Politico September 18, 2024
Erin Schumaker, Robert King, Carmen Paun, Ruth Reader and Daniel Payne

TECH MAZE

AI assurance labs are coming, Micky Tripathi, assistant secretary for technology policy and acting chief artificial intelligence officer at HHS, forecasted during POLITICO’s The Future of Patient Care + Access event in Washington on Wednesday.

The labs would supplement FDA regulation of AI-powered medical devices, vetting AI tools that fall outside the FDA’s regulatory scope.

Whether assurance labs should be private, public-private partnerships or government-certified is still an open question, Tripathi said, adding that he is waiting for AI developers and purchasers to reach consensus on what the vetting process should include.

He said HHS is closely following a number of private sector-led efforts, including those of the Coalition for Health AI, whose members include Microsoft and the...

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