Bradley Merrill Thompson, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in MedCity News, in “Clinical Decision Support Guidance Tops FDA’s Agenda for 2022,” by Elise Reuter.
Following is an excerpt:
At the top of the Food and Drug Administration’s agenda for the next 12 months: clarifying the rules for AI in healthcare. The FDA’s Center for Devices and Radiological Health (CDRH) recently shared a list of proposed guidances it plans to publish in fiscal year 2022.
To start, the agency plans to publish a long-awaited final guidance on the use of clinical-decision support tools. It would come at a time when the software tools, such as sepsis alerts for clinicians, have come under scrutiny as researchers find they’re not always as accurate as advertised. The FDA has been working on guidance to address this since the 21st Century Cures Act passed five years ago, but has yet to finalize it.
Under the most recent proposed draft, the FDA would look to expand its oversight of algorithms used to treat serious conditions, in addition to those where clinicians can’t review the basis for the suggestion. The change drew several comments, with some groups, like the American Hospital Association, raising concerns that it would result in many existing algorithms becoming subject to the FDA approval process.
Bradley Merrill Thompson, a partner at Epstein Becker & Green, said he was pleased to see clinical decision support at the top of the FDA’s “A-list” for 2022.
“There’s lots of ambiguity,” he said. “The FDA came up with a new draft guidance in September of 2019. We’ve been waiting since then for them to do something.”
