A report from PLOS Digital Health highlights the urgent need for improved regulation of medical AI products, as more than 1,000 have been cleared by the FDA. The FDA’s approval criteria for these tools are less stringent than for pharmaceuticals, and because these AI tools can evolve post-approval, continuous oversight is essential. Recent government actions signal a possible reduction in AI regulation, increasing the risks of misinformation in patient care. Experts argue that relying solely on the FDA for safeguards may be unrealistic, necessitating broader regulatory strategies.
Without proper oversight, there is a risk that medical algorithms could give misleading recommendations and compromise patient care. "There have to be safeguards," says Leo Anthony Celi.
Low bar for approval: The criteria used by the FDA to review and authorize AI medical tools are often less rigorous than those for drugs.
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