October 20, 2026
Top News for Informatics
AMIA Responds to FDA’s Generative AI Medical Device Discussion Paper
AMIA submitted comments to the FDA on its discussion paper addressing regulation of generative AI-enabled medical devices. AMIA recommends clarifying which functions fall under FDA oversight and using a risk framework centered on the probability and severity of harm, adjusted for context. The response also supports proportionate premarket testing, usability and subgroup analysis, interoperable AI exposure tracking, continuous postmarket monitoring, and flexible change-control pathways that protect patients while enabling responsible innovation and ongoing accountability.
AMIA Urges NIH to Preserve Transparency in Peer Review Reporting
AMIA
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