STAT+: In a sharp rebuke, health officials toss Trump-era proposal to exempt medical AI tools from review
In a searing rebuke, the Biden administration is formally withdrawing a last-minute proposal by the Trump administration to exempt a wide swath of medical devices and artificial intelligence tools from regulatory review.
Officials with Biden’s Health and Human Services Department and the federal Food and Drug Administration posted a document on the federal register indicating that they will not proceed with the proposed exemptions. The document sharply criticizes a lack of transparency by Trump officials and badly flawed logic in proposing to relax scrutiny of some devices whose malfunctioning could result in serious harm or even death.
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