EXPLANATORY STATEMENT
Health Insurance Act 1973
Health Insurance (Quality Assurance Activity – Australian Corneal Graft Registry) Declaration 2025
Purpose and operation
Part VC of the Health Insurance Act 1973 (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 Health Insurance (Quality Assurance Activity – Australian Corneal Graft Registry) Declaration 2025 (the Declaration) is to declare the Australian Corneal Graft Registry (the Activity) to be a quality assurance activity to which Part VC of the Act applies.
The body authorising the Activity is Flinders University. The Activity will be undertaken by the Australian Corneal Graft Registry (ACGR) Advisory Board consisting of clinicians and scientists, who oversee the management of the registry. The methods employed by the ACGR are also overseen and reviewed regularly by the Southern Adelaide Human Research Ethics Committee.
Registry data provides information to surgeons, eye banks, the international transplantation community, the Australian Government via DonateLife and other interested parties including ophthalmologists, optometrists and other health care professionals. This information assists transplantation choices and optimal treatment to people receiving corneal grafts, supports ongoing clinical procedures and practices and research and policy making.
Register results are provided to contributing surgeons and eye banks on an annual basis via an industry meeting, through an annual report and approximately three yearly major registry reports, via online Academic Commons and publication in international scientific literature.
The Australian Corneal Graft Registry is listed on the Australian Register of Clinical Registries list under ID ACSQHCARCR- 818 (see Australian Commission on Safety and Quality in Health Care website).
Authority
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 Declaration declares the Australian Corneal Graft Registry (the Activity), to be a quality assurance activity to which Part VC of the Act applies.
Commencement
This Declaration commences on the day after registration of the instrument on the Federal Register of Legislation.
Consultation
Flinders University, as the applicant declaring the Activity, was consulted in relation to the content of the Declaration. Additional information to the original application was also requested, and provided by Flinders University, to understand how recommendations about the provision of health services are made from participation in the Registry, and how health service recommendations are communicated and to whom.
Information provided by the applicant subsequently noted that registry data has assisted donation services and surgical practices to amend their own services, plan for the future and noted a doubling of the rate of corneal transplantation over the past twenty years.
Flinders University also outlined as further explanation that the Registry provides information and responds to:
1. Australian contributing ophthalmic surgeons, trainees, Eye Bankers and others.
2. Any interested individual through free major reports.
3. Contributing ophthalmologists through audits of individual performance, benchmarked
against the national average.
4. Australian Eye Banks through annual reporting and audits on request.
5. Outside bodies requesting de-identified, amalgamated information.
6.Their current funding body, the Australian Organ and Tissue Authority (Donate Life).
7. Ophthalmologists nationally and internationally who wish to use their published data.
No concerns were raised from the application and content provided by the applicant, as part of seeking departmental feedback, noting there was support for the application from the Australian Commission on Safety and Quality in Health Care.
Wider consultation was not considered necessary as the quality assurance activity only relates to the gathering of information for the Activity, as conducted by Flinders University. 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 – Australian Corneal Graft Registry) Declaration 2025
Part 1—Preliminary
Section 1 – Name
This section provides that the name of the Declaration is the Health Insurance (Quality Assurance Activity – Australian Corneal Graft Registry) 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 ‘Australian Corneal Graft Registry’.
Item 2 – Description of activity
Item 2 of Schedule 1 describes the quality assurance activity as the Australian Corneal Graft Registry (ACGR) whose objective is to collect patient and surgeon data relating to corneal transplantation surgery in Australia. These data are aggregated and analysed to provide de‑identified performance information back to ophthalmic surgeons, Eye Banks, the international transplantation community, the Australian Government via DonateLife, the National Organ and Tissue Donation and Transplantation Authority, the Medical Services Advisory Board (MSAC) and other interested parties regarding the outcomes of corneal graft procedures and factors that may positively or negatively affect outcomes after the procedure. Through provision of these results, informed choices can be made for providing optimal treatment to recipients of corneal grafts.
The ACGR is conducted by Flinders University staff who collect information on a voluntary basis from eye banks, ophthalmic surgeons and other health professionals. The information collected includes demographic data about corneal graft recipients, limited data about cornea donors, and information about the surgical procedures performed. Information from follow-up appointments is collected at 12–18-month intervals after the surgery.
An Advisory Board, consisting of clinicians and scientists, oversees the management of the registry. The methods employed by the ACGR are overseen, and reviewed regularly, by the Southern Adelaide Human Research Ethics Committee. The ACGR collects nationwide data relating to corneal transplantation. The ACGR currently contains over 47,000 records of corneal transplants. The ACGR analyses this data on corneal transplantation surgery, on the outcomes of corneal transplantation, and the factors that may positively or negatively affect transplant outcomes.
At regular intervals of 12 to 36 months, follow-up postal information regarding transplantation surgery outcomes is sought from the surgeon, or from an alternative health practitioner caring for the corneal transplant recipient. This post-surgical follow up continues to be sought until the time of graft failure, recipient death, or loss to the recipient.
Graft recipients provide consent to their surgeon for data to be submitted to the ACGR, as well as for a minimum dataset to be submitted to the Australian Institute of Health and Welfare (AIHW) at 5-year intervals, for linkage with the National Death Index. Recipient consent is indicated initially on the registration form and can also be withdrawn from the registry at any time. Outcomes from the ACGR are always reported in a de-identified, aggregated form.
Since previous declaration, the ACGR has included further datasets related to new forms of corneal transplantation and is moving towards more secure online submission of register data to encourage registry participation. Surgeons have informed the ACGR that paper-based forms are a barrier to participating and it is expected that online submissions will increase the graft registration rate substantially, from the current 80-85% participation rates.
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 Corneal Graft Registry) Declaration 2025
This 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 Health Insurance (Quality Assurance Activity – Australian Corneal Graft Registry) Declaration 2025 (the Declaration) declares the Australian Corneal Graft Registry (ACGR) (the Activity), conducted by Flinders University, 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 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 outcomes for recipients of corneal transplants.
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.
Graft recipients provide consent to their surgeon for data to be submitted to the ACGR, and for data linkage with the National Death Index. Recipient consent is indicated on the registration form. Original paper records are then scanned into an optic disk database, located on the secure SAHealth Network. Once data is entered electronically, the original forms are stored by the Flinders Medical Centre secure medical records system.
This SAHealth Network provides secure backup of all records and information technology support. Backup copies of the registry and associated files are kept on password protected, encrypted external hard drives health within locked built-in cupboards, located in a secure room within a secure building
Outcomes from the ACGR are also always reported in de-identified, aggregated form. Data are not released in any identifiable form to any source, including contributors, except for the provision of a minimum dataset to the Australian Institute of Health and Welfare (AIHW) for linkage with the National Death Index at approximately 5-year intervals. This linkage enables the ACGR to determine if recipients have died. No information relating to recipient outcomes is provided during this process, and once ACGR records are updated, the linkage data are destroyed. This process has ethics approval granted by the AIHW. If a graft recipient has not provided consent for data linkage, they are excluded from this process.
De-identified outcome analyses are provided to eye banks with respect to tissue they have retrieved and processed to assist with quality audits. Surgeons can also share individual results for benchmarking purposes, only with written permission, and all information regarding individual recipients, donors, and eye banks is de-identified.
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 AO
Chief Medical Officer
Department of Health, Disability and Ageing