EXPLANATORY STATEMENT
Health Insurance Act 1973
Health Insurance (Quality Assurance Activity – Australasian Registry of Electrocardiograms in National Athletes (ARENA)) Declaration 2025
Authority
This instrument is made under subsection 124X(1) of the Health Insurance Act 1973 (the Act).
Purpose and operation
Part VC of the Health Insurance Act 1973 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.
Subsection 124X(1) of 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 purpose of the Health Insurance (Quality Assurance Activity – Australasian Registry of Electrocardiograms in National Athletes (ARENA)) Declaration 2025 (the Declaration) is to declare the Australasian Registry of Electrocardiograms in National Athletes (ARENA) (the Activity) to be a quality assurance activity to which Part VC of the Act applies.
The Activity is conducted by the University of Sydney. The Activity applies only to health services provided in Australia. The University of Sydney has contracted the South Australian Health and Medical Research Institute (SAHMRI) Registry Centre to host ARENA and to provide ongoing advice with registry operations and governance. ARENA is funded by National Health and Medical Research Council grants.
The Activity consists of a registry of athlete screening data, including electrocardiograms (ECGs) and other cardiac tests, collected in Australasia. All elite sporting organisations in Australia conducting cardiac screening of athletes are eligible to participate and provide data.
The activity provides a long-term data repository to improve our understanding of ECG interpretation and cardiac diagnoses, and the rates of major cardiovascular outcomes in screened athletes, by allowing the analysis of data that includes comparisons between sex, age, sport/event, screening date, ECG findings, cardiac test results, follow-up details, sport participation status, cardiac diagnosis, and major cardiovascular outcomes, defined as sudden cardiac arrest/death.
ARENA was developed in collaboration with sporting bodies, team physicians, and players association representatives. Data is entered into the registry via a database, securely stored at SAHMRI, and de-identified datasets are developed for use for analysis, recommendations, and research purposes, with the results to be published.
Athlete cardiac screening information, including ECGs, are collected and collated by the contributing organisation. ARENA provides a secure link to the contributing organisation for the purpose of information transmission. Information is securely stored with restricted access to only those approved by the ARENA Director. Approved data entry staff enter data into the REDCap database which automatically allocates a unique ID upon data entry. A de-identified version with all identifiers redacted is saved using the REDCap ID as the file name. This forms the analysis data which is restricted to those only approved by the ARENA Director. All ECG screening information is reviewed for accuracy by the data entry officer. If a discrepancy is found in the reported outcome, an ARENA review is triggered and an expert review is undertaken. If there is a different view to the original finding, the medical officer of the contributing organisation is notified of the outcome.
The analysis of national level data contained in ARENA will be used to inform improvements to screening policies and guidelines, particularly for underrepresented athlete groups like female athletes and Indigenous populations, including to improve the accuracy of athlete ECG interpretation.
The disclosure of information related to the Activity will use de-identified and aggregated data to produce reports and disseminate information through specific journal publications, publication data in annual reports on the ARENA website, and presentations at annual conferences which include suggested improvements and recommendations in practice.
Commencement
This Declaration commences on the day after registration of the instrument on the Federal Register of Legislation.
Consultation
The University of Sydney, 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 the University of Sydney. 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 – Australasian Registry of Electrocardiograms in National Athletes (ARENA)) Declaration 2025
Part 1—Preliminary
Section 1 – Name
This section provides that the name of the Declaration is the Health Insurance (Quality Assurance Activity – Australasian Registry of Electrocardiograms in National Athletes (ARENA)) 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 ‘Australasian Registry of Electrocardiograms in National Athletes (ARENA)’.
Item 2 – Description of activity
Item 2 describes the quality assurance activity as a retrospective and prospective, multicentre, longitudinal, observational registry of athlete cardiac screening results and outcomes for elite athletes in Australia. It involves the collection and centralising of cardiac screening data for athletes, including ECGs and results of other cardiac tests, already collected in routine screening of athletes by elite sporting organisations in Australia. The Activity aims to analyse national level data contained in ARENA to inform improvements to screening polices and guidelines, including to improve the accuracy of electrocardiogram interpretation.
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 – Australasian Registry of Electrocardiograms in National Athletes (ARENA)) Declaration 2025
The Health Insurance (Quality Assurance Activity – Australasian Registry of Electrocardiograms in National Athletes (ARENA)) 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 Australasian Registry of Electrocardiograms in National Athletes (ARENA) (the Activity), conducted by the University of Sydney, to be a quality assurance activity to which Part VC of the Health Insurance Act 1973 (the Act) applies. Information known solely as a 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 the accuracy of electrocardiogram interpretation.
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. The Activity involves 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