Kyle Faget Quoted on FDA’s Approach to AI in Digital Health

Foley & Lardner LLP partner Kyle Faget is quoted in the Modern Healthcare article, “FDA is digital health’s gatekeeper amid AI boom,” offering insight on how companies implementing artificial intelligence in the digital health industry are navigating oversight from the U.S. Food and Drug Administration.

“There’s just been an explosion of innovation in this space,” Faget said. “What’s hard for young innovators is that they have to make a determination at the outset, whether or not the product they’re developing is subject to FDA oversight.”

Faget noted that what can make it difficult for the agency is how AI models can change over time based on evolving data inputs, meaning that guidance can be a moving target that requires companies to submit a predetermined change control plan.

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