The UK Medicines and Healthcare products Regulatory Agency (MHRA) has launched a call for evidence seeking input from the healthcare providers, industry, public, and clinicians on AI regulation in national healthcare.
The initiative aims to shape future standards and safeguards for the way AI is used in healthcare settings.
This call for evidence will inform the work of the newly established National Commission into the Regulation of AI in Healthcare.
The commission brings together experts from global AI fields, clinicians, patient advocates, and regulators to advise MHRA on the future regulatory landscape for health-related AI.
MHRA is inviting opinions from a broad group, including health professionals, patients, members of the public, and innovators.
It aims to gather a diverse range of perspectives to guide the development of proportionate regulation for the wider healthcare system and emerging AI technologies in the NHS.
The call addresses several themes, including clarification of responsibilities among companies, healthcare organisations, individuals, and regulators involved in deploying AI technology; whether current rules for AI in healthcare are adequate or require modernisation; and strategies for maintaining patient safety as AI systems evolve.
MHRA CEO Lawrence Tallon led the formation of the commission.
Tallon said: “AI is already revolutionising our lives, both its possibilities and its capabilities are ever-expanding, and as we continue into this new world, we must ensure that its use in healthcare is safe, risk-proportionate and engenders public trust and confidence.
“Today we are asking the public to contribute by sharing their thoughts, experiences and opinions.
“We want everyone to have the chance to help shape the safest and most advanced AI-enabled healthcare system in the world at this truly pivotal moment.”
The commission’s call for evidence will run from 18 December 2025 to 2 February 2026. The findings will inform its recommendations to the MHRA in 2026.
In November 2025, MHRA granted approval to Roche’s Itovebi (inavolisib) for the treatment of adults with hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer.
