Expressions of interest are being sought from manufacturers and Greater London NHS organisations for MHRA’s AI regulatory sandbox for the London region, with projects to be selected to participate in the initial phase deploying tech into live clinical settings.
The initiative, London Region I, is set to create a real-world environment for the safe deployment of AI-enabled medical devices, offering the chance to generate evidence of benefits from NHS settings, and promote earlier patient access to new technologies, the MHRA reports.
Areas of particular interest, according to the agency, include AI devices to support preventative and proactive care, neighbourhood health services and community-based care, digital access to health services including the NHS App, and innovations to improve patient outcomes and service delivery in the London region.
Providers should be located in Greater London, and will be required to complete a DPIA prior to sharing or using any health and care data, it states. A plan should be in place to support the adoption and scaling of a device as part of the programme, the agency continues, and providers must be willing to commit the “necessary resource” to embed or deploy the selected device and support evaluation.
From providers, the expression of interest form asks for a summary of relevant AI governance infrastructure across sites, governance infrastructure or processes to support innovation adoption, and clinical, strategic, and operational leadership capacity committed to supporting participation.
Manufacturers are expected to have products designated as medical devices under the UK Medical Devices Regulations 2002, to be a legal entity with the rights to market medical devices in the UK, and to commit to working with the London Region I team and partners on the assessment of the programme.
Questions from the expression of interest form cover intended purpose, structure and function, target patient population, users, and the intended environment, as well as proposed device classification and rationale.
The call will remain open until the ten devices have been selected, assessed, and deployed, according to the agency, with further information to follow at a later date.
Wider trend: Health AI
For a recent session focusing on AI in healthcare, HTN was joined by an expert panel including Simon Brown, head of digital at Royal Papworth Hospital NHS Foundation Trust; Wahida Jabarzai, clinical AI and automation delivery lead at University Hospitals of Northamptonshire and University Hospitals of Leicester; and Julian Wiggins, healthcare solution director at Rackspace Technology. Our panel considered the wider challenge of AI adoption, looking at what makes a successful deployment, introducing AI safely and sustainably at scale, and some of the use cases currently delivering value across their organisations.
The MHRA has published findings from the National Commission into the Regulation of AI in Healthcare research, pointing to the need to balance a desire to use AI in improving patient care and supporting healthcare professionals, with “safe, fast and trusted” regulation. Almost three-quarters of respondents (73 percent) disagreed or strongly disagreed that the current regulatory framework is sufficient to ensure safety and performance standards; with 61 percent disagreed or strongly disagreed with its effectiveness in tackling data governance and data privacy. 61 percent also thought current requirements for clinical evidence are insufficient, and 65 percent pointed to a need for more to be done on post-market surveillance.
An AI system is being used to colour code internal anatomy during surgery at London North West University Healthcare NHS Trust, said to help surgeons to see subtle structures that might be hard to distinguish with the eye. The Eureka system analyses the surgical field in real-time, overlaying colours onto structures such as nerves and connective tissue. Surgeons are able to choose between keeping the overlay constant, or having it pulse intermittently during different stages of a procedure. St Mark’s National Bowel Hospital is one of the sites helping to evaluate the system. Kapil Sahnan, colorectal surgeon, was one of the first to try out the new system during a bowel resection procedure, describing it as like having an “extra arm”.
