both industry and government to create an optimal set of specifications that meet compatibility and interoperability needs, enable regulatory requirements, and allow for continued innovation and technology advancement by a variety of vendors. The organizations associated with the development of the three types of standards required—data interchange, terminologies, and knowledge representation—have differing methods for developing and implementing those standards. Both standards and methods have remained rather uncoordinated to date, resulting in overlaps and gaps in the comprehensive set of data standards needed for full operation of the national health information infrastructure. This chapter describes current processes for setting each type of standard; reviews current standards activities in the federal and private sectors; and presents the committee’s recommendations for how the standards development, implementation, and dissemination process can be streamlined and coordinated for greater usefulness and efficiency.

CURRENT STANDARDS-SETTING PROCESSING

Data Interchange Standards

Data interchange standards are developed by three means—federal mandate by legislation or regulation, voluntary consensus through balloting of an industry professional group or sector, or de facto as the result of dominance in the commercial marketplace (see Figure 3-1). Once standards have been developed and approved, an integral part of their utilization is the conformity assessment process used to evaluate the compliance of products and processes with particular standards.

Most technical standards in the health sector and other industries are developed at the national and international levels through the voluntary consensus process, with the participation of industry members of standards development organizations (SDOs) and government representatives having an interest in the use of the standard. More recently, these three pathways have converged, primarily as a result of the administrative simplification provisions of the Health Insurance Portability and Accountability Act (HIPAA), which require that standards for transactions be selected from those developed through the voluntary consensus process and/or those available because of marketplace dominance, rather than from government-unique standards.

The American National Standards Institute (ANSI) bears the responsibility for endorsing consensus standards in the United States and for representing U.S. interests internationally in the International Organization for



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