Health Insurance (Quality Assurance Activity – BreastSurgANZ Quality Audit) Declaration 2025

The instrument rests on a small number of concrete statutory and programmatic concepts, expressed in the Schedule and in the sections that bring the instrument into legal force.

• Quality assurance activity declaration: The instrument’s core legal effect is to declare the BQA to be “a quality assurance activity to which Part VC of the Health Insurance Act 1973 applies,” but expressly only “to the extent that the quality assurance activity relates to health services provided in Australia” (s 5). The declaration therefore creates a statutory relationship between the BQA and Part VC; the text does not itself reproduce Part VC or set out its consequences.

• Clinical audit and KPI benchmarking: The Schedule defines the BQA as “a clinical audit that collects breast cancer surgery and treatment pathway information from breast surgeons” and compares clinical results to “Quality Thresholds for Key Performance Indicators (KPIs) set by the BQA Subcommittee” (Schedule item 2). The KPI mechanism is central: the audit’s outputs are comparisons between individual surgeon data and the Quality Thresholds determined by the BQA Subcommittee.

• Data access rights described: The Schedule states that “Surgeons may access their own data and analyse aggregate data from the BQA,” which is presented as a mechanism for establishing an evidence base to change recommended treatments to improve outcomes (Schedule item 2). The instrument thus records certain data access and analytic uses for participating surgeons.

• Organisational roles: The Schedule identifies BreastSurgANZ as the entity that “will be engaged in” the BQA, describing it as “a sub-specialty society for surgeons treating breast cancer” (Schedule item 2). It also identifies a BQA Subcommittee as the body that sets Quality Thresholds for KPIs.

• Temporal and procedural formalities: Commencement is specified in a table: the whole instrument commences the day after registration (s 2). The table also carries an express note that information in column 3 is not part of the instrument and that the table only records the instrument as originally made (s 2(1)-(2)). The instrument is made under subsection 124X(1) of the Health Insurance Act 1973 (s 3) and is repealed when it ceases to be in force under subsection 124X(4) of that Act (s 4).

• Continuity with previous declaration: The Schedule expressly links this 2025 declaration to the earlier Health Insurance (Quality Assurance Activity - BreastSurgANZ Quality Audit) Declaration 2020, and asserts that the current declaration is likely to encourage greater participation through explicit program expansions and governance changes (Schedule item 2).

These concepts combine legal naming and program description. The declaration is the statutory act; the Schedule supplies the operational description (audit scope, KPI benchmarking, data access, governance and membership changes). The instrument does not itself reproduce or amend Part VC, nor does it articulate the legal effects that flow from Part VC; it places the BQA within the statutory category that Part VC covers.

The instrument identifies a limited set of actors and a circumscribed scope of application.

• BreastSurgANZ and the BQA Subcommittee: The Schedule states that “the BQA activity will be engaged in by BreastSurgANZ” and that Quality Thresholds for KPIs are set by the “BQA Subcommittee” (Schedule item 2). Those two bodies are the primary organisers and decision-makers named in the instrument. BreastSurgANZ is therefore the organisation responsible for conducting the declared activity; the BQA Subcommittee has the internal governance role of setting KPI thresholds.

• Breast surgeons: The Schedule makes clear that the audit “collects breast cancer surgery and treatment pathway information from breast surgeons” and that “surgeons may access their own data and analyse aggregate data from the BQA” (Schedule item 2). The primary subjects whose information is collected, who may access individual and aggregate data, and whose clinical performance is compared to KPI thresholds are breast surgeons , specifically, surgeons treating breast cancer who interact with the BQA.

• Members and categories within BreastSurgANZ: The Schedule refers to “redefined membership categories,” and asserts that the current declaration is “likely to encourage a greater level of participation” through KPI/database expansion and alterations in membership categories (Schedule item 2). That implies that membership status and any redefinition of categories within BreastSurgANZ may affect which surgeons are involved or eligible to participate in the audit.

• Patients, indirectly represented by data: The Schedule describes KPIs that relate to “a patient’s optimal care pathway,” and the audit collects treatment-pathway information (Schedule item 2). While patients are not named as direct recipients of regulatory obligations or rights in the instrument, the instrument’s stated aims , improved outcomes and evidence-based changes in recommended treatments , position patient care pathways as the substantive subject of measurement and potential change.

• Territorial limitation: The legal effect of the declaration applies only “to the extent that the quality assurance activity relates to health services provided in Australia” (s 5). That territorial phrase limits the statutory declaration to activities connected with Australian-provided services; international activity of BreastSurgANZ or surgeons practising outside Australia would not fall within the declared scope insofar as the instrument only covers services provided in Australia.

• Wider stakeholders not explicitly named: The instrument does not name state or territory health bodies, private hospitals, research institutions, or regulators other than the Health Insurance Act machinery. Any effect on those actors would flow indirectly from participation decisions or from Part VC consequences; the instrument itself identifies only BreastSurgANZ, the BQA Subcommittee, and breast surgeons as operative parties.

The instrument does not impose explicit statutory reporting obligations or sanctions on any of the named groups within its text. The Schedule describes the audit’s collection of surgeon data and surgeons’ access rights to data, but it does not set out compulsory duties, data-submission rules, or mandatory membership criteria. The precise effect on any individual surgeon will therefore depend on the BQA’s governance, membership rules, and any obligations or incentives that BreastSurgANZ creates under its own processes, together with any legal effects conferred by Part VC of the Health Insurance Act 1973.

The declaration itself performs a classificatory function: it declares the BQA to be a quality assurance activity under Part VC (s 5). The instrument does not enumerate a list of statutory duties, obligations or penalties; rather, it records certain operational features that create practical duties and rights within the audit programme. Those are the principal operational “duties and rights” that appear in the instrument.

Rights recorded in the Schedule

• Access to data: The Schedule states that “Surgeons may access their own data and analyse aggregate data from the BQA” (Schedule item 2). That is an express right described in the Schedule for surgeons participating in the audit: they can obtain their individual results and use aggregate audit data for analysis.

Decision rights and internal duties

• KPI-setting authority: The Schedule assigns the role of setting Quality Thresholds for KPIs to the “BQA Subcommittee” (Schedule item 2). That gives the Subcommittee a decision-making function over the content of the performance thresholds to which surgeon results are compared. The instrument does not, however, describe legal constraints on the Subcommittee’s decision-making, nor does it specify procedural requirements for setting KPIs.

Operational duties implicit in the audit description

• Data collection: The Schedule states that the BQA “collects breast cancer surgery and treatment pathway information from breast surgeons” (Schedule item 2). That raises a practical duty on the part of those who supply data to the audit and on BreastSurgANZ as the body running the audit to receive and manage the data. The instrument does not specify whether data supply is voluntary or mandatory, nor does it set out timelines, formats, or verification obligations.

Rights to analyse aggregate data and use it for change

• Use for practice improvement: The Schedule frames one of the audit’s purposes as enabling surgeons to “establish an evidence base to make changes in recommended treatments to improve breast surgery outcomes” (Schedule item 2). That describes a use-right: participating surgeons may use audit findings to inform clinical practice or professional development.

Statutory duties not set out in this instrument

• Part VC consequences not reproduced: While the declaration connects the BQA to Part VC of the Health Insurance Act 1973 (s 5), the instrument does not itself describe the statutory duties, procedural protections, confidentiality regimes, or enforcement measures that Part VC may provide. Any duties or rights conferred or limited by Part VC must be identified by referring to the Health Insurance Act 1973 itself; they are not enumerated in this instrument.

Temporal and repeal aspects

• Commencement and repeal: The instrument commences the day after registration (s 2) and is repealed when it “ceases to be in force” under subsection 124X(4) of the Health Insurance Act 1973 (s 4). Those temporal rules affect the duration of the rights and duties the declaration creates or records.

In short, the instrument sets out a framework of organisational roles and programme-design features (data collection, KPI benchmarking, surgeon access to data), but does not itself allocate statutory sanctions or detailed compliance obligations. The operative legal consequences of the declaration beyond the Schedule’s descriptive rights (for example, any statutory confidentiality protections or evidentiary consequences) reside in Part VC of the Health Insurance Act 1973 rather than in the instrument itself.

The instrument does not set out any penalties, enforcement mechanisms, or sanctions within its text. Its operative effect is to declare the BQA a “quality assurance activity to which Part VC of the Health Insurance Act 1973 applies” where the activity relates to health services provided in Australia (s 5). Any penalty, enforcement, or statutory mechanism tied to that classification therefore derives from the provisions of Part VC of the Health Insurance Act 1973, not from this instrument.

Relevant textual points

• No penalties in the instrument: There is no clause within the declaration or the Schedule that prescribes penalties, fines, or enforcement steps for failure to participate, failure to provide data, breaches of confidentiality, or other non-compliance matters. The Schedule is descriptive , it states the audit’s operation, data uses, and governance , but does not prescribe enforcement mechanisms.

• Part VC as the locus of enforcement law: Because the declaration connects the BQA to Part VC (s 5), any statutory enforcement or regulatory effects associated with being a declared quality assurance activity must be extracted from Part VC of the Health Insurance Act 1973. This instrument identifies the activity as falling within that statutory category; it does not detail the content of Part VC.

• Repeal mechanism instead of enforcement steps: The instrument includes a repeal clause: “This instrument is repealed when it ceases to be in force in accordance with subsection 124X(4) of the Health Insurance Act 1973” (s 4). That establishes an end-point mechanism for the declaration itself but does not specify enforcement against individuals.

Practical implications from the text

• Unspecified enforcement consequences: For participants, the absence of enforcement detail in the instrument means that questions about mandatory reporting, compulsion, sanctions for non-provision of data, or protections available to data subjects cannot be answered from this instrument alone. One must examine Part VC and any BreastSurgANZ or BQA governance rules for enforcement detail.

• Administrative decisions fall to Part VC reference: Any authority to compel or to withhold certain legal effects because the activity is declared will be located in the Health Insurance Act 1973 provisions that the instrument invokes in the declaration and in the subsection under which the instrument was made (s 3 citing subsection 124X(1)).

To determine specific penalties, sanctions, or enforcement pathways relevant to the BQA after this declaration, a practitioner must consult Part VC of the Health Insurance Act 1973 and any subordinate instruments or internal BQA rules that implement participation, data-handling and outlier procedures. The declaration itself signals inclusion within Part VC and supplies descriptive details about the audit, but it contains no standalone enforcement apparatus.

This instrument performs a single legal function: it brings the BQA within the scope of Part VC of the Health Insurance Act 1973 for activities that “relate to health services provided in Australia” (s 5). The instrument thus creates a statutory intersection between the BQA as described in the Schedule and the Health Insurance Act 1973. The instrument does not identify or reference other federal statutes, state or territory laws, or privacy and data-protection regimes; any interaction with those other laws would be consequential and must be assessed by reference to those texts rather than this declaration.

Key statutory connections stated in the instrument

• Authority and enabling provision: The instrument is made under subsection 124X(1) of the Health Insurance Act 1973 (s 3). That identifies the statutory power used to make the declaration; it is the direct legal basis for the instrument.

• Application of Part VC: The declaration explicitly states that the BQA is “declared to be a quality assurance activity to which Part VC of the Health Insurance Act 1973 applies,” but only insofar as the activity relates to health services provided in Australia (s 5). The instrument therefore ties the programme to the procedural and substantive framework of Part VC, even though it does not reproduce Part VC’s content.

Territorial limitation and cross-jurisdictional activity

• Australian service limitation: The declaration is expressly limited to activities relating to health services provided in Australia (s 5). That territorial qualifier limits the statutory declaration: elements of the BQA that relate to services provided outside Australia would not be caught by the statutory declaration’s effect, at least as expressed here.

Absence of express interaction with other regulatory regimes

• No explicit reference to privacy, medical regulation, or evidence-law consequences: The instrument does not mention privacy laws, state health regulation, professional conduct regimes, or evidentiary rules. It also does not describe whether data collected by the BQA are subject to particular disclosure limits, confidentiality regimes, or admissibility constraints. Any such interactions would have to be determined by reference to Part VC or to other laws, which are not set out in this instrument.

Continuity with previous declaration

• Replacement or continuation of prior declaration: The Schedule explicitly links this declaration to the prior Health Insurance (Quality Assurance Activity - BreastSurgANZ Quality Audit) Declaration 2020 and frames the 2025 declaration as following that earlier instrument (Schedule item 2). That locational link suggests administrative continuity and may be relevant where queries concern what changed from 2020 to 2025; however, the instrument itself does not specify the legal effect on or interaction with the 2020 instrument beyond that statement.

Administrative notes in the instrument

• Commencement and table notes: The commencement table is formalised (s 2), and s 2(2) records that information in column 3 of the table is not part of the instrument. That procedural note is relevant when cross-referencing the instrument against published versions that may carry editorial or informational table notes.

In practice, to understand the BQA’s full legal position one must read this declaration together with Part VC of the Health Insurance Act 1973 and any applicable privacy, health practitioner regulation, medical records or research-governance laws. This instrument creates the cross-reference to Part VC and describes the audit’s operation; it does not itself map out the contours of interactions with other statutory regimes.

The instrument provides only limited historical and amendment-related information within its text. The Schedule explicitly situates the 2025 declaration in relation to a prior declaration, and the commencement table contains formal notes about amendment scope.

References to prior instrument

• Continuation from 2020 declaration: The Schedule states that “This declaration follows the previously declared activity Health Insurance (Quality Assurance Activity - BreastSurgANZ Quality Audit) Declaration 2020” (Schedule item 2). The instrument therefore records that there was a previous 2020 declaration of the same activity and that this 2025 declaration is presented as a successor of that earlier instrument.

Statement about increased participation via program design changes

• Programmatic changes referenced as a reason for the 2025 declaration: The Schedule says the 2025 declaration is “likely to encourage a greater level of participation than the previously declared activity through KPI and database expansion, redefined membership categories, and the implementation of an outlier process” (Schedule item 2). The instrument does not itself change the earlier declaration; rather, it replaces or supersedes the 2020 instrument by way of a new declaration. The instrument does not provide a side-by-side list of amendments or the specific textual differences between 2020 and 2025.

Commencement and amendment notes

• Commencement of the whole instrument: The commencement table records that “The whole of this instrument” commences “The day after this instrument is registered” (s 2 table). The table carries an editorial note that the table “relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument” (s 2). That means the table documents original commencement only and will not be updated to reflect later changes.

• Non-authoritative content in column 3: Section 2(2) states that any information in column 3 of the table “is not part of this instrument” and may be edited in published versions. That clause separates formal legal text from ancillary publication material.

Repeal and duration

• Repeal mechanism referenced: The instrument includes an express repeal provision: it “is repealed when it ceases to be in force in accordance with subsection 124X(4) of the Health Insurance Act 1973” (s 4). That refers amendment or termination to the Health Insurance Act mechanics rather than providing an independent expiry or sunset clause in the instrument itself.

Absence of subsequent amendments within this text

• No textual amendments or variations recorded in this instrument: Aside from referencing the 2020 declaration, the instrument contains no amendment history, dictionary of revisions, or schedules showing tracked changes. Any later amendments to this declaration would need to be located through the legislative instrument register or consolidated versions of subordinate instruments.

For practitioners tracking change, the instrument gives three concrete reference points: the name and date (s 1), the commencement rule (s 2), and the link to the 2020 declaration (Schedule item 2). To identify specific textual amendments or to trace precisely how the 2025 wording differs from 2020, one must consult the earlier instrument text and the legislative instrument registry for any subsequent instruments that specifically amend or replace the declaration.

The instrument does not record, reference, or summarise any litigation, judgments, disputes, or case law. It contains no citations to court decisions and no description of past or pending legal challenges related to the BQA or to the declaration. The Schedule references only the prior 2020 declaration as an administrative predecessor; it does not mention any litigation arising from that instrument.

What the instrument records

• Silence on litigation: There are no clauses describing legal proceedings, judicial review, or disputes. The Schedule and the operative sections are administrative and descriptive in nature.

Implications for research and due diligence

• No internally recorded cases to cite: Because the instrument contains no litigation history, anyone seeking precedential or adjudicative guidance on how courts have treated such declarations or Part VC activities will need to conduct an external search of case law and judicial decisions relating to the Health Insurance Act 1973 and Part VC. Those materials are not provided within this instrument.

• Administrative focus rather than legal precedent: The instrument functions as a statutory declaration of program status rather than as an interpretive or litigated text. Where legal risk or contested application is a concern, the practitioner should examine Part VC and any decisions under that Part in separate sources.

In sum, the instrument offers no litigation history and therefore provides no support for claims about how courts have interpreted declared quality assurance activities of this type. Any litigation history relevant to the BQA, to BreastSurgANZ, or to Part VC must be located outside this instrument.

The instrument is short and narrowly focused. Several practical points of potential uncertainty or “gotchas” arise directly from the way the instrument frames the BQA and from what it does not say. Each of the following statements is grounded in the text of the instrument or in an absence of provision in the instrument.

• The statutory effect is limited to activities relating to Australian-provided services: The declaration applies “to the extent that the quality assurance activity relates to health services provided in Australia” (s 5). Any element of the BQA that collects or uses data about services provided outside Australia is not covered by the declaration’s stated legal effect.

• The instrument does not itself state compulsory reporting or participation: The Schedule says that the BQA “collects breast cancer surgery and treatment pathway information from breast surgeons” and that surgeons “may access their own data” (Schedule item 2). The instrument does not say whether surgeons are required to supply data, nor does it specify sanctions for non-submission. Consequently, whether participation is mandatory, incentivised, or voluntary is not resolved within this instrument.

• KPI setting is an internal Subcommittee function with no procedural detail in the instrument: The Schedule assigns KPI threshold-setting to the BQA Subcommittee (Schedule item 2). The instrument does not specify how those thresholds are set, whether there is consultation, appeal, or external review, or what methodology is used. The Subcommittee’s authority is recorded but not constrained in this instrument.

• Outlier process is mentioned but not defined: The Schedule notes that this declaration is likely to encourage participation through “the implementation of an outlier process” (Schedule item 2). The instrument provides no procedural or definitional detail about what constitutes an outlier, how outliers are identified, what follow-up occurs, or what consequences attend identification as an outlier.

• No penalties or enforcement mechanisms in the instrument: The declaration brings the BQA within Part VC (s 5) but does not itself set penalties or enforcement processes. Any enforcement or protective mechanisms derive from Part VC of the Health Insurance Act 1973 and are not reproduced here.

• Data access rights are limited in expression: The Schedule states that “Surgeons may access their own data and analyse aggregate data from the BQA” (Schedule item 2). The instrument does not define timeframes, access procedures, third-party access rules, or confidentiality protections. Practitioners should not assume broader access rights exist beyond what the Schedule specifies.

• The instrument replaces or follows a prior declaration but does not list concrete differences: The Schedule states the 2025 declaration “follows” the 2020 declaration and is likely to encourage greater participation through specific program changes (Schedule item 2). The instrument does not detail how text or legal effects differ from the 2020 instrument; one must compare the two instruments to see what changed.

• Commencement is quick and non-negotiable: The instrument commences “the day after this instrument is registered” (s 2 table). That timing gives little room for staged rollout from the statutory perspective; operational rollouts will need to align with that commencement rule.

• Published table metadata is not authoritative: Section 2(2) explicitly states that “Any information in column 3 of the table is not part of this instrument” and may be edited in published versions. Users must rely on the instrument’s text and not ancillary published notes in column 3.

• Repeal depends on the Health Insurance Act mechanism: The instrument’s repeal is linked to subsection 124X(4) of the Health Insurance Act 1973 (s 4). The instrument itself does not provide a date or condition that clearly defines when it will cease; practitioners must consult the Act’s mechanics to understand cessation.

These “gotchas” arise from what the instrument chooses to declare and from the notable absences in its text. Where the instrument is silent, operational detail will come from BreastSurgANZ governance rules, the BQA Subcommittee’s procedures, and Part VC of the Health Insurance Act 1973. The instrument should be treated as the legal declaration that positions the BQA under Part VC, not as a comprehensive rulebook for the audit’s operation.

This instrument is a declaratory legislative instrument; it does not itself contain a detailed compliance regime. Compliance therefore has two aspects: statutory compliance associated with the declaration (which is essentially a linkage to Part VC of the Health Insurance Act 1973), and operational compliance with the BQA’s internal processes as described or later established. The instrument provides limited specific compliance steps; the following practical steps are grounded in what the instrument actually states and in the operational features it records.

1. Read the declaration and the Health Insurance Act 1973 together

• The declaration’s legal effect is to bring the BQA within Part VC when the activity “relates to health services provided in Australia” (s 5). To understand any statutory compliance obligations, protections, or enforcement that may apply because of that classification, read Part VC of the Health Insurance Act 1973 alongside this instrument. The declaration does not itself set out statutory duties.

2. Identify your role relative to the BQA

• If you are a breast surgeon or a member of BreastSurgANZ, note that the Schedule describes the BQA as “collect[ing] breast cancer surgery and treatment pathway information from breast surgeons” and that “surgeons may access their own data and analyse aggregate data from the BQA” (Schedule item 2). Determine whether you fall within the redefined membership categories referenced in the Schedule and whether your membership or employment relationship imposes any internal obligation to participate.

3. Engage with BreastSurgANZ governance

• The instrument names BreastSurgANZ as the entity “engaged in” the activity and the BQA Subcommittee as the KPI-setting body (Schedule item 2). Compliance with operational requirements , data formats, submission deadlines, consent procedures, and membership eligibility , will be governed by BreastSurgANZ and the BQA Subcommittee, not by the declaration text. Contact BreastSurgANZ or consult its published BQA protocols to determine the audit’s reporting and data-access procedures.

4. Prepare for KPI benchmarking and outlier processes

• The Schedule states that clinical results are compared against “Quality Thresholds for Key Performance Indicators (KPIs) set by the BQA Subcommittee” and that the declaration entails “the implementation of an outlier process” (Schedule item 2). Practitioners should obtain the KPI methodology, threshold definitions, and the outlier process protocol from the BQA to understand measurement bases, statistical methods, and any remedial or investigatory steps that follow an outlier identification.

5. Secure and manage data access and privacy

• The Schedule records that surgeons may access their own data and analyse aggregate data (Schedule item 2), but it does not set out access procedures or privacy protections. To comply practically and protect patient and surgeon interests, obtain the BQA’s data-handling, de-identification, and storage policies, and ensure local recordkeeping and consent practices align with those policies and with applicable privacy obligations (note: the instrument does not specify privacy rules; consult relevant privacy legislation and BreastSurgANZ policies).

6. Monitor commencement and repeal timing

• The instrument commences the day after registration (s 2 table). Ensure operational preparations align with that statutory commencement if timing matters to reporting or governance. The instrument will be repealed when it “ceases to be in force” under subsection 124X(4) of the Health Insurance Act 1973 (s 4); monitor any notices or instruments that implement cessation.

7. Distinguish programme participation from statutory compulsion

• The declaration does not state whether participation is compulsory. Where obligations are unclear, ask BreastSurgANZ for participation rules and consult Part VC for any statutory compulsion or protection that follows from the activity’s declared status. Do not assume that the declaration creates individual statutory duties; the text does not supply them.

8. Retain documentary proof of any interactions

• Because the declaration does not include procedural detail, preserve copies of membership admissions, data submissions, KPI reports, and any correspondence with the BQA Subcommittee or BreastSurgANZ. That documentation will be important should questions arise about obligations, data provision, or status under Part VC.

9. Compare the 2025 declaration with the 2020 instrument

• The Schedule notes that the 2025 declaration follows the 2020 declaration and is likely to encourage greater participation through specific program changes (Schedule item 2). For compliance planning, compare the texts to identify any changes in scope, membership categories, KPI coverage, or database scope that affect whether and how you participate.

10. Seek legal advice to understand Part VC consequences

• The declaration references Part VC; it does not reproduce Part VC’s content. If statutory protections, evidentiary effects, or potential enforcement consequences under Part VC are material to your risk position, obtain legal advice and review Part VC directly. The declaration flags legal linkage but does not substitute for a reading of the Health Insurance Act 1973.

These steps align with what the instrument actually provides: a statutory declaration and an operational description of a clinical audit. Practical compliance depends on the BQA’s published protocols and on the statutory content of Part VC, neither of which is specified in detail in the declaration itself.