Quality assurance activities able to be declared
Qualified Privilege declarations and the public interest
Responsibilities associated with declared quality assurance activities
Areas not covered by a declaration
State and Territory qualified privilege legislation
Applying for Qualified Privilege

Quality assurance activities able to be declared

The Quality Assurance Confidentiality Framework (the Qualified privilege) embrace a wide range of activities, such as academic studies of incidents, some registries, and information involved in the performance evaluation of the relevant services rendered by health care professionals. Quality assurance is the process of measuring, evaluating and studying the quality of health care services provided by a person. A quality assurance activity involves measuring the effectiveness of a procedure or process carried out by health professionals and making evidence based improvements in relation to the particular health care services.

Qualified privilege arrangements provided under Part VC of the Health Insurance Act 1973 are intended to address concerns by clinicians that information or data they provide may be attributed directly to them. Qualified privilege addresses these concerns by encouraging health care professionals to participate openly in quality assurance activities by:

• Ensuring the confidentiality of information that may identifies individuals, either directly or indirectly, where this information is provided solely as a result of a declared quality assurance activity; and
• Protecting individuals from the risk of civil proceedings in relation to a committee, whose members or a majority of the members are health professionals that are the subject of a declared quality assurance activity.

Qualified Privilege declarations and the public interest

When the Minister, or the delegate of the Minister makes a declaration for a quality assurance activity, they must be satisfied of the following key questions:

• are the people or the organisation undertaking the activity authorised to do so as one of the bodies specified in Part VC of the Health Insurance Act 1973; and
• is it in the public interest for the Commonwealth Qualified privilege to apply to the activity?

When considering whether it is in the public interest to declare the activity, the Minister must consider the criteria set out in Part 10 of the Health Insurance Regulations 2018.

When making a decision, the Minister, or delegate of the Minister, must be satisfied it is in the public interest to declare the activity on the grounds that the activity will:

• encourage participation in the activity, or in the case of an activity having previously been undertaken, encourage participation to a greater extent than in the previous activity; and
• encourage acceptance, implementation and monitoring of any recommendations which arise from the activity.

The Minister, or the delegate of the Minister may also take into account whether the activity has, or should have, ethics committee approval. Qualified privilege declarations once made are legislative instruments and are subject to Parliamentary scrutiny, in particular by the Senate Committee on Regulations and Ordinances. Once approved, each declaration is registered and can be accessed on the Federal Register of Legislation. The Parliament has the power to request additional information or disallow a declaration. If this occurs a declaration would cease to have effect.

Responsibilities associated with declared quality assurance activities

Once an activity is declared, participants must comply with the confidentiality requirements in the legislation. This means that any person (including a participant) who acquires information that identifies individuals that became known solely as a result of a declared activity must not disclose, or make a record, of that information. Failure to do this is a criminal offence that is punishable by up to two years imprisonment.

Obligations, rights and responsibilities of participants in a declared quality assurance activities

As doctors and clinicians participating in any declared quality assurance activities, the data that you agree to submit as part of a declared activity under qualified privilege is strictly confidential. Any data about an individual, or data that can identify an individual that you submit can only be released with your written consent, or through an authorisation made by the Minister. It is important that any data arising solely as a result of the declared activity must be kept confidential and not disclosed in any manner unless it is with written consent of the individual concerned, or expressly authorised by the Minister.
It is also a requirement to provide regular public disclosures of de-identified information arising from the quality assurance activity. Public disclosures may be provided as de-identified aggregated information such as clinical performance data, key themes, clinical issues identified, recommendations made implemented and monitored, as well as improvements to services arising from evidence obtained through the declared activity, and evidence of participation.

Areas not covered by a declaration

In the past there has been some misunderstanding about the purposes and scope of protection provided by a declaration. For example:

• Patient Consent - One misunderstanding is that a declaration overrides the general law relating to confidentiality and patient consent and thereby obviates any requirement that may exist to seek patient consent for a patient’s medical records to be viewed by other than a treating doctor. A declaration is irrelevant to the issue of whether or not patient consent is required.
• Disclosure of Information - Another misunderstanding is that ‘all’ information generated as a result of a declared activity can be kept confidential. This is not the case. The only information protected by a declaration is information that may potentially identify individuals. In fact, the legislation requires participants of declared activities to provide regular public disclosures on the progress and outcomes of the activity (without identifying individuals).

If you are unsure of whether a particular area of activity is covered by the declaration or not, please contact the Accreditation and Registration Policy Section on (02) 6289 4155 or email QPS@health.gov.au.

State and Territory qualified privilege legislation

Commonwealth qualified privilege legislation complements legislation in place in all Australian States and the Australian Capital Territory. The Northern Territory does not currently have legislated qualified privilege arrangements.

Many quality assurance activities take place in only one State or Territory. In these circumstances, the Australian Government would usually recommend the application be referred for consideration by that State or Territory, except in circumstances where a quality assurance activity involves a methodology that is new in Australia or has the potential to affect the quality of health care on a national scale. If a quality assurance activity is to take place in more than one State or Territory, it is generally appropriate to seek a declaration under the Commonwealth legislation.

Health care professionals who are interested in legislative protection for their quality assurance activities and are not sure which legislation (State, Territory or Commonwealth) applies should contact their State or Territory Department of Health to discuss which form of protection is most appropriate.

Applying for Qualified Privilege

A person who wishes to seek a declaration in relation to a quality assurance activity under the Commonwealth legislation must do so by completing the application form approved by the Minister, or delegate of the Minister. Applicants are required to provide a range of information including details about the design and expected outcomes of the quality assurance activity. It is essential that this application form be completed in full to ensure comprehensive and accurate assessment of the application against criteria set out in the legislation.

A declaration only relates to the specific quality assurance activity that is the subject of the application. It does not extend to associated or consequential quality assurance activities - these must be the subject of a separate application.

The application form can be downloaded from the Applying for a declaration under the Commonwealth Qualified Privilege Scheme page. Further information about the relevant legislation and regulations are available at the following locations:

Legislation and Regulations

• Part VC of the Health Insurance Act 1973 - Federal Register of Legislation
• Part 10, Sections 84-89 of the Health Insurance Regulations 2018  

Completed applications may be emailed to QPS@health.gov.au or posted to:

The Director
Accreditation and Registration Policy Section
Department of Health
MDP 610
GPO Box 9848
CANBERRA ACT 2601

If you have any questions relating to Commonwealth Qualified Privilege Scheme or would like assistance completing your application form please contact the Accreditation and Registration Policy Section by phone on (02) 6289 4155 or by email at QPS@health.gov.au.

Please note: This information does not replace the provisions of the Health Insurance Act 1973 and the Health Insurance Regulations 2018. This information is intended to provide a summary of the Commonwealth Qualified Privilege arrangements to assist organisations who wish to apply for qualified privilege and participants understand the main purposes of the scheme and obligations for those who manage declared quality assurance activities. For detailed requirements, it is advisable that applicants and participants read the legislation and regulations, or seek legal advice on whether your activity meets the requirements to be declared.