Improving Cancer Outcomes (Diagnosis Reporting) Regulations 2025
S.R. No. 89/2025
Version as at
18 September 2025
TABLE OF PROVISIONS
Regulation Page
1 Objectives 1
2 Authorising provision 1
3 Commencement 1
4 Revocation 1
5 Definitions 2
6 Types of cancer and precursor diagnosis required to be reported 2
7 Persons and organisations required to report cancer or precursor 3
8 Diagnosis reports 3
Schedule 1—Types of cancer and precursors to cancer to be reported to Secretary 5
Schedule 2—Information to be reported by centre, hospital or service 7
Schedule 3—Information to be reported by pathology service 10
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Endnotes 12
1 General information 12
2 Table of Amendments 14
3 Explanatory details 15
Version No.001
Improving Cancer Outcomes (Diagnosis Reporting) Regulations 2025
S.R. No. 89/2025
Version as at
18 September 2025
1 Objectives
The objectives of these Regulations are to prescribe—
(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
(b) the persons and organisations that must report that diagnosis; and
(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.
2 Authorising provision
These Regulations are made under section 28 of the Improving Cancer Outcomes Act 2014.
3 Commencement
These Regulations come into operation on 18 September 2025.
4 Revocation
The Improving Cancer Outcomes (Diagnosis Reporting) Regulations 2015[1] are revoked.
5 Definitions
In these Regulations—
borderline tumour means a neoplasm displaying morphologic, phenotypic or genotypic characteristics that—
(a) are not benign; and
(b) do not establish a diagnosis of malignancy;
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;
healthcare identifier has the same meaning as in section 5 of the Healthcare Identifiers Act 2010 of the Commonwealth;
in-situ tumour means a group of abnormal cells that are found only in the place where those cells formed in the body;
medicare number has the same meaning as in section 84(1) of the National Health Act 1953 of the Commonwealth;
perianal skin means hair-bearing skin within a
5-centimetre radius of the outer edge of the anal opening.
6 Types of cancer and precursor diagnosis required to be reported
For 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.
7 Persons and organisations required to report cancer or precursor
For the purposes of section 9(1) of the Improving Cancer Outcomes Act 2014, the following persons and organisations are prescribed—
(a) any of the following within the meaning of section 3(1) of the Health Services Act 1988—
(i) a day procedure centre;
(ii) a denominational hospital;
(iii) a private hospital;
(iv) a privately-operated hospital;
(v) a public health service;
(vi) a public hospital;
(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;
(c) any pathology service that provides a service for testing for cancer, or a precursor to cancer, of a type prescribed by regulation 6.
8 Diagnosis reports
For the purposes of section 9(3) of the Improving Cancer Outcomes Act 2014—
(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
(b) the prescribed time is—
(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
(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
(c) the prescribed information is—
(i) for a centre, hospital or service referred to in regulation 7(a) or (b), the information in Schedule 2; and
(ii) for a pathology service referred to in regulation 7(c), the information in Schedule 3.
Schedule 1—Types of cancer and precursors to cancer to be reported to Secretary
Regulation 6
(1) Subject to clause (6), malignant tumours (other than skin cancers that are basal cell carcinomas and squamous cell carcinomas) of all sites.
(2) Subject to clause (6), in-situ tumours (other than skin cancers that are basal cell carcinomas and squamous cell carcinomas) of all sites.
(3) Borderline tumours or tumours of uncertain behaviour of—
(a) the brain; or
(b) the cerebral and spinal meninges; or
(c) any other part of the central nervous system; or
(d) the female genital organs including ovaries; or
(e) the urinary tract, except the kidney parenchyma; or
(f) the haematological and lymphoid system.
(4) Benign tumours of—
(a) the brain; or
(b) the cerebral and spinal meninges; or
(c) the spinal cord; or
(d) cranial nerves; or
(e) any other part of the central nervous system.
(5) Subject to clause (6), skin cancers (other than basal cell carcinomas and squamous cell carcinomas) of all sites.
(6) Squamous cell carcinomas of the—
(a) labia majora; or
(b) labia minora; or
(c) vulva; or
(d) prepuce; or
(e) penis; or
(f) scrotum; or
(g) perianal skin (including anal margin); or
(h) mucosal surface and vermilion border of the lip.
Schedule 2—Information to be reported by centre, hospital or service
Regulation 8(c)(i)
1 Name of centre, hospital or service.
2 Hospital identification number.
3 Hospital unit record number.
4 The following patient details of an individual—
Medicare number (if known);
Individual healthcare identifier (if known);
Family name;
Given name(s);
Previous name(s) and alias(es) (if applicable);
Residential address (including the building or property name, street address, suburb, town, locality name and postcode, as the case may be);
Postal address (if different to the residential address);
Email address;
Telephone number;
Date of birth;
Sex at birth;
Country of birth;
Whether or not the individual identifies as an Aboriginal person, a Torres Strait Islander person, or both (if known—please specify);
Language spoken at home (if known—please specify).
5 The following details of the doctor in charge of the case—
Medicare provider number (if known);
Name;
Business address (including the building or property name, street address, suburb, town, locality name and postcode, as the case may be);
Postal address (if different to the business address);
Email address;
Business telephone number.
6 The following details of the general practitioner—
Medicare provider number (if known);
Name;
Business address (including the building or property name, street address, suburb, town, locality name and postcode, as the case may be);
Postal address (if different to the business address);
Email address;
Business telephone number.
7 Date of first admission of the individual as a patient for this cancer.
8 Date of diagnosis of this cancer.
9 Eastern Cooperative Oncology Group performance status at time of diagnosis (if known).
10 Date of discharge of the individual as a patient from the centre, hospital or service (as the case may be).
11 Investigations relevant to diagnosis of cancer.
12 Primary site of cancer.
13 Laterality of primary site of cancer.
14 Morphology of primary cancer.
15 Grade or differentiation of primary cancer.
16 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).
17 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).
18 The following treatment details for each primary tumour—
Details of initial treatment;
Details of treatment of recurrence(s) (if any).
19 Cancer recurrence information—
Date of cancer recurrence;
Site(s) of cancer recurrence.
20 Name of person completing form.
21 Date form completed.
Schedule 3—Information to be reported by pathology service
Regulation 8(c)(ii)
1 Name of pathology service.
2 Pathology group identification number.
3 Laboratory case reference number.
4 The following patient details of an individual—
Medicare number (if known);
Individual healthcare identifier (if known);
Family name;
Given name(s);
Residential address (including the building or property name, street address, suburb, town, locality name and postcode, as the case may be);
Postal address (if different to the residential address);
Email address;
Telephone number;
Date of birth;
Sex at birth;
Country of birth;
Whether or not the individual identifies as an Aboriginal person, a Torres Strait Islander person, or both (if known—please specify);
Language spoken at home (if known—please specify).
5 The following details of the doctor responsible for the case—
Medicare provider number (if known);
Name;
Business address (including the building or property name, street address, suburb, town, locality name and postcode, as the case may be);
Postal address (if different to the business address);
Email address.
6 Details of reporting pathologist—
Medicare provider number (if known);
Name.
7 Date of report.
8 The following minimum information—
Primary site of cancer;
Laterality of primary site;
Cancer morphology type;
Tumour size;
Depth of invasion;
Metastatic sites;
Number of nodes sampled;
Number of nodes positive;
Date of diagnosis;
Stage of cancer at diagnosis (to be reported in accordance with "Cancer staging—cancer staging scheme source, code N[N]" as
published by the Australian Institute of Health and Welfare from
time to time);
Grade/differentiation;
Results of testing for cancer or precursor biomarkers.
9 Name of person completing form.
10 Date form completed.
11 Name of pathologist authorising the report.
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Endnotes
1 General information
See www.legislation.vic.gov.au for Victorian Bills, Acts and current Versions of legislation and up-to-date legislative information.
The 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.
The 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).
INTERPRETATION OF LEGISLATION ACT 1984 (ILA)
Style changes
Section 54A of the ILA authorises the making of the style changes set out in Schedule 1 to that Act.
References to ILA s. 39B
Sidenotes 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.
Interpretation
As from 1 January 2001, amendments to section 36 of the ILA have the following effects:
• Headings
All headings included in a Statutory Rule which is made on or after
1 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.
This 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.
See section 36(1A)(2A)(2B).
• Examples, diagrams or notes
All 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).
• Punctuation
All punctuation included in a Statutory Rule which is made on or after
1 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.
See section 36(3B).
• Provision numbers
All provision numbers included in a Statutory Rule form part of that Statutory Rule, whether inserted in the Statutory Rule before, on or after
1 January 2001. Provision numbers include regulation numbers, rule numbers, subregulation numbers, subrule numbers, paragraphs and subparagraphs. See section 36(3C).
• Location of "legislative items"
A "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.
• Other material
Any 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).
2 Table of Amendments
There are no amendments made to the Improving Cancer Outcomes (Diagnosis Reporting) Regulations 2025 by statutory rules, subordinate instruments and Acts.
3 Explanatory details
Reg. 4: S.R. No. 107/2015.
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Table of Applied, Adopted or Incorporated Matter
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.
| **Statutory rule provision** | **Title of applied, adopted or incorporated document** | **Matter in applied, adopted or incorporated document** |
| --- | --- | --- |
| 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 |