MHRA launches AI regulatory sandbox

The Medicines Healthcare Products Regulatory Agency (MHRA) has launched a regulatory sandbox for artificial intelligence (AI), named AI Airlock.

The AI sandbox is part of a pilot programme, and the MHRA is initially looking for four to six virtual or real-world projects to allow the agency to test a series of regulatory issues for standalone AI medical devices (AIaMD) when they are used directly for clinical purposes.

The aim is for the sandbox to balance appropriate oversight to protect patient safety with the agility needed to respond to the challenges these products bring, ensuring regulation does not act as a barrier to innovation.

The AI Airock will take into account other evidence-based work produced by other bodies, such as the NHS AI Lab and the Department of Health and Social Care (DHSC), and are working collaboratively with them.

The MHRA also sees the devolved nations are key when it comes to regulatory discussions, particularly around AIaMD products, as they are deployed via NHS infrastructure.

Paul Campbell, head of software and AI at MHRA, said there is currently a “marked increase in innovative AIaMD products entering the UK market that have the potential to revolutionise the healthcare landscape and provide improved ways to address patient and public needs”.

“As a regulator, we must balance appropriate oversight to protect patient safety with the agility needed to respond to the particular challenges presented by these products to ensure we continue to be an enabler for innovation,” he said.

“The launch of the AI Airlock will enhance our collective understanding and accelerate solutions to novel regulatory challenges, ultimately improving the experience of patients.”

The aim is that the findings from the pilot, which is partnership between government, regulators and industry, will inform future AI Airlock projects and influence future national and international guidance on AIaMD.

In April 2024, the MHRA set out its AI regulatory strategy, outlining its approach to ensure patient safety and industry innovation.

The agency also launched a roadmap for regulations on medical technologies in January 2024, explaining plans for a new framework.

The framework will cover both existing technologies, as well as future ones, including new implantable devices, the use of artificial intelligence (AI), software, and any diagnostic technologies used for early detection and prevention of disease.

The MHRA, which sits under the Department for Health and Social Care (DHSC), aims for the core elements of the framework to be in place by 2025.

As part of its med tech innovation drive, the government opened a £10m fund in September 2023 to help suppliers create innovative technologies that can quickly be introduced to the NHS.

The funding for the Innovative Devices Access Pathway allows manufacturers and innovators to apply for targeted support and advice on how to create products that will be adopted by the NHS.

In October 2023, the government also launched a £30m fund for integrated care systems across England to bid for funding to invest in medical technologies.