AMIA responded to FDA’s discussion paper on generative AI-enabled medical devices, recommending clearer boundaries between regulated device functions and non-device software. The comments propose a risk framework centered on the probability and severity of harm, adjusted by contextual factors such as human oversight, autonomy, evidence traceability, equity, and deployment scale […]
AMIA’s comments on NIH’s proposed changes to peer-review reporting support holistic funding decisions while urging NIH to retain numerical impact scores and percentiles. AMIA recommends using categorical ratings alongside existing review information, documenting programmatic funding decisions, and piloting changes before broader implementation. The comments also emphasize preserving data for research […]