{"id":"sr:improving-cancer-outcomes-diagnosis-reporting-regulations-2025","name":"Improving Cancer Outcomes (Diagnosis Reporting) Regulations 2025","slug":"improving-cancer-outcomes-diagnosis-reporting-regulations-2025","collection":"regulation","jurisdiction":"vic","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":183893,"registerId":"vic-sr:improving-cancer-outcomes-diagnosis-reporting-regulations-2025-current","compilationNumber":null,"startDate":"2026-04-05","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Improving Cancer Outcomes (Diagnosis Reporting) Regulations 2025","content":"Version No. 001\n\n**Improving Cancer Outcomes (Diagnosis Reporting) Regulations 2025**\n\n**S.R. No. 89/2025**\n\nVersion as at  \n18 September 2025\n\n**TABLE OF PROVISIONS**\n\n*Regulation Page*\n\n1 Objectives 1\n\n2 Authorising provision 1\n\n3 Commencement 1\n\n4 Revocation 1\n\n5 Definitions 2\n\n6 Types of cancer and precursor diagnosis required to be reported 2\n\n7 Persons and organisations required to report cancer or precursor 3\n\n8 Diagnosis reports 3\n\nSchedule 1—Types of cancer and precursors to cancer to be reported to Secretary 5\n\nSchedule 2—Information to be reported by centre, hospital or service 7\n\nSchedule 3—Information to be reported by pathology service 10\n\n═════════════\n\nEndnotes 12\n\n1 General information 12\n\n2 Table of Amendments 14\n\n3 Explanatory details 15\n\n**Version No.** **001**\n\n**Improving Cancer Outcomes (Diagnosis Reporting) Regulations 2025**\n\n**S.R. No. 89/2025**\n\nVersion as at  \n18 September 2025\n\n\t1 Objectives\n\nThe objectives of these Regulations are to prescribe—\n\n(a) the types of cancer, and precursors to cancer, for which a diagnosis must be reported to the Secretary under the **Improving Cancer Outcomes Act 2014**; and\n\n(b) the persons and organisations that must report that diagnosis; and\n\n(c) the form of the reports, the time within which the reports must be provided to the Secretary and the information to be included in the reports.\n\n\t2 Authorising provision\n\nThese Regulations are made under section 28 of the **Improving Cancer Outcomes Act 2014**.\n\n\t3 Commencement\n\nThese Regulations come into operation on 18 September 2025.\n\n\t4 Revocation\n\nThe Improving Cancer Outcomes (Diagnosis Reporting) Regulations 2015[[1]](#endnote-1) are **revoked**.\n\n\t5 Definitions\n\nIn these Regulations—\n\n***borderline tumour*** means a neoplasm displaying morphologic, phenotypic or genotypic characteristics that—\n\n(a) are not benign; and\n\n(b) do not establish a diagnosis of malignancy;\n\n***Eastern Cooperative Oncology Group performance status*** means a score given at the time of an individual's cancer diagnosis outlining the extent to which the disease affects the individual's daily living abilities;\n\n***healthcare identifier*** has the same meaning as in section 5 of the Healthcare Identifiers Act 2010 of the Commonwealth;\n\n***in-situ tumour*** means a group of abnormal cells that are found only in the place where those cells formed in the body;\n\n***medicare number*** has the same meaning as in section 84(1) of the National Health Act 1953 of the Commonwealth;\n\n***perianal skin*** means hair-bearing skin within a  \n5-centimetre radius of the outer edge of the anal opening.\n\n\t6 Types of cancer and precursor diagnosis required to be reported\n\nFor the purposes of section 9(1) of the **Improving Cancer Outcomes Act 2014**, the prescribed types of cancer and precursors to cancer are in Schedule 1.\n\n\t7 Persons and organisations required to report cancer or precursor\n\nFor the purposes of section 9(1) of the **Improving Cancer Outcomes Act 2014**, the following persons and organisations are prescribed—\n\n(a) any of the following within the meaning of section 3(1) of the **Health Services Act 1988**—\n\n(i) a day procedure centre;\n\n(ii) a denominational hospital;\n\n(iii) a private hospital;\n\n(iv) a privately-operated hospital;\n\n(v) a public health service;\n\n(vi) a public hospital;\n\n(b) any radiotherapy service that provides a service for treating individuals with cancer, or a precursor to cancer, of a type prescribed by regulation 6 involving the use of ionising radiation, including but not limited to external beam photon, particle radiation, brachytherapy and injected radioisotopes;\n\n(c) any pathology service that provides a service for testing for cancer, or a precursor to cancer, of a type prescribed by regulation 6.\n\n\t8 Diagnosis reports\n\nFor the purposes of section 9(3) of the **Improving Cancer Outcomes Act 2014**—\n\n(a) a report of a diagnosis of cancer or a precursor to cancer is in the prescribed form if it contains the information prescribed by regulation 8(c); and\n\n(b) the prescribed time is—\n\n(i) for a centre, hospital or service referred to in regulation 7(a) or (b), 60 days after the date on which the person in charge of the centre, hospital or service becomes aware that an individual has a diagnosis of cancer, or a precursor to cancer, of a type prescribed by regulation 6; and\n\n(ii) for a pathology service referred to in regulation 7(c), 30 days after the date on which the person in charge of the laboratory where the test analysis is conducted becomes aware that a test indicates that an individual has a diagnosis of cancer, or a precursor to cancer, of a type prescribed by regulation 6; and\n\n(c) the prescribed information is—\n\n(i) for a centre, hospital or service referred to in regulation 7(a) or (b), the information in Schedule 2; and\n\n(ii) for a pathology service referred to in regulation 7(c), the information in Schedule 3.\n\nSchedule 1—Types of cancer and precursors to cancer to be reported to Secretary\n\nRegulation 6\n\n(1) Subject to clause (6), malignant tumours (other than skin cancers that are basal cell carcinomas and squamous cell carcinomas) of all sites.\n\n(2) Subject to clause (6), in-situ tumours (other than skin cancers that are basal cell carcinomas and squamous cell carcinomas) of all sites.\n\n(3) Borderline tumours or tumours of uncertain behaviour of—\n\n(a) the brain; or\n\n(b) the cerebral and spinal meninges; or\n\n(c) any other part of the central nervous system; or\n\n(d) the female genital organs including ovaries; or\n\n(e) the urinary tract, except the kidney parenchyma; or\n\n(f) the haematological and lymphoid system.\n\n(4) Benign tumours of—\n\n(a) the brain; or\n\n(b) the cerebral and spinal meninges; or\n\n(c) the spinal cord; or\n\n(d) cranial nerves; or\n\n(e) any other part of the central nervous system.\n\n(5) Subject to clause (6), skin cancers (other than basal cell carcinomas and squamous cell carcinomas) of all sites.\n\n(6) Squamous cell carcinomas of the—\n\n(a) labia majora; or\n\n(b) labia minora; or\n\n(c) vulva; or\n\n(d) prepuce; or\n\n(e) penis; or\n\n(f) scrotum; or\n\n(g) perianal skin (including anal margin); or\n\n(h) mucosal surface and vermilion border of the lip.\n\nSchedule 2—Information to be reported by centre, hospital or service\n\nRegulation 8(c)(i)\n\n1 Name of centre, hospital or service.\n\n2 Hospital identification number.\n\n3 Hospital unit record number.\n\n4 The following patient details of an individual—\n\nMedicare number (*if known*);\n\nIndividual healthcare identifier (*if known*);\n\nFamily name;\n\nGiven name(s);\n\nPrevious name(s) and alias(es) (*if applicable*);\n\nResidential address (including the building or property name, street address, suburb, town, locality name and postcode, as the case may be);\n\nPostal address (*if different to the residential address*);\n\nEmail address;\n\nTelephone number;\n\nDate of birth;\n\nSex at birth;\n\nCountry of birth;\n\nWhether or not the individual identifies as an Aboriginal person, a Torres Strait Islander person, or both (*if known—please specify*);\n\nLanguage spoken at home (*if known—please specify*).\n\n5 The following details of the doctor in charge of the case—\n\nMedicare provider number (*if known*);\n\nName;\n\nBusiness address (including the building or property name, street address, suburb, town, locality name and postcode, as the case may be);\n\nPostal address (*if different to the business address*);\n\nEmail address;\n\nBusiness telephone number.\n\n6 The following details of the general practitioner—\n\nMedicare provider number (*if known*);\n\nName;\n\nBusiness address (including the building or property name, street address, suburb, town, locality name and postcode, as the case may be);\n\nPostal address (*if different to the business address*);\n\nEmail address;\n\nBusiness telephone number.\n\n7 Date of first admission of the individual as a patient for this cancer.\n\n8 Date of diagnosis of this cancer.\n\n9 Eastern Cooperative Oncology Group performance status at time of diagnosis (*if known*).\n\n10 Date of discharge of the individual as a patient from the centre, hospital or service (as the case may be).\n\n11 Investigations relevant to diagnosis of cancer.\n\n12 Primary site of cancer.\n\n13 Laterality of primary site of cancer.\n\n14 Morphology of primary cancer.\n\n15 Grade or differentiation of primary cancer.\n\n16 Stage group (to be reported in accordance with the \"Cancer staging—cancer staging scheme source, code N[N]\" as published by the Australian Institute of Health and Welfare from time to time).\n\n17 TNM stage categories (including T, N and M categories) (to be reported in accordance with the \"Cancer staging—cancer staging scheme source, code N[N]\" as published by the Australian Institute of Health and Welfare from time to time).\n\n18 The following treatment details for each primary tumour—\n\nDetails of initial treatment;\n\nDetails of treatment of recurrence(s) (*if any*).\n\n19 Cancer recurrence information—\n\nDate of cancer recurrence;\n\nSite(s) of cancer recurrence.\n\n20 Name of person completing form.\n\n21 Date form completed.\n\nSchedule 3—Information to be reported by pathology service\n\nRegulation 8(c)(ii)\n\n1 Name of pathology service.\n\n2 Pathology group identification number.\n\n3 Laboratory case reference number.\n\n4 The following patient details of an individual—\n\nMedicare number (*if known*);\n\nIndividual healthcare identifier (*if known*);\n\nFamily name;\n\nGiven name(s);\n\nResidential address (including the building or property name, street address, suburb, town, locality name and postcode, as the case may be);\n\nPostal address (*if different to the residential address*);\n\nEmail address;\n\nTelephone number;\n\nDate of birth;\n\nSex at birth;\n\nCountry of birth;\n\nWhether or not the individual identifies as an Aboriginal person, a Torres Strait Islander person, or both (*if known—please specify*);\n\nLanguage spoken at home (*if known—please specify*).\n\n5 The following details of the doctor responsible for the case—\n\nMedicare provider number (*if known*);\n\nName;\n\nBusiness address (including the building or property name, street address, suburb, town, locality name and postcode, as the case may be);\n\nPostal address (*if different to the business address*);\n\nEmail address.\n\n6 Details of reporting pathologist—\n\nMedicare provider number (*if known*);\n\nName.\n\n7 Date of report.\n\n8 The following minimum information—\n\nPrimary site of cancer;\n\nLaterality of primary site;\n\nCancer morphology type;\n\nTumour size;\n\nDepth of invasion;\n\nMetastatic sites;\n\nNumber of nodes sampled;\n\nNumber of nodes positive;\n\nDate of diagnosis;\n\nStage of cancer at diagnosis (to be reported in accordance with \"Cancer staging—cancer staging scheme source, code N[N]\" as  \npublished by the Australian Institute of Health and Welfare from  \ntime to time);\n\nGrade/differentiation;\n\nResults of testing for cancer or precursor biomarkers.\n\n9 Name of person completing form.\n\n10 Date form completed.\n\n11 Name of pathologist authorising the report.\n\n═════════════\n\nEndnotes\n\n1 General information\n\nSee [www.legislation.vic.gov.au](http://www.legislation.vic.gov.au) for Victorian Bills, Acts and current Versions of legislation and up-to-date legislative information.\n\nThe Improving Cancer Outcomes (Diagnosis Reporting) Regulations 2025, S.R. No. 89/2025 were made on 16 September 2025 by the Governor in Council under section 28 of the **Improving Cancer Outcomes Act 2014**, No. 78/2014 and came into operation on 18 September 2025: regulation 3.\n\nThe Improving Cancer Outcomes (Diagnosis Reporting) Regulations 2025 will sunset 10 years after the day of making on 16 September 2035 (see section 5 of the **Subordinate Legislation Act 1994**).\n\nINTERPRETATION OF LEGISLATION ACT 1984 (ILA)\n\nStyle changes\n\nSection 54A of the ILA authorises the making of the style changes set out in Schedule 1 to that Act.\n\nReferences to ILA s. 39B\n\nSidenotes which cite ILA s. 39B refer to section 39B of the ILA which provides that where an undivided regulation, rule or clause of a Schedule is amended by the insertion of one or more subregulations, subrules or subclauses the original regulation, rule or clause becomes subregulation, subrule or subclause (1) and is amended by the insertion of the expression \"(1)\" at the beginning of the original regulation, rule or clause.\n\nInterpretation\n\nAs from 1 January 2001, amendments to section 36 of the ILA have the following effects:\n\n• Headings\n\nAll headings included in a Statutory Rule which is made on or after  \n1 January 2001 form part of that Statutory Rule. Any heading inserted in a Statutory Rule which was made before 1 January 2001, by a Statutory Rule made on or after 1 January 2001, forms part of that Statutory Rule.  \nThis includes headings to Parts, Divisions or Subdivisions in a Schedule; Orders; Parts into which an Order is divided; clauses; regulations; rules; items; tables; columns; examples; diagrams; notes or forms.  \nSee section 36(1A)(2A)(2B).\n\n• Examples, diagrams or notes\n\nAll examples, diagrams or notes included in a Statutory Rule which is made on or after 1 January 2001 form part of that Statutory Rule. Any examples, diagrams or notes inserted in a Statutory Rule which was made before 1 January 2001, by a Statutory Rule made on or after 1 January 2001, form part of that Statutory Rule. See section 36(3A).\n\n• Punctuation\n\nAll punctuation included in a Statutory Rule which is made on or after  \n1 January 2001 forms part of that Statutory Rule. Any punctuation inserted in a Statutory Rule which was made before 1 January 2001, by a Statutory Rule made on or after 1 January 2001, forms part of that Statutory Rule.  \nSee section 36(3B).\n\n• Provision numbers\n\nAll provision numbers included in a Statutory Rule form part of that Statutory Rule, whether inserted in the Statutory Rule before, on or after  \n1 January 2001. Provision numbers include regulation numbers, rule numbers, subregulation numbers, subrule numbers, paragraphs and subparagraphs. See section 36(3C).\n\n• Location of \"legislative items\"\n\nA \"legislative item\" is a penalty, an example or a note. As from 13 October 2004, a legislative item relating to a provision of a Statutory Rule is taken to be at the foot of that provision even if it is preceded or followed by another legislative item that relates to that provision. For example, if a penalty at the foot of a provision is followed by a note, both of these legislative items will be regarded as being at the foot of that provision. See section 36B.\n\n• Other material\n\nAny explanatory memorandum, table of provisions, endnotes, index and other material printed after the Endnotes does not form part of a Statutory Rule. See section 36(3)(3D)(3E).\n\n2 Table of Amendments\n\nThere are no amendments made to the Improving Cancer Outcomes (Diagnosis Reporting) Regulations 2025 by statutory rules, subordinate instruments and Acts.\n\n3 Explanatory details\n\n1. Reg. 4: S.R. No. 107/2015.\n\n  ——\n\n  **Table of Applied, Adopted or Incorporated Matter**\n\n  The following table of applied, adopted or incorporated matter was included in S.R. No. 89/2025 in accordance with the requirements of regulation 5 of the Subordinate Legislation Regulations 2024.\n\n    | **Statutory rule provision** | **Title of applied, adopted or incorporated document** | **Matter in applied, adopted or incorporated document** |\n    | --- | --- | --- |\n    | Schedule 2<br>Schedule 3 | \"Cancer staging—cancer staging scheme source, code N[N]\" as published by the Australian Institute of Health and Welfare from time to time | The whole |\n\n   [↑](#endnote-ref-1)","sortOrder":0}],"analysis":{"issue_detection":{"absurdities":[],"contradictions":[]},"kimi_summary":{"content_quality":"ok","complexity_score":4,"scope_assessment":{"changed":false,"description":"The regulations remain tightly focused on their original purpose: prescribing what cancer diagnoses must be reported, by whom, and in what form. This is a direct replacement of the 2015 regulations with the same structural approach, updated definitions, and refined reporting requirements. The scope has not expanded beyond cancer diagnosis reporting."},"complexity_factors":["8 defined terms in the interpretation section, including technical medical definitions like 'borderline tumour' and 'in-situ tumour'","3 detailed schedules containing extensive data fields (Schedule 2 has 21 fields, Schedule 3 has 11 fields)","Multiple cross-references to external documents: the Australian Institute of Health and Welfare's cancer staging scheme, which is 'incorporated by reference' and can change over time","Nested exceptions in Schedule 1: general exclusions for basal cell and squamous cell carcinomas, with specific carve-outs (exceptions to the exclusions) for certain anatomical sites","Dual reporting timelines: 60 days for hospitals/treatment centres versus 30 days for pathology services","References to 3 separate Acts (Improving Cancer Outcomes Act 2014, Health Services Act 1988, Healthcare Identifiers Act 2010)"],"plain_english_summary":"**What this legislation does**\n\nThese regulations set up a mandatory cancer reporting system for Victoria. They require hospitals, day procedure centres, radiotherapy services, and pathology labs to report specific cancer diagnoses to the Victorian Government's Secretary (a senior public servant).\n\n**Who must report and what**\n\n- **Hospitals and treatment centres** (public and private hospitals, day procedure centres, radiotherapy services): Must report most malignant cancers, in-situ tumours (early-stage cancers that haven't spread), and certain brain/spinal tumours. They have **60 days** to report after becoming aware of a diagnosis.\n- **Pathology services**: Must report the same types of cancers when they conduct tests. They have **30 days** to report.\n\n**What's covered and what's excluded**\n\n- **Included**: Most cancers, including borderline brain tumours, ovarian tumours, and certain skin cancers (melanomas and squamous cell carcinomas of sensitive areas like genitals, lips, and around the anus).\n- **Excluded**: Common skin cancers (basal cell carcinomas and most squamous cell carcinomas) are generally **not** reported, unless they appear in specific high-risk locations listed above.\n\n**What information must be shared**\n\nThe regulations require extensive personal and medical details:\n- Patient identifiers (Medicare number, healthcare identifier, name, address, Indigenous status)\n- Doctor details (treating specialists and GPs)\n- Cancer specifics (type, stage, grade, size, whether it has spread)\n- Treatment information\n- Test results for cancer biomarkers (biological markers that indicate cancer)\n\n**Why it matters**\n\nThis data collection helps Victoria track cancer rates, plan health services, and improve cancer outcomes. The previous 2015 regulations are revoked (cancelled) and replaced with these updated 2025 rules, which come into effect on 18 September 2025."},"flash_summary":{"complexity_score":6,"scope_assessment":{"changed":true,"description":"The instrument expressly revokes the 2015 diagnosis‑reporting Regulations (reg 4) and re‑prescribes the scope of mandatory reporting (reg 6) and the classes of reporters (reg 7). Key scope changes reflected in the new text include: explicit differentiation of timeframes for centres/services (60 days) and pathology laboratories (30 days) (reg 8(b)); expanded and detailed mandatory data fields including identifiers and clinician details (Schedules 2 & 3); specified lists and carve‑outs for tumour types (Schedule 1); and adoption of the AIHW cancer staging scheme by reference (Schedules 2 & 3; explanatory table). The revocation plus these new prescriptions indicate a revised regulatory scope and operational requirements for reporting entities."},"complexity_factors":["Multiple classes of reporting entities with differing duties (hospitals/day procedure centres/denominational/private/public health services, radiotherapy services, pathology services) (reg 7).","Different reporting timeframes for clinical centres and pathology laboratories (60 days v. 30 days) (reg 8(b)).","Detailed, extensive data requirements including personal identifiers, clinician details, staging, treatment and recurrence information (Schedules 2 & 3).","Complex lists, carve-outs and definitions for reportable tumour types (Schedule 1) and definitional detail (eg. perianal skin) (reg 5; Schedule 1).","Incorporation by reference of an external, updatable staging standard published by the Australian Institute of Health and Welfare (Schedules 2 & 3; explanatory table), creating external dependency and potential versioning risk.","Cross-reference dependency on the primary statute (Improving Cancer Outcomes Act 2014) for the reporting obligation and on other Acts for defined identifiers (reg 2; reg 6; reg 5 definitions).","Revocation of the 2015 Regulations and a 10-year statutory sunset noted in the endnotes, requiring future legislative attention (reg 4; Endnotes).","Operational and privacy compliance implications from collecting identifiable health data (Medicare number, healthcare identifier, contact details) (Schedules 2 & 3)."],"plain_english_summary":"These Regulations require specified health services to report diagnoses of listed cancers and precursors to the Secretary under the Improving Cancer Outcomes Act 2014. They prescribe which tumour types are reportable, who must report, the data fields to be provided, and the timeframes for reporting.\n\nHospitals and radiotherapy services must report within 60 days and pathology laboratories within 30 days. Reports include personal identifiers, clinical staging (using the AIHW staging scheme), treatment and recurrence information, so reporting entities bear the compliance burden and the Secretary receives standardised case data."},"summary":{"complexity_score":3,"scope_assessment":{"changed":false,"description":"Based on the available content, the regulations appear consistent with their stated purpose of governing cancer diagnosis reporting. However, the document provided lacks sufficient substantive text to make a definitive assessment about whether the scope drifted from the original legislative intent of the enabling Act."},"complexity_factors":["Insufficient legislative text provided — only metadata and version history labels are present, preventing full complexity assessment","Regulations of this type typically involve technical reporting obligations with specific data fields and timeframes","Interaction with parent legislation (the Improving Cancer Outcomes Act) would add a layer of complexity","Healthcare data privacy obligations under the Privacy Act may intersect with these regulations","Based on the limited content available, the substantive rules appear narrow and sector-specific, keeping complexity relatively low"],"plain_english_summary":"These regulations govern reporting when cancer is diagnosed, setting rules about how, when, and to whom diagnosis information is sent—likely obliging healthcare providers (hospitals, pathology labs, doctors) to report to a central registry or health authority and specifying format, timeframes, and data types. \n\nThey affect clinicians and health authorities and matter because accurate cancer reporting supports tracking, resource allocation, and improved outcomes. Caveat: the provided document lacks substantive text, so specifics cannot be confirmed."},"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"}},"importantCases":[],"_links":{"self":"/api/acts/improving-cancer-outcomes-diagnosis-reporting-regulations-2025","history":"/api/acts/improving-cancer-outcomes-diagnosis-reporting-regulations-2025/history","analysis":"/api/acts/improving-cancer-outcomes-diagnosis-reporting-regulations-2025/analysis","conflicts":"/api/acts/improving-cancer-outcomes-diagnosis-reporting-regulations-2025/conflicts","importantCases":"/api/acts/improving-cancer-outcomes-diagnosis-reporting-regulations-2025/important-cases","documents":"/api/acts/improving-cancer-outcomes-diagnosis-reporting-regulations-2025/documents"}}