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37–983PS 2008

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

(II)

COMMITTEE ON SCIENCE AND TECHNOLOGY

HON. BART GORDON, Tennessee, Chairman

JERRY F. COSTELLO, Illinois

EDDIE BERNICE JOHNSON, Texas

LYNN C. WOOLSEY, California

MARK UDALL, Colorado

DAVID WU, Oregon

BRIAN BAIRD, Washington

BRAD MILLER, North Carolina

DANIEL LIPINSKI, Illinois

NICK LAMPSON, Texas

GABRIELLE GIFFORDS, Arizona

JERRY MCNERNEY, California

LAURA RICHARDSON, California

PAUL KANJORSKI, Pennsylvania

DARLENE HOOLEY, Oregon

STEVEN R. ROTHMAN, New Jersey

JIM MATHESON, Utah

MIKE ROSS, Arkansas

BEN CHANDLER, Kentucky

RUSS CARNAHAN, Missouri

CHARLIE MELANCON, Louisiana

BARON P. HILL, Indiana

HARRY E. MITCHELL, Arizona

CHARLES A. WILSON, Ohio

RALPH M. HALL, Texas

F. JAMES SENSENBRENNER JR.,

Wisconsin

LAMAR S. SMITH, Texas

DANA ROHRABACHER, California

ROSCOE G. BARTLETT, Maryland

VERNON J. EHLERS, Michigan

FRANK D. LUCAS, Oklahoma

JUDY BIGGERT, Illinois

W. TODD AKIN, Missouri

JO BONNER, Alabama

TOM FEENEY, Florida

RANDY NEUGEBAUER, Texas

BOB INGLIS, South Carolina

DAVID G. REICHERT, Washington

MICHAEL T. MCCAUL, Texas

MARIO DIAZ-BALART, Florida

PHIL GINGREY, Georgia

BRIAN P. BILBRAY, California

ADRIAN SMITH, Nebraska

PAUL C. BROUN, Georgia

(III)

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, YaleNew 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

Page

IV

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, YaleNew 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

(1)

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.

2

3

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 sysVerDate 11-MAY-2000 21:49 Feb 22, 2008 Jkt 037983 PO 00000 Frm 00007 Fmt 6633 Sfmt 6621 C:\WORKD\FULL07\092607\37983 SCIENCE1 PsN: SCIENCE1
4

tems 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 standVerDate 11-MAY-2000 21:49 Feb 22, 2008 Jkt 037983 PO 00000 Frm 00008 Fmt 6633 Sfmt 6621 C:\WORKD\FULL07\092607\37983 SCIENCE1 PsN: SCIENCE1
5

ards 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 costeffective 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 Interoperable 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

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 interoperability 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.

7

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 docVerDate 11-MAY-2000 21:49 Feb 22, 2008 Jkt 037983 PO 00000 Frm 00011 Fmt 6633 Sfmt 6601 C:\WORKD\FULL07\092607\37983 SCIENCE1 PsN: SCIENCE1
8

tors. 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

9

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.

10

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 interoperable 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

11

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

12

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

13

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 techVerDate 11-MAY-2000 21:49 Feb 22, 2008 Jkt 037983 PO 00000 Frm 00017 Fmt 6633 Sfmt 6601 C:\WORKD\FULL07\092607\37983 SCIENCE1 PsN: SCIENCE1
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nology 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.

15

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 interVerDate 11-MAY-2000 21:49 Feb 22, 2008 Jkt 037983 PO 00000 Frm 00019 Fmt 6633 Sfmt 6601 C:\WORKD\FULL07\092607\37983 SCIENCE1 PsN: SCIENCE1
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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

17

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

18

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.

19

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 interoperability 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 paVerDate 11-MAY-2000 21:49 Feb 22, 2008 Jkt 037983 PO 00000 Frm 00023 Fmt 6633 Sfmt 6601 C:\WORKD\FULL07\092607\37983 SCIENCE1 PsN: SCIENCE1
20

tients. 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.

21

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

22

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 interoperability 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

23

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

24

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

25

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.

26

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.

27

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.

28

• 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 interoperability 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,

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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.

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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 StandVerDate 11-MAY-2000 21:49 Feb 22, 2008 Jkt 037983 PO 00000 Frm 00034 Fmt 6633 Sfmt 6601 C:\WORKD\FULL07\092607\37983 SCIENCE1 PsN: SCIENCE1
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ards 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.

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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?

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• 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 eprescribing, 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

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• 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 interoperability 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.

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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.

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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.

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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.

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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.

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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.

49

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:]

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1The EHRVA inter-operability roadmap can be found at http://www.himssehrva.org

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 interoperability, 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

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

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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

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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 costsavings 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-forperformance program.

2. Harmonization of security standards and practices, especially with respect to the ‘‘four As’’ identified by HISPC (authentication, authorization,

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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® CarecastΤΜ 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

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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-,

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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

56

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

57

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

58

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.

59

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.

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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 healthinformation 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.

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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 coordinaVerDate 11-MAY-2000 21:49 Feb 22, 2008 Jkt 037983 PO 00000 Frm 00065 Fmt 6633 Sfmt 6601 C:\WORKD\FULL07\092607\37983 SCIENCE1 PsN: SCIENCE1
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tion 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 reVerDate 11-MAY-2000 21:49 Feb 22, 2008 Jkt 037983 PO 00000 Frm 00066 Fmt 6633 Sfmt 6601 C:\WORKD\FULL07\092607\37983 SCIENCE1 PsN: SCIENCE1
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lated, 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

64

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 nonNIST-oriented question. In a field hearing and in roundtables that

we held on this topic, in addition to the challenge of inter-operVerDate 11-MAY-2000 21:49 Feb 22, 2008 Jkt 037983 PO 00000 Frm 00068 Fmt 6633 Sfmt 6601 C:\WORKD\FULL07\092607\37983 SCIENCE1 PsN: SCIENCE1
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ability 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 physicianVerDate 11-MAY-2000 21:49 Feb 22, 2008 Jkt 037983 PO 00000 Frm 00069 Fmt 6633 Sfmt 6601 C:\WORKD\FULL07\092607\37983 SCIENCE1 PsN: SCIENCE1
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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 housecall 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

67

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

68

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 nondiscrimination 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.

69

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.

70

And with that, the hearing stands adjourned. Thank you all very

much.

[Whereupon, at 12:15 p.m., the Committee was adjourned.]

(71)

Appendix 1:

ANSWERS TO POST-HEARING QUESTIONS

72

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 interoperability 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?

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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

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(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.

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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?

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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

77

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.

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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.

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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

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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 ‘‘usecases.’’ 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.

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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.

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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.

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Appendix 2:

ADDITIONAL MATERIAL FOR THE RECORD

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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

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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,

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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

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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

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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.

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