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Federal regulators have cleared dozens of AI products used in health care, which might give the impression that the Food and Drug Administration has a firm handle on a technology that is already changing how patients are treated.

But a meeting on AI regulation last week told a different story. The agency is still grappling with fundamental questions about algorithmic bias, data transparency, and how to ensure that patients benefit equally from AI’s rapid progress in medicine.


Several speakers at the meeting of the agency’s Patient Engagement Advisory Committee pointed to a lack of clear ground rules in how products are evaluated by the agency.

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