Declaration of Quality Assurance Activity under section 124X of the Health Insurance Act 1973 – QAA 13/2016

Administered by Department of Health, Disability and Ageing

Legislation au F2016L01273 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

ISSUED BY THE AUTHORITY OF THE MINISTER FOR HEALTH AND AGED CARE

HEALTH INSURANCE ACT 1973

DECLARATION OF QUALITY ASSURANCE ACTIVITY UNDER SECTION 124X OF THE HEALTH INSURANCE ACT 1973 - QAA 13/2016

 

Part VC of the Health Insurance Act 1973 (the Act) creates a scheme to encourage efficient quality assurance activities.  Those activities help to ensure the quality of health services that are funded by the Government including, through Medicare benefits, the Pharmaceutical Benefits Scheme, and/or Health Program Grants.  The scheme encourages participation in such activities by protecting certain information from disclosure, and also by providing some protection from civil liability to certain persons engaged in those activities in good faith, in respect of those activities. 

In order for Part VC to apply to an activity, the Minister must make a declaration pursuant to section 124X of the Act, that the activity is a quality assurance activity to which Part VC applies. 

The Declaration of Quality Assurance Activity under section 124X of the Health Insurance Act 1973 - QAA 12/2016 (the Declaration) has effect from the day after registration on the Federal Register of Legislation. 

 

The Declaration applies Part VC of the Act to the following activity, to the extent it relates to health services provided in Australia:

 

  1. Royal Australian and New Zealand College of Radiologists (RANZCR): RANZCR Quality and Accreditation Program

 

An overview of the activity is contained in Attachment A.

Before making a declaration under section 124X, the Minister must be satisfied that the persons engaging in the activity are authorised to do so in one of the ways set out in paragraph 124X(3)(a) of the Act.  The persons engaged in the RANZCR Quality and Accreditation Program are authorised to do so by RANZCR, which is an association of health professionals and an educational institution (see subparagraphs 124X(3)(a)(vi) and (iv)).

Secondly, paragraph 124X (3)(b) of the Act provides that the Minister must be satisfied that it is in the public interest that Part VC of the Act apply to the activity. In doing so, the Minister must have regard to criteria prescribed by regulations. The criteria are set out in regulations 23C to 23G of the Health Insurance Regulations 1975 (the Regulations).

The RANZCR Quality and Accreditation Program meet the criteria as follows:

  • As required by regulation 23C, the activity includes the disclosure of non-identifying information that concerns the quality of service assessed, evaluated or studied. The RANZCR will publish annual results of accreditation activities on the RANZCR website, and provide reports to the Standards of Practice and accreditation Committee and management panels.
  • Regulation 23D does not apply as the activity will be undertaken in more than one State or Territory.
  • Regulation 23E does not apply as the activity has previously been engaged in Australia.

  • Regulation 23F applies as the activity has previously been carried out in Australia. The Minister’s declaration will encourage greater participation in the activity by persons who provide health services by providing participants with a greater degree of confidence and security that their participation is solely to the benefit of establishing and improving quality assurance.
  • Regulation 23G does not apply as the activity will not include the assessment or evaluation by a person of the services, skill or performance of a health practitioner for the purpose of determining the health care practitioner’s clinical practicing rights.

 

CONSULTATION

 

The RANZCR Quality and Accreditation Program was previously declared to be quality assurance activity under section 124X of the Act (see Declaration of Quality Assurance Activity under section 124X of the Health Insurance Act 1973 (QAA 2/2011)). RANZCR applied to continue the declaration of their activity as a quality assurance activity to which Part VC applies.

 

An assessment of the application included an assessment of the potential value of declaring the activity as a quality assurance activity for the purposes of the Act, the methodology used to conduct the activity, and whether the application met the criteria required for declaration as set out in the Regulations.

 

The declaration of this activity will not result in any direct or substantial indirect effect on business.

 

The Declaration comes into operation on the day after registration on the Federal Register of Legislation.

 

Subsection 124X(4) of the Act provides that, unless sooner revoked, a declaration ceases to be in force at the end of 5 years after it was signed.  Accordingly, the Declaration provides that it is repealed at the end of 5 years after it is signed.

 

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

 

ATTACHMENT A

OVERVIEW OF THE ACTIVITY

  1.                PURPOSE OF ACTIVITY

The RANZCR Quality and Accreditation Program provides a framework for the development and implementation standard of practice for medical imaging services.  These standards are implemented through a series of quality assurance processes, some of which involve imaging practices’ submission of data to RANZCR for expert peer review.  Participating radiologists obtain professional expert feedback and advice to support their continuous quality improvement processes in medical imaging

The Program covers mammography and MRI services.

 The objectives of the activity are to:

  • support and promote quality mammograph and MRI services that meets community needs;
  • ensure the diagnostic quality of clinical images being produced;
  • ensure that imaging equipement is operating optimally, which is partciular important for mammography which is ionising radiation;
  • provide peer reviewed feedback to sites on quality improvements;
  • identify and improve system and process shortfalls that effect the delivery of safe imaging services; and
  • assist in the development and implementation of best practice standards and guidelines.

General accreditation against the full suite of RANZCR standards by the National Association of Testing Authorities (NATA) is not part of the RANZCR Quality and Accreditation Program.


Statement of Compatibility with Human Rights

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

 

Declaration of Quality Assurance Activity under section 124X of the Health Insurance Act 1973 - QAA 13/2016

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 Declaration of Quality Assurance Activity under section 124X of the Health Insurance Act 1973 – QAA 13/2016 (the Declaration) declares the RANZCR Quality and Accreditation Program to be a quality assurance activity to which Part VC of the Health Insurance Act 1973 (the Act) applies. Information known solely as the result of the RANZCR Quality and Accreditation Program, or documents created solely for the purposes of the RANZCR Quality and Accreditation Program, will be covered by qualified privilege.

Human rights implications

This Declaration engages the right to health as set out in Article 12 of the International Covenant on Economic, Social and Cultural Right by assisting with the progressive realisation by all appropriate means of the right of everyone to the enjoyment of the highest attainable standard of physical and mental health.

The Qualified Privilege Scheme established by Part VC of the Act is aimed at encouraging participation in quality assurance activities that help ensure the highest possible health care standards are maintained. The quality assurance activity described in this Declaration will provide participants with a greater degree of confidence and security that their participation is solely for the benefit of establishing and improving outcomes of the community health care.

Conclusion

This Declaration is compatible with human rights as it promotes the right to health.

 

Overview

The Health Insurance Act 1973 was enacted to facilitate the provision of quality healthcare services in Australia, particularly by ensuring that healthcare providers meet certain standards. The Act was designed to address the need for a systematic approach to quality assurance in the healthcare sector, aiming to protect sensitive information and provide legal protection to those participating in quality assurance activities. This legislative framework was introduced by the Australian Parliament to enhance the overall quality of healthcare services, including those funded by the Government through Medicare, the Pharmaceutical Benefits Scheme, and Health Program Grants. The policy objective of the Act is to encourage participation in quality assurance activities by offering protections that promote confidence among healthcare providers, ultimately benefiting the community by ensuring high standards of healthcare. The Declaration of Quality Assurance Activity under section 124X of the Health Insurance Act 1973 - QAA 13/2016 specifies that the Royal Australian and New Zealand College of Radiologists' (RANZCR) Quality and Accreditation Program is recognised as a quality assurance activity. This recognition ensures that the information generated by the program is protected and that participants are afforded certain legal protections, thereby encouraging greater participation in quality assurance activities. The declaration highlights the program's focus on improving the quality of mammograph and MRI services, ensuring optimal operation of imaging equipment, and providing peer-reviewed feedback to participating sites. By declaring the RANZCR Quality and Accreditation Program as a quality assurance activity, the Act aims to uphold and enhance the quality of healthcare services in Australia.

Scope and Application

The Declaration of Quality Assurance Activity under section 124X of the Health Insurance Act 1973 - QAA 13/2016 applies Part VC of the Health Insurance Act 1973 to the Royal Australian and New Zealand College of Radiologists (RANZCR) Quality and Accreditation Program, which relates to health services provided in Australia. The Act applies to persons authorised to engage in the RANZCR Quality and Accreditation Program by RANZCR, which is recognised as an association of health professionals and an educational institution. The activity includes the disclosure of non-identifying information concerning the quality of service assessed, evaluated, or studied, as mandated by regulation 23C of the Health Insurance Regulations 1975. The Minister must be satisfied that the activity meets the criteria set out in regulations 23C to 23G, and that it is in the public interest for Part VC to apply. The Declaration protects information obtained solely in the course of the RANZCR Quality and Accreditation Program and documents created for this purpose by conferring a qualified privilege. This legislative instrument is compatible with human rights, particularly the right to health as it encourages quality assurance activities that aim to improve health care standards and outcomes.

Key Provisions

The main operative sections of the Declaration of Quality Assurance Activity under section 124X of the Health Insurance Act 1973 - QAA 13/2016 (the Declaration) establish the Royal Australian and New Zealand College of Radiologists (RANZCR) Quality and Accreditation Program as a quality assurance activity under Part VC of the Health Insurance Act 1973 (the Act). This means that the information generated by this program and documents created for its purposes are protected under a qualified privilege scheme. This scheme aims to encourage participation in quality assurance activities that help ensure high health care standards (section 124X(4)). The Declaration outlines the objectives of the RANZCR Quality and Accreditation Program, which include supporting quality mammograph and MRI services, ensuring the diagnostic quality of clinical images, and providing peer-reviewed feedback to sites on quality improvements (Attachment A). The Declaration imposes certain obligations on the entities involved in the RANZCR Quality and Accreditation Program. Primarily, these entities must ensure that the activity complies with the criteria set out in the Health Insurance Regulations 1975 (the Regulations), such as the disclosure of non-identifying information concerning the quality of services assessed, evaluated, or studied (regulation 23C). Furthermore, the Declaration requires that the activity be conducted in good faith and for the purpose of improving health care outcomes in Australia. The Minister for Health and Aged Care must be satisfied that the participants are authorised to engage in the activity under section 124X(3) of the Act and that it is in the public interest (section 124X(3)(b)). The Declaration does not explicitly outline specific offences, penalties, or civil/criminal consequences for breaches. However, the qualified privilege scheme established by Part VC of the Act provides some protection from civil liability to persons engaged in quality assurance activities in good faith. This protection encourages participation in the RANZCR Quality and Accreditation Program. The Declaration specifies that it will cease to be in force at the end of five years after it was signed, unless sooner revoked (subsection 124X(4)). This limitation ensures that the protections and obligations outlined in the Declaration are periodically reviewed and updated as necessary.

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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.