The UK’s medicines watchdog has warned that new laws are required to police the use of artificial intelligence in healthcare, including the power to issue heavy fines to tech firms that put patients at risk.
The National Commission into the Regulation of AI in Healthcare published its final blueprint on 10 September 2026, marking the conclusion of a major inquiry established a year earlier. The report sets out recommendations for how the NHS and private providers should handle the rapid integration of AI into diagnosis, surgery, and patient data management.
Lawrence Tallon, chief executive of the Medicines and Healthcare products Regulatory Agency (MHRA), stated that regulation needs a “hard edge.” He has specifically called for enhanced enforcement mechanisms, giving the regulator the authority to fine AI companies if their software leads to patient harm.
The ‘L-plate’ system for AI
One of the central proposals in the report is a move away from “one-off” approvals for medical technology. Because AI software can learn and change over time, the commission recommends a “staged authorisation” model, described as an “L-plate” system.
Under this framework, AI tools would be tested and monitored in real-world clinical settings before receiving full certification. This “lifecycle monitoring” approach would replace the current system, where a device is typically certified once before being sold to hospitals.
The commission’s work was informed by a consultation with more than 12,000 stakeholders, including doctors, nurses, and patient groups.
Rights for patients
The report calls for continuous, real-world monitoring of AI throughout its lifecycle rather than a single point-in-time approval.
The commission also addressed the issue of legal liability. It has proposed a “shared-responsibility model,” where both the software manufacturers and the healthcare providers using the technology are held accountable for safety.
A full copy of the National Commission’s recommendations has been submitted to the government.
Pending government response
The government is expected to provide a formal response to the commission’s recommendations in the coming months. Until new legislation is passed, the MHRA will continue to operate under existing medical device regulations, which do not currently include the specific “hard edge” fining powers requested by the watchdog.