Health Care: Continued Leadership Needed to Define and Implement 
Information Technology Standards (29-SEP-05, GAO-05-1054T).	 
                                                                 
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.				 
-------------------------Indexing Terms------------------------- 
REPORTNUM:   GAO-05-1054T					        
    ACCNO:   A38880						        
  TITLE:     Health Care: Continued Leadership Needed to Define and   
Implement Information Technology Standards			 
     DATE:   09/29/2005 
  SUBJECT:   Accountability					 
	     Information technology				 
	     Interagency relations				 
	     Interoperability					 
	     IT standards					 
	     Medical information systems			 
	     Standards						 
	     Strategic planning 				 
	     Quality-of-care					 

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GAO-05-1054T

United States Government Accountability Office

GAO Testimony

Before the Committee on Government Reform, House of Representatives

For Release on Delivery 10:00 a.m. EDT

September 29, 2005 HEALTH CARE

Continued Leadership Needed to Define and Implement Information Technology
                                   Standards

Statement of David A. Powner
Director, Information Technology Management Issues

GAO-05-1054T

September 29, 2005

HEALTH CARE

Continued Leadership Needed to Define and Implement Information Technology
Standards

What GAO Found

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 FrameworkforStrategicAction.
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.

                 United States Government Accountability Office

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

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 forStrategic 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.

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

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 Interoperabilityis the ability of two or more systems or components to
exchange information and to use the information that has been exchanged.
Portabilityis the degree to which a computer program can be transferred
from one hardware configuration or software environment to another.

3 GAO, Automated MedicalRecords:LeadershipNeeded toExpediteStandards
Development, GAO/IMTEC-93-17 (Washington, D.C.: April 30, 1993).

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

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: Information TechnologyStrategyCould
StrengthenFederalAgencies' AbilitiestoRespondtoPublicHealthEmergencies,
GAO-03-139 (Washington, D.C.: May 30, 2003).

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

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

8 GAO, HealthCare: NationalStrategyNeeded toAccelerate the Implementation
of InformationTechnology, 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, Information Technology:FederalAgenciesFaceChallengesinImplementing
InitiativestoImprovePublicHealthInfrastructure, GAO-05-308 (Washington,
D.C.: June10, 2005).

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:

o 	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,

including industry clinical messaging and terminology standards, national
standard nomenclature for drugs and biological products, and standards
related to clinical terminology.

o 	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.

o 	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.

o 	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.

o 	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

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.

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 [email protected]. Other individuals who
made key contributions to this testimony are M. Yvonne Sanchez, Assistant
Director, and Amos Tevelow.

(310803)

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