Experts call for dedicated regulatory framework for clinical AI models, UK MHRA unveils AI-focused strategy

Former FDA commissioner Scott Gottlieb, now at the American Enterprise Institute, wrote an opinion piece urging Congress to create a specific regulatory framework for artificial intelligence models used in academic medical centers. He argues these systems should not be treated as commercial medical devices nor left without oversight.

Gottlieb’s view is backed by three experts who spoke with Focus, all of whom expressed support for a tailored regulatory approach that balances innovation with patient safety.

In parallel, the UK Medicines and Healthcare products Regulatory Agency (MHRA) announced a multi‑year strategy aimed at streamlining regulation in the AI era. The plan sets out commitments through 2030 to keep pace with rapid technological advances and to bring safe, effective treatments to patients more quickly.

The MHRA strategy outlines steps to adapt regulatory processes for emerging AI and personalized medicine, emphasizing a continued patient‑centered focus.