MedPage Today December 31, 2024
— Regulation isn’t expected, leaving industry and health systems to work it out
This year, MedPage Today reported on a slew of developments for artificial intelligence (AI) in healthcare. In this report, we examine what lies ahead for healthcare AI in the new year.
In November, a newly-assembled FDA advisory committee held a 2-day meeting to develop guidance for the agency on questions around generative AI-enabled medical devices. The Digital Health Advisory Committee advocated developing a regulatory approach that focuses on premarket performance evaluation and risk management as well as continuous performance monitoring after these devices are on the market.
However, the committee stopped short of offering specific recommendations, suggesting that regulatory changes are not in the immediate future for...
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