STAT January 16, 2021
Days before leaving office, President Trump’s top health official is proposing to permanently exempt from regulatory review a wide swath of artificial intelligence products used to help physicians detect serious conditions such as cancer and respiratory disease on medical images.
The proposal, posted to the Federal Register on Friday and signed by Health and Human Services Secretary Alex Azar, asserts that FDA review of several categories products, including AI imaging devices, is not necessary because they are seldom associated with reports of adverse events.
But notice of the proposed policy change raised alarms among health technology experts who said careful review of these products is essential to ensuring they meet basic performance standards before they are adopted in clinical practice.
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