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Health Information Architecture, Data Modeling, and Enterprise Architecture Planning

The Federal Role in Establishing and Using Health Informatics Standards

Health Informatics Standards

Voluntary Consensus Standards

Current Health Informatics Standards Activities

All content copyright © 2002, 2003 by Mark Diehl.  All rights reserved.

The Federal Government has a substantial role to play in the world of standards, principally as a facilitator, user, and in the case where appropriate private sector standards do not exist, developer. 

The National Institute of Standards and Technology (NIST) is a key technical contributor to the nation's standards infrastructure.  Previously known as the National Bureau of Standards, NIST is now celebrating 100 years of service to the nation.  NIST is a non-regulatory federal agency within the Commerce Department's Technology Administration.  Its mission is to promote economic growth by working with industry to develop and apply technology, measurements, and standards.

NIST is the nation's measurement laboratory, performing a job originally assigned to the federal government by the Constitution.  NIST also plays a variety of roles in support of voluntary standardization efforts that respond to market and industry needs. NIST staff provide technical expertise and facilitate consensus and agreement within the private sector.  In addition, NIST contributes to the harmonization of standards and regulatory requirements within the US and internationally.  NIST is not a voluntary consensus standards developer – those standards which NIST authors and promotes generally do not undergo the extensive industry-wide exposure and review process characteristic of the voluntary consensus standards organizations.

Where NIST has a non-regulatory role, the Food and Drug Administration is a regulatory body of the Federal government.  The Federal Food Drug and Cosmetic Act as amended by the FDA Modernization Act of 1997 (P.L. 105-115) provides the legislative authority for FDA regulatory activities.   The FDA references standards in their regulation of medical devices.  A long-lived initiative by the FDA involves the regulation of medical software as a medical device.  FDA software regulation draft policy goes back to November 13, 1989.  Initially intended for regulation of embedded software having no human over-ride, such as used in controlling certain types of X-Ray systems or infusion pumps, the FDA has been taking a more expansive view to include regulation of all patient-care software.

In the mid-1990s, the Federal government began migrating away from mandating standards that duplicate industry standards.  The National Technology Transfer and Advancement Act of 1995 (P.L. 104-113) directed Federal government departments and agencies to use private sector, technical industry standards that are developed in voluntary consensus standards bodies.  The Executive Branch of the Federal Government also took the initiative to simplify the procurement process and curb the growth of Federal standards making activities.  The Office of Management and Budget publication OMB A119 directs all Federal activities to use existing private sector standards.  This publication also establishes the National Institute of Standards and Technology in Gaithersburg, MD, as the lead agency for the coordination and execution of all standards activities in the Federal Government.