The National Commission into the Regulation of AI in Healthcare has published a report covering a set of recommendations for artificial intelligence (AI-)enabled healthcare.
The commission gathered evidence from more than 12,000 people over the course of a year, including patients, the public, clinicians, healthcare leaders, industry and technology developers. In-depth research was additionally conducted by Health Foundation with members of the UK public to provide a detailed insight into the UK public’s priorities and expectations for the regulation of AI in healthcare.
It has recommended that the Medicines and Healthcare products Regulatory Agency (MHRA), which is responsible for regulating all medicines and medical devices in the UK, introduce staged authorisations for new AI models where new models are deployed under close supervision and tight guardrails.
The commission said this allows them to demonstrate real-world safety and performance before they are granted fuller authorisation. It said the staged approach is designed to give UK patients world-first access to promising new models, while ensuring risk is carefully controlled at every step.
The commission wants AI-enabled medical devices to be subject to continuous, real-world monitoring throughout their working life. It said this reflects how AI technologies evolve after they are deployed, rather than at the point of approval alone, and helps to ensure that as AI systems learn and adapt, patients remain protected and regulators have the visibility they need to act quickly if problems emerge.
Looking specifically at the recommendation for continuous monitoring, Stephen Harden, president of the Royal College of Radiologists, said: “The AI landscape is only getting more complex, and so we are proud to have contributed to this important work. We are particularly pleased to see specific support for monitoring of AI-enabled medical devices once they are in use; getting this right will give doctors confidence to use AI tools, while protecting patient safety. We urge the government and the MHRA to put these important recommendations into practice without delay.”
The third recommendation covers providing the public with easily searchable information relating to the safety of specific AI-enabled medical devices, including any adverse incidents. The commission said this would build on tools such as the MHRA’s interactive Drug Analysis Profiles, giving patients and the public clear, accessible information. Alongside this, the commission said there needs to be a proportionate approach to keep patients informed about how AI is being used in their care as the technology becomes more embedded in NHS services.
Its final recommendation calls for stronger powers for the MHRA, including enhanced enforcement powers, to ensure that the regulator can act decisively where AI systems fall short of the standards patients expect.
The report’s authors, Alastair Denniston and Henrietta Hughes, both practicing NHS doctors, said: “The National Commission into the Regulation of AI in Healthcare is about defining what we want our future AI-enabled healthcare system to look like, and how we use regulation to shape that future. This is about creating a future healthcare system that is increasingly tech-enabled and always people-centred.”
Among the challenges the MHRA and the NHS will need to address is how to regulate AI effectively.
Jennifer Dixon, chief executive of the Health Foundation, said: “The real test will be whether the NHS has the capacity, skills and systems in place to implement and monitor AI applications safely and effectively at the scale now needed.”
Commenting on the report, Lawrence Tallon, the MHRA’s chief executive, said: “We have heard clearly about the opportunities of AI to speed up and improve care, and to release more of clinicians’ time for the essentially human aspects of their work with patients.
“We will only realise those opportunities if we have a modern, dynamic regulatory framework that accelerates safe adoption, protects patients and commands public and professional confidence.”
The government and the MHRA will now be assessing the commission’s recommendations.
