The sandbox will help to inform future AI Airlock projects and influence future AlaMD guidance
The Medicines and Healthcare products Regulatory Agency (MHRA) has launched AI Airlock, a new regulatory sandbox, to address the challenges of regulating medical devices that use artificial intelligence (AI).
In alignment with the regulator’s goal for the UK to be a science and technology superpower by 2030, the new sandbox builds on the MHRA’s strategic approach to AI in April, which was set out to respond to a white paper published by the government in 2023.
It highlighted that the regulator is considering the opportunities and risks of AI from three perspectives: as a regulator of AI products, as a public service organisation delivering time-critical decisions and as an organisation that produces evidence-based decisions that impact public and patient safety, where evidence is often supplied by third parties.
The new sandbox for AI as a Medical Device (AIaMD) will help to address novel regulatory challenges across sectors and aims to seek out and support up to six virtual or real-world projects through simulation to test a range of regulatory issues for these devices when used for direct clinical purposes within the NHS.
The MHRA’s AI Airlock is “designed to assist in [the] safe development and deployment of AIaMDs” and will help manufacturers “deliver what is required to ensure the real-world viability of these devices,” outlined the regulator.
It takes into consideration evidence-based work produced by other bodies and will work collaboratively with the NHS AI Lab and the Department of Health and Social Care to inform future AI Airlock projects and influence future UK and international AlaMD guidance.
Dr Paul Campbell, head of software and AI, MHRA, commented: “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.
“The launch of the AI Airlock will enhance our collective understanding and accelerate solutions to novel regulatory challenges, ultimately improving the experience of patients.’’
