The Medicines and Healthcare products Regulatory Agency (MHRA) has opened applications for its AI Airlock pilot, offering innovators the chance to benefit from expert support and sandbox testing for medical devices utilising AI.
Launched in spring of 2024, the AI Airlock programme is described by the MHRA as “a proactive, collaborative, agile and the first of its kind approach to identifying and addressing the challenges faced by AI as a Medical Device (AIaMD)”.
The pilot phase is intended to run until April of 2025, with applicants expected to be able to complete their testing within a six-month timeframe. The deadline for applications to be submitted is given as 7 October 2024.
Potential applicants are asked to complete an application form designed to “gather information about AI Medical Devices (AIaMD) and prototypes and evaluate their suitability for the AI Airlock pilot”. MHRA seeks information about the regulatory challenge innovators would like to address using the regulatory sandbox, the intended use summary of their proposed product, and their estimated data access requirements.
Applications will be assessed on their potential to deliver benefits for patients, the innovativeness of the proposed product or concept application, the regulatory challenge that it presents, and the existence of a plan outlining a clear challenge, high-level objectives, data access, and quality management systems.
As far as outputs, project reports will be completed by each project team, and a report of learnings will be published to “inform future guidance and implications for the regulatory framework”, along with a programme evaluation report to share learnings on the regulatory sandbox approach.
To find out more about the AI Airlock pilot, please click here.
AI regulation and innovation
A recent HTN Now panel discussion in mid-August focused on the outlook for AI, managing bias, the deployment of AI in the NHS, and the potential for AI to support the shift from reactive to proactive care. Our panel included Puja Myles, director at MHRA Clinical Practice Research Datalink, who shared that “the AI revolution is going to be fuelled by data, and we’re constantly getting asked whether our data is ready for AI”.
In August, we also explored some recent updates from across the NHS which share insight into how AI tools are being utilised and tested, covering their use in identifying abnormalities, predicting Alzheimer’s, tackling waiting lists, and more. Two questions posed to our audience in the same month highlighted some of the biggest concerns for AI in healthcare, and barriers to responsible AI, including transparency, equitability, and regulation.
Just this month, new guidance was published by Health Level Seven International (HL7) on the artificial intelligence and machine learning data lifecycle, intended as an “informative document” to help developers in promoting the use of of standards to “improve the trust and quality of interoperable data used in AI models”.
Innovation in health and care
HTN’s panel discussions from the last couple of months have taken a strong focus on innovation, with one event in August exploring innovation in primary care, considering what that innovation looks like, digital and patient access, and barriers for innovators. The same month saw us welcome expert panellists from the primary care space, who presented a case study of innovation at a medical centre in the North East Of England, looking specifically at patient experience, practice improvement, and the future of innovation in primary care.
August also brought news of the launch of a partnership between the NHS Clinical Entrepreneur Programme (CEP) and Alzheimer’s Society to develop the Dementia Innovators programme, a pilot designed to explore ideas with the potential to support dementia care from professionals inside and outside the NHS.
Funding news for innovation for September to date has included the launch of a new £250,000 fund for innovation and digital tools in wound care has been announced, designed to improve outcomes for patients with chronic wounds by supporting widespread adoption of digital wound management in community nursing. SBRI Healthcare also announced a new funding competition seeking “work-related digital innovations for individuals with poor mental health”, focusing on supporting individuals to stay in work, return to work, or overcome barriers to workforce entry.
