These Regulations make provision about the duty of candour procedure to be undertaken in terms of section 22 of the Health (Tobacco, Nicotine etc. and Care) (Scotland) Act 2016 (“the 2016 Act”) in health and social care settings.

Regulation 2 sets out the form and manner of communications for any communication required by virtue of these Regulations.

Regulation 3 sets out limitations on the provision of information.

Regulation 4 provides for the relevant person to be notified by the responsible person and the information to be included in such notification.

Regulation 5 provides that the responsible person must offer a written apology to the relevant person and must provide such apology where the relevant person wishes it.

Regulation 6 provides that the responsible person must invite the relevant person to attend a meeting, and sets out the information to be provided to the relevant person during and after such a meeting as well as the information to be offered to the relevant person if the relevant person does not wish to or is unable to attend the meeting.

Regulation 7 provides that the responsible person must carry out a review of the circumstances which it considers led, or contributed, to the incident and sets out how this is to be done.

Regulation 8 requires the responsible person to provide training and support to relevant employees.

Regulation 9 provides that the responsible person must keep a written record for each incident in respect of which the duty of candour procedure is followed.

A Business Regulatory Impact Assessment has been prepared and can be obtained from the Scottish Government website.