Evidence on what works in regulating health and social care

Overview

• The Care Quality Commission (CQC) is the main regulator of health and social care quality in England. It is currently rebuilding its regulatory model following several reviews that were critical of its approach, and The King’s Fund is working with them to support this work. This is an important signal of CQC’s intention to bring evidence and learning into the development of its new approach.

• As part of working ‘in the open’, this report shares findings from an evidence review, where we examined existing literature, interviewed experts and engaged with CQC staff to understand what good regulation looks like. We worked with CQC to identify five challenges they are facing where evidence could help.

• We set out five key pieces of learning for CQC to consider as it rebuilds its approach. This work was part of scoping an evaluation, and the report wording reflects that.

Why we did the research

CQC is the main regulator of health and social care quality in England. In 2023, it introduced several changes to its approach. These included a single assessment framework, a new IT platform and different ways of working. Three major reviews identified significant problems with these changes, and CQC is now rebuilding its regulatory model under new leadership. This improvement work focuses on tackling immediate issues such as the backlog in provider registrations and foundational improvements, that in the first half of 2025 included a refreshed organisational vision and purpose. CQC asked The King’s Fund to develop an evaluation to support this work and help ensure the new approach is based on the best evidence and learning.

What we did

The first phase of this work lasted from February – June 2025. This was a scoping phase to identify key learnings for CQC from the evidence about what good regulation looks like and to design a formative evaluation that will support the development and roll out of the new model. We reviewed existing literature and research, interviewed experts in regulation and engaged with CQC staff.

What we found

We worked with CQC to identify five challenges they are facing where evidence could help. This report sets out learning about what works in regulation in relation to those five challenges. The aim is to give CQC information that it can use to help rebuild its regulatory model.

Setting regulatory expectations

Organisations that are regulated by CQC have complained that they are not clear what standards they are expected to meet or how their performance will be assessed. Our review of evidence found that CQC needs to clearly communicate its expectations for what good-quality care looks like and how they will assess it. Effective regulatory models are fully aligned with the regulator’s mission and purpose, use a range of methods to achieve the regulator’s purpose (not just inspection) and are tailored to the different organisations it regulates. Standards should be co-designed with regulated providers, and set high to promote improvement. ‘Enforced self-regulation’ (where regulators specify outcomes and give organisations the flexibility to achieve them in their own way) is also a potentially useful tool, but only when accompanied by a facilitative and supportive approach from the regulator.

Ensuring expertise in the regulatory workforce

Inspectors are the face of CQC, but recent reviews found that they sometimes lacked knowledge of the sectors they were inspecting, which affects their credibility with providers, and that they did not have enough training and support. A strong message from the literature is that investing in effective training and development for inspectors is vital. The literature also highlights three key skill sets that inspection teams need to be credible and effective: sector expertise, regulatory expertise and relational skills. Staff with a broad range of experiences should be part of inspection teams, and inspection teams need freedom to use their professional judgement. Without this, inspectors may not be as aware of risks or may deliver inconsistent judgements.

Adopting risk-based regulation

CQC’s latest regulation strategy adopted a risk-based approach to regulation, where the risk a regulated organisation is judged to pose drives the amount of attention it receives from CQC. However, evidence across different sectors shows it is very difficult to enact risk-based regulation, and CQC faced several challenges enacting it. Using data models to identify risk is challenging because of the gaps in the data. Risk-based approaches always involve a process of learning and require ongoing evaluation and development. Finally, even though using data is helpful, it is not perfect. Inspectors need the right tools and time to use the data properly, and they still need to talk to people and understand what is really going on.

Developing relationships and trust

The problems with CQC’s current regulatory model have severely damaged its relationships with providers and other stakeholders. The literature highlights the importance of investing in developing good relationships with the people they regulate. Regulators need to be flexible in the way they work with providers and be able to use different styles of engagement when appropriate. If people trust the regulator, they can feel safe and confident in the care they receive. People will also be more likely to trust providers, and so providers will in turn be more likely to listen and improve.

Changing the regulatory model

When changing a regulatory model, the literature highlights the importance of piloting new approaches and investing in training to support their rollout; evaluating whether new approaches are achieving their intended impact; and ongoing work to embed a culture of learning and evaluation. Piloting and testing should not be confused with a phased rollout in stages, which does not allow time for staff to implement learning between one phase and the next.

This overview has been updated in February 2026 to reflect a change in the project.