Ministers give go-ahead to all 44 recommendations made by National Commission into the Regulation of AI in Healthcare, led by NHS doctors
NHS patients are to benefit from safe, effective and trusted AI technology, while robust safeguards are maintained. At least, that’s the claim made by the government as it accepts all the recommendations proposed last month by the independent National Commission into the Regulation of AI in Healthcare.
The commission’s report, Recommendations for a future regulatory framework, focused on three key themes. First, it called for proportionate product lifecycle regulation, with clear routes to market, flexible mechanisms to support rapid device iteration and stronger use of real-world evidence to support ongoing assurance.
The idea is that AI-enabled medical devices should be assessed and monitored throughout their working life rather than relying on one-time assessments. The Medicines and Healthcare products Regulatory Agency (MHRA) is putting this into practice immediately through the rollout of its
‘AI Airlock Phase 3’: it will work with developers, regulators and healthcare partners to test how AI devices can be safely monitored and managed for post-market surveillance after they are deployed, generating insights, evidence and solutions that will directly inform further MHRA guidance and policy. Applications are now open for developers of eligible AI-enabled medical devices; a webinar for prospective applicants will be held on October 22.
Next, the commission called for system-wide responsibility and safe management beyond regulation, with collaborative, system-wide effort from manufacturers, healthcare providers, healthcare professionals, regulators and policymakers. Thirdly, it made a number of recommendations related to trust, transparency and predictability. That includes working with partners across the health system to strengthen patient engagement in decision-making, improve access to redress where standards of care fall below expectations, and ensure the benefits of AI are shared fairly across all communities, including underserved groups.
In its formal response, the government has accepted all 44 recommendations made in the report. A full ‘roadmap’ of implementation, setting out timelines and responsibilities across all 44 recommendations, will be published by the spring of next year, with regular progress updates to follow.
James Frith MP, Minister for Health Innovation, says: ‘ We want all patients to benefit from the life-saving potential of AI, with the confidence that it is safe, effective and properly overseen. We also want to see the NHS harness the best new technologies to give patients faster, better care and give staff more time to focus on patients. But innovation must never come at the expense of patient safety.
‘This will be a continually-evolving process as the technology itself develops, but we are acting now by accepting in full all 44 recommendations of the Independent Commission, which will provide a foundation to embrace the opportunities AI brings while putting strong safeguards, transparency and public confidence at the heart of its use.’
Lawrence Tallon, Chief Executive of MHRA, adds: ‘The independent National AI Commission, led by NHS doctors, has given us a clear and ambitious blueprint for how we make the UK the best place to get AI products to patients safely, quickly and in a way that maintains public trust. I am pleased that today the Government is accepting its recommendations in full, whilst setting out a clear plan and oversight structure to deliver them. The MHRA’s AI Airlock is already opening its doors to more innovators who want to help us understand how these technologies can be implemented and monitored safely throughout their working life. This is about making sure patients can benefit from safe, trusted AI more quickly, while never losing sight of the safeguards that maintain public confidence.’
Professor Alastair Denniston, Chair of the National AI Commission, says: ‘I am delighted to welcome the government’s response to the National AI Commission, and its full acceptance of all our recommendations. This response shows that government has listened, not just to the Commission, but to the more than 12,000 patients, clinicians and members of the public who shaped our recommendations.
‘The government’s response is a welcome confirmation that it is committed to the Commission’s guiding principles namely that our approach to AI should be people-centred, and be underpinned by a regulatory system that is safe, fast, and trusted. The regulatory challenges being prioritised by AI Airlock Phase 3 is an early sign of that shift in practice, putting the lifecycle-based approach we recommended into action from day one.’
Photo by Nappy / Unsplash
In related news:
Online abuse is now a fact of life for UK women, says report
Leave a Reply