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MarkDiehl.com
Health Information Architecture, Data Modeling, and Enterprise Architecture Planning |
The U.S. Standards Environment |
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American National Standards Institute ANSI Health Informatics Standards Board National Institute of Standards and Technology
International Standards Development U.S. Health Informatics Standards Activities
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Throughout the United States and Internationally, standards organizations have been actively pursuing initiatives in the health information area. The focal point for standards activities in the United States are the American National Standards Institute along with its accredited standards development organizations. Worldwide, the International Standards Organization mission is to assemble national standards representatives, such as ANSI, and harmonize their standards with a view toward international commerce. The American National Standards Institute The American National Standards Institute (ANSI) has been the administrator and coordinator of the United States private sector voluntary standardization system for over 80 years. Since its founding in 1918 by five engineering societies and three government agencies, the Institute has remained a private, not-for-profit, membership organization. ANSI operations are supported by a diverse constituency of private and public sector organizations. The primary goals of ANSI are to improve the global competitiveness of U.S. business and to enhance the American quality of life. ANSI achieves these goals by promoting and facilitating the development of voluntary consensus standards, standards conformity assessment, and standards integrity and harmonization. ANSI does not itself develop standards but designates American National Standards (ANSs) from its constituent organizations. ANSI principal activities are facilitating development by establishing consensus among qualified standards developer groups and ensuring that its guiding principles (consensus, due process and openness) are rigorously followed by standards developers. Currently almost 200 entities are accredited under one of three ANSI methods of accreditation (organization, committee or canvass). ANSI-accredited SDOs are committed to supporting the development of national and, in many cases international standards, addressing such critical issues as technological innovation, marketplace globalization and regulatory reform. ANSI promotes the use of U.S. standards internationally. ANSI advocates U.S. policy and technical positions in international and regional standards organizations, and encourages the adoption of international standards as U.S. national standards where these meet the needs of the U.S. user community. ANSI is the only U.S. representative to the International Organization for Standardization (ISO). ANSI was a founding member of the ISO and remains a member of the governing ISO Council, and the ISO Technical Management Board. As such ANSI is the sole U.S. organization that may express an official U.S. position and vote on international standards issues. Organizations in the United States have immediate access to the ISO standards development processes through ANSI. As part of its responsibilities as the U.S. member body to ISO, ANSI accredits various U.S. Technical Advisory Groups (U.S. TAGs) to represent national interests in ISO activities. The primary purpose of the U.S. TAG is to develop and transmit U.S. positions on activities of and vote in the international technical committee. U.S. standards are often taken forward, by ANSI through the U.S. TAG, to the ISO where these may be adopted in whole or in part, or may contribute to international standards. The ANSI Health Informatics Standards Board An essential standards coordination activity by the American National Standards Institute is the hosting of standards boards, such as the boards for medical devices and health informatics. For a decade, the American National Standards Institute has been leading the voluntary coordination of healthcare informatics standards among all United States' standard developing organizations. The ANSI Healthcare Informatics Standards Board (HISB) is the third of a sequence of standards harmonization activities, Initially the Healthcare Informatics Standards coordinating Committee (HISCC) sought to bring together SDOs to share information. This effort was followed by the ANSI Healthcare Informatics Standards Planning Panel (HISPP) which sought to actively coordinate future direction of standards development. ANSI HISB provides an open, public forum available to every major developer of healthcare informatics standards in the United States. Of the approximately two dozen 26 voting members and more than 100 participants are ANSI-accredited and other standards developing organizations, professional societies, trade associations, private companies, federal agencies, and business entities.
The scope of the ANSI Healthcare Informatics Standards Board addresses the coordination of U.S. standards for:
ANSI HISB is a primary vehicle for the dissemination of information among the SDOs and among Federal agencies and departments, and the SDOs. Particular attention is directed toward the implementation of requirements of the Health Insurance Portability and Accountability Act of 1996 (HIPAA). The National Institute for Standards and Technology In the United States, responsibility for setting product and process standards rests almost exclusively with the private sector. The private sector often calls upon NIST to provide technical support that contributes to the development of high-quality domestic and international standards. More than 300 NIST staff participate in over 1,200 national and international standards developing activities. In addition, the National Technology and Advancement Act of 1995 provides specific responsibilities for NIST to coordinate federal use of and participation in documentary standards. Government agencies rely heavily on voluntary standards, which they often incorporate into regulatory and procurement requirements. The National Technology Transfer and Advancement Act of 1995 (P.L. 104-113) directs all Federal departments and agencies to use standards developed by voluntary consensus organizations. The aim is to eliminate unnecessary duplication of private sector activities by the government and to reduce the complexity of the standards. NIST coordinates the use of civilian voluntary consensus standards by federal agencies and coordinates the federal government's standard-related activities with the private sector. In the past, NIST developed standards in four key areas:
Information technology standards facilitate system interoperability, data interchange, and underpin computer security and information privacy. These are critical to realizing many widespread benefits offered by advances in healthcare and electronic and mobile commerce. Prior to 1996, NIST developed numerous Federal Information Processing Standards (FIPS) that covered both the hard and soft technologies, providing specifications for disk media, interface connections, data interchange formats, etc. Following P.L. 104-113, the role of NIST changed to assist industry groups as they develop IT standards, for example to provide testbeds that industrial collaborators may use to evaluate prospective standards implementability and especially to assess compliance. Typical FIPS that remain relevant to health information technology are:
Current FIPS listings and descriptions may be viewed at the NIST FIPS Web page (http://www.itl.nist.gov/fipspubs/). Many of the withdrawn FIPS were replaced by adopting voluntary industry standards for Federal government use, had not been updated to adopt current or revised industry standards, were applicable to obsolete technology, or in some cases, commercial products implementing industry standards became widely available. NIST actively coordinates standards activities with those of the private sector, in particular ANSI and ANSI accredited standards developers. Because ANSI serves to coordinate US activities, particularly with respect to the International Organization for Standardization and the International Electrotechnical Commission, and develop cross-cutting policy positions within the United States, there is potential for confusion of functions. In December 2000, NIST and ANSI signed a memorandum of understanding that recognizes the particular responsibilities of each.
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