The Medicines and Healthcare products Regulatory Agency has identified 10 key conclusions from its report on regulation of AI in healthcare.
Following a call for evidence in late 2025, the SoR joined 760 healthcare professionals, providers, industry bodies, patients and the public in submitting their perspectives on safe and effective use of AI in healthcare.
Now, the MHRA has published ‘Information on how AI is used in Health and the Current Regulatory Frameworks’, collecting their findings to provide an evidence base on how AI is used in practice and its regulatory challenges.
Patient and staff protection
Jeanette Carter, professional officer for Clinical Imaging, AI, Assistive & Digital Technologies, with Research at the SoR, contributed to the organisation’s response to the commission, alongside Julie Rankin, professional officer for Scotland and radiation protection, Lynda Johnson, professional officer for clinical imaging, and Sue Johnson, professional officer for clinical imaging.
Jeanette said: “The response has come out and overall, the feedback given positively reflects the feedback that we gave as an organisation. There was minimal reference to specific regulations; however, this isn’t a radiography-specific framework. We continue to keep updated and assess the guidance that aims to come out by the end of summer and will give feedback where appropriate.
“Our submission was aimed at patient and staff protection, to ensure that clear regulations can be given around the ever-changing world of AI in healthcare and specifically radiography. As a Society we recognise that AI is and will be part of the future of radiography and we want to ensure the voice of our profession was given to ensure safety to staff and patients.”
The SoR saw a need to change the current regulation framework, which had no clear structure for AI.
Answers were needed to questions around post-market surveillance, the SoR said, as well as AI responsibility, training and literacy of AI and the need for human oversight – as is required by the Ionising Radiation (Medical Exposure) Regulations.
'Enhancing quality, speed, convenience'
From the report, the MHRA has identified 10 key findings, including:
- That there is a clear call for a proportionate, lifecycle-based approach to regulation - current framework doesn't suit the adaptive AI system, strong clinical evidence is required with a need for enhancing post-market surveillance
- That there is strong consensus for significant regulatory reform
- That there was broad consensus that AI systems will increasingly require continuous post-market surveillance and monitoring - performance drift requires monitoring
- That responsibility should be shared across the system, with each individual and institution understanding their essential role and responsibilities - liability to be looked at across the lifecycle. Healthcare providers wanted a robust and clear governance structure/organisational responsibility. Patient/public wants the current gaps addressing - needed greater clarity and consistency in liability - views were split
- That human oversight and responsibility for clinical judgment should be retained.
- That transparency and explainability will be key for the ongoing deployment of AI systems
- That data access and use is central to the role of AI in healthcare moving forward - healthcare data is an enabler and a barrier to the development
- That there is a need for robust training and improved AI literacy
- That there is a need to improve incident reporting and learning mechanisms - limited knowledge of existing yellow card scheme
- That patient and public engagement, trust and communication will continue to be key for the deployment of AI systems
Professor Alastair Denniston, chair of the National Commission into the Regulation of AI in Healthcare, said: “This programme of research and evidence gathering from people across the UK has been an absolutely critical part of the National Commission, and will directly influence the final recommendations we make. I would like to personally thank everyone for their contributions, taking the time to contribute their experience, insights and views.
“The increasing AI in healthcare will affect all of us. These views consistently highlight the potential to bring many benefits, enhancing quality, speed, convenience and increasing safety, but also highlight that this is a change that the regulators and wider health system need to actively engage with, including ensuring that our regulations and governance systems match the risks and benefits of these new technologies.”
Alongside these findings, the MHRA has published the ‘National Commission into the Regulation of AI in Healthcare: research, engagement and call for evidence findings’ report, which combines research, stakeholder engagement, surveys, and evidence reviews to provide in-depth insight and a broader system perspective.
The MHRA established the National Commission into the Regulation of AI in Healthcare in September 2025 as an independent advisory body to bring together expertise from across sectors and inform future regulatory approaches.
Read the summary of evidence submissions and the regulation report online now.
(Image: Photo by aire images by Getty Images)