There are important regulatory considerations when putting place new models of care and new organisational forms. Organisations need to understand the registrations and licences that they need to have in place and make sure they have robust governance processes to ensure ongoing compliance with them. In particular:


The CQC requires that that every organisation which carries on a regulated activity must be registered (and this covers all NHS services). Organisations working together in new care models will need to consider their registration requirements. So:

  • Any new organisation set up to provide services is likely to have to make an application for CQC registration
  • A subsidiary or franchise holder will also usually require separate CQC registration where it is responsible for the services (not the franchisor or parent)
  • Registration requirements will also need to be considered if organisations change the services they provide by increasing or decreasing their regulated activities.

In delivering services organisations also need to consider how they can comply with the fit and proper persons test and fundamental standards of care for regulated activities, as required by the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014.

NHS Improvement

In addition, all Foundation Trusts and independent providers of NHS services require a licence from NHS Improvement (subject to some exemptions including where only a small volume of services is being provided). As for the CQC, organisations working together in new care models will need to consider their licence requirements.

For existing licensees NHS Improvement may need assurance on the impact that service re-design and the (increased) involvement of other organisations in delivering services will have on governance and continuity of service ratings under the licence (as assessed under the Risk Assessment Framework).

Information Commissioner

Registrations with the Information Commissioner’s Office (ICO) will need to be considered in the context of sharing of personal data by organisations. The Data Protection Act 1998 requires every data controller who is processing personal information to register with the ICO, unless they are exempt.

Regulatory considerations – key questions

  • Do you know which registrations and licences your organisation needs from the CQC, Monitor, ICO and other regulators?
  • Do any of your existing registrations and licences need varying?
  • Have you checked that your potential partners have the right registrations and licences?
  • What governance arrangements need to be in place to monitor compliance with regulatory requirements?
  • If a new governance group is set up to oversee a new care model, what will its role be in regulation?

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