Bradley Merrill Thompson, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in MobiHealthNews, in “FDA Takes First Steps Toward New Guidance for Adaptive Medical AI,” by Jonah Comstock.

Following is an excerpt:

FDA Commissioner Dr. Scott Gottlieb may be stepping down, but he isn’t slowing down on his way out the door. Yesterday the agency dropped a 20-page exploratory whitepaper on how it could address artificial intelligence and machine learning algorithms.

“As algorithms evolve, the FDA must also modernize our approach to regulating these products,” Gottlieb wrote in a statement. “We must ensure that we can continue to provide a gold standard of safety and effectiveness. We believe that guidance from the agency will help advance the development of these innovative products.” …

The whitepaper is not a draft guidance, and the FDA is seeking comments on it before moving further.

Why It Matters

The industry has been asking for this kind of guidance for a long time. Epstein Becker Green partner and CDS Coalition chairman Bradley Merrill Thompson penned a piece on the topic for MobiHealthNews nearly two years ago raising some of these same concerns.

“On the whole, I'm very excited to see FDA so enthusiastic about the future of AI, and so willing to look at new innovative approaches to regulating it,” Thompson told MobiHealthNews in an email. “I just hope that the agency can carry through with some of these new initiatives all the way to completion. As between the two programs — precertification and this new AI initiative — speaking personally I think I'm more excited about the new AI initiative.”

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