{"id":"F2025L01418","name":"Health Insurance (Quality Assurance Activity – Australian Corneal Graft Registry) Declaration 2025","slug":"health-insurance-quality-assurance-activity-australian-corneal-graft-registry-declaration-2025","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":443050,"registerId":"F2025L01418-fast-fetch-1775957954601","compilationNumber":null,"startDate":"2026-04-12","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Health Insurance (Quality Assurance Activity – Australian Corneal Graft Registry) Declaration 2025","content":"---\nmeta-content-style-type: text/css\nmeta-content-type: application/xhtml+xml; charset=utf-8\n---\n\n![Commonwealth Coat of Arms of Australia](image.001.jpeg)\n\n \n\nHealth Insurance (Quality Assurance Activity – Australian Corneal Graft Registry) Declaration 2025\n\nI, Michael Kidd, delegate for the Minister for Health and Ageing and Minister for Disability and the National Disability Insurance Scheme, make the following declaration under section 124X of the Health Insurance Act 1973.\n\nDated       19.11.2025\n\n  \n\n \n\nProfessor Michael Kidd AO\n\nChief Medical Officer\n\nDepartment of Health, Disability and Ageing\n\n \n\n \n\n \n\nContents\n\nPart 1—Preliminary\n\n1  Name\n\n2  Commencement\n\n3  Authority\n\n4  Repeal\n\n5  Schedule\n\nSchedule 1—Description of quality assurance activity\n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\nPart 1—Preliminary\n\n1  Name\n\nThis instrument is the Health Insurance (Quality Assurance Activity – Australian Corneal Graft Registry) Declaration 2025\n\n2  Commencement\n\n(1) Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.\n\n \n\n- Commencement information\n- Column 1 Column 2 Column 3\n- Provisions Commencement Date/Details\n- 1. The whole of this instrument The day after this instrument is registered.\n\n\nNote: This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.\n\n(2) Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.\n\n3  Authority\n\nThis instrument is made under subsection 124X(1) of the Health Insurance Act 1973.\n\n4  Repeal\n\n \n\nThis instrument is repealed when it ceases to be in force in accordance with subsection 124X(4) of the Health Insurance Act 1973.\n\n5  Schedule\n\nThe quality assurance activity described in the Schedule to this declaration is, to the extent that the quality assurance activity relates to health services provided in Australia, declared to be a quality assurance activity to which Part VC of the Health Insurance Act 1973 applies.\n\n \n\n\n\n\nSchedule 1—Description of quality assurance activity\n\n \n\n1  Name of activity   \n\nThe name of the quality assurance activity is Australian Corneal Graft Registry\n\n \n\n2  Description of activity\n\n \n\nThe Australian Corneal Graft Registry (ACGR) quality assurance activity 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.\n\n \n\nThe 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.\n\n \n\nAn 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 analyse this data on corneal transplantation surgery, on the outcomes of corneal transplantation, and the factors that may positively or negatively affect transplant outcomes.\n\n \n\nAt 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.\n\n \n\nGraft 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.\n\n \n\nSince 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. \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n","sortOrder":0}],"analysis":{"flash_summary_failed":{"failed":true,"reason":"A positive credit balance is required for all requests, including BYOK, so fallback providers remain available. Add credits at https://vercel.com/d?to=%2F%5Bteam%5D%2F%7E%2Fai%3Fmodal%3Dtop-up to continue.","source":"analysis-cron"},"flash_summary":{"complexity_score":3,"scope_assessment":{"changed":true,"description":"The Schedule records that, since the previous declaration, the ACGR has added datasets for new forms of corneal transplantation and is moving from paper forms toward secure online data submission to encourage participation and increase the graft registration rate above the current 80–85% (Schedule)."},"complexity_factors":["Short, single-purpose declaration with limited provisions (Name, Commencement, Authority, Repeal, Schedule) (clauses 1–5).","Legal effect depends on cross-reference to subsection 124X(1) and Part VC of the Health Insurance Act 1973 (clause 3; clause 5).","Data collection is voluntary but ongoing: initial registration, 12–36 month follow‑ups until graft failure, death or loss to follow-up (Schedule).","Recipient consent and right to withdraw are required; minimum dataset submitted to AIHW at five‑year intervals for linkage with the National Death Index (Schedule).","Ethics and governance oversight: Southern Adelaide Human Research Ethics Committee review and an Advisory Board of clinicians/scientists (Schedule).","Operational change noted: expanded datasets for new transplant types and planned move from paper forms to secure online submission to boost participation (Schedule).","Repeal timing governed by subsection 124X(4) of the Health Insurance Act 1973 (clause 4), so duration depends on the parent Act’s mechanism.","Practical compliance and administrative burdens rest with contributing clinicians, eye banks and registry staff due to follow-up obligations, data submission and de‑identification processes (Schedule)."],"plain_english_summary":"This declaration makes the Australian Corneal Graft Registry (ACGR) a quality assurance activity under Part VC of the Health Insurance Act 1973. It authorises Flinders University to collect, aggregate and report de‑identified corneal transplant recipient, donor and surgical data with recipient consent and human research ethics oversight.\n\nSurgeons, eye banks and practitioners supply data voluntarily; results feed back to clinicians and government and can be linked to the National Death Index at five‑year intervals. The instrument notes expanded datasets and a move to secure online submission to raise participation."},"kimi_summary":{"content_quality":"ok","complexity_score":2,"scope_assessment":{"changed":false,"description":"This declaration maintains the same scope as previous iterations. It continues the long-standing practice of declaring the Australian Corneal Graft Registry as a protected quality assurance activity under Part VC of the Health Insurance Act 1973. The 2025 version updates operational details (noting the move to online submissions and expanded datasets for new transplant techniques) but does not expand the legal scope or purpose beyond quality assurance for corneal transplantation."},"complexity_factors":["Very short instrument (approximately 1,500 words)","Only 5 formal sections in Part 1 plus Schedule 1","No defined terms section — terms used in plain English","Single cross-reference to section 124X of the Health Insurance Act 1973","No conditional logic or nested exceptions","Straightforward declarative structure: 'The activity described in the Schedule is declared...'","Schedule contains descriptive narrative rather than technical legal provisions"],"plain_english_summary":"This declaration recognises the Australian Corneal Graft Registry (ACGR) as a quality‑assurance activity under the Health Insurance Act 1973, extending Part VC legal protections so eye banks, surgeons and researchers can share de‑identified transplant data without it being used in most legal proceedings.\n\nThose protections—together with consent/withdrawal rights and ethics oversight—help track 47,000+ corneal grafts to improve surgical outcomes and encourage honest reporting of complications."}},"importantCases":[],"_links":{"self":"/api/acts/health-insurance-quality-assurance-activity-australian-corneal-graft-registry-declaration-2025","history":"/api/acts/health-insurance-quality-assurance-activity-australian-corneal-graft-registry-declaration-2025/history","analysis":"/api/acts/health-insurance-quality-assurance-activity-australian-corneal-graft-registry-declaration-2025/analysis","conflicts":"/api/acts/health-insurance-quality-assurance-activity-australian-corneal-graft-registry-declaration-2025/conflicts","importantCases":"/api/acts/health-insurance-quality-assurance-activity-australian-corneal-graft-registry-declaration-2025/important-cases","documents":"/api/acts/health-insurance-quality-assurance-activity-australian-corneal-graft-registry-declaration-2025/documents"}}