{"id":"F2024L00439","name":"Health Insurance (Quality Assurance Activity – Australian Breast Device Registry) Declaration 2024","slug":"health-insurance-quality-assurance-activity-australian-breast-device-registry-declaration-2024","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":105199,"registerId":"commonwealth-F2024L00439-current","compilationNumber":null,"startDate":"2026-04-03","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Name","content":"#### 1 Name\n\n This instrument is the Health Insurance (Quality Assurance Activity – Australian Breast Device Registry) Declaration 2024","sortOrder":0},{"sectionNumber":"2","sectionType":"section","heading":"Commencement","content":"#### 2 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```html\n

Commencement information

Column 1

Column 2

Column 3

Provisions

Commencement

Date/Details

1. The whole of this instrument

The day after this instrument is registered.

\n```\n\n> Note: This table relates only to the provisions of this instrument as originally made.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.","sortOrder":1},{"sectionNumber":"3","sectionType":"section","heading":"Authority","content":"#### 3 Authority\n\n This instrument is made under subsection 124X(1) of the Health Insurance Act 1973.","sortOrder":2},{"sectionNumber":"4","sectionType":"section","heading":"Repeal","content":"#### 4 Repeal\n\nThis instrument is repealed when it ceases to be in force in accordance with subsection 124X(4) of the Health Insurance Act 1973.","sortOrder":3},{"sectionNumber":"5","sectionType":"section","heading":"Schedule","content":"#### 5 Schedule\n\n The 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\nSchedule 1—Description of quality assurance activity\n\n1 Name of activity \n\nThe name of the quality assurance activity is the Australian Breast Device Registry.\n\n2 Description of activity\n\nThis quality assurance activity is operated by the Monash University School of Public Health and Preventive Medicine which tracks the performance of high-risk implantable breast devices and identifies long-term device safety issues for breast implants, tissue expanders and matrices used in reconstructive and cosmetic breast surgery.\n\nData relating to implantation, revision or explantation of breast devices is collected from participating hospitals and surgeons.\n\nThe overall aim is to improve the safety of breast devices for patients in the following ways:\n\n  Collection of population-level data regarding breast devices implanted, revised and explanted, to assist patients, surgeons and hospitals, should a device warning or recall by made by the Therapeutic Goods Administration (TGA).\n\n  Monitoring and reporting the long-term performance of breast devices to identify potential device safety issues, and providing performance information to the TGA, to assist it in its regulatory capacity.\n\n  Monitoring and reporting on potential trends and complications associated with breast device surgery.\n\nDe-identified results are reported back to participating clinicians, health service providers and other key stakeholders on the long-term performance of breast implant devices to enhance long-term monitoring and improve patient safety.\n\nDe-identified aggregated data is also published in:\n\n  Annual reports produced by the Australian Breast Device Registry\n\n  Academic publications in surgical journals\n\n  Quality and safety reports provided to device companies.","sortOrder":4}],"analysis":{"kimi_summary":{"content_quality":"ok","complexity_score":2,"scope_assessment":{"changed":false,"description":"This instrument performs a narrow, specific function exactly as intended by the parent Act: declaring a particular quality assurance activity to receive statutory protections. It has not expanded beyond this purpose."},"complexity_factors":["Very short instrument (only 5 sections plus a brief schedule)","No defined terms section","Single cross-reference to the enabling legislation (Health Insurance Act 1973, subsection 124X(1))","Straightforward declaratory structure: simply declares an existing activity to be a 'quality assurance activity'","No conditional logic, exceptions, or nested provisions","Schedule contains descriptive material rather than operative provisions"],"plain_english_summary":"This law formally recognises the Australian Breast Device Registry as a quality-assurance activity under the Health Insurance Act, giving Monash University legal protection to collect and de‑identify data on breast implants, expanders, revisions and removals from hospitals and surgeons. \n\nIt affects patients, clinicians, the TGA and device makers by enabling safer, confidential national monitoring—helping spot faulty devices early, support recalls and improve patient safety by encouraging clinician participation through legal protections."},"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":false,"description":"The instrument simply declares the Australian Breast Device Registry to be a quality assurance activity for Part VC in respect of health services provided in Australia (Schedule; s5). It does not assert any expanded or reduced scope compared with the activity as described in the Schedule, and contains no language indicating a change from an earlier declared scope. The instrument’s timing and repeal remain tied to the Health Insurance Act provisions (Commencement, s2; Repeal, s4)."},"complexity_factors":["Legal cross-reference to the Health Insurance Act 1973 (made under subsection 124X(1)) creates dependence on Part VC’s definitions and protections not reproduced here (Authority, s3).","Repeal and duration are governed by Part VC (ceasing in accordance with subsection 124X(4)), so the instrument’s lifespan is conditional on external statutory rules (Repeal, s4).","Immediate commencement timing (the day after registration) creates prompt legal effect and operational lead time constraints for participants (Commencement, s2).","Operational scope requires collection of clinical data from participating hospitals and surgeons and de‑identified reporting to clinicians, health services and regulators — implementation and compliance burdens sit with those data providers (Schedule, Description of activity).","The instrument specifies de‑identified aggregated publication channels including annual reports, academic journals and quality/safety reports to device companies, which raises data governance and disclosure controls to be resolved in practice (Schedule, Description of activity).","Key practical details are unspecified in the instrument: funding, patient consent or opt‑out arrangements, data custodianship, and specific sharing agreements are not set out and must be handled separately, increasing regulatory and administrative ambiguity (Schedule, Description of activity).","Multiple stakeholders are affected (Monash University as operator, participating hospitals/surgeons, patients, the TGA, and device companies), which increases coordination complexity despite the instrument’s short text (Schedule, Name and Description)."],"plain_english_summary":"This declaration designates the Australian Breast Device Registry, run by Monash University, as a \"quality assurance activity\" under Part VC of the Health Insurance Act 1973. It brings the Registry’s collection and de‑identified reporting of breast implant, expander and matrix implantation, revision and explantation data within that legal framework. The instrument says the registry’s purpose is device safety monitoring and reporting (Schedule), but it does not specify who funds it or the mechanics of consent and data‑sharing."}},"importantCases":[],"_links":{"self":"/api/acts/health-insurance-quality-assurance-activity-australian-breast-device-registry-declaration-2024","history":"/api/acts/health-insurance-quality-assurance-activity-australian-breast-device-registry-declaration-2024/history","analysis":"/api/acts/health-insurance-quality-assurance-activity-australian-breast-device-registry-declaration-2024/analysis","conflicts":"/api/acts/health-insurance-quality-assurance-activity-australian-breast-device-registry-declaration-2024/conflicts","importantCases":"/api/acts/health-insurance-quality-assurance-activity-australian-breast-device-registry-declaration-2024/important-cases","documents":"/api/acts/health-insurance-quality-assurance-activity-australian-breast-device-registry-declaration-2024/documents"}}