Reflections on building the AI and Digital Regulations Service

The Care Quality Commission (CQC) regulates health and adult social care services in England. We recognise the potential of innovation and technology-enabled care, including artificial intelligence (AI) to provide high-quality care. We therefore co-founded the AI and Digital Regulations Service (AIDRS) alongside the National Institute for Health and Care Excellence (NICE), the Medicines and Healthcare products Regulatory Agency (MHRA) and the Health Research Authority (HRA) with funding from the NHS Artificial Intelligence Laboratory (NHS AI Lab).

Our AIDRS journey started in 2021, and we have learned a lot about the importance of working with the organisations involved in ensuring AI enhances care quality. In this blog, I reflect on some of the key learnings through my lens as a CQC policy manager.

Why did we get involved in the AIDRS?

We recognise that innovative practice and technological change present an opportunity for rapid improvement in health and care and that we have a role in creating a culture where innovation can flourish. Encouraging innovation and technology-enabled services to provide effective and efficient care is an important theme in our strategy. From helping clinicians in diagnosing diseases to streamlining administrative tasks, AI has the potential to improve health and social care. However, these benefits come with the need for clear regulation and evaluation pathways, including clear information on the roles of AIDRS partners.

What have we learned so far?

Working together is crucial

Making sure that AI supports high-quality care is part of the remits of different organisations. For example, the MHRA regulates medicines and medical devices, including software. CQC’s role is to make sure services in England provide people with safe, effective, compassionate, and high-quality care. Read more information about AIDRS partners.

Each organisation has an important part to play in regulating and evaluating the development and use of in health and social care. By joining forces, we are able to think about existing regulations and evaluation pathways in their entirety. As such, mapping existing pathways was an important milestone in our early work. It illustrated where different agency’s remits align – a steep but necessary learning curve that enabled us to think holistically about AI regulation and the moving parts involved. This formed the foundation for the AIDRS website.

This approach of working together received positive feedback; we heard from adopters and developers during user research that we had "the right organisations in the room" which, in turn, gave credibility to AIDRS and its website.

The whole is greater than the sum of its parts

We have also heard from users how much they value having the relevant information from AIDRS partners in one place.

Working together made opportunities for cross-cutting conversations, for example about regulating AI technology and AI-assisted care. This has made it easier for CQC and our partners to provide holistic input into government consultations on AI regulations, drawing on the combined perspectives and expertise of partner organisations.

Communication is key

While the benefits of working with other regulators are clear, we have learned that to do it well, we need to keep the dialogue going. AIDRS partners have their own goals and, in some cases, statutory remits. We’ve found that agreeing and maintaining a shared understanding of collective goals is important. This needs time, clear communication, and a shared aim to reach consensus.