Lexology January 13, 2025
U.S. Food and Drug Administration (FDA) Commissioner Robert Califf, M.D., and other senior FDA officials recently published a “Special Communication” in JAMA describing FDA’s concerns with the use of AI in medical product development, clinical research, and clinical care, which we summarized here. We are now taking a closer look at specific issues raised by FDA in the JAMA article: (1) potential uses of AI in clinical trials, such as employing “digital twins” to generate simulated clinical records; (2) AI in medical devices; and (3) privacy considerations regarding the use of AI in clinical research.
In the JAMA article, FDA lists several areas of clinical research that could benefit from AI, including participant recruitment; selection and stratification of trial participants...
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