Part 7Quality improvement and research

Part 7—Quality improvement and research 63—Preliminary (1) In this Part, unless the contrary intention appears— authorised activity means an activity within the ambit of a declaration under section 64; authorised person means a person within the ambit of a declaration under section 64, including by being the member of a group (or committee) as it may be constituted from time to time; confidential information means— (a) information relating to a health service in which the identity of a patient or person providing the service is revealed; (b) other information declared by the regulations to be confidential information for the purposes of this Part; court includes a tribunal, authority, board or person having power to require the production of documents or the answering of questions; disclose, in relation to information, means to give, reveal or communicate in any way; governing body of an entity means the person or body (however named or described) having the general direction or control of the operations of the entity; prescribed health‑sector body means— (a) a college, professional association or university; or (b) a body established wholly or partly for the purposes of research; or (c) a hospital (including a private hospital); or (d) the Department; or (e) SAAS; or (ea) an entity that provides health services at a private day procedure centre; or (f) any other entity concerned with the provision of health services; or (g) any other entity brought within the ambit of this definition by the regulations; produce includes permit access to; research ethics committee means— (a) a committee established in accordance with guidelines or other requirements published by the National Health and Medical Research Council and recognised by the Minister by notice published in the Gazette for the purposes of this definition; or (b) a committee, or a committee of a class, designated by the regulations for the purposes of this definition. (2) The purpose of this Part is to allow the authorisation of activities associated with undertaking or making assessments, evaluations or recommendations with respect to the practices, procedures, systems, structures or processes of a health service— (a) where the purpose of any such activity is wholly or predominantly to improve the quality and safety of health services; and (b) where the public disclosure of, or public access to, information is restricted in order to achieve the best possible outcomes associated with the improvement of health services. (3) This Part has effect despite the Freedom of Information Act 1991. (4) If the provisions of this Part are inconsistent with any other Act or law, this Part prevails to the extent of the inconsistency. 64—Declaration of authorised activities and authorised persons (1) Subject to this Part, the Minister may, by notice published in the Gazette— (a) declare an activity described in the declaration to be— (i) an authorised quality improvement activity; or (ii) an authorised research activity; (b) declare a person or group of persons (including a group formed as a committee) described in the declaration to be an authorised entity for the purposes of carrying out— (i) an authorised quality improvement activity; or (ii) an authorised research activity. (2) The Minister must— (a) in the case of a declaration under subsection (1)(a)(i)—relate the declaration to any activity that involves— (i) an assessment or evaluation of the quality of services provided by prescribed health‑sector bodies, including by assessing or evaluating clinical practices or by conducting studies of the incidence or causes of conditions or circumstances that may affect the quality of any such services; or (ii) the making of recommendations about the provision of services provided by prescribed health‑sector bodies after taking into account the outcome of any activity of a kind described in paragraph (a); or (iii) the monitoring of the implementation of any recommendations or other initiatives that are relevant to improving the quality of services provided by prescribed health‑sector bodies; (b) in the case of a declaration under subsection (1)(a)(ii)—relate the declaration to research activities that relate to the causes of mortality or morbidity; (c) in the case of a declaration under subsection (1)(b) that relates to a person—ensure that the person holds an appropriate authorisation from the governing body of the prescribed health‑sector body and, if relevant, an appropriate approval from a research ethics committee; (d) in the case of a declaration under subsection (1)(b) that relates to a group of persons—ensure— (i) that the group is established in accordance with the rules of the governing body of the prescribed health‑sector body; and (ii) that the functions of the group include activities involved in carrying out a quality improvement activity or research activity within the contemplation of this Part; and (iii) that each member of the group will hold a qualification or have experience or training that is relevant to the performance of its functions in relation to a quality improvement activity or research activity; and (iv) if the relevant rules so require—that the group holds an appropriate authorisation from the governing body of the prescribed health‑sector body and, if relevant, an appropriate approval from a research ethics committee. (3) The Minister must, in acting under this section, make the health and safety of the public the primary consideration. (4) In addition, the Minister must not make a declaration under this section unless satisfied— (a) that the performance of an activity within the ambit of the declaration, or the functions or activities of a person or group of persons within the ambit of the declaration, would be facilitated by the making of the declaration; and (b) that the making of the declaration is in the public interest. (5) The Minister must also take into account any criteria prescribed by the regulations for the purposes of this section. (6) To avoid doubt, the Minister may— (a) make a declaration under subsection (1)(a) without specifying a particular person or group of person as being an authorised entity to which the declaration is to apply at that particular time; (b) make a declaration under subsection (1)(b)— (i) without specifying a particular authorised quality improvement activity or authorised research activity that is to be carried out by the authorised entity at any particular time; (ii) by defining the group rather than by specifying particular members (on the basis that the constitution of the group may change from time to time). (7) A declaration under this section does not confer authority on a person or group of persons to conduct an investigation for the purpose of determining the competence of a particular person in providing services. (8) The Minister may, by subsequent notice in the Gazette, vary or revoke a declaration under this section. (9) A declaration, unless sooner revoked, ceases to be in force at the end of 3 years after it is made, but this subsection does not prevent the Minister from making a further declaration in respect of the same activity or person or group of persons. (10) The Minister may, as the Minister thinks fit, determine various protocols or procedures that must be complied with by a person or group of persons acting under this Part. 65—Provision of information Information (including confidential information) may be disclosed for the purposes of an authorised activity without the breach of any law or principle of professional ethics. 66—Protection of information (1) This section applies to— (a) a person who is, or has been, an authorised person; or (b) a person— (i) who provides, or has provided, technical, administrative or secretarial assistance to an authorised person or in connection with an authorised activity; or (ii) who receives or gathers information on behalf of an authorised person in connection with an authorised activity. (2) A person to whom this section applies must not— (a) make a record of information gained as a result of, or in connection with, an authorised activity; or (b) make use of or disclose information gained as a result of, or in connection with, an authorised activity, except— (c) to the extent necessary for the proper performance of the authorised activity; or (d) in pursuance of any reporting requirements of a prescribed kind to a governing body of an entity; or (e) as part of making a disclosure to another authorised person; or (f) to the extent allowed by the regulations. (3) Without limiting subsection (2), a person to whom this section applies cannot be required— (a) to produce to a court, agency or other body any document that has been brought into existence for the purposes of an authorised activity; or (b) to disclose to a court, agency or other body any information that has become known for the purposes of an authorised activity. (4) Subsections (2) and (3) do not apply to any information or document that does not identify, either expressly or by implication, a particular person or particular persons. (5) This section does not prohibit a disclosure of information if the person, or each of the persons, who would be directly or indirectly identified by the disclosure consents to that disclosure of the information. 67—Protection from liability No act or omission of a person in good faith for the purposes of an approved activity, or for the purposes of an activity that the person reasonably believes to be an approved activity, gives rise to any liability against the person, or against any governing body or other entity involved in authorising or managing a person or group of persons involved in an authorised activity (or a purported authorised activity) under this Part.