EXPLANATORY STATEMENT
Health Insurance Act 1973
My Health Records Act 2012
Health Legislation Amendment (Share by Default - Pathology) Rules 2026
Purpose and operation
The Health Legislation Amendment (Share by Default - Pathology) Rules 2026 (the Instrument) amends the Health Insurance (Share by Default) Rules 2025 and the My Health Records (Share by Default) Rules 2025 (referenced together in this document as the current Share by Default Pathology Rules) to clarify the scope of Share by Default requirements for certain pathology services.
The current Share by Default Pathology Rules provide for reports to be shared to My Health Record in relation to a broad range of pathology services. This requirement will apply unless an exception applies.
This instrument clarifies that pathology services that would otherwise be in scope, are not subject to the requirement to upload information to My Health Record, if the results relate to analysis of the compatibility of a donor and potential recipient of human biological products or materials where the results, with information on both the donor and the recipient, are provided in a single summary document or report.
Background
Sharing of information to an individual’s My Health Record is currently voluntary for healthcare providers. The Health Legislation Amendment (Modernising My Health Record – Sharing by Default) Act 2025, amended the My Health Records Act 2012 (My Health Records Act) and the Health Insurance Act 1973 (Health Insurance Act) to implement a new framework to mandate the sharing, or upload, of individuals’ health information to My Health Record.
The current Share by Default Pathology Rules made under those Acts specify certain pathology services provided by constitutional corporations, or for which Medicare is payable, as subject to upload requirements.
The upload requirements are subject to exceptions outlined in section 19AD of the Health Insurance Act, and section 10B of the My Health Records Act, including when:
- the healthcare recipient or their representative has advised that they do not want the information uploaded
- a healthcare provider reasonably believes that the information should not be uploaded due to a serious concern for the health, safety or wellbeing of the healthcare recipient
- the healthcare recipient is not registered for My Health Record
- the information cannot be shared due to other reasons beyond the control of the healthcare provider.
In a small number of cases, pathology services may involve the testing of samples from two individuals involved in the donation of human organs, tissue, cells or other materials. Where this compatibility testing or cross matching may occur, results that contain information about both a donor and a potential recipient may be provided in a single report or document. In most cases, these types of joint compatibility analysis are de-identified and would only be provided to clinical teams involved with donation and transplantation decisions, and care planning, and would not be shared to My Health Record. This instrument clarifies that where a pathology service involves compatibility testing on donors and potential recipients, a joint report or test results which includes information about both the donor and recipient is not required to be shared to My Health Record.
Authority
Section 19AI of the Health Insurance Act provides that the Minister may make rules about matters required or permitted by that Act to be prescribed by the upload rules.
Subsection 19AD(1) provides that rules may specify the types of professional services rendered by (or on behalf of) specified persons, for which medicare benefits are not payable if prescribed information is not uploaded to the My Health Record system (as defined in section 5 of the My Health Records Act).
Section 109 of the My Health Records Act provides that the Minister may make rules about matters required or permitted by that Act to be dealt with in the My Health Records Rules.
Section 78A provides that rules may specify the types of healthcare that the upload obligation applies to.
Commencement
This instrument commences on 1 July 2026.
Consultation
This Instrument has been developed following consultation with the Organ and Tissue Authority, relevant industry representatives and the National Clinical Governance Committee for Digital Health (NCGC-DH).
The NCGC-DH was established by the Australian Digital Health Agency to provide national clinical governance for digital health, system safety and quality, lived experience perspectives and expert clinical advice. This includes supporting safe implementation of the Share by Default and other digital health reforms. The NCGC-DH includes representatives from medical peak bodies, healthcare providers, consumer bodies and other Australian jurisdictions. A number of Expert Advisory Groups have been established which support and report to the NCGC-DH. The NCGC-DH and its Expert Advisory Group on Better and Faster Access to My Health Record provided advice on key considerations and the clinical workflows associated with the donation of human organs, tissue and other biological products, recommending and informing these amendments.
General
This instrument is a legislative instrument for the purposes of the Legislation Act 2003.
Details of this instrument are set out in Attachment A.
This instrument is compatible with the human rights and freedoms recognised or declared under section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011. A full statement of compatibility is set out in Attachment B.
ATTACHMENT A
Details of the Health Legislation Amendment (Share by Default - Pathology) Rules 2026
Section 1 – Name
Section 1 provides that the name of the instrument is the Health Legislation Amendment (Share by Default - Pathology) Rules 2026.
Section 2 – Commencement
This instrument commences on 1 July 2026.
Section 3 – Authority
Section 3 provides that the instrument is made under the:
- the Health Insurance Act 1973 (Health Insurance Act); and
- the My Health Records Act 2012 (My Health Records Act).
Section 4 – Schedules
Section 4 provides that each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.
The instruments that are amended are the:
- the Health Insurance (Share by Default) Rules 2025; and
- the My Health Record (Share by Default) Rules 2025.
Schedule 1
Health Insurance (Share by Default) Rules 2025
Item 1 – Section 4
Item 1 adds a new definition for compatibility testing purposes, which means testing conducted on samples from donors and potential recipients in relation to the donation of human organs, tissues, blood and plasma products, cells and fluids, including reproductive cells and materials, for compatibility purposes and where the results are provided in a single summary or report with information about both the donor and potential recipient.
The definition is intended to broadly cover compatibility testing associated with the donation of human biological products, including organs, tissue, stems cells and bone marrow, blood, platelets, milk and other materials. For the purposes of the Share by Default Rules, compatibility testing purposes involves the generation or output of results from such testing in a single report or summary document that includes information about both the donor and potential recipient of the donated product.
As an example, in some organ donation workflows, tissue typing may be conducted in a pathology laboratory with a crossmatch report prepared on the results, which includes information on both a donor and potential recipient to determine compatibility and inform transplantation decisions.
The corresponding amendment to section 8 of the Health Insurance (Share by Default) Rules means that services producing these joint or paired test results will not be subject to the upload requirement.
Item 2 – At the end of section 8
This item amends section 8 so that a pathology service rendered for compatibility testing purposes, as defined in section 4, will not be subject to the condition that information about the service be uploaded to My Health Record.
The exclusion of these types of reports is intended to ensure the privacy of donors and recipients as, in current clinical practice, such dual-labelled or paired reports are only available to clinicians to support donation procedures and ongoing care. They are not available to consumers so as to maintain the anonymity of donors and recipients. This amendment will ensure the confidentiality of donor and recipient identities is maintained.
Where pathology services are conducted for compatibility analysis, but results or reports relate to, and only include, one individual’s information – that is information about one or the other of the donor or potential recipient of the donated product – each individual report or result would remain subject to the Share by Default requirements.
Schedule 2
My Health Record (Share by Default) Rules 2025
Item 1 – Section 4
This item adds a new definition for compatibility testing purposes, which means testing conducted on samples from donors and potential recipients in relation to the donation of human organs, tissues, blood and plasma products, cells and fluids, including reproductive cells and materials, for compatibility purposes and where the results are provided in a single summary or report with information about both the donor and potential recipient.
As with the definition inserted into the Health Insurance (Share by Default) Rules, the definition is intended to broadly cover compatibility testing associated with the donation of human biological products, including organs, tissue, stems cells and bone marrow, blood, platelets, milk and other materials. For the purposes of the Share by Default Rules, compatibility testing purposes involves the generation or output of results from such testing in a single report or summary document that includes information about both the donor and potential recipient of the donated product.
The corresponding amendment to add a new subsection 11(4) to the My Health Record (Share by Default) Rules means that these test results will not be subject to the upload requirement.
Item 2 – At the end of section 11
This item amends section 11 so that a pathology service rendered for compatibility testing purposes, as defined in section 4, will not be subject to the requirement to upload information to My Health Record.
The exclusion of these types of reports is intended to ensure the privacy of donors and recipients as, in current clinical practice, such dual-labelled or paired reports are only available to clinicians to support donation procedures and ongoing care, while maintaining the anonymity of donors and recipients. This amendment will ensure the confidentiality of donor and recipient identities is maintained.
Where pathology services are conducted for compatibility analysis, but results or reports relate to, and only include, one individual’s information – that is information about one or the other of the donor or potential recipient of the donated product – each individual report or result would remain subject to the Share by Default requirements.
ATTACHMENT B
Statement of Compatibility with Human Rights
Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011
Health Legislation Amendment (Share by Default - Pathology) Rules 2026
This Disallowable Legislative Instrument is compatible with the human rights and freedoms recognised or declared in the international instruments listed in section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011.
Overview of the Disallowable Legislative Instrument
The Health Legislation Amendment (Share by Default - Pathology) Rules 2026 (the Instrument) amends the Health Insurance (Share by Default) Rules 2025 and the My Health Records (Share by Default) Rules 2025 (referenced together in this document as the current Share by Default Pathology Rules) to clarify the scope of Share by Default requirements for certain pathology services.
The Share by Default framework, under the My Health Records Act 2012 and the Health Insurance Act 1973, is intended to support consistent and streamlined health information sharing while maintaining robust privacy protections. It embeds the principles of transparency, accountability, and consumer choice and control.
The current Share by Default Pathology Rules provide for reports to be shared to My Health Record in relation to a broad range of pathology services. This requirement will apply unless an exception applies.
This instrument clarifies that pathology services that would otherwise be in scope, are not subject to the requirement to upload information to My Health Record if the results relate to analysis of the compatibility of a donor and potential recipient of human biological products and materials where the results are reported in a single summary document or a report.
The effect of the amendments in this instrument is to ensure the privacy and anonymity of the donors and recipients of human biological products, by confirming that reports which include information about both a donor and recipient are not required to be shared to My Health Record.
Human rights implications
The Instrument engages the following right:
- The right to privacy under Article 17 of the International Covenant on Civil and Political Rights (ICCPR).
The Right to Privacy
The protection against arbitrary or unlawful interference with privacy is contained in Article 17 of the ICCPR. Article 17 provides that no one shall be subjected to arbitrary or unlawful interference with his or her privacy, family, home or correspondence, nor to unlawful attacks on their honour or reputation, and that everyone has the right to the protection of the law against such interference or attacks.
Although the United Nations Human Rights Committee has not defined ‘privacy’, it should be understood to comprise freedom from unwarranted and unreasonable intrusions into activities that society recognises as falling within the sphere of individual autonomy.
The right to privacy includes respect for informational privacy, including in respect of storing, using and sharing private information and the right to control the dissemination of personal and private information. The right to privacy also includes the right to the protection of one’s personal data. The Human Rights Committee has said that, pursuant to Article 17(2) of the ICCPR, States are required to regulate the processing, use and conveyance of automated personal data, and to protect those affected against misuse. The Committee has said, moreover, that State Parties must take all appropriate measures to ensure that the gathering, storage and use of sensitive personal data is consistent with their obligations under Article 17.
This instrument is privacy enhancing, as it clarifies that pathology testing resulting in paired or dual-labelled pathology reports that are produced for compatibility analysis purposes associated with the donation and transplantation of organs, tissues and other materials are not subject to the Share by Default requirements.
The Share by Default legislative framework, contained in the My Health Records Act and the Health Insurance Act, contains protections to ensure health information is being collected, used and disclosed in an appropriate and non-invasive manner to achieve legitimate public health aims and objectives. This instrument further operates to preserve the privacy of donors and recipients, so that reports that include information about a donor and recipient and may therefore disclose their identities, are not required to be uploaded to My Health Record. This instrument will ensure the confidentiality of donor and recipient identities is maintained.
Conclusion
The Instrument is compatible with human rights because it operates to exclude certain test results from Share by Default requirements to protect the privacy and anonymity of the donors and potential recipients in organ, tissue and other donation and transplantation processes.
Mark Butler
Minister for Health and Ageing