The AI & Digital Regulations Service is a project funded by the NHS AI Lab. The project is a collaboration between four regulatory bodies ('Project partners'):

1.1. the National Institute for Health and Care Excellence (NICE; with project oversight) provides national guidance and advice to improve health and social care,

1.2. the Care Quality Commission (CQC) is the independent regulator of health and social care in England,

1.3. the Health Research Authority (HRA) provides a unified national system for the governance of health research, and;

1.4. the Medicines and Healthcare products Regulatory Agency (MHRA) ensures that medicines and medical devices work and are acceptably safe.

Based on the research undertaken to date in the discovery, alpha and beta phases 1 and 2, the service component of the project (as distinct from policy development) focuses on the following two features:

(i) An informational website which maps out and clarifies the regulatory and HTA pathway for AI and data-driven technologies, highlighting relevant guidance and materials that developers and adopters need when they need it, so that they can make regulatory progress more effectively whilst (ideally) expending less resource. The developer area of the website launched in public beta in March 2023 under the title of the AI and Digital Regulations Service. The adopter area is in private beta at time of writing this spec. The whole website is expected to launch in public beta in June 2023.

(ii) A centralised transactional resource that makes it easier for developers and adopters to access advice and support they need by triaging them to the most appropriate of existing support offers whilst 'hiding the wiring'.

Our requirement is for the supplier for the public beta improvement phase to build upon significant foundational work undertaken in phases 1 and 2, including but not limited to: • Revising and improving the design and build of the service based on findings from private beta testing in phases 1 and 2 • Conducting user research with developers and adopters to test the public beta version of the website and ensure the web platform continues to meet the needs of all users.

At the time of on-boarding, the service will be running in public beta. The supplier will be expected to provide technical / service desk support. In line with government funded digital services, a project with a transactional service must pass the Central Digital and Data Office (CDDO) / Government Digital Services (GDS) assessments to progress to different stages of development, e.g. from public beta to live.

Please apply via The Digital Capability for Health framework - RM6221.