Declaration of Quality Assurance Activity under section 124X of the Health Insurance Act 1973 - QAA 2/2016

Administered by Department of Health, Disability and Ageing

Legislation au F2016L00847 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

ISSUED BY THE AUTHORITY OF

THE MINISTER FOR HEALTH

HEALTH INSURANCE ACT 1973

DECLARATION OF QUALITY ASSURANCE ACTIVITY

UNDER SECTION 124X

QAA No.  2/2016

 

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, through Medicare benefits, the Pharmaceutical Benefits Scheme, Public Hospitals 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 described in the Declaration is a quality assurance activity to which Part VC applies.  Regulations 23C to 23G of the Health Insurance Regulations 1975 (the Regulations) set out the public interest criteria that must be met by quality assurance activities in order to be declared under the section 124X.

 

The Declaration is a legislative instrument for the purposes of the Legislative Instruments Act 2003.  This Declaration has effect from the day after registration on the Federal Register of Legislative Instruments.  Section 124X(4) of the Act prescribes that, unless sooner revoked, this determination ceases to be in force at the end of 5 years after the instrument of declaration was signed. 

 

This declaration under subsection 124X(1) applies Part VC of the Act to the following activity:

 

  1. Royal Australasian College of Surgeons (RACS) Morbidity Audit and Logbook Tool (MALT): Audit of Surgical Care

 

An overview of the activity for which the Declaration pursuant to s124X is made is contained in Attachment A.

Before the Minister can make a declaration, certain requirements must be met.

Firstly, the Minister must be satisfied that the persons engaged in the activity are authorised to do so as described in paragraph 124X(3)(a) of the Act.


The activity meets the requirements of paragraph 124X (3)(a) in that the persons engaged in this activity are authorised to do so by the Royal Australasian College of Surgeons, which is an association of health professionals and an educational institution.

Secondly, paragraph 124X (3)(b) of the Act provides that the Minister must be satisfied that it is in the public interest to have Part VC of the Act apply to the activity. In doing so, the Minister must have regard to criteria prescribed by the Regulations. The criteria relevant to the activity are in regulations 23C, 23D and 23E or 23F.

The activity meets 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. Information on MALT is available on the College of Surgeons website: http://www.surgeons.org/for-health-professionals/audits-and-surgical-research/morbidity-audit-and-logbook-tool/.
  • 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 re-declaration will continue to encourage full 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 does 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

 

This 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. Those consulted including Department of Health’s Principal Medical Advisor, Doctor Andrew Singer.

 

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 Legislative Instruments.

 

As provided by subsection 124X(4) a declaration ceases to be in force at the end of 5 years after the instrument of declaration is signed, unless revoked earlier.

 

QAA No. 2/2016

ATTACHMENT A

OVERVIEW OF THE ACTIVITY

1. PURPOSE OF ACTIVITY

The Activity is for feedback and self-reflection on surgical performance during the Training/Assessment process, for all Fellows and trainees, and international medical graduates on a pathway to Fellowship of the College. It is also used with junior doctors wishing to engage with the College prior to entering into a specialty training program.

 

The Audit involves reviewing actual surgical performance, including outcomes. The individual’s and team’s clinical experiences are compared with accepted standards of performance, and provide stimulus for learning and quality improvement.

The objectives of the activity are:

  • To identify ways of improving and maintaining the quality of care for patients in Australia;
  • To assist in the continuing education of surgeons; and
  • To help make the most of resources available for the provision of surgical services..

 


 

 

 

Overview

The Health Insurance Act 1973 was enacted to regulate and administer the Medicare system in Australia, ensuring efficient and effective health services. Part VC of the Act introduces a scheme to encourage quality assurance activities, addressing the gap in mechanisms to ensure the quality of health services funded by the government. The policy objective is to protect certain information from disclosure and provide some protection from civil liability to persons engaged in quality assurance activities in good faith. The Minister for Health has the authority to declare a quality assurance activity under Section 124X, provided the Minister is satisfied that the activity meets specific criteria and is in the public interest. This protection extends to the Royal Australasian College of Surgeons (RACS) Morbidity Audit and Logbook Tool (MALT) activity, which was declared to encourage full participation by health service providers by offering them confidence and security in their involvement. The declaration ensures the protection of non-identifying information concerning the quality of services assessed, evaluated, or studied. This protection is crucial for the ongoing improvement of surgical care and the education of surgeons, as well as the efficient use of resources for surgical services in Australia. The declaration was made following consultations with relevant stakeholders and is subject to a review and potential revocation after five years, unless earlier revoked.

Scope and Application

The Declaration under section 124X of the Health Insurance Act 1973 applies Part VC of the Act to the Royal Australasian College of Surgeons (RACS) Morbidity Audit and Logbook Tool (MALT), which is an audit of surgical care. This activity is intended to facilitate feedback and self-reflection on surgical performance among Fellows, trainees, and international medical graduates pursuing Fellowship of the College, as well as with junior doctors before entering a specialty training program. The activity involves reviewing actual surgical performance and outcomes, comparing them against accepted standards of performance, and using the findings to stimulate learning and quality improvement. The declaration ensures that certain information related to the quality assurance activity is protected from disclosure and provides protection from civil liability for those participating in the activity in good faith. The declaration applies across the Commonwealth, where the activity is carried out by authorised persons, and it is in the public interest to encourage participation in quality assurance activities, as determined by the Minister. The declaration ceases to be in force at the end of five years after the instrument of declaration is signed unless revoked earlier.

Key Provisions

The main operative sections of the Health Insurance Act 1973, as declared under section 124X, pertain to the quality assurance activities that the Act seeks to protect and encourage. Specifically, Part VC of the Act (section 124X) allows the Minister for Health to declare certain activities as quality assurance activities, thereby conferring upon them the protections outlined in the Act. In this case, the Minister has declared the Royal Australasian College of Surgeons (RACS) Morbidity Audit and Logbook Tool (MALT) as a quality assurance activity (section 124X(1)). This declaration means that MALT, which audits surgical care, is now subject to the protections and requirements of Part VC of the Act. The obligations imposed by the Act on the parties involved in the declared activity primarily centre around ensuring that the activity meets certain criteria and is conducted in good faith. Firstly, the Minister must be satisfied that the persons engaged in the activity are authorised to do so (section 124X(3)(a)). In this instance, the RACS, an association of health professionals and an educational institution, authorises the individuals involved in the MALT activity. Secondly, the Minister must be satisfied that it is in the public interest to apply Part VC to the activity (section 124X(3)(b)), and this must be determined in accordance with the criteria set out in the Health Insurance Regulations 1975 (sections 23C to 23G). The MALT activity meets these criteria as it involves the disclosure of non-identifying information related to the quality of surgical care and has been previously conducted in Australia. In terms of potential offences, penalties, or civil/criminal consequences for breach, the Act does not explicitly outline specific penalties for non-compliance with the quality assurance activity protections. However, the overarching principle is that those engaged in the activity in good faith are protected from certain civil liabilities. Should there be any breaches of the criteria outlined in the Regulations, the Minister may choose to revoke the declaration, thereby removing the protections conferred by Part VC. Additionally, any misuse of the protected information beyond the scope of the quality assurance activity could potentially lead to civil or criminal consequences under other relevant legislation, though this is not explicitly detailed within the Act itself. The declaration remains in force for five years from the date of signing, unless sooner revoked (section 124X(4)).

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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.