[House Hearing, 110 Congress]
[From the U.S. Government Publishing Office]
MEETING THE NEED FOR INTER-OPERABILITY AND
INFORMATION SECURITY IN HEALTH IT
=======================================================================
HEARING
BEFORE THE
COMMITTEE ON SCIENCE AND TECHNOLOGY
HOUSE OF REPRESENTATIVES
ONE HUNDRED TENTH CONGRESS
FIRST SESSION
__________
SEPTEMBER 26, 2007
__________
Serial No. 110-57
__________
Printed for the use of the Committee on Science and Technology
Available via the World Wide Web: http://www.house.gov/science
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______
COMMITTEE ON SCIENCE AND TECHNOLOGY
HON. BART GORDON, Tennessee, Chairman
JERRY F. COSTELLO, Illinois RALPH M. HALL, Texas
EDDIE BERNICE JOHNSON, Texas F. JAMES SENSENBRENNER JR.,
LYNN C. WOOLSEY, California Wisconsin
MARK UDALL, Colorado LAMAR S. SMITH, Texas
DAVID WU, Oregon DANA ROHRABACHER, California
BRIAN BAIRD, Washington ROSCOE G. BARTLETT, Maryland
BRAD MILLER, North Carolina VERNON J. EHLERS, Michigan
DANIEL LIPINSKI, Illinois FRANK D. LUCAS, Oklahoma
NICK LAMPSON, Texas JUDY BIGGERT, Illinois
GABRIELLE GIFFORDS, Arizona W. TODD AKIN, Missouri
JERRY MCNERNEY, California JO BONNER, Alabama
LAURA RICHARDSON, California TOM FEENEY, Florida
PAUL KANJORSKI, Pennsylvania RANDY NEUGEBAUER, Texas
DARLENE HOOLEY, Oregon BOB INGLIS, South Carolina
STEVEN R. ROTHMAN, New Jersey DAVID G. REICHERT, Washington
JIM MATHESON, Utah MICHAEL T. MCCAUL, Texas
MIKE ROSS, Arkansas MARIO DIAZ-BALART, Florida
BEN CHANDLER, Kentucky PHIL GINGREY, Georgia
RUSS CARNAHAN, Missouri BRIAN P. BILBRAY, California
CHARLIE MELANCON, Louisiana ADRIAN SMITH, Nebraska
BARON P. HILL, Indiana PAUL C. BROUN, Georgia
HARRY E. MITCHELL, Arizona
CHARLES A. WILSON, Ohio
C O N T E N T S
September 26, 2007
Page
Witness List..................................................... 2
Hearing Charter.................................................. 3
Opening Statements
Statement by Representative Bart Gordon, Chairman, Committee on
Science and Technology, U.S. House of Representatives.......... 7
Written Statement............................................ 9
Statement by Representative Ralph M. Hall, Minority Ranking
Member, Committee on Science and Technology, U.S. House of
Representatives................................................ 11
Written Statement............................................ 12
Statement by Representative David Wu, Chairman, Subcommittee on
Technology and Innovation, Committee on Science and Technology,
U.S. House of Representatives.................................. 13
Written Statement............................................ 14
Statement by Representative Phil Gingrey, Minority Ranking
Member, Subcommittee on Technology and Innovation, Committee on
Science and Technology, U.S. House of Representatives.......... 15
Written Statement............................................ 16
Prepared Statement by Representative Jerry F. Costello, Member,
Committee on Science and Technology, U.S. House of
Representatives................................................ 17
Prepared Statement by Representative Harry E. Mitchell, Member,
Committee on Science and Technology, U.S. House of
Representatives................................................ 17
Witnesses:
Dr. David E. Silverstone, Clinical Professor of Ophthalmology and
Visual Science, Yale School of Medicine; Assistant Chief of
Ophthalmology, Yale-New Haven Hospital; Practicing
Ophthalmologist, The Eye Care Group, New Haven, CT
Oral Statement............................................... 19
Written Statement............................................ 21
Biography.................................................... 22
Ms. Noel Brown Williams, President, Senior Vice President, and
Chief Information Officer, Hospital Corporation of America
Information Technology and Services, Inc.
Oral Statement............................................... 23
Written Statement............................................ 25
Biography.................................................... 29
Ms. Linda L. Kloss, Chief Executive Officer, American Health
Information Management Association, Chicago, IL
Oral Statement............................................... 29
Written Statement............................................ 31
Biography.................................................... 48
Mr. Michael Raymer, Vice President and General Manager, Global
Product Strategy, GE Healthcare Integrated IT Solutions
Oral Statement............................................... 48
Written Statement............................................ 50
Biography.................................................... 53
Mr. Justin T. Barnes, Vice President of Marketing, Corporate
Development and Government Affairs, Greenway Medical
Technologies, Inc.
Oral Statement............................................... 53
Written Statement............................................ 55
Biography.................................................... 57
Discussion....................................................... 58
Appendix 1: Answers to Post-Hearing Questions
Dr. David E. Silverstone, Clinical Professor of Ophthalmology and
Visual Science, Yale School of Medicine; Assistant Chief of
Ophthalmology, Yale-New Haven Hospital; Practicing
Ophthalmologist, The Eye Care Group, New Haven, CT............. 72
Ms. Noel Brown Williams, President, Senior Vice President, and
Chief Information Officer, Hospital Corporation of America
Information Technology and Services, Inc....................... 73
Ms. Linda L. Kloss, Chief Executive Officer, American Health
Information Management Association, Chicago, IL................ 75
Mr. Michael Raymer, Vice President and General Manager, Global
Product Strategy, GE Healthcare Integrated IT Solutions........ 79
Mr. Justin T. Barnes, Vice President of Marketing, Corporate
Development and Government Affairs, Greenway Medical
Technologies, Inc.............................................. 81
Appendix 2: Additional Material for the Record
Statement of Good Samaritan Hospital on behalf of the Mid-
Nebraska Telemedicine Network, provided by Lesley A. Bollwitt-
Maria, Director, Grants & Special Projects, Good Samaritan
Hospital Foundation............................................ 84
H.R. 2406, To authorize the National Institute of Standards and
Technology to increase its efforts in support of the
integration of the health care information enterprise in the
United States.................................................. 89
MEETING THE NEED FOR INTER-OPERABILITY AND INFORMATION SECURITY IN
HEALTH IT
----------
WEDNESDAY, SEPTEMBER 26, 2007
House of Representatives,
Committee on Science and Technology,
Washington, DC.
The Committee met, pursuant to call, at 10:10 a.m., in Room
2318 of the Rayburn House Office Building, Hon. Bart Gordon
[Chairman of the Committee] presiding.
hearing charter
COMMITTEE ON SCIENCE AND TECHNOLOGY
U.S. HOUSE OF REPRESENTATIVES
Meeting the Need for Inter-operability and
Information Security in Health IT
wednesday, september 26, 2007
10:00 a.m.-12:00 p.m.
2318 rayburn house office building
1. Purpose
On Wednesday, September 26, 2007 the Committee on Science and
Technology will hold a hearing entitled ``Meeting the Need for Inter-
operability and Information Security in Health IT.'' The hearing will
examine progress toward the broad use of information technology in
health care and the investments in technology and standards development
that are needed to create a national system of secure, inter-operable
health care information technology. Witnesses will comment on barriers
to the implementation of these systems, with an emphasis on the role of
technical standards. They will also comment on the need for legislation
to push toward the adoption of such standards. This includes a
discussion of H.R. 2406.
2. Witnesses
Ms. Linda L. Kloss is Chief Executive Officer of the American Health
Information Management Association (AHIMA).
Dr. David E. Silverstone is Clinical Professor at Yale School of
Medicine and Assistant Chief of Ophthalmology at Yale New Haven
Hospital. He serves as Chairman of the Health Information Technology
Committee of the American Society of Cataract and Refractive Surgery.
Mr. Michael Raymer is Vice President and General Manager for Product
Strategy and New Business Initiatives at GE Healthcare Integrated IT
Solutions.
Ms. Noel Williams is President of the Hospital Corporation of America
(HCA) Information Technology & Services, Inc.
Mr. Justin T. Barnes is Vice President of Marketing and Government
Affairs for Greenway Medical Technologies, Inc.
3. Brief overview
Information technology (IT) offers enormous potential benefits to
U.S. health care. According to the Institute of Medicine, as many as
98,000 people die in hospitals each year from medical errors such as
incorrect medications and improper diagnoses, many of which are
preventable. A study by the Health Care Information Management Systems
Society found that as much as 49 percent of clinical diagnostic testing
is performed because previous test results are unavailable when needed.
Applications of IT to health care such as electronic health care
records (EHRs), computerized ordering of prescriptions and tests, and
updated medical information for clinical decision support could save
thousands of lives and billions of dollars by reducing medical errors
and miscommunication.
The entry of IT into the health care arena has been slow and
disjointed. Only 12 percent of practices with five or fewer physicians,
where most Americans receive their primary health care, have adopted
EHRs. The health care industry spends only two percent of revenues on
information technology, much lower than the 10 percent average of other
information-intensive industries.
A key barrier to the adoption of a national, inter-operable health
care information technology (HIT) system is the lack of robust, widely
accepted technical standards. Despite efforts at the Department of
Health and Human Services (HHS) since 2004, such standards have yet to
be fully developed and widely promulgated. Moreover, there is also a
lack of conformance testing to ensure that products and systems comply
with established HIT inter-operability standards. In the absence of
these standards and conformance tests, health care providers are
reluctant to invest in HIT systems because there is no assurance that
they will be able to communicate with other systems.
The Federal Government's lead agency for the development and
promulgation of technical standards, the National Institute of
Standards and Technology (NIST), has been involved with HIT standards
development work since 2005. Because of its extensive expertise with
issues of system inter-operability, data security and privacy, and
consensus standards development, NIST is well positioned to make a
larger contribution to HIT standards development work and speed the
deployment of a national secure and inter-operable HIT system.
On May 21, 2007, Chairman Bart Gordon introduced H.R. 2406, a bill
to authorize NIST to increase its efforts in support of the integration
of the U.S. health care information enterprise. The bill: (1) directs
NIST to establish an initiative for advancing HIT integration and
allows it to assist health care representatives and organizations and
federal agencies in developing technical roadmaps for HIT standards;
(2) requires NIST to develop or adopt existing technology-neutral
guidelines and standards to enable federal agencies to effectively
select and use HIT systems that are secure, inter-operable, and ensure
patient privacy; (3) requires the Department of Commerce to establish a
Senior Interagency Council on Federal Health Care Information
Technology Infrastructure to coordinate the development and deployment
of federal HIT systems, the associated technology transfer, and federal
work with private HIT standards development organizations; (4) requires
NIST to establish a university grant program for multi-disciplinary
research in HIT-related fields; and (5) directs the National High-
Performance Computing Program to coordinate federal HIT R&D programs.
4. Issues and concerns
What is the true cost of insufficient use of information technology
within the U.S. health care system? The burden on U.S. health care due
to confusion, miscommunication, insufficient or outdated clinical
information and other information shortfalls is enormous. According to
a study in the Annals of Family Medicine, miscommunication is a major
cause of 80 percent of medical errors, including poor communication
between physicians, misinformation in medical records and misfiled
charts. Research published in the Archives of Internal Medicine found
that there are medication errors in one in five doses given in
hospitals and skilled nursing facilities, and seven percent of those
errors are potentially life-threatening. A study published in the
Journal of the American Medical Association estimates that only
slightly more than half of patients receive the known ``best practice''
treatment for their illness. Inter-operable health care information
systems could allow physicians to share patient medical information and
lab results between hospitals, labs, and clinics; order drug
prescriptions; and alert patients of drug recalls much faster than by
sharing paper records. While quantitative studies across the entire
health care sector are difficult to conduct, several health
associations estimate that the potential savings of greater IT adoption
by the health care industry run into the tens of billions of dollars. A
study published in the journal Health Affairs estimates that a fully
inter-operable national health care IT network could yield $77.8
billion per year in savings, or five percent of annual U.S. health care
spending.
What can the Federal Government do to accelerate the pace of standards
development and promulgation leading to inter-operability of HIT
systems? Are current federal efforts appropriately leveraging all
resources for this effort? In April 2004, President Bush signed an
executive order establishing the position of the National Health
Information Technology Coordinator (National Coordinator) at the
Department of Health and Human Services (HHS). The first National
Coordinator announced a plan to achieve health care IT inter-
operability nationwide. As part of this plan, HHS signed a memorandum
with NIST, transferring $6 million from HHS to NIST to pay for
technical work in support of HIT. NIST is the primary U.S. agency for
developing and promulgating technical standards in conjunction with
industry, standards development organizations, and foreign governments.
NIST's current HIT work under the memorandum with HHS may not be fully
utilizing NIST's expertise in technical standards, data security and
privacy, and electronic commerce, and its familiarity with systems
inter-operability and device communication issues.
How can a national, inter-operable HIT system be made compatible with
privacy and data security concerns? An essential feature of a practical
HIT system is that it protect the privacy and confidentiality of
patients' medical information. It must also have strong data security
provisions, so that medical information cannot be tampered with,
altered, or destroyed by unauthorized entities. HIT standards will need
to incorporate privacy and security in the original standards design
(as opposed to a later addition) in order to ensure that these features
will be a central element of a national HIT system. Within the Federal
Government, data security standards for all non-classified IT systems
are set by NIST, under the framework established by the Federal
Information Security Management Act of 2002 (FISMA). In addition, NIST
has been deeply involved in the development and adoption of
information-exchange standards in electronic business and electronic
voting systems, which have related privacy and data-security
requirements.
What can be done to improve HIT inter-operability within the Federal
Government? The Federal Government has not yet adopted inter-operable
HIT systems. The largest federal electronic medical records systems--
those of the Departments of Defense (DOD) and Veterans Affairs (VA),
and the Bureau of Indian Affairs (BIA)--are not mutually inter-operable
or inter-operable with the private sector. The Federal Government
should set the gold standard on inter-operability of HIT systems,
particularly as the demands on military and veterans' health care
infrastructures are increasing due to the wars in Iraq and Afghanistan.
Demonstrating the efficiency of inter-operable HIT systems in the
federal health care system could also spur private sector adoption of
these systems by providing a cost-effective model.
What research and development efforts are needed to anticipate and
adapt HIT standards for the next generation of medical technologies,
human-machine interfaces, and patient needs? With the current pace of
biomedical research and information technology, there will doubtless be
new demands on HIT systems and new opportunities for IT to play an
important role in health care. R&D will be needed to enable the
incorporation of new technologies such as voice or facial recognition
into HIT systems and to modify HIT systems to respond to new medical
treatments and procedures, such as remote surgery and active
implantable medical devices. These R&D activities will need to span
many disciplines and synthesize work in the medical, biological,
engineering, information technology and computer science fields, and
others.
5. Background
Although the United States is the most technologically advanced
nation in the world, the U.S. health care system continues to rely on
pen and paper for the bulk of its information needs. From patient
medical histories, to prescriptions, to hospital charts, handwritten
notations are the basis for patient care information. This system is
costly, antiquated, and prone to dangerous or life-threatening medical
errors. More than 98,000 Americans die and more than one million
patients suffer injuries each year as a result of broken health care
practices and system failures. According to the National Academies,
between 30 and 40 percent of health care costs--more than half a
trillion dollars per year--is spent on ``overuse, under-use, misuse,
duplication, system failures, and unnecessary repetition, poor
communication, and inefficiency.''
Information technology offers enormous potential benefits to
improve the functioning and efficiency of U.S. health care. A fully
realized national inter-operable health care IT (HIT) system could
reduce errors, improve communication, help eliminate redundancy, and
provide numerous other benefits that would protect patients and save up
to tens of billions of dollars per year. The central challenge to
achieving such a system is inter-operability--the ability of data
systems, medical devices and software from different vendors based on a
diverse array of platforms to share patient electronic health care
records (EHRs), electronic physician orders for lab tests and drug
prescriptions, electronic referrals to specialists, electronic access
to information about current recommended treatments and research
findings, and other information.
In February 2006, the Subcommittee on Environment, Standards and
Technology of the Committee on Science held a field hearing in
Portland, Oregon, titled ``Health Care Information Technology: What Are
the Opportunities For and Barriers to Inter-operable Health Information
Technology Systems?'' Representatives David Wu and Dave Reichert
oversaw the proceedings, whose purpose was to review the potential
benefits of IT to both patients and the health care industry, and to
determine what actions Federal and State governments and the private
sector should take to speed the adoption of inter-operable HIT systems.
Witnesses stressed the need for standardization in the HIT industry,
and encouraged strong investment by the Federal Government, especially
NIST, in standards development and education and training activities
for health care providers.
6. Bill summary of H.R. 2406
Section 1. Findings
Establishes Congressional findings that the National Institute of
Standards and Technology (NIST) is well equipped to address HIT
enterprise integration because of its experience with electronic
commerce, security, and privacy, as well as health care business
through its Malcolm Baldrige National Quality Program.
Section 2. Health Care Information Enterprise Integration Initiative
Directs NIST to establish an initiative to advance HIT enterprise
integration nationally, building on existing efforts at NIST and
involving government and industry consortia. Technical activities of
this program may focus on standards and inter-operability analysis and
the development of technical testbeds, software conformance and
certification, security and privacy, medical device communication, data
management and retrieval architecture, conformance testing
infrastructure, and health care information usability and decision
support. The initiative may also include assistance to outside
organizations and federal agencies in developing technical roadmaps for
HIT enterprise integration, relying on voluntary consensus standards
where possible. The Director shall report to Congress annually on these
activities.
Section 3. Federal Health Care Information Technology Systems and
Infrastructure
Directs NIST to develop new or adopt existing technology-neutral
HIT guidelines and standards for use by federal agencies within six
months of enactment. The guidelines and standards shall enable agencies
to select HIT systems that provide security and privacy and are inter-
operable. They shall promote the use of commercial HIT systems by
federal agencies, include conformance-testing procedures, provide
privacy profiles, establish inter-operability specifications, and
include validation criteria to enable agencies to select appropriate
HIT systems. NIST will report annually on the progress toward and
barriers to adoption of inter-operable, secure and private HIT systems
by federal agencies. Directs the Department of Commerce to establish a
Senior Interagency Council on Federal Health Care Information
Technology Infrastructure, with responsibilities to coordinate
development and deployment of HIT systems across the Federal
Government, associated technology transfer, and federal funding for and
participation in private standards-development organizations as related
to HIT.
Section 4. Research and Development Programs
Directs NIST, in consultation with NSF, to establish a grant
program for institutions of higher education partnering with
businesses, non-profits and government laboratories to establish
Centers for Health Care Information Enterprise Integration. Grants
shall be awarded on a competitive, merit-reviewed basis. The Centers
will generate innovative approaches to HIT enterprise integration by
conducting research on the interfaces between human information and
communications technology systems, voice-recognition systems, inter-
operability software, software dependability, metrics of the impact of
information technology on health care, health care information
enterprise management, and information technology security and
integrity. Grant applications shall include descriptions of proposed
projects, efforts to foster multi-disciplinary collaboration, and
technology transfer and education activities. The National High-
Performance Computing Program established by the High-Performance
Computing Act of 1991 shall coordinate federal R&D programs related to
HIT.
Chairman Gordon. I want to welcome everyone today. This
hearing is entitled Meeting the Need for Inter-operability and
Information Security in Health IT. Before we start with the
hearing, we need to take a moment to deal with some committee
business, and I am pleased to welcome two new Members to our
committee. The first is from California. I am pleased to
welcome Ms. Laura Richardson to the Committee. She is a new
Member, is also on another committee, and will be coming here
soon. So we are glad to have Ms. Richardson. She was a member
of the legislature in California and brings expertise in that
area. And I also want to welcome Mr. Paul Broun. He brings
particular expertise in that he is a physician, and this is a
good way to start your first meeting. You should be one of our
witnesses, and we want you to be a full participant. And let me
say, Dr. Broun, just in quick passing, you haven't been here
long, but you have been here long enough to know that there is
a little tenseness in the air sometimes. We hope you can find
that you can put that aside and feel that you can be
comfortable in getting work done. We have had 29 bills out of
this committee. All have been bipartisan. All, but one, have
been unanimous. Even Dr. Gingrey had a decent bill that came
out of here. There hasn't been a Democrat or Republican bill
that has been introduced that hasn't gotten prompt action, and
we want you, again, to use your expertise to help us to do an
even better job. And you are sitting at the right hand of a
good mentor, so I would listen to Dr. Ehlers for his good
advice.
And since we have some new Committee Members, we have to
update our Subcommittee rosters. The new Subcommittee roster
should be in front of you, and I have asked unanimous consent
that the Committee do ratify the Subcommittee rosters. With
that taken care of, I will now begin my opening statement.
Over the past 20 years, we have experienced a dramatic
change in the way we share information because of the rapid
emergence of information technology. Nearly every industry
across our economy from financial services to media to retail
has embraced information technology and integrated it
seamlessly into daily operations. Yet the health care industry
has lagged far behind. The broad use of IT in the health care
sector could have far-reaching benefits, including cost savings
in the billions, improved quality of care, and fewer dangerous
medical errors. Though there are a number of factors that have
contributed to the slow adoption of health IT, I believe one of
the most significant is the lack of technical standards for
inter-operability and the protection of patient privacy.
I will also note that this is an area that Newt Gingrich
and Hillary Clinton have agreed upon some time back. I now hope
that we can take their agreement and put it into some action. I
am sending copies of this legislation to our fellow colleague,
Mr. Gingrich, and hope we will have him one day, to come and
testify here.
According to most estimates, a fully inter-operable health
care IT system could save U.S. health care tens of billions of
dollars a year and help prevent some of the mistakes that lead
to the deaths of over 98,000 patients annually. But meeting the
challenge of developing and maintaining such a system is not
simple. Most Americans get their primary health care at offices
with five or fewer doctors. These small offices cannot easily
afford the initial investment in health IT equipment and
software or the time for training on these complicated systems.
Doctors and health IT developers also face medical-privacy laws
that vary state by state, some of which do not support the
digital exchange of patient information. Much more work needs
to be done to update laws and regulations in order to encourage
the adoption of this important technology.
And let me not forget that Governor Bredesen of Tennessee
and Governor Douglas of Vermont, a Democrat and Republican,
have been working on this with the Governor's Association. We
were in contact with them just the other day. I hope that we
are going to be able to have inter-operability between Congress
and the Governor's Association, so they can then push down this
uniformity of rules and regulations on the local level.
But the biggest barrier to the broad implementation of
health IT systems is the lack of technical standards to support
inter-operability while protecting data security. It is
wasteful to start investing in technology until we know it is
inter-operable, as the cost of upgrading to new systems could
eat up many immediate cost savings. To achieve inter-
operability, we need to have simple technical standards for
data formats, data-exchange protocols and other systems-
communication needs. These will enable different manufacturers
and vendors to build and sell medical software and hardware
devices that are based on the same underlying communications
technologies. Doctors and hospitals are reluctant to invest in
health care IT systems that are not inter-operable with other
such systems owned by other health care providers.
The National Institute of Standards Technology, NIST, is
uniquely positioned to meet this challenge. NIST was
instrumental in the guiding the creation of standards for the
financial-services industry and others as they transitioned to
an IT-based business model. It also sets and maintains the
technical standards for the IT security across the Federal
Government to protect against data theft and unauthorized
access. That expertise is essential for helping to create
inter-operable standards for health care IT.
In addition to discussing the challenges to implement
health care IT systems in the U.S., our witnesses today will
also address, I hope, H.R. 2406, which authorizes NIST to
increase its efforts to support the integration of the health
care-information enterprise in the United States.
This bill is not a complete solution to the problem we are
discussing today. But it is my hope that it is a starting point
for the broad efforts needed on the part of the Federal
Government, State governments, and health care and IT
industries to move towards a fully inter-operable health care
IT system.
The bill is based on the recommendations of a report by the
President's Information Technology Advisory Committee from 2004
and a study by the National Academies from 2005. It instructs
NIST to advance health IT integration while working with health
care representatives and federal agencies to develop technical
roadmaps for health IT standards. The bill also requires NIST
to create or adopt existing technology-neutral guidelines and
standards for federal agencies. It directs the Department of
Commerce to establish a senior interagency council on federal
health IT infrastructure to coordinate the development and
deployment of federal health IT systems. And finally, it
mandates a university-grant program at NIST for multi-
disciplinary research in health-IT-related fields. And thank
you, Mr. Wu, for that recommendation.
Secure, inter-operable health care IT systems are critical
for saving time and money. But we cannot lose focus on the
ultimate goal of all health policy, protecting patients' lives
as well as saving money.
I typically do not tell personal stories during hearings,
but if the Committee will indulge me, this drives home the
purpose of this legislation. The Committee staffer who has been
handling health IT issues is a gentleman named Mike Quear, a
very able, capable, bright public servant. Last year, Mike had
an open-heart surgery and was diagnosed with diabetes. He was
concerned what would happen if he ever needed emergency care,
so he started keeping a record of every condition that he had,
every specialist that he had visited, and every medication that
he was prescribed on a small card in his wallet. Unfortunately,
that card became larger and larger as he had additional
situations. That card was the only comprehensive record of care
that Mike had available to him. This past August, Mike had a
stroke and was taken to the hospital where emergency room
doctors were immediately able to evaluate his preexisting
conditions, contact Mike's team of specialists and provide him
with the best care, because they had that card. Now,
thankfully, he is now recovering at home, and we welcome him
and want him back to finish this legislation. But if those
records hadn't been available, who knows what might have
happened. I would venture to guess that not many people in this
room or in this county take the time to record their medical
history on a wallet card, nor should we need to. Technology in
this country is far enough advanced that we should be able to
expect doctors to access our complete medical records in any
emergency situation.
So I am eager to hear our witnesses' thoughts and
recommendations on how to most effectively promote the broad
implementation of health information technology systems in the
near future to save money, to save time, and to save lives.
[The prepared statement of Chairman Gordon follows:]
Prepared Statement of Chairman Bart Gordon
I want to welcome everyone to today's hearing on Meeting the Need
for Inter-operability and Information Security in Health IT. Over the
past 20 years, we have experienced a dramatic change in the way we
share information because of the rapid emergence of information
technology. Nearly every industry across our economy, from financial
services to media to retail, has embraced information technology and
integrated it seamlessly into daily operations. Yet, the health care
industry has lagged far behind.
The broad use of IT in the health care sector could have far
reaching benefits, including cost savings in the billions, improved
quality of care, and fewer dangerous medical errors.
Though there are a number of factors that have contributed to slow
adoption of health IT, I believe one of the most significant is the
lack of technical standards for inter-operability and the protection of
patient privacy.
Inter-operable communications for the exchange of information are a
requirement for conducting business across the country and around the
globe. Unfortunately, the health care industry has not yet adopted
common standards to allow for the broad management and transmission of
health related information.
According to most estimates, a fully inter-operable health care IT
system could save U.S. health care tens of billions of dollars a year,
and help prevent some of the mistakes that lead to the deaths of over
98,000 patients annually.
But meeting the challenge of developing and maintaining such a
system is not simple. Most Americans get their primary health care at
offices with five or fewer doctors. These small offices cannot easily
afford the initial investment in health IT equipment and software, or
the time for training on complicated systems. Doctors and health IT
systems developers also face medical privacy laws that vary state by
state, some of which do not support the digital exchange of patient
information.
Much more work needs to be done to update laws and regulations in
order to encourage the adoption of this important technology.
But the biggest barrier to the broad implementation of health IT
systems is the lack of technical standards to support inter-operability
while protecting data security.
It is wasteful to start investing in technology until we know it is
inter-operable, as the cost to upgrade to new systems would eat up any
immediate cost savings.
To achieve inter-operability, we need simple technical standards
for data formats, data exchange protocols, and other system
communication needs. These will enable different manufacturers and
vendors to build and sell medical software and hardware devices that
are based on the same underlying communication techniques. Doctors and
hospitals are reluctant to invest in health IT systems that are not
inter-operable with other such systems owned by other health care
providers.
The National Institute of Standards and Technology (NIST) is
uniquely positioned to meet this challenge.
NIST was instrumental in guiding the creation of standards for the
financial services industry and others as they transitioned to an IT-
based business model. NIST also sets and maintains the technical
standards for IT security across the Federal Government to protect
against data theft and unauthorized access. That expertise is essential
for helping to create inter-operability standards for health IT.
In addition to discussing the challenges of implementing a health
IT system in the U.S., our witnesses today will be addressing H.R.
2406, which authorizes NIST to increase its efforts to support the
integration of the health care information enterprise in the United
States.
This bill is not a complete solution to the problem we are
discussing today.
But it is my hope that it is a starting point for the broad efforts
needed on the part of the Federal Government, State governments, and
the health care and IT industries to move towards a fully inter-
operable national health IT system.
The bill is based on the recommendations of a report by the
President's Information Technology Advisory Committee (PITAC) in 2004
and a study by the National Academies in 2005. It instructs NIST to
advance health IT integration while working with health care
representatives and federal agencies to develop technical roadmaps for
health IT standards.
The bill also requires NIST to create or adopt existing technology-
neutral guidelines and standards for federal agencies. It directs the
Department of Commerce to establish a Senior Interagency Council on
Federal Health IT Infrastructure to coordinate the development and
deployment of federal HIT systems. And finally, it mandates a
university grant program at NIST for multi-disciplinary research in
health IT-related fields.
Secure, inter-operable health IT systems are crucial for saving
time and money. But we cannot lose focus on the ultimate goal of all
health policy: protecting patients' health and saving lives.
I typically do not tell personal stories during hearings, but if
the Committee will indulge me, I want to share a story that drives home
the purpose of this legislation. The Committee staffer who has been
handling health IT issues for me is a gentleman named Mike Quear. Last
year, Mike had open heart surgery and was diagnosed with diabetes. He
was concerned what would happen if he ever needed emergency care, so he
started keeping a record of every condition that he had, every
specialist he visited, and every medication he was prescribed on a
small card in his wallet.
That card was the only comprehensive record of care that Mike had
available to him.
This past August, Mike had a stroke and was taken to the hospital,
where emergency room doctors were immediately able to evaluate his
preexisting conditions, contact Mike's team of specialists and provide
him with the best care because they had that card. Thankfully, he's now
recovering at home. If those records hadn't been available, who knows
what might have happened.
I would venture to guess that not many people in this room, or in
this country, take the time to record their medical history on a wallet
card. Nor should we need to. Technology in this country is far enough
advanced that we should be able to expect doctors to access our
complete medical records in any emergency situation.
I'm eager to hear our witnesses' thoughts and recommendations on
how to most effectively promote the broad implementation of health
information technology systems in the near future to save money, save
time, and save lives.
Chairman. Gordon. Mr. Chair--the Chair now recognizes Mr.
Hall for an opening statement.
Mr. Hall. You can call me Mr. Chair if you want to.
Mr. Chairman, I thank you for a good opening statement, and
I, too, look forward to learning more about health information
technology inter-operability and information security as well
as about your bill, H.R. 2406, this morning from our various
esteemed panel of witnesses.
As a long-term supporter of Mike, what wonderful guy he is,
and of course, we keep him in our prayers, and I admire him for
keeping that list there. I started doing that some-80 years
ago, and my list got so heavy, I couldn't lift it, but Mike is
a wonderful guy. He has rendered great service to this
committee and to this Congress and to our nation, and we have
him on our prayer list.
And Mr. Chairman, as a long-term supporter of initiative
such as Tele-health for rural communities, I understand the
value of health information technologies, and many sectors of
our economy rely on information technology to increase
efficiency and minimize errors. The health care sector should
not be different. We invest 1.7 trillion, annually, in health
care, and yet the system is plagued with inefficiency. A recent
Rand Corporation study stated that if most hospitals and doctor
offices adopted health information technology, the efficiency
savings alone would average over $77 billion a year. Of course,
the good things they do far outnumber the inefficiencies, but
we, at a time like this, point up the lack of efficiencies and
hope to look to you as one, two, three, four--five people that
know more about it than we do or you wouldn't be there because
we write our legislation based on your information and how you
back it up, and then we battle it pro or con.
But the study found that if hospitals implemented a health
information technology system around 200,000 adverse-drug
events could be eliminated if they did. It could eliminate that
many annually. Despite these obvious benefits, developing a
nationwide HIT network is expensive, and of course, as the
Chairman said, it is challenging. One of the biggest
challenges, I guess, involves sharing information from system
to system, also known as inter-operability. We have to develop
inter-operable standards so that the systems being developed
today and tomorrow will function together smoothly, and in
order to address this need, President Bush established the
Office of the National Coordinator at the Department of Health
and Human Services, and that office has put together a
consortium with public and private entitles, including NIST, to
develop inter-operability and conformance standards. This
consortium, the American Health Information Community, AHIC,
has been working over the last few years on this very important
task, and I applaud your efforts at bringing a health
information technology bill before this committee, Mr.
Chairman, and I would like to know more about H.R. 2406 and how
it will affect the process currently underway at the Department
of Health and Human Services. For instance, it appears that the
bill would give NIST overall authority for writing standards,
procedures and guidelines for the health care industry. If that
is the case, I wonder whether NIST is the best vehicle for
full-scale adoption of standards. While I certainly agree that
NIST has a role to play, it is my understanding that NIST has
never before been a body that has set policy. Instead, they
have taken an agreed-upon policy and set about standardizing
it. Since there is already a vehicle in place setting policy at
AHIC, will this bill derail that process, or will this
legislation establish a parallel process between the two
agencies, and additionally, I am not sure on where the money
will come from for NIST to undertake HIT initiatives. Would it
have to come at the expense of other NIST projects and
priorities? The Administration asked Congress for $118 million
for fiscal year 2008 for HIT, and it looks like Congress will
appropriate somewhere between $60 and $70 million. Will NIST
projects be cut in order to complete with what the
Administration has already undertaken? That is a question that
I hope we can answer today. I think it is clear that we are all
seeking to improve Health Information Technology Systems as
quickly and as smoothly as possible, and I look forward to
hearing from all of the witnesses on this important topic, and
Mr. Chairman, I really do thank you and yield back the balance
of my time.
[The prepared statement of Mr. Hall follows:]
Prepared Statement of Representative Ralph M. Hall
Mr. Chairman, I look forward to learning more about Health
Information Technology, Inter-operability and Information Security, as
well about your bill H.R. 2406 this morning from our esteemed panel of
witnesses.
As a longtime supporter of initiatives such as telehealth for rural
communities, I understand the value of Health Information Technology.
Many sectors of our economy rely on information technology to increase
efficiency and minimize errors. The health care sector should not be
different. We invest over $1.7 trillion annually in health care, and
yet the system is plagued with inefficiency. A recent RAND Corporation
study stated that if most hospitals and doctors' offices adopted Health
Information Technology, the efficiency savings alone would average over
$77 billion a year. Moreover, the study found that if hospitals
implemented a Health Information Technology system, around 200,000
adverse drug events could be eliminated annually.
Despite these obvious benefits, developing a nationwide HIT network
is expensive and challenging. One of the biggest challenges involves
sharing information from system to system, also known as inter-
operability. We must develop inter-operable standards so that the
systems being developed today and tomorrow will function together
smoothly. In order to address this need, President Bush established the
Office of the National Coordinator at the Department of Health and
Human Services and that office has put together a consortium of public
and private entities, including NIST, to develop inter-operability and
conformance standards. This consortium, the American Health Information
Community (AHIC) has been working over the last few years on this
important task.
I applaud your efforts at bringing a Health Information Technology
bill before this committee, and I would like to know more about how
H.R. 2406 will affect the process currently underway at the Department
of Health and Human Services. For instance, it appears that the bill
would give NIST overall authority for writing standards, procedures and
guidelines for the health care industry If that is the case, I wonder
whether NIST is the best vehicle for full scale adoption of HIT
standards. While I certainly agree that NIST has a role to play, NIST
has never before been a body that has set policy. Instead, they have
taken an agreed upon policy and set about standardizing it. Since there
is already a vehicle in place that is setting policy at HHS, will this
bill derail that process? Or will this legislation establish a parallel
process between two agencies?
Additionally, I am unclear on where the money will come from for
NIST to undertake HIT initiatives. Will it have to come at the expense
of other NIST projects and priorities? The Administration asked
Congress for $118 million for FY '08 for HIT, and it looks like
Congress will appropriate somewhere around $60 to $70 million dollars.
Will NIST projects be cut in order to compete with what the
Administration has already undertaken?
I think that it is clear that we are all seeking to improve Health
Information Technology Systems as quickly and as smoothly as possible.
I look forward to hearing from all the witnesses on this important
topic. Thank you Mr. Chairman, and I yield back the balance of my time.
Chairman Gordon. Thank you, Mr. Hall. I think you raised
some very important issues. Let me make it very clear that we
are not interested in NIST setting any kind of policy. That
should not be the case, but rather, setting standards, not
picking winners or losers, but rather setting standards. They
also have the entire situation--they have tests so once those
standards are developed for both hardware and software they can
get the Good Housekeeping Seal of Approval, so that a small
firm or a large hospital can invest with the certainty that
they are not going to have to see this technology be obsolete
soon. So you raised some good questions, and I know those are
things we want to get into.
Since this is a hearing starting at the Full Committee
level--we typically go through regular order of bringing things
up through the Subcommittees. But by virtue of the interest in
this particular topic, we decided to start at the Full
Committee level, but I would like to hear from our Subcommittee
Chairman. I would like to now yield to Mr. Wu for his opening
remarks.
Mr. Wu. Thank you, Mr. Chairman, and thank you for holding
this very important hearing.
The health sciences continually push the envelope in new
technologies, new medicine and new research; however, health
care systems lag far behind in information technology
capabilities. In an increasingly digital society, paper records
are still a primary mode of information transfer in health
care. Improving health care IT will make health care more
efficient, safer for patients, and a better practice
environment for health care professionals and may wind up
saving some money. We need technical standards to create a
functional, inter-operable IT network, and we should enhance
the relationship between the Department of Health and Human
Services and NIST so that they can work together to create the
standards of the future.
As the government agency which is responsible for creating
technical standards, NIST is well equipped to address health
care IT standards for inter-operability and security. I often
note the important role of NIST in metrology. If you can't
measure something, it is not really real in terms of science or
economics. Similarly, NIST plays a critical role for inter-
operability. If there are not standards to guide folks,
creating inter-operable IT systems will be extremely difficult,
if at all possible. While digitizing medical information will
increase efficiency, we must also address the issue of
security. NIST can also properly develop standards that not
only address inter-operability but the need for proper security
measures as well; it has done so in the past.
I commend Chairman Gordon for his work to address the issue
of health care IT by introducing H.R. 2406. This bill will
increase inter-operability and security in health care IT by
directing NIST to continue its work in developing standards.
Earlier this year, the House passed my bill to train health
care IT professionals, who are knowledgeable in both
information technology and in health care so that new IT
systems don't sit on desktops as dark boxes. As we move forward
with the Chairman's bill and develop secure, inter-operable IT
systems, we need to ensure these systems can be developed and
implemented by trained professionals.
Again, I commend the Chairman for his fine work and look
forward to the testimony of the witnesses.
[The prepared statement of Chairman Wu follows:]
Prepared Statement of Chairman David Wu
The field of medicine continually pushes the envelope in new
technologies, new medicine, new research--which improves our overall
ability to stay healthy. However, health care systems lag far behind in
information technology capabilities. In an increasingly digital
society, handwritten records are still a primary mode of record keeping
in health care. Improving health care IT will make health care more
efficient, while minimizing medical errors--reducing health care costs
and ultimately saving lives.
We need technical standards to create a functional, inter-operable
IT network. I am pleased with the relationship between HHS and NIST. As
the government, which is responsible for creating technical standards,
NIST is well equipped to address Health IT standards for inter-
operability and security.
I often note the importance of NIST's role in metrology. If you
cannot measure something, it does not exist. Similarly, NIST plays a
critical role for inter-operability. If there is no standard to follow,
creating an inter-operable IT system will be difficult.
While digitizing medical information will increase efficiency, we
must also address the issue of security. The sensitive data of personal
medical records requires sufficient security measures are taken into
consideration. NIST can also develop standards that not only address
inter-operability, but the need for proper security measures as well.
I commend Chairman Gordon's for his work to address the issue of
Health Care IT by introducing H.R. 2406. This bill will help inter-
operability and security issues in Health Care IT by directing NIST to
continue its work in developing standards.
Earlier this bill, the House passed a bill that will provide
technical training to health care professionals regarding Health Care
IT. As we move forward with the Chairman's bill, and develop secure
inter-operable IT systems, we need to ensure these systems can be
implemented by trained staff.
I look forward to the testimony of the witnesses, and I yield back.
Chairman Gordon. Thank you, Mr. Wu. In continuing to try to
answer some of Mr. Hall's very legitimate questions--one was
about funding, and I just want to state that the COMPETES Act
that was passed overwhelming by Congress and signed by the
President this August put NIST on track to double over the next
seven years, and we hope this will be a part of that, although
not take seven years.
And Ms. Richardson, we welcomed you with great flair in
absentia earlier, but let me once again point out that Ms.
Richardson, as a member of the State legislature in California,
comes with a lot of background and expertise. Also as a
freshman she had her choice of a lot of committees, and she was
a top draft choice because she did come with such a good
background, and we are pleased that you chose the Science
Committee as one of those committees. So welcome, and you are
an official Member of this committee now.
Ms. Richardson. Thank you, Mr. Chairman.
Chairman Gordon. And Dr. Gingrey, now we welcome your
opening testimony.
Mr. Gingrey. Mr. Chairman, thank you, and certainly, I do
appreciate you giving Chairman Wu and I additional time to
address today's hearing.
As you know, Health Information Technology is a topic of
great importance to me as a physician member, and so I
certainly appreciate your holding of this hearing, Mr.
Chairman, on developing inter-operability standards for health
information technology, an area, as has already been said, of
critical importance to our health care system, and an area with
so much untapped potential.
Health Information Technology is one of the most promising
ways to tackle today's problems with skyrocketing health care
costs. It has been mentioned by some of my colleagues in regard
to the cost savings, but I am quoting an even bigger number and
this is based on a recently ran study revealing that inter-
operable HIT system, if it is implemented correctly, and of
course, widely adopted, could/would save the American health
care system more than $162 billion annually. So that is maybe a
little bit more than our Ranking Member Hall had said. But who
knows? Whether it is $77 billion or $160 billion, you are
talking about a lot of money. I mean there is potential for
some huge savings in cost.
Of course, in addition, there are numerous other advantages
that are also extremely compelling. Properly implemented, HIT
would enormously increase the efficiency within our health care
system by increasing access to things like offsite charting and
flagging of charts for follow-up on recommended procedure. It
has the potential to eliminate duplicate testing that wastes
patients' money and times, and yes, often causes patients
unnecessary pain and discomfort. As the Chairman was talking
about in reference to our great staff member Michael, what
could have happened had he not had the foresight to have that
record on his person? Even more vital is the possibility of
eliminating medical errors. And not sure of this estimate by
the National Institute of Medicine is correct, but a number of
years ago, they come out with a study and said something like
90,000 deaths occur in a hospital setting on an annual basis
because of medical errors. It may not be 90,000, but if it is
9,000 it is too many.
So I see two important roles for the government in Health
Information Technology. First, we must make sure that every
provider is able to adopt HIT. And secondly, we must ensure
that the technology and standards--this is what the Chairman's
bill is about--that the technology and standards measure up to
the 21st century standards so that Health Information
Technology is implemented properly and promptly so that we get
the right software.
In regard to the first issue, I want to maybe toot my own
bill a little bit and let you know that I am sponsoring H.R.
1952 in collaborating with Charles Gonzales of Texas. He is the
Subcommittee Chairman on the Small Business Committee. This
bill is called the National Health Information Incentive Act of
2007. The bill that I had introduced as a stand-alone is a
section of Chairman Gonzales's bill, but it would encourage HIT
adoption by proving optional financial incentives to small
health care providers and incentives to implement such an
infrastructure. And I am so glad that Chairman Gordon has
called this hearing to explore the second part of this process,
the creation and implementation of HIT inter-operability
standards. It is vital that these standards are developed in
the most efficient way to ensure that HIT is not only
implemented quickly but properly and promptly. And I am looking
forward, Mr. Chairman, to hearing from our witnesses, and I
thank them all for being here today.
[The prepared statement of Mr. Gingrey follows:]
Prepared Statement of Representative Phil Gingrey
Mr. Chairman, I appreciate your giving Chairman Wu and I additional
time to address today's hearing. As you know, health information
technology is a topic of great importance to me as a physician Member
of this body--so I appreciate your holding this hearing on developing
inter-operability standards for Health Information Technology--an area
of critical importance to our health care system and an area with so
much untapped potential.
Health Information Technology is one of the most promising ways to
tackle today's problem of skyrocketing health care costs. A recent RAND
study reveals that an inter-operable HIT system that is implemented
correctly and widely adopted would save the American health care system
more than $162 billion annually.
In addition, there are numerous other advantages that are also very
compelling. Properly implemented HIT would enormously increase the
efficiency within our health care system by increasing access to off-
site charting and flagging charts for follow-up on recommended
procedures. It has the potential to eliminate duplicate testing that
wastes patients' money and time and often causes patients unnecessary
pain and discomfort. Even more vital is the possibility of eliminating
medical errors that that lead to almost 100,000 deaths each year.
I see important roles for the government in promoting Health
Information Technology. First we must make sure that every provider is
able to adopt HIT. Secondly, we must ensure that the technology and
standards measure up to 21st century standards so that health
information technology is implemented properly to promote the inter-
operability of HIT software.
To address the first issue I am sponsoring H.R. 1952, in
collaboration with Rep. Charles Gonzales from Texas. This bill is
called the National Health Information Incentive Act of 2007. My bill
would encourage HIT adoption by providing optional financial incentives
to small health care providers and entities to implement such an
infrastructure.
I am so glad that Chairman Gordon has called this hearing to
explore the second part of this process, the creation and
implementation of HIT inter-operability standards. It is vital that
these standards are developed in the most efficient way to ensure that
HIT is not only implemented quickly but properly.
I want to again thank the Chairman for taking the initiative on
this important matter, and look forward the witness testimony.
Chairman Gordon. Thank you, Dr. Gingrey. I know you would
rather hear them than me. But I am so passionate about his. I
just want to follow up on something you said about the savings.
You know, right now, we spend more per capita on health care
than any other nation in the world, yet as you know, we are
struggling--we have different ways we want to do it--but
struggling to get all children to be able to have health care.
Right now, as you well know, there is a 10 percent cut looming
for doctors in terms of their Medicare reimbursement. But it is
the fastest-growing part of the federal expense; it is the
fastest-growing part of our individual--in most cases, our
expenses. But we are already spending so much as a nation; it
is hard to just keep stacking more money on. And so if we are
going to meet these needs, we have got to find a way to find
efficiencies within this system. This is a way. We don't know
whether it is tens of billions or hundreds of billions, but we
know it is many billons of dollars that can be saved, and with
these savings, hopefully we can capture and use those for those
other needs within this health care system that are so
important to our nation. And so we are going to work together
on this bill. We have got other bills we are going to work
together on, and I think we are going to meet those needs.
[The prepared statement of Mr. Costello follows:]
Prepared Statement of Representative Jerry F. Costello
Mr. Chairman, thank you for calling today's important hearing to
examine the need for inter-operability and information security in
health care information technology (HIT) and legislation that
authorizes the National Institute of Standards and Technology (NIST) to
increase its efforts in this area.
The Science and Technology Committee strives to accelerate
research, development, and advancements in new technology and
processes. With all of the advancements in medicine and tools in the
medical industry, it is shocking to see more than 98,000 people in
hospitals die from medical errors, including incorrect medications or
improper diagnosis. Further, it is frustrating that because of high
costs, at a time when our nation has access to the most sophisticated
health care technology, as much as 49 percent of clinical diagnostic
testing is performed due to the lack of accessibility to previous test
results. These issues can be addressed and I believe we owe it to the
American people to find solutions to the current challenges in
successfully implementing HIT.
Having stated the above, there are obvious vital areas, such as
unifying national standards, developing security protections to ensure
patient's information, and addressing the financial costs associated
with research, development, and full implementation of HIT, that must
be addressed.
Technological advancements in the health care industry have been
enormous. Today, I believe we will hear many of the great
accomplishments that have occurred in working towards HIT as well as
the challenges we must overcome to successfully implement HIT. I
believe we must identify and recognize the work that we have
accomplished up to this point and be cautious as to not undo these
advances. Instead, we should build around them with a focus on the
barriers that exist to succeeding in implementing such a system.
I thank the witnesses for appearing before our committee and look
forward to their testimony.
[The prepared statement of Mr. Mitchell follows:]
Prepared Statement of Representative Harry E. Mitchell
Mr. Chairman,
Thank you for organizing this morning's hearing on inter-
operability and security in health care information technology. This is
an issue that has come up in my work on the Committee on Veterans
Affairs. The Departments of Veterans' Affairs and Defense are working
on some demonstration projects in this area and I am eager to learn if
we are applying any of the lessons learned from their effort on a
system wide basis.
To date, the Federal Government has struggled to develop and define
widely acceptable technology for a national, inter-operable health care
technology system. In 2004, the Department of Health and Human Services
was charged to take the lead in developing and implementing a
nationwide inter-operable health IT (HIT) infrastructure to improve
quality and efficiency in health care. One obstacle inhibiting progress
in this effort is the lack of widely accepted technical standards.
The lead agency for developing and disseminating technical
standards is the National Institute of Standards and Technology (NIST).
Developing technical standards that work is NIST's expertise. It is
experienced in dealing with issues of systems inter-operability, data
security, privacy issues, and standards development.
The subject of health information technology produces an eye-
glazing effect on most Americans. Nonetheless, it is a critical factor
to making our health care system more efficient and economical and to
improving the quality of patient care.
Research conducted by the Committee staff in preparation for this
hearing notes that ``98,000 Americans die and more than one million
patients suffer each year as a result of broken health care practices
and system failures.'' Improvements in information technology can
reduce the incidence of medical error, produce billions in savings in
health care expenditures, and better protect patients. The significance
of this matter cannot be understated. . .improvements in health care
information technology is critical to patient safety.
I look forward to hearing from today's witnesses, especially in
regard to legislation our esteemed Chairman has introduced, H.R. 2406,
a bill designed to support NIST's efforts to advance the progress of
health information technology integration nationally.
Mr. Chairman, that concludes my remarks, and I yield back the
balance of my time.
Chairman Gordon. Now, at this time, I would like to
introduce our witnesses. We are glad you are here.
First is Dr. David Livingstone. He is a clinical Professor
at Yale School of Medicine and a doctor with the Eye Care Group
in Connecticut. He is testifying on behalf of the Alliance of
Specialty Medicine, and he was an advisor early on, and again,
I thank you for helping.
Ms. Noel Williams is the President of the Hospital
Corporation of America, HCA for the ones of you that aren't in
our area, Information Technology and Services. She is
testifying on behalf of the American Hospital Association, and
welcome, neighbor.
Ms. Linda Kloss is the Chief Executive Officer of the
American Health Information Management Association. We welcome
you.
And Dr. Michael Raymer is the Vice President and General
Manager of product strategy and new business initiatives at GE
Healthcare Integrated IT Solutions. GE has certainly been a
leader in this area.
And Dr. Gingrey, I know you have a witness here today, and
I would like for you to introduce him.
Dr. Gingrey. Mr. Chairman, thank you for giving me that
opportunity, and the opportunity to have a witness from my
district, the 11th of Georgia, the Northwest portion of the
State. I have nine counties, and our witness is from
Carrollton, Georgia, in Carroll County, almost-Alabama, I call
it. But that is Mr. Justin Barnes. I have known Justin for a
number of years. He has worked very diligently as Vice
President of marketing and corporate development and government
affairs for the Greenway Medical Technologies Company in
Carrollton, Georgia, and they develop a lot of software
programs and have been at this for a number of years. They have
recruited, actually, some general surgeons and some OB-GYNs
from the community and have many, many years of clinical
experience and practice who are now working with the company in
the development--well, actually they have developed very
impressive software programs for those specialties in
particular, general surgery and OB-GYN, and it is something
that is out there on the market and working very well. Justin
is such a smart young man, I thought, surely, he was a graduate
of Georgia Tech, but I had to go over and speak to him to make
sure about that. And he said, no, Congressman, I am a graduate
of U. Mass. I won't try to Massachusetts, because I don't do
very good--but a graduate of U. Mass in legal studies. And I
very proud to welcome one of our witnesses, Mr. Justin Barnes
from Greenway. Thank you.
Chairman Gordon. And do you know, did he have a son that
played on the Little League team? Didn't you just win the
world's championship? And that is what? Two out of three?
Dr. Gingrey. That is right, Mr. Chairman, two out of three.
I think one time Macon, and this last time Columbia, not
Carrolton, but pretty close.
Chairman Gordon. So Dr. Silverstone, if you would, please,
you can begin with your opening statement. Dr. Silverstone, if
you will, hit the button there to make it turn on, we will all
hear you better.
STATEMENT OF DR. DAVID E. SILVERSTONE, CLINICAL PROFESSOR OF
OPHTHALMOLOGY AND VISUAL SCIENCE, YALE SCHOOL OF MEDICINE;
ASSISTANT CHIEF OF OPHTHALMOLOGY, YALE-NEW HAVEN HOSPITAL;
PRACTICING OPHTHALMOLOGIST, THE EYE CARE GROUP, NEW HAVEN, CT
Dr. Silverstone. Wow, that sounds different. Okay, Mr.
Chairman, and Members of the Committee, thank you for holding
this hearing on health information technology and the need for
inter-operability standards that will promote and support the
integration of private and secure health information
enterprises. I appreciate the opportunity to present the
perspective of specialty physicians on your legislative
proposal, H.R. 2406, which is pending before the Committee.
I am David Silverstone. I am a practicing ophthalmologist
at the Eye Care Group in New Haven, Connecticut, where I am
also a clinical professor of ophthalmology and visual science
at the Yale School of Medicine and the assistant chief of
ophthalmology at Yale-New Haven Hospital. I serve as the Chair
of the American Society of Cataract and Refractive Surgery's
(ASCRS) Subcommittee on Health Information Technology as well
as the ASCRS liaison to the American Society of Ophthalmic
Administrators Executive Board. Today, I am here representing
the Alliance of Specialty Medicine, a coalition of 11 medical
societies, representing nearly 200,000 specialty physicians.
First, we would like to thank you for your efforts to
advance health information technology, HIT, legislation and for
including specialty physicians in the development process. We
believe that your legislation, H.R. 2406, which authorizes the
National Institute of Standards and Technology to enhance
efforts to integrate health information enterprises in the
United States, will help to promote the widespread adoption of
effective HIT. Health information technology has the potential
to increase efficiency and quality of care, but this cannot be
achieved until we have effective standards of communication and
interaction among systems. In addition, the technology has the
potential, as you have all indicated, to significantly lower
costs in the health care industry. In addition, we support the
development of an electronic-information network that is
reliable, inter-operable, secure, and protects patient privacy.
Specialty physicians have been and continue to be actively
engaged in the quality-improvement area. Through the
development of measure specifications for service and the
development of a rational system for collecting, aggregating,
and reporting data across numerous public and private insurance
programs in the least burdensome way, we have played a pivotal
role in shaping the future of our health care-delivery system.
However, in order to continue making progress in these areas,
we believe that specialty physicians, and indeed all health
care providers, must employ reliable and secure HIT systems.
These systems are a needed and an essential component that will
help us to continue to participate in these programs and to
improve the quality of care we provide to our patients. In
addition, these systems will help us to harness medical
knowledge to enable health care providers to deliver the most
effective and up-to-date medical information in an efficient
and cost-effective manner.
As you know, the adoption of electronic health care records
and other health-related information technology has been slow
to say the least. According to the e-Health Initiative, the
health care industry invests only two percent of its revenues
in IT, whereas other information-intensive industries, such as
financial services, invest 11 percent of revenues in IT in
order to improve the quality, diversity and efficiency of their
products and services. We agree that in this age of rapid
technology advancement, the slow adoption of health IT by the
health care industry is undesirable. The absence of an
efficient HIT system is hampering the integration of effective
treatment plans into mainstream medicine, the effective and
efficient evaluation of current practices and efforts to
improve both the quality of medical care and the cost-
effectiveness of health care delivery. We believe that an
effective quality-improvement program must incorporate the use
of HIT while recognizing the considerable administrative costs
that physicians and other health professionals would incur for
participating in such a program.
Most physicians and other health professionals lack the
necessary health IT and administrative infrastructures to
participate in the majority of quality-improvement programs for
physician services. As you know, the typical American small
physician practices and physicians not employed by large
institutions will continue to face challenges in financing the
purchase of integrated HIT systems. In addition, many
progressive practices that were early adopters of HIT are now
finding themselves with costly systems that are now out of
date. The cost of updating these systems will be too great to
bear in the light of the pending health care service
reimbursement reductions and the lack of inter-operability
standards. Most physicians do not have HIT systems and are
watching and waiting. They do not feel confident making such a
large investment in health IT because of the cost and the
uncertainty of future system compatibility.
Therefore, as Congress addresses this legislation and
similar legislation in the future, we hope that additional
efforts to promote health IT and inter-operability include more
financial assistance for physicians to obtain HIT. Efforts to
ease the burden on physicians seeking to purchase health
information technology, especially in the face of annual
updates below medical inflation due to the falling sustainable
growth rate formula are greatly appreciated and also essential.
Your bill, which would accelerate the development of inter-
operability guidelines and standards is both a necessary and
essential step in developing and utilizing IT effectively and
efficiently in our health care system. IT systems must use
common standards for data transmission, data sharing, medical
terminology, communications, security, and other features.
Developing these inter-operability standards will allow
disparate IT systems and software applications to communicate,
exchange data and use that information to both improve the
quality of care provided to our nation's patients and to
decrease the cost of providing that care.
We concur that NIST, with its experience and expertise in
electronic commerce, information technology, security and
privacy, coupled with the health care component of the Malcolm
Baldrige National Quality Program, and its expertise in working
with the information technology and health care industries is
well equipped to address the clinical challenges posed by
health information enterprise integration.
[The prepared statement of Dr. Silverstone follows:]
Prepared Statement of David E. Silverstone
Mr. Chairman and Members of the Committee, thank you for holding
this hearing on health information technology and the need for inter-
operability standards that will promote and support the integration of
private and secure health information enterprises. I appreciate the
opportunity to present the perspective of specialty physicians on your
legislative proposal, H.R. 2406, which is pending before the Committee.
I am David Silverstone. I am a practicing ophthalmologist at The
Eye Care Group in New Haven, Connecticut where I am also a Clinical
Professor of Ophthalmology and Visual Science at the Yale School of
Medicine and the Assistant Chief of Ophthalmology at Yale-New Haven
Hospital. I serve as the Chair of the American Society of Cataract and
Refractive Surgery's (ASCRS) Subcommittee on Health Information
Technology, as well as the ASCRS liaison to the American Society of
Ophthalmic Administrator's Executive Board. Today, I am here
representing the Alliance of Specialty Medicine--a coalition of 11
medical societies, representing nearly 200,000 specialty physicians.
First, we would like to thank you for your efforts to advance
health information technology (HIT) legislation and for including
specialty physicians in the development process. We believe that your
legislation, H.R. 2406, which authorizes the National Institute of
Standards and Technology (NIST) to enhance efforts to integrate health
care information enterprises in the United States, will help to promote
the wide spread adoption of effective HIT. Health Information
Technology has the potential to increase efficiency and quality of care
but this cannot be achieved until we have effective standards for
communication and interaction among systems. In addition, the
technology has the potential to significantly lower costs in the health
care industry. Furthermore, we support the development of an electronic
information network that is reliable, inter-operable, secure, and
protects patient privacy.
Specialty physicians have been and continue to be actively engaged
in the quality improvement arena. Through the development of measure
specifications for services and the development of a rational system
for collecting, aggregating, and reporting data across numerous public
and private insurance programs in the least burdensome way, we have
played a pivotal role in shaping the future of our health care delivery
system. However, in order to continue making progress in this area, we
believe that specialty physicians, and indeed all health care
providers, must employ reliable and secure health information
technology systems. These systems are a needed and essential component
that will help us to continue to participate in these programs and to
improve the quality of care we provide to our patients. In addition,
these systems will help us to harness medical knowledge to enable
health care providers to deliver the most effective and up-to-date
medical care in an efficient and cost effective manner.
As you know, the adoption of electronic health care records and
other health-related information technology (IT) has been slow, to say
the least. According to the e-Health Initiative, the health care
industry invests only two percent of its revenues in IT, whereas other
information intensive industries, such as financial services, invest 11
percent of revenues in IT in order to improve the quality, diversity
and efficiency of their products and services. We agree that in this
age of rapid technological advancement, the slow adoption of health IT
by the health care industry is undesirable. The absence of an effective
health information technology system is hampering the introduction of
effective treatment plans into mainstream medicine, the effective and
efficient evaluation of current practices, and efforts to improve both
the quality of medical care and the cost effectiveness of health care
delivery. We believe that an effective quality improvement program must
incorporate the use of health IT, while recognizing the considerable
administrative costs that physicians and other health professionals
would incur for participating in such a program.
Most physicians and other health professionals lack the necessary
health IT and administrative infrastructures to participate in the
majority of quality improvement programs for physicians' services. As
you know, the typical American small physician practices and physicians
not employed by large institutions will continue to face challenges in
financing the purchase of integrated HIT systems. In addition, many
progressive practices that were ``early adopters'' of HIT are now
finding themselves with costly systems that are now out-of-date. The
cost of updating these systems will be too great to bear in light of
pending health care services reimbursement reductions and the current
lack of inter-operability standards. Most physicians do not have HIT
systems and are ``watching and waiting''; they do not feel confident
making such a large investment in health IT because of the cost and the
uncertainty of future system compatibility.
Therefore, as Congress addresses this legislation or similar
legislation in the future, we hope that additional efforts to promote
health IT and inter-operability include more financial assistance for
physicians to obtain health IT. Efforts to ease the burden on
physicians seeking to purchase health information technology,
especially in the face of annual updates below medical inflation due to
the flawed sustainable growth rate (SGR) formula, are greatly
appreciated but also essential.
Your bill, which would accelerate the development of inter-
operability guidelines and standards, is both a necessary and essential
step in deploying and utilizing IT effectively and efficiently in our
health care system. IT systems must use common standards for data
transmission, data sharing, medical terminology, communications,
security and other features. Developing these inter-operability
standards will allow disparate IT systems and software applications to
communicate, exchange data and use that information to both improve the
quality of care provided to our nation's patients and to decrease the
cost of providing that care.
We concur that NIST, with its expertise in electronic commerce,
information technology, security and privacy, coupled with the health
care component of the Malcolm Baldrige National Quality Program and its
expertise in working with the information technology and health care
industries, is well equipped to address the technical challenges posed
by health care information enterprise integration.
As you know, an integrated information enterprise is critical for
useful HIT. Involving an entity, such as NIST, with the capacity to
promote guidelines and standards in the public and private sectors will
encourage functional uniformity among HIT products. Current problems
resulting from the fragmentation of health care in the United States
would be greatly diminished and physicians will be able to choose
products that conform to specific practice needs, while also ensuring
adequate and appropriate information is available to other providers.
In addition, encouraging inter-operability between entities through
research and development grants to institutions of higher education and
for profit/non profit centers that promise to form ``Centers for Health
Care Information Enterprise Integration'' will establish a precedent of
the importance of inter-operability.
It is also essential to identify, early-on, any problems with HIT
in order to minimize costs and mitigate risks prior to widespread
adoption. A realistic timeline for HIT adoption should allow ample time
to develop, test, and validate appropriate HIT criteria, standards and
guidelines. Physicians, largely inexperienced with HIT, will also
benefit from a timeline that allows sufficient time to acclimate to a
new system.
On behalf of the Alliance for Specialty Medicine, thank you for
your leadership in advancing the quality of our health care system by
addressing the needs of the health care industry in the area of HIT.
And, thank you again for continuing to include specialty physicians,
those as myself who will be most affected by practice changes, in the
process. We applaud the leadership of Chairman Gordon for an extremely
well thought out plan that promotes the adoption of HIT by authorizing
NIST and others with expertise in the area of technical standards
development to take on this monumental task. The Alliance stands ready
to work with the Chairman and this committee on this legislation and
the rapid implementation of inter-operability standards.
At this time, I would be happy to answer questions from the
Committee Members.
Thank you.
Biography for David E. Silverstone
David E. Silverstone, M.D., founded Temple Eye Physicians in 1977,
which merged with Ophthalmic Surgical Associates in 2001 to form The
Eye Care Group. He specializes in cataract and lens implant
microsurgery and glaucoma and is board-certified by the American Board
of Ophthalmology.
Dr. Silverstone received his undergraduate degree from Columbia
College and his medical degree from New York Medical College. He
completed his ophthalmology residency, a glaucoma research fellowship,
and a chief residency at Yale. He did a fellowship in Intraocular Lens
Implantation at New York Medical College.
Dr. Silverstone is a Clinical Professor and Assistant Chief of
Ophthalmology at Yale. He has served as the Chief of ophthalmology at
the West Haven VA Hospital and is on staff at the Temple Surgical
Center and the Hospital of Saint Raphael.
He was part of the Yale team that developed Timolol, the first
modern medication for the treatment of glaucoma and has developed
computer software that has been adopted by ophthalmologists nationwide.
Dr. Silverstone serves as the Director of Continuing Medical
Education for the American Society of Cataract and Refractive Surgery
and sits on the Governing Board of Directors of the American Society of
Ophthalmic Administrators and the National Board of Certified
Ophthalmic Executives. He is also a fellow of the American Academy of
Ophthalmology, which has awarded him its Honor Award, and serves on the
Executive Committee of the Connecticut Society of Eye Physicians. He is
also a member of the New England Ophthalmologic Society, the
Connecticut Glaucoma Society, the Connecticut State Medical Society,
the Association for Research in Vision & Ophthalmology and the American
Public Health Association.
Chairman Gordon. Thank you, Dr. Silverstone. Your full
testimony is a part of the record, and we are not strict on our
five minutes, but you are already three-and-a-half over, so we
would want you to explore more of your interests as we go into
the questions. And so I will say, we have everybody's
testimony; we have reviewed that. And you know, Beulah doesn't
honk at five minutes, and so we want you to get your full
thoughts in, but we want to try to move along in an expeditious
way.
So Ms. Williams, you are next.
STATEMENT OF MS. NOEL BROWN WILLIAMS, PRESIDENT, SENIOR VICE
PRESIDENT, AND CHIEF INFORMATION OFFICER, HOSPITAL CORPORATION
OF AMERICA INFORMATION TECHNOLOGY AND SERVICES, INC.
Ms. Williams. Good morning, Mr. Chairman. I am Noel
Williams, Senior Vice President and Chief Information Officer
for Hospital Corporation of America, better known as HCA. Of
our 192 HCA hospitals, 20 are in 11 Congressional districts,
represented by this committee, with over 16,000 employees. On
behalf of the American Hospital Association's nearly 5,000
member hospitals, health systems and other health care
organization and our 37,000 individual members, I appreciate
this opportunity to address the Committee on the importance of
inter-operability and security in health information
technology.
The mission of America's hospitals is caring for patients.
Every day, the women and men of our hospitals strive to improve
the safety and quality of the care they provide. Research has
shown that certain kinds of IT such as electronic health
records, computerized physician order entry, computerized
decision-support system and bar coding for medication
administration can limit errors and improve care as well as
lower cost and improve efficiency. Hospitals have been pioneers
in harnessing the power of IT for improvement. Our challenge
now is to extend the use of IT to all hospitals, large and
small, in both urban and rural areas.
Last year, the AHA conducted a survey to assess the state
of IT implementation in America's hospitals. Half of hospitals
indicated a moderate or high use of IT, up from 37 percent in
2005. Overall, IT use was higher at larger, urban, and teaching
hospitals, and not surprisingly, those with positive financial
margins. These hospitals also reported rates of growth in their
use of IT compared to their small and rural counterparts.
Despite these impressive gains, there are still obstacles
to the goal of universal IT adoption. Hospitals continue to
cite cost as a major barrier. Hospitals currently bear almost
all of the cost with no increase in payment for the use of
these new technologies. And the benefits of IT such as
decreased need to repeat tests, lower readmission rates, and
shorter lengths of stay accrue to those who pay for care by
reducing their costs.
A lack of inter-operability with current IT systems also
poses a significant challenge for hospitals. In 2006, 79
percent of hospitals listed inter-operability as either a
significant or somewhat of a barrier, compared with 77 in 2005.
We commend you, Mr. Chairman, for introducing H.R. 2406 and
for your recognition of the critical role health IT plays in
improving health care delivery in America. Legislation can help
create a policy environment in which technology can be best
used to support a safer more efficient health care system. We
support the bill's assertion that confidentiality and security
must be underlying components of any IT standards that may be
developed or adopted as a result. Hospitals have and will
continue to work diligently to ensure the confidentiality and
security of personal health information. We also agree with the
assessment of the National Institute of Standards and
Technology. This organization has, through its standards and
process-development work in many industries, established itself
as a valuable resource to both the private and public sector,
but there are already many, perhaps too many duplicative
efforts launched by the government in attempts to speed health
care IT adoption. In the past few years alone, the government
has created or partially funded several overlapping
initiatives. These organizations lack coordination. The AHA
believes that what is needed to speed the adoption of health IT
in America is a common vision for the future of health IT, a
roadmap and timeline for change, a detailed implementation
plan, developed together with key stakeholders that articulates
each stakeholder's roles and responsibilities. We are concerned
that H.R. 2406 could give NIST overlapping responsibilities
without addressing the key needs of a national inter-operative
health IT network. NIST's core competencies are measure
science, rigorous tracibility, and the development and use of
standards. While these competencies, combined with NIST's
resources could serve as a resource to the public and private
sector, NIST is likely not the organization to provide the
transformational leadership required in health care. NIST could
develop resources for health care providers as it has done for
manufacturing to help hospital leaders, while striving to
achieve higher standards of quality, safety and efficiency, who
are limited to local influence. They, therefore, must look to
national leadership to create an environment that will enable
them to make significant investments in IT. There must be a
reasonable expectation on the part of hospitals that they are
heading towards the same goal and using the same measures of
success as every other hospital in the country.
Mr. Chairman, it is the mission of every hospital in every
community in America to provide the best care possible, and
health IT is a crucial tool to providing safe and effective
care to the right patient, in the right setting at the right
time. We look forward to working with this committee to forge
ahead towards a shared goal of improving the reach of health
IT, and as a result our nation's health care community.
[The prepared statement of Ms. Williams follows:]
Prepared Statement of Noel Brown Williams
Good morning, Mr. Chairman. I am Noel Williams, President of HCA
Information Technology & Services, Inc., a subsidiary of the Hospital
Corporation of America (HCA). I also have the privilege of serving as
Senior Vice President and Chief Information Officer for HCA, where I am
responsible for the day-to-day operation of HCA's extensive information
technology systems and services, as well as the development of our
overall technology strategy. On behalf of the American Hospital
Association's (AHA) nearly 5,000 member hospitals, health systems and
other health care organization, and our 37,000 individual members, I
appreciate the opportunity to speak to you and your colleagues about
the importance of inter-operability and security in health information
technology (IT).
STATE OF IT ADOPTION IN AMERICA'S HOSPITALS AND HEALTH SYSTEMS
The mission of America's hospitals is caring for patients, and
every day the women and men of our hospitals strive to improve the
safety and quality of the care they provide. Research has shown that
certain kinds of IT--such as computerized physician order-entry (CPOE),
computerized decision support systems and bar-coding for medication
administration--can limit errors and improve care. IT also can be a
tool for improving efficiency and costs. Hospitals have been pioneers
in harnessing IT to improve patient care, quality and efficiency; the
challenge now is to extend its use and integrate it into the routine
care processes in all hospitals, large and small, in both urban and
rural areas.
A 2006 AHA survey of hospitals and health systems sought to assess
the state of health IT implementation in America's hospitals. The
survey included questions about the use of IT applications such as CPOE
and electronic health records (EHRs), perceived barriers to
implementation, IT financing and the use of non-clinical IT
applications.
Over 1,500 hospitals (about one-third of the field) responded to
the survey. The data again indicated that hospitals are making great
strides in embracing health IT: about half of the respondents indicated
a moderate or high use of IT, up from 37 percent in 2005. This figure
was determined by the number of clinical IT functions a hospital had
fully implemented, such as medication order-entry, test results review
or clinical alerts.
Over two-thirds of hospitals reported either fully or partially
implemented electronic health records. Larger, urban and teaching
hospitals were more likely to have fully implemented EHR systems, and
accounted for 11 percent of the total. Use of CPOE is also becoming
more common. In 2006, at 10 percent of hospitals, physicians routinely
ordered medications electronically at least half of the time. For
laboratory and other tests, orders were placed electronically at least
half of the time in 16 percent of hospitals.
One of the most dramatic changes from year to year was in the use
of computerized alerts designed to prevent negative drug interactions.
In 2006, 51 percent of hospitals used real-time drug interactions
alerts, up from 23 percent the year before.
As with EHR systems, general health IT use was higher at larger,
urban and teaching hospitals, as well as those with positive financial
margins. These hospitals also reported greater rates of growth in their
use of IT than their smaller and rural counterparts.
Despite these impressive gains, there are still obstacles to the
goal of universal IT adoption, and, not surprisingly, cost issues top
the list. Ninety-four percent of hospitals reported that the initial
costs of adoption were a significant or somewhat of a barrier to IT
adoption, down just one percent from 2005. Smaller hospitals were more
likely to see costs as a barrier, but even the largest hospitals
struggle to afford health IT. Accelerating adoption across the hospital
field will require a shared investment between providers, payers and
purchasers. Hospitals currently bear almost all the costs of IT
investment, with no increase in payment for the use of these new
technologies. However, many of the financial benefits of IT, such as
decreased need for repeat tests, lower re-admission rates, and shorter
lengths of stay, accrue to those who pay for care.
The lack of inter-operability with current IT systems also poses a
mounting challenge for hospitals. In the 2006, 79 percent of hospitals
listed this issue as either a significant or somewhat of a barrier,
compared with 77 percent in 2005.
PRINCIPLES FOR REALIZING THE PROMISE OF HEALTH IT
As the survey demonstrates, an increasing number of hospitals and
health systems are harnessing the power of health IT to improve
quality, safety and efficiency. However, the hospital field is now
challenged to extend the use of IT and integrate it into routine care
processes in hospitals big and small, urban and rural. The AHA strongly
supports the growing use of health IT. As Congress and the
Administration consider ways to encourage increased adoption and
greater information exchange, we will continue to advocate for
solutions that address major barriers to realizing the promise of
health IT.
The AHA believes the following principles should guide efforts to
extend IT use in health care:
IT is an enabling tool for improving the quality and safety of care.
Technology adoption is not a goal in and of itself. Investments should
be driven by quality and safety improvements that can be brought about
by technology.
A lack of standards is not the problem. Both adoption and information
sharing will increase when health information and IT applications are
more standardized. For example, to have data at the point of care,
laboratory information systems need to be integrated with pharmacy
systems and the patient's health record. Currently, hospitals devote
considerable staff and financial resources to creating interfaces
between systems or other IT ``workarounds.'' The problem is we need to
select a single set of standards and get consensus among health care
stakeholders to use those standards.
Greater standardization across information technologies, and
improvements that make IT systems easier for caregivers to use, would
facilitate adoption. Information exchange requires even greater
standardization across care settings, such as a physician's office and
a hospital's emergency department.
Standards-setting organizations have already developed many
different standards, and the sheer volume of standards from which to
choose is stunning. A survey conducted by the National Alliance for
Health Information Technology discovered over 2,000 standards related
to health IT, and over 400 organizations that either create, maintain
or license those standards.
Standards are needed not just for the useful exchange of data, but
also for a smarter application of IT throughout the health care
setting. For example, standards can help hospitals prevent errors in
medication ordering and administration, allow hospitals to verify
patients' medications, integrate data from IV pumps and other medical
devices and exchange data between CPOE and pharmacy systems. A first
standard needed in this area is unique identification of medications at
the unit dose level using a standard that is common across all
settings.
Hospitals now use many different medical devices that produce
digital health information, including IV pumps, ventilators, pulse
oximeters, and others. We could improve safety if hospitals could
connect the pieces of equipment so that, for example, data from an IV
pump can be shared with a monitor and a ventilator. Another first
standard needed is a communication standard for medical devices.
And we still lack the most basic of all--a standardized way of
matching individual patients to their records.
Information exchange should be promoted as a public resource. Improved
care comes when the right information is available to the right
provider at the right time. Data cannot belong to an organization,
physician or vendor. The community and regional organizations that will
emerge to accomplish this will require governance structures that both
promote exchange and articulate the value of doing so.
Funding. Health IT is costly. Most of the initial cost is borne by
hospitals, while the financial benefits often flow downstream to other
providers, payers and employers. For this reason, the AHA believes that
providers and payers must share these investments. Moreover,
maintenance costs are significant. Adoption of health IT is more
difficult for small and rural hospitals because they likely have a less
developed infrastructure and less staff support (both technical and
administrative). Increased Medicare payments to support the ongoing
costs of IT, as well as low-interest loans and grants to support both
hospitals' initial investments in IT and the development of health
information exchange projects are needed.
Regulatory relief. Many physicians do not have the financial or
technical resources needed to navigate the complex IT market. As a
result, despite the links to improved quality of care, only about 20 to
25 percent of physicians use EHRs. To facilitate the sharing of
clinical information and improve patient care, hospitals with more
advanced IT systems than the physicians practicing in their community
may want to provide physicians with hardware, software, connectivity or
other assistance that would allow them to maintain EHRs for their
patients and share clinical data with the hospital. However, hospitals
cannot do so because of physician self-referral, or ``Stark,''
regulations. Some regulatory relief has recently been granted in this
area: The hospital field would like to see this made permanent in law.
A single set of privacy laws. The multiplicity of privacy rules from
local, State and Federal Governments, accrediting bodies and other
organizations makes compliance difficult and can interfere with patient
care. Simply identifying all of the relevant rules can be a monumental
task, let alone determining how to comply when the laws may conflict. A
single set of privacy rules is needed to facilitate the use of IT and
ensure access by health care providers to needed information at the
point of care. Specifically, federal privacy laws as laid out in the
Health Information Portability and Accountability Act (HIPAA) should
preempt State and local privacy laws.
A uniform approach to matching patients to their records. The
electronic exchange of health information requires a consistent,
reliable mechanism for matching patients to their records. This is best
achieved with an individual health information authentication number.
Without a single authentication number, there are serious safety risks
that could arise from attributing a medical record to the wrong
individual. For individuals with common names, a cluster of demographic
information may not be sufficient to distinguish between the 37-year-
old Mary Jones with diabetes and a penicillin allergy and the 37-year-
old Mary Jones in perfect health. Mixing up their records could have
serious consequences.
VIEWS ON H.R. 2406
We commend you Mr. Chairman and the other co-sponsors of H.R. 2406
for your recognition of the critical role health IT plays in the
improvement of the U.S. health care delivery system. Legislation is a
powerful tool that demonstrates the commitment of leadership not only
to raise awareness of the issues, but to help create a policy
environment in which technology can be best used to support a safer,
more efficient health care system.
We support the bill's recognition of confidentiality and security
as underlying components of any IT standards that may be developed or
adopted as a result. Hospitals have and will continue to work
diligently to ensure the confidentiality and security of personal
health information. This too is an essential piece of that larger
environment that must be in place for IT implementation to succeed.
Commitment to this concept must be evident along each step of this
complex process in order to engage the support of the public.
The AHA shares the bill's acknowledgement of the accomplishments
and reputation earned by the National Institute of Standards and
Technology (NIST). This organization has, through its standards and
process development work in many industries, established itself as a
valuable resource to both the private and public sectors. Founded in
1901, NIST is a non-regulatory federal agency within the U.S.
Department of Commerce. NIST's mission is to promote U.S. innovation
and industrial competitiveness by advancing measurement science,
standards, and technology. Four cooperative programs comprise the NIST
mission: NIST Laboratories conducts research that advances the Nation's
technology infrastructure; Hollings Manufacturing Extension Partnership
offers technical and business assistance to smaller manufacturers
through a nationwide network of local centers; NIST's Advanced
Technology Program co-funds research and development partnerships with
the private sector to develop innovative technologies that can benefit
the entire Nation; and the Baldrige National Quality Program promotes
excellence in several business sectors, including health care. Through
its annual Malcolm Baldrige National Quality Award, NIST recognizes
these quality achievements.
Currently, there are several--perhaps too many--efforts to lead the
health IT movement in the U.S. In the past few years, the government
has:
Created through the Department of Health and Human
Services (HHS) the American Health Information Community
(AHIC), ``a federal advisory body, chartered in 2005 to make
recommendations to the Secretary of the U.S. Department of
Health and Human Services on how to accelerate the development
and adoption of health information technology. AHIC was formed
by the Secretary to help advance efforts to achieve the goal
for most Americans to have access to secure electronic health
records by 2014.'' Plans are currently in development to
convert the AHIC into a public/private entity by 2008.
Created the Office of the National Coordinator for
Health Information Technology (ONC). According to the ONC, it
``provides counsel to the Secretary of Health and Human
Services and departmental leadership for the development and
nationwide implementation of an inter-operable health
information technology infrastructure. Use of this
infrastructure will improve the quality, safety and efficiency
of health care and the ability of consumers to manage their
health information and health care. ONC also provides
management and logistical support for AHIC.''
Initially funded the creation of the Certification
Commission for Health Information Technology (CCHIT). According
to CCHIT, it is ``a recognized certification body for
electronic health records and their networks, and an
independent, voluntary, private-sector initiative. It is our
mission is to accelerate the adoption of health information
technology by creating an efficient, credible and sustainable
certification program.''
Initially funded the creation of the Health
Information Technology Standards Panel (HITSP), through the
American National Standards Institute (ANSI), ``to serve as a
cooperative partnership between the public and private sectors
for the purpose of achieving a widely accepted and useful set
of standards specifically to enable and support widespread
inter-operability among health care software applications, as
they will interact in a local, regional and national health
information network for the United States. Comprised of a wide
range of stakeholders, the Panel will assist in the development
of the U.S. Nationwide Health Information Network (NHIN) by
addressing issues such as privacy and security within a shared
health care information system.'' The NHIN is viewed as a
``network of networks'' that will allow the seamless exchange
of health information anywhere in the U.S., and is currently in
the planning stages. An executive order specifies that any new
federal health information system launched after January 1,
2008 to be compliant with HITSP recommended standards. HHS
Secretary Michael Leavitt has already accepted 30
recommendations for inter-operability standards that will be
required to build a NHIN.
We are concerned that there are already too many overlapping,
duplicative efforts launched by the government to try to speed health
care IT adoption. These organizations lack coordination, a common
vision for the future of health IT, a roadmap and timeline for change,
and a detailed implementation plan that articulates each stakeholder's
roles and responsibilities. We are afraid that H.R. 2406 could position
NIST as just another government entity with overlapping responsibility
without addressing the key needs noted above. It is instead our hope
that NIST will function as a common resource to the different players
and help advance the goals we have articulated.
For example, the ``Technical Activities'' described include
standards and inter-operability analysis, software conformance and
certification. These areas are already under intense scrutiny by
several groups. Coming to agreement on the standards to be used will
require collaboration and a private-public partnership that prioritizes
where standards are needed, follows a consensus-building process to
determine which standards to adopt, and ensures that they can be
operationalized. Key stakeholders, including providers, payers,
standards organizations, vendors and regulators must be part of the
discussion and agree to an implementation process.
In addition, NIST's core competencies, by its own definition, are:
measurement science; rigorous traceability; and the development and use
of standards. While these competencies, combined with NIST resources,
could serve as a resource to both the public and private sectors, NIST
is likely not the organization to provide the transformational
leadership required in health care. However, the AHA believes NIST may
be able to develop implementation tactics for health care providers, as
it has done for manufacturing and its associated supply chain
operations. Toolkits and guidance that enable hospital leaders to
achieve Baldridge-level quality within their organizations that also
scale nationally are required for success.
CONCLUSION
Hospital leaders, while striving daily to achieve higher standards
of quality, safety and efficiency, are limited to local influence
within an organization. When we discuss the merits of national health
care information networks, inter-operability and the resulting
improvements in safety and efficiency, hospitals must look to national
leadership to create an environment that will enable a hospital to make
significant IT investments. This is especially true if the
beneficiaries of those investments exist outside of the boundaries of
the individual hospital or hospital network. In order for a hospital to
make an investment that ultimately benefits the greater good, there
must be a reasonable expectation on the part of that hospital that it
is heading toward the same goal and using the same measures of success
as every other hospital in the country.
Mr. Chairman, it is the mission of every hospital in every
community in America to provide the best care possible to people in
need. Inter-operable health information technology is a crucial tool in
providing safe and effective care to the right patient, in the right
setting, at the right time. We look forward to working with this
committee and staff to forge ahead toward to a shared goal of improving
the inter-operability and deployment of health IT and, as a result, our
nation's health care delivery system. Again, I thank you for the
opportunity to testify before this committee.
Biography for Noel Brown Williams
Noel Brown Williams is President of HCA Information Technology &
Services, Inc., a wholly owned subsidiary of Nashville, TN-based HCA,
the Nation's leading provider of health care services. She also serves
as Senior Vice President and Chief Information Officer for HCA.
In her second stint with HCA, Williams is responsible for the
development and operation of the company's extensive information
technology systems and services as well as the development of HCA's
overall technology strategy.
Williams spent 16 years in HCA's Information Services Department in
a variety of positions, including serving as Vice President of
Information Services from 1993 to 1995. Prior to rejoining the company
in 1997, Williams served as Chief Information Officer for American
Service Group in Brentwood, TN.
Born in Pasadena, TX, Williams has a Bachelor of Engineering in
Computer Science and Mathematics from Vanderbilt University and a
Master of Science in Health Care Financial Management from the
University of South Carolina. Williams resides in Nashville with her
husband and two children.
Chairman Gordon. Thank you, Ms. Williams, and welcome, Ms.
Kloss.
STATEMENT OF MS. LINDA L. KLOSS, CHIEF EXECUTIVE OFFICER,
AMERICAN HEALTH INFORMATION MANAGEMENT ASSOCIATION, CHICAGO, IL
Ms. Kloss. Chairman Gordon, Mr. Hall, and Members of the
Committee, thank you for this opportunity to testify on health
information standards and inter-operability. I am Linda Kloss,
and I represent the American Health Information Management
Association as its chief executive officer. This topic is of
great importance to my colleagues in health information
management and our over 50,000 members of the association.
Today our professionals are on the front lines, sort of in
the trenches if you will, in implementing electronic health
records and other health information technologies. This
includes health information exchange among providers, new ways
for consumers to access their own health information.
Confidentiality, privacy, security, data integrity, and
consumer access are core value we bring to this important work.
Before I begin, I want to thank you for your support and
passage of H.R. 1467, the Ten Thousand Trained by 2010 Act. The
Bureau of Labor Statistics, our own research and that of
others, substantiates the needs for more experienced health IT
information management and workforce to achieve inter-
operability, and we certainly urge the Senate to follow your
leadership in addressing the important heath IT workforce
issue.
Our prepared comments addressed all of the questions that
the Committee put forward, but I want to just concentrate my
oral testimony today on a few subjects relating to integrating
the health care information enterprise.
They are: first, the need for uniform and coordinated data
standards necessary for inter-operability, in other words, some
focus on what types of standards we are talking about; and
secondly, the need for a stable long-term strategy for
standards harmonization that goes to the point Ms. Williams
made.
Over the past four years, there really have been quite
remarkable accomplishments in advancing standards for
functionality and data interchange for the EHR and Health
Information Exchange. However, the discussion on data content
standards, what Dr. Silverstone referred to as the medical
terminology, the focus of that to date, critical information
that makes up the EHR and is actually what is transmitted has
received too little attention.
I compare these distinctions of building reservoirs and
pipelines but not addressing the quality of the water that is
flowing through those pipelines. So I urge that as we are
thinking of standards, we expand our thinking to take in the
standards relating to clinical terms and contents that are used
to describe medical and care services, the critical language of
medicine. These terms and contents making up the language of
medicine are embodied in terminologies and classification
systems that are used to catalog them so that they can be
stored, exchanged, retrieved, analyzed, and inter-operability
really requires the sender and the receiver to understand the
exchange and interpret that information correctly. Terminology
in classifications systems is critical for not only information
exchange for patient-care purposes, but for public health,
quality reporting and other purposes. But today, we have over
100 terminology and classification systems, and the U.S. has
not put in place, as other nations have, a way to ensure a
proper foundation for these systems as critical standards for
inter-operability. Along with our colleagues from the American
Medical Informatics Association, AHIMA has looked into this
issue, and we convened an expert taskforce and prepared a set
of recommendations under a white paper called Healthcare
Terminologies and Classification and Action Agenda for the
United States, and we provided an extract from that white paper
attached to our testimony. It calls for a formation of a
public-private authority or an entity to be established to
ensure that we have robust and up-to-date terminologies and
classification standards and authoritative ways of keeping
track of them, and we also call, in that report, for further
research, planning research, as to how we are going to do this
well in the United States. So as part of the bill before us
today, we are pleased to see a focus on research, and we think
one of the critical areas for research, in fact, is how we are
going to stand and have the authority and a process for
terminologies and classifications that will really make health
care information inter-operable.
As a second area of focus today, we would just speak to--it
does ring.
Chairman Gordon. That is not you. We are, I guess, going
into session, so please go forward.
Ms. Kloss. Our second area for comment is regarding
standards harmonization. We do believe important progress has
been made towards adoption and use of EHRs, and we acknowledge
the work of the Office of the National Coordinator, the
American Health Information Community, the Health Information
Technology Standards Panel, and the Certification Commission
for Health Information Technology. All of these efforts have
really been organized and set in place over the last four
years, and they have provided a significant boost towards
inter-operability.
We do believe there is an important role for NIST in
bringing both standards development and resources to this. NIST
has done a lot to harmonize standards and to bring adoption
guidelines forward, but this is largely a voluntary effort, and
it is suffering from the woes of many hundreds of people
working through, essentially, a voluntary effort that is
contract funded, whereas what we do believe is going to be
needed is a long-term strategy for standards harmonization. We
do believe that NIST, well known for its expertise in
information security and other standards, can supply the health
information standards harmonization object with ready standards
that can be applied and harmonized and test laboratories
contributing to the Certification Commission.
Chairman Gordon. Ms. Kloss, we have just been called for a
vote. We have five minutes. So if you would like to quickly
conclude, then I think we will have time to hear from the other
two witnesses.
Ms. Kloss. I actually can conclude here. I would just say
that we are ready to work with you and the Committee to
mobilize all available resources to help with this important
effort.
[The prepared statement of Ms. Kloss follows:]
Prepared Statement of Linda L. Kloss
Chairman Gordon, Mr. Hall, and Members of the Committee, good
morning and thank you for this opportunity to testify on the issues
relating to Meeting the Need for Inter-operability and Information
Security in Health IT. This topic is of great importance to my
colleagues in health care information management and has been for many
years.
I am Linda Kloss and I represent the American Health Information
Management Association (AHIMA) as its Chief Executive Officer. AHIMA is
an association of over 51,000 health information management (HIM)
professionals deeply committed to and actively participating in the
adoption of standards-based and inter-operable health IT. Since 1928,
HIM professionals have worked to improve the accuracy, completeness,
confidentiality and security of medical record information to support
clinical care and improve health care of all Americans.
Today, HIM professionals are on the front lines in implementing
electronic health records and other technologies to improve health
care. This includes information exchange among providers and new ways
for consumers to access their own health information. Confidentiality,
privacy, security, data integrity, and consumer access are core values
we bring to this important work.
As I speak this morning, I must inform you that AHIMA, through its
Foundation for Research and Education (FORE) has been a contractor for
several health information improvement projects initiated by the
Department of Health and Human Services' (HHS) Office of the National
Coordinator for Health Information Technology (ONC), the Agency for
Healthcare Research and Quality (AHRQ), and the National Institute of
Health's (NIH) National Library of Medicine (NLM). These projects have
included evaluating the mapping of classification systems, studies of
the potential for improved fraud deterrence through the use of
electronic health record technology (EHR), analyses of privacy and
security roadblocks to implementation of EHRs and health information
exchange, and development of best practices for State level health
information exchange. The FORE foundation, in conjunction with the
Medical Group Management Association (MGMA) also addressed aspects of
the collection and reporting of performance measurement data. AHIMA is
also one of three organizations that founded the Certification
Commission for Health Information Technology (CCHIT) which later
received a three-year contract from ONC and is now an independent not-
for-profit organization recognized by the Secretary of HHS as a
certifying organization for HIT.
AHIMA is active in a number of standards activities. Currently
AHIMA is a voting member of the Health Information Technology Standards
Panel (HITSP) and representatives are active on its Security Technical
Committee. AHIMA and several of its members have been active for a
number of years in the Health Level 7 (HL7) standards development
organization (SDO). Currently our involvement is in developing EHR
system and personal health record (PHR) system functional models, legal
EHR functionality, and the clinical document architecture CDA.
AHIMA is also an active participant in a number of national and
international terminology and classification standards organizations.
We serve as a member of the ICD-9-CM Coordination and Maintenance
Committee with the American Hospital Association (AHA), the Centers for
Medicare and Medicaid Services (CMS), and the Centers for Disease
Control and Prevention's (CDC), National Center for Health Statistics
(NCHS). We also serve as a member of the Cooperating Parties, the group
that sets the guidance for use of ICD-9-CM in the U.S., the editorial
advisory panels for the American Medical Association's Common Procedure
Terminology (CPT), and the Healthcare Common Procedure Coding System
(HCPCS) which is operated by CMS. Internationally we have been
appointed by the NCHS to serve with the World Health Organization's
(WHO) education, and ICD-10 and ICD-11 reference terminology work
groups. We also have worked with the International Healthcare
Terminology Standards Development Organization (IHTSDO), which is the
standards group that has taken up the SNOMED terminology system.
Costs and Benefits
Standards-based electronic health record technology is the
essential building block for much of what we seek to achieve in inter-
operability. After years of slow and inconsistent progress, I believe
that considerable progress is now being made to define core
functionality and data exchange standards and to drive their adoption.
The greater focus on standards over the past five years has led to
progress by SDOs, formation of the Health Information Technology
Standards Panel and the Certification Commission for Health IT and
other collaborative projects which have in effect broken the log jam.
However, the recent momentum must be supported so progress can continue
and even accelerate. With the continual evolution of technology and
growing experience of those who are using it, this work will require
effective leadership, incentives for adoption, and financial support
for the effort for some years to come.
With a solid road map and full support, the benefits of inter-
operability include the ability to:
Exchange crucial health information between health
care providers so that medical treatment for any individual can
be rendered accurately and completely.
Access, transfer and use the extraordinary body of
knowledge about medical care and personal health and to grow
that body of knowledge through accelerated research and
dissemination of learning.
Report and transfer crucial public health data in
seconds to improve effective local and national response to
individual and population events and be effective participants
in improving global health.
Achieve a high performing health system in terms of
outcomes, safety and cost through performance improvement and
public reporting.
Engage people as full participants in improving their
health and wellness.
Understand effective ways to transform care delivery,
including how we pay for it.
There are numerous forecasts and models about the costs of
implementing EHRs and health information exchange by researchers at
RAND, The Center for Information Technology Leadership, the Robert Wood
Johnson Foundation, and the Commonwealth Fund to name a few, as well as
studies by AHRQ and ONC. While the specific estimates may vary some
depending on the sets of assumptions used in the forecasts, the
conclusion is clear: The benefits will outweigh the cost of investing
in secure and inter-operable health IT. But it will not be inexpensive
and the return on investment will not be quick. Any consideration of
cost must take into account the costs of the current state of health
care. For example,
What is the cost of treating patients with limited
and inaccessible information about their medical condition and
history?
What is the cost of our inability to manage an
individual's care across a multiple number of providers just in
trying to get the information needed?
What is the cost increased administrative duties and
operations due to our inability to exchange uniform data
electronically for secondary purposes such as research, claims
processing and a variety of other administrative activities
that are now restricted by our paper-based information system,
restrained by our ability to review and analyze paper data, and
our ability to locate and exchange information when and where
it is needed?
What is the cost of having our limited data due to
the inappropriate use or limits placed on our terminology and
classification standards and systems?
What is the cost in loss of life and poor health,
because the right data is not available at the right time?
Real improvements are being documented by medical practices and
hospital that are using health information technology. Except for
delivery systems such as the Veteran's Health Administration, other
integrated systems and networks such as e-prescribing, improvement are
for the most part isolated. Without consistent standards it is
difficult to accrue the values that require inter-operability.
Standards, Guidelines, and Coordination.
I will address three inter-operability and security issues in my
comments today that we believe are important for the Committee to take
into account in its work. These are: terminologies and classifications,
data stewardship, and the harmonization of standards.
Terminologies and Classifications
The U.S. needs greater uniformity and coordination of health care
terminologies and classifications, a type of health information
standard that is perhaps not as well understood as are other types of
standards. Clinical terms and concepts are the language of medicine and
form the information content in electronic health records.
Terminologies and classifications catalogue these terms and concepts so
they can be stored, exchanged, retrieved and analyzed. Inter-
operability requires that the sender and receiver understand the
exchange and interpret it correctly. Terminology and classification
systems are critical for information exchange, for public health
reporting, performance measurement, quality reporting, research, and
billing and payment for health care services.
AHIMA and the American Medical Informatics Association recently
published a white paper entitled Healthcare Terminologies and
Classifications: An Action Agenda for the United States. I have
attached a short summary of that paper and its recommendations,
Healthcare Terminologies and Classifications: Essential Keys to Inter-
operability to my testimony. This report was prepared by a joint task
force of experts who call for the establishment of a public-private
authority responsible for ensuring the U.S. has:
Robust and up-to-date terminologies and
classifications for inter-operability between systems;
Standards for developing terminologies and
classifications in the EHR and PHR, including implementation
guides;
Principles and guideline for development,
distribution, and maintenance of systems and coordination
across systems;
Timely and reliable industry guidance;
A coherent set of policies and procedures to ensure
openness and performance for terminologies, classifications,
and the systems that convert data encoded in one terminology or
classification to another; and,
Business process automation to ensure cost-effective
development of systems and cost-effective use by providers,
payers, and other organizations.
While federal and private entities have made genuine progress, the
task force recommends public funding for a research and development
project to design a permanent governance mechanism and formulate
strategies and plans for:
Contemporary and standardized processes for
development, adoption, and maintenance of terminologies and
classifications;
The structure, function, and operating practices for
a U.S. public/private authority to oversee terminologies and
classifications;
Gaining commitment of terminology and classification
stakeholders--developers, end users, and other service and
technology suppliers--to principles and guidelines for open and
transparent approaches that permit cost-effective inter-
operability of complete and accurate information; and
U.S. participation in the IHTSDO--the international
organization now addressing SNOMED terminology which we believe
is the base terminology for a standard EHR.
AHIMA and AMIA are prepared to coordinate such an effort, and I ask
your consideration to support this effort. Without standard and
consistent data content--which comes from terminologies and
classifications--the U.S. will not achieve inter-operability of usable
information. As described in the task force report, the U.S. has fallen
behind other countries in developing; deploying and using these
critical and new approaches to coordination are urgently needed.
Data Stewardship
A second and similar effort is needed in the area of quality
measurement and secondary data. Recently, AHRQ issued a request for
information related to the data measures, data sets, or standards used
for the collection of quality measurement information--the potential to
have a data steward to coordinate the groups and the group processes
for developing data collection. This concept was expanded to include
data also collected for a variety of secondary purposes, research,
public health, reimbursement, and other public policy requirements.
As I noted earlier, the ability to use secondary data from a large
population offers vast opportunities to improve the health of this
nation and reduce error and costs. At the same time secondary data also
supports reimbursement for health care services not only in the
traditional sense of the billing claim, but also in the form of
information to support effective payment policy.
As with terminologies and classifications, the U.S. lacks a
coordinating body with requisite authority to set a vision and
operating policies for secondary use of data, a data stewardship
entity. An acknowledged data steward entity would coordinate the
various public/private groups working on quality measurement and the
employer/purchaser, research and public health communities which use
these data. AHIMA's members oversee the collection of these data in
many health care organizations. They report that lack of uniformity in
the data sets requested and uniformity of definitions results in costly
manual work and concerns about the quality and validity of data used to
measure quality. Standardizing measures and policies regarding
secondary uses of health information will enable the IT industry to
design solutions capture data once and use it for multiple legitimate
and authorized purposes.
Standards Harmonization
The third area relates to the harmonization of technical standards
and consistent guidelines for their use, including standards for
clinical terminologies and classifications, as described earlier.
In the 1980s HL7 was formed to address health care institutions'
inability to share data between or among their own data systems and
programs. Today, HL7 and other SDOs have become and are addressing
international information exchange.
Throughout the U.S., industries are sharing data and cutting their
administrative costs because they are using uniform standards, such as
the Accredited Standards Organization X12 standards. Besides using
standards, however, these industries also use and require guideline
standards--how the particular industry's members will use a chosen
standard, under what conditions it will be used, and what data sets
will be used, and so forth.
This has not been the case in the past in health care. For instance
today we use standards required by HIPAA. We, therefore, adopted an X12
standard for claims, the X12-837. Unfortunately as testimony last year
at the National Committee for Vital and Health Statistics (NCVHS)
indicated there are now over 1,000 different instructions for the use
of the X12-837 in the health care industry. If we are to achieve inter-
operability and use standard like other industries, this should not
happen or be allowed to happen.
The health care industry has over one million providers, thousands
of health plans and payers, a potential consumer base of over 300
million individuals, and some 1.44 million employers offering some
level of health care, along with numerous government agencies,
clearinghouses, and vendors. Achieving consensus on complex standards
and an understanding of their uniform application is a monumental task
even with a shared vision. In the U.S., our standards data
organizations are essentially groups of volunteers that come from
industry and the professions. It is difficult to get and keep
volunteers who work for provider organizations working on standards,
yet their participation is critical.
To address the consistent use of a standard, the harmonization of
standards--to make the standards work with each other, and to choose
the collection of standards necessary to perform a function or
functions requires a significant effort. Over the last three years we
have seen, through the efforts of HHS, ONC, and the American Health
Information Community (AHIC), the establishment of the Health
Information Technology Standards Panel (HITSP). HITSP and its numerous
volunteers have addressed the need for standards for a variety of
health care functions and performed the harmonization task. While the
question of adherence to this harmonization still remains to be seen,
the task is the first time (outside of some limited and similar work
done by the NCVHS with e-prescribing and the HIPAA standards) such an
effort has occurred in health care.
AHIMA has three concerns with HITSP in its current capacity. First,
it is largely a volunteer effort and while this improves acceptance, it
is a slow process. H.R. 2406, introduced in this committee, has the
potential to provide some of the resources, through the National
Institute of Standards and Technology (NIST), needed to sustain and
accelerate the role that HITSP plays. This does not negate the need for
an industry (public-private) oversight group with a role to approve,
reject, or amend the final choices for harmonization of standards.
Public/private involvement is crucial for acceptance, buy-in and use.
Similarly, NIST could also provide some of the tools for groups
like CCHIT, whose role is to identify and test that the standards
harmonized by HITSP and other groups, and ensuring those standards are
contained and functioning within the products sold on the market. This
assures buyers that the products they are purchasing technology that
will allow them to be inter-operable with the industry and the networks
under development.
Our second concern related to the need for coordination among
HITSP, CCHIT, and the entities charged with coordinating terminologies
and classifications, data stewardship, health information exchange and
other related functions critical to achieve an secure, inter-operable
system. Such an entity and role is currently under discussion
throughout the industry, and I will not comment further at this time
since that is not the nature of today's hearing.
Our third concern with HITSP is funding. How does the Nation fund
such a body that does not itself develop standards, but rather proves
the harmonization process? In other industries there are councils, but
no such body exists in health care. If the benefits from harmonization
and eventual inter-operability accrue to the population, should the
population, as a whole, pick up this cost? That is a discussion
Congress should undertake. Should H.R. 2406 become law and the NIST
involvement occur, the investment in NIST will assume some of the costs
incurred in the harmonization process, but not all.
Barriers to Inter-operability
I was asked to address barriers to inter-operability and I have
already mentioned several. Let me recap: Industry consensus guidelines
for the prioritization, adoption and use of standards,
Financial support and staffing for the coordination
and harmonization of standards and the development of
guidelines,
A mechanism for uniform adoption and implementation
of standards, and
The current reimbursement system for health care.
To date, the U.S. health care system has only limited success with
the adoption and use of standards. The standards chosen to be included
under HIPAA were reviewed by the NCVHS and the guidelines were written
by the ASC X12. SDOs normally do not write the guidelines for their
standards, but there was no other group to do so. The NCVHS, while
holding considerable public comment would not, today, be considered a
public/private entity that engages the industry and government. The
result, as I have noted, is a limited adoption of several of the HIPAA
standards, and an inconsistent use of the more common claims standard
and remittance standard.
More recently we have seen the HITSP work diligently to harmonize
standards and recommend guidelines, but we have not had an opportunity
to see if the industry will actually be able to adopt and consistently
use the standards HITSP has proposed. Without consistent adoption and
use we cannot achieve uniformity. This does not have to mean that all
products have to look the same, but the data being exchanged, and the
mechanisms for transmitting and receiving it have to be standard so no
one can question the integrity of the data or finds themselves is a
position of not being able to send or receive the data.
The HITSP entity and process provide great promise. For the first
time we have a body that can be seen as providing public/private
involvement in the harmonization and guideline processes, but HITSP has
its barriers as well.
I have suggested the need for financial support and staffing for
coordination and harmonization. Without this staffing and the financial
support needed to provide the staffing, the move to identify, adopt,
guide, and see consistent standards being used will lag. Other nations,
and industries have addressed this issue and the U.S. must address it
as well. Perhaps a small fee can be associated with each claim or some
other mechanism that will allow the industry and its consumers to
spread the cost of the work that needs to be done. First, we need
funding to establish the processes and standards, and then later
maintain the system to keep it refreshed and consistent with medical
practice and knowledge. Similar funding needs to be examined for the
groups we suggest for terminologies and classifications and data
stewardship. While we must maintain industry oversight through some
inclusive public/private entity or entities, we must also move from a
volunteer to a full-time mechanism to keep the process progressing. The
benefits of the standard EHR and systems we are discussing are too
valuable to wait on a disjointed volunteer effort.
If we have the funding and the standards and guides, how do we
compel there use? This is a question I hear very often. Standards have
been around for many years, yet the health care industry or market has
not been able to sit down and achieve universal compliance seen in
other industries and countries. HIPAA was an attempt, but it did not
have industry involvement and buy-in at the level needed and there is
no industry pressure to make covered entities abide by the few rules it
has, including the Federal Government.
If we cannot develop some entity or mechanism that has the power to
not only oversee the choice standards and guidelines we have been
discussing, then we will see a very slow achievement of the steps
necessary for full inter-operability. This is a somber statement, and I
want to acknowledge the work of the Secretary, ONC, and AHIC who are
trying an approach based on the Medicare market and the assumption that
the Federal Government will adopt and abide by the selected standards
and guidelines. Essentially, this is an industry-wide voluntary system
that suggests that others will be as compliant as the Federal
Government says it will be. We have not seen the results of this effort
yet and much has to be done. If we do not have the actual up-front buy-
in and then demonstrated compliance from all parties, including the
federal agencies, even at maximum capacity it will take many more years
before we get to the exchange of information we are all seeking under
the current system,. Today, it is not clear who will lead this charge.
The last barrier related to standards I want to mention is
reimbursement. Unfortunately, reimbursement runs the show.
Many physicians indicate they will not even consider adoption of
HIT and standards until the Medicare and Medicaid reimbursement
formulas are corrected and they are paid adequately. I understand
Congress is addressing this concern, but with the Federal Government
paying such a big portion of the health care bill, reimbursement,
especially physician reimbursement is a barrier to adoption.
It is more than the amount of reimbursement. The reimbursement
process controls other aspects of standards use that affect the
achievement of inter-operability. The U.S. use of classification
systems that reflect 21st century medicine have been thwarted
continually because many health plans and payers do not want to convert
to a contemporary system. In the U.S., our ICD-9-CM classification
system is seen as part of the reimbursement system. Quality
measurements are similarly fast becoming viewed this way as well--
administrative data, rather than information something that can be
accurately used to actually describe our care, diagnoses, and
treatment.
As we build processes like quality measurements and data
repositories like the personal health record, the reliance on health
care claims data raises questions regarding the completeness and
accuracy of the information for clinical use or analysis. We must keep
our clinical data free from manipulation for reimbursement purposes,
and require our reimbursement processes to find another way to develop
their payment mechanisms rather than to appropriately control or impact
our collection of clinical data. If we cannot rely on the integrity of
clinical data any inter-operability benefit will be greatly diminished.
As we build the system to adopt and harmonize standards and design
guidelines and implementation, we have to build it as intended to
provide data that accurately describes the patient and medical
encounter. Yes, payers or health plans need to be involved in these
processes, but lets build our EHRs and information systems to maximize
our health information and ensure data integrity.
Security and Privacy
HIM professionals have been deeply involved in the need for
confidentiality and security, and committed to implementing and
enforcing laws, regulations, and best practices to assure maximum data
and individual protections. We see our role as to provide maximum
protection for the consumer and the information. HIM professionals are
often the privacy officer in health care institutions, and are usually
involved in the process of releasing an individual's health information
for its intended use. I have attached to my testimony a recent
statement on the issue of confidentiality that we produced jointly with
AMIA.
AHIMA and its members have been involved in the recent process of
reviewing laws, regulations, and practices associated with
confidentiality, privacy, and security across the states and the
Federal Government. Many of these laws and regulations go back decades
and are intertwined with purposes now forgotten. It will take time to
unravel these relationships and allow the states and the Federal
Government to develop uniform laws that protect health information. I
can assure the Committee that we are engaged in and see a tremendous
amount of effort directed as developing maximum uniform protection and
developing the security mechanisms necessary to secure our data and
networks.
HIM professionals believe that use of standard electric health
records will permit more secure protections for personal health
information than what exists for the current paper record. We are in a
transition period, moving from a paper-based system to an electronic
record. This change is not without confusion and gaps that must be
addressed are being addressed. I want to note our support for H.R.
2406's approach to having NIST assist in the identification of
potential security standards that should be considered under the HITSP
process. NIST has a demonstrated expertise in this arena that can
benefit and accelerate the industry's efforts considerably.
With the adoption of electronic health records we have the
technology to provide confidentiality or privacy through a variety of
security processes. Just how we adopt and use security processes or
standards is under considerable and appropriate debate. Identified
health information flows throughout the health care industry, and other
industries, as well as to consumers themselves, and in some cases
employers. This flow is through consumer request, reimbursement
systems, government reporting requirements, school requirements, and so
on. The process is complex and some of the uses of technology just as
complex. Therefore, we must be careful to use technology wisely or we
could impede the movement of information when it is most needed.
Surveys indicate that most individuals want their health
information where it is most needed for their own clinical care and for
the benefit of the population. What consumers do not want is to have
their health information misused. They do not want to be
inappropriately discriminated against because of their health status or
information.
In addition to uniform rules, regulations and technology to achieve
health information confidentiality and security, AHIMA believes in
essentially three basic principles for over all protection:
1. Personal health information should be protected wherever it
lays or is transported--whether or not the entity or person
accessing, transferring, storing, or holding the information is
a health care entity or covered by HIPAA.
2. Individuals should be protected against inappropriate
discrimination on the basis of their health information--this
would include situations of employment and insurance.
3. Individuals should be protected against the intentional
misuse of their health information.
There are two caveats to these three principles. To be effective
laws and regulations related to discrimination and misuse must include
provisions for active prosecution and penalties, and the public must
see active prosecution and penalties.
There are and probably never will be absolute secure systems that
will provide the confidentiality or privacy sought by some of the
public and expected by all of the public. But inter-operability will be
a failure if we cannot build trust in the system of EHRs, PHRs, and
health information exchange. We can never undue an actual disclosure of
an individual's health information, but we can take steps to ensure
that any one intentionally discriminating against an individual or
misusing health information will know that they face severe penalties
for doing so.
Global Harmonization
My comments on terminologies and classifications gave a glimpse of
international collaboration. Many of the classifications used in the
U.S. are actually either international standards, or a U.S. version of
an international standard. The SNOMED terminology, for instance has
recently moved from a U.S.-based standard to an international standard.
The HL7 standards are international standards. There are other
standards as well. Disease and public health are not controlled by
state or international borders. So we have to consider the global
harmonization of some of the standards we use in U.S. health care,
especially terminology and classification standards used for clinical
care.
I am sorry to report that the U.S. is behind in this matter. I
alluded to the restraints in some of our classification systems. While
most of the world is using the current WHO ICD-10 classification
standard for disease or a modification of it, the U.S. remains over 10
years behind, still using ICD-9-CM for morbidity reporting, a version
developed in the 1970's. While U.S. uses ICD-10 for reporting mortality
information, we run into situations such that, currently, until the
next change in codes, the U.S. can report that you died of avian flu,
but cannot report that you survived avian flu. Similar delays have
occurred with other outbreaks since the ICD-9-CM numeric classification
cannot accommodate the WHO ICD-10 alpha-numeric codes, making it
necessary for the U.S. to manufacture an alternative code when needed
and when possible. When we exchange information with most other
countries, the codes must be converted, and information coming from
outside the U.S., has to be maintained in a separate database.
WHO has begun the process to update ICD-10 to the next version ICD-
11. A final ICD-11 classification is expected in eight or nine years.
ICD-11 is based on the ICD-10 structure, and its development will be
based on the use of ICD-10, which limits U.S. input. We are concerned
that the failure to move our national terminologies and classification
forward in sync with international progression leaves our health care
industry behind and exposes our public health system to additional
barriers and costs because we have not kept up with public health in
the rest of the world.
We believe our recommendations related to terminologies and
classifications will help change our role in the international
community. Groups like the HL7 should continue to be encouraged to
develop standards for clinical care information exchange that are
international in flavor. While our reimbursement systems might differ,
our ability to share data for clinical care, research, and public
health should not be restrained. The U.S. is a world leader in health
research and technology and a move to insure international standards
can only help make our role internationally stronger.
Mr. Chairman, Mr. Hall, this concludes my responses to the
Committee's questions. There has been remarkable progress in the last
four years to move health care from paper to a technology enabled
inter-operable system. Developing and deploying standards is
fundamental prerequisite. But so is sound policy and sound governance
to ensure that technology and policy are aligned and are being advanced
over time. This is an effort that requires the full engagement of all
three sectors of our society, government, industry and the private non-
profit. It is not a project like Y2K that has an end point. It is a
process that requires a long-term view and a public and private
commitment to the public good. Federal and State funding is required as
is the authority that can only come through intelligent government
action. The HIM profession and AHIMA stand ready to work with Congress,
the Administration, and our health care colleagues to continue on a
path that becomes ever more critical.
I thank you for your invitation, your time, and your attention, and
I am ready to answerer any questions you might have.
Thank you again.
Biography for Linda L. Kloss
Linda L. Kloss, MA, RHIA, is Chief Executive Officer of the
American Health Information Management Association (AHIMA), the premier
association of 51,000 members serving the health information management
(HIM) community. Founded in 1928, AHIMA today has a staff of 125 and is
comprised of 52 component state chapters and the Foundation for
Research and Education (FORE). Kloss serves on the Board of Directors
for AHIMA and FORE.
In her role at AHIMA, Kloss is responsible for delivering services
to the fast changing HIM community, promoting its mission and values,
and executing the Association's strategic plan. She also oversees
AHIMA's industry outreach and partnership activities with key
stakeholder organizations. Kloss led the Association's efforts to co-
found the Certification Commission for Healthcare Information
Technology, a private industry initiative to accelerate the adoption of
inter-operable health care technology. Additionally, Kloss serves on
the Steering Committee of Connecting for Health, a public-private
partnership funded by the Markle Foundation and Robert Wood Johnson
Foundation; the Board of Directors for National Alliance for Health
Information Technology (The Alliance); the Leadership Council for the
e-Health Initiative; and as a delegate to the International Federation
of Health Records Organizations.
Prior to joining AHIMA in 1995, Kloss served as one of the founding
officers for MediQual Systems, Inc., a developer of computer based
clinical performance improvement technology and data tools, and
InterQual, Inc, a quality improvement consulting and education company.
Her health information management leadership experience also includes
both academic and practice positions.
Kloss holds a Master of Arts degree in Organizational Development
with a concentration in Change Leadership from DePaul University in
Chicago, and a Bachelor of Science degree in Medical Record Science
from the College of St. Scholastica where she now serves as a member of
the Board of Trustees. Other designations include Certified Association
Executive (CAE), and Fellow of AHIMA (FAHIMA).
Chairman Gordon. Thank you, Ms. Kloss, and Mr. Raymer?
STATEMENT OF MR. MICHAEL RAYMER, VICE PRESIDENT AND GENERAL
MANAGER, GLOBAL PRODUCT STRATEGY, GE HEALTHCARE INTEGRATED IT
SOLUTIONS
Mr. Raymer. Well, good morning, Chairman Gordon and
Committee Members. My name is Michael Raymer, and I am vice
president and general manager, responsible for global product
strategy for GE's Integrated IT Solutions. I appreciate the
opportunity this morning to testify.
As a large purchaser of health care services, GE very much
supports the goal of creating a nationwide health-information
infrastructure that we believe will save time, money, and most
importantly lives. To that end, we support initiatives to
coordinate the work of the various Federal and State agencies
and the private sector in achieving that goal. It is important,
however, that this coordination does not interfere with the
valuable work that has been done today.
The National Institute of Standards and Technology, or
NIST, is charged with developing and promoting measurement,
standards, and technology to enhance productivity, facilitate
trade and improve the quality of life. While NIST's portfolio
is not specific to health care, much of the research done at
NIST's laboratories with respect to advancing the Nation's
technology infrastructures is directly applicable to the
creation of an NHIN, or National Health Information Network.
H.R. 2406 envisions an expanded role for NIST in the
development of HIT. GE supports NIST's increased involvement,
but not at the expense of processes that have been working
well, to date.
We believe there are four areas in which NIST can provide
and can be most valuable in advancing this national resource.
One is to facilitate coordination among the federal agencies.
The 2005 memo of understanding between Health and Human
Services and the Department of Commerce charges NIST with the
responsibility of strategic policy and program coordination
among the federal agencies. While such an effort is a lot like
herding cats, we believe NIST has the capability and should be
given the opportunity to fill this mandate. NIST's role would
not be to create standards or to certify standards, but to work
with other governmental agencies to ensure that existing
standards are implemented appropriately.
Secondly, we believe that NIST can enhance the already
effective HITSP process. HITSP recommends a best practice in
public/private collaboration. We should be wary of any action
that would result in diminishing the effectiveness of this
group. That said, we believe it is possible to build upon the
current successes of HITSP and CCHIT, and NIST can play a very
important role in that process. To ensure this, we suggest that
HITSP be specifically recognized in this legislation and that
NIST authority should enforce federal agency compliance with
standards, and implementation should be strengthened.
Thirdly, to provide coordination for testing of inter-
operability standards: the utility of inter-operability testing
is to demonstrate that products comply with a defined set of
standards. Over the past 10 years, the IHE Connectathon has
proven to be an effective, transparent testing process.
Development of a parallel testing process, as currently being
contemplated by CCHIT, would waste certification resources on
duplicative efforts. To the extent there are testing processes
not within the scope of the Connectathon, and there is room for
CCHIT or other entities, either alone or in combination in the
context of both private and public collaboration to develop
their own testing processes, NIST could help oversee these
efforts to ensure there is no duplication.
Finally, fourth, focused research on areas not covered by
HITSP or other public/private-sector activities: there is
certainly room among all of the other activities for NIST's
extensive research capabilities, especially in areas where the
agency has particular expertise. These would include, one,
investigating information technology to support and pay for
performance; secondly, harmonization of security standards and
practices; and third, working with the private sector to
provide clarity in HIPAA security regulation and guidance.
In summary, NIST has played a role and continues to play an
effective role in coordinating the efforts of public and
private sectors towards developing HIT. Our support for
extending or expanding NIST's participation in these activities
is contingent upon the agency leveraging its strengths and not
duplicating or reinventing good work that is currently being
carried by other public/private entities. On behalf of GE
Healthcare, Mr. Chairman, I want to express my gratitude for
the opportunity to share with you our own perspective on
creating a nationwide health-information infrastructure. I
would be happy to answer any questions that you and the
Committee may have.
[The prepared statement of Mr. Raymer follows:]
Prepared Statement of Michael Raymer
Good morning. My name is Michael Raymer, and I am Vice President
and General Manager of global product strategy for GE Healthcare
Integrated IT Solutions. I want to thank the Committee for giving me
the opportunity to testify today.
GE supports the goal of creating a nationwide health information
infrastructure. To that end, we also support initiatives to coordinate
the work of various federal and State agencies and the private sector
in achieving that goal. It is important, however, that this
coordination does not interfere with the valuable work that has been
done to date.
GE's Role in Promoting Inter-operability
GE has a long history of successfully driving open, standards-based
data exchange with other vendors. The earliest example is the Digital
Imaging and Communications in Medicine (DICOM) standard, which has
enabled diagnostic imaging devices and software systems to exchange
images and related information regardless of vendor. Diagnostic imaging
vendors historically created proprietary formats for the CT or MR
images created by their systems. While image exchange was inter-
operable between systems supplied by the same vendor, this was not the
case among systems supplied by competing vendors. This lock-in limited
the flexibility of hospital radiology departments to utilize imaging
technology in an optimum fashion. DICOM allowed images to move from
system to system, enabled hospitals to centralize storage of images to
reduce costs, and led the radiology department to move towards
diagnosing images on a computer screen. Consequently, DICOM enabled the
creation of today's $2 billion picture archiving and communications
systems (PACS) market, while also enabling many hospitals to eliminate
one of their highest expenses from their operating budgets: film. PACS
has transformed the work flow within the radiology department, leading
to increased efficiency and higher quality of care. Physicians at
different locations can consult while simultaneously examining the same
images and comparing them with other clinical results to get a more
complete picture of the patient's condition.
GE has been instrumental in HL7 standards efforts, representing
users and vendors in the definition of clinical document sharing and
context setting (user and patient) standards. GE's Centricity EMR was
the first major health care information system to provide a production-
ready CCOW-compliant product. GE also worked with the HL7 board and
industry vendors to define strategies for broad vendor adoption of
CCOW.
And, GE is one of the founders of the Health Information and
Management Systems Society (HIMSS) EHR Vendor Association (EHRVA), a
group of the top 42 EHR vendors committed to making EMRs inter-operable
and to accelerating EMR adoption in hospital and ambulatory care
settings. EHRVA is playing a pivotal role in creating and driving a
single set of standards for electronic health records inter-
operability, similar to the role NEMA played in transforming diagnostic
imaging inter-operability in the 1990s. Standards for electronic
medical records are complex, because they involve multiple types of
data and terminologies that are not 100 percent congruent from one
specialty to the next--or even from one hospital to the next.
GE is a co-author of the EHRVA Inter-operability Roadmap--an effort
to articulate an achievable path to inter-operability. The roadmap sets
out a phased timeline for the inter-operability needed to implement a
nationwide health information infrastructure (NHIN). The first phase of
that roadmap was demonstrated at the HIMSS Conference in 2006, with GE
joining 37 other IT vendors, including the VA and DOD, in showcasing
multiple inter-operability use-cases. One of the NHIN pilot
implementations used several aspects of the roadmap, and GE and EHRVA
are reaching out to other stakeholders to encourage further
implementation and convergence of the roadmap.\1\
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\1\ The EHRVA inter-operability roadmap can be found at http://
www.himssehrva.org
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Don Woodlock, GE Healthcare's General Manager of Imaging Solutions,
was the only speaker at the Secretarial Summit on Health Information
Technology, July 21, 2004, to advocate open, standards-based inter-
operability. And numerous GE employees contribute their time and energy
to establishing and staffing bodies, including the Certification
Commission for Health IT (CCHIT) and the Health Information Technology
Standards Panel (HITSP).
IHE: A Proven Inter-operability Development Process
GE has also been a long-term leader in Integrating the Healthcare
Enterprise (IHE), an industry-led initiative that is creating a
standards-based framework for clinical IT. IHE was established in 1998
by the Radiological Society of North America (RSNA) and HIMSS. At that
time, the popularity of DICOM led to the desire to improve imaging
information exchange beyond the radiology department to other clinical
IT systems in the hospital. Early on IHE recognized that solving health
care inter-operability problems sometimes requires multiple standards,
and established a process that allowed multiple standards to be
profiled and specified in a precise manner to resolve work flow
challenges while maintaining plug-and-play capabilities.
IHE defines precise inter-operability specifications to ensure
truly compatible implementations by different vendors. IHE couples
these specifications with a comprehensive testing process, the IHE
Connectathon. These inter-operability showcases, held at major industry
conferences, encourage competing vendors to build and demonstrate data
exchange between their products, in a collaborative and transparent
process. This includes laboratory results, radiology images, medical
summaries, and cardiology reports--the very information that today is
often still faxed, couriered, or mailed between the majority of health
care organizations in the U.S. Beginning with the 2005 HIMSS Conference
IHE Cross-Enterprise Showcase, 14 companies--including seven EHRVA
members and NIST--demonstrated the document-sharing health information
exchange concept using medical summary information, lab reports, static
text reports (.pdfs), and structured information. The product
demonstrations focused on use cases that would enable plug-and-play
inter-operability with the types of clinical information that patients
and clinicians utilize in typical medical settings.
IHE's implementation and testing process has been leveraged by many
countries and regions around the world, including the United States
(through HITSP), France, Canada, Austria, Italy, and Japan. In the
spring of 2005, for example, 16 European vendors participated in the
IHE-Europe Connectathon for cross-enterprise information exchange; this
has since grown to more than 70 companies participating in the North
American and European IHE Connectathon process. The IHE Cross-
Enterprise Document Sharing (XDS) profile and associated integration
profiles achieved connectivity between inpatient and ambulatory EHR
systems (including products from different EU countries) that had not
previously communicated. By establishing a larger-scale market for HIT
inter-operability, IHE helps reduce the cost of achieving inter-
operability and makes the inherent technology risk more acceptable for
vendors. The backbone of the HITSP health information exchange
infrastructure utilizes many of the same IHE inter-operability
specifications that are already recognized and being deployed around
the world.
The Role of NIST Today
The National Institute of Science and Technology (NIST) is charged
with developing and promoting measurement, standards, and technology to
enhance productivity, facilitate trade, and improve the quality of
life. While NIST's portfolio is not specific to health care, much of
the research done at the NIST Laboratories with respect to advancing
the Nation's technology infrastructure is directly applicable to the
creation of an NHIN. Further, virtually all of NIST's projects are
conducted in cooperation with a wide variety of public and private
stakeholders.
Within the health care realm, NIST Information Technology
Laboratory has been involved with IHE on the development of XDS, which
was adopted by EHRVA as the approach to electronic health information
sharing for the Inter-operability Roadmap. NIST provided a test
environment for vendors to test their implementations, and coordinated
specification development with the web-services standards development
organization OASIS that provided the standards used to implement XDS.
NIST is also an invaluable resource in the area of data security
and privacy. Because of the sensitivity of personal medical
information, consumer opposition to an NHIN largely centers on concern
about unauthorized access to and misuse of medical records. Among the
methodologies pioneered by NIST is role-based access control--
technology that limits the type of information that can be viewed by
any individual depending on that individual's function. So, for
example, hospital-billing clerks would be authorized to see only the
parts of a patient's medical record necessary to generate invoices for
a specific admission, while physicians with access to the same system
would be able to see the patient's entire medical history. NIST's
expertise in data security can both accelerate the process of achieving
an NHIN, and enhance public confidence in those efforts.
A Future Role for NIST
H.R. 2406 envisions an expanded role for NIST in the development of
HIT. GE supports NIST's increased involvement--but not at the expense
of processes that are already working well, such as HITSP. We note also
that NIST has not yet been allowed to fulfill its role under the 2005
Memorandum of Understanding (MOU) between the Department of Health and
Human Services (HHS) and the Department of Commerce (DOC).
The areas where we believe NIST can be most valuable are:
Facilitate coordination among federal agencies.
The 2005 MOU charges NIST with the responsibility for
strategic, policy, and program coordination among federal
agencies. While such an effort is often likened to ``herding
cats,'' we believe that NIST has the capability and should be
given the opportunity to fulfill this mandate.
The Federal Government is the largest health care payer in
the country, and therefore stands to benefit the most from the
increased efficiencies and cost-savings that can be garnered
through HIT. NIST's role would not be to create or certify
standards, but to work with other government agencies to ensure
that existing standards are being implemented appropriately.
Enhance the already effective HITSP process.
HITSP represents a best practice in public/private
collaboration. We should be wary of any action that would
result in diminishing the effectiveness of this group. That
said, we believe it is possible to build on the current
successes of HITSP (and of CCHIT), and NIST can play an
important role in doing so. To ensure this, we suggest that
HITSP be specifically recognized in this legislation.
As a facilitator and coordinator among other federal
agencies, NIST can help to accelerate the HITSP process by
working between meetings to achieve consensus among the public
sector participants. And NIST's authority to enforce federal
agency compliance with standards implementation should be
strengthened.
NIST's track record of promoting collaboration through IHE
demonstrates that it can also play an effective facilitation
role in the private sector.
Finally, NIST can serve as a resource to State governments,
helping to disseminate information about technology roadmaps
and other information that is available to support local HIT
efforts.
Provide coordination for testing inter-operability
standards.
The utility of inter-operability testing is to demonstrate
that products comply with a defined set of standards. Over the
past 10 years, the IHE Connectathon has proven to be an
effective, transparent testing process. Development of a
parallel testing process, as CCHIT has proposed, covering the
same standards can be done only to the detriment of the
industry. We should not waste certification resources on
duplicative efforts, and we should not ask vendors--who have
already contributed to creation of the IHE process--to pay a
second time, in the form of increased CCHIT certification
costs. And if the parallel processes yield disparate results
for the same product, it would undercut the underlying
rationale for certification.
To the extent there are testing processes not within the
scope of the Connectathon, there is room for CCHIT or other
entities--either alone or in the context of a public/private
collaboration--to develop their own testing processes. NIST
could help to oversee these efforts and ensure that there is no
duplication. NIST's position within the DOC makes it uniquely
suited to drive global standards harmonization.
In other industries, NIST has effectively served as a single
clearinghouse for testing tools, whether they were created by
NIST or by another entity. We suggest that NIST should be given
the same responsibility with respect to inter-operability
standards, working in conjunction with HITSP.
Focus research on areas not currently covered by
HITSP and other public/private sector activities.
There is certainly room amid all these other activities for
NIST's extensive research capabilities, especially in areas
where the agency has particular expertise. These include:
1. Investigating the information technology necessary
to support pay-for-performance program.
2. Harmonization of security standards and practices,
especially with respect to the ``four As'' identified
by HISPC (authentication, authorization, access, and
audit), and making robust authentication more
accessible to the consumer.
3. Working with the private sector and HHS to provide
clarity in HIPAA security regulation guidance.
Summary
NIST has played, and can continue to play, an effective role in
coordinating the efforts of the public and private sectors toward
developing HIT. Our support for expanding NIST's participation in these
activities is contingent on the agency leveraging its strengths, and
not duplicating or reinventing the good work that is currently being
carried out by other public/private entities. NIST's research
activities should be directed to the areas where there are currently
gaps, such as data security.
With respect to HISTP, we believe that NIST's highest and best use
is to facilitate communication and consensus among the government
entities represented. NIST can also help coordinate efforts in the
private sector with respect to the efficiency and effectiveness of
inter-operability testing.
Biography for Michael Raymer
Mike Raymer leads a strategic team that drives global clinical and
financial/administrative product strategy, evaluates new business
initiatives, provides market analysis and research, optimizes strategic
partnerships, and monitors government relations across all product
lines in the GE Healthcare Integrated IT Solutions organization.
Raymer's team impacts GE software solutions for inpatient and
ambulatory care, including such capabilities as enterprise clinical
information systems; ambulatory electronic medical records;
departmental systems; Picture Archiving Communication Systems (PACS)
and imaging information; solutions for patient access, patient
accounting and practice management; and Web-based portals for both
patients and referring physicians.
Prior to GE's acquisition of IDX, Raymer served as Senior Vice
President and General Manager of the IDX Carecast Operating Unit (now
part of GE Healthcare), responsible for total profit and loss for the
IDX CarecastTM enterprise clinical system (now GE Centricity
Enterprise), as well as leadership of IDX's 500-employee Seattle
office.
Prior to joining IDX in 2002, Raymer served as Vice President,
Products for Shared Healthcare Systems, where he was responsible for
product development, quality assurance, web services and data
warehousing. There, he completed development cycles for two new, web-
based clinical products, while maintaining three legacy software
products.
Earlier in his career, Raymer was General Manager/Director of the
Clinical Information Systems Division at Nellcor Puritan Bennett/
Mallinckrodt Corporation, the world's foremost supplier of pulse
oximetry and a leading supplier of airway management (ventilator)
devices. In this role, he oversaw marketing, engineering, operations,
training and support activities, and led the market launch of a point
of care system for mobile health care workers, as well as a wireless
ventilator monitoring product.
During a 10-year period, Raymer led a start-up operation to a
consistent level of quarter-by-quarter profitability. At Continental
Healthcare Systems, Inc., he served as Vice President of Marketing,
responsible for the definition and market position of multiple hospital
information systems--including automated pharmacy and materials
management systems--as well as product management and marketing
communications.
Chairman Gordon. Thank you, Mr. Raymer. Right on time.
Mr. Barnes.
STATEMENT OF MR. JUSTIN T. BARNES, VICE PRESIDENT OF MARKETING,
CORPORATE DEVELOPMENT AND GOVERNMENT AFFAIRS, GREENWAY MEDICAL
TECHNOLOGIES, INC.
Mr. Barnes. Thank you very much, Chairman Gordon, Ranking
Member Hall, Dr. Gingrey, and distinguished Members of the
Committee and staff. My name is Justin Barnes. I am the vice
president of marketing and government affairs for Greenway
Medical Technologies, a leading provider of integrated
electronic health record practice management and inter-
operability-software solutions for physicians practices. It is
always a great honor and pleasure to work with Members of
Congress and their staff, as I believe we all have a common
goal to shape the face of the health care industry by utilizing
the vast contributions that you have heard about today that IT
offers health care providers, patients, and payers in achieving
goals of reduced medical errors, lower costs, better quality,
and improved efficiency within our nation's health care system.
In addition to representing Greenway, I am a board member
of HIMSS Electronic Health Records Vendors Association, the
EHRVA, which is comprised of the Nation's leading EHR
companies, currently representing roughly 96 percent of all
EHRs implemented in America today. In addition, I reside on the
Board of the National Governors Association Health Information
Protection Task Force and the Certification Commission for
Healthcare Information Technology, CCHIT, Privacy Expert Panel.
My perspective today will be that of a small business
software and services provider that is actively engaging every
facet of the health care industry to support developing a
national strategy for the widespread adoption of health-
information technology and for converting this adoption into
quality and efficiency improvements. The faster we align
incentive, technical standards, and guideline requirements, the
faster we improve care, increase quality, contain costs, and
save lives.
This statement focuses on Greenway's and our industry's
dedication to assisting Congress, the U.S. House Committee on
Science and Technology, and the National Institute of Standards
and Technology in their goals of supporting the integration of
the health care information enterprises. In this pursuit,
Greenway, HIMSS, and the EHRVA support a truly transparent
process and equal cooperation of public and private entities.
This collaboration has proven, recently, to reduce barriers
with federal regulations as well as barriers with harmonizing
standards. Over the past few years, Greenway and the entire
health care industry has made significant strides with EHR
adoption, standards convergence, inter-operability, and
improving ROI for long-term sustainability of our nation's
health care transformation process. Specifically, Greenway
customer practices now have the opportunity for inter-
operability among their local community which encompasses
regional care providers, patients, and hospitals. Our customers
alone have realized annual $21,000 to $81,000 on post-
implementation return on investment per physician. With
paperwork reduced, collections increased and coding improved,
physicians provide a higher quality of care and also operate a
more efficient business.
While HIT and EHR adoption currently grows at a record
pace, we possess the responsibility to ensure that every policy
enacted and every rule that is proposed must sustain our
current investment and progress. We applaud the focus that the
President, Congress, and HHS have applied to this industry
transformation, but we must ensure that all decisions are
created by entities that have the essential experience,
dedication and factual evidence necessary to put plans and
policy in place. An example of a Greenway-, HIMSS- and the
EHRVA-endorsed article of legislation is H.R. 2377, the ADOPT
Act of 2007, which uses section 179 of the tax code to provide
physician purchasing incentives that can further increase HIT
adoption by reducing upfront practice costs of the first year
of EHR implementation. This bill has currently been introduced
in the House.
Greenway applauds the efforts to authorize NIST to increase
its efforts in support of the integration of the health care
information enterprise. NIST already plays and import role in
public and private sector collaboration, such as Integrating
the Healthcare Enterprise (IHE), and the Health Information
Technology Standards Panel (HITSP), and that role should be
maintained. In addition, NIST should be encouraged to work
collaboratively to make these initiatives even more effective,
and Congress can assist by formally recognizing HITSP in any
legislative language. HITSP is a best practice because of its
public and private collaboration, transparency, and use of
multi-stakeholder processes like IHE. IHE has a 10-year legacy
of standards and testing harmonization with global
ramifications, and for that reason, it is imperative for NIST
to recognize HITSP and IHE processes.
From a financial investment standpoint, it is estimated
that the private sector has invested $50 to $100 million,
collectively, in the past few years following IHE, HITSP and
certification initiatives, and that has resulted in the
important areas of HIT adoption and inter-operability. More
momentum has been created nationally and internationally in
these areas than ever before. While this momentum could be
better, it is crucial that influential bodies like Congress,
the President Administration and NIST work together to maintain
this impetus and not create alternative de facto testing
standards or certification authority.
It is an exciting time to help and guide and sustain the
momentum in the health care information technology industry. We
have the opportunity to create the most efficient health care
system in the world, and while this is daunting challenge, it
is certainly achievable. If we continue to work together in
public and private collaboration, build on present successes
with HITSP and take the prudent and fiscally reasonable steps
necessary, we will achieve health transition goal and recognize
the estimate $100 to $200 billion in U.S. annual saving with a
fully integrated and inter-operable health care system.
Speaking on behalf of the private sector, we are ready as
an industry to continue our process and partnership with
Congress and federal agencies in making these goals a reality.
Chairman Gordon and distinguished Members of Congress and
staff, I want to thank you for this opportunity and your
dedication to the integration of the health care information
enterprise. I hope my comments will help steer ideas and
thoughts that can be transmitted into innovative policies
shaping the future of health care in this country. Thank you
very much.
[The prepared statement of Mr. Barnes follows:]
Prepared Statement of Justin T. Barnes
Thank you very much Chairman Gordon, Ranking Member Hall and
distinguished Members of the Committee and staff. My name is Justin
Barnes and I am the Vice President of Marketing and Government Affairs
for Greenway Medical Technologies, a leading provider of integrated
electronic health record (EHR), practice management and inter-
operability software solutions for physicians' practices. It is always
a great honor and pleasure to work with Members of Congress and their
staff as I believe we all have a common goal to shape the new face of
the health care industry by utilizing the vast contributions that
information technology (IT) offers health care providers, patients and
payers in achieving goals of reduced medical errors, lower costs,
better quality and improved efficiency within our nation's health care
system.
In addition to representing Greenway, I am a board member of the
HIMSS Electronic Health Record Vendor's Association (EHRVA) which is
comprised of the Nation's leading EHR companies currently representing
roughly 96 percent of all EHR's implemented in America today. In
addition, I reside on the board of the National Governors Association
(NGA) Health Information Protection Task Force and the Certification
Commission for Healthcare Information Technology (CCHIT) Privacy Expert
Panel. My perspective today will be that of a small business software
and services provider that is actively engaging every facet of the
health care industry to support developing a national strategy for
widespread adoption of health information technology (HIT) and for
converting this adoption into quality and efficiency improvements. The
faster we align incentives, technical standards and guideline
requirements, the faster we improve care, increase quality, contain
costs and save lives.
This statement focuses on Greenway's and our industry's dedication
to assisting Congress, the U.S. House Committee on Science and
Technology and the National Institute of Standards and Technology
(NIST) in their goals of supporting the integration of the health care
information enterprise in the United States. In this pursuit, Greenway,
HIMSS and the EHRVA support a truly transparent process and equal
collaboration of public and private entities. This collaboration has
proven recently to reduce barriers with federal regulations as well as
barriers with harmonizing standards. Over the past few years, Greenway
and the entire health care industry has made significant strides with
EHR adoption, standards convergence, inter-operability and proven
return on investment (ROI) for long-term sustainability of our nation's
health care transformation process. Specifically, Greenway customer
practices now have the opportunity for inter-operability among their
local community which encompasses regional care providers, patients and
hospitals. Our customers alone have realized an annual $21,600 to
$81,500 post-implementation ROI per physician. With paperwork reduced,
collections increased and coding improved, physicians provide a higher
quality of care and also operate a more efficient business.
While HIT and EHR adoption currently grows at a record pace, we
possess the responsibility to ensure that every policy enacted and
every rule that is proposed must sustain our current investments and
progress. While we applaud the focus that the President, Congress and
the U.S. Department of Health & Human Services have applied to this
industry transformation, we must ensure that all decisions are created
by entities that have the essential experience, dedication and factual
evidence necessary to put self-sustaining plans and policy in place. An
example of a Greenway, HIMSS and EHRVA-endorsed article of legislation
is U.S. House bill 2377, the ADOPT HIT Act of 2007, which uses Section
179 of the tax code to provide physician purchasing incentives that can
further increase HIT adoption by reducing up-front practice costs over
the first year of EHR implementation. This bill has been introduced in
the U.S. House.
Greenway applauds your efforts to authorize NIST to increase its
efforts in support of the integration of the health care information
enterprise in the United States. NIST already plays an important role
in public and private sector collaborations such as Integrating the
Healthcare Enterprise (IHE) and the Health Information Technology
Standards Panel (HITSP) and that role should be maintained. In
addition, NIST should be encouraged to work collaboratively to make
these initiatives even more effective and Congress can assist by
formally recognizing HITSP in any legislative language. HITSP is a best
practice because of its public and private collaboration, transparency
and use of multi-stakeholder processes like IHE. IHE has a 10-year
legacy of standards and testing harmonization with global ramifications
and for that reason, it is imperative for NIST to recognize HITSP and
IHE processes.
From a financial investment standpoint, it is estimated that the
private sector has invested $50 million-$100 million collectively in
the past few years following IHE, HITSP and certification initiatives
and that has resulted in a health care transformation in the important
areas of HIT adoption and inter-operability. More momentum has been
created nationally and internationally in these areas than ever before.
While this momentum could be better, it is crucial that influential
bodies like Congress, the President's Administration and NIST work
together to maintain this impetus and not create a new alternative de
facto testing, standards or certification authority.
This is an exciting time to help guide and sustain the momentum in
the health care information technology industry. We have the
opportunity to create the most efficient health care system in the
world and while this is a daunting challenge, it is certainly
achievable. If we continue to work together in public and private
collaboration, build on present successes with HITSP and take the
prudent and fiscally responsible steps necessary, we will achieve our
health care transformation goals and recognize the estimated $100-$200
billion of U.S. annual savings with a fully-integrated and inter-
operable health care system. Speaking on behalf of the private sector,
we are ready as an industry to continue our progress in partnership
with Congress and federal agencies in making these goals a reality.
Chairman Gordon and distinguished Members of the Committee and
staff, I want to thank you for this opportunity and your dedication to
the integration of the health care information enterprise. I hope that
my comments will help steer ideas and thoughts that can be transmitted
into innovative policies shaping the future of health care in this
country. Thank you very much.
Biography for Justin T. Barnes
As a health care software executive and public policy expert,
Justin Barnes manages Greenway's Strategy, Marketing, Corporate
Development and Government Affairs departments. With a background in
health care information technology (HIT), corporate operations and
legislative policy, Barnes is responsible for building and executing
Greenway's corporate strategy, industry and government relations.
Barnes resides on several HIT and Electronic Health Record (EHR)
industry governance boards and brings the essential continuum of
experience from Silicon Valley Start-up's to Industry-leading Fortune
20 conglomerates.
Prior to Greenway Medical Technologies, Barnes was a member of the
founding team and Vice President of Sales Operations and Account
Development at Healinx Corporation. Today, Healinx is known as the
RelayHealth Division of McKesson and continues as the premier provider
of secure online health care communication services linking patients,
health care professionals, payors, and pharmacies efficiently,
affordably and securely.
Before joining Healinx, Barnes held several Sales and Operations
positions with HBO & Company that subsequently merged with McKesson in
1999. He served under the Enterprise Group and was responsible for
sales operations of the Pathways Smart Medical Record (SMR)
application.
Barnes has formally addressed Congress and the President's
Administration on seven occasions between 2005 and 2007. Barnes has
also been published in 27 journals, magazines and broadcast media
outlets relating to national leadership of HIT and EHR adoption
efforts.
Elected and Appointed Governance & Advisory Positions
Member of National Governors Association (NGA) Health Information
Protection Task Force of the State Alliance for E-Health
Board Member of the HIMSS Electronic Health Record Vendors Association
(EHRVA)
Board Member of Georgia Tech's Center for Health, Healthcare and
Eldercare Innovation (CHHEI)
Member of Certification Commission for Healthcare Information
Technology (CCHIT) Privacy Expert Panel
Co-Chair, Government Relations, National HIT Week
Chairman of Membership Committee of EHRVA
Member of HIMSS Advocacy and Public Policy Steering Committee
Member of e-Health Initiatives Policy Work Group
Member of EHRVA Government Relations Work Group
Member of HIMSS HIT Advisory Council
Member of HIMSS Government Relations Roundtable
Discussion
Chairman Gordon. I bet you were getting ready to say
something good there.
Mr. Barnes. Thank you.
Chairman Gordon. We have only two minutes, so we are going
to have to go vote. I hope we will be back in 15 or 20. And so
the Committee will be in recess.
[Recess.]
Chairman Gordon. Ms. Williams, you had, I think, indicated
some concern that there is a number of folks working on this
issue, and would NIST just be one more, and there is going to
be a problem. You know, hopefully that is not the case. I think
the intention is that we need to have somebody that is going to
coordinate these activities, and I would remind you back, I
guess it was in 1990, that HHS was directed, through the
Nutrition and Labeling Education Act, to develop standards for
baby food. Eight years later, they didn't get it done, and so
they turned it over to NIST, and six months later it was done.
That is what we want to try to accomplish.
And Ms. Kloss, you have generally been positive about the
health IT standards panel process, of which you are a member,
but as you point out, it is largely a voluntary organization
with a lack of professional staff resources. For such a
critical task as advancing health care IT and operability,
doesn't it make sense that the primary-standards-harmonization
work be guided by a federal agency such as NIST rather than a
voluntary organization?
Ms. Kloss. Well, we think it is quite important that this
process remain a public/private process, and certainly the
resources and services of NIST would be a huge additional
resource to HITSP, but there does just need to be some public/
private mechanism because it is aiding adoption and learning as
we go to----
Chairman Gordon. I think that you are right, and I think
that is really the beauty of NIST in that it is a non-
regulatory agency, so we can bring everyone together without
fear of regulation. This is what they did a few years ago with
financial data security. They brought the financial industry
together, helped them through a collaborative process, set
those common standards, not picking winners or losers, and then
being able to have the test beds there to make sure that they
would work.
Mr. Raymer, you note that NIST has not yet been allowed to
fulfill its role under the memorandum of understanding between
NIST and HHS, and you further note some of the work NIST is
doing through the MOU. So wouldn't you also agree that
codifying this role at a central location to ensure development
of technical standards would be a worthy endeavor?
Mr. Raymer. Absolutely. I think the testimony, you know,
covered a variety of things that we would encourage the
Committee to look at with respect to what their role would be,
but we clearly see that there is a need for NIST in the
process. And we believe as it was originally conceived under
the memorandum of understating, that that would be an
appropriate direction for the Committee to head, with the
caveats that we placed in the testimony.
Chairman Gordon. And back to a real, live doctor, Dr.
Silverstone, to what extent would improved inter-operability
with health care IT systems in hospitals, labs, and other
medial facilities give medial specialty practices the
confidence to make the investment in health care IT?
Dr. Silverstone. You know, physicians really need to know
that the investment that they are making is going to be a
worthwhile investment. I mean our practices are being
challenged on a daily basis by reimbursement and inter-
operability is that key that we need to know that the systems
that we purchase are going to be able to work with other
systems.
You know, as a specialty physician, I am not the primary-
care provider most of the time, and patients are referred to
me, and when they are referred, we have to recreate the wheel
each time. We have to recreate histories. We oftentimes have to
repeat tests because we don't have access to the tests. Very
often, patients have been cared for elsewhere, and we might be
able to get that data in paper format. Often, we can't even get
that. If we could get the data in an electronic format, then we
would be able to continue to analyze the data and to put the
data that we are creating alongside that and provide better
patient care. So these standards, we feel, are absolutely
critical.
Chairman Gordon. That is how we save money and save lives.
Dr. Silverstone. Absolutely.
Chairman Gordon. And as I pointed out earlier, most
Americans are treated by physicians and practices of five
physicians or less, and with the reduction in reimbursements,
with difficulties that many practices face right now, it is
difficult to justify trying to make that investment,
particularly if you are not comfortable that it is going to be
a long-range investment, and that is that whatever software you
are going to buy is going to still be the premium software, or
it can be inter-operable with the various groups that you deal
with. So that is what we want to try to accomplish. But we need
to do more than that.
The purpose of this bill is not to integrate it into the
health care offices, but rather to establish, again, those
standards so that software can be developed. Then, quite
frankly, we go to Ways and Means and we go to the Energy and
Commerce Committee, where we need to provide incentives, both
in terms of making it a government standard as well as trying
to--I would hope we can provide financial incentives for doctor
and hospitals through rapid write-off or other types of ways
that we would encourage them to get on this system.
Dr. Silverstone. Chairman Gordon, I can't agree with you
more. I mean this will absolutely jumpstart the whole process
of making health information technology a cornerstone of
American medicine and will enable American ingenuity to really
flower. I congratulate you on this.
Chairman Gordon. Well, again, I want to thank our witnesses
for being here. My time is up. I would like to ask Dr. Baird to
chair the Committee, and I am sure that Mr. Hall will give him
plenty of help.
Mr. Baird. [Presiding] Mr. Hall.
Mr. Hall. Thank you, Mr. Chairman. Mr. Barnes, you said
that the private sector has invested $50 to $100 on
certification initiatives for HIT. If H.R. 2406 were passed
into law, could that slow down the progress that has already
been made to date, and if so, why. And if no, why not?
Mr. Barnes. In its current form, I think it could be a
disruption to the progress that we have made over the past
several years. We are committed to the progresses that we have
made. I outlined them in my statement. I think that NIST
certainly has a role. We have outlined that here, on the panel,
and also several Members up there. NIST does have a history of
public and private collaboration, so as long as NIST followed
those guidelines and processes, which I am sure they would,
then they would certainly have a positive influence on the
process. But completely owning the process and not working more
collaboratively with HITSP and taking what HITSP has done by
name, not just by process or anything else, but literally, by
name, then I think we could slow down adoption and the progress
that we have made.
So if we could take specifically HITSP's progress and move
that into a forum where NIST has authority and maintain its
progress and build upon that as a foundation, then I would
support that.
Mr. Hall. Mr. Raymer, you said that NIST helped to pioneer
``role-based accessed-controlled technology that limits the
type of information that can be viewed by any individual,
depending upon that individual's function.'' Can you elaborate
a little on that?
Mr. Raymer. Yes, and specifically its role and application
in health care is that as there becomes more widely available
health-information system, a national health information
infrastructure, we think the idea of role-based security is
really critical so that those individuals that have the need to
know during the care-delivery workflow at the appropriate time
are given the appropriate access to the information that they
need.
We believe NIST could play an important role relative to
those security standards that could be more widely adopted. And
NIST has some history of having successfully done this in other
areas outside of health care and inside of health care.
Mr. Hall. And you also state in your testimony that you
support an increase in NIST involvement, but not at the expense
of the processes that are already working well. Would you
elaborate a little on that, sir?
Mr. Raymer. Well, I think Mr. Barnes covered that to some
extent in his statement. It is just HITSP, we believe, has been
a valuable process. IHE has a Connectathon that happens each
year, where even a wider array of vendors each year are coming
together to demonstrate the inter-operability of their
products. So to the extent that NIST would derail current
things that are working, we think that it would be better for
NIST to apply their resources; like the one area would be
compliance among the federal agencies. It is one of the largest
purchasers of health care in the world, and certainly in this
country.
The government would greatly benefit from the utilization
of standards, even within its own health care delivery system.
So I think we have outlined in the testimony some specific
areas that are gaps today.
Mr. Hall. It is an area to be careful in, isn't it?
Mr. Raymer. Yes, absolutely.
Mr. Hall. And did you crank into your computer the fact
that NIST has never before been a body that set policy?
Mr. Raymer. Yes.
Mr. Hall. You state in your testimony that you ``support an
increase in NIST involvement, but not at the expense of the
processes that are already working well.'' And you stated that.
Now, do you believe that the passage of H.R. 2406 could
potentially hurt progress that has already been made in health-
information technology?
Mr. Raymer. I think to the extent it circumvents or slows
down the work of HITSP, of IHE, and other successful
initiatives, it would be very damaging. I think that, you know,
if the Committee listens to the testimony today, and I think
focuses the bill on directing NIST towards the areas in which
we are currently gapped from our National Health Information
infrastructure and technology platform, that what you would do
would be accelerate the rate of adoption, because you are
ensuring that resources are being brought to bear in an area in
which there is not appropriate focus today.
Mr. Hall. Well, I think that is a good answer. And I think
that when the Chairman introduces a bill, it is often that we
need to support that bill if at all possible, but we need to
point out the pitfalls that might show, and I think this is a
very good panel to give us those answers. And I think my time
is up, so I yield back my time.
I will have some questions that I wasn't to submit to each
of you in writing, and if the Chair agrees to allow us to do
that--I ask unanimous consent that the panel be asked to answer
our questions that we submit to them in conjunction with this
hearing.
Mr. Baird. Without objection.
Mr. Hall. Thank you, sir. I yield back.
Mr. Baird. I am sorry I wasn't able--I had another hearing,
as we often do here. From what I hear the situation seems to be
that you have got some positive initiative going forward that
seems to be moving at pace. We all recognize that, and there
seems to be consensus that, we need to adopt this as quickly as
possible. The question is NIST does not necessarily have to
approach this by saying we are kings here. We are going to set
the standards for you. Do you have objection to NIST providing
a facilitative role? Or maybe that is what you were saying, Mr.
Raymer, a facilitative role to work together with the various
established processes to see if they can't move things a little
more quickly, because it seems that is going more slowly, so I
want to open that up to anybody. And then, as part of that, how
does H.R. 2406 relate to that in your judgment?
Mr. Raymer. Well, to respond to your question about
facilitation, we think that there are some important roles that
NIST could play. One, as I mentioned before would be to ensure
compliance to the standards by the federal agencies themselves,
and the government would benefit from that.
Secondly, as you go through any kind of collaborate, both
public and private collaborative, like HITSP, having this be
the coordination to ensure that the dialogue continues on the
public side within the governmental agencies is kind of being
that guiding, facilitation mechanism we think would be very
good.
The other area is that there is some good work that goes on
with regard to testing and certification today, but as the
standards move forwards, and let us say in the areas of role-
based security, there may be a specific thing and specific role
that NIST may play, then, in covering gaps of where
certification or testing activities today are not appropriately
validating the inter-operability between products.
So we do view there to be a role of facilitation, both
within government, outside of government, and more importantly,
there could be specific roles that NIST might have in providing
gaps that would accelerate the adoption of health care IT in
the country.
Mr. Baird. Ms. Williams, you seem to have something you
want to add. You might want to hit your mic there. I am not
sure it is on.
Ms. Williams. Thank you. I generally concur with Mr.
Raymer. We think that NIST could probably play a strong role in
enforcing the standards, perhaps in implementation of those
standards. I am just not sure that they are the appropriate
group to bring the public and private sectors in step.
Mr. Baird. Ms. Kloss.
Ms. Kloss. I would add that, with respect, specifically, to
the Certification Commission for Health IT and the work Mr.
Raymer just referred to, that organization is now beginning to
build a testing resource and is hopeful that there will be
collaboration and that NIST will bring its expertise in
building testing beds. Secondly, certainly, bringing forth
standards in the area of security would be very valuable to the
work going forward. And thirdly, as I mentioned earlier, we
think we need a new mechanism study on how to look at clinical
terminologies and classifications and bring that more robustly
and squarely into the standards process.
Mr. Barnes. I actually would like just to add just a little
bit to that and especially where NIST, if they were involved
before now, could have played a more positive role. In the area
of CCHIT and certification, they have chosen a testing bed
called miter, and whereas that could be considered a
duplicative process because they could have chosen IHE, which
NIST has been very involved in. And from a vendor standpoint,
that is expensive for us. We now have to create tools to work
with miter and their testing bed, and we have tools already
that we paid for and use on IHE. So there certainly is a role
for NIST in this. I almost wish it was a little bit, maybe
sooner regarding that CCHIT item. So that is certainly to
continue on in their efforts. Yes.
Mr. Baird. One of the things we are working on elsewhere in
a different committee is this whole issue of national health
care, and I am a big believer in that you ought to give
patients upfront information about what their options are and
what the empirical data are and what their costs are, and I
think that ought to be standardized across insurance policies,
so we all get the same kind of information. Is that kind of
issue being addressed? Or is it right now, you are focusing
mostly on the technological aspect? But that is related,
because will your technology allow for that kind of data, both
collection and presentation to patients?
Ms. Kloss. I would comment that that was the reason behind
our discussion on classification and vocabulary as a type of
standard that we feel have not gotten sufficient attention. It
really is the common language of medicine that will allow this
information to be understandable across the industry, and more
work needs to be done on that to bring together disparate
processes for developing, maintaining those systems and keeping
them up to date, creating crosswalks between them, all of this
internal information-management work.
Mr. Baird. Thank you. My time has expired. I want to yield
to Dr. Gingrey.
Mr. Gingrey. Dr. Baird, thank you.
You know, the entire hearing has been very, very
informative, and of course, with the background of the
Chairman's bill, I think all of us want to understand exactly
what role that NIST will have in regard to, if this legislation
is approved.
And I guess my main question is, the President said a
couple of years ago that we want to have a fully integrated,
inter-operability, electronic medical records systems by 2014,
I think, was the deadline. I think we ought to get there,
hopefully, before then. I think the need is so great. When we
sit here and talk about the various studies that suggest the
amount of savings anywhere from $75 billion to $160 billion a
year, and we just vote on a bill, the S-Chip program, which is
by anybody's standards a fairly massive expansion, we still
have 40 million people in this country uninsured. We have got
other needs, war-fighting, not the least of which. I mean so we
are talking about real money here. And the quicker we can get
to the point of achieving those savings and saving lives, the
better.
So I guess the main question for all the witnesses--I will
start with Mr., Barnes, my friend from my district from a
courtesy--but you know, is there something about what we have
been doing with the national coordinator, the HITSP that just
gets into the realm of moving too slow, foot-dragging, not
getting the job done? And what is that NIST can do to put on
the afterburners, if you will, to make it better, and to not
to--I think Mr. Barnes was expressing some concern about what
would happen to the small vendors, and Mr. Raymer, too, in
regard to the large vendors, GE, if you have already gone down
a certain road, based on what ONC and HITSP have recommended,
then we don't want to undo all of that process. So that is
really my question: what can we do to make it better, other
than the fact that maybe NIST is more recognizable acronym than
HITSP or ONC.
Mr. Barnes. Thank you very much, Dr. Gingrey. Most
certainly, there has been a lot of work and progress over the
last couple of years, through the ONC and leadership through
HHS and by the President. And this progress, I don't think it
is going to be--hopefully, it will not be undone, but you have
seen--you have heard in my testimony that though standards
harmonization certification, we have really increased adoption.
We obviously could have done it better. There is always a
better way to do items and perform tasks, but in my personal
opinion, I think it has gone as smoothly--actually surprisingly
smoothly, as any of us have anticipated. GE and my company, we,
initially, when we were embarking upon learning about
certification and standards harmonization, we certainly,
naturally, had a lot of questions and concerns, and I think,
now, speaking for my company directly, we were pleasantly
surprised on the progress and how our investment that we have
made--my company alone has made over $500,000 in investments in
this, and not just on the personal investment side, but
watching what this has done in the industry, watching inter-
operability come together. So it is exciting.
I mean we are watching our customers. We have got 17,000
across the county that just came from a user conference, and
they are excited. They are seeing how inter-operability is
changing their lives, their patients' lives. So it out there.
It is successful. It could be better. This is where NIST can
come in. I mean they have essential experience. They have long-
valued experience in this area of standards and testing, and so
I think bringing that knowledge to bear within the current
processes would be invaluable. So I mean I certainly would
encourage NIST. The more minds that come together to make this
a better process, I think is certainly welcome, just not to
modify or derail all of the progress that we have invested in.
Mr. Gingrey. I am short of time, but I welcome any other
comments in regard to that.
Ms. Williams.
Ms. Williams. It is a daunting challenge that we have, and
I would say that IT is a tool to help us solve a complicated
problem in the health care system. It isn't that we don't have
any standards. Part of the problem is that we have too many
standards. The National Alliance for Health Information
Technology did a survey recently, and the result was that, in
fact, we have over 2,000 standards in the health care industry,
with over 400 organizations that are either developing
standards, maintaining standards, or licensing standards. So we
need to invest the authority in some coordinating body to sort
through all of this. That starts with a vision, and the
President laid out a very high-level vision for what we need to
achieve by 2014. We need to agree on a common vision, you know,
sort of on how we are going to get there, and then we need to
agree on a set of standards that will help us get there. That
would be sort of the rules of the road or the roadmap. So we
need a common vision; we need standards; we need a roadmap; and
then, we need an implementation process. And perhaps--NIST
definitely has role there in perhaps enforcing and helping with
the implementation process.
Mr. Gingrey. Thank you. My time expired. And thank you, Mr.
Chairman.
Mr. Baird. Thank you, doctor. Mr. Wu.
Mr. Wu. Thank you, Mr. Chairman. My apologies, I was called
away earlier for what I thought would be a quick vote, which
took a long time, and now, I have been told again, I have been
called for a quick vote in my other committee, but I will risk
that briefly. And I want to ask this panel a non-standards-
oriented, a non-NIST-oriented question. In a field hearing and
in roundtables that we held on this topic, in addition to the
challenge of inter-operability and standards, there are other
significant barriers to adoption of health care IT, one of them
being the misalignment of cost and benefits. For example, if a
small medical group were to adopt health care IT, they would
have to bear the preponderance of costs, whereas a
preponderance of benefits would go upstream somewhere, if you
will, to Medicare or an insurance company and so on. Do you
have thoughts on how to either better align these financial
costs and benefits or for some way for the beneficiaries to
help finance the cost of health care IT?
Mr. Raymer. Well, certainly, GE has been a large purchaser
of health care services in this county and are concerned about
the misalignment that takes place today in the care-delivery
environment. I think the movement towards pay for performance,
I think, is an important movement, and to have part of the pay
for performance tried in-process clinical measures that are
only possible when you have an electronic system in place. So
you can choose to do it on paper, but your cost of reporting
that in an in-process basis would be more expensive than the
cost of the system itself. Also, I remind you that CMS put of
1303-P last fall, which provided a relaxation of Stark and a
Safe Harbor or health care entities to offset the cost of
donation for physicians. I conducted research last fall----
Mr. Wu. Mr. Raymer, my apologies. Let me interrupt you.
This time, they tell me it is really for real, and it is really
urgent, but I would like the witnesses, if possible, to proceed
to answer the questions, and I look forward to reading the
answers, and my deepest apologizes to you all for this
multiple-ring affair that we have going in the Congress.
Mr. Raymer. Well, I was just going into 1303-P last fall,
created Safe Harbor and the exception to Stark to allow health
care entities like hospital systems or integrated delivery
networks to offset up to 85 percent of the cost of the EMR for
physicians. I did research last fall with an independent group
that identified that that regulatory change will stimulate
adoption and probably likely double the rate of adoption over
the next three years by physicians. So you know, I think it is
a combination of a move towards pay for performance that is
based on in-process measures. And the number-one barrier for
adoption for physicians in studies that we have done is all
about economics. And so if you couple, you know, that
reimbursement will be better when you provide better care, and
the methodology by which you do that is--IT is one tool to
accomplish that.
Ms. Kloss. I would add that we also have to guard against
any failure in implementation. That is these implementations
need to go very well, and we need to be seeing providers really
benefiting from the technologies, and so the work that you have
done on workforce development is key, and additional insights
into best practices and workflow improvements. So it is not
just getting them in. It is really making them work well and
return.
Ms. Williams. And I would add that that is an ongoing
process. In my written testimony, we did outline that hospitals
with more advanced IT systems than what physicians currently
have could provide help in both hardware and software
implementation and ongoing support. But we can't do so today
because the physician-referral or Stark regulations. Those have
been recently relaxed to some extent. We would like to see the
relaxation made permanent.
Dr. Silverstone. My perspective is a little bit different,
because it comes from the trenches. It comes from the
physician's office. And I have talked to many, many physicians
over the years, especially specialists, and they really want
this technology.
They can see that at its best, this technology can really
help them to provide exceptional care to patients and make that
exceptional care the norm. But there is a tremendous problem
with the cost, and there is a tremendous fear with the cost.
And physicians are small businessmen. Most physicians do not
have very, very close ties to hospitals and don't want those
ties. They want to remain independent business concerns, and
they want to be able to control their lives. And they need to
be able to afford it, and they need to be able to know, going
into the future, that they will be able to continue to afford
the technology.
So the financial aspects, yes, are a major one, and the
financial aspects really need to be addressed. Physicians are
also looking at what it takes to maintain these systems in
their offices, and as soon as you get inter-operability, as
soon as you get standards, as soon as you take your hundreds,
and hundreds of sets of standards and get an organization that
can combine them and can take the best of all of the sets of
standards and really make them routine, then you are producing
a system that requires less maintenance and a system that
physicians' offices can really afford. I have the advantage of
being in an 11-doctor practice. In that practice, we have a
full-time HIT person, a full-time person to manage our networks
and our systems, and most practices can't afford that.
Mr. Barnes. I would like to follow up with a quick comment
here.
Mr. Baird. It is going to have to be real quick, because I
have a couple of other Members who want to----
Mr. Barnes. Well, just real quickly, I think that if I was
a physician, I wouldn't think about not investing in
technology. They do need to streamline their practices. Most of
my customers, which I have a very hands-on relationship with,
do not have any HIT staff in their office. They are four-,
five-, and six-doctor practices across America, and if you have
the right system made for your specialty, you do not need--I am
saying that if they do their due diligence, they will receive
the benefits.
Mr. Baird. All right. Dr. Broun.
Mr. Broun. Thank you, Mr. Chairman. I am a physician. In
fact, I am a primary care provider and I have done a full-time
house-call practice the last few years just prior to just
recently being elected to Congress. When I was in an office,
and then as a sole practitioner, I looked into doing electronic
medical records for my own patients, and what I found after
doing a through investigation is, frankly, I could not afford
it. I don't have Dr. Silverstone's blessing of having a large
practice of being able to afford a full-time IT person, and so
I think affordability, practicality for small, community
practitioners--sometimes we have one, two or three doctors in a
practice who want to be independent, who is not tied to a
hospital. It is a certainly a tremendous probe that we need to
face, and I could not overcome the cost, as well as it was
difficult for me to try to figure out how to go up the learning
curve to be able to integrate information technology into my
own practice.
The other thing is our local hospital in Athens, Georgia, I
have talked to the administrator recently, and they are trying
to develop an IT system through Athens Regional Hospital where
all of the doctor in the community are all tied into one
computer system, and I think that is a very laudable goal, but
the thing that concerns me is privacy and confidentiality. I
would, in my own practice, all of my employees knew that if
anything went out of the door of my practice, it was immediate
grounds for dismissal, no questions asked. Fortunately, I never
had to dismiss anybody.
But last year, the U.S. Department of Veterans Affairs
announced that the theft of laptops contained information
concerning, I think it is 26.5 million veterans and active-duty
military members, and we have government workers losing laptops
all of the time with confidential, even top-secret information,
on those computers. And it just really concerns me that people
social security numbers, not only in these instances that I
just mentioned, but as a medical doctor, I am really concerned
about the privacy of my patients and the confidentiality and
when you set up this information sharing, I see a very real
potential for discrimination against parents for insurability,
discrimination in hiring practices, and these types of things.
So could you all please answer to me how we can ensure that
confidentiality, how we can prevent the discrimination to my
patients in a new IT type of world.
Mr. Raymer. I will take that to start with. I think that
the conundrum you are in is that the paper record is also not
very secure, so the reality that is if you walk into a hospital
today, and it has got a lot of paper charts, there is ready
access to the public to that.
The majority of technology solutions that we are talking
about is not having the data stored in one location, but more
of a federated model where the data resides back in the
practice, and the individual practice has control of that, and
that you, when you have a patient referred into your practice,
that you, with the appropriate credentials, have the ability to
go out under the patient's HIPAA concurrence to go out and
secure other relevant data, whether it be problem lists,
medication, allergies, which are all important things that you
would like to know about a patient being referred into your
practice.
So we do believe that NIST can play a role, particularly in
the security and privacy side. And my testimony talked about
the need for role-based security and how critical of importance
that will be, so you know, I think that it is certainly
something that is internalized, but it is very personal, so
that one thing you can say about health care is it affects
everyone in this room. And so I think that in both the public
and the private area GE is very concerned about this very issue
as you look to the future of genomics, which is a whole other
universe of personal medical information that, you know, could
be accessed, so it is a big concern that we have.
Ms. Kloss. I would add that the Certification Commission
for Health IT in the foundational testing that they are doing
for all certified electronic health records is meeting certain
privacy and security common standards and that those are being
ratcheted up over time as all of us learn to use systems with
more robust certification and privacy controls. So I think that
is one of the step-wise processes in the standards deployment
now. What we have, however, and what the e-Health--the State e-
Health Alliance and other groups are looking at is the wide
disparity among states and how, in fact the current law is
actually being put into place. We just do have more need for
education across the board and practices. It is not all
technology standards.
Mr. Baird. Those buzzers you have been hearing means we
have a vote underway, and so we have just enough time for Mr.
Akin to ask a couple of questions, and then we will----
Mr. Akin. Thank you very much, Mr. Chairman. Actually, one
of the questions was asked--I was just curious about the, you
know, legal problems, but in terms of data security, is that
something that we have to change the laws, because we get
pretty hyper-sensitive about anybody, you know, knowing whether
you had a 101-degree fever or something? I mean it wasn't quite
that bad, but we really go pretty hyper about his. Do we have
to change the laws any in that regard, and is that a big
problem?
Mr. Barnes. I will start with that one. I think that that
is probably being scoped right now. I mean I sit on the
National Governor's Association Privacy Board for that exact
reason, and we are looking at all of the 50 states' privacy
laws as well as HIPAA to see what recommendations that we will
made to all 50 states and to Congress on does HIPAA need to be
modified? Does it just need to be enforced? Better interpreter?
Or what do we need to do across state lines? I mean every state
sees consent and authorization differently, and so we are
trying to provide guidance, and that is underway, currently,
right now. We meet every month to discuss this and should have
some further recommendations at the end of this year, so I
don't know if there is a yes or no answer quite yet. There
might be by some panel----
Ms. Kloss. There is a gap, and that is the gap in genetic
non-discrimination disclosure, where we have been advocating
for law in that area, specifically to cover an area of
vulnerability.
Mr. Akin. You do need some additional protection, no easing
off on things that already exist?
Ms. Kloss. That is correct.
Mr. Akin. Are there places where we need to ease off things
where we are too strict, or not necessarily?
Ms. Kloss. I think we have always viewed HIPAA as a floor,
and that a floor, over time, as we gain more experience and get
that in place, we should look to, you know, raising the bar as
technology enable things like robust audit trails and other
mechanisms to really keep raising the bar. And I think we need
a commitment to that over time.
Mr. Akin. I mean I was thinking--what I am talking about is
maybe it was too high. I remember there were times that you
couldn't tell the dentist that the patient had AIDS or
something, and then you have people that are--their health is
at risk and things like that. So I was wondering if we get--you
know, if there was a balancing act. I mean it seems to me there
would be a balancing act, not that you are always ratcheting
something up.
Mr. Barnes. I think that adding interpretation also might
be an answer. It might be a regulatory guideline or regulatory
interpretation, maybe not on the legislative side. It's in what
you are trying to uncover because HIPAA is just misinterpreted,
and so unfortunately, people interpret it as conservatively as
possibly so they don't enter any hot water, so I think that is
what we are still ungoverned.
Mr. Akin. And then the second thing, is there--I used to
work for IBM and the magnitude of this question is sort of mind
numbing to me, but is there any single organization now that
can do some systems design and at least define some interfaces
so that as people design systems that the things can plug
together at the--or is this something that is still--but is
there any one, single organization that is trying to define
what the system might look like?
Mr. Raymer. Well, certainly, there is from a standards
standpoint, a definition. No one is trying to write a standard
that defines one system. In the State of Vermont, GE happens to
be the provider of the regional health information
infrastructure in that we are providing a product, but there
are other states that are doing something similar. We are all
leveraging the same work product that is coming out of HITSP,
so the standard shouldn't define a de facto product solution.
The standard should define what a product should look like, and
then there should be the incentive, commercially, to develop a
system that is responsive to those standards.
Mr. Akin. So it is a two-tier thing. You have some
standards, and then you let the private sector work those, and
that is the way we--because those of us in government are very
sensitive to the fact that, you know, we are not effective as
business in terms of being able to put products in good
quality. You know, at the same time, there needs to be some
kind of guidance, and so is that balanced? You think that this
bill sets that balance about right from what you see?
Dr. Silverstone. I would agree with that. I would say that
is exactly what it does do: it provides the framework, the
foundation that enables the private sector to be able to come
in and create the programs and the systems that we need.
Mr. Akin. And my hope is--of course, all of us can see the
benefits of it. I am a prostate cancer survivor, so you say you
got to go see--you are going to get surgery and this and that,
and if those statistics are really recorded well, it is going
to be a tremendous tool, medically, to know all kinds of
different things. But yes, I am hoping the day will come when
the individual practitioner--that there is stuff that is cheap
enough off the shelf and that it is not too complicated, but I
also walk into a room with computers, and they start laughing,
so I am one of the guys that needs two IT people. Thank you. We
have got to go vote.
Mr. Baird. Mr. Akin, we are down to five minutes.
I want to thank the panelists and the witnesses and
everyone else who attended here. I also want to thank my
colleagues. The record will be open for additional statements
for two weeks for Members and for answers to any follow-up
questions. If you have additional things that we didn't cover,
but you feel are important to submit for the record, please do
that, and Members, of course, have that prerogative as well.
And with that, the hearing stands adjourned. Thank you all
very much.
[Whereupon, at 12:15 p.m., the Committee was adjourned.]
Appendix 1:
----------
Answers to Post-Hearing Questions
Submitted to David E. Silverstone, Clinical Professor of Ophthalmology
and Visual Science, Yale School of Medicine; Assistant Chief of
Ophthalmology, Yale-New Haven Hospital; Practicing
Ophthalmologist, The Eye Care Group, New Haven, CT
These questions were submitted to the witness, but were not
responded to by the time of publication.
Questions submitted by Chairman Bart Gordon
Q1. What are the major factors that discourage medical specialist
practices from investing in health care IT (HIT) systems? To what
extent would improved inter-operability with HIT systems at hospitals,
labs, and other medical facilities give medical specialty practices the
confidence to make investments in HIT?
Q2. How could an inter-operable HIT system better enable practicing
specialty physicians to keep up-to-date on the latest medical
treatments and diagnosis procedures? How do specialty physicians
currently track the latest advances in medical information and the
recommended best-practice treatments in their field?
Q3. How are the needs of specialty medical practitioners different
from those of hospitals and general-medicine providers? What are some
examples of these needs, and how can HIT standards be made flexible
enough to accommodate the needs of specialists?
Questions submitted by Representative Ralph M. Hall
Q1. I understand that the Administration supported establishment of a
health IT standards harmonization process in 2006 through the
Healthcare Information Technology Standards Panel (HITSP) which has
made considerable progress over the past two years in the development
and harmonization of data and technical standards for inter-operable
health information exchange. How do you see this bill building on the
current standards harmonization process through the HITSP?
Q2. In August 2006, the President issued Executive Order 13410, which
requires federal agencies to utilize, where available, health
information technology systems and products that meet inter-operability
standards recognized by the Secretary of Health and Human Services. The
American Health Information Community (AHIC) has recommended several
sets of standards that HITSP has developed or harmonized. How do you
feel this bill would affect that process, given HHS' expertise in
health IT standards?
Answers to Post-Hearing Questions
Responses by Noel Brown Williams, President, Senior Vice President, and
Chief Information Officer, Hospital Corporation of America
Information Technology and Services, Inc.
Questions submitted by Chairman Bart Gordon
Q1. You have suggested the problem with adoption of health care IT
(HIT) is that the industry has not yet selected a single set of inter-
operability standards and gotten consensus among health care
stakeholders to use those standards. Given NIST's long history of
acting as a neutral government body working with industry and other
groups to select consensus technical standards in a broad array of
technical fields, isn't NIST well positioned to guide this very
necessary standards-selection and standards-buy-in process?
A1. The short answer is yes. NIST is well positioned to play an
important role in the standards selection and buy-in process. The lack
of a single set of inter-operability standards is just one reason for
the slow adoption of HIT. While the best standards are created through
a consensus process, there must be commitment on the part of
stakeholders to make the necessary investments to implement those
standards. Commitment to implementation involves vendors, providers,
laboratories and a broad array of stakeholders with a legitimate need
to share health data. NIST could make a valuable contribution to this
piece of implementation. Other components of the commitment process
include initial financing, maintenance costs, payment and privacy
policies, as well as quality reporting and other issues we believe are
best resolved by other efforts and agencies already in place.
Q2. You cite as one example of the lack of HIT standards the fact that
there is no standardized method to associate a patient with his or her
medical records. What is the consequence of this lack of HIT standards,
and what does it prevent health care providers from being able to do
for patient care?
A2. The lack of a standardized method to match a patient with his or
her medical record is a fundamental problem that must be resolved
before we can attain the vision of an interconnected, nationwide health
information network. A provider can never be 100 percent certain that
the record under review belongs to the right patient without such
measures in place. Both false negatives and positives have consequences
and could affect patient safety, as well as expose the physician to
liability if the wrong information is used during an episode of care.
Q3. How would a fully inter-operable HIT system within the Federal
Government advance the adoption of HIT in the private sector?
A3. A fully inter-operable federal HIT system would advance the
adoption of HIT in the private sector by demonstrating, once in place,
that inter-operability reduces costs, improves patient safety and the
efficiency of the care process. Furthermore, a government system could
be used to pressure the private sector into compliance with its system
in order to expedite payments and claims handled by the Centers for
Medicare & Medicaid Services.
Questions submitted by Representative Ralph M. Hall
Q1. I understand that the Administration supported establishment of a
health IT standards harmonization process in 2006 through the
Healthcare Information Technology Standards Panel (HITSP) which has
made considerable progress over the past two years in the development
and harmonization of data and technical standards for inter-operable
health information exchange. How do you see this bill building on the
current standards harmonization process through the HITSP?
A1. This bill builds upon the progress already made by HITSP by adding
NIST's expertise to transform the result of HITSP's consensus-based
decision-making process into a set of tools and guidelines that would
enable the implementation of the decisions made. HITSP's expertise is
in guiding stakeholders to consensus on which standards should be used;
NIST takes it to the next logical step of implementation.
Q2. In August 2006, the President issued Executive Order 13410, which
requires federal agencies to utilize, where available, health
information technology systems and products that meet inter-operability
standards recognized by the Secretary of Health and Human Services. The
American Health Information Community (AHIC) has recommended several
sets of standards that HITSP has developed or harmonized. How do you
feel this bill would affect that process, given HHS' expertise in
health IT standards?
A2. Given the uncertain future of AHIC and its role in this process,
this bill would allow NIST, HITSP, AHIC and HHS to identify where
NIST's expertise could best be leveraged We believe NIST could, if
positioned correctly, complement rather than constrain progress.
Answers to Post-Hearing Questions
Responses by Linda L. Kloss, Chief Executive Officer, American Health
Information Management Association, Chicago, IL
Questions submitted by Chairman Bart Gordon
Q1. You noted AHIMA's support for the approach in H.R. 2406 of having
NIST work on security standards for health care IT (HIT). How important
is robust security and confidentiality of medical information for the
broad public acceptance of HIT systems? How can it best be achieved?
A1. AHIMA members, health information management (HIM) professionals,
believe that for public acceptance of HIT and electronic health
information exchange (HIE) there must be trust that the electronic
systems and manual practices involved include the necessary functions
or steps taken to secure their personal health information (PHI) and
maintain confidentiality subscribed to in the agreements between
consumers and entities that hold or transfer PHI. In addition to a
number of confidentiality practices and physical security, ``security''
includes a number of software elements including, but not limited to,
identification and authentication, access controls, system audits and
access tracking, data integrity, and so forth.
Security is not a new issue in the exchange of health information.
HIM professionals have made this a key element of our practice for
decades, but when it comes to having acceptable standard security
software systems; the health care industry has remained behind other
industries. Development of functional security standards have been an
important activity of NIST, and AHIMA believes the resources of NIST in
combination with health care industry oversight must be brought
together so that the industry can have available the security tools and
resources necessary to combine with conscientious confidentiality
practices in order to ensure the public's trust in our collection,
storage, and transfer of their PHI.
Although not under the jurisdiction of NIST, AHIMA believes that
penalties are an essential element of robust confidentiality
requirements and building broad public acceptance of HIT systems.
Penalties need to be severe and should encompass security and
confidentiality breaches along with non-compliance with laws,
regulations and standards. The HIPAA Privacy Rule has now been in
effect since April 14, 2003 (April 14, 2004 for small health plans) and
non-compliance, at this stage, is inexcusable.
Q2. What are the research and development needs to ensure that
advances in information technology and medical technology can be
incorporated into HIT standards in the future?
A2. Standards must be chosen that meet the current functional needs and
can be harmonized with other standard that also must support a
particular functional model. This means that the bodies harmonizing
standards must review not only the potential transaction, terminology,
or classification standard(s) involved, but also ensure that the body
that develops and maintains the standard and subscribes to principles
such as:
Transparent and open business practices by all
participating organizations--this includes end users of the
standard or the data included or represented by the standard,
Organization, mechanisms, and a timely process
necessary to keep standards robust and up-to-date with current
medical practices and technology (national and international).
Section 201 of H.R. 4157, the ``Health Information Technology
Promotion Act'' in the 109th Congress, provided good language
to reduce the time and streamline the process to modify and
update HIPAA standards,
Standard development principles and guidelines for
development, distribution, and maintenance of systems and
coordination across systems,
The provision of timely and reliable guidance on the
use of the standard (also a role for any coordinating body).
Q3. In your testimony you noted that there are over 2,000 standards
related to HIT and over 400 organizations that either create, maintain,
or license those standards. If the most important job in making HIT a
reality is to work towards a single set of standards and get consensus
on using that set of standards, isn't the leadership of a neutral
government body such as NIST, with its long history of working with the
private sector on consensus standards development, essential?
A3. The numbers in your question were not part of AHIMA's testimony.
Even so, there are many standards and many organizations. Yet, the
issue of choosing or harmonizing standards remains. The active
involvement of a skilled neutral group, such as NIST, will do much to
accelerate the harmonization process, but there also has to be
consensus and buy-in from the health care industry, which is currently
operating on a public-private model--the Health Information Technology
Standards Panel (HITSP) and the American Health Information Community
(AHIC). Were the health care industry not so invested in this model,
the NIST leadership role you suggest might be an acceptable
alternative. However, the current Administration has pushed for a
public/private model and the industry has invested considerable
resources and time to make this approach work. We appreciate the
Committee's acceptance of the roles of HITSP and CCHIT and working NIST
into the current model will to help accelerate the harmonization
process, support security standard development, and provide the needed
testing mechanisms.
Q4. What would be the benefits to public health, in terms of tracking
disease outbreak, adverse drug reactions, or other issues, from a fully
inter-operable HIT system?
A4. Presuming the health care industry can arrive at uniform and
consistent use of terminologies and classifications in electronic
health records (EHRs); address confidentiality concerns through the use
of good security standards, compliance and enforcement; establish the
network and decision support necessary to determine reporting paths;
and, use the same network to provide public health notices and
guidelines, then the benefits of collecting data for population health
purposes (public health, research, and similar reporting) are expected
to be enormous. Currently, none of these activities and reporting
mechanisms (networks) are in place. Most reporting is done by hand,
systems operate in silos, and the classification systems in use are
mapped in few systems, but not capable of reporting, in any detail,
21st century diseases or medical practices and technology. Moreover,
because of our nation's inconsistent use of uniform and consistent
terminologies, we are unable to efficiently exchange information with
most of the international community including the World Health
Organization and its Global Outbreak Alert and Response Network. This
is severely detrimental to our ability to track the progress of
outbreaks of diseases as avian influenza, SARS and potential
bioterrorism events.
Substantial efforts are underway to achieve this vision for
population health. The Science and Technology Committee's attention to
the terminology and classification standards coordination and
improvements needed as well as the harmonization of transaction,
functional, and security standards will give this movement a
considerable boost.
Q5. How could an inter-operable HIT system better enable practicing
physicians to keep up-to-date on the latest medical treatments and
diagnosis procedures? How could inter-operable HIT systems support
decision-making by practicing physicians and other health care
providers?
A5. AHIMA would interpret ``inter-operable'' in this question to mean
uniform and consistent use of contemporary medical terminologies and
classifications as well as the adoption of a standard EHR and networked
health information exchange (HIE).
If the medical community is capable of reporting findings and
questions in the same uniform and consistent language, then a variety
of public and private organizations, including the CDC, AHRQ, NIH, NLM,
and various private foundations and medical research organizations, can
respond with what is known regarding a particular disease or problem
and provide guidelines for how to respond.
Currently, the language of medicine in the U.S. is not consistent
or uniform which limits communication both to asking the question as
well as providing an answer. The ability to use either uniform
terminologies to exchange the actual health record, or classifications
to identify diagnoses, procedures, and technology, must be detailed,
and the ability to transmit such information uniformly then permits the
use of computer technology to scan information and provide links to
potential responses or experts. Today, most communication is visual and
the data is limited, therefore reducing the ability and increasing the
time to search the vast body of knowledge available. Time is a very
important factor with physicians, both in the time they have available
and the timely needs for information as they are treating individuals
and reporting key information for population health purposes, research
and so on.
Q6. To encourage the rapid adoption of HIT systems by health care
providers, it is important to guard against failures of implementation,
which would reduce confidence in the benefits of HIT systems and make
other providers reluctant to invest in them. How will technical test
beds for testing HIT products help prevent implementation failures?
What other actions can reduce the risk of implementation failures?
A6. The technical test beds discussed in AHIMA's testimony were
recommended to allow for certification of HIT products to ensure the
purchaser that the product: included applicable, adopted (HITSP/AHIC)
standards; provided the capability for inter-operability; and possessed
the capability to be upgraded as the industry upgrades its standards,
systems and system requirements, and so forth.
HIT vendors must have their own test beds to ensure their products
meet the industry and customer demands, and some of this testing could
use the same technical test beds suggested for development by NIST and
harmonization by HITSP. Vendors must also be able to test their product
against any networking or HIE that exists in the purchasers
environment.
Implementation, however, is more than buying a good, a certified
HIT product, that has the capacity to use uniform contemporary
terminologies and classifications. Implementation requires careful
planning, work flow and other administrative changes, new ways of doing
business for the clinicians, patients, and the other professionals and
administrative persons involved, and on-going maintenance and education
after implementation has occurred. If successful implementation of a
standard EHR and HIE is going to be accomplished across this country, a
workforce of educated and trained health information management and
informatics professionals must be present and available to the
organizations, physician practices, and other entities involved with
implementing these systems et al. The Science and Technology Committee
took significant steps to address this need in passing H.R. 1467, and
we hope that the Senate will soon pass complementary legislation.
Questions submitted by Representative Ralph M. Hall
Q1. How could an inter-operable HIT system better enable practicing
physicians to keep up-to-date on the latest medical treatments and
diagnosis procedures? How could inter-operable HIT systems support
decision-making by practicing physicians and other health care
providers?
A1. AHIMA would interpret ``inter-operable'' in this question to mean
uniform and consistent use of contemporary medical terminologies and
classifications as well as the adoption of a standard EHR and networked
health information exchange (HIE).
If the medical community is capable of reporting findings and
questions in the same uniform and consistent language, then a variety
of public and private organizations, including the CDC, AHRQ, NIH, NLM,
and various private foundations and medical research organizations, can
respond with what is known regarding a particular disease or problem
and provide guidelines for how to respond.
Currently, the language of medicine in the U.S. is not consistent
or uniform which limits communication both to asking the question as
well as providing an answer. The ability to use either uniform
terminologies to exchange the actual health record, or classifications
to identify diagnoses, procedures, and technology, must be detailed,
and the ability to transmit such information uniformly then permits the
use of computer technology to scan information and provide links to
potential responses or experts. Today, most communication is visual and
the data is limited, therefore reducing the ability and increasing the
time to search the vast body of knowledge available. Time is a very
important factor with physicians, both in the time they have available
and the timely needs for information as they are treating individuals
and reporting key information for population health purposes, research
and so on.
Q2. To encourage the rapid adoption of HIT systems by health care
providers, it is important to guard against failures of implementation,
which would reduce confidence in the benefits of HIT systems and make
other providers reluctant to invest in them. How will technical
testbeds for testing HIT products help prevent implementation failures?
What other actions can reduce the risk of implementation failures?
A2. The technical test beds discussed in AHIMA's testimony were
recommended to allow for certification of HIT products to ensure the
purchaser that the product: included applicable, adopted (HITSP/AHIC)
standards; provided the capability for inter-operability; and possessed
the capability to be upgraded as the industry upgrades its standards,
systems and system requirements, and so forth.
HIT vendors must have their own test beds to ensure their products
meet the industry and customer demands, and some of this testing could
use the same technical test beds suggested for development by NIST and
harmonization by HITSP. Vendors must also be able to test their product
against any networking or HIE that exists in the purchasers
environment.
Implementation, however, is more than buying a good, a certified
HIT product, that has the capacity to use uniform contemporary
terminologies and classifications. Implementation requires careful
planning, work flow and other administrative changes, new ways of doing
business for the clinicians, patients, and the other professionals and
administrative persons involved, and on-going maintenance and education
after implementation has occurred. If successful implementation of a
standard EHR and HIE is going to be accomplished across this country, a
workforce of educated and trained health information management and
informatics professionals must be present and available to the
organizations, physician practices, and other entities involved with
implementing these systems et al. The Science and Technology Committee
took significant steps to address this need in passing H.R. 1467, and
we hope that the Senate will soon pass complementary legislation.
Answers to Post-Hearing Questions
Responses by Michael Raymer, Vice President and General Manager, Global
Product Strategy, GE Healthcare Integrated IT Solutions
Questions submitted by Chairman Bart Gordon
Q1. How should NIST interact with the Healthcare Information
Technology Standards Panel (HITSP), and in what ways would that
interaction further the rapid adoption of consensus technical standards
for health care IT (HIT)?
A1. Interaction between NIST and HITSP is already occurring. Two areas
that could enhance this interaction to accelerate adoption of standards
are:
1. Utilize NIST's experience in security standards technology,
e.g., role based access controls.
2. Leverage NIST to enforce the harmonization of a single set
of test tools it has championed through its private sector
collaboration with Integrating the Healthcare Enterprise (IHE).
NIST has already played a key role in providing test tools/
methodologies to test conformance of HITSP standards.
Q2. How would a fully inter-operable HIT system within the Federal
Government advance the adoption of HIT in the private sector?
A2. A fully inter-operable HIT system within the Federal Government
would be a positive step forward if it would encourage further adoption
of the HITSP specifications. This is important because it helps drive
harmonization of standards throughout all of health care (public and
private) and it would ensure the positive momentum that HITSP has
encouraged the last two years. Additionally, use of the HITSP
specifications would enable improved inter-operability between the VA
and the DOD HIT systems.
Q3. American patients are very concerned that HIT systems must protect
the confidentiality of their personal medical information. How has NIST
contributed to the security of HIT systems to date, and what further
contributions could it make to ensuring patient confidentiality?
A3. As we noted in our testimony, NIST is widely recognized for its
expertise in security standards, most notably role-based access control
standards and associated policy and processes for its implementation.
This technology has been widely used in just about every economic
sector, and NIST has helped champion its usage in the health care
sector. In addition, NIST championed the development of the
infrastructure standards identified by HITSP to enable secure exchange
of health information in the Nationwide Health Information Network.
NIST's collaborative involvement with IHE in developing these health
information exchange standards has accelerated the ability to securely
exchange health information not only in the U.S., but in health
information exchange projects globally. The global use of these
standards helps enable commerce and national security by promoting
common standards to support clinical research and enable health
information sharing for pandemic surveillance.
Questions submitted by Representative Ralph M. Hall
Q1. I understand that the Administration supported establishment of a
health IT standards harmonization process in 2006 through the
Healthcare Information Technology Standards Panel (HITSP) which has
made considerable progress over the past two years in the development
and harmonization of data and technical standards for inter-operable
health information exchange. How do you see this bill building on the
current standards harmonization process through the HITSP?
A1. The bill would allow NIST to help existing collaborative efforts by
using its subject matter expertise in areas such as testing and
security standards development to accelerate the implementation of HIT
standards in the private sector. It is critical to ensure that NIST
support the positive momentum of multi-stakeholder efforts such as
HITSP. Lending its expertise in the promulgation of security standards,
working collaboratively with HITSP, would be a positive step.
Q2. In August 2006, the President issued Executive Order 13410, which
requires federal agencies to utilize, where available, health
information technology systems and products that meet inter-operability
standards recognized by the Secretary of Health and Human Services. The
American Health Information Community (AHIC) has recommended several
sets of standards that HITSP has developed or harmonized. How do you
feel this bill would affect that process, given HHS' expertise in
health IT standards?
A2. For clarification, AHIC does not and did not recommend standards.
Rather, AHIC provided areas of health care delivery that could be
greatly improved through the use of HIT. Once these delivery scenarios
(i.e., use-cases) were identified, HITSP then identified the standards
necessary for HIT systems to enable these new ``use-cases.'' NIST does
not have the expertise to determine what use-cases would impact U.S.
health care. Nor does NIST have expertise in the health care-specific
standards needed, including vocabulary and terminology standards.
Therefore, the bill would not and should not affect those areas
relating to health care delivery use-case prioritization or the health
care specific standards related to their implementation. However, there
are specific areas, such as security standards, information exchange
infrastructure standards, and related testing tools/resource expertise
that NIST provides. NIST also provides a culture of collaboration with
the private sector that would benefit the health care sector.
Answers to Post-Hearing Questions
Responses by Justin T. Barnes, Vice President of Marketing, Corporate
Development and Government Affairs, Greenway Medical
Technologies, Inc.
Questions submitted by Chairman Bart Gordon
Q1. How are the economic incentives for investment in health care IT
(HIT) systems different for small versus large health care providers?
A1. Economic incentives tend to be more valuable for smaller physician
group practices than larger physician group practices. The relative
cost of HIT adoption is greater for a small practice because the costs
are not shared by as many providers and stakeholders. In larger
physician group practices, the cost of HIT adoption is usually shared
over a greater number of providers and stakeholders, thus the ``per
provider'' cost is lower.
Q2. Can small practitioners expect a financial return on their
investment in HIT systems in the same timeframe as large hospitals and
large practices?
A2. For the most part, yes. Smaller physician practices can expect a
return on investment (ROI) from their HIT implementation in similar
timeframes as larger practices. It may take an extra few months for
smaller practices but in overall, both groups realize the ROI benefits
6-12 months after implementation. Sometimes even sooner if the practice
thoroughly researched products and purchased an integrated and inter-
operable electronic health record (EHR) that was proven to perform well
in their specialty. This is a very, very important factor in
recognizing ROI from HIT and EHRs.
Q3. How could an inter-operable HIT system better enable practicing
physicians to keep up-to-date on the latest medical treatments and
diagnosis procedures?
A3. Many of the leading HIT and EHR solutions today automatically
receive regular updates electronically that keep treatments, protocols,
procedures and coding updated. These updates are automatically
integrated seamlessly into HIT and EHR work flows and are added
monthly, quarterly, semi-annually or annually based on practice
preferences.
Q4. How could inter-operable HIT systems support decision-making by
practicing physicians and other health care providers?
A4. Many of the leading HIT and EHR solutions today have financial and
clinical decision support tools and modules integrated into their
functionality. Practices, colleagues, peers and medical associations
can all share treatment protocols, best practices and much more to
increase care quality through the utilization of inter-operable HIT and
EHRs.
Q5. How would a fully inter-operable HIT system within the Federal
Government advance the adoption of HIT in the private sector?
A5. Not sure it would unless it was referenced as an example or ``best
practice'' on increasing care quality, saving lives and decreasing
costs. If those were shown to be proven factors of a Federal Government
HIT system, then it should lead the private sector to adopt and
implement a fully inter-operable HIT system to ascertain those same
results. I feel the issue here is that the Federal Government does not
operate in a similar manner to the private sector so many do not
compare or correlate results and experiences.
Q6. Could you provide us with some examples of the drawbacks of a lack
of coordination of technical standards in the realm of conformance-
testing for HIT systems?
A6. The drawbacks would be significant certainly in the areas of time,
lives and money. Coordination of these efforts will get inter-
operability promulgated much more quickly and therefore we begin
increasing care quality, saving lives and decreasing health care costs
more rapidly. If there is a lack of coordination, it would add on
several more years to achieve full health care industry inter-
operability and therefore unnecessarily reducing care quality, losing
more lives to medical errors and increasing wasteful spending on
duplicative measures.
Questions submitted by Representative Ralph M. Hall
Q1. I understand that the Administration supported establishment of a
health IT standards harmonization process in 2006 through the
Healthcare Information Technology Standards Panel (HITSP) which has
made considerable progress over the past two years in the development
and harmonization of data and technical standards for inter-operable
health information exchange. How do you see this bill building on the
current standards harmonization process through the HITSP?
A1. This bill authorizes NIST, whose primary mission is to promote U.S.
innovation and industrial competitiveness by advancing measurement
science, standards, and technology in ways that enhance economic
security and improve our quality of life, to increase its efforts in
support of the integration of the health care information enterprise in
the United States. NIST has a successful history of collaboration with
Health Information Technology Standards Panel (HITSP) and Integrating
the Healthcare Enterprise (IHE) and that role should be maintained.
This bill further encourages this collaboration to make these
initiatives even more effective, efficient and comprehensive.
Q2. In August 2006, the President issued Executive Order 13410, which
requires federal agencies to utilize, where available, health
information technology systems and products that meet inter-operability
standards recognized by the Secretary of Health and Human Services. The
American Health Information Community (AHIC) has recommended several
sets of standards that HITSP has developed or harmonized. How do you
feel this bill would affect that process, given HHS' expertise in
health IT standards?
A2. This bill could negatively affect HITSP progress if NIST was
authorized to lead any health care standards-creating, setting or
harmonizing processes. Additionally, if this bill authorized the
creation of any alternative health care standards outside of the HITSP
process, that would be confusing and distracting to our current
industry progress. It is best that NIST plays a supporting role in
health care standards and continues their important collaboration with
HITSP.
Appendix 2:
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Additional Material for the Record
Statement of Good Samaritan Hospital
on behalf of the Mid-Nebraska Telemedicine Network
Rural Telehealth Success Story: Mid-Nebraska Telemedicine Network
Provided by Lesley A. Bollwitt-Maria, MPA
Director, Grants & Special Projects
Good Samaritan Hospital Foundation
Kearney, Nebraska
Mr. Chairman and Members of the Committee, thank you for this
opportunity to provide testimony in support of the use of health
information technology to enhance access to health care services.
My name is Lesley A. Bollwitt-Maria, and I am Director of Grants &
Special Projects with Good Samaritan Hospital in Kearney, Nebraska. One
of my primary objectives over the last seven years has been to assist
with the expansion and enhancement of the services provided through
Good Samaritan's Mid-Nebraska Telemedicine Network.
Organizational Description
Good Samaritan Hospital (GSH) located in Kearney, Nebraska is a
not-for-profit, 501 (c) 3, health care system affiliated with Catholic
Health Initiatives of Denver, Colorado, a faith-based organization.
Good Samaritan, a U.S. Designated Regional Referral Center, is a two-
hospital system serving approximately 350,000 people throughout central
and western Nebraska, northern Kansas and northwestern Colorado. The
overall service area encompasses a region approximately the size of the
State of Indiana. Good Samaritan is one of only three American College
of Surgeons accredited Level II Trauma Centers in Nebraska.
Good Samaritan serves as the hub facility for a thirteen member
Critical Access Hospital Network and for the Mid-Nebraska Telemedicine
Network, a Telehealth network including twenty-two rural hospitals
located in both Kansas and Nebraska. Good Samaritan Hospital is also
one of the founding members of the Nebraska Telehealth Network, a
project connecting every hospital and public health department in the
State of Nebraska for telehealth services.
Members of the Sisters of St. Francis of Colorado Springs
established Good Samaritan Hospital in 1924. Now licensed for 207 beds,
Good Samaritan Hospital (GSH) is the largest regional referral center
between Lincoln, Nebraska and Denver, Colorado. In addition, in 1987
Good Samaritan purchased Richard Young Hospital, an 80-bed behavioral
health hospital also located in Kearney that provides care for
children, adolescents and adults. Established in 1981, the Good
Samaritan Hospital Foundation directs all fund-raising activities for
the health system.
The Mission of Good Samaritan and Catholic Health Initiatives is to
nurture the healing ministry of the Church by bringing it new life,
energy and viability in the 21st century. Fidelity to the Gospel urges
us to emphasize human dignity and social justice as we move toward the
creation of healthier communities.
Defining the Problem: Increasing Access to Health Care
Rural communities across the State of Nebraska are faced with the
challenge of providing access for all citizens to quality health care
services. Numerous barriers exist which make this challenge even more
daunting. These barriers often include: distance to specialty health
care services, hazardous driving conditions due to harsh Nebraska
winter weather, lack of a state-wide public transportation system,
increased poverty for rural citizens resulting from the struggling farm
economy, the increasing age of patients and the crisis level shortage
of health care professions.
According to the Nebraska Rural Health Plan for the Critical Access
Hospital Program (2002), the rural health care system exists in a
fragile environment. Rural Nebraska faces many challenges, including a
loss of population in some areas, a growing number of uninsured and
under-insured, and an increase in the Medicare and Medicaid
populations. Given the lack of employment opportunities and the rising
cost of health care these trends are likely to worsen over the next few
years.
Additionally, the report indicated that about 19 percent of the
state's population must travel for thirty minutes or more to visit a
doctor. In rural areas, this travel time significantly increases when
that doctor needed becomes a specialist. The distance of the rural
communities from a tertiary care center can represent travel time of
one to three hours one way. Travel also becomes more difficult as the
populations of these rural communities age. The total percent of
individuals over the age of 65 for the state averages 13.6 percent;
however, in the rural areas, like central Nebraska, this percentage
jumps to 21 percent. In most cases, a family member must accompany an
elderly individual to their doctor's appointment in a larger community
like Omaha, resulting in missed time away from work and family. This
travel time becomes increasingly more difficult when the weather is
bad.
Improving Health Care Access Through Technology
The use of technology to improve access to health care services in
Nebraska is not new. Actually, Nebraska has the distinction of
introducing the world to the concept of using video-conferencing for
clinical applications. Leaders in the field of telemedicine/telehealth
suggest that the current state of technology is moving from its second
generation into its third. The ``first generation'' can be traced as
far back as the 1950s. One of the earliest uses was at the University
of Nebraska where psychiatric consultations were conducted on two-way
closed circuit TV using microwave technologies.
Established in 1994, the Mid-Nebraska Telemedicine Network is an
interactive video and data network. The major functions of the Network
are to improve quality and access to care, particularly in rural
Nebraska and Kansas, to provide patient, provider and community
education and to provide another communication source in the event of a
natural, man-made or terrorist emergency.
The Mid-Nebraska Telemedicine Network has the distinction of being
one of the longest federally funded telehealth networks in the county
with funding beginning in 1994 and continuing through today. The
network was just awarded its third USDA/RUS DLT grant so funding will
continue beyond 2007. Funding has been received through the Office of
Rural Health Policy, Office for the Advancement of Telehealth (OAT) and
the USDA/RUS DLT grant programs. These federal dollars have been put to
successful use in improving access to health care services in rural
areas, like Nebraska and Kansas. Since becoming fully functioning in
December 1995, the network has totaled over 11,000 Patient Encounters,
30,000 Teleradiology, and 3,000 Educational Programs.
Statement of Experience
The Mid-Nebraska Telemedicine Network (MNTN) became operational in
December 1995 as a result of a start-up grant through the Office of
Rural Health Policy. The network included the hub site of Good
Samaritan Hospital (Kearney) and five rural network members consisting
of Tri-Valley Hospital (Cambridge), Cozad Community Hospital (Cozad),
Callaway District Hospital (Callaway), Jennie M. Melham Memorial
Medical Center (Broken Bow) and the Sargent Hospital (Sargent),
Nebraska.
In October 1997, the Good Samaritan Hospital Foundation received a
second grant through the Office of Rural Health Policy. Through this
second grant award, the MNTN expanded its services to include five
additional rural hospitals located in Rock County Hospital (Bassett),
Dundy County Hospital (Benkelman), Valley County Hospital (Ord),
Phillips County Hospital (Phillipsburg, KS), Norton County Hospital
(Norton, KS). In 1999 the Sargent District Hospital closed and
Gothenburg Memorial Hospital (Gothenburg) took its place.
In August 2000, the Office of Rural Health Policy awarded a third
grant. Through this third grant, the Mid-Nebraska Telemedicine Network
expanded its services to include the two additional rural hospitals of
Franklin County Memorial Hospital (Franklin) and the Chase County
Hospital (Imperial).
In September 2004, the Good Samaritan Hospital Foundation received
notification that the MNTN was awarded a congressionally mandated
grant. Through this funding, six additional sites were added to the
network. These sites included: Kearney County Community Hospital
(Minden), Webster County Hospital (Red Cloud), St. Anthony's Hospital
(O'Neill), Jewell County Hospital (Mankato, KS), Brown County Hospital
(Ainsworth, Nebraska) and the Smith County Community Hospital (Smith
Center, KS).
In September 2005, the Good Samaritan Hospital Foundation was
awarded the program's second congressionally mandated grant. Through
this funding, two additional sites were added to the network. These
sites included: Harlan County Health Systems (Alma, Nebraska) and Tri-
County Hospital (Lexington, Nebraska).
The Mid-Nebraska Telemedicine Network has also been a recipient of
funding through the USDA-RUS Distance Learning and Telemedicine grant
program in 2004, 2006 and 2007. Through the 2006 USDA-RUS DLT grant,
two additional rural hospitals were added to the network: Community
Hospital (McCook, Nebraska) and Phelps Memorial Health Center
(Holdrege, Nebraska).
As of 2007, the Mid-Nebraska Telemedicine Network includes one hub
site (Kearney), which includes additional site capabilities in the
education department, telemedicine room, emergency room, Family
Advocacy Network and at the Richard Young Hospital campus, and twenty-
two rural remote sites in both Nebraska and Kansas. Of the MNTN
members, eighteen of the nineteen Nebraska members are certified as
Nebraska Critical Access Hospitals (CAH). The only non-CAH facility is
the hub/end-user site of Good Samaritan Hospital.
The mission of the Mid-Nebraska Telemedicine Network is to use
technology to improve access to quality care by providing consultation
and treatment in both routine and emergency situations, to increase
health-related educational opportunities for providers and the
community, and to provide a venue for health-related administrative
meetings.
System Uses: The Mid-Nebraska Telemedicine Network provides for a wide
variety of uses, including:
Patient consultations including specialty areas
(orthopedics, cardiology, neurology, oncology and others);
Behavioral Health video consultations;
Teleradiology and the transmission of other digitized
clinical images in areas such as cardiology;
Connection to abuse examination and interviewing
(Family Advocacy Network);
Trauma and emergency room care;
Continuing medical education for health care
professionals;
Education leading to licensure or certification of
health care professionals;
Education for emergency services providers;
Administrative meetings;
Support groups and community education programs;
Emergency communications and bioterrorism
preparedness training;
Video medical interpreting services for persons who
do not have English as their first language.
In addition, the Nebraska members of the Mid-Nebraska Telemedicine
Network are also connected into the Nebraska Telehealth Network, which
helps to promote the long-term project sustainability. Good Samaritan,
as a leader in Telehealth activities in Nebraska, has served as the
catalyst for the development of the statewide Telehealth network. The
Nebraska Telehealth Network is an interactive video and data network
that provides integration among the hospitals, public health
departments, public health laboratories and other entities across the
entire State of Nebraska. The major functions of the Network are to
improve quality and access to care, particularly in rural Nebraska, to
provide patient, provider and community education and to provide
another communication source in the event of a natural, man-made or
terrorist emergency.
Advantages of Telehealth
The Mid-Nebraska Telemedicine Network provides value to the
network's users in a number of ways, including the following:
1) The Network improves the access of the public to medical
consultation resources, thus improving the quality of care
available;
2) The Network serves as an aid in the training, retention and
recruitment of the rural health care workforce;
3) The Network provides another avenue for bringing community
education and information to rural Nebraska;
4) The Network, through its ability to help strengthen the
rural health care resources, helps strengthen the local
economy;
5) The Network provides an additional resource in case of an
emergency caused by a man-made, natural or bioterrorist threat
as well as providing another avenue for education on how to
deal with these emergencies;
6) The Network provides an avenue for bringing together
entities in public health, the health care field, education and
government as well as other quasi-public and private agencies
through the participation in the Nebraska Telehealth Network.
As a member of the Nebraska Telehealth Network, members of the Mid-
Nebraska Telemedicine Network has adopted the following project goals.
Project Goals: To bring together the hospitals within the state into a
single connected system that can:
Provide patient clinical consultation;
Offer health care providers continuing education and
professional development as well as advancement opportunities;
Provide an avenue for administrative meetings;
Provide access to Teletrauma and Emergency Mental
Health services via hospital emergency rooms;
Expand access for the hospitals to Nebraska's Public
Health Departments, State Government and State Bioterrorism
Labs in order to facilitate emergency alert capabilities, as
well as educational opportunities pertaining to bioterrorism
acts and other naturally occurring emergencies;
Provide a structure that can bring together resources
beyond just those of health care to create an environment of
sharing of resources throughout the State of Nebraska;
Invite other potential partners in this network,
including education at various levels (elementary through post-
secondary and community education), and various governmental
agencies, whether local, regional, State or national;
Develop an organizational structure that supports
these goals in a cost effective, efficient and sustainable
fashion and addresses the identified critical success factors
involving technical support, hospital and provider training,
scheduling and technology upgrades;
Provide the backbone for the development of a
statewide electronic medical record project through the
Nebraska Medical Association.
Testimony Summary
On behalf of the members of the Mid-Nebraska Telemedicine Network,
thank you for this opportunity to describe the journey that our
organizations have taken down the path of implementing technology to
improve access to health care services in rural America. The success
that our network has had over the past thirteen years is a direct
result of the continued investment by the Federal Government in health
information technology. By providing funding opportunities through
various grant programs, these federal dollars have the opportunity to
work in concert with local matching monies to expand and enhance the
services being offered over telehealth networks, like the Mid-Nebraska
Telemedicine Network and the Nebraska Statewide Telehealth Network. As
a representative of a rural health care provider, Good Samaritan
Hospital, and a rural health care consumer, thank you for your
continued interest and attention to the vital role that health
information technology plays in our health care system.