We want to create a network called MARGARITA to help innovators to reduce risks when developing and regulating medical tests (In vitro diagnostics or IVDs). This network will bring together experts in technology, research, and healthcare, along with input from regulatory bodies and policy makers. We'll have meetings and workshops to assist IVD developers, especially those just starting out, in setting priorities and creating practical uses for their tests. We will gather knowledge from these engagements to develop better ways of understanding different settings and users. This will help innovators to select appropriate settings for their products and regulators to set up appropriate safety and performance standards. MARGARITA also provides an opportunity for horizon scanning and testing regulatory theories for new and innovative technologies. Our project is innovative because currently there is no system to examine such decisions which happen at a very early stage of product development. Innovators often do not have opportunities to validate their ideas. This understanding is however crucial, as it defines the route an innovation will be commercialised, for whom, where and how to use. Our ambition is to systematically integrate into commercial planning such information on risks, benefits and costs. This, we believe, would bridge the gap and increase the chances that the technology better fits the needs and can reach the market. Regulators will benefit from influencing early stage developments, and set appropriate performance goals as well as develop new schemes. Ultimately this means safer, more effective tests for the patients and public. We will borrow insights from best practices in related fields, including regulating risks in drugs, decision making, risk analysis, and behavioural sciences. At the core of our network we have academic centres (e.g. London IVD, Imperial College), healthcare providers (e.g. Imperial College NHS trust), and industry body (e.g. ABHI). We are already connected to larger networks including BIVDA, Royal Marsden, UCLH, CRUK, PCUK etc as well as Patient and Public Involvement and Engagement (PPIE) groups. These allow us to gather the expertise, experiences required and to disseminate our learning widely.

The UK has a unique opportunity to lead the way in the rapidly growing fields of artificial intelligence (AI) and digital healthcare. To consolidate its position as a global leader in this field, the UK needs to ensure regulation is optimised to accelerate innovation ('pro-innovation') whilst also ensuring these technologies are cost-effective, safe, equitable, and sustainable ('responsible innovation'). Regulatory science brings scientific methodology to support this optimisation process, but most regulators currently lack this expertise 'in house', especially for novel and advanced technologies. Ensuring regulators strike this balance will be the remit of the UK Regulatory Science and Innovation Network for AI and Digital Health Technologies. The Network will bring together experts working in different sectors to enhance the efficiency, effectiveness, safety, fairness, and sustainability of regulation and innovation. It will do so by connecting experts and supporting their ability to work together on pressing scientific questions which will streamline regulatory policy and facilitate a faster translation of these technologies from concept to consumer. The Network brings together for the first time the UK's leading regulatory partnerships addressing the urgent questions of AI and digital healthcare, and builds on an existing UK community of over 200 experts through the NIHR Incubator for AI & Digital Healthcare focused on Regulatory Science and Responsible Innovation (launched in 2023), and which is supporting this bid. The Network will convene experts to identify and prioritise regulatory science questions, understand existing expertise and where gaps remain, and where scientific opportunities lie for advancing innovation. We will support new research areas and collaborations, facilitate consensus-building and translation of evidence into regulatory policy, and co-create educational resources and training programmes for regulatory professionals. By adopting a regulatory science approach, the network aims to instil confidence in innovators, regulators, the NHS and patients that innovation and regulatory processes are pro-innovation and pro-patient safety. The Regulatory Science and Innovation Network in AI & Digital Healthcare will empower innovators to create products that benefit patients and the healthcare system, while also streamlining the process for innovators and businesses. It will be the critical 'innovation optimiser' to unlock the opportunity of AI and digital healthcare for the health and wealth of the UK.