United States Government Accountability Office

GAO Testimony

Before the Committee on Government Reform, 

House of Representatives 

HEALTH CARE For Release on Delivery 

10:00 a.m. EDT 

September 29, 2005 

Continued Leadership 

Needed to Define and 

Implement Information 

Technology Standards 

Statement of David A. Powner 

Director, Information Technology Management Issues 

GAO-05-1054T
What GAO Found

United States Government Accountability Office

Why GAO Did This Study

Highlights

Accountability Integrity Reliability

September 29, 2005

HEALTH CARE

Continued Leadership Needed to Define

and Implement Information Technology

Standards 

Highlights of GAO-05-1054T, testimony

before the Committee on Government

Reform, House of Representatives 

As GAO reported in 2003, health care data, communications, and security 

standards are necessary to support interoperability between IT systems;

however, the identification and implementation of such standards at that 

time was incomplete across the health care industry. Further, while several

standard setting initiatives were underway, GAO raised concerns about 

coordinating and implementing these initiatives. To address these

coordination and implementation challenges, it recommended that the 

Secretary of Health and Human Services (HHS), among other things, reach 

further consensus across the health care industry on the definition and use 

of standards, establish milestones for defining and implementing these 

standards, and create a mechanism to monitor their implementation

throughout the health care industry. Last summer, GAO testified before your 

technology subcommittee, highlighting progress made in announcing 

additional standards and plans to incorporate standard setting initiatives into 

the Federal Health Architecture. GAO reported that progress in assuming

leadership had occurred with the President’s establishment of the National

Coordinator for Health IT to guide the nationwide implementation of 

interoperable health information systems, but noted that as health IT 

initiatives were pursued, it would be essential to have continued leadership, 

clear direction, measurable goals, and mechanisms to monitor progress. 

In following up on these recommendations, GAO determined that HHS has 

taken several actions that should help to further define standards for the 

health care industry. First, the coordinator has assumed responsibility for 

the Federal Health Architecture that is expected to establish standards for 

interoperability and communication throughout the federal health 

community. Second, several HHS agencies continue their efforts to define 

standards as part of the department's Framework for Strategic Action. For 

example, the Agency for Healthcare Research and Quality is working with 

the private sector to identify standards for clinical messaging, drugs, and 

biological products. Third, HHS expects to award a contract to develop and 

evaluate a process to unify and harmonize industry-wide information 

standards. Fourth, in July of this year, HHS announced plans for a publicprivate committee to help transition the nation to electronic health records 

and to provide input and recommendations on standards. All of these are 

positive steps, however, much work remains to reach further consensus 

across the health care sector on the definition and use of standards. Until

this occurs, federal agencies and others throughout the health care industry 

will not be able to ensure that their systems are capable of exchanging data 

when needed, and consequently will not be able to reap the cost, clinical

care, and public health benefits associated with interoperability. 

Health care delivery in the United

States has long-standing problems 

with medical errors and 

inefficiencies that increase costs. 

Hence, health information 

technology (IT) has great potential

to improve the quality of care, 

bolster preparedness of our public

health infrastructure, and save 

money on administrative costs. The 

threats of natural disasters and 

terrorist attacks further underscore 

the need for interoperable 

information systems, and the 

critical importance of defining and 

implementing standards that would 

enable such interoperability.

GAO has reported on the quality of 

care benefits derived by using IT, 

federal agencies’ existing and 

planned information systems to 

support national preparedness for 

public health emergencies, and the 

status of health IT standards 

settings initiatives. 

The House Committee on 

Government Reform asked GAO to 

summarize (1) its previously issued 

reports and recommendations on

health IT standards and (2) recent 

actions taken by HHS to facilitate

the development of health IT

standards. 

www.gao.gov/cgi-bin/getrpt?GAO-05-1054T.

To view the full product, including the scope 

and methodology, click on the link above.

For more information, contact David Powner 

at (202) 512-9286 or pownerd@gao.gov.
Mr. Chairman and Members of the Committee: 

I am pleased to be here today to discuss the importance of defining 

and implementing standards to speed the adoption of interoperable 

information technology (IT) in the health care industry. It has been 

widely recognized that the use of IT for delivering care, supporting 

the public health infrastructure, and performing administrative 

functions has great potential to improve care, bolster preparedness, 

and save money. Health and Human Service’s Secretary Leavitt 

recently stated that Hurricane Katrina has underscored the need for 

interoperable electronic health records as thousands of people have 

been separated from their health care providers, and medical 

records have been lost. Standards are critical to enabling this 

interoperability. 

At your request, today I will summarize (1) our previously issued 

reports and recommendations on health IT standards and (2) recent 

actions taken by the Department of Health and Human Services

(HHS) to develop health IT standards. In preparing this testimony, 

we summarized our prior reports and updated progress toward 

implementing recommendations in accordance with generally 

accepted auditing standards. 

Results in Brief

We reported in 2003 that the identification and implementation of 

health care data, communications, and security standards—which 

are necessary to support interoperability of IT systems—remained 

incomplete across the health care industry. Further, while several 

standards-setting initiatives were underway, we raised concerns

about the coordination of these initiatives. To address the 

challenges of coordinating and implementing a set of standards, we 

recommended that the Secretary of HHS, among other things, reach 

further consensus on the definition and use of standards, establish 

milestones for their definition and implementation, and create a 

mechanism to monitor their implementation throughout the health

care industry. Following up on our recommendations, last summer 

we testified before your technology subcommittee, highlighting 

progress made in announcing additional standards and plans to

Page 1 GAO-05-1054T
incorporate standard setting initiatives into the federal health

architecture. We also reported that progress in assuming leadership

had occurred with the President’s establishment of the National 

Coordinator for Health IT, but noted that it was essential to have 

continued leadership, clear direction, measurable goals, and 

mechanisms to monitor progress.

In following up on our recommendations, we determined that HHS

has taken several actions that should help to further define 

standards for the health care industry. First, the Office of the 

National Coordinator for Health Information Technology has

assumed responsibility for developing a federal health architecture 

that is expected to, among other things, establish standards for 

interoperability and communication throughout the federal health 

community. Second, several HHS agencies continue to further 

define standards as part of the Framework for Strategic Action. For 

example, the Agency for Healthcare Research and Quality is 

working with the private sector to identify standards for clinical 

messaging, drugs, and biological products. Third, HHS expects to

award a contract to develop and evaluate a process to unify and 

harmonize industry-wide information standards. Fourth, in July of

this year, a public-private committee was formed to help transition 

the nation to electronic health records and to provide input and 

recommendations on the standards and other issues. 

Although the Coordinator has provided needed leadership and 

direction, much work remains to reach further consensus on the 

definition and use of standards. Until this successfully occurs and 

health IT standards are more fully implemented, federal agencies 

and others throughout the health care industry cannot ensure that

their systems will be capable of exchanging data with other systems

when needed, and consequently will not be able to reap the cost, 

clinical care, and public health benefits associated with

interoperability. 

Page 2 GAO-05-1054T
Background 

According to the Institute of Medicine, health care delivery in the 

United States has long-standing problems with medical errors and 

inefficiencies that increase health care costs. The U.S. health care 

delivery system is an information-intensive industry that is complex 

and highly fragmented, with estimated spending of $1.7 trillion in 

2003. Hence, the uses of IT—in delivering clinical care, performing 

administrative functions, and supporting the public health

infrastructure—have the potential to yield both cost savings and 

improvements in the care itself. Information technologies such as

electronic health records (EHR)1 have been shown to save money 

and reduce medical errors. 

Key Standards for Health Care 

IT standards, including data standards, enable the interoperability 

and portability2 of systems within and across organizations. Many 

different standards are required to develop interoperable health 

information systems. This reflects the complex nature of health care 

delivery in the United States.3

Vocabulary standards, which provide common definitions and codes

for medical terms and determine how information will be 

documented for diagnoses and procedures, are an important type of

data standard. These standards are intended to lead to consistent

 

t l :

1

 There is a lack of consensus on what constitutes an EHR, and thus multiple definitions

and names exist for EHRs, depending on the functions included. An EHR generally includes

(1) a longitudinal collection of electronic health information about the health of an

individual or the care provided, (2) immediate electronic access to patient- and populationlevel information by authorized users, (3) decision support to enhance the quality, safety, 

and efficiency of patient care, and (4) support of efficient processes for health care 

delivery. 

2 Interoperability is the ability of two or more systems or components to exchange

information and to use the information that has been exchanged. Portability is the degree

to which a computer program can be transferred from one hardware configuration or

software environment to another. 

3

 GAO, Au omated Medica Records Leadership Needed to Expedite Standards

Development, GAO/IMTEC-93-17 (Washington, D.C.: April 30, 1993). 

Page 3 GAO-05-1054T
descriptions of a patient’s medical condition by all practitioners. 

The use of common terminology helps in the clinical care delivery 

process, enables consistent data analysis from organization to 

organization, and facilitates transmission of information. Without

such standards, the terms used to describe the same diagnoses and 

procedures sometimes vary. For example, the condition known as

hepatitis may also be described as a liver inflammation. The use of

different terms to indicate the same condition or treatment

complicates retrieval and reduces the reliability and consistency of 

data. 

In addition to vocabulary standards, messaging standards are 

important because they provide for the uniform and predictable 

electronic exchange of data by establishing the order and sequence 

of data during transmission. These standards dictate the segments in 

a specific medical transmission. For example, they might require the 

first segment to include the patient’s name, hospital number, and 

birth date. A series of subsequent segments might transmit the 

results of a complete blood count, dictating one result (e.g., iron 

content) per segment. Messaging standards can be adopted to

enable intelligible communication between organizations via the 

Internet or some other communications pathway. Without them, the

interoperability of federal agencies’ systems may be limited and may 

limit the exchange of data that are available for information sharing. 

In addition to vocabulary and messaging standards, there is also the 

need for a high degree of security and confidentiality to protect 

medical information from unauthorized disclosure. 

Need for Standards Has Been Recognized 

The need for heath care standards has been recognized for a number 

of years. The development, approval, and adoption of standards for 

health IT is an ongoing, long-term process and includes federally 

mandated standards requirements and a voluntary consensus 

process within a market-based health care industry. The use of some 

standards, such as those defined by the Health Insurance Portability 

and Accountability Act of 1996 (HIPAA)4

 and the Medicare 

 4

 Public Law 104-191, sec 262 (1996). 

Page 4 GAO-05-1054T
Prescription Drug and Modernization Act of 20035

, is mandated by 

the federal government, while others are defined by standards

development organizations such as the American Association of 

Medical Instrumentation and the National Council for Prescription 

Drug Programs. HHS identifies and researches standards defined by 

the organizations that develop them, and determines which of the 

approved ones are appropriate for use in federal agencies’ health IT 

systems. 

In August 1996, Congress recognized the need for standards to 

improve the Medicare and Medicaid programs in particular and the 

efficiency and effectiveness of the health care system in general. It 

passed HIPAA, which calls for the industry to control the 

distribution and exchange of health care data and begin to adopt

electronic data exchange standards to uniformly and securely 

exchange patient information. According to the National Committee 

on Vital and Health Statistics (NCVHS), significant progress has

occurred on several HIPAA standards, however, the full economic 

benefits of administrative simplification will be realized only when 

all of them are in place.

In 2000 and 2001, the NCVHS reported on the need for standards, 

highlighting the need for uniform standards for patient medical 

record information, and outlining a strategy that included their 

development and use. The Institute of Medicine and others had also 

reported on the lack of national standards for the coding and 

classification of clinical and other health care data, and for the 

secure transmission and sharing of such data.

In 2001, the Office of Management and Budget created the 

Consolidated Health Informatics (CHI) initiative as one of its

e-government projects to facilitate the adoption of data standards

for, among others, health care systems within the federal

government. The CHI initiative was an interagency work group led 

by HHS and composed of representatives from the Departments of

Defense and Veterans Affairs, as well as other agencies. Recognizing 

the need to incorporate standards across federal health care 

 5

 Public Law 108-173 (2003). 

Page 5 GAO-05-1054T
systems, the group announced in March 2003 the adoption of 5, and 

in May 2004 the adoption of another 15. Once federal agencies 

adopted the recommended standards, they were expected to

incorporate them into their architectures and build systems 

accordingly. This expectation applied to all new systems acquisition 

and development projects. 

In April 2004, the President issued an executive order that called for

the establishment of a National Coordinator for Health IT and the 

issuance of a strategic plan to guide the nationwide implementation 

of interoperable health information systems. The National 

Coordinator for Health IT was appointed in May 2004; in July 2004, 

HHS released a framework for strategic action—the first step 

toward a national strategy. The framework defines goals and 

strategies that are to be implemented in three phases. Phase I 

focuses on the development of market institutions6

 to lower the risk

of health IT procurement, phase II involves investment in clinical 

management tools and capabilities, and phase III supports the 

transition of the market to robust quality and performance 

accountability. The framework includes a commitment to standards

and reiterates that a key component of progress towards

interoperable health information systems is the development of 

technically sound interoperability standards.

Actions Needed for Implementation of Health Information 

Technology Standards

In May 2003, we reported that federal agencies recognized the need

for health care standards and were making efforts to strengthen and 

increase their use.7

 However, while they had made progress in 

 

i t t i

l

6

 According to HHS, market institutions include certification organizations, group 

purchasing entities, and low-cost implementation support organizations that do not

currently exist but are necessary to support clinicians as they procure and use IT. 

7

 GAO, Bioterrorism: Informat on Technology Stra egy Could S rengthen Federal Agenc es’ 

Abilities to Respond to Public Hea th Emergencies, GAO-03-139 (Washington, D.C.: May 30, 

2003). 

Page 6 GAO-05-1054T
defining standards, the identification and implementation of data

standards necessary to support interoperability were incomplete

across the health care sector. 

First, agencies lacked mechanisms that could coordinate their 

various efforts so as to accelerate the completion of standards 

development and ensure consensus among stakeholders. The 

process of developing health care data standards involves many 

diverse entities, such as individual and group practices, software 

developers, domain-specific professional associations, and allied 

health services. This fragmentation slowed the dissemination and 

adoption of standards by making it difficult to convene all of the 

relevant stakeholders and subject matter experts in standards 

development meetings and to reach consensus within a reasonable 

period of time. 

Second, not all of the federal government’s standard setting 

initiatives had milestones associated with efforts to define and

implement standards. For example, while the CHI initiative—the 

primary initiative to establish standards for federal health 

programs—had announced several standards and implementation

requirements for health care information exchange, it had not yet 

established milestones for future announcements. 

Finally, there was no mechanism to monitor the implementation of

standards throughout the health care industry. NCVHS had reported 

on a need for a mechanism, such as compliance testing, to ensure 

that health care standards were uniformly adopted as part of a 

national strategy, but without an implementation mechanism and 

leadership at the national level, problems associated with systems’ 

incompatibility and lack of interoperability would persist 

throughout the different levels of government and the private sector 

and, consequently, throughout the health care sector. 

We stated that until these challenges were addressed, agencies 

risked promulgating piecemeal and disparate systems unable to 

exchange data with each other when needed, and that this could 

hinder the prompt and accurate detection of public health threats. 

We recommended that the Secretary of HHS define activities for 

ensuring that the various standards-setting organizations coordinate

Page 7 GAO-05-1054T
their efforts and reach further consensus on the definition and use 

of standards; establish milestones for defining and implementing 

standards; and create a mechanism to monitor the implementation

of standards through the health care industry. 

Following up on our recommendations, we testified in July 2004 on 

HHS’s efforts to identify applicable standards throughout the health

care industry and across federal health care programs.

8

 Progress 

was continuing with the establishment of the National Coordinator 

for Health IT, who, among other things, assumed federal leadership

to expedite the standards development process in order to 

accelerate the use of EHRs. The Coordinator also assumed 

responsibility for identifying standards for federal health programs

as part of the CHI initiative. While plans for the CHI initiative called 

for it to be incorporated into HHS’s Federal Health Architecture9 by 

September 2004, many issues—such as coordination of the various 

standards-setting efforts and implementation of the standards that

had been identified—were still works in progress. We reiterated our 

conclusions that unless these standards were more fully 

implemented, federal agencies and others throughout the health

care industry could not ensure that their systems would be capable 

of exchanging data with other systems when needed. Further, we 

concluded that as federal health IT initiatives moved forward, it 

would be essential to have continued leadership, clear direction, 

measurable goals, and mechanisms to monitor progress.

In June of this year, we issued a report to this committee on the 

challenges faced by federal agencies in implementing the public 

health infrastructure.10 We reported that, among others, HHS’s

Centers for Disease Control and Prevention and the Department of 

 i t t i

l

I f i l i i

8

 GAO, Health Care: Nat onal Stra egy Needed to Accelerate the Implemen at on of

Information Techno ogy, GAO-04-947T (Washington, D.C.: July 14, 2004). 

9

 FHA was initiated in 2003 in HHS’s Office of the Chief Information Officer. It is intended 

to provide a structure for bringing HHS’s divisions and other federal departments together,

initially targeting standards for enabling interoperability. The FHA program is supported by

four advisory work groups. 

10 GAO, n ormat on Technology: Federa Agenc es Face Challenges in Implement ng

Initiatives to Improve Public Health Infrastructure, GAO-05-308 (Washington, D.C.: June10, 

2005). 

Page 8 GAO-05-1054T
Homeland Security faced challenges developing and adopting 

consistent standards to encourage interoperability of public health 

initiatives. 

Recent Actions Taken by HHS to Develop Health Information 

Technology Standards

Following up on our recommendations, we reported in May 2005 

that HHS was working towards a national strategy for health IT that 

called for a sustained set of actions to help to further define 

standards for the health care industry. The Office of the National 

Coordinator for Health IT is now responsible for the FHA program,

which is to provide the structure or “architecture” for collaboration 

and interoperability among federal health efforts. FHA partners are 

responsible for improving coordination and collaboration on federal 

health IT investments and improving efficiency, standardization, 

reliability, and availability of comprehensive health information 

solutions. This fall, HHS plans to produce the first release of an 

information architecture for the federal health enterprise. This 

release will contain foundational elements to support the 

development and evolution of the full architecture, which will occur 

over several years. In addition, the CHI activities are now moving 

forward under the FHA. HHS, through the CHI initiative, is 

encouraging the implementation of standards within the federal 

government to order to catalyze private sector action in this area. 

Progress towards achieving standards and policies is a key 

component of progress toward the implementation of a national 

strategy that provides interoperable health IT systems. 

The framework also builds upon already existing work in HHS 

divisions and includes plans to identify and learn from agencies’ 

experiences. HHS divisions have been and continue to be 

responsible for selecting and adopting standards. Among other 

activities:

• The Agency for Healthcare Research and Quality is working to 

identify and establish clinical standards and research to help 

accelerate the adoption of interoperable health IT systems,

Page 9 GAO-05-1054T
including industry clinical messaging and terminology standards,

national standard nomenclature for drugs and biological 

products, and standards related to clinical terminology. 

• The Centers for Medicare and Medicaid are responsible for 

identifying and adopting standards for e-prescribing and for 

implementing the administrative simplification provisions of

HIPAA, including electronic transactions and code sets, security, 

and identifiers. 

• The National Institutes of Health’s National Library of Medicine 

is working on the implementation of standard clinical 

vocabularies, including support for and development of selected 

standard clinical vocabularies to enable ongoing maintenance 

and free use within the United States’ health communities, both 

private and public. In 2003, the National Library of Medicine 

obtained a perpetual license for the Systematized Nomenclature 

of Medicine (SNOMED)11 standard and ongoing updates, making 

SNOMED available to U.S. users. Other efforts at the National 

Library of Medicine include the uniform distribution and 

mapping of HIPAA code sets, standard vocabularies, and Health

Level 712 code sets. 

• The Centers for Disease Control and Prevention, through its

Public Health Information Network initiative, is working on the 

development of shared data models, data standards, and 

controlled vocabularies for electronic laboratory reporting and 

public health information exchange that are compatible with

federal standards activities such as CHI. 

• The Food and Drug Administration and the National Institutes of

Health, together with the Clinical Data Interchange Standards 

Consortium (a group of over 40 pharmaceutical companies and 

clinical research organizations), have developed a standard for 

representing observations made in clinical trials—the Study 

Data Tabulation Model.

 11 SNOMED is a nomenclature classification for indexing medical vocabulary, including

signs, symptoms, diagnoses, and procedures. It was adopted as a CHI standard in May 2004. 

12 HL7 is a standards development organization that creates message format standards for

electronic exchange of health information 

Page 10 GAO-05-1054T
HHS expects to award a contract to develop and evaluate a process 

to unify and harmonize industry-wide information standards. In June 

2005, HHS issued four requests for proposals (RFPs).13 The 

department also expects to award contracts based on these 

proposals by October 2005. The proposals focus on four areas, 

including the development of a process to unify and harmonize 

industry-wide health information standards development,

maintenance and refinements over time. The standards-focused RFP

states that the current landscape of standards does not ensure 

interoperability due to many factors such as conflicting and 

incomplete standards. The other RFPs include (1) the development 

of a certification process for health IT to assure consistency with

standards, (2) the development of prototypes for a nationwide 

health information network architecture for widespread health 

information exchange, and (3) an assessment of variations in

organization-level business policies and state laws that affect 

privacy and security practices. 

In addition, in July of this year, HHS announced plans for a publicprivate committee—known as the American Health Information 

Community—to help transition the nation to electronic health

records and to provide input and recommendations on standards.

Chaired by the Secretary of HHS, it will provide input and 

recommendations on use of common standards and how 

interoperability among EHRs can be achieved while assuring that 

the privacy and security of those records are protected. HHS is also 

working with other private sector groups to develop standards and 

certification requirements for EHR functionality in order to reduce 

the risk of implementation failure. 

The importance of a national health information network that

integrates interoperable databases was just recently highlighted 

when the Office of the National Coordinator for Health IT facilitated 

the rapid development of a Web-base portal to access prescription 

information for Katrina evacuees. This online service is to allow 

authorized health professionals to access medication and dosage 

 13 In November 2004, HHS issued a request for information seeking public input and ideas

for developing a national health information network and received over 500 responses. 

Page 11 GAO-05-1054T
information from anywhere in the country. A broad group of

commercial pharmacies, government health insurance programs 

such as Medicaid, private insurers, and others compiled and made 

accessible the prescription data. Although the scope of this effort is 

much smaller than the national network and comprehensive EHRs

(which contain much more than prescription information) 

envisioned, it demonstrates the need called for by the President. 

In summary, identifying and implementing health IT standards is 

essential to achieving interoperable systems and data in the health 

care industry and is critical in the pursuit of effective EHRs and 

public health systems. Although federal leadership has been 

established and plans and several actions have positioned HHS to 

further define and implement relevant standards, consensus on the 

definition and use of standards still needs to occur. Otherwise, the 

health care industry will continue to be plagued with incompatible 

systems that are incapable of exchanging key data that is critical to 

delivering care and responding to public health emergencies. HHS 

needs to provide continued leadership, sustained focus and 

attention, and mechanisms to monitor progress in order to bring 

about measurable improvements and achieve the President’s goals.

Mr. Chairman, this concludes my statement. I would be happy to

answer any questions that you or members of the committee may 

have at this time. 

Contacts and Acknowledgements 

If you should have any questions about this testimony, please 

contact me at (202) 512-9286 or by e-mail at powderd@gao.gov. 

Other individuals who made key contributions to this testimony are 

M. Yvonne Sanchez, Assistant Director, and Amos Tevelow. 

Page 12 GAO-05-1054T

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