Health Insurance (Quality Assurance Activity – Australian Orthopaedic Association National Joint Replacement Registry) Declaration 2022

Administered by Department of Health, Disability and Ageing

Legislation au F2022L00986 In force Legislative Instrument

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EXPLANATORY STATEMENT

Health Insurance Act 1973

Health Insurance (Quality Assurance Activity – Australian Orthopaedic Association National Joint Replacement Registry) Declaration 2022

Authority

The Health Insurance (Quality Assurance Activity – Australian Orthopaedic Association National Joint Replacement Registry) Declaration 2022 (the instrument) is made under subsection 124X(1) of the Health Insurance Act 1973 (Act).

Subsection 124X(1) of the Act provides that the Minister for Health may, by legislative instrument, declare a quality assurance activity described in a declaration to be a quality assurance activity to which Part VC applies. The Health Insurance (Quality Assurance Activity – Australian Orthopaedic Association National Joint Replacement Registry) Declaration 2022 declares the Australian Orthopaedic Association National Joint Replacement Registry (Activity) to be a quality assurance activity to which Part VC of the Act applies.

Purpose

Part VC of the Act creates a scheme to encourage efficient quality assurance activities in connection with the provision of health services. Those activities help to improve the quality of joint replacement and knee osteotomy surgeries that receive funding from the Government, including through the Medicare Benefits Schedule, the Pharmaceutical Benefits Scheme, and Health Program Grants. The scheme encourages participation in such activities by protecting certain information from disclosure and by providing some protection from civil liability to certain persons in respect of their engagement in those activities in good faith.

The purpose of this instrument is to declare the Activity to be a quality assurance activity to which Part VC of the Act applies.

The Activity is undertaken by the Australian Orthopaedic Association (AOA). The AOA is the peak professional representative organisation for orthopaedic surgeons in Australia. The AOA is a not-for-profit organisation and is responsible for the management of the Activity, including publicly disseminating Registry data and research outcomes. 

The purpose of the Activity is to identify factors that result in improved standards in prostheses and orthopaedic surgical techniques, as well as to improve the benefits and cost effectiveness of those procedures, including patient views.

Consultation

The AOA, as the applicant for declaring the Activity, was consulted in relation to the Activity and content of the instrument.  

The instrument will not result in any direct or substantial indirect effect on business.

Commencement

The instrument is a disallowable legislative instrument for the purposes of the Legislation Act 2003 and commences on the day after registration on the Federal Register of Legislation.

Details of the instrument are set out in Attachment A.

The instrument is compatible with the rights and freedoms recognised or declared under section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011. A statement of compatibility with human rights is set out in Attachment B.

 

ATTACHMENT A

Section 1 – Name

This section provides that the name of the instrument is the Health Insurance (Quality Assurance Activity – Australian Orthopaedic Association National Joint Replacement Registry) Declaration 2022 (instrument).

Section 2 – Commencement

This section provides that the instrument commences on the day after it is registered on the Federal Register of Legislation.

Section 3 – Authority

This section provides that the instrument is made under subsection 124X(1) of the Health Insurance Act 1973.

Section 4 – Repeal

This section provides that the instrument will be repealed when it ceases to be in force in accordance with subsection 124X(4) of the Health Insurance Act 1973.

Subsection 124X(4) of the Health Insurance Act 1973 provides that a declaration of a quality assurance activity ceases to be in force at the end of 5 years after it is signed, unless sooner revoked.

Section 5 – Schedule

This section provides that the Activity described in the Schedule is declared to be a quality assurance activity to which Part VC of the Health Insurance Act 1973 applies.  

Schedule 1 – Description of quality assurance activity

Clause 1 – Name of activity

Clause 1 of Schedule 1 provides that the name of the Activity is the ‘Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR)’.

Clause 2 – Description of activity

The AOANJRR is a registry that aims to improve the outcome of joint replacement surgery by identifying the factors affecting the outcomes of hip, knee, shoulder, elbow, wrist, ankle and spinal disc replacement, and knee osteotomy procedures, and it educates stakeholders on the comparative performance of and different approaches to joint replacement procedures. Clause 2 of Schedule 1 describes the health services of the AOANJRR that relates to as all joint replacement and knee osteotomy procedures and managing the information that is collected and used for public disclosures to be made by the AOANJRR.

The AOANJRR also collects Patient Reported Outcome Measures (PROMs) data which capture the patient’s perspective on the success of their treatment for these procedures. PROMs data is collected through pre- and post-operative surveys covering the extent of the pain and disability prior to surgery, as well as the extent and timing of recovery and the presence of complications. Information derived from PROMs is used to enhance outcomes, and assist in the design, delivery and funding of health services by aligning clinical outcomes and patient satisfaction.

The integration of PROMs data with other AOANJRR data augments surgeons’ ability to evaluate their performance by linking the patient’s view with the surgeon’s reflections on the outcomes of procedures. PROMs data is also translated into population-based statistics that will be used to inform improvements to clinical practice and patient care standards.

 


 

ATTACHMENT B

Statement of Compatibility with Human Rights

Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011

Health Insurance (Quality Assurance Activity – Australian Orthopaedic Association National Joint Replacement Registry) Declaration 2022

This legislative instrument is compatible with the human rights and freedoms recognised or declared in the international instruments listed in section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011.

 

Overview of the legislative instrument

The Health Insurance (Quality Assurance Activity – Australian Orthopaedic Association National Joint Replacement Registry) Declaration 2022 (the Declaration) declares the Australian Orthopaedic Association National Joint Replacement Registry (Activity) to be a quality assurance activity to which Part VC of the Health Insurance Act 1973 (Act) applies. The Activity will be conducted by the Australian Orthopaedic Association (AOA). The AOA is the peak not-for-profit professional representative organisation for orthopaedic surgeons in Australia. Information known solely as the result of conducting the Activity, or documents created solely for the purposes of the Activity, will be covered by qualified privilege.

Human rights implications

The Declaration engages the right to health as set out in Article 12 of the International Covenant on Economic, Social and Cultural Rights by assisting with the progressive realisation by all appropriate means of the right of everyone to the enjoyment of the highest attainable standard of physical and mental health.

The qualified privilege scheme established by Part VC of the Act is aimed at encouraging participation in quality assurance activities that help to ensure that the highest possible health care standards are maintained. The quality assurance activity described in the Declaration will provide participants with a greater degree of confidence and security that their participation is for the benefit of improving healthcare. Patient Reported Outcome Measures (PROMs) data, which captures the patient’s perspective on the success of their treatment, is collected on a voluntary basis from patients completing pre- and post-operative surveys covering pain and disability prior to surgery, as well as the extent and timing of recovery and the presence of complications. This information is translated into population-based statistics that are used to inform clinical practice and patient care standards.

The Declaration also engages, but does not limit, the right to privacy as contained in Article 17 of the International Covenant on Civil and Political Rights by involving the collection, storage, security, use, disclosure or publication of personal information. Data collected as part of the Activity will be de-identified to ensure that no individual or individuals are identified prior to analysis or disclosure of the information. Public disclosures of de-identified information derived from the AOANJRR data will be published in annual reports and used to enhance surgical outcomes, and assist in the design, delivery and effectiveness of health services by aligning clinical outcomes and patient satisfaction with safe, efficient, and best practice care.

Conclusion

The Declaration is compatible with human rights as it promotes the right to health and does not limit the right to privacy.

 

Professor Paul Kelly

Chief Medical Officer

Department of Health

Overview

The Health Insurance (Quality Assurance Activity – Australian Orthopaedic Association National Joint Replacement Registry) Declaration 2022, made under the Health Insurance Act 1973, aims to enhance the quality of joint replacement and knee osteotomy surgeries funded by the Australian Government. The purpose of this instrument is to recognise the Australian Orthopaedic Association National Joint Replacement Registry as a quality assurance activity, thereby encouraging its participation in improving healthcare standards. The Australian Orthopaedic Association, a not-for-profit organisation representing orthopaedic surgeons, manages the Registry to identify factors that improve surgical outcomes and patient satisfaction. This initiative aligns with the right to health by progressively achieving the highest attainable standard of physical and mental health and ensures that personal information is de-identified, thereby not limiting the right to privacy. The Declaration is compatible with human rights, fostering better health outcomes and maintaining patient confidentiality.

Scope and Application

The Health Insurance (Quality Assurance Activity – Australian Orthopaedic Association National Joint Replacement Registry) Declaration 2022, made under the Health Insurance Act 1973, designates the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) as a quality assurance activity subject to Part VC of the Act. This Act applies to the AOA, a not-for-profit organisation that manages the registry, which collects and analyses data on joint replacement and knee osteotomy procedures to improve surgical outcomes and patient satisfaction. The Act's purpose is to safeguard certain information from disclosure and offer some protection from civil liability to those involved in quality assurance activities in good faith. The declaration is effective across the Commonwealth of Australia and applies to all joint replacement and knee osteotomy surgeries funded by the Government, including those covered by the Medicare Benefits Schedule and the Pharmaceutical Benefits Scheme. The instrument is compatible with the rights and freedoms recognised or declared in the international human rights instruments, as it promotes the right to health and ensures the protection of privacy through the de-identification of data. The instrument will cease to be in force at the end of five years unless sooner revoked.

Key Provisions

The Health Insurance (Quality Assurance Activity – Australian Orthopaedic Association National Joint Replacement Registry) Declaration 2022 (section 1) names the instrument and specifies its commencement on the day after its registration on the Federal Register of Legislation (section 2). It is made under subsection 124X(1) of the Health Insurance Act 1973 (section 3) and will be repealed when it ceases to be in force (section 4). The Schedule describes the Activity, which is the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) (Schedule 1, clause 1), and details the nature of the quality assurance activity, including the collection and use of Patient Reported Outcome Measures (PROMs) data (Schedule 1, clause 2). The Act imposes certain obligations on parties participating in the Activity, primarily centred around the management and disclosure of data collected. Information known solely as a result of conducting the Activity or documents created solely for the purposes of the Activity are covered by qualified privilege (Part VC, section 124Y). This privilege is intended to protect certain information from disclosure and to encourage participation by providing some protection from civil liability to certain persons in respect of their engagement in the Activity in good faith (Part VC, section 124Z). The Act also includes provisions for the de-identification of data to ensure privacy and to protect individuals from identification prior to analysis or disclosure of the information (Part VC, section 124Y(3)). Failure to comply with the Act’s requirements may result in civil penalties. Under section 124ZA of the Health Insurance Act 1973, any person who contravenes a provision of the Act may be liable to a civil penalty not exceeding the greater of $50,000, three times the benefit obtained, or three times the loss caused. The instrument is compatible with the rights and freedoms recognised or declared under section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011. The qualified privilege scheme under Part VC of the Act is designed to encourage participation in quality assurance activities, thereby supporting the right to health and ensuring high healthcare standards. The right to privacy is also considered, as data is de-identified to prevent individual identification prior to analysis or disclosure, thereby protecting personal information.

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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.