“Candour is integral to a ‘just culture’... Candour cannot be an ‘add on’ or a simple matter of compliance – it will only be effective as part of a wider commitment to safety, learning and improvement. Good progress has been made… but more needs to be done to ensure that the culture of openness is fully embedded.” (Ted Baker, CQC’s Chief Inspector of Hospitals)

Regulation 20 of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 imposes a duty of candour on health and social care providers - to be open and transparent with service-users and their families, in relation to their treatment and care. The CQC has updated its guidance for providers, making clear what they must do to meet the requirements of regulation and the circumstances in which it must be applied.  

First principles

There are two distinct duties of candour. The general duty to act in an open and transparent way with people in relation to all care and treatment provided to them. There is no ‘harm threshold’ for this duty to apply.

A separate statutory duty applies in all cases where there has been a Notifiable Safety Incident (‘NSI’). This duty requires a face to face discussion with the service-user (or their lawful representative), followed up with a letter. Read our Insight on ‘The Duty of Candour – are you doing it right?’

What’s new?

The updated guidance provides a more specific explanation of what is defined as an NSI and provides examples covering a range of scenarios. In addition it clarifies that the apology required to fulfil the duty of candour is not an admission of liability and will not adversely impact the provider’s indemnity cover.

Notifiable Safety Incidents

The updated guidance includes a useful flow chart on how to determine whether an incident is an NSI. It is important to remember that the presence or absence of fault on the part of a provider has no impact on whether something is defined as an NSI. The scenarios include the impact of patient consent, involvement of multiple providers, near misses and incidents which are not unexpected (such as recognised complications of surgery). Worked examples are provided for maternity, care homes, surgery, mental health, dental and general practice


The guidance emphasises that saying sorry is not an admission of fault. It is always the right thing to do. NHS Resolution’s guidance 'Saying Sorry' is highlighted. It includes how, when and who should give the apology, how it fits with the duty of candour and that an apology will not affect indemnity cover. An apology is the starting point of a longer conversation over time with the patient / family about what went wrong and the steps being taken to prevent recurrence.


It is crucial that all healthcare staff understand that the general duty of candour applies at all times and the circumstances in which the statutory duty applies. The updated guidance should assist with the latter, in particular identifying what is an NSI. It should also be borne in mind that the CQC will investigate breaches of regulation 20 and, if appropriate, prosecute. In September 2020, University Hospitals Plymouth were fined £1600 (maximum fine £2500), for a breach of regulation 20. Healthcare providers need to ensure that Serious Incident Policies are properly aligned with the associated Duty of Candour Policies to ensure that incidents which cause moderate harm and above are correctly classified as ‘candour cases’ even if they are not classed as Serious Incidents. All staff should be trained on what is required – openness and transparency when things go wrong – and reassured that an apology is not the same as an admission of liability.

How Capsticks can help  

Capsticks’ specialist clinical claims and advisory teams are experts in patient safety. We have supported many NHS and private providers to achieve greater compliance with CQC standards and better outcomes for patients. In the last 12 months, we have seen an increase in civil and criminal enforcement action intimated by the CQC and have worked with our clients to ensure that CQC reports and interventions are reasonable and proportionate to the compliance issues identified.

For further information on how we can assist your organisation, please contact Francis Lyons, Tracey Lucas or Ian Cooper.