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Journal of the American Medical Informatics Association 4:442-457 (1997)
© 1997 American Medical Informatics Association

Position Paper

Recommendations for Responsible Monitoring and Regulation of Clinical Software Systems

Randolph A. Miller, MD, Reed M. Gardner, PhD, the American Medical Informatics Association (AMIA), the Computer-based Patient Record Institute (CPRI), the Medical Library Association (MLA), the Association of Academic Health Science Libraries (AAHSL), the American Health Information Management Association (AHIMA) and the American Nurses Association

Affiliations of the authors: Past President (RAM), and President (RMG) of the American Medical Informatics Association, Bethesda, MD.

Correspondence and reprints: Randolph A. Miller, MD, Room 436, Eskind Library, 2209 Garland Ave., Vanderbilt University Medical Center, Nashville, TN 37232.E-mail: randy.miller{at}mcmail.vanderbilt.edu

Abstract In mid-1996, the FDA called for discussions on regulation of clinical software programs as medical devices. In response, a consortium of organizations dedicated to improving health care through information technology has developed recommendations for the responsible regulation and monitoring of clinical software systems by users, vendors, and regulatory agencies. Organizations assisting in development of recommendations, or endorsing the consortium position include the American Medical Informatics Association, the Computer-based Patient Record Institute, the Medical Library Association, the Association of Academic Health Sciences Libraries, the American Health Information Management Association, the American Nurses Association, the Center for Healthcare Information Management, and the American College of Physicians. The consortium proposes four categories of clinical system risks and four classes of measured monitoring and regulatory actions that can be applied strategically based on the level of risk in a given setting. The consortium recommends local oversight of clinical software systems, and adoption by healthcare information system developers of a code of good business practices. Budgetary and other constraints limit the type and number of systems that the FDA can regulate effectively. FDA regulation should exempt most clinical software systems and focus on those systems posing highest clinical risk, with limited opportunities for competent human intervention.




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Copyright © 1997 by the American Medical Informatics Association.