Physician Congressman Urges Califf to Advance AI Rules

Encouraging the FDA to put in place rules that govern the use of AI in healthcare is the focus of a letter Rep. Greg Murphy (R-N.C.) has sent to FDA Commissioner Robert Califf, pointing to the need to clarify liability guidance and overlapping governance, both of which he says are undermining manufacturers.

Murphy pointed to his role as the “only practicing physician in Congress” in seeking answers to questions about how the FDA plans “to cultivate an environment that advances innovation in the development and use of artificial intelligence in health care.”

Murphy’s five questions to Califf are very specific to the FDA’s current policies and programs, focusing on the agency’s preparedness for a rapid increase in applications for machine learning and AI devices, future plans for its 510(k) third party review program, alternative pathways to approval for AI products, a liability safe harbor for physicians, and how to establish standards of use for AI devices.

Read Rep. Murphy’s letter here.

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