Summary recommendations for responsible monitoring and regulation of clinical software systems

Annals of Internal Medicine

Volumn 127, Issue 9, 1997, Pages 842-845

  Miller, Randolph A ^a,b   Gardner, Reed M ^a,c  

^a American Medical Informatics Association   (United States)

^b VANDERBILT UNIVERSITY MEDICAL CENTER   (United States)

^c LDS HOSPITAL   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; COMPUTER PROGRAM; FOOD AND DRUG ADMINISTRATION; MEDICAL INFORMATION; MONITORING; PRIORITY JOURNAL; REGULATORY MECHANISM;

EID: 0030669717     PISSN: 00034819     EISSN: None     Source Type: Journal    
DOI: 10.7326/0003-4819-127-9-199711010-00014     Document Type: Article

References (5)

1. Federal Register. 15 July 1996. 61:36886-7.
2. Young FE. Validation of medical software: present policy of the Food and Drug Administration. Ann Intern Med. 1987;106:628-9.
3. Miller RA, Gardner RM, American Medical Informatics Association, Computer-based Patient Record Institute, Medical Library Association, Association of Academic Health Sciences Libraries, et al. Recommendations for responsible monitoring and regulation of clinical software systems. J Am Med Inform Assoc. [In press].
4. Public Law 94-295. Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act (passed on 28 May 1976).
5. Geissbuhler AJ, Miller RA. Desiderata for product labeling of medical expert systems. International Journal of Medical Informatics. [In press].