(1) A health service body must act in an open and transparent way with relevant persons in relation to care and treatment provided to service users in carrying on a regulated activity.

(2) As soon as reasonably practicable after becoming aware that a notifiable safety incident has occurred a health service body must--
(a)notify the relevant person that the incident has occurred in accordance with paragraph (3), and
(b)provide reasonable support to the relevant person in relation to the incident, including when giving such notification.

(3) The notification to be given under paragraph (2)(a) must--
(a)be given in person by one or more representatives of the health service body,
(b)provide an account, which to the best of the health service body's knowledge is true, of all the facts the health service body knows about the incident as at the date of the notification,
(c)advise the relevant person what further enquiries into the incident the health service body believes are appropriate,
(d)include an apology, and
(e)be recorded in a written record which is kept securely by the health service body.

(4) The notification given under paragraph (2)(a) must be followed by a written notification given or sent to the relevant person containing--
(a)the information provided under paragraph (3)(b),
(b)details of any enquiries to be undertaken in accordance with paragraph (3)(c),
(c)the results of any further enquiries into the incident, and
(d)an apology.

The duty of candour requires providers to be open with the people who use their service. When a specified safety incident has occurred in respect of care provided, the regulation sets out a clear set of legal duties on registered providers about how and when to notify people using their service (or their relevant representatives) about those safety incidents. The regulation also describes when a notification about a safety incident needs to be made to CQC.

When something goes wrong with the health or social care that is provided to you, the organisation that provides the care has a legal duty to be open with you, to explain what has happened and to apologise to you.