the particular kidney cancer they thought
I had at the time came out. After failed attempts for 3 months myself
at pulling together my data to be eligible for the trial--and then 3
months more with an attorney doing so on my behalf--I couldn't enter
the trial because we couldn't pull my records together in time. In my
advocacy on behalf of cancer patients--1,220 people so far and
counting--I still see this happening every week, even with new laws &
technologies that should make it possible.
Much more recently, I was in full kidney failure and running out of
options. On what I thought might be my last business trip as head of
Intel's healthcare group, I met a genomic startup company that offered
to sequence my DNA. After half a year of shipping hard drives of data
across the country between oncologists, computer scientists, and data
experts, my medical team came back with a plan based on my molecular
makeup. Within months, I was miraculously cancer-free and suddenly on
the path to a kidney transplant that saved my life because, for the
first time in 23 years, my oncologists had real and detailed data about
me as an individual to act upon. I came back to Intel ready to help
scale precision medicine to everyone.
In all of these examples, it was simply too hard to collect all of
this information on a timely basis so my doctors could determine the
best care plan for me. Across my experiences as a cancer patient and
advocate--and in the studies of patient experiences Intel has done
across more than 20 countries--I see four recurring barriers that often
keep data out of the hands of citizens who want it:
(1) Medical institutions using privacy/security policies and laws
like HIPAA as excuses for why they cannot risk sending patients their
data;
(2) Medical professionals lacking easy, affordable, interoperable
tools to share patient data, especially because app and device vendors
fail to use--or correctly implement--standards;
(3) Widespread beliefs that patients do not have the abilities to
use their own medical data safely, which may be true in many or even
most cases, but fail to give them the choice; and
(4) A growing attitude among almost everyone in the patient data
chain--hospitals, labs, payers, software companies, device developers--
that patient data sets are theirs to be monetized.
Revisiting the four-circle model described earlier (which is over-
simplified but useful for illustration), we can see that, despite a
great deal of progress, each type of data is still not readily
available to individuals--or even their clinicians--in most cases:
Electronic health record data and claims: Under the Health
Insurance Portability and Accountability Act (HIPAA), patients have a
right to see and obtain a copy of their medical records. The American
Recovery and Reinvestment Act (ARRA) extends those rights through
modifications to HIPAA, requiring healthcare providers who utilize EHRs
to give patients copies of their medical records in an electronic
format, to another person or entity like a doctor, caregiver, a
personal health record or mobile health application. The information is
typically provided on paper or through a flash drive or CD, or an
online clinic portal. Unfortunately, the regulations have two
significant loopholes. First, patients can receive the information in
their preferred electronic format only if the provider is capable of
producing the copy in the requested format; and second, providers have
30 days (and an additional 30 if the information is stored offsite) to
make the information available to the patient. (Certification for
Meaningful Use Stage 2 is a huge improvement by requiring the
information to be made available within 4 business days.) Congress must
have envisioned a much easier and faster method for patient access to
data. This could be much more readily achieved with today's technology,
particularly if more of the information was captured as common data
sets in standardized formats.
Consumer-generated health data: Today, there is a plethora
of apps and services that collect health and wellness data from devices
we wear, carry around with us, or use in our homes and workplaces.
However, generally speaking, each have different logins, different and
confusing user interfaces, different calibration of sensors, different
apps and services. Very few integrate with the systems used by
clinicians who make up an individual's care team. And consumers have a
very difficult time pulling this information into one repository,
controlled by them, that will outlast the particular device, app,
employer, or insurance company they are currently associated with. As a
founding member of Continua (http://www.continuaalliance.org/), Intel
supports a developing ecosystem of certified devices that ``plug and
play'' to give consumer-friendly connectivity to individuals who wish
to better manage their health and wellness no matter where they are. If
industry adopts common standards, the information from the various
devices can be curated and exchanged with the goal of helping
individuals understand their information, track their progress, stay on
track with their care plans, and generally take more ownership of their
health. The potential is enormous for remote monitoring of patients
with chronic diseases, with continuous feedback and more efficient,
two-way communication between the patient and clinicians, but only if
these data are securely shareable and interoperable.
Imaging and diagnostic data: Medical images make up a
large percentage--estimated as high as one-third--of all stored data in
the world. The storage demands are very high. Fortunately, cloud-
computing environments enable much more cost-effective storage of
medical imaging, and there have been great strides in transitioning the
hosting of medical images to the cloud for electronic retrieval through
healthcare provider systems. However, providing individuals with
convenient, on-the-go access to these often-large data files remains
nascent. Think of the advantage to you as a patient if you were able to
log on to access all your X-rays, MRIs, ultrasounds, etc., any time you
go to a new provider or the ER, instead of filling out request forms
and waiting for the files to be shipped, or paying for an expensive
test to be unnecessarily repeated. Since these data types are not
usually part of the official EHR per se, the progress on patient access
to their own data misses important classes of personal information
today.
Genomics and other ``omic'': The data from whole human
genome sequencing are so large they are impractical to send back and
forth across institutions, and we are in the early days of having tools
for clinicians--let alone consumers--to make use of this data. I
learned this myself when my own 5-terabyte files were being shipped
across the country from oncologist to oncologist while trying to figure
out the optimal way to treat my cancer. As these new data types begin
to scale, it is important that we start with commitments to--and
validation of--interoperability and standards from the outset so we do
not recreate the problems that have plagued us with EHR data. Also, new
tools for big data analytics are necessary to scale the potential for
precision medicine, such as the Collaborative Cancer Cloud that I
describe below.
Because each of these data streams are important to understand each
person's whole health picture, providing the individual with access to
parts of electronic health record (EHR) systems is necessary but not
sufficient. As the National Institutes of Health builds out the
extremely exciting Precision Medicine Initiative, the 1 million person
cohort, and our national strategy to compete globally in the economic
opportunity that precision medicine will present, let's make sure we
build an architecture for individual access to personal health
information from the beginning. It cannot be an afterthought, or it
will never happen. We need to learn from the hard lessons from the
Nation's multibillion investments in subsidies for EHRs and grants for
health information exchanges. We must think about interoperability in
much broader terms than merely the doctor-to-doctor exchanges of EHR
data. We need to continue to support the concept of individual's having
personal health records available to them and their care team, anytime
and anywhere, and not tied exclusively to a particular institution or
company.
To help show what's possible, I'd like to share what Intel is doing
in its own journey to make health care more effective and affordable
and to accelerate the possibilities for precision medicine for all.
intel's connected care program--an employer initiative for
value-based purchasing
The Connected Care vision is to improve Intel employees and
families' healthcare experiences, outcomes, and reduce costs over time.
EHR interoperability plays an important role to help Intel achieve this
vision. In 2013, Intel launched the Connected Care program in
Albuquerque, NM. It is essentially an employer-sponsored and -
facilitated accountable care organization (ACO). In focus groups, we
heard from our employees and families that they wanted streamlined
access to primary care and specialists. In response, Intel
significantly changed its relationship with the healthcare system in
the Connected Care Program. We contracted directly with the healthcare
supply chain, removing middle men. We built a network of 11 primary
care medical homes, including an onsite clinic, and medical
neighborhood of specialists and facilities. To ensure timely access to
care, Intel and Presbyterian Health Services agreed on protocols for
call responsiveness and established acceptable levels of appointment
availability. We contracted directly with Presbyterian Health System in
an arrangement that aligned incentives and shared risk, with outcomes
measured according to the following accountability metrics:
Right care: Use of evidence-based medicine to improve
population health, focusing on diabetes, hypertension and depression.
Right time: Timely access to care in the optimal setting,
including a nurse hot line.
Best outcome: Patient satisfaction 100 percent of the
time.
Right price: Material decrease in the cost of care, per
patient per month.
Best life: Rapid return to productivity.
Employee response has been excellent: More than three in four
eligible employees opted to join the Connected Care Program. So far,
major successes have included greater member engagement with the
healthcare system, very high satisfaction ratings, and statistically
significant improvements in diabetes control. We have yet to
demonstrate an improvement in costs. In the long term, we believe that
promoting proactive primary care with deep patient engagement and
accountability should improve health outcomes and costs as we iterate
this program.
Successful preliminary results in New Mexico drove the decision to
scale Connected Care to Oregon this year. The Oregon implementation had
a deeper need for sharing of our employees' electronic health records
because it included two large health systems--Kaiser Permanente and
Providence Health and Services--in addition to ambulatory providers The
Portland Clinic and Premise Health. With our partners, we addressed the
data liquidity problem head-on first through contracts that focused on
seamless care that required data sharing across institutional
boundaries.
The Connected Care interoperability team at Intel selected the
Direct messaging standard and the Healtheway eHealth Exchange (recently
renamed The Sequoia Project) to support the business and clinical
requirements for coordinated care. The Connected Care data exchange
model utilizes the HL7 Consolidated Clinical Documentation Architecture
(C-CDA), which is a key part of the data interoperability
specifications in Meaningful Use Stage 2. The EHR interoperability
model in Oregon is nationally recognized for having an innovative
approach for point-of-care access to electronic health records. New
care coordination workflows are using data exchange with healthcare
information coming to them in real time, resulting in quicker access to
care with less work for everyone involved. Having the most up-to-date
healthcare data means a more efficient model where physicians and
patients can now make the best possible choices about their care
planning, leading to lower costs over time. And, critically, this data
exchange model is enabling consumer health pilots that will improve
Intel employee experience and improve health engagement.
We relied upon the security, authorization and privacy measures
governed by national standards (eHealth Exchange/NHIN and Direct
messaging), and HIPAA for exchange of clinical records. This includes
end-to-end encryption of data, authorization, PKI/digital signatures
and appropriate access controls. The underlying technology standard is
called SAML, which is used to assert authentication of the user.
Members of the eHealth Exchange secure their communications using x.509
certificates whose chain-of-trust begins with the same Root Certificate
Authority (CA), thus facilitating trust between organizations without
the need to exchange certificates.
For more specific information on the interoperability challenges
and the value provided from joining Healtheway/Sequoia for a query-
based system, Intel, Kaiser Permanente, and Providence Health and
Services, The Portland Clinic and Premise Health have produced a white
paper accessible at the following URL: https://www-ssl.intel.com/
content/www/us/en/healthcare-it/advancing-interoperability-healthcare-
paper.html.
intel's work with consumer-generated health data
The Michael J. Fox Foundation for Parkinson's Research (MJFF) and
Intel Corporation are collaborating on improving research and treatment
for Parkinson's disease--a neurodegenerative brain disease second only
to Alzheimer's in worldwide prevalence. The collaboration includes a
multiphase research study using a new big data analytics platform that
detects patterns in participant data collected from wearable
technologies used to monitor symptoms. This effort is an important step
in enabling researchers and physicians to measure progression of the
disease, improve medication adherence and speed progress toward
breakthroughs in drug development.
With wearable technology, the potential to collect and analyze data
from thousands of individuals on measurable features of Parkinson's,
such as slowness of movement, tremors and sleep quality, could enable
researchers to assemble a better picture of the clinical progression of
Parkinson's and track its relationship to molecular changes. Wearables
can unobtrusively gather and transmit objective, experiential data in
real time, 24 hours a day, 7 days a week. With this approach,
researchers could go from looking at a very small number of data points
and burdensome pencil-and-paper patient diaries collected sporadically
to analyzing hundreds of readings per second from thousands of patients
and attaining a critical mass of data to detect patterns and make new
discoveries. It is a dramatic shift from data-poverty to data-wealth--
and in my view it signals the future of research and discovery.
MJFF and Intel share a commitment to increasing the rate of
progress made possible by open access to data. The organizations' aim
to share data with the greater Parkinson's community of physicians and
researchers as well as invite them to submit their own de-identified
patient and subject data for analysis. Teams may also choose to
contribute de-identified patient data for inclusion in broader,
population-scale studies.
We have also launched the YOU.24x7 Study, a 6-month observational
pilot study of nearly 500 participants that uses an end-to-end
prototype platform consuming patient-generated data for research into
health trends and behaviors to analyze cardiovascular risk factors and
potentially improve outcomes. Patient data are collected through a
number of devices: a Basis watch to track sleep and activity, plus
blood pressure and weight scales in the home. These data are combined
with electronic medical record information, labs and other key metrics
to give more holistic view of the population. Data scientists and
cardiologists are using an advanced analytics platform created by
Intel, looking at the de-identified data to gain trending and
correlation insights into cardiovascular wellness. Meanwhile, the
individual participant has 24x7 access to all of his or her own
information through the secure personal health collaboration hub
provided online by a company we helped to form called Dossia.
intel's work in precision medicine
Intel and Oregon Health & Science University (OHSU) recently
announced the Collaborative Cancer Cloud, a precision medicine
analytics platform that allows medical institutions to securely share
insights from their private patient genomic data for potentially
lifesaving discoveries. Intel announced that key technology components
of the Collaborative Cancer Cloud (CCC) will be opened sourced.
Hospitals and research institutions of all sizes could use the
technology to advance personalized cancer research. They can also apply
it to advance personalized research in other diseases that are known to
have a genetic component, including Alzheimer's, diabetes, and more.
Intel and OHSU also announced that they will partner with two other
large cancer institutions to extend this capability in 2016.
The project combines next-generation Intel technologies and
bioscience to enable solutions that can be used to make it easier,
faster, and more affordable for developers, researchers, and clinicians
to understand any disease that has a genetic component, starting with
cancer. It will enable large amounts of data from sites all around the
world to be analyzed in a distributed way, without having to move the
data itself, preserving the privacy and security of that patient data
at each site. The end goal is to empower researchers and doctors to
help patients receive a diagnosis based on their genome and potentially
arm clinicians with the data needed for a targeted treatment plan. By
2020, we envision this happening in 24 hours--a challenge to the
computing and life science industries that we call All in One Day. The
focus is to help cancer centers worldwide--and eventually centers for
other diseases--share with one another the insights that reside in
their private clinical and research data without having to share the
data itself. This approach is designed to protect data privacy and the
business models of the research centers while at the same time unlock
the insights from far larger datasets to benefit research and inform
the specific treatment of individual patients.
As an employer faced for years with unsustainable healthcare cost
inflation for the 53,000 employees we are proud to employ in the United
States and their 88,000 Intel Health Plan dependents, Intel has
initiated these projects for business reasons--both to support a
healthy, productive workforce and to grow the global market for the
powerful computing needed to scale precision medicine. We hope these
programs can become examples for the rest of the country to buildupon.
And we believe congressional support of four key themes can help
examples like these proliferate across the country.
(1) Sustain momentum toward standards and interoperability. As
Intel's Connected Care Interoperability team demonstrated, a standards-
based approach for health information technology enables quicker and
more efficient deployments to share data from different sources. This
provides scalability, interoperability, and innovation as new services
can be built upon a common framework of standards, data models and
clinical vocabularies. Intel supports an implementation specification
compatible with baseline standards that are specific, well-documented,
tested vigorously, and shared publicly, as described in H.R. 6, the
21st Century Cures Act.
(2) Encourage patient engagement by removing obstacles for patients
to access and share their data. With the adoption of electronic health
records comes enormous potential for creating value from data held in
millions of patient records. Today, the use of this information is
regulated by a series of highly regulated consent requirements
constructed by not only the Federal Government, but by States. Intel
invites policymakers to partner with industry to pursue a standardized
machine readable consent form to allow patients to donate their data to
ongoing research without the need for securing and faxing consent forms
each time patient data is requested. The International Rare Disease
Research Consortium has recognized this problem. The Consortium has
assembled a task team from the Global Alliance for Genetics and Health
to explore the machine readability of consent and its impact on data
use and accessibility. PCORI has launched research into patient
preferences for consent,\1\ and The Broad Institute has launched
``Count Me In'', a patient consent effort to facilitate genomic
research. Consistent with the 2013 memo from the HHS Office of Civil
Rights,\2\ individual access to personal health data could advance if
personal health record organizations are allowed on the eHealth
exchange network run by The Sequoia Project to collect information
across provider systems on the patient's behalf. Credible personal
health records should be allowed to securely capture and transmit
patient consent electronically to the source systems and establish
connectivity.
---------------------------------------------------------------------------
\1\ http://www.pcori.org/research-results/2014/demonstrating-
respect-and-acceptable-consent-strategies-what-matters-patients.
\2\ http://www.hhs.gov/ocr/privacy/hipaa/understanding/consumers/
righttoaccessmemo.pdf.
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(3) Continue to push toward value-based care. We support the HHS
goal announced this year to move 30 percent of care to alternative
payment models by 2016 and to 50 percent by 2018. When incentives are
aligned toward value-based care and managing population health, the
demand for information-sharing goes up. Fee-for-service models work the
opposite way, in which providers are paid based on the volume of
service they deliver. Based upon Intel's experience with Connected
Care, we have seen increased patient engagement and better outcomes
based upon shared risk, shared goals and consistent metrics for
success. As the U.S. healthcare system moves to outcome-based payments
through the Medicare Access and Chip Reauthorization Act (MACRA),
Congress can assist through providing funding for new care delivery
tools for training and discovery until the 2019 implementation date.
Specifically, pilots should be funded for remote patient monitoring
(RPM), which remains mostly unpaid in today's fee-for-service
environment in spite of studies showing as much as a 75 percent
reduction in hospital re-admissions when provided to chronic care
patients.\3\
---------------------------------------------------------------------------
\3\ http://healthaffairs.org/blog/2014/04/04/the-role-of-remote-
care-management-in-population-health/ http://
www.telehealthresourcecenter.org/sites/main/files/file-attachments/
snell-smalley_hospital_physician-summit-feb-2013.pdf.
---------------------------------------------------------------------------
(4) Erase disparities. Despite amazing advances in health and
healthcare, many dimensions of disparity remain, particularly in
health. The recommendations that we've outlined today--standards and
interoperability, giving people access to their health data, lowering
barriers for people to participate in and access precision medicine,
and value-based purchasing must be achieved with a mindful eye on the
diversity of our Nation, ensuring that solutions are a good fit for
people across the array of incomes and ethnicities and in both rural
areas and in urban ones. Achieving health equity means making sure that
all Americans have a fighting chance to own their health, which is not
possible if they can't first own and use their own health data.
conclusion
I am a lucky, living prototype of the precision medicine future
that countries around the world are competing to develop for their own
citizens and for their own economic growth through the invention and
intellectual property of precision medicine. As a cancer survivor and
kidney transplant recipient, I collaborate on improving my health (and
lowering my costs) together with my care teams, and I am very engaged
in owning my own care. At every step of the way in my health journey,
access to my own health information has factored heavily in the
difference between success and failure. But Congress and the health
sector should not be designing our infrastructure, systems, and
policies for me, a fortunate, well-educated, well-compensated Intel
executive who has connections with health experts all over the world.
We should design policies, standards and economic incentives to promote
individual access to personal health information for people who have
none of my advantages. We need to design for people with big health
needs but low health literacy, and then those systems will work well
for everyone. On behalf of Intel Corporation, thank you for your
leadership and opportunity to speak today.
Senator Collins. Thank you so much for such an
extraordinary story and for being here today.
Dr. Ratwani, we've just heard Mr. Dishman explain all of
the inappropriate care that he got before, through sheer
perseverance, he was able to secure the treatment that he
needed. Studies show that some 400,000 Americans die each year
as the result of medical errors, including 80,000 Americans who
died because doctors are unable to easily access needed
information.
You mentioned in your testimony that there's overwhelming
evidence that health IT systems and whether or not they're
effective affects patient safety. Could you expand specifically
on what your advice to us, as policymakers, would be so that we
can help Mr. Dishman, Ms. Giusti, not go through this struggle
to get information that directly affects the efficacy of their
care?
Mr. Ratwani. Senator Collins, that's an excellent question.
A key component of this is patient safety. What we're finding
with several of the health IT systems that are being designed,
developed, and implemented across the Nation is that there are
tremendous safety hazards that arise from these systems, things
like wrong selection of the patient in the record, wrong
medication orders, wrong laboratory tests being ordered.
A key component of this is dramatically improving the
usability of these systems. We need to design these systems so
that they're intuitive for clinicians to use, intuitive for
patients to be able to adjust their information.
And, importantly, it's not just about the interaction
pieces. It's also about how the information is represented. So
if a physician is looking at a patient record and looking at
laboratory results, it's important to ensure that those
laboratory results are represented in a way where the critical
values pop out to the physician, where the patients are able to
understand why those values are important to their care. So it
comes back to usability and visualization of that information
to drive analysis, insight, and, ultimately, patient and
clinician action.
Senator Collins. Ms. Giusti, you stated that an astonishing
85 percent of newly diagnosed patients participating in your
research foundation programs know that they have a patient
portal, and more than 95 percent of them are using it. As you
mentioned, that is far, far higher than the population at
large, where only 36 percent of Americans are using patient
portals.
How did you do it? How did you educate patients about the
portals and about using them?
Ms. Giusti. What we did was we educated patients on the
value of knowing their own data, and I think that's one of the
most important things we can say today. If patients understand
the value of their data, they will understand the importance of
taking the time to go into a portal and look at their
electronic health record information.
What we found was by telling them that if you follow your
own biomarker, your own tests in myeloma, you will be a more
informed patient. You will know whether you are actually in a
remission, a complete remission. You would know your genome so
that if a child opened up for you, you could raise your hand
for that child.
By explaining to them the power of numbers, not a huge list
of numbers, but a few numbers that they can follow, we gave
them the incentive to go on and become knowledgeable. In
addition to that, what we also explained to our patients--it's
really important--is if you know the data of yourself, you will
improve your outcomes. But if you let your data be aggregated
with others, you will improve the opportunities to know more
about the biology of your disease and develop new treatments
for your disease. When you see the value both ways, why would
you not go on and learn this information?
Then we provide you with a website, a call center with
nurses, chat rooms, gateways where you can go on and talk. You
have to remember it's a little bit about reaching frequency to
people. Tell them the value and keep explaining it a few times
over. They will get there, and it will make a huge difference.
Senator Collins. Thank you.
Senator Warren.
Senator Warren. Thank you, Senator Collins.
The Federal Government has spent more than $30 billion
supporting the adoption of electronic health records, and we
did it because we know that exchanging health information and
providing patients with access to their data can reduce
healthcare costs and can improve patient outcomes, as you've
just been talking about. We've come a long way, but today, many
providers still can't exchange information, and, as Ms. Giusti
and Mr. Dishman have just testified, many patients still can't
easily access their information.
Mr. Dishman, I'd like to ask you about Intel's health
insurance plan for its employees. I understand that in some
areas, it provides highly coordinated care. As part of the
coordination, Intel requires that any provider that's part of
the Intel plan must be able to exchange patient health
information, including tests or diagnoses, with any other
doctor in the system.
Can you say something about how that requirement has
affected the health of your employees, generally?
Mr. Dishman. Sure. For one thing, it started to produce the
results that we wanted. Just in the first year, in New Mexico,
where we rolled out this Connected Care program, as we aimed
for the triple aim, the costs were held about the same, but we
significantly improved outcomes in things like management of
diabetes and the reduction of cost of diabetes.
Senator Warren. So the same costs, but much better
outcomes.
Mr. Dishman. Same costs, but much better outcomes. We had
to write into our RFPs about the providers and their vendors,
saying,
``We're going to hold you accountable, not only for
showing that you are saying that you are a standards-
based EHR, but vigorously testing against it to
actually prove it,''
and they did not get full payment unless they could actually
show that they did this.
We're a very engineering culture at Intel, so it's not
surprising. You might think, oh, were our employees surprised,
and it was like no, they expected it. They said, ``We're a
data-driven bunch of engineers who are expecting to have this
information.''
The big surprise in the study so far, as we've rolled this
out in Oregon and now New Mexico and California next, has been
the clinicians. The clinicians across these multiple providers,
multiple insurance companies, different versions of Epic
implementations of their EHR, some of them using a different
EHR with Greenway, were like,
``Oh, my gosh. Now that I've tasted interoperability,
I can do what I'm supposed to do with my Hippocratic
Oath, deliver high-quality care to my patients.''
Senator Warren. OK. You've given us some idea of what we
can get with interoperability. Let me ask you more about it.
As part of Medicare Access and the CHIP Reauthorization Act
that was signed into law earlier this year, Congress set a
national objective of achieving widespread interoperability by
the end of 2018. The Department of Health and Human Services
has recently proposed rules for the final stage of the
Electronic Health Record Meaningful Use Program.
Mr. Dishman, I want to ask if you think that the proposed
rule alone will ensure that health records can be easily
exchanged and that patients in this country will have the same
benefits that the employees at Intel have.
Mr. Dishman. First, I would say I know there's lots of
pressure from folks who want to delay. Don't delay. This is a
hard transformation. Keep it going in 2017 and 2018. We're not
done with meaningful use by that stage. We may call it
something different out in time.
But the fact of the matter is if we want a complete medical
record--what's currently in the EHR today, the clinical data,
doesn't include the claims data, doesn't include the imaging
data, doesn't include the genomic data that's coming, and
doesn't include the consumer health data. We need to get out
and establish standards for these new data types ahead of
them----
Senator Warren. Common standards.
Mr. Dishman. Common data models, common standards. Test and
validate to make sure that those standards are actually being
implemented and be ready to sort of understand that a complete
medical record that I need to save my life with cancer, or that
Kathy's folks do with multiple myeloma, is not just what's in
the traditional EHR. We're going to have to keep driving toward
that innovation model, and it's probably going to take us 4 or
5 more years to really get there.
Senator Warren. All right. Thank you. I just want to
underline what I'm hearing you say on this, that even though
the Meaningful Use Program has had a lot of success in driving
doctors and hospitals to adopt electronic health records, the
final stage, as proposed, does not guarantee interoperability
or true patient engagement.
This is really frustrating, because the technology to
create a patient-centric interoperable healthcare system
exists, as you are proving, and Intel and others have
demonstrated that it can work. As the committee continues to
look into this issue, I hope that we can find ways to build on
the Meaningful Use Program to break down the remaining barriers
to interoperability.
Thank you, Madam Chair.
Senator Collins. Thank you.
Senator Alexander.
Statement of Senator Alexander
The Chairman. Thanks, Senator Collins.
I want to thank Senator Collins and Senator Warren for
their leadership on this issue. They are very diligent members
of this committee and have attended all the hearings that we've
had on the subject. We've had five.
This is a subject which Senator Murray and I are trying to
work on together in a bipartisan way to see if we can realize
the promise of electronic medical records. Our goal is to put
patients first. We want to make sure that these massive changes
actually work to do that. We've formed a working group that is
bipartisan to achieve that, and as you can see from the
attendance at this hearing, there's a lot of interest in it.
Today, I'd like to use my time to make a statement before I
ask a question. I might add that in our work together, we've
also been working with the administration, with Secretary
Burwell, with the Office of the National Coordinator, and my
goal, anyway, is to make sure that we implement an electronic
health record system as efficiently and effectively and as
rapidly as we can in a way that genuinely helps patients, which
leads me to my statement.
I believe we should delay until January 1, 2017, the making
of the final rules for Stage 3 of the Federal Government's
program to require doctors and hospitals to use electronic
health record systems. I believe then that the Stage 3
requirements should be phased in at a rate that reflects how
successfully the program is being implemented. I believe also
that the modified rules already proposed for Stage 2 of this
program should be adopted immediately, because it will help
most doctors and hospitals comply with the government's
requirements.
Patients need the interoperable system that we just talked
about that enables doctors and hospitals to share their
electronic health records. The government, doctors, and
hospitals need time to do it right.
Some hospitals have told me they are, ``terrified'' by the
prospect of Stage 3. These are some of the finest medical
centers in the United States, some of those who have been the
pioneers and leaders in electronic healthcare records; some of
those who believe that Stage 1 was very helpful in changing the
habits of providers; that Stage 2 was difficult.
But even these leaders say that Stage 3, as proposed,
terrifies them. It does not help patients to make these massive
changes fast and wrong. It does help patients to do this
deliberately and correctly, so that hospitals and doctors
embrace the changes instead of dread them.
Since 2009, the Federal Government has spent more than $30
billion to encourage the nearly 500,000 physicians and more
than 5,000 hospitals who serve Medicare and Medicaid recipients
to establish electronic healthcare records. About half of these
doctors and most hospitals have established such systems.
Beginning this year, the government is assessing penalties on
those who haven't. About a quarter of a million physicians have
begun losing 1 percent of their Medicare reimbursements, and
200 hospitals may be losing more than that.
All hospitals and most physicians met the requirements of
the first stage of the so-called Meaningful Use Program. As I
said earlier, most of them thought it was helpful in changing
habits. Stage 2 requirements are so complex that only about 12
percent of eligible physicians and about 40 percent of eligible
hospitals have been able to comply. That's why we should
immediately adopt the proposed modifications to Stage 2
requirements so the physicians and hospitals have time to adapt
to these huge changes, and we should delay, until January 1,
2017, making the final rules for Stage 3 so that we can do it
properly.
I look forward to working with Senator Murray, with
Secretary Burwell, other members of the committee, and the
administration on finding the best ways to modify this program
and these requirements so that we can realize the promise of
electronic medical records. I would emphasize again that our
goal is to help patients, and it does not help them to do this
fast and wrong. It does help them to do it deliberately,
carefully, and right.
Thank you, Madam Chairman.
Senator Collins. Thank you, Senator Alexander.
Senator Franken.
Statement of Senator Franken
Senator Franken. Thank you, Madam Chair.
This is for anyone. What is the No. 1 barrier to
integrating electronic health records and interoperability? Is
it that the leading companies in this want to keep their market
share and don't want to share--you know, I've got a big part of
the market, and if you stay with me, you'll be fine? And is
there something we can do about that since we're a part of the
lawmaking process in the country, I believe. Right?
[Laughter.]
Ms. Giusti. I would answer that question by saying that one
of the greatest disconnects when you are a patient is who
actually owns the whole patient. When we're seeing all
different physicians for specialized care, there's not one
person that gets rewarded on their overall health outcomes.
In addition, in today's world, where it's tough out there
in healthcare and different centers want to maintain the
patient population they have rather than lose them to other
centers, there's not always an incentive for everybody just to
share all of their data across every center. I do believe that
the centers that work with the best vendors to build integrated
and centralized areas where we can house our data--I believe
those centers will win in terms of patients wanting to work
more closely with them.
Part of this comes back to who has the responsibility for
the overall health of the patient, and where are we looking to
go for that central repository of integrated data.
Mr. Dishman. I would just add to it and say I believe that
the software vendors have realized where the puck is going and
are moving toward interoperability. Some of the standards are
not specific enough and they leave too much leeway. That means
you implement them differently, and then even software from the
same vendor doesn't talk to each other unless you hire a bunch
of health IT experts to do this--tightening the details on some
of these things.
What we at Intel are referring to--and we recommended this
for the House 21st Century Cures Act as well--is we need
implementation specs. It's one thing to have the standard, but
as part of what I mentioned in my testimony about the out-of-
the-box experience, if you're adhering to the standard, but the
clinician gets the new software after this huge investment,
either from stimulus or from private sources, and it doesn't
work out of the box because there's not a common implementation
standard that's linked to the pretty much common standards of
care that almost all clinicians need to do, this is like
getting a car, but it's not yet ready to drive until you get
somebody to put all the pieces together to actually use it.
An implementation spec that's very specific and that's
common across all of these would help to drive the standards
that are becoming real into actual practice.
The other thing we should just say--and this is the
challenge of meaningful use. It's not just a technical
challenge. This is a redefinition of the social covenant of
what it means to be a patient and what it means to be a
clinician and to have a coordinated care team. We're undoing
150 years of the doctor having the information as a lone
practitioner, moving to the paradigm of coordinated care teams,
where patients are part of it.
This is hard. Right? I had to fight to actually be a member
of--a bona fide member of my care team. I teach the patients
that I teach to do this today.
To step back from the technology for a moment, there are
specific things we can do and realize. We're on a path to
change the social covenant for a two-way interaction between
patients and families and their care teams and a two-way
exchange of data between the two of them. That requires re-
education of the patient to have more responsibility. That
requires re-education of the clinicians. That's why these
things are hard. It's not just the technical pieces.
Mr. Ratwani. I would like to just briefly add the safety
hazards and the inefficiencies that arise from these systems
for both clinicians and patients is a critical issue. As we
look to interoperability, it's critically important to have the
exchange of information, but it's also critically important to
ensure that the information is integrated in an appropriate way
so that there's no duplications that are going to pose issues,
that the information is reconciled and represented so we can
make sense of it. So interoperability is a key step, but so is
the way that information is then integrated and represented.
Senator Franken. The interoperability is not just about
delivering high-value care and good care. It's about safety,
too. It seems like it's incumbent upon us in this process, in
this whole process that we've undertaken.
I want to thank the Chairman and I want to thank the
Ranking Member for this series of hearings. It seems to me that
we have to really take seriously--and I know we are--the
approach that we do this so that we're fulfilling the promise
of this, and we're doing it in a way that increases the value
of care and lets patients have the access to their own
information, and that it's interoperable so that we can get the
real benefits out of this thing.
Thank you.
Senator Collins. Thank you.
Senator Isakson.
Statement of Senator Isakson
Senator Isakson. Thank you, Senator Collins.
I thank all of you for your testimony. You've testified to
a great advertisement for Senator Warner's and Senator
Isakson's bill on care coordination, which is in this committee
now and is currently getting comments. We've had over 500
comments already, and we're trying to aggregate those in hopes
the Chairman will look favorably upon it being a part of the
omnibus bill that we bring in terms of care for our patients.
But care coordination is absolutely critical. Eighty-two
thousand people a year die because of medical errors, many of
them because misinformation is available rather than
coordinated information.
What Senator Warner and I have done is said that we've
created a reimbursement to Medicare doctors for care
coordination for seniors with two or more chronic diseases. We
think that will improve the quality of care to the patient and
lower the cost because of the coordination. I think your
testimony and the nodding heads I've seen from the committee
members have all attested to that being a good thing to do, and
I hope we can do it.
As one who has been managing Parkinson's for 3 years, I
want to echo what you said, Mr. Dishman, and what you said, Ms.
Giusti. The aggregate information that's available to you and
the more you can get, the better you can manage a disease and
the better you can notice those things that are triggers that
your doctor should know about. The less information you have,
the less healthy you're going to be. I commend the Michael J.
Fox Foundation and the Parkinson's Foundation for the work
they've done on that.
Not to do too much advertising, but Senator Murray and I
have Senate bill 849, which is the registry for neurological
diseases we're trying to bring forward to do exactly that, to
see to it that we attract as much patient information as
possible, aggregate it in a form that is risk--aware of the
risk of doing that, but gets the patients the information they
need to manage the diseases that they have.
I commend all three of you on your testimony. I commend
both of you, in particular, on managing your disease and
becoming a victor over what was a very dangerous disease.
Thank you, Madam Chairman.
Senator Collins. Thank you very much.
Senator Murray.
Statement of Senator Murray
Senator Murray. First of all, let me thank Senator Collins
and Senator Warren for taking the time to lead this important
conversation and for all of your work in our effort on this. We
all know that strengthening our health IT infrastructure is
really a critical part of continuing the progress we've made
toward a healthcare system that really works for our families
and for people. Empowering patients with information is such an
important part of this.
Mr. Dishman, your personal story really illustrates why
patients have to be able to easily access their data when they
need it. I really appreciate you coming all the way out here.
Thank you for sharing that with us. I listened to your
testimony and your answers to questions, and it's a cultural
battle as much as a technological battle, and we all need to
appreciate that as we move forward on this.
Senator Franken asked you a little bit about this. In this
committee, we've heard a lot of stories just like yours about
the barriers that patients face in trying to get their
electronic health information. You talked about fighting for it
as much as you were fighting your cancer. That's just crazy. We
just assume, especially on our end of the country, that people
have access to information. So I really appreciate the battles
that you are fighting.
Talk to me a little bit about, based on your experience,
what the Federal Government should do to really address the
barriers that you fought through.
Dr. Dishman. The first is to continue the drive toward
value-based payment, because it's sort of prerequisite for
everything that we're talking about. While Intel has had
success creating our own ACO--and we are a tech company, so
it's easier for us to make all of that stuff work together than
somebody who's not, and that's what we want to get to. You
don't have to be a tech company to be able to make this stuff
work for your employees.
If the Federal Government had not driven and signaled that
we were moving to value-based payment, I believe, even with
Intel's size and clout, the providers would have ignored us and
not done the work that they said when we said,
``We want a direct contract with you, and we want to
hold you to some very aggressive quality metrics, so
the folks who manage our FABS, who are very good at
managing quality metrics, are going to build with
measures with teeth.''
So that's a first.
Driving a common data model is key. At the end of the day,
if we don't have common data elements that are designed the
same and common data models and--let's do it for clinical and
claims data and things that we know about, but let's go ahead
and set up those common data models.
Kathy and I both served on the President's PMI working
group, and one of the things that you'll see in our report that
comes out tomorrow at 1 o'clock is recommendations that we've
got to get the common data models in place for the new kinds of
data types like omics, like consumer-generated data, so that
that stuff can become a trusted part both to the clinicians and
to the researchers.
I mentioned the implementation specs. It's not just having
the standards. It's actually showing that there are
implementation specs, that these things are ready to go out of
the box.
One other is if we started auto pushing the EHR data into
the relevant and authorized health information exchanges with
all the security that we actually need and that is achievable
and doable, this would go a long way, and add the personal
health tools that consumers use, whether it's a personal health
record, to those exchanges. We have conceived of the exchanges
as a clinician-to-clinician capability.
It's like there is no reason that consumers should not be
able to use the exchanges to get access to their own data. If
it's auto pushed from all of the EHR players into there, and
now, suddenly, there are tools on the exchange that I, as a
consumer, can use, then the exchange is not just about
clinician-to-clinician, but about coordinated care teams having
access to the same data.
Senator Murray. Excellent. I really appreciate your
response.
Dr. Ratwani, you talked about certification requirements
for health information technology needing a renewed focus on
usability. I just heard about a woman who wanted the results of
her pregnancy test, but her electronic health record reported
her hormone levels rather than whether or not she was pregnant.
So you can imagine how frustrating that is when you're trying
to get accurate information and that's is hugely consequential,
what you're looking at.
How user friendly is today's health information technology
for patients?
Mr. Ratwani. Senator Murray, let me start by saying you're
a tremendous leader in the area of health usability, so I
appreciate the question. When we look at the usability from the
patient side, if we look at the current safety enhanced design
certification requirements, those requirements are focused on
eight capabilities that are primarily medication-related and
are provider facing, things like computerized provider order
entry, medication reconciliation. There are currently no
certification usability standards around patient portals,
patient information, discharge paperwork. None of that is
currently covered by the certification requirements.
What the committee could certainly look to do is leverage
existing research and literature in the area and develop a set
of guidelines that could be offered to the vendors to better
facilitate usability of patient facing aspects of health IT.
Senator Murray. We need to really focus on that, what
patients want, rather than how we are just putting information
into a system. The doctors can talk to each other--important.
Patients want information, too, and that's something we really
have to think about.
Ms. Giusti, I'm sorry. I am out of time. Thank you so much
for sharing your personal story and your expertise on this. I
really appreciate it.
Senator Collins. Thank you.
Senator Cassidy, also known as Dr. Cassidy.
Statement of Senator Cassidy
Senator Cassidy. Thank you, Madam Chair.
I agree with you all so much that it's a little bit hard
for me to formulate a question, because there's nothing to
challenge. Maybe we can illuminate.
We're working on a bill that would somehow--and I've spoken
to vendors, to providers--I'm a doc--to insurers, and, frankly,
the vendors have a point. They say,
``Listen, you go to Georgetown, and they always
measure height in feet and inches, but we go across
town and they measure it in centimeters, so we have to
customize.''
The more customization, obviously, the harder it is to
interface.
You spoke, Mr. Dishman, regarding how one Epic doesn't
speak to another Epic. Epic will logically say, well, that's
because they made it speak its own dialect, as opposed to--
sure, it may go back to being Indo-European, but the fact is
that many Indo-Europeans don't speak with one another.
I hate to talk to Dishman, because he's from Intel. Who in
the hell--like, Intel is--of course, you can do it. You know
what I'm saying?
[Laughter.]
My mom can't. She doesn't, by the way, and nor does her
son.
I guess my question is if you come up with a standards
committee, with stakeholders, it inevitably becomes somewhat
bureaucratic, and probably somewhat dominated by people from
Intel, who are, again, kind of three standard deviations out in
terms of their ability to understand, or a businesswoman who is
so incredibly motivated that, really, your ability to speak on
a sixth grade level, as how you're supposed to write a medical
consent form, has long been lost. I say that in no other way
but to observe.
If we're going to come together with a working committee
that's going to have standards, how do we prevent it from
becoming a bureaucratic process in which the average person who
reads on a sixth grade level will not be able to comprehend? I
don't know. I'm asking your thoughts.
Ms. Giusti. I guess one thought I would have, No. 1, is if
we're saying that these need to be used by patients for
patients, then patients should be at the table as we try to
bring all these disparate groups together to go over what we
are actually looking for in the EHRs. The other piece----
Senator Cassidy. Can I stop you for just a second? I want
to ask a technical question.
Ms. Giusti. Yes.
Senator Cassidy. My staff whispered to me API, the
application program interface. I guess we don't really care
about what the program itself does. We're just concerned about
the API. Correct?
Ms. Giusti. Yes. We get into this whole discussion of what
is--first of all, what is the patient seeing. You've got EHRs,
and you've got everything that a patient sees. Even that can be
a disconnect. The other thing that you're hearing today is--we
all just said the patients don't know they have these. If
patients----
Senator Cassidy. I'll tell you, I go into a doctor's
office--I take my mom to see her oncologist--do you want to see
your medical records? I think it's out there that you can
access your medical record. It may not register.
Ms. Giusti. Right.
Senator Cassidy. It's out there that you can see your
medical record.
Ms. Giusti. It's out there, but as we can tell, quite a few
are still not aware or not using it. If you have a chronic
disease, or you have cancer, you have to keep going in and
tracking your numbers. You'd be crazy not to. I think we tend
to----
Senator Cassidy. Yes, but I'm a physician. I don't track my
mother's numbers. You know what I'm saying?
Ms. Giusti. Right. When we look at the data, what we're
finding is with the baby boomer group, we will go in and look
at some of the data, if you are tracking some of it. If you
look at the millennials, they're actually going in to use these
interfaces more to schedule appointments and actually learn
health information just because that's the way they learn.
At some point, we have to bring the different groups in to
say, ``Well, what's everybody looking for in these tools, and
how do we make them easy to use?'' One of the concerns you're
hearing from Eric and me is there's the ability of a patient to
understand their health and their disease by looking at these
EHRs and portals. There's also the ability to use EHRs for
research purposes and actually understand a lot.
Senator Cassidy. Can I stop you there?
Ms. Giusti. Yes.
Senator Cassidy. Mr. Dishman, you bring up one of the
barriers that we have not discussed, which is institutions and
companies trying to control patient data because they wish to
monetize.
Mr. Dishman. Yes.
Senator Cassidy. When I was on the Energy and Commerce
Committee last year, we had a guy testify, and all these
physicians plug in on all this data in order to do population
health. As it turns out, it's only available if you put down
$500,000 and you purchase it. The taxpayer didn't finance this
to create another business model for a provider of information.
Do you agree with that?
Mr. Dishman. I agree. I'm helping a veteran right now who
has Parkinson's and cancer. He has eight devices, some provided
by the VA and some that he self-purchased to monitor different
aspects of his very complex health. I have been trying to help
him get one simple view--because he's not an engineer at
Intel--of what's going on with his data. We need patient
accessible APIs to all of these devices. Some of the devices
have been purchased by himself.
Senator Cassidy. But that's a different issue. Then the
company holding onto the data and not sharing it with the
population----
Mr. Dishman. No. That's the thing. They don't want to open
up their APIs, because they have the raw data and they're
trying to look across----
Senator Cassidy. Do we need to legislate that people have a
common API?
Dr. Dishman. If you purchase a device yourself or someone
is using it, you as a patient ought to have a right to that
data, not just the data that they have summarized into
information using their algorithms, but the raw data that
you're wearing on your body every single day.
Senator Cassidy. Let me ask a question, and I'll finish
with this. I don't know this, but you all have your own
perspective. If you're an insurance company, and you have big
data sets of de-identified patient data, should we mandate that
that be made available to medical researchers of a certain
qualification to do population health?
Right now, I'm told if you can put down $500,000, you get
it. But if you're at the School for Public Health at you-name-
it, you cannot access it without that $500,000, in which case
it ceases to be proprietary and it becomes something of common
usage. Any thoughts on that?
Mr. Dishman. Mandate that the patients can direct where
their data goes.
Senator Cassidy. That's different than what you said,
ma'am, because you're saying why wouldn't you aggregate your
data with others because it's only in the aggregation that it
becomes most powerful for population research.
Ms. Giusti. Absolutely. I also agree that that's the
decision of the patient. That's absolutely the decision of the
patient. If they know, then they----
Senator Cassidy. Then if the patient agrees to aggregate
their data, and you have this aggregated data set, again, do we
mandate that it be made available to researchers without paying
$500,000 or whatever the fee is? Do you follow what I'm saying?
Mr. Ratwani. I would like to add--yes, we need to reduce
the cost of researchers to engage in these data. It's going to
be the most meaningful way for us to make advancements here.
When it comes to the APIs and people's own personal health
information, if we want to see innovation in this area, we need
to open up the APIs and allow third-party vendors to come in
and innovate in this space.
I do want to come back to, Senator Cassidy, one of your
other initial comments about standards and EHR vendors. It's
important to recognize that this is not a new problem. Other
industries have gone through this.
If we look to transportation, if I walk into any vehicle in
this country, there's a hazard warning light that looks the
same in every vehicle. The accelerator is in the same place in
every vehicle. That industry has come to consensus on what
those standards should be. Coming to consensus might be new for
EHR vendors, but it's certainly not new to several of the high-
risk domains that we embark on.
Senator Cassidy. I'm way over time. I yield back. Thank
you.
Senator Collins. Thank you.
Senator Baldwin.
Statement of Senator Baldwin
Senator Baldwin. Thank you. I want to really thank the
witnesses, and you've given us an opportunity for another great
discussion on this issue.
Mr. Dishman, you talked at the outset of your testimony
about the goals of deep patient engagement and full
interoperability. I wanted to share a brief, sort of, Wisconsin
snapshot and maybe spur some discussion off of that.
In one of our communities in western Wisconsin, the city of
La Crosse, a staggering, I'm told, 99.4 percent of patients at
the end of life have an advanced care plan that is easily
accessible in their medical record. This is thanks to a
voluntary program called Respecting Choices that was pioneered
back in 1991 by one of our leading health systems, Gundersen.
They have--Gundersen had a robust electronic health record and
a portal for patients and families to use to update and review
the plans that they have on record.
I wanted to start with sharing this, because it really does
combine this concept of deep patient engagement and full
interoperability, at least for that system. We've talked more
about interoperability in the IT side of this than we have
about the deep patient engagement and the education around
helping people find the value in that data and interacting with
it.
I kind of use this example because I think you can't really
do advanced care plans without really thinking--now,
hypothetically, you might not be facing something imminently,
but it requires you to really think about your future health
and your treatment that you would like to receive under various
different scenarios. If you do want to change your mind, it
doesn't require that you go back in and alter those wishes.
I'm wondering if--I'd like to hear your comments about
whether there are similar types of initiatives we could start,
or communities could start, in order to engage people more
deeply at an earlier stage, knowing that the thought that they
give to their wellness and health will become a part of an
electronic health record that will guide the medical
professionals they interact with as it follows.
Mr. Dishman. I would mention that one pilot that we're
doing right now is targeted toward--and we've done a lot of
work at Intel with dual eligible populations and focusing on
independent living and chronic care management for seniors.
We're also trying to look at the other end of the spectrum that
says let's take people who are young enough to still think that
they're immortal, that, unlike me, they haven't gotten cancer
at age 19.
We have this one study right now that's called YOU.24x7,
and it's inviting people to really do preventive care and to
really focus on cardiovascular wellness. It's a mix of a
wearable, access to their clinical data if they've had any
diagnostic data ever done, and giving them tools to actually
engage with their providers on a shared care plan that both the
patient and--or they're not a patient yet--both the person and
the clinician work on.
You heard from Kathy's point as well in response to Senator
Collins' question. If you just give patients a bunch of access,
there'll be 10 percent to 20 percent like me that are going to
take hold of it. You've got to wrap those things in a new
relationship, a new program, like the one that you mentioned,
where it's humans plus data infrastructure coming together to
do things differently.
Senator Baldwin. Any other comments on that?
Ms. Giusti. I would agree with it, and the thing we're
finding is that when you actually have any third party that
says, ``Here's a reason to go into your electronic health
record and look for something''--and it can be as simple as, in
myeloma, you can track your disease with one biomarker. So we
just say to them, ``Follow that one number.'' If it's
cholesterol, high blood pressure, whatever it may be, just
teach a patient to track it. The moment you get them into that
EHR looking at that data to track one number where they're not
so overwhelmed, now they're in and they're working around it
and they're starting to use it.
What we've found with the MMRF is that for our newly
diagnosed patients, 75 percent of them felt they were highly
knowledgeable, because they were getting these numbers. If they
weren't working with the MMRF, only 45 percent thought they
were knowledgeable about their disease.
You have to work with a lot of trusted third parties out
there--there's many that are doing it--that can help raise
awareness of this issue around EHRs. It's not just the doctors
and the vendors. There are many people that can help with the
problem.
Mr. Ratwani. The use of these systems is going to be
critically dependent on the value that the patient actually
receives from it. A concrete example of that--we were looking
at a colleague's patient portal for their 5-year-old son, and
in the patient portal, it lists social history, smoking, status
unknown. Why is that relevant for a 5-year-old, and what parent
wants to look at that in a patient portal?
That's the kind of information that does not need to be
presented there, not in that format, not for that parent, and
there's several examples of that. Another one is a vaccine,
hepatitis, formula unknown. If I'm a parent, and I see
``formula unknown,'' does that mean I need to call my provider?
Does that mean there's something that's gone wrong here? So
unless we make these tools absolutely useful for the patients,
we're going to see a complete underutilization by the public.
Senator Collins. Thank you.
Senator Whitehouse.
Statement of Senator Whitehouse
Senator Whitehouse. Thank you, Chairman Collins. Thank you,
acting Ranking Member Warren.
I have a recurring theme through these hearings with
respect to health information exchange, and I've mentioned in
prior hearings the concern I have that we have poured immense
resources into the meaningful use support of information
technology on the desks of providers, but we've been very
parsimonious about supporting health information exchange.
We have one in Rhode Island called CurrentCare, which is as
good as any in the country, and I think they've won every
possible Federal grant that has come their way, and still it's
such a struggle to sort through all the problems of information
exchange, whether they're legal or technical or have to do with
making the information display in reasonable ways. I'm a strong
advocate for health information exchange.
It's putting a lot on big provider groups to do their own
health information exchange between each other. Many of them
have pretty strong vested interest in not sharing information,
as, unfortunately, we have heard here--kind of part of the
business strategy sometimes.
Ms. Giusti, you've articulated so well that putting that on
the patient is not only wrong, but it's bloody unfair, because
you've got enough to think about without having to build your
own health information data base for yourself. Today's
conversation reinforces for me the importance of a really
robust health information exchange and supporting the network,
the infrastructure that provides that, and improving it. I'm
trying to get it right.
In that context, I'd love to have your advice, looking
specifically at the health information exchange mechanism. It's
called Current-
Care in Rhode Island. It's an independent organization, and it
works closely with all the providers to maximize the utility of
this information and to get as much information in as possible
and to work automatically and efficiently and so forth.
What, from your experience, should be the things that we
should take away? If we're going to push more emphasis onto the
health information exchange piece of this, what should be the
key patient-based safeguards you'd like us to be looking for,
or the risks that we'd want to be staying away from? If you
could just go right across the panel--and I only left you 2
minutes, so they'll have to be pretty quick answers.
Mr. Dishman. I'll just say Healthy Way health information
exchange was key for us achieving our ACO, and our one
suggestion is you will help the business models of exchanges if
you do what I mentioned earlier, auto pushing data, with
patients' permission to the exchange. The procedure is done.
It's on the exchange for them so that anybody in the pool can
actually do it. It will help--the exchanges have enough volume
of data to where they can start to figure out their business
models.
Senator Whitehouse. Yes, which is the way we do it.
Go ahead.
Ms. Giusti. I would just say that, I think at this point in
time, you have some areas that are doing very well in terms of
making progress and others that are not. I would recommend
looking at the best practices of what's going on out there and
say these are working and then modify the incentives based off
of what you're seeing and the information you've gotten from
the hearings. I would do a potential reset.
Mr. Ratwani. I would say it's right information, right
representation. We want to ensure that the appropriate
information is available, it's accurate, it's up to date, and
that it's represented in a way that the patient can actually
understand. If I'm looking at a medication list, I certainly
don't want three different medication lists in front of me.
How do we actually combine those to make sense so the
patient is safe, understands, critically, what they need to do
next, and is represented in a way that makes sense to the
patient? If we are saying for medications--in medical jargon,
you might say, ``Take three times daily.'' What a patient cares
about is when do I need to take it, breakfast, lunch, dinner?
As we combine this information, we want to make sure it's
presented to the patient in a way the patient thinks about it.
Senator Whitehouse. I suppose it's safe to say that it goes
without saying from all of you that it has to be clear and
helpful to the provider that in the cases of patients who are
severely disabled or don't have the capacity to address their
healthcare themselves are counting entirely on the provider's
ability to do this. You can't sacrifice that in pursuing the
patient integration piece.
Mr. Ratwani. Senator Whitehouse, I would like to comment on
that. It's important, as you point out, that we look at this as
a system. It's the provider and it's the patient together.
Senator Whitehouse. Yes.
Mr. Ratwani. As the committee looks to forward progress
with health IT, the committee should ensure that the patient's
needs are able to be serviced by the provider. It fits with the
way the provider works. It fits with their structure. That's
critically important as we move forward with this.
Senator Whitehouse. Thank you very much.
And thank you to Chairman Collins and Co-Chairman Warren
for the hearing today. I just want to thank Chairman Alexander
and Ranking Member Murray for their continued focus on this
issue.
This is really important, and we have to get this right,
and there's nothing really partisan about it. This is about
getting it right and trying to make sure that the system does
what we want it to do in an effective way and people aren't
cheating and all the usual stuff we have to deal with. The
continued focus from this committee has really been terrific,
and I appreciate it.
Senator Collins. Thank you. I'm going to suggest to my
colleagues that we each have the opportunity for one final
question before we adjourn this very interesting hearing. I'm
doing so because I have a question for Mr. Dishman that I
didn't get to ask in the first round.
Mr. Dishman, you obviously are a technology expert. You're
very savvy. You live in a part of the country where access to
the internet is very common, where the population tends to be
younger. That's very different from the State that I represent.
Maine is the oldest State in the Nation. There are parts of our
State where internet access is simply not available at all.
It's one thing to say that patients should be accessing
their portal and getting their medical information in
California or Seattle or Massachusetts. It's a lot harder if
you are an elderly person without a computer, living in rural
Maine, where access to the internet is very limited or non-
existent. That's one barrier that I haven't heard anyone really
talk about today.
The second barrier that I perceive is when you go online
and look at your medical records, it's like reading Greek for
most people. If you're getting regular blood tests for temporal
arteritis and you're having a regular blood test, but you don't
know what C-reactive protein and your sed rate means, then
looking at every single week that you have the test in your
medical records, accessing it through the portal, really isn't
very helpful.
I see two barriers that go beyond interoperability, that go
beyond--is the provider's computer compatible with the computer
at the local hospital, much less other medical centers or
providers.
There's a basic, more fundamental problem of access, and I
think one of the reasons that fewer than half of patients
access their medical records and only 26 percent use that
portal more than once is, if you get something that doesn't
mean anything to you, or, worse yet, you can't get on in the
first place, then you really--all the interoperability in the
world is not going to help you. I would say that you're unusual
in a lot of ways.
Mr. Dishman. I wrote that in my testimony, Senator Collins.
I could not agree more. I said don't design it for me. Part of
what we do at Intel--I just mentioned dual eligibles. When we
go design technologies, we focus on dual eligibles in rural
parts of the country, and if we can make those systems work for
them and there, we know they're going to work elsewhere. That's
what's called universal design. We follow this principle when
we design and work on things.
The second thing I would recommend--and you're going to see
this in the PMI report that comes out tomorrow from the
committee. We keep saying it's not just about the data. It's
about the information. We're going to need to aim these systems
at probably 10 different levels of health literacy and make
sure that we've got the tools in place.
I'm a social scientist at Intel, not a techie. I study
doctor-patient interaction. I barely can understand these
things myself. So the kind of usability that he's been talking
about--we need to recognize there's probably 8 to 10 different
levels of health literacy and make sure that we have the
systems in place to do that.
Senator Collins. Thank you.
Ms. Giusti, I also want you to comment on this because
you've managed to surmount this problem.
Mr. Dishman. She's much smarter about healthcare than I am.
[Laughter.]
Senator Collins. Obviously, people of all ages are
diagnosed with the disease. I suspect, though I haven't been on
your website, that your website explains a lot of terms and
treatments. Does it?
Ms. Giusti. We try. It's always a changing paradigm. The
one thing that helps us, though, as I mentioned before, is the
fact that you can follow specific numbers. We're like the
concierge of so many patients that after a while, you get used
to saying, ``These are the three numbers you need to track when
you have this cancer.'' Often, it really is three different
things you're tracking.
Once you explain that to them, when they go on and look at
their EHRs, they know what they're looking for. Otherwise,
you're right. It's like drinking water out of a fire hose.
You're so overwhelmed by it you may never go back. That kind of
education--this is the important data for you to look for, and
this is where to find it--is important.
The other trend we're seeing is for many people, they do
have smart phones, and the challenge we're going to have is
we're all looking at it on our computers. The next generation
is not going to do that. They're going to be looking at
everything on their phones.
But one thing I want to add to this--and Eric touched upon
it, too--is we spent months working on the Obama Precision
Medicine Initiative. It's called precision medicine, but it
could easily be called precision health as well, because it
really is a 1 million cohort to everybody in this country, and
it doesn't mean that you're sick. It's very healthy people,
too.
This is an interesting time when we're trying to build
awareness of the importance of precision medicine and building
a million-
patient cohort. It's very apropos to what we're trying to do
here, too, which is know your data, make sure you're getting
the most robust data set you can, integrate it, aggregate it,
and we'll all benefit. I think the two things are going to go
hand-in-hand.
Senator Collins. Dr. Ratwani, does this also require a
cultural change on the part of some physicians who really have
not been trained to open up all of the medical records to their
patients? Does that make some physicians uncomfortable? Do they
feel they have to be more careful about what they write? Are
they willing to make their patients true partners?
Mr. Ratwani. It's difficult for me to comment on how many
clinicians would feel about this. Clinicians are deeply
involved in the care of their patients. They care about seeing
their patients get better. As we look at how we can improve
access, as we look at how we can make sure that the terminology
used in patient portals and the information is represented in
the right way, it's going to take input from patients and
clinicians to make all of that work.
The user-centered design methodology is exactly about that.
It's about engaging patients, providers, and any users of this
technology early and often, doing it in an iterative way so
that we get people's feedback on what these systems should
like, how they think about the problems, and, ultimately, it
will lead to the most effective product, system, interface that
can be developed.
Senator Collins. Thank you.
Senator Warren.
Senator Warren. Thank you. I want to ask about medical
research. We all know of the importance of medical research and
now the digitization of health information opens up tremendous
potential for facilitating clinical research.
Ms. Giusti, some of your testimony about this is truly
amazing. You have made the point that many patients and their
families want to participate. They want to be part of this.
When we talk about what serves patients, we talk about what
serves them one at a time to track their own numbers, but we
talk about it in terms of medical research and how the
aggregated information is far more valuable for creating new
research opportunities. I want to ask two quick questions about
this.
I want to start, Mr. Dishman, if I can, with you. Could you
just identify some of the barriers that researchers face when
they conduct clinical research using self-reported patient
data?
Mr. Dishman. Let's take cancer for an example. First of
all, you have to understand that there's so little data out
there for people who do cancer research. Fewer than 1 percent
of cancer patients have actually had a whole genome sequence.
If you go look at the data that researchers have access to
in something like cancer, 4 percent of the data that's out
there is sitting in the public data sets where the data has
been curated so that they can actually make meaningful research
out of it. The other 96 percent is sitting in the private data
centers of the hospitals, clinical centers, and cancer centers
that are out there.
The ability to tap into what's below the iceberg and do
research on that is the key, and the only way that's going to
be facilitated is through secure sharing. Once you have the
secure sharing infrastructure, you can start to combine self-
reported data, consumer-generated data from things like
wearables, omic data, and clinical data. It is the
triangulation of those data sets against one another where the
truth may lie.
A lot of the resistance for researchers sometimes in using
the self-reported data is they just don't have enough of the
data sets to triangulate all of these pieces. One of the things
that's starting to happen is let's create a stream where
patients themselves can contextualize their clinical data, not
change it in the record, but actually put a stream next to it
that says,
``Hey, I don't really have asthma. It was a response
to a chemo side effect that I was on for 3 months. But
now everybody believes I have asthma.''
That kind of data could help both the future clinicians
looking back at it, but also can help the researchers make
sense of the self-report data against the stream of clinical
data.
Senator Warren. I get your point about a data repository,
and I get your point about multiple data sets. If I could just
ask you one more--the role of standards in reporting. Can you
just say a word about that?
Mr. Dishman. Yes. This is back to standards at all levels
and security at all levels. There are many known self-report
measures now that have been clinically proven, if they're
executed in the standard way, to be reliable self-report
measures. So the notion that you can't make clinical outcomes
or research outcomes out of self-report is just not true.
Senator Warren. Good.
Maybe I can followup, then, with Ms. Giusti, and you can
talk just a little bit about how the foundation has overcome
many of the barriers to doing research in multiple myeloma.
Ms. Giusti. Right. You could tell that I was very focused
on a trial we were calling CoMMpass, where we sequenced 1,000
myeloma patients and built our own data bank. The barriers we
had to overcome in CoMMpass itself were we needed all the
academic centers to share. Otherwise, we'd never build a
critical mass of data. Every center sees some myeloma patients,
but not enough to get that critical mass.
By the way, myeloma is not alone. Most diseases are
breaking down into smaller and smaller types of diseases.
The second one is we had to allow everybody to give up
intellectual property so that they would be able to share all
this data. And the third was the importance of maintaining all
the patients in getting the longitudinal data. We have to keep
them in this data set over time, and the way you do that is by
sharing the data with them and aggregating the data and telling
them what they're learning from it.
But, importantly, for EHRs, one of the most expensive
pieces of this was developing the protocol, but also the case
report forms by which to study the CoMMpass trial over an
extended number of years and the money it cost to do the trial,
which was $40 million for a small nonprofit like ours to raise.
Looking forward, if you had good standards, and if we could
integrate all of this information, you could, No. 1, use EHRs
to start to identify--especially if you have genomics--what's
going on in these diseases.
Second, think about this. If you're a patient that goes on
and knows your genomics, when the trial opens, you can raise
your hand. Like I mentioned to you before, finding patients for
clinical trials and accruing trials quickly is the No. 1
obstacle in drug development. If you can do this wisely, not
only do you improve outcomes and improve drug development, but
you build in so much efficiency, and that's why it's so
important.
Senator Warren. Thank you both so much. I thank our entire
panel.
Researchers are on the cusp of so many great discoveries,
and we need to make sure they're not slowed down by data
systems that are just working in siloes, that are not sharing
the information. The work done by the Multiple Myeloma Research
Foundation, by Intel, by other partners working to overcome
these data barriers and their success in using patient data,
really shows us the future.
I hope that as this committee continues to focus on health
information that we're going to make sure that we're building
an approach to data that will support a 21st century research
enterprise.
Thank you all so much, and thank you, Madam Chair.
Senator Collins. Thank you.
Senator Baldwin.
Senator Baldwin. What a treat to get a second opportunity.
There's so many things I'd like to discuss, but I wanted to try
to limit myself.
There was a conversation earlier about how this health IT
has sort of developed around usability for the medical
practitioner, around doctors, not patients. You could make an
argument that there are almost--many doctors I talked to would
make the argument that they're really made for the billing
department, and, really, that the choices, whenever they were
made, to acquire a certain health IT was so that in that
medical system that existed at the time--but we've obviously
gone through quite a lot of changes--but was purchased so that
the right bill was generated for the patient, the insurer, the
supplement, whatever it is.
That's why the comment, Mr. Dishman, that you made about
really continue your--no, it was somebody else who--really
continue your work toward value-based payment models--or was it
you--because that's going to, hopefully, align all of that
usability for each of--you know, for the patient, for the
doctor, and for the setting in which that practitioner has
their practice.
I wanted to just ask a couple of questions. You had a
discourse with Senator Cassidy about APIs, which is rather a
new term for me. In terms of driving patient engagement, it
seems like this is a huge opportunity, whether it's condition-
specific or disease-
specific devices that are user friendly for the patient and
they engage in on a routine basis because they're motivated to
do so, and it makes sense, and it deals with a number of the
issues that have been raised.
We've been talking about interoperability between the major
health IT platforms. To what degree is it necessary for us, at
this point, to start engaging in the interoperability issues
about all of these, the wearables, the other devices that
assist patients?
You were talking about some of the VA programs. I had a
conversation with a constituent over the August recess who said
that, really, the health buddy program that he's dealing with
has been essential to him. Any comments on that for driving
greater patient engagement and interoperability?
Mr. Dishman. About 8 to 10 years ago, when my team at Intel
started building things for independent living for seniors, we
said,
``You know what? There's going to be a whole wide
range of wearable devices, and there's going to be
phones that even have medical diagnostic, great
equipment built into them, and that world is coming
very quickly.''
Senator Baldwin. If I can interrupt, phones, not internet-
based----
Mr. Dishman. That's right.
Senator Baldwin [continuing]. So that it can serve our
constituents who have less reliable internet service or none.
Mr. Dishman. That's right. That's right. That world is
coming, and we helped to form something called the Continua
Health Alliance that said just as we've struggled because we
did not have standards at the outset for what we've created for
the medical equipment side of the world, as the consumer health
side of the world emerges and these two start to combine, we
need to make sure that we have standards in that place.
We would do well--we would serve the country well by making
sure that these new data types, like omics and consumer-
generated data, start to have standards. If you're a diabetic
today, you can go on an app store, whatever OS that you use,
and find thousands of diabetes apps, which ones are high
quality, which ones are used, which ones were downloaded more
than once and actually sort of sustained.
The art of design for developing a consumer experience that
will sustain your behavior change is the key to fundamental
healthcare reform. Making sure that these devices that we're
going to have on our persons and are going to be around us and
part of our everyday life technologies--we need to get ahead of
that now and not let it become the same bogged down data swamp
that we have now in trying to pull clinical data into the era
of interoperability.
Ms. Giusti. You're already starting to see this happen in
startup companies left and right, where we're seeing companies
that will step in and say,
``We'll look at the employer groups. We'll look at
certain companies. We actually will sequence their
genomes, and we'll actually coach them and follow them,
and we'll require them all to wear a Fitbit, and we're
tracking their data. When things go awry, we just coach
them and reign them in on health, so that we're not
here trying to pay for disease, but we're actually
trying to prevent disease.''
Many, many companies are already looking at this and using
wearables as a huge part of it. The more time that goes by as
we try to build EHRs and make them as strong as they possibly
can be, the one thing we're facing is that technology is
growing so fast that almost the needs are changing.
You're hearing us say you have to educate the patient.
There's also amazing needs in research, because genomic
sequencing is taking off like crazy, and now you're asking a
slightly different question, which we all dealt with on the
Obama PMI piece as well, which is, yes, but now everybody's got
wearables and sensors. How is that data being brought in, too?
It's a challenging time.
Mr. Ratwani. If there's time, I'd love to comment. The EHR
vendors are generally the ones that put forward the patient
portals, and we've seen from research that we've done that.
Oftentimes, EHR vendors are not meeting the certification
requirements for the usability guidelines that are in place
now, which are focused on, generally, provider or clinician
facing aspects. It's unlikely that many vendors are investing
in usability resources for patient portals.
As we look to APIs and open APIs, it'll spur innovation in
the area. It'll allow new entrance into the market that
consumes that data. That will build really great products that
will serve patients' needs. As we do that, It'll also be
important to have other health information consumer health
products that feed that. The more data that we can bring
together, there's going to be a stronger data source for us to
better understand health outcomes and encourage good health.
Senator Collins. Thank you very much.
Let me thank each of our panelists today. You truly have
been extraordinary and have added immensely to the committee's
deliberations on this very important issue. We're trying to
figure out how giving access to electronic health information
can improve patient care and what the challenges are from the
perspective of both providers and patients. We want a patient-
centered system. That is our goal.
We have a better understanding of the challenges as a
result of your testimony and the work that you've been doing,
and we very much appreciate your sharing your insights with all
of us.
I want to thank all of the members of the committee, but
particularly my Ranking Member, Senator Warren, for their
participation today.
The hearing record will remain open for 10 days. There may
be some additional questions that are submitted by members of
the committee, or if you have something more that you want to
tell us, feel free to send that in as well.
The next committee hearing is being planned for October 1.
Thank you, and this hearing is now adjourned.
[Whereupon, at 11:39 a.m., the hearing was adjourned.]
[all]