Scott Gottlieb Urges FDA to Ease AI Regulations for Clinical Decision Support Tools

Scott Gottlieb, who led the FDA from 2017 to 2019, is calling for a rollback of recent AI regulations, arguing that increased oversight has introduced uncertainty and discouraged electronic medical record (EMR) developers from integrating advanced analytical tools. In a JAMA article, he suggests the FDA should revert to an older interpretation of the 21st Century Cures Act, which previously allowed more clinical decision support software to operate without premarket review, as long as the tools were meant to assist rather than replace clinical judgment. His concerns stem from policies implemented in 2022 that placed risk-scoring AI tools under FDA regulation, following scrutiny of flawed sepsis prediction software.

With the Trump administration pushing for deregulation in AI and digital health, the future of FDA oversight remains uncertain, especially as the agency awaits a permanent commissioner. The FDA's 2022 guidance was meant to address risks like automation bias and reliance on AI in critical care settings, but Gottlieb argues that these policies have forced developers to strip useful features from EMRs or create costly standalone AI modules. He believes that if AI tools are designed to support rather than autonomously dictate clinical decisions, they should not require premarket review, a stance that could influence the FDA’s evolving approach under the current administration.