FDA leader talks evolving strategy for AI and machine learning validation

At a virtual meeting of the U.S. Food and Drug Administration’s Center for Devices and Radiological Health and Patient Engagement Advisory Committee on Thursday, regulators offered updates and new discussion around medical devices and decision support powered by artificial intelligence.

One of the topics on the agenda was how to strike a balance between safety and innovation with algorithms getting smarter and better trained by the day.

In his discussion of AI and machine learning validation, Bakul Patel, director of the FDA’s recently-launched Digital Health Center of Excellence, said he sees huge breakthroughs on the horizon.

“This new technology is going to help us get to a different place and a better place,” said Patel. “You’re seeing a great opportunity. You’re seeing automated image diagnostics. We have seen some advanced prevention indicators. Data is becoming the new water. And AI is helping healthcare professionals and patients get more insights into how they can translate what we already knew in different silos into something that’s useful.”

As new tools like those are deployed to “augment what we already have in place,” he said, “we’re also seeing that evidence and information that used to be in different areas that were only