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UK National Commission into the Regulation of AI in Healthcare

Date
September 10, 2026
Category

UK Regulations

Description

On 26 September 2025 the UK government announced the formation of a new UK National Commission on the Regulation of AI in Healthcare to help accelerate NHS use of AI.  This Commission was tasked with advising the Medicines and Healthcare products Regulatory Agency (MHRA) on how to re-write the regulatory rulebook on AI in healthcare.  Whilst the focus for this Commission was primarily on A-enabled medical devices, there will undoubtedly carry over into the controls that MHRA expect for AI used in pharmaceuticals.

This Commission issued its report and recommendations on 10 September 2026, see full report at National Commission into the Regulation of AI in Healthcare: Recommendations for a future regulatory framework - GOV.UK and a summary of the recommendations at National Commission into the Regulation of AI in Healthcare: Recommendations for a future regulatory framework - GOV.UK. 

The Commission’s central conclusion is that the regulation and assurance of AI in healthcare must become more proportionate, lifecycle-based and system-wide.  More continuous monitoring of AI-enabled products, once deployed, will be needed to provide ongoing assurance across the lifecycle.  The Commission’s vision for a future UK regulatory framework is illustrated below:

Commissions vision for future

A cross-government response will follow separately, setting out how government and system partners will consider and take forward the recommendations.