Health tech experts caution FDA against waiving regulatory review of AI-based imaging tools
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.
“With these kinds of devices, you’re not necessarily going to experience the side effect right away,” Karandeep Singh, a physician and professor at University of Michigan Medical School, said to STAT. “It might take time to uncover issues with these products, so the absence of an adverse event being reported isn’t justification to completely waive all requirements.”
The document doesn’t specifically call out AI, but nearly a dozen of the 91 products involve AI-based decision-making.
According to STAT, the incoming Biden administration would need to analyze and approve this policy, but as of now, it’s unclear how the president-elect will handle this situation.
Matt joined Chicago’s TriMed team in 2018 covering all areas of health imaging after two years reporting on the hospital field. He holds a bachelor’s in English from UIC, and enjoys a good cup of coffee and an interesting documentary.