Introduction to the National Commission into the Regulation of AI in Healthcare
The UK government wants to create a healthcare system that is fit for the future, using artificial intelligence (AI) to help improve care. To support this, new proposals are being considered for regulating medical devices that use AI.
AI has the potential to make healthcare safer, faster, and more personalised. It could help NHS staff work more efficiently and support the growth of health technology companies in the UK. However, AI also brings new challenges for how we regulate and oversee these technologies.
The MHRA, as the regulator for medicines, medical devices, and blood products, is continuing to consider what the regulatory rules should be for AI as a medical device. We have established the National Commission into the Regulation of AI in Healthcare to support this goal.
The National Commission brings together experts from technology, healthcare, law, patient groups, the public, government, and the NHS. The National Commission will tackle the most important questions about how AI should be regulated and to give recommendations to the MHRA, which will be published in 2026.
The Commission is chaired by Professor Alastair Denniston; with the England Patient Safety Commissioner Professor Henrietta Hughes as deputy chair.
The Commission and its four Working Groups includes leading health professionals, regulators, AI specialists and experts from across England, Scotland, Wales, and Northern Ireland.
There is a research and engagement programme, supported by the MHRA and Health Foundation, to ensure that patients’ and service users’ views are central to the Commission’s work.
About the Call for Evidence
To make sure the Commission hears from a wide range of people, this Call for Evidence invites contributions from people and organisations across the UK and internationally. The information gathered will help inform the Commission’s recommendations and help address key challenges in regulating AI in healthcare.
Other opportunities such as workshops are also planned to hear directly from patients and members of the public.
Anyone can take part, but we especially want to hear from:
- Patients, the public, and charities
- AI health tech companies and industry groups
- NHS and independent healthcare leaders and health and care professionals
- Healthcare provider organisations and professional bodies
- UK and international healthcare regulators
Topics considered in the Call for Evidence
The Call for Evidence invites evidence and views on:
- whether the UK’s framework for regulating AI in healthcare is sufficient
- how the UK’s regulatory framework may need to be improved to ensure fast access to safe and effective AI medical devices
- approaches to checking safety once AI medical devices are in use
- how responsibility and liability are managed between different parties involved in the deployment of AI medical devices.
Your views
Excerpt from the official page. The original is authoritative. Continue reading at UK MHRA ↗