New UK Commission to set regulatory rulebook for AI in healthcare

The UK Government has established a Commission to drive quicker adoption of AI across the NHS and healthcare sector.

The National Commission on the Regulation of AI in Healthcare will publish a regulatory rulebook on AI in healthcare, due out in 2026.

The Commission combines regulators, clinicians and AI industry leaders. It will play a central role advising the MHRA on a regulatory regime for safe, accelerated access to the latest technologies.

Lawrence Tallon, Chief Executive of the MHRA, confirmed: “The MHRA will act on the recommendations of the Commission to support the NHS’s digital transformation and advance the UK’s ambition to become a global hub for health tech investment.”

With a suite of regulatory reforms due to be implemented by the MHRA in 2026, it is unclear yet whether the Commission’s work will further delay the timetable for new statutory instruments. It is also unclear how the Commission’s guidance will be adopted by the MHRA in practice. 

The Commission brings together a multidisciplinary group of experts and says it will engage directly with representatives from big tech such as Google and Microsoft. It will be chaired by Professor Alastair Denniston, NHS clinician and head of the UK’s Centre of Excellence in Regulatory Science in AI & Digital Health (CERSI-AI), and supported by the Patient Safety Commissioner, Professor Henrietta Hughes. The full list of members and further details can be found here. 

The Commission’s remit includes:

• advising the MHRA on ways to accelerate adoption via a “regulatory rulebook“ to support the safe and effective deployment of AI in healthcare
• an early focus on accelerating NHS access to AI-assistants and other Ambient Voice Technology
• providing regulatory clarity on various AI tools previously held back from usage due to regulatory uncertainty

The Commission forms part of the government’s broader “Plan for Change” and aligns with commitments in the 10-Year Health Plan and Life Sciences Sector Plan. 

The Commission will soon be holding a call for evidence, which will provide an opportunity for industry and the NHS to shape the future regulatory landscape.

If you would like to discuss any of the above, please contact a member of our Health, Care and Life Sciences team. 

This article was written by Rory Trust and Ryan Millett.

The MHRA will act on the recommendations of the Commission to support the NHS’s digital transformation and advance the UK’s ambition to become a global hub for health tech investment.

https://www.gov.uk/government/news/new-commission-to-help-accelerate-nhs-use-of-ai