Signal of the Day · Regulation & Policy
AHA asks FDA to make developers primarily responsible for monitoring generative AI devices after deployment
What happenedIn an October 19 letter on FDA's generative AI device discussion paper, the AHA asks FDA to assign developers primary responsibility for premarket and post-deployment monitoring.
Why it mattersFor SNF and AL/SL operators, the answer decides whether drift monitoring of vendor AI falls on their own staff or on the developer.
For leadersTrack whether FDA sets vendor performance thresholds, and whether the AHA bid to keep decision-support tools outside FDA oversight succeeds.