The Medicines and Healthcare products Regulatory Agency’s (MHRA’s) ‘policy-shaping’ consultation surrounding the regulation of artificial intelligence (AI) in healthcare has revealed that most respondents favour substantial or complete reform, with existing regulation falling short in many areas.
The National Commission’s call for evidence to inform the planned AI regulation’s development ran from 19 December 2025 through 2 February 2026. 761 unique responses from stakeholders, including NHS bodies, industry, academia, and patient groups, were obtained during the evidence window.
Go deeper with GlobalData
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
Regarding the current regulation of AI under the MDR, 50% of respondents said the existing framework needed substantial revision, while 21% called for a complete overhaul. Areas of concern highlighted in the survey included safety, performance standards, data governance, and privacy.
In the UK, AI in healthcare is currently regulated under the nation’s medical device regulation (MDR), with the technology classified under the designations of software-as-a-medical-device (SaMD) or AI-as-a-medical-device (AIaMD).
Announced on 26 September 2025, the MHRA’s National Commission on the Regulation of AI in Healthcare is setting out to deliver a new framework that aims to modernise how AI in healthcare is regulated.
According to the MHRA, in the “absence of clear global consensus”, the UK is well-placed to play a leading role in shaping the regulation of AI in healthcare. And if the regulatory challenges posed by the technology are addressed properly, the agency asserts that AI could “transform patient care to be safer, faster and more personalised”, improve productivity within the NHS, and accelerate a “thriving health technology sector” that would support UK growth.
As per the findings, 73% of respondents disagreed or strongly disagreed that the existing regulation was sufficient with regard to safety and performance standards, while a collective 61% said the same about the existing regulation’s sufficiency regarding data privacy and governance.
Similar disagreement was levelled in response to the existing framework’s sufficiency regarding transparency, the current requirements for clinical evidence, and post-market surveillance dictates, at 71%, 61%, and 65%, respectively.
Meanwhile, other questions contained in the evidence call were more freeform, providing respondents with a chance to present their own suggestions across a range of topics in relation to AI regulation.
Regarding post-market surveillance for AI health technologies, respondents highlighted the importance of maintaining patient safety, ensuring that healthcare professionals undertake the training needed to operate AI systems, and confirming that AI systems address an unmet clinical need.
Regarding safety, respondents highlighted that further work should be undertaken to define clearer, shared responsibilities for those involved in deploying AI systems in healthcare. Some also called for more comprehensive governance structures to help oversee the deployment of AI systems, highlighting that such frameworks would help ensure responsible development, deployment, and monitoring across the lifecycle of an AI system.
Next steps towards developing new AI regulation
In the foreword to the National Commission’s report, which was authored by Professor Alastair Denniston, chair, and Professor Henrietta Hughes, deputy chair of the National Commission into the Regulation of AI in Healthcare, the authors wrote: “Across the evidence, we have seen a shared ambition. People want AI to improve patient care, support healthcare professionals, and deliver benefits across the system.
“They also want confidence that these technologies are safe, effective, and appropriately governed. The challenge is not choosing between innovation and safety; it is ensuring that both are achieved. This requires a new regulatory framework that is safe, fast and trusted.”
Findings from the National Commission’s report will now inform its final recommendations regarding a new AI regulatory framework, set to be released in the coming months to the MHRA, health system and wider government.
Once these have been published, the MHRA will work with the NHS, regulators and government to consider implementation. The agency’s work is mooted to consider how the National Commission’s recommendations align with commitments in the NHS 10-year plan and the Life Sciences Sector Plan. Both released in July 2025, these policy papers outline a commitment for the NHS to become the ‘most AI-enabled’ healthcare system in the world, driven by AI’s potential impact on workflows across the NHS, as supported by AI-based medical devices and software.
