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UK AI Healthcare Rules Face Major Overhaul Calls
11 Jun
Summary
- Most favor substantial or complete reform of AI healthcare regulation.
- Key concerns include safety, performance, data governance, and privacy.
- New framework aims to modernize AI regulation by late 2026.
A significant consultation by the Medicines and Healthcare products Regulatory Agency (MHRA) has shown that most stakeholders desire substantial or complete reform of artificial intelligence (AI) regulation within the UK's healthcare sector. The current system, which regulates AI as medical devices, is considered by many to be falling short.
Conducted from December 19, 2025, to February 2, 2026, the call for evidence gathered 761 responses. A majority expressed dissatisfaction with the existing regulations concerning safety, performance standards, data governance, and privacy. Specifically, 73% disagreed with the current safety and performance standards, while 61% felt the same about data privacy and governance.
The MHRA announced on September 26, 2025, its National Commission on the Regulation of AI in Healthcare to create a modern framework. The agency believes the UK can lead globally in shaping AI healthcare regulation. Addressing these challenges could transform patient care, enhance NHS productivity, and foster a strong health technology sector.
Respondents emphasized the need for clearer responsibilities in deploying AI systems, robust governance structures, and comprehensive training for healthcare professionals. They also stressed maintaining patient safety and ensuring AI addresses unmet clinical needs.
Findings from the National Commission's report will inform final recommendations due in the coming months. These will guide the MHRA, NHS, and government in developing and implementing a new regulatory framework, aligning with the NHS's goal to be the most AI-enabled healthcare system.
