[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

                               __________

 Printed for the use of the Committee on Health, Education, Labor, and 
                                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]