Independent Commission led by NHS doctors sets out blueprint to accelerate safe AI adoption in healthcare

An independent commission established by the Medicines and Healthcare products Regulatory Agency (MHRA) has published recommendations to strengthen the regulation of AI in healthcare, aiming to balance innovation with patient safety and public trust. The Commission gathered evidence from over 12,000 individuals, including patients, clinicians, and technology developers, to inform its proposals. Its findings highlight broad public support for AI in healthcare, provided there are strong safety standards, meaningful human oversight, and transparency about its use in patient care.

The Commission recommends a staged authorisation process for new AI models, similar to provisional driving licences, allowing them to be deployed under close supervision before full approval. It also proposes continuous real-world monitoring of AI-enabled medical devices throughout their use, rather than relying solely on initial approval. This approach aims to ensure patient safety as AI systems evolve and adapt after deployment.

To enhance transparency, the Commission suggests creating a public searchable database for information on the safety of AI-enabled medical devices, including adverse incidents. Patients would also be informed when AI is used in their care, addressing concerns about clarity and accountability in AI-assisted treatments.

The government and MHRA will now consider the Commission’s recommendations, with a formal response expected in due course. The proposals aim to position the UK as a global leader in safely regulating and adopting AI in healthcare, while ensuring that innovation serves patients and clinicians without compromising trust.