This briefing outlines the key implications for trusts of changes to the UK's National Health Service regulatory framework, in the context of accelerating system working and legislative change.

Key points:

• In response to the acceleration of system working and the introduction of the Health and Care Bill, the national regulators – Care Quality Commission (CQC) and NHS England and NHS Improvement – are adapting their regulatory models to more effectively align with new ways of working. Respectively, NHS England and NHS Improvement has introduced its system oversight framework (SOF) and CQC is implementing its revised regulatory approach as part of its new strategy.
   
• Regulation is an important driver of behaviours and can therefore incentivise and encourage trusts to work more collaboratively within their system(s) to deliver care. Trusts feel that an enabling framework will help to drive further progress and deliver on the opportunities and benefits of system working. Trusts are also supportive of regulation and oversight which reflects the value of partnership at both integrated care system (ICS) and place levels.
   
• However, there are a complex series of unanswered questions which will need to be worked through carefully as new models of regulation and oversight are rolled out. In particular, trusts are concerned about the impact of system-focused regulation on their accountabilities, whereby holding systems to account for performance risks cutting across their own statutory duties.
   
• The challenge of meaningfully assessing quality across a system and identifying what contribution an ICS's leadership has made to that picture of quality, is significant. ICSs do not provide care, however their functions do nonetheless contribute to how well services can meet local populations' needs. The link between what is being assessed at system level, and how an integrated care board (ICB) has influenced any fluctuations in local quality or performance, will need to be clear.
   
• There is still a need for further clarity about how non-NHS bodies outside the reach of the current regime will be considered as part of system-level assessments. Primary care, social care, and services commissioned by local authorities all make meaningful contributions to pathways, patient flow, patient experience and health outcomes, but do not fall within the remit of the SOF. However, CQC does see a role in bringing together insights about wider organisations given its remit to regulate social care, primary care and the independent sector.
   
• There remains a risk of additional bureaucracy and duplication at trust and system-level as national regulators will need to continue to carry out assurance on how trusts are meeting their duties. Trusts are particularly keen to see a more streamlined approach to regulation.
   
• Regulation in the context of systems could also become particularly challenging for those trusts spanning multiple ICSs, as they could be subject to multiple judgements and duplicative assessments, particularly as ICSs begin to take on oversight responsibilities. Some trusts which straddle multiple ICS boundaries, such as ambulance trusts, some community service trusts and those providing specialised services, have highlighted the risk that they could be held accountable by more than one ICS, leading to an increased bureaucratic burden, and overlapping data requests and assessments.