UK Medicine and Healthcare Regulator Launches Sandbox for AI-driven Medical Services

The UK Medicines and Healthcare products Regulatory Agency has announced going forward with its new regulatory sandbox, ‘AI Airlock.’ The pilot project is part of MHRA’s strategic approach to AI.

The regulatory sandbox will help the agency identify and address the challenges for regulating standalone AI medical devices. Initially, it will seek out and support 4-6 virtual or real-world projects through simulation. This will enable the agency to test a range of regulatory issues of the devices when they are used for clinical purposes within the NHS.

The AI Airlock is designed to assist in the safe development and deployment of AI as a Medical Device (AIaMD). Moreover, this project will follow that robust process so manufacturers can deliver what is required to ensure the real-world viability of these devices.

The regulatory sandbox takes into account the evidence-based, similar work that other bodies produce. Further, the MHRA will collaborate with the NHS AI lab and the Department of Health and Social Care (DHSC).

Dr. Paul Campbell, MHRA Head of Software and AI, says, “The new AI-Airlock scheme run by the MHRA will give us answers about how best to provide safe and effective products, such as AI-driven medical devices, to the NHS and patients.”

Dominic Cushnan, NHS England AI, Imaging & Deployment Director, says, “The NHS is already a leader in the testing of new AI technologies, and I am proud that we are now funding and collaborating on this new initiative with the MHRA to help move the dial even further, to bring the latest state-of-the-art AI and its benefits to the NHS and patients faster.”

This partnership between government, regulators, and industry will lead to advanced AI technology being used in NHS settings with strict safety controls ahead of navigating regulatory approval.