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Health tech experts caution FDA against waiving regulatory review of AI-based imaging tools – Health Imaging


Healthcare technology experts are warning that a recent move by the U.S. Food & Drug Administration to eliminate regulatory review of some artificial intelligence tools, including imaging devices, may have detrimental effects.

The Department of Health and Human Services proposal, published Friday, would completely toss out the FDA review process for 91 products for which traditional review was waived to offer flexibility during the COVID-19 public health emergency. In the document, HHS Secretary Alex Azar argues such reviews aren’t necessary for products because they are rarely associated with adverse events.

Technology researchers, however, have stepped forward saying a careful review of AI is necessary, particularly given the “uneven” performances of such software, including those focused on breast imaging, according to a Jan. 16 story published by STAT.

The new federal proposal also appears to be at odds with a plan released by the FDA last week designed to oversee and evaluate AI software.



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