HRA welcomes new recommendations on AI regulation in healthcare

Last updated on 10 Sep 2026

We welcome today's publication of the National Commission into the Regulation of AI in Healthcare report, which sets out recommendations to support the safe, effective and proportionate adoption of artificial intelligence across health and care.

As a key stakeholder, we worked closely with the Commission throughout the development of its recommendations bringing expertise on research governance and regulation, public trust and public involvement.

In our feedback we highlighted the challenges that arise as AI technologies move through development, evaluation, deployment and ongoing use. We also emphasised the need for greater clarity about when AI-related activities constitute research, what regulatory and governance arrangements apply and how these interact with other regulatory routes.

The report includes recommendations that recognise the HRA's role in helping organisations understand these requirements and supporting researchers and developers to navigate the wider regulatory landscape.

We will now consider the recommendations alongside delivery of our new two-year plan to enable safe AI-powered innovation in health and social care research, which sets out how we will provide clearer guidance, improve our processes, and help researchers and developers understand when research governance requirements apply. We will continue working with the Medicines and Healthcare products Regulatory Agency (MHRA) and other partners to provide clearer, better-connected and proportionate routes through the regulatory and governance system.

The HRA has already committed, through its 2025-28 strategy, to enabling researchers to use new technologies such as AI to improve care in ways that people can trust.

The report rightly places public trust, transparency and meaningful patient and public involvement at the heart of the future regulatory framework for AI-enabled technologies.

"Artificial intelligence has enormous potential to improve health and social care research and ultimately deliver better outcomes for patients and the public. To realise those benefits, it is essential that innovation is ethical and is supported by clear governance, transparency and public trust.

"Today's report recognises the importance of helping organisations navigate the increasingly blurred boundaries between research, innovation and clinical care, while ensuring patients and the public remain at the centre of decision-making.

"We are committed to making it easier to do health and social care research that people can trust. We therefore welcome the report's focus on transparency, accountability and public confidence, and its recognition that meaningful public involvement must remain central as the use of AI continues to grow.

"We look forward to continuing our work with partners across the health and regulatory landscape to support the safe and trusted use of AI in health and social care research."

Matt Westmore, Chief Executive of the HRA
Back to news and updates