The 10 Year Health Plan for England and the Life Sciences Sector Plan commit to the NHS becoming the most AI-enabled healthcare system in the world, acknowledging the need for a modernised regulatory framework.
The UK regulator, the MHRA, has undertaken an extensive evidence-gathering process on the use of AI in healthcare. I had the opportunity to participate in this process as part of the Stakeholder Engagement programme forming part of this project. The aim is to develop an effective and proportionate regulatory framework which has both industry buy-in and public support in this rapidly evolving area of technology.
Two reports have now been published by the UK National Commission into the Regulation of AI in Healthcare reflecting this wide-ranging consultation. Together, they confirm strong interest in AI’s potential, coupled with clear expectations that adoption must be safe, trustworthy and properly governed.
The existing regulatory framework is seen as providing a foundation for safety, although falling short in its response to evolving AI systems. Some frustration with the whole system is apparent, with a healthcare professional quoted as saying:
“The current UK pathway for getting AI and digital health technologies into the NHS feels too restrictive and creates unnecessary friction for safe, evidence-based innovation.”
This chimes with our experience. Current systems are not a good fit and inhibit take-up of efficiency-enhancing innovations with little apparent link to real risk profiles.
Both reports indicate broad support for the use of AI in healthcare, while focusing on how it can be used safely, effectively and legitimately. Maintaining trust is a central concern.
The evidence points toward a regulatory model with the following features:
- lifecycle-based, involving ongoing monitoring and continuous post-market surveillance, rather than one-off approval
- risk-proportionate, with greater levels of scrutiny for higher-risk uses
- clarity and consistency as to how responsibility and liability is allocated across manufacturer, healthcare organisation and healthcare professionals
- embedding human oversight and clinical judgment
- transparency and explainability to enable both patients and users to understand the AI system, and manufacturers to understand regulatory and procurement processes
Alongside these regulatory changes, contributors also highlighted the need for training and improved AI literacy among users, as well as ways to enable access to patient data subject to clear governance arrangements and access standards. New approaches to enabling access to data, as well as promoting take-up of effective new technologies in the clinic, will be required alongside updates to the regulatory framework.
The UK has undertaken a major review of its medical device laws in recent years. This is nearing completion, with post-market surveillance changes in place, and legislative changes for pre-market requirements recently published in draft form. The pre-market reforms include several relevant provisions, such as requirements addressing pre-determined change control plans. The National AI Commission expects to publish its final recommendations in late summer 2026 - regulatory changes specifically addressing the use of AI in healthcare will need to dovetail with the updated regulations.
This will be a challenging task for regulators and the NHS, but this work has the potential to realise real benefits for innovative industry, healthcare providers and, most importantly, patients.
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