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GAO/NAS Report On AI In Health Care Critical Of FDA Slowness On SaMD Rulemaking

While agency issued framework for software as a medical device, lack of rules hamper clarification of software’s safety, efficacy

 
• By Sue Darcey

A joint report by the US Government Accountability Office and the National Academy of Sciences slams the FDA for dawdling on final software as a medical device rules.

Futuristic portable device and many pictures.

Ensuring the safety and efficacy of artificial intelligence used in clinical decision software (CDS) and other AI-related devices is within the US Food and Drug Administration’s purview, but the agency “has not yet promulgated” any final software as a medical device (SaMD) regulations, charges a new report from the Government Accountability Office (GAO) and the National Academy of Sciences.

In the 30 November GAO/NAS report, “Artificial Intelligence in Health Care,” the GAO and the NAS acknowledged that in...

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