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MHRA launches AI regulatory sandbox

The Medicines and Healthcare products Regulatory Agency (MHRA) has launched a regulatory sandbox for artificial intelligence (AI) called AI Airlock.

The AI ​​sandbox is part of a pilot program, and the MHRA is initially looking for four to six virtual or real-world projects that would enable the agency to test a range of regulatory issues relating to standalone AI medical devices (AIaMDs) when they are used directly for clinical purposes.

The goal of the sandbox is to balance appropriate oversight to protect patient safety with the agility needed to address the challenges these products present, while ensuring that regulation does not act as a barrier to innovation.

AI Airock will take into account and work with other evidence-based work from other bodies such as the NHS AI Lab and the Department of Health and Social Care (DHSC).

The MHRA also believes that the devolved countries have a key role in regulatory discussions, particularly around AIaMD products, as they are implemented through NHS infrastructure.

Paul Campbell, director of software and artificial intelligence at the MHRA, said the UK market is currently seeing “significant growth in the number of innovative AIaMD products that have the potential to revolutionize the healthcare landscape and provide better ways to meet the needs of patients and society.”

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

“The launch of the AI ​​airlock will improve our collective understanding and accelerate solutions to new regulatory challenges, ultimately improving the patient experience.”

The aim is for findings from the pilot, a partnership between government, regulators and industry, to 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, setting out its approach to ensuring patient safety and innovation in the industry.

The agency also launched a roadmap on health technology regulation in January 2024, explaining plans for the new framework.

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

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

As part of Health Technology Innovation, the Government launched a £10 million fund in September 2023 to help providers create innovative technologies that can be quickly introduced into the NHS.

Innovation Device Access Pathway funding enables manufacturers and innovators to apply for targeted support and advice to create products that will be adopted by the NHS.

In October 2023, the government also launched a £30 million fund for integrated care systems across England to bid for funding for health technology investment.