From Principle to Practice: Early Indicators for AI Regulation in Healthcare

This year the UK Government introduced its ‘Fit for the Future: 10 Year Health Plan for England’, with the goal of making the NHS “the most artificial-intelligence-enabled care system in the world”. As part of this initiative, the National Commission into the Regulation of AI in Healthcare (‘the Commission’) was launched in September 2025. The Commission unites global AI leaders, clinicians and regulators to advise the Medicines and Healthcare products Regulatory Agency (‘MHRA’) on developing a new regulatory framework for AI in healthcare. The framework is expected to be published in 2026.

The potential for AI to revolutionise healthcare is undeniable, offering a vast range of opportunities from disease diagnostics to AI-assisted surgery. Last week, Professor Alastair Denniston, the Chair of the Commission, described AI’s arrival as the ‘X ray moment’ of our time, noting that like previous technological breakthroughs it has the power to significantly progress the healthcare sector. However, as with previous innovations, including the X ray, it is essential to learn to control the associated risks whilst unlocking AI’s potential benefits. Regulation is fundamental to achieving that aim.

Professor Denniston advised that a regulatory framework tailored to the specific requirements of AI in healthcare is still in its early stages, but it is expected that it will be guided by the following three key principles, namely:

Principle 1: Safe

The regulatory framework must have the safety of patients and the public at its core. However, an overly cautious, innovation-averse approach does the patient no favours. The framework will, therefore, ensure that risks will be managed proportionately.

Principle 2: Fast

The framework will ensure that new technologies will be brought to patients and the public as quickly and smoothly as possible.

Principle 3: Trusted

Trust in the safety and quality of AI technology is essential for both patients and healthcare professionals. The regulatory framework must clearly demonstrate how it will ensure safety through robust measures, including transparent processes such as reporting safety issues arising after a piece of technology is integrated into routine care. To maintain this trust, the framework must be able to evolve and adapt to ensure the safety of both current and emerging AI technologies.

The regulatory framework is still being shaped, and the Commission is due to issue a ‘call for evidence’ in due course, thereby providing an opportunity for public input on the regulation of AI in healthcare.

If you would like any further information or advice on the information mentioned within this article, please contact Ellen Donaghy from our Healthcare team.

*This information is for guidance purposes only and does not constitute, nor should be regarded as, a substitute for taking legal advice that is tailored to your circumstances.