August 25, 2026
Top News for Informatics
FDA Explores Regulatory Framework for Generative AI Medical Devices
The FDA released a discussion paper seeking public feedback on a potential regulatory framework for generative AI-enabled medical devices. It addresses risk assessment, competency-based premarket evaluation, foundation models, agentic systems, and risk-proportionate post-market monitoring. For informaticians, the proposal highlights emerging expectations for validating evolving AI performance, clinical safety, and real-world reliability. Comments are due October 19.
AMIA’s Suggestions to NIH’s RFI on Measuring and Rewarding Scientific Impact
AMIA recommended NIH to evaluate scientific impact beyond publication counts, journal impact factors, and citations. It recommended rewarding rigorous and
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