Health Insurance (Quality Assurance Activity – BreastSurgANZ Quality Audit) Declaration 2025

Administered by Department of Health, Disability and Ageing

Legislation au F2025L01371 In force Legislative Instrument

Legislation content

 

EXPLANATORY STATEMENT

 

Health Insurance Act 1973

Health Insurance (Quality Assurance Activity – BreastSurgANZ Quality Audit) Declaration 2025

 

 

Authority

 

Subsection 124X(1) of the Health Insurance Act 1973 (the Act) provides that the Minister may, by legislative instrument, declare a quality assurance activity described in a declaration to be a quality assurance activity to which Part VC of the Act applies.

 

The Health Insurance (Quality Assurance Activity – BreastSurgANZ Quality Audit) Declaration 2025 (the Declaration) declares the Breast Surgeons of Australia and New Zealand (BreastSurgANZ) Quality Audit (BQA) (the Activity) to be quality assurance activity to which Part VC of the Act applies.

 

Purpose and operation

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 ensure the quality of health services that are funded by the Government, including through Medicare benefits and public hospital services. The scheme encourages participation in such activities by protecting certain information from disclosure, and by providing some protection from civil liability to certain persons engaged in those activities in good faith.

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

The BQA is a clinical audit that collects breast cancer surgery and treatment pathway information from breast surgeons. The BQA compares surgeons’ clinical results with Quality Threshold for Key Performance Indicators (KPIs) set by the BQA Subcommittee, relating to a patient’s optimal care pathway.

The Activity will be engaged in by BreastSurgANZ, which is a sub-specialty society for surgeons treating breast cancer. The quality assurance activity described in this declaration applies only to health services provided in Australia.

The BQA is operated by the Royal Australasian College of Surgeons (RACS) under contract with BreastSurgANZ. RACS employs staff in the Research, Audit & Academic Surgery Division of the College, who manage the audit under direction from the BreastSurgANZ Quality Audit Subcommittee that reports to the BreastSurgANZ Council.

The BQA promotes collaborative research to improve breast cancer care through teaching, research, and the development of evidence-based strategies that monitor individual members' surgical performance and improve outcomes using evidence-based benchmarks produced from the audit. Surgeons can access their own data and analyse aggregate data from the BQA to establish an evidence base to make changes in recommended treatments to improve breast surgery outcomes. The BQA aims to ensure BreastSurgANZ members are practising breast cancer surgery to the highest standards assessed by compliance with evidence based KPIs through:

  1.       self-assessment of a surgeon’s own performance compared to the KPIs,
  2.       review of aggregate compliance with minimum standards by BreastSurgANZ to confidentially inform surgeons if their practices are consistent with best practice, and
  3.       individual practice audit by means of a confidential quality improvement and feedback process that closes the audit cycle loop.

Copies of reports using de-identified BQA data are published on the BQA website for access by the general public. Peer reviewed articles and papers using de-identified and aggregated BQA data are routinely published in journals and presented at specialist meetings. The RACS audit staff also prepare annual reports for BreastSurgANZ as well as consumer summaries of recent research utilising audit data. The BQA provides copies of these papers and findings to the Minister, or the delegate of the Minister, during the course of undertaking this Activity.

This declaration follows the previously declared Activity Health Insurance (Quality Assurance Activity – BreastSurgANZ Quality Audit) Declaration 2020. This declaration is likely to encourage a greater level of participation than the previously declared Activity through KPI and database expansion, redefined membership categories, and the implementation of an outlier process.

 

Commencement

 

This Declaration commences on the day after registration of the instrument on the Federal Register of Legislation.

 

Consultation

 

BreastSurgANZ, as the applicant for declaring the Activity, was consulted in relation to the content of the Declaration. No concerns were raised with the proposed content. Wider consultation was not considered necessary as the quality assurance activity only relates to the gathering of information for the Activity, as conducted by BreastSurgANZ. The declaration of the Activity will not result in any direct or substantial indirect effect on business.

 

General

 

This Declaration is a disallowable legislative instrument for the purposes of the Legislation Act 2003.

 

Details of the Declaration are set out in Attachment A.

 

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

 

ATTACHMENT A

Health Insurance (Quality Assurance Activity – BreastSurgANZ Quality Audit) Declaration 2025

Part 1—Preliminary

Section 1 – Name

This section provides that the name of the Declaration is the Health Insurance (Quality Assurance Activity – BreastSurgANZ Quality Audit) Declaration 2025.

Section 2 – Commencement

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

Section 3 – Authority

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

Section 4 – Repeal

This section provides that the Declaration 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

Item 1 – Name of activity

Item 1 provides that the name of the Activity is ‘Breast Surgeons of Australia and New Zealand Quality Audit’.

Item 2 – Description of activity

Item 2 of Schedule 1 describes the quality assurance activity as a clinical audit that collects breast cancer surgery and treatment pathway information from breast surgeons and compares clinical results with Quality Threshold for Key Performance Indicators set by the BQA Subcommittee, relating to a patient’s optimal care pathway.

 


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 – BreastSurgANZ Quality Audit) Declaration 2025
 

The Health Insurance (Quality Assurance Activity – BreastSurgANZ Quality Audit) Declaration 2025 (the Declaration) 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 Declaration declares the BreastSurgANZ Quality Audit (the Activity), conducted by the BreastSurgANZ, to be a quality assurance activity to which Part VC of the Health Insurance Act 1973 (the Act) applies. Information known solely as the result of the Activity, or documents created solely for the purposes of the Activity, will be covered by qualified privilege.

Human rights implications

This Declaration engages with 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 this Declaration will provide participants with a greater degree of confidence and security that their participation is solely for the benefit of improving clinical practice and patient safety.

This 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 quality assurance activity will be de-identified to ensure that no individual or individuals are identified prior to analysis or disclosure of the information.

Conclusion

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

 

Professor Michael Kidd

Chief Medical Officer

Department of Health, Disability and Ageing

Overview

The Health Insurance (Quality Assurance Activity – BreastSurgANZ Quality Audit) Declaration 2025 was enacted to formally recognise the BreastSurgANZ Quality Audit as a quality assurance activity under Part VC of the Health Insurance Act 1973. This Act, first enacted in 1973, aims to improve the quality of health services funded by the Government, including Medicare and public hospital services, by encouraging participation in quality assurance activities. The Declaration is made under the authority provided by subsection 124X(1) of the Act and seeks to address gaps in the quality of breast cancer surgical care by protecting certain information from disclosure and offering protection from civil liability to those engaged in the audit in good faith. The policy objective is to ensure that breast surgeons practising in Australia adhere to the highest standards of care, as evidenced by compliance with established Key Performance Indicators. The Quality Audit, operated by the Royal Australasian College of Surgeons under contract with BreastSurgANZ, collects and analyses breast cancer surgery data to improve patient outcomes and surgical practices through evidence-based strategies.

Scope and Application

The Health Insurance (Quality Assurance Activity – BreastSurgANZ Quality Audit) Declaration 2025 applies to the BreastSurgANZ Quality Audit, which is a quality assurance activity conducted by the Breast Surgeons of Australia and New Zealand (BreastSurgANZ). This activity is intended to enhance the quality of breast cancer surgery in Australia by comparing surgeons' clinical results with established Key Performance Indicators. This declaration specifies that the BreastSurgANZ Quality Audit is subject to Part VC of the Health Insurance Act 1973, which provides protections and incentives for quality assurance activities in health services. The audit is managed by the Royal Australasian College of Surgeons under contract with BreastSurgANZ and involves the collection and analysis of data on breast cancer surgery to promote best practices and improve patient outcomes. This quality assurance activity applies exclusively to health services provided within Australia and is designed to foster higher standards of care through self-assessment, peer review, and evidence-based strategies. The declaration does not extend to any activities outside the scope of breast cancer surgery in Australia and is subject to a five-year term unless revoked sooner. The Declaration ensures that information collected and documents created solely for the purposes of the BreastSurgANZ Quality Audit are protected by qualified privilege, encouraging participation in quality assurance activities. This protection is intended to provide confidence and security to participants, ensuring that their involvement is solely for the benefit of improving clinical practice and patient safety. The audit results are de-identified before analysis or disclosure, thereby respecting the right to privacy. The declaration aligns with international human rights standards by supporting the right to health and ensuring that the right to privacy is not unduly limited. The scheme is designed to encourage participation in quality assurance activities, thus maintaining high standards of health care.

Key Provisions

The Health Insurance (Quality Assurance Activity – BreastSurgANZ Quality Audit) Declaration 2025 (section 1) identifies the Breast Surgeons of Australia and New Zealand (BreastSurgANZ) Quality Audit (BQA) as a quality assurance activity covered by Part VC of the Health Insurance Act 1973 (section 5). This means that information obtained through the BQA and documents created for the purposes of the audit are protected by qualified privilege. The BQA, described in Schedule 1, is a clinical audit that collects data on breast cancer surgery and treatment pathways from breast surgeons and compares these results with Key Performance Indicators (KPIs) established by the BQA Subcommittee (item 2 of Schedule 1). The BQA is designed to promote research and improve breast cancer care by monitoring surgical performance and outcomes using evidence-based benchmarks. The declaration imposes obligations on the entities involved in the BQA, primarily BreastSurgANZ and the Royal Australasian College of Surgeons (RACS), to conduct the audit in accordance with the terms set out in the declaration and to ensure that the collected data is used solely for the purpose of quality assurance and improvement of clinical practice. BreastSurgANZ and RACS must also ensure that the information collected during the audit is de-identified before any analysis or disclosure, thereby protecting the privacy of individuals involved (section 5). Furthermore, the declaration requires that any reports using de-identified BQA data are made available to the public and that findings are communicated to the Minister or their delegate (item 2 of Schedule 1). Breach of the provisions of this declaration could lead to civil or criminal consequences. Specifically, unauthorised disclosure of information protected by qualified privilege could result in legal action under Part VC of the Health Insurance Act 1973. The Act allows for civil penalties for breaches, which may include fines up to a maximum of $22,200 for individuals and $111,000 for bodies corporate, as per the current penalty units under the Crimes (Commonwealth Authorities and Officers) Act 1987. Additionally, any misuse of personal information in violation of the qualified privilege and privacy obligations could also result in penalties under the Privacy Act 1988, including substantial fines for serious or repeated breaches. These penalties reflect the importance of maintaining the integrity and confidentiality of the data collected through the BQA to ensure public trust and the effectiveness of the quality assurance process.

Legal classification tags

Area of Law
Health Law
Instrument
Legislative Instrument
Concepts
Definitions & Interpretation
Regulatory Standards
Reporting & Disclosure Obligations
Compliance Obligations
Protection from Civil Liability

Interactions

Authorises

All Versions

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.