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Following extensive engagement, an independent expert commission led by doctors working in the NHS has published a blueprint for the regulation of AI in healthcare.
An independent expert commission led by doctors working in the NHS has published its blueprint for the regulation of AI in healthcare. The recommendations were made following extensive public, professional and industry engagement.
The National Commission into the Regulation of AI in Healthcare found there is broad public support for AI when used to improve healthcare. But strong safety standards, human oversight and transparency whenever AI is used is also essential.
“We innovate because we believe tomorrow’s healthcare can be better than today,” explained Alastair Denniston, chair of the National Commission, who is an NHS consultant ophthalmologist and professor of regulatory science and innovation at the University of Birmingham. “But any new innovation – including AI – needs to earn its place and earn our trust. These technologies need to show that they are safe, effective and bring benefits to patients, staff and the wider NHS, without leaving people behind.”
Input from all parties
Established by the Medicines and Healthcare products Regulatory Agency (MHRA) in September last year, the independent National Commission sought input from more than 12,000 people over the course of a year. This included patients, the general public, clinicians, healthcare leaders, plus industry and technology developers.
“One message came through clearly,” Denniston said, “people are open to AI improving their care, but only if it safe, overseen by humans, and if they know when it is being used. These recommendations are designed to make that trust possible, so that the UK can lead the world not just in developing AI for healthcare, but in showing how it can be regulated and used responsibly.”
The MHRA has welcomed the report and praised it for setting out “in more detail than ever before how we should best regulate AI in healthcare”.
“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,” said Lawrence Tallon, the MHRA’s chief executive. “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.”
Chief recommendations
The National Commission has highlighted four key recommendations to strengthen the regulation of AI in healthcare to enable it to remain safe, keep pace with innovation, and continue to earn people’s trust.
First, faster access to safe and effective AI. The introduction of staged authorisations for new AI models, similar to L-plates for learner drivers, would facilitate earlier patient access to promising new AI models.
Next, continuous monitoring through AI device’s lifecycle – the independent commission recommends that AI-enabled medical devices should be subject to continuous, real-world monitoring throughout their working life.
“We are particularly pleased to see specific support for monitoring of AI-enabled medical devices once they are in use,” said Stephen Harden, president of the Royal College of Radiologists, one of the organisations that contributed evidence to the Commission. “Getting this right will give doctors confidence to use AI tools, while protecting patient safety.”
Third, public access to safety information. Members of the public should be able to easily search for information about the safety of specific AI-enabled medical devices. This would build on tools such as the MHRA’s interactive Drug Analysis Profiles, and would give patients and the public clear, accessible information they can trust.
And fourth, tougher powers to protect patients – the independent commission has recommended the introduction of stronger powers for the MHRA, including enhanced enforcement powers, to ensure that where AI systems fall short of the standards that patients expect, the regulator can act decisively.
Statement of intent
The Professional Standards Agency and 38 health and social care regulators have newly released a statement of intent in response to the National Commission’s recommendations. They will jointly develop a set of high-level principles to guide how they will regulate the use of AI by health and social care professionals across the UK.
Bernie O’Reilly, registrar and chief executive of the Health and Care Professions Council said public trust will be “essential” if the benefits of AI are to be realised. “People should be able to understand when AI is being used in their care and have confidence that professionals can explain how it has informed decisions affecting them. Health and care professionals remain responsible for the decisions they make, regardless of whether AI has been used to support them,” she added.
The government and the MHRA have said they will carefully consider the National Commission’s recommendations, and a formal response will follow in due course.
