Experts call for Congress to create a dedicated regulatory framework for AI models used in academic medical centers

On Oct. 15, 2026, several health policy experts voiced support for a new regulatory approach specifically aimed at clinical artificial‑intelligence models that are developed and deployed in academic medical centers.

Former FDA commissioner Scott Gottlieb, writing in JAMA Health Forum, argued that such AI systems should not be treated as commercial medical devices nor left without any oversight. He urged Congress to enact legislation that would establish clear, tailored rules for these tools.

Three additional experts interviewed by Focus echoed Gottlieb’s view, saying a dedicated framework would balance innovation with patient safety and provide certainty for institutions using AI in care delivery.

The call for targeted regulation reflects growing concern that existing medical‑device rules do not adequately address the unique nature of AI models in research and clinical settings.