FDA's point of reckoning with AI

Health care regulators are facing a defining moment for artificial intelligence. 

The FDA is tasked, among other things, with monitoring the safety and efficacy of next-gen medical imaging devices meant to complement radiologists' opinions with AI. Devices like this are already trickling into use across the country; now the FDA has to quickly adapt its policies to oversee approval of these tools, and whether they really do improve patient outcomes, writes STAT’s Casey Ross, reporting from a two-day meeting at the agency’s headquarters. 

“Understanding the risks really does not stop with FDA approval,” one predictive analytics expert told STAT. “Even after these are released, we’re going to have to put a lot of effort into understanding whether they are improving outcomes for our patients.” 

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