My Health Records Amendment (System Operator) Regulation 2016

Administered by Department of Health, Disability and Ageing

Legislation au F2016L00737 Regulations Not in force Legislative Instrument

Legislation content

EXPLANATORY STATEMENT

Issued by Authority of the Minister for Health

My Health Records Act 2012

My Health Records Amendment (System Operator) Regulation 2016

The My Health Records Act 2012 (My Health Records Act) provides for the establishment and operation of the My Health Record system (formerly referred to as the personally controlled electronic health record (PCEHR) system).  The My Health Record system allows healthcare recipients and their healthcare providers to access their key health information online, where and when they need it.  A My Health Record is an electronic summary of a healthcare recipient’s health records.

Subsection 112(1) of the My Health Records Act provides that the Governor‑General may make regulations prescribing matters which are required or permitted by each Act, or matters which are necessary or convenient in order to carry out or give effect to each Act.

Section 14 of the My Health Records Act establishes that the My Health Record System Operator is either the Secretary of the Department of Health (paragraph 14(a)) or a body established by Commonwealth law that is prescribed by regulations to be the System Operator (paragraph 14(b)).  There is currently no body prescribed by regulations for this purpose which means that the Secretary of the Department of Health is the System Operator.

The My Health Records Amendment (System Operator) Regulation 2016 (the Regulation) amends the My Health Records Regulation 2012 (the My Health Records Regulation).

The purpose of the Regulation is to amend the My Health Records Regulation to prescribe the Australian Digital Health Agency, as established by the Public Governance, Performance and Accountability (Establishing the Australian Digital Health Agency) Rule 2016, to be the System Operator.

Details of the Regulation are set out in the Attachment.

Subsection 112(3) of the My Health Records Act requires that the Minister consult the Ministerial Council before regulations are made.  Further, subsection 14(2) of the My Health Records Act requires that such consultation must be undertaken before regulations are made for the purposes of paragraph 14(b) of the My Health Records Act.  Accordingly, the Council of Australian Governments Health Council was consulted on the Regulation in February 2016 and it supported the making of the Regulation.

The My Health Records Act does not specify any other conditions that need to be met before the power to make regulations may be exercised.

The Regulation commences on the governance restructure day as defined by the Health Legislation Amendment (eHealth) Act 2015.

The Regulation is a legislative instrument for the purposes of the Legislation Act 2003.

ATTACHMENT

Details of the My Health Records Amendment (System Operator) Regulation 2016

  1. Name of Regulation

This section provides that the title of the Regulation is the My Health Records Amendment (System Operator) Regulation 2016.

2.      Commencement

This section provides that the Regulation takes effect on the governance restructure day as defined by the Health Legislation Amendment (eHealth) Act 2012.  This is a day proclaimed by the Governor-General to be the governance restructure day for the purposes of the Health Legislation Amendment (eHealth) Act 2012.

3.      Authority

This section provides that the Regulation is made under the My Health Records Act 2012 (My Health Records Act).

4.      Schedules

This section provides that each instrument that is specified in a Schedule to the Regulation is amended or repealed as set out in the applicable items in the Schedule concerned.  Any other item in a Schedule to the regulation has effect according to its terms.

Schedule 1―Amendments to the My Health Records Regulation 2012

The items in the Schedule amend the My Health Records Regulation 2012 (the My Health Records Regulation) as set out below.

Item 1

Item 1 inserts a new definition into regulation 1.1.3 to define the Australian Digital Health Agency for the purposes of regulation 2.1.1 (item 2 refers).

Item 2

Item 2 inserts regulation 2.1.1 into the My Health Records Regulation to prescribe that the Australian Digital Health Agency to be the My Health Record System Operator for the purposes of paragraph 14(b) of the My Health Records Act.

The Australian Digital Health Agency was established by the Public Governance, Performance and Accountability (Establishing the Australian Digital Health Agency) Rule 2016 on 30 January 2016.

The Australian Digital Health Agency is expected to be fully operation by 1 July 2016 and will be responsible for overseeing the operation and evolution of the national digital health capability.

Statement of Compatibility with Human Rights

Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011

My Health Records Amendment (System Operator) Regulation 2016

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 review of the personally controlled electronic health record system (now known as the My Health Record system) found that governance for digital health nationally is in need of significant changes as it does not have the confidence of the industry.  Further, it is not representative of the potential users and potential beneficiaries of the digital health system.

New governance arrangements are being implemented which include the establishment of the Australian Digital Health Agency which will become the single accountable organisation for digital health in Australia.

The Disallowable Legislative Instrument will prescribe the Australian Digital Health Agency, as established by the Public Governance, Performance and Accountability (Establishing the Australian Digital Health Agency) Rule 2016, to be the My Health Record System Operator.

Human rights implications

This Disallowable Legislative Instrument does not engage any of the applicable rights or freedoms.

Conclusion

This Disallowable Legislative Instrument is compatible with human rights as it does not raise any human rights issues.

 

Overview

The My Health Records Amendment (System Operator) Regulation 2016 was enacted to address governance issues within the My Health Record system, previously known as the personally controlled electronic health record (PCEHR) system. This regulation was necessary following a review that identified significant deficiencies in the governance structure, which lacked the confidence of industry stakeholders and did not adequately represent the interests of potential users and beneficiaries. The My Health Records Act 2012 established the framework for the My Health Record system, enabling healthcare recipients and providers to access key health information online. However, it lacked a designated System Operator, with the Secretary of the Department of Health currently fulfilling this role. The Regulation was made under the authority of the My Health Records Act and was supported by the Council of Australian Governments Health Council after consultation in February 2016. The primary objective of the Regulation is to amend the My Health Records Regulation 2012 to prescribe the Australian Digital Health Agency as the new System Operator, thereby enhancing governance and ensuring the system's evolution aligns with national digital health objectives.

Scope and Application

The My Health Records Act 2012, supported by the My Health Records Amendment (System Operator) Regulation 2016, governs the establishment and operation of the My Health Record system, which is an electronic summary of a healthcare recipient's health records, accessible to healthcare recipients and their providers. This Act applies to all individuals who are healthcare recipients in Australia, as well as to healthcare providers who are authorised to access these records. The Act encompasses all entities involved in the operation of the My Health Record system, including the System Operator, which is now prescribed as the Australian Digital Health Agency as per the 2016 Regulation. This legislative framework extends across the Commonwealth of Australia and is integral to the national health infrastructure, ensuring the secure and efficient sharing of health information. The Act does not specify exclusions or thresholds, but it does provide for the regulation of conduct and transactions related to the My Health Record system. The Act’s application may be extended or restricted through subordinate instruments, which allows for adjustments in response to evolving health information technology and privacy requirements.

Key Provisions

The My Health Records Amendment (System Operator) Regulation 2016 (the Regulation) amends the My Health Records Regulation 2012 by prescribing the Australian Digital Health Agency (ADHA) as the My Health Record System Operator under section 14(b) of the My Health Records Act 2012. The Regulation, which takes effect on the governance restructure day as defined by the Health Legislation Amendment (eHealth) Act 2012, was made under the authority of the My Health Records Act 2012. It includes amendments to the My Health Records Regulation 2012, defining the ADHA and prescribing it as the System Operator. These amendments are detailed in the Schedule of the Regulation. The obligations and requirements imposed by the Regulation on the parties or entities it governs are primarily focused on the designation of the ADHA as the My Health Record System Operator. This means that the ADHA is responsible for overseeing the operation and evolution of the national digital health capability. The establishment of the ADHA as the System Operator is intended to improve governance arrangements for digital health, ensuring that the system is representative of the potential users and beneficiaries of the digital health system. The Regulation does not specify any new offences or penalties for breach. However, it does provide a framework for the governance of the My Health Record system, which is expected to enhance the efficiency and effectiveness of the system. By prescribing the ADHA as the System Operator, the Regulation aims to address the governance issues identified in the review of the personally controlled electronic health record system, ensuring that the system has the confidence of the industry and is representative of its potential users and beneficiaries. The Regulation 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. The Statement of Compatibility with Human Rights indicates that the Regulation does not engage any of the applicable rights or freedoms, and therefore, it does not raise any human rights issues. The establishment of the ADHA as the System Operator is intended to improve governance arrangements for digital health, ensuring that the system is representative of the potential users and beneficiaries of the digital health system.

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Sourced from the Federal Register of Legislation at 26 August 2026. For the latest information on Australian Government law please go to https://www.legislation.gov.au.