Declaration of Quality Assurance Activity under section 124X of the Health Insurance Act 1973 – QAA 3/2015

Administered by Department of Health, Disability and Ageing

Legislation au F2015L00717 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

 

ISSUED BY THE AUTHORITY OF

 

THE MINISTER FOR HEALTH

 

HEALTH INSURANCE ACT 1973

 

DECLARATION OF QUALITY ASSURANCE ACTIVITY

 

UNDER SECTION 124X

 

QAA No. 3/2015

 

Part VC of the Health Insurance Act 1973 (the Act) creates a scheme (known as the Commonwealth Qualified Privilege Scheme) to encourage efficient quality assurance activities. Those activities help to ensure the quality of health services that are funded by the Government, including through Medicare benefits, the Pharmaceutical Benefits Scheme and/or Health Program Grants. The scheme encourages participation in such activities by protecting certain information from disclosure, and also by providing some protection from civil liability to certain persons engaged in those activities in good faith, in respect of those activities.

 

In order for Part VC of the Act to apply to an activity, the Minister must make a Declaration pursuant to section 124X of the Act that the activity described in the declaration is a quality assurance activity to which Part VC applies. Regulations
23C to 23G of the Health Insurance Regulations 1975 (the Regulations) set out the public interest criteria that must be met by quality assurance activities in order to be declared under section 124X of the Act.

 

This Declaration under subsection 124X(1) applies to Part VC of the Act to the following activity:

 

  1. CareTrack Kids – The appropriateness of healthcare delivered to Australian children (the Activity).

 

An overview of the Activity for which the Declaration pursuant to section 124X of the Act is made is contained in the Attachment.

 

Before the Minister can make a Declaration, certain requirements must be met:

 

  • Firstly, the Minister must be satisfied that the persons engaged in the Activity are authorised to do so as described in paragraph 124X(3)(a) of the Act.

    The Activity meets the requirements of paragraph 124X(3)(a) as the persons engaged in the Activity are authorised to do by the Australian Institute of Health Innovation (AIHI) (a research body) in partnership with other bodies and State Government and with the support of the Australian Commission on Safety and Quality in Healthcare (a government authority).

 

  • Secondly, paragraph 124X(3)(b) of the Act provides that the Minister must be satisfied that it is in the public interest to have Part VC of the Act apply to the Activity. In doing so, the Minister must have regard to criteria prescribed by the Regulations.
     

The Activity meets the criteria as follows:
 

  • As required by regulation 23C, the Activity includes the disclosure of
    non-identifying information that concerns the quality of service assessed, evaluated or studied. Results of this study will include by AIHI annual reporting to the Department of Health and publication of information in
    peer-reviewed journals for presentation at conferences and workshops.
     
  • Regulation 23D does not apply as the Activity will be engaged in more than one State or Territory.

 

  • Regulation 23E applies because the Minister is satisfied that the Activity is of a kind that has not been engaged in previously in Australia. The Declaration is needed to make the Activity effective by encouraging full participation in the Activity by persons who provide health services by providing participants with a greater degree of confidence and security that their participation is solely for the benefit of establishing and improving quality assurance.

 

  • Regulation 23F does not apply as the Activity has not previously been carried out in Australia.

 

  • Regulation 23G does not apply as the Activity does not include the assessment or evaluation by a person of the services, skill or performance of a health practitioner for the purpose of determining the health care practitioner’s clinical practising rights.

 

Consultation

Consultations regarding the application for declaration of this Activity were undertaken in 2014 (September and December) and 2015 (January to March). This included obtaining advice on the potential value of declaring this Activity as a quality assurance activity for the purposes of the Act, the methodology used to conduct the Activity, and whether the application met the criteria required for declaration to be made, particularly the criteria relating to whether it is in the public interest to declare the Activity.

 

Those consulted included members of the Qualified Privilege Advisory Group, which includes an external clinician; a legal expert; a quality manager working in the field of health care quality assurance; and a consumer representative.

 

The Declaration of this Activity will not result in any direct or substantial indirect effect on business.

 

This Declaration has effect from the day after registration on the Federal Register of Legislative Instruments. This Declaration ceases to be in force at the end of 5 years after it is signed.

 

The Declaration is a legislative instrument for the purposes of the Legislative Instruments Act 2003.

         ATTACHMENT

 

  1. CARETRACK KIDS – THE APPROPRIATENESS OF HEALTHCARE DELIVERED TO AUSTRALIAN CHILDREN

 

Purpose

This Activity aims to identify the appropriateness and adherence to evidence and consensus-based care delivered to children in Australia during 2012-2013 for
16 common conditions. At the same time, it will examine the frequency and type of adverse events specifically involving children in Australia in acute and primary healthcare settings and will test an intervention to improve this.

 

Objective/s

The primary objective of this Activity is to measure the appropriateness of healthcare delivered to children during 2012-13 in Australia based on sets of indicators for the management of 16 common conditions including diabetes and gastroenteritis.

 

This Activity also involves:

  • measuring the appropriateness of the healthcare delivered to children in Australia in acute, primary and community healthcare settings; and
  • measuring the frequencies and types of adverse events encountered in Australian paediatric care.

 

 

 

 

 

 

Overview

The Health Insurance Act 1973 was enacted to establish a scheme aimed at encouraging efficient quality assurance activities within the health sector, particularly those related to the quality of services funded by the government, including through Medicare benefits and the Pharmaceutical Benefits Scheme. The Act was designed to address the gap in ensuring the quality of healthcare services by protecting certain information from disclosure and providing some protection from civil liability to individuals engaged in these activities in good faith. This legislation was enacted by the Parliament of Australia, with the policy objective of enhancing the quality of healthcare services through the implementation of quality assurance activities. Under the Act, the Minister for Health can declare certain activities as quality assurance activities if they meet specific criteria, such as being authorised and in the public interest. This framework is intended to foster participation in quality assurance activities by providing participants with greater confidence and security, thereby encouraging the improvement of healthcare quality.

Scope and Application

The Health Insurance Act 1973, specifically Part VC, introduces the Commonwealth Qualified Privilege Scheme to facilitate efficient quality assurance activities in the healthcare sector. This scheme is designed to safeguard information from being disclosed and to offer some degree of protection from civil liability for individuals participating in quality assurance activities in good faith. To apply Part VC, the Minister for Health must issue a Declaration under section 124X identifying the activity as a quality assurance activity. The explanatory statement outlines the application of this scheme to the CareTrack Kids activity, which assesses the appropriateness of healthcare delivered to Australian children. The Minister's Declaration under subsection 124X(1) hinges on satisfying certain conditions, including the authorisation of the persons involved and the alignment of the activity with public interest criteria set out in the Health Insurance Regulations 1975. The CareTrack Kids activity, conducted by the Australian Institute of Health Innovation in collaboration with various entities, meets these conditions as it involves the disclosure of non-identifying information concerning the quality of healthcare services and is deemed to be in the public interest, particularly given its novelty in Australia. The Declaration is effective from the day after its registration on the Federal Register of Legislative Instruments and remains in force for five years unless otherwise terminated.

Key Provisions

The main sections of the Health Insurance Act 1973 relevant to this Declaration are sections 124X and those in Part VC, which establish the Commonwealth Qualified Privilege Scheme (sections 124A to 124D). Section 124X allows the Minister for Health to declare an activity as a quality assurance activity, thereby bringing it under the protection of Part VC. The Act's purpose is to encourage efficient quality assurance activities related to health services funded by the government, such as Medicare benefits and the Pharmaceutical Benefits Scheme, by providing protections from disclosure and civil liability for participants engaged in good faith (sections 124A and 124B). The obligations and requirements imposed by the Act on parties involved in quality assurance activities include ensuring that those engaged in the activity are authorised to do so (section 124X(3)(a)) and that the activity meets specific public interest criteria as outlined in the Health Insurance Regulations 1975 (section 124X(3)(b)). For the CareTrack Kids activity, this means that the Australian Institute of Health Innovation, in partnership with other bodies, must be authorised to conduct the study, and the Minister must be satisfied that the activity is in the public interest, considering criteria such as the disclosure of non-identifying information concerning the quality of service (regulations 23C to 23G). The Act and associated regulations establish a framework for declaring activities as quality assurance activities, which provides protections from disclosure and civil liability. However, failure to comply with these requirements or engaging in activities that do not meet the declared criteria may result in civil or criminal consequences. For instance, unauthorised disclosure of information protected under the Act could lead to penalties under the Privacy Act 1988, which includes maximum penalties for breaches of privacy principles. Similarly, any breach of the Act's provisions regarding quality assurance activities could result in civil liability for those who engage in such activities without the requisite authorisation or in violation of the declared criteria. While specific penalties are not detailed in the Act itself, breaches of related legislative instruments may attract penalties as prescribed under applicable laws.

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Sourced from the Federal Register of Legislation at 26 August 2026. For the latest information on Australian Government law please go to https://www.legislation.gov.au.