Consultation on principles and strategic plan 7A Duty to consult on principles and strategic plan (1) Before finalising a document mentioned in subsection (2), the Commissioner— 10 (a) must consult on a draft of it with— 1 (i) the Parliamentary corporation, (ii) the advisory group established in accordance with section 16, and (iii) any other person the Commissioner considers appropriate having regard to the importance of the document reflecting patients’ concerns, 15 (b) may consult on a draft of it with any other person the Commissioner considers appropriate. (2) The documents are— (a) a statement of principles (see section 3), and (b) a strategic plan (see section 5). 20 Formal investigations 8 Initiation of formal investigation (1) A formal investigation into a health care safety issue begins when the Commissioner first makes the investigation’s terms of reference publicly available. (2) As soon as practicable after making a formal investigation’s terms of reference publicly 25 available, the Commissioner must take reasonable steps to bring them to the attention of any person who, in the Commissioner’s opinion, is likely to be— (a) required under section 13 to supply information in relation to the investigation, or (b) the addressee of a recommendation in the report produced at the conclusion of 30 the investigation. (3) Nothing in this section precludes the Commissioner from investigating an issue otherwise than by way of a formal investigation. 9 Further provision about terms of reference (1) The terms of reference for a formal investigation under section 8 must— 35 (a) describe the issue to be investigated, 4 Patient Safety Commissioner for Scotland Bill (b) identify (by name or description) any person to whom the Commissioner expects to address a recommendation in the report produced at the conclusion of the investigation, (c) state whether the Commissioner expects to need access to individuals’ information 5 in the course of the investigation, (d) if the Commissioner does expect to need access to individuals’ information, state— (i) why that is the Commissioner’s expectation, and (ii) why the Commissioner expects to need that information in a form that does, or does not (as the case may be), allow individuals to be identified. 10 (2) Before finalising the terms of reference for a formal investigation, the Commissioner— 1 (a) must consult the advisory group established in accordance with section 16, (b) may consult any other person that the Commissioner considers appropriate. 10 Investigation report (1) Having concluded a formal investigation under section 8, the Commissioner must— 15 (a) prepare a report on the investigation, and (b) lay a copy of it before the Scottish Parliament. (2) The report must state— (a) the Commissioner’s findings in relation to the issue investigated and the reasons for them, and 20 (b) the Commissioner’s recommendations in light of those findings. (3) The Commissioner must give a copy of the report to any person to whom a recommendation in the report is addressed. (4) The Commissioner may address a recommendation to a person in a report on a formal investigation whether or not— 25 (a) the person was identified in the investigation’s terms of reference as a person to whom the Commissioner expected to address a recommendation, (b) the Commissioner took steps to bring the investigation’s terms of reference to the person’s attention in accordance with section 8(2)(b). 11 Requirement to respond to report 30 (1) A person is subject to a requirement to respond to a recommendation in a report under section 10 if— (a) the report states— (i) that the recommendation is addressed to the person, and (ii) the period within which the person’s response to the recommendation is 35 required, and (b) the Commissioner gives the person a copy of the report. (2) A person complies with a requirement to respond to a recommendation by giving the Commissioner a written response to it before the end of the period within which the report states that the person’s response is required. 5 Patient Safety Commissioner for Scotland Bill (3) A written response to a recommendation is a document setting out— (a) what the person responding has done, or proposes to do, to give effect to the recommendation, and (b) if the person does not intend to do anything to give effect to the recommendation 5 (wholly or partly), the person’s reasons for that. (4) The Commissioner may, in whatever manner the Commissioner considers appropriate— (a) make publicly available (in full or in part) a person’s written response to a recommendation, (b) publicise a person’s failure to comply with a requirement to respond to a 10 recommendation. 1 use of information Gathering and 12 Power to require information (1) The Commissioner may require a person to which subsection (3A) applies to supply the Commissioner with information that— 15 (a) is in the person’s possession or control, (b) may be relevant to the work of the Commissioner, (c) is not information of a kind that the Commissioner is prohibited by subsection (3) from requiring the person to supply. (2) A requirement under this section is imposed on a person when the Commissioner gives 20 the person written notice specifying— (a) the information that the person is required to supply, (b) the way in which the person is required to supply it, and (c) either— (i) the time by which the person is to supply it, or 25 (ii) the period throughout which the person is to supply it and the intervals within that period at which it must be supplied. (3) The following are the kinds of information that the Commissioner is prohibited from requiring a person to supply under this section— (a) information that the person would be entitled to refuse to provide in proceedings 30 in a court in Scotland, (b) information about an individual (whether or not it is anonymised). (3A) This subsection applies to a person who is— (a) a health care provider, (b) a body constituted by virtue of the National Health Service (Scotland) Act 1978. 35 (4) In this section, “information” includes unrecorded information. 12A Information under the Health and Care (Staffing) (Scotland) Act 2019 (1) The Health and Care (Staffing) (Scotland) Act 2019 is amended as follows. 6 Patient Safety Commissioner for Scotland Bill (2) In section 2 (guiding principles etc. in health care staffing and planning), in subsection (3), after “Ministers” insert “and the Patient Safety Commissioner for Scotland”. 13 Further power to require information in a formal investigation (1) When carrying out a formal investigation under section 8, the Commissioner may require 5 any person to supply information that— (a) is in the person’s possession or control, (b) may be relevant to the investigation, and (c) is not information that the person would be entitled to refuse to provide in proceedings in a court in Scotland. 10 (2) But the Commissioner may only impose a requirement to supply information under this 1 section if the Commissioner is satisfied that requiring the information to be supplied is proportionate to the seriousness of the issue being investigated. (3) A requirement under this section is imposed on a person when the Commissioner gives the person written notice specifying— 15 (a) the information that the person is required to supply, (b) the way in which the person is required to supply it, and (c) the time by which the person is to supply it. (4) The Commissioner may require a person to supply information under this section whether or not— 20 (a) the Commissioner stated in a formal investigation’s terms of reference that the Commissioner expected to need access to the information, (b) the Commissioner took steps to bring the investigation’s terms of reference to the person’s attention in accordance with section 8(2)(a). (5) The Commissioner’s power to require a person to supply information under this section 25 is without prejudice to the Commissioner’s power to require a person to supply information under section 12. (6) In this section, “information” includes unrecorded information. 14 Failure to supply required information (1) The Commissioner may take the action mentioned in subsection (3) or (4) (or both 30 actions) where— (a) a requirement to supply information has been imposed on a person by a written notice under section 12 or 13, and (b) the person refuses, or fails without reasonable excuse, to supply the information in accordance with the terms of the notice. 35 (2) The Commissioner may take the action mentioned in subsection (4) where— (a) a requirement to supply information has been imposed on a person by a written notice under section 12 or 13, and (b) the Commissioner suspects the person has deliberately altered the information. (3) The Commissioner may publicise the person’s refusal, or failure, to supply the 40 information. 7 Patient Safety Commissioner for Scotland Bill (4) The Commissioner may report the matter to the Court of Session. (5) After receiving a report under subsection (4), and hearing any evidence or representations on the matter, the Court may (either or both)— (a) make any order for enforcement that it considers appropriate, 5 (b) deal with the matter as if it were a contempt of court. 15 Confidentiality of information (1) A person mentioned in subsection (3) commits an offence if the person knowingly or recklessly makes an unauthorised disclosure of information that— (a) has been obtained by or on behalf of the Commissioner for the purposes of 10 exercising the Commissioner’s functions, 1 (b) is not, and has not been, in the public domain when the disclosure is made. (2) A disclosure of information is authorised for the purpose of subsection (1) in so far as it is— (a) made with the consent of the person from whom the information was obtained, 15 (b) necessary for the purpose of enabling, or assisting, the exercise of the Commissioner’s functions, (c) made for the purpose of legal proceedings, whether civil or criminal (including for the purposes of investigating an offence or suspected offence), (d) made for the purpose of assisting one of the following persons in exercising their 20 statutory functions— (i) Healthcare Improvement Scotland, (ii) the Commissioner for Patient Safety in relation to England, which is an office established by section 1 of the Medicines...