Signal UK commission proposes 44 recommendations to overhaul AI healthcare regulation

Summary

An independent body established by the UK medicines regulator MHRA, co-chaired by two NHS clinicians, published 44 recommendations for a future AI medical device regulatory framework. The commission gathered evidence from more than 12,000 people. Its recommendations include staged learner-phase authorization for new AI models under tight guardrails, requiring them to demonstrate real-world safety before full approval. They also call for continuous monitoring of deployed AI devices with authority to withdraw approval if performance degrades. Patients would be guaranteed the right to know when AI is involved in their care and access to related information. The recommendations also call for giving regulators power to penalize developers whose products fail to meet required standards.