LETTER
Monitoring and Regulating Clinical Software
Eta S. Berner, EdD
1 August 1998 | Volume 129 Issue 3 | Page 254
TO THE EDITOR:
Drs. Miller and Gardner and the organizations they represent are to be commended for developing guidelines for monitoring the performance of medical software [1]. Using the concepts of risk to the patient and the opportunity for competent clinician intervention to determine the stringency of the regulation and monitoring is a reasonable way to frame the recommendations. However, in allowing less strict regulation of systems in which a competent clinician has the opportunity to override the system, the authors assume that clinicians will routinely review the system output and will accurately recognize when to ignore the software's suggestions. Such vigilance is more likely when the software's performance is known to be mediocre and require frequent overrides than when the software is consistently accurate in its recommendations. Ironically, as the software improves, fewer errors may occur, but these errors may be less likely to be detected. Because "closed-loop" systems do not allow human intervention, mechanisms are usually built in to assure fail-safe operation. As developers of other types of software systems continue to improve their products, they may need to give more attention to similar internal measures to compensate for failures of human intervention.
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Author and Article Information
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University of Alabama at Birmingham; Birmingham, AL 35294
1. Miller RA, Gardner RM. Summary recommendations for responsible monitoring and regulation of clinical software systems. The American Medical Informatics Association, the Computer-based Patient Record Institute, the Medical Library Association, the Association of Academic Health Science Libraries, the American Health Information Management Association, and the American Nurses Association. Ann Intern Med. 1997; 127:842-5.
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