The Food and Drug Administration proposed on Thursday to streamline its regulation of health software tools, but remained largely silent on the crucial question of how it will treat products that rely on artificial intelligence, experts said.
The agency’s draft guidance on so-called clinical decision support tools is a long-awaited attempt to define the rules in a regulatory gray area where many new products are promising to change the delivery of medicine. The experts said the document appears to broadly grant latitude to developers of software that helps doctors diagnose and treat a range of conditions, including cancer, diabetes, and heart disease.
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