RCP engagement on AI regulation and the future of digital healthcare

Since the publication of its RCP view on digital and AI report in January, the Royal College of Physicians (RCP) has been working to help shape the national conversation on the safe and effective use of AI in healthcare.

We submitted a written response to the Medicines and Healthcare products Regulatory Agency (MHRA) consultation on the regulation of AI in healthcare. Our submission highlighted the urgent need for a stronger, clearer and more coherent regulatory system that enables innovation while ensuring patient safety, transparency and accountability.

AI is already beginning to shape clinical practice across the NHS. But as the recent RCP view on digital and AI report makes clear, digital transformation and the use of AI can put patients at risk if the NHS does not get the digital basics right first. Safe care depends on reliable digital infrastructure, secure and interoperable systems, high quality data, strong governance and tools that are designed around real clinical need.

In our response, we stressed that the current regulatory landscape is not keeping pace with the speed of AI development, and that this has potential patient safety implications and concerns regarding liability. Findings from our June 2025 member snapshot survey show that:

• 36% said a lack of regulation was a key barrier to introducing AI safely
• 54% highlighted concerns around liability
• 73% said the risk of error was their biggest concern when using AI in clinical practice.

Our response calls for:

• A joined up national regulatory framework, with safety and transparency at its core. Standards for interoperability, preventing further fragmentation of NHS digital systems
• Improved oversight of data governance, ensuring datasets are representative, secure and high-quality
• Clearer procurement standards, so NHS organisations can confidently adopt safe, compliant tools.

Alongside the formal consultation response, the RCP attended a focus group to support the National Commission for Regulation of AI in Healthcare, established by the MHRA. This provided a further opportunity to represent physicians’ perspectives as the regulatory framework is developed.

This engagement forms part of the RCP’s wider commitment to shaping the rapidly evolving landscape on AI in healthcare. The RCP will continue to advocate for regulation that enables safe, effective and equitable adoption of AI across the NHS.

For more information on the RCP’s work on digital and AI, read the full report RCP view on digital and AI and the snapshot survey here.