National Commission sets out recommendations for the future of AI in healthcare

The National Commission into the Regulation of AI in Healthcare has published its recommendations for how the UK’s regulatory framework should evolve as AI becomes increasingly developed and used across healthcare. 

AI is transforming healthcare. Regulation must keep pace  

AI has the potential to support earlier diagnosis, more personalised care, improved patient outcomes and better experiences for healthcare professionals, while helping the NHS and wider health system meet rising demand. 

But AI can also evolve over time, perform differently across settings and patient populations, and depend on the environments in which it is used. The regulatory framework therefore needs to evolve with the technology. 

"As healthcare continues to evolve, it is vital that innovation is supported by a regulatory framework that is both robust and responsive. Health Innovation Wessex welcomes these recommendations, which will help create the conditions for innovators, healthcare organisations and regulators to work together in bringing safe, effective AI solutions into everyday care. 

“Across Wessex, we are supporting the adoption and evaluation of emerging technologies, from the use of AI to safely reduce administrative burden through Ambient Voice Technology, to the development of digital tools that support clinical decision-making and remote patient monitoring. We are also helping build the evidence, confidence and partnerships needed to adopt these technologies safely and at scale. 

“The Commission's recommendations provide an important foundation for responsible innovation that can keep pace with technological change and help to strengthen public trust while ensuring patients, clinicians and communities can benefit from advances in AI." 

Nicola Bent, Chief Executive Officer, Health Innovation Wessex 

What the Commission heard 

The Commission’s recommendations have been shaped by evidence, expertise and extensive engagement. This has included input from its four expert working groups and wider research and engagement with patients and the public, healthcare professionals, healthcare organisations, industry, researchers, regulators and others across the health system. 

The evidence showed strong support for the use of AI in healthcare, but that support is conditional rather than automatic. People want to know that AI can be used safely, fairly and transparently, with clear evidence of benefit, meaningful human oversight and accountability. Trust cannot simply be assumed. It must be earned. 

The Commission’s response 

The Commission’s central conclusion is that the regulation and assurance of AI in healthcare needs to become more proportionate, lifecycle-based and system-wide. Its vision is for a future framework that is Safe, Fast and Trusted: Safe in protecting patients and managing risk; Fast in enabling responsible innovation and timely access to beneficial technologies; and Trusted in giving confidence across the healthcare system.  

The Commission’s recommendations are organised around three connected areas of change. 

1. Proportionate lifecycle regulation 

This means having the right safeguards, at the right time, for the right level of risk. Regulatory requirements should reflect what a technology does, the benefits it could bring, the risks it presents and the level of uncertainty around it.  

Safe, low-risk tools that support staff, improve services and patient care, should face lighter requirements, so those benefits are not unnecessarily delayed. However, products that have a greater effect on someone’s health or care, or where there is greater uncertainty, would need stronger safeguards matched to their level of risk. Oversight must continue throughout the lifecycle; this means ensuring safety from the start but also continuing through deployment, monitoring, updating and ongoing learning from real world use.  

2. System-wide responsibility and safe management 

This means recognising that keeping AI safe is a shared responsibility. Regulation alone cannot ensure the safe and effective use of AI. Manufacturers, healthcare providers, healthcare professionals, regulators and policymakers all have a role to play.  

The future framework should support clearer responsibilities, stronger organisational readiness, appropriate workforce capability and effective governance. No one should be left responsible for something they cannot understand control or act on. 

3. Trust, transparency and predictability 

This means recognising that trust must be earned. Patients and healthcare professionals need clear and accessible information about how AI is being used, alongside transparency, accountability and meaningful involvement so they can have confidence in the technologies supporting their care. Developers and manufacturers also need clearer and more predictable pathways through the regulatory system, helping them understand what is expected and giving them greater confidence to bring safe and beneficial technologies into healthcare responsible.  

What this means for you 

Patients and the public: Confidence and clarity 

Greater confidence that AI is safe, effective, fair and properly governed, with clearer information, continued safety checks and routes to raise concerns. 

Healthcare professionals: Confidence to use AI safely 

Better evidence and information, clearer responsibilities, appropriate training and practical support to use AI confidently while keeping professional judgement and patient care central. 

Healthcare providers: Readiness and safe adoption 

Clearer evidence, responsibilities and practical tools to help organisations choose, introduce, monitor and manage AI safely. 

Developers and manufacturers: Clarity and predictability 

A clearer, more proportionate and predictable regulatory environment, with better-defined requirements and expectations across the product lifecycle.  

How we can help you  

Health Innovation Wessex is committed to supporting the safe and responsible adoption of AI and digital innovation, helping NHS organisations realise benefits for patients, staff and services at scale. Our Chief Commercial Officer holds a joint role with Wessex Secure Data Environment, and is responsible for shaping data-enabled transformation, innovation adoption, and unlocking value for patients, the NHS and industry. These opportunities include the use of the AI Sandbox to generate real world evidence for industry partners. For more information about our data, digital and AI expertise, contact enquiries@hiwessex.net.