Health Care: Continued Leadership Needed to Define and Implement Information Technology Standards
Published: 2005-09-29T00:00:00

Fast Facts:

Highlights:
section_title: Why GAO Did This Study
paragraphs: 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.
section_title: What GAO Found
paragraphs: 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.

section_title: Letter
paragraphs: 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.
subsections: section_title: Background
paragraphs: 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) have been shown to save money  and reduce medical errors.
IT standards, including data standards, enable the interoperability  and portability 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.
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.
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) and the Medicare  Prescription Drug and Modernization Act of 2003, 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 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.
section_title: Actions Needed for Implementation of Health Information Technology Standards
paragraphs: 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. 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. 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 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. 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.
section_title: Recent Actions Taken by HHS to Develop Health Information Technology Standards
paragraphs: 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) 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 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). 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.
section_title: Contacts and Acknowledgements
paragraphs: 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.
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