National Commission into the Regulation of AI in Healthcare: Recommendations for a future regulatory framework

Summary

In September 2025 the Medicines and Healthcare products Regulatory Agency (MHRA) announced the creation of a new National Commission into the Regulation of AI in Healthcare. The Commission’s purpose was to advise the MHRA on improving its regulatory framework and to accelerate safe access to AI in healthcare and across the NHS. This report summarises the Commission's final recommendations.

Content

The Commission’s recommendations are organised around three connected areas of change.

1. Proportionate lifecycle regulation

AI-enabled devices require regulatory approaches that reflect their distinctive characteristics. The future framework should support proportionate and tailored oversight across the product lifecycle, including clear routes to market, flexible mechanisms to support rapid device iteration and stronger use of real-world evidence to support ongoing assurance.

2. System-wide responsibility and safe management

Safe and effective use of AI in healthcare depends on more than regulation alone. Regulation cannot be the only enabler of change; the safe and effective use of AI will require a collaborative, system-wide effort. Manufacturers, healthcare providers, healthcare professionals, regulators and policymakers all have a role to play. The future framework should support clear responsibilities, organisational readiness, workforce capability and effective governance across the healthcare system.

3. Trust, transparency and predictability

Public confidence is essential to realising the benefits of AI in healthcare. The future framework should strengthen transparency, accountability and patient involvement, while providing clearer and more predictable pathways for innovators.

The Commission's overall vision

Next Steps

The report states that the Commission’s recommendations aim to provide a foundation for the MHRA, government and wider system partners to achieve that ambition. A cross-government response will follow separately, setting out how government and system partners will consider and take forward the recommendations.