Regulatory Hurdles Grow for Generative AI in Diagnostics

The MHRA has signaled a stricter stance on black-box algorithms in clinical settings.

By Marcus Vane7 min read

A firmer line from the MHRA

The UK regulator has published draft guidance that reframes diagnostic AI as a device requiring clinical evidence at the same bar as physical equipment.

Vendors respond

Industry submissions broadly welcome the clarity.

Share

The Vanadium Brief

Every Monday morning, the definitive analysis of healthcare markets in your inbox.