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The objectives of these Regulations are to prescribe—
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
the persons and organisations that must report that diagnosis; and
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.
These Regulations are made under section 28 of the Improving Cancer Outcomes Act 2014.
These Regulations come into operation on 18 September 2025.
The Improving Cancer Outcomes (Diagnosis Reporting) Regulations 2015[1] are revoked.
In these Regulations—
borderline tumour means a neoplasm displaying morphologic, phenotypic or genotypic characteristics that—
are not benign; and
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.
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.
For the purposes of section 9(1) of the Improving Cancer Outcomes Act 2014, the following persons and organisations are prescribed—
any of the following within the meaning of section 3(1) of the Health Services Act 1988—
a day procedure centre;
a denominational hospital;
a private hospital;
a privately-operated hospital;
a public health service;
a public hospital;
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;
any pathology service that provides a service for testing for cancer, or a precursor to cancer, of a type prescribed by regulation 6.
For the purposes of section 9(3) of the Improving Cancer Outcomes Act 2014—
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
the prescribed time is—
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
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
the prescribed information is—
for a centre, hospital or service referred to in regulation 7(a) or (b), the information in Schedule 2; and
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
Subject to clause (6), malignant tumours (other than skin cancers that are basal cell carcinomas and squamous cell carcinomas) of all sites.
Subject to clause (6), in-situ tumours (other than skin cancers that are basal cell carcinomas and squamous cell carcinomas) of all sites.
Borderline tumours or tumours of uncertain behaviour of—
the brain; or
the cerebral and spinal meninges; or
any other part of the central nervous system; or
the female genital organs including ovaries; or
the urinary tract, except the kidney parenchyma; or
the haematological and lymphoid system.
Benign tumours of—
the brain; or
the cerebral and spinal meninges; or
the spinal cord; or
cranial nerves; or
any other part of the central nervous system.
Subject to clause (6), skin cancers (other than basal cell carcinomas and squamous cell carcinomas) of all sites.
Squamous cell carcinomas of the—
labia majora; or
labia minora; or
vulva; or
prepuce; or
penis; or
scrotum; or
perianal skin (including anal margin); or
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.
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).
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.
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.
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).
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