National Commission into the Regulation of AI in Healthcare
This document is a call for evidence issued by the Medicines and Healthcare products Regulatory Agency (MHRA) to support the National Commission into the Regulation of AI in Healthcare. It invites input from the public, industry, healthcare professionals, and regulators to shape future regulatory frameworks for AI health technologies in the UK. The document outlines current uses of AI in healthcare, existing medical device and data protection regulations, and specific questions regarding safety, performance, liability, and post-market surveillance.
Summary and content fields are drawn from the document text and are pending editorial review.
Who issued it
Who it governs
This document is for patients, healthcare professionals, AI health technology developers, and regulatory experts who wish to contribute evidence to shape the UK's future regulation of AI in healthcare.
What the document contains
The document addresses the current use of artificial intelligence in healthcare, existing regulatory frameworks including medical device regulations and data privacy laws, post-market surveillance requirements, and specific questions concerning liability and regulatory reform.
It does not contain final regulatory rulings, binding compliance mandates, or technical AI definitions, as it functions solely as a consultative call for evidence.
- The National Commission into the Regulation of AI in Healthcare aims to position the NHS as a world leader in AI-enabled healthcare.
- The MHRA is gathering evidence from patients, industry, and healthcare professionals to inform new regulatory recommendations in 2026.
- The call for evidence covers existing regulatory frameworks, pre-market and post-market safety, data privacy, and liability across the AI supply chain.
- The document details current healthcare AI uses ranging from administrative chatbots and ambient voice technologies to clinical screening and diagnosis.
- Respondents can submit feedback via an online survey or alternative formats until February 2, 2026.
· Introduction to the National Commission · Commission Membership · About the call for evidence · Audience · Scope · Issue date and duration · Respond online · Other ways to respond · Confidentiality and data protection · Enquiries · The response · Section 1 – Respondent information · Section 2 – Information on how AI is used in Health and the Current Regulatory Frameworks · Section 3 – Questions
How it scores
Each score is backed by a quote verified against the document text. Editorial review has not yet confirmed them.
Accountability
3/5Clear responsibility for AI outcomes
How liability and responsibility is managed within the regulatory system, and distributed across the AI supply chain.
Page 4
screening score · 2026-10-23
Fairness
1/5Non-discrimination and equitable treatment
the MHRA will ask if you are willing to provide personal data – your sex as registered at birth, your ethnic group, and your email address
Page 5
screening score · 2026-10-23
Human Dignity
0/5Respect for the inherent worth of persons
screening score · 2026-10-23
Human Oversight
2/5Humans remain in control of consequential decisions
When the AI tool gives the correct answer, but is incorrectly overridden by the healthcare professional
Page 17
screening score · 2026-10-23
Privacy
4/5Protection of personal data and private life
When accessing and using and managing patient data, all parties involved need to ensure this data is used in a secure way
Page 11
screening score · 2026-10-23
Transparency
2/5Openness about how AI systems work and are used
c) Transparency
Page 15
screening score · 2026-10-23
Enforcement
4/5Consequences and compliance mechanisms with real force
(3) Report serious incidents to MHRA (4) Investigate serious incidents and report to MHRA on the conclusions
Page 12
screening score · 2026-10-23
Impact Assessment
4/5Required assessment of an AI system's risks/impacts before or during use
Approved Bodies carry out independent assessment of conformity of medium and high-risk medical devices, reviewing for example the clinical evidence and risk management
Page 11
screening score · 2026-10-23