Artificial intelligence is making critical health care decisions. The sheriff is MIA.

Key Facts

A new report from the Government Accountability Office, the watchdog arm of Congress, said the agency wants more power — to request AI performance data and to set guardrails for algorithms in more specific ways than its traditional risk assessment framework for drugs and medical devices allows, the GAO said.
The FDA does regulate first-gen AI tools as it does medical devices, and 14 months ago Congress granted the agency the power to allow makers of devices, some of which include early AI, to implement preplanned updates without having to reapply for clearance.
The Healthcare Information and Management Systems Society, a trade group that represents health technology companies, also expressed confusion over the scope of FDA authority and how power over AI regulation is split among it and other agencies within the Department of Health and Human Services, like the Office of the National Coordinator for Health Information Technology.
Ayers thinks the FDA should be handling AI validation within its own walls and that makers of AI systems should at a minimum have to show that they improve outcomes for patients, regardless of who does the oversight.