Health Care
Continued Leadership Needed to Define and Implement Information Technology Standards Gao ID: GAO-05-1054T September 29, 2005Health 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.
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 the House Committee on Government Reform's 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 public-private 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.
GAO-05-1054T, Health Care: Continued Leadership Needed to Define and Implement Information Technology Standards
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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:
GAO Highlights:
Highlights of GAO-05-1054T, testimony before the Committee on
Government Reform, House of Representatives:
Why GAO Did This Study:
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.
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 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 public-private 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.
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.
[End of section]
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 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.
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)[Footnote 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
portability[Footnote 2] 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.[Footnote 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 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)[Footnote 4] and the Medicare Prescription Drug and
Modernization Act of 2003[Footnote 5], 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 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 institutions[Footnote 6] 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.[Footnote 7] However, while they had made progress
in 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.[Footnote 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 Architecture[Footnote 9] 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.[Footnote 10] We reported that, among others, HHS's
Centers for Disease Control and Prevention and the Department of
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, 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)[Footnote 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 7[Footnote 12] 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.
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)[Footnote 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 public-
private 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 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.
FOOTNOTES
[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 population-level 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, Automated Medical Records: Leadership Needed to Expedite
Standards Development, GAO/IMTEC-93-17 (Washington, D.C.: April 30,
1993).
[4] Public Law 104-191, sec 262 (1996).
[5] Public Law 108-173 (2003).
[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 Technology Strategy Could Strengthen
Federal Agencies' Abilities to Respond to Public Health Emergencies,
GAO-03-139 (Washington, D.C.: May 30, 2003).
[8] GAO, Health Care: National Strategy Needed to Accelerate the
Implementation of Information Technology, 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: Federal Agencies Face Challenges in
Implementing Initiatives to Improve Public Health Infrastructure, GAO-
05-308 (Washington, D.C.: June10, 2005).
[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
[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.
