14/10/2025
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has established the ‘UK National Commission on the Regulation of AI in Healthcare’ to review current regulations, and to provide recommendations for a new regulatory framework for the use of AI in healthcare, with the aim of accelerating the safe introduction and adoption of AI across the NHS.
AI plays a critical role in the NHS’ 10 Year Plan and the intention to shift ‘from Analogue to Digital’. Whilst AI has the potential to revolutionise health and social care, increasing efficiency and reducing costs, it presents new challenges and areas of uncertainty for regulators, including how to avoid infringing on patient privacy and mitigate bias.
The Commission aims to ensure the UK leads the way in responsible innovation, whilst increasing the availability of AI technologies that can support better health for everyone. Utilising AI within the NHS brings significant and exciting opportunities, as it holds one of the most extensive patient datasets globally, and data sits at the core of any AI system. It is essential, therefore, that the UK focuses on strong governance and regulation from the outset, to mitigate any risks, maintain public trust and prioritise patient safety, whilst keeping pace with the rate of innovation.
With that in mind, the intention is to publish a new regulatory rulebook for AI in healthcare in 2026. By creating a clear regulatory pathway, the commission will contribute to the UK’s efforts to establish itself as a global hub for health tech investment, in support of the Government’s Plan for Change.
In the meantime, the Commission intends to provide regulatory clarity on the use of various AI tools and accelerate their introduction into use. For example, the NHS has trialled the use of AI ambient voice technology for doctors, with early tests indicating it reduces the administrative burden and allows clinicians to spend more time focusing on patients.
It is positive to see that the Commission is bringing expertise from global AI leaders, clinicians, patient advocates and regulators, as well as welcoming a broad range of perspectives through a formal call for evidence. This will help inform the Commission’s recommendations and identify the critical barriers of AI regulation across the healthcare landscape.
Bevan Brittan advises a range of clients on the procurement, implementation and use of AI in healthcare and more broadly. If you have any questions about the new Commission or you would like to discuss implementing AI in your organisation, please do get in touch.
