Generative AI medical device rules start with two questions
The FDA expects draft guidance on generative AI devices within months. Its framework asks how independently a tool acts and how much harm a wrong answer could do.
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AI in healthcare
Most hospital AI isn't built. It arrives. Keep a health system AI inventory
Inova went from one AI review a month to more than twelve. Most of that AI arrives as vendor features, which is why a health system AI inventory, an owner per feature and staff training matter.
Monitoring AI after approval is the part most teams skip
Approving an AI tool is only the start. Health systems are finding unknown AI, quiet model swaps and uneven local testing, and building habits to keep watch.
Generative AI medical devices should be tested like new clinicians
The FDA wants generative AI medical devices vetted the way new clinicians are, then monitored after launch. Here is why ongoing checkups matter.