The sandbox will help inform future AI Airlock projects and influence future AlaMD guidance.
The Medicines and Healthcare products Regulatory Agency (MHRA) has launched a new regulatory sandbox, AI Airlock, to address the challenges of regulating medical devices that use artificial intelligence (AI).
In line with the regulator’s aim to make the UK a science and technology powerhouse by 2030, the new sandbox is part of the MHRA’s strategic approach to AI, which was set out in April in response to the government’s white paper in 2023. Based on the approach.
The report examines regulators from three perspectives: as regulators of AI products, as public service organizations making time-sensitive decisions, and as organizations making evidence-based decisions that impact public and patient safety. We emphasized that we are considering the opportunities and risks of AI. , evidence is often provided by a third party.
The new AI as a Medical Device (AIaMD) sandbox will help address emerging regulatory challenges across sectors, discovering and supporting up to six virtual or real-world projects through simulation to It is intended to test various regulatory issues. Used for direct clinical purposes within the NHS.
MHRA’s AI Airlock is “designed to support the safe development and deployment of AIaMD” and will provide manufacturers with “what they need to ensure the real-world viability of these devices.” ”, the regulator outlined.
It takes into account evidence-based research produced by other agencies and will work with the NHS AI Lab and the Department of Health and Social Care to inform future AI Airlock projects and help future UK and international is expected to influence AlaMD’s guidance.
Dr Paul Campbell, Head of Software and AI at MHRA, commented: “As regulators, if we are to remain an enabler, we must balance appropriate oversight to protect patient safety with the agility needed to respond to the specific challenges posed by these products. ” for innovation.
“The launch of AI Airlock deepens our collective understanding, accelerates solutions to emerging regulatory challenges, and ultimately improves the patient experience.”
