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. [MedPageToday}
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 healthcare AI.
"There is a level of caution and thoughtfulness that I'm hearing more from the regulatory community recently," Brian Anderson, MD, chief executive officer of the Coalition for Health AI (CHAI), told Medpage Today, adding that "it's getting the cart in front of the horse, if you create a robust regulatory process that's not informed by where private sector innovators are going."
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