FDA developing new rules for artificial intelligence in medicine

The Food and Drug Administration announced Tuesday that it is developing a framework for regulating artificial intelligence products used in medicine that continually adapt based on new data.

The agency’s outgoing commissioner, Scott Gottlieb, released a white paper that sets forth the broad outlines of the FDA’s proposed approach to establishing greater oversight over this rapidly evolving segment of AI products.

It is the most forceful step the FDA has taken to assert the need to regulate a category of artificial intelligence systems whose performance constantly changes based on exposure to new patients and data in clinical settings. These machine-learning systems present a particularly thorny problem for the FDA, because the agency is essentially trying to hit a moving target in regulating them.

The white paper describes criteria the agency proposes to use to determine when medical products that rely on artificial intelligence will require FDA review before being commercialized.

The review may examine the underlying performance of a product’s algorithms, a manufacturer’s plan to make modifications, and the manufacturer’s ability to manage the risks associated with any modifications.

“A new approach to these technologies would address the need for the algorithms to learn and adapt when used in the real world,” Gottlieb wrote in a statement accompanying the white paper. “It would be a more tailored fit than our existing regulatory paradigm for software as a medical device.”

By Casey Ross | STAT

Image Credit: Adobe

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About Peter Coffaro 629 Articles
A growth-driven and strategic executive, Peter Coffaro commands more than 20 years of progressive management success within the medical device industry. As a District Sales Manager for Stryker Orthopaedics, Peter was responsible for managing and directing a regional sales force to achieve sales and profit goals within the Rocky Mountain region. Previously, he was the Director of Sales & Marketing for Amp Orthopedics. In this role, Peter was responsible for planning, developing, and leading all sales and marketing initiatives. Peter is a former orthopedic distributor in the Pacific Northwest. He has also worked with DePuy Orthopaedics as well as Zimmer, and held positions in sales, sales training, and sales management. Peter has an extensive background in organizational development, business development, sales management, negotiating and P&L management. Peter holds a B.S. degree in Biology from Northern Illinois University.

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