Private Health Insurance (Medical Devices and Human Tissue Products) Repeal Instrument 2025

Administered by Department of Health, Disability and Ageing

Legislation au F2025L01308 Not in force Legislative Instrument

Legislation content

EXPLANATORY STATEMENT

Issued by the authority of the Minister for Health and Ageing

 

Private Health Insurance Act 2007

 

Private Health Insurance (Medical Devices and Human Tissue Products) Repeal Instrument 2025

 

Purpose

 

The purpose of the Private Health Insurance (Medical Devices and Human Tissue Products) Repeal Instrument 2025 (the Repeal Instrument) is to repeal the Private Health Insurance (Medical Devices and Human Tissue Products) Rules 2025 (the Previous Rules) on 1 November 2025. The Previous Rules will be replaced by the Private Health Insurance (Medical Devices and Human Tissue Products) Rules (No. 2) 2025 (the New Rules) on 1 November 2025.

 

The New Rules update the list of medical devices and human tissue products for which a benefit must be paid, where the listed item is provided in the conditions and circumstances specified in the Private Health Insurance Act 2007 (the Act). The New Rules set out the minimum benefit payable for each listed item.

 

Legislative authority

 

Item 4 of the Table in section 333-20 of the Act provides that the Minister may make the Medical Devices and Human Tissue Products Rules (the MDHTP Rules), providing for matters required or permitted by Part 3-3 of the Act, or necessary or convenient in order to carry out or give effect to Part 3-3 of the Act.

 

Reliance on subsection 33(3) of the Acts Interpretation Act 1901

 

In addition to the power to make this instrument under section 333-20 of the Act, subsection 33(3) of the Acts Interpretation Act 1901 provides that where an Act confers a power to make, grant or issue any instrument of a legislative or administrative character (including rules, regulations or by-laws), the power shall be construed as including a power exercisable in the like manner and subject to the like conditions (if any) to repeal, rescind, revoke, amend, or vary any such instrument.

 

Commencement

 

The Repeal Instrument commences on 1 November 2025.

 

Consultation

 

It was not necessary to undertake consultation on the Repeal Instrument as this instrument is necessary to ensure there is only a single set of MDHTP Rules. The Repeal Instrument repeals the Previous Rules so that the New Rules (which have previously been consulted on) can take effect on 1 November 2025 without there being another set of MDHTP Rules on the Federal Register of Legislation.

 

General

 

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

 

Details of the Repeal Instrument is set out in Attachment A.

 

The Repeal 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 Private Health Insurance (Medical Devices and Human Tissue Products) Repeal Instrument 2025

 

Part 1 ­ Preliminary

 

Section 1 ­ Name

 

Section 1 provides that the name of the instrument is the Private Health Insurance (Medical Devices and Human Tissue Products) Repeal Instrument 2025.

 

Section 2 ­ Commencement

 

Section 2 provides that the instrument commences on 1 November 2025. This commencement aligns with the commencement of the Private Health Insurance (Medical Devices and Human Tissue Products) Rules (No. 2) 2025 (i.e. New Rules). This instrument is intended to ensure that there is, on 1 November 2025, a single set of Medical Devices and Human Tissue Products Rules on the Federal Register of Legislation.

 

Section 3 ­ Authority

 

Section 3 provides that the instrument is made under item 4 of the Table in section 333‑20 of the Private Health Insurance Act 2007.

  

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.

 

Schedule 1 – Repeals

 

This schedule lists the Private Health Insurance (Medical Devices and Human Tissue Products) Rules 2025 (i.e. the Previous Rules) as the sole legislative instrument to be repealed by this instrument.

ATTACHMENT B

Statement of Compatibility with Human Rights

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

Private Health Insurance (Medical Devices and Human Tissue Products) Repeal Instrument 2025

This 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 Legislative Instrument

The purpose of the Private Health Insurance (Medical Devices and Human Tissue Products) Repeal Instrument 2025 (the Repeal Instrument) is to repeal the Private Health Insurance (Medical Devices and Human Tissue Products) Rules 2025 (the Previous Rules) on 1 November 2025. The Previous Rules will be replaced by the Private Health Insurance (Medical Devices and Human Tissue Products) Rules (No. 2) 2025 (the New Rules) from 1 November 2025.

 

Human rights implications

 

The Repeal Instrument repeals the Previous Rules and is made to ensure there is a single set of Medical Devices and Human Tissue Products Rules on the Federal Register of Legislation from 1 November 2025. The human rights implications of the 1 November 2025 changes to the Medical Devices and Human Tissue Products Rules and the compatibility of those changes with human rights is outlined in the Statement of Compatibility with Human Rights for the New Rules.

Conclusion

The Repeal Instrument is compatible with human rights.

   

Avi Rebera

Assistant Secretary

Medical Services and Devices Assessment Branch

Technology Assessment and Access Division

Health Resourcing Group

Department of Health, Disability and Ageing

Overview

The Private Health Insurance (Medical Devices and Human Tissue Products) Repeal Instrument 2025, initiated by the Minister for Health and Ageing, is designed to repeal the existing Private Health Insurance (Medical Devices and Human Tissue Products) Rules 2025 and replace them with the Private Health Insurance (Medical Devices and Human Tissue Products) Rules (No. 2) 2025. This repeal is scheduled to take effect on 1 November 2025, ensuring a streamlined regulatory framework for medical devices and human tissue products covered under the Private Health Insurance Act 2007. The primary objective of this legislative instrument is to maintain a single, updated set of rules on the Federal Register of Legislation, thereby avoiding confusion or duplication. The Repeal Instrument is authorised under item 4 of the Table in section 333-20 of the Act and is supported by the legislative authority provided in the Acts Interpretation Act 1901, ensuring its compliance and effectiveness in updating the existing regulatory framework.

Scope and Application

The Private Health Insurance (Medical Devices and Human Tissue Products) Repeal Instrument 2025 applies to the repeal of the Private Health Insurance (Medical Devices and Human Tissue Products) Rules 2025, which will be replaced by the Private Health Insurance (Medical Devices and Human Tissue Products) Rules (No. 2) 2025 on 1 November 2025. The repeal instrument targets the existing set of rules governing the benefits payable for medical devices and human tissue products under the Private Health Insurance Act 2007. It ensures that the legislative framework is streamlined and updated, with the New Rules providing a revised list of items and the minimum benefits payable. This repeal and replacement process is intended to maintain the integrity and effectiveness of the legislative framework governing private health insurance benefits related to medical devices and human tissue products in Australia. The instrument is made under the authority of the Minister for Health and Ageing and is effective from 1 November 2025.

Key Provisions

The Private Health Insurance (Medical Devices and Human Tissue Products) Repeal Instrument 2025 (the Repeal Instrument) primarily serves to repeal the Private Health Insurance (Medical Devices and Human Tissue Products) Rules 2025 (the Previous Rules) on 1 November 2025, as detailed in Section 2. These Previous Rules will be replaced by the Private Health Insurance (Medical Devices and Human Tissue Products) Rules (No. 2) 2025 (the New Rules) on the same date. This transition is intended to ensure there is only one set of Medical Devices and Human Tissue Products Rules in effect from that date. The instrument is made under item 4 of the Table in section 333-20 of the Private Health Insurance Act 2007 (the Act), as outlined in Section 3. The obligations and requirements imposed by the Repeal Instrument primarily revolve around the repeal of the Previous Rules and the introduction of the New Rules on 1 November 2025. The instrument mandates that the Previous Rules be repealed and that the New Rules come into effect on the same date. This ensures a smooth and uninterrupted transition from the old rules to the new ones, maintaining consistency and clarity in the regulations governing medical devices and human tissue products under private health insurance. Additionally, the instrument ensures that the New Rules, which have already been subject to consultation, will take effect without any overlapping or conflicting rules being present on the Federal Register of Legislation. In terms of consequences for non-compliance, the Repeal Instrument does not explicitly outline specific offences, penalties, or civil/criminal consequences for breach. However, it is important to note that the New Rules, which the Repeal Instrument facilitates, will govern the benefits payable for listed medical devices and human tissue products. Failure to adhere to the provisions set forth in the New Rules could potentially lead to disputes or legal actions related to the coverage and benefits provided under private health insurance policies. It is therefore crucial for parties governed by the Act to ensure compliance with the New Rules to avoid any potential repercussions. The Repeal Instrument is a legislative instrument for the purposes of the Legislation Act 2003, and it is compatible with the human rights and freedoms recognised or declared under section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011. The compatibility of the Repeal Instrument with human rights is outlined in Attachment B, which provides a Statement of Compatibility with Human Rights. This ensures that the changes implemented by the Repeal Instrument do not infringe upon the human rights and freedoms recognised under relevant international instruments.

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Health Law
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Statutory Instrument
Concepts
Commencement Provisions
Regulatory Standards
Repeal & Amendment

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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.