	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. 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. 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. 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. 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 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. The Coordinator also assumed  responsibility for identifying standards for federal health programs  as part of the CHI initiative. 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. 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. 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. HHS expects to award a contract to develop and evaluate a process  to unify and harmonize industry-wide information standards. 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. 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.
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 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.