UK regulator calls for new AI regulations in healthcare

Sep 9, 2026

The UK National Commission into the Regulation of AI in Healthcare has released 44 recommendations to overhaul how medical artificial intelligence is regulated. Backed by the MHRA and shaped by 12,000 contributors, the proposals advocate for a staged 'L-plate' approval process, continuous post-market monitoring, and stronger enforcement powers to address 'model drift.' The review also highlights patient rights to transparency, amid findings that 40% of UK GPs already use AI scribes.

MHRA AI regulation recommendations

▪The National Commission into the Regulation of AI in Healthcare was launched in 2025 by the UK Medicines and Healthcare Products Regulatory Agency to develop a regulatory framework for generative AI tools
▪The National Commission into the Regulation of AI in Healthcare published 44 recommendations on September 10, 2026, to update UK policies for regulating artificial intelligence in medicine
▪The National Commission into the Regulation of AI in Healthcare compiled its recommendations based on evidence from more than 12,000 people, including patients, clinicians, healthcare leaders, and technology developers

Continuous monitoring requirements

▪The National Commission into the Regulation of AI in Healthcare recommended the continuous monitoring of artificial intelligence products and their removal from regulatory approval if they malfunction or lose effectiveness over time
▪The National Commission into the Regulation of AI in Healthcare proposed establishing a searchable source of safety information on AI-enabled medical devices, including reports of adverse incidents and malfunctions

Patient information rights

▪The National Commission into the Regulation of AI in Healthcare recommended giving patients the right to know if artificial intelligence is involved in their care and providing easy access to information about the products used
▪A study by the University of Edinburgh found that patients could be less likely to share personal information, such as substance abuse history, if they knew their consultation was being processed by artificial intelligence

AI scribes in general practice

▪Professor Henrietta Hughes stated that while many patients are comfortable with artificial intelligence scribes during consultations, some choose to opt out because they do not want to talk to a robot
▪Approximately 40% of UK-based general practitioners use artificial intelligence note-takers, known as scribes, to record consultations and generate reports

Regulatory framework challenges

▪The National Commission into the Regulation of AI in Healthcare recommended granting the Medicines and Healthcare Products Regulatory Agency stronger enforcement powers to penalize AI developers if their products fail to meet required standards
▪Medicines and Healthcare Products Regulatory Agency chief Lawrence Tallon stated that current medical device regulatory frameworks date from a period focused on physical devices like hip replacements and stethoscopes, making them ill-suited for adaptive AI models