Health (Western Australian Register of Developmental Anomalies) Regulations 2010

The central concept is "developmental anomaly", defined in regulation 4. It covers cerebral palsy, plus any structural or functional anomaly that is present at conception or occurs before the end of pregnancy, and is diagnosed during pregnancy, after stillbirth or termination of pregnancy, or after live birth but before six years of age. Structural and functional anomalies include congenital malformations, congenital deformations, chromosomal anomalies, inborn errors of metabolism, and inherited conditions (regulation 4(2)). Importantly, minor structural, chromosomal, metabolic and functional anomalies are excluded unless they are disfiguring or require treatment (regulation 4(3)). This exclusion prevents the register from being cluttered with trivial or self-resolving conditions, but it also introduces judgement calls for diagnosing practitioners about what counts as "disfiguring" or "requiring treatment."

"Notified information" means information notified under Part 2 (regulation 3). Notification is triggered when a developmental anomaly is diagnosed. The "responsible person" must notify the Chief Health Officer within six months of the diagnosis. In a hospital, the responsible person is the chief executive officer; otherwise it is the medical practitioner who makes the diagnosis or who is responsible for the patient's care (regulation 6). The notification must be in a form required by the Chief Health Officer and must include information relating to the diagnosis. There is no exemption for cases previously diagnosed in another state or territory; the responsible person in Western Australia must still notify the WA Chief Health Officer even if the condition was already diagnosed interstate (regulation 6(3)).

The "register" is the Western Australian Register of Developmental Anomalies, which the Chief Health Officer must keep. It contains all notified information less any identifying information removed under regulation 12, plus any inter-state data from corresponding officers and any other information the Chief Health Officer considers appropriate for the statutory purposes (regulation 8). The register must be kept in a manner and form determined by the Chief Health Officer (regulation 8(5)), giving significant administrative discretion over its operation.

"Identifying information" is defined as information from which the identity of the person to whom it relates is apparent or can reasonably be ascertained (regulation 3). This concept is critical because it governs what can be removed from the register. Only identifying information can be removed after six years; non-identifying information can be retained indefinitely (regulation 12). The distinction also matters for disclosure: the Chief Health Officer may authorise disclosure of non-identifying information for statutory purposes without consent, but disclosure of identifying information requires either consent or one of the specific authorisations under regulation 10.

"Corresponding officer" means a person in another state or territory who has functions substantially corresponding to the Chief Health Officer's functions under these regulations (regulation 3). This facilitates interstate data sharing about developmental anomalies, which is sensible given that families may move between jurisdictions. However, the regulation does not require the corresponding officer to have equivalent privacy protections, creating some risk that data may be handled less restrictively elsewhere.

The regulations primarily affect medical practitioners, chief executive officers of hospitals, and the Chief Health Officer's office. For medical practitioners who diagnose a developmental anomaly outside a hospital setting, they become the "responsible person" and must personally ensure notification occurs within six months (regulation 6(1)(b)). This is an administrative burden that falls especially on paediatricians, obstetricians, geneticists, and other specialists who identify conditions covered by the definition. GPs who diagnose a child under six years with a condition like cerebral palsy would also be captured. The penalty applies directly to the individual practitioner for non-compliance, not to their employer.

Hospital chief executive officers are affected when a diagnosis is made within the hospital. They are the responsible person in that context (regulation 6(1)(a)). This means the CEO must have systems in place to capture every diagnosis of a developmental anomaly made by any doctor in the hospital and ensure it is reported to the Chief Health Officer within six months. Hospitals likely delegate this to medical records or clinical coding staff, but the legal obligation rests on the CEO. Failure carries the same escalating fines.

The Chief Health Officer (and delegated staff) is affected as the keeper of the register. The officer must receive notifications, store them, search the register when requested by individuals, respond to requests for removal of identifying information, and decide when to authorise disclosures. The Chief Health Officer also has power to request further information from medical practitioners or hospital CEOs beyond the initial notification, with a 30-day compliance deadline (regulation 7). This creates a potential ongoing information-gathering burden on healthcare providers.

Parents and guardians of children diagnosed with developmental anomalies are affected in several ways. They may be asked for written consent to disclose register information for research under regulation 9(a) or for treatment under regulation 10(1)(c). They can exercise the right to know what information is on the register (regulation 11) and can request removal of identifying information after six years on behalf of their child (regulation 12, read with regulation 13). However, parents are not given a right to object to the initial notification; the regulations impose no requirement to inform parents that their child's details have been added to the register. A parent might only discover the register's existence when consent is sought for research. This is a notable gap in transparency to the affected individuals.

Researchers who wish to access register data are affected because they cannot obtain it directly from the register without following the authorisation process under regulation 10. They must have their research approved in accordance with NHMRC guidelines (regulation 10(1)(a)). The Chief Health Officer must authorise disclosure in writing. This gatekeeping creates a barrier to research but also protects privacy. The Australian Institute of Health and Welfare is a named recipient of data if the Chief Health Officer is satisfied the information will be used solely for one of the statutory purposes (regulation 10(1)(b)). Corresponding officers in other states are also affected as potential recipients of identifying information about persons residing in their jurisdiction (regulation 10(1)(d)).

The primary duty is notification. Regulation 6(2) provides that when a developmental anomaly is diagnosed, the responsible person must, within six months, cause the Chief Health Officer to be notified and provided with information relating to the diagnosis in such form as the Chief Health Officer may from time to time require. The duty is absolute: it applies regardless of whether the condition was already diagnosed interstate (regulation 6(3)). The notification must be done even if the child is not expected to survive, and even if the diagnosis is made prenatally, after stillbirth, or after termination of pregnancy, because "child" includes a human fetus (regulation 3). The form of notification is not prescribed in the regulations but is left to the Chief Health Officer's discretion, which creates compliance risk if the form changes without adequate notice.

The Chief Health Officer has a duty to keep the register (regulation 8(1)). The Chief Health Officer also has a duty to search the register and provide information to any person who makes a written request relating to themselves (regulation 11). That duty is to "as soon as reasonably practicable" tell that person there is no information, or give them a copy of any information relating to them. There is no fee mentioned, so this right is exercisable at no cost to the individual. The Chief Health Officer also has a duty to remove identifying information when requested by the person, provided it has been on the register for six years or more (regulation 12). The compliance must be as soon as practicable. However, non-identifying information may be retained, meaning a person cannot fully erase their history from the register even after six years.

The right to know is a positive right: any person can request information about themselves. This is a significant transparency provision, but it only applies to the person themselves, not to parents of a live child unless the child is under a legal disability (regulation 13). For a child who is not under a legal disability, presumably only the child can request after turning 18, but the regulations are silent on minors with capacity.

The right to request removal of identifying information after six years is another important individual right. However, it is not automatic; the person must make a written request. There is no obligation on the Chief Health Officer to notify the person that the six-year period has elapsed. Many individuals will be unaware of this right. The six-year clock starts from the time the information was "kept on the register" not from the date of diagnosis or notification. This ambiguity could lead to disputes about when the period begins.

The right to give or withhold consent to disclosure under regulation 9 is found in the regulation 9 exception: disclosure with the written consent of the person to whom the information relates. There is no requirement that consent be informed, but presumably it would be. For persons under a legal disability, a parent or guardian can give consent (regulation 13). The Chief Health Officer also has the discretion to authorise disclosure without consent for research approved under NHMRC guidelines, for transfer to AIHW, for urgent diagnosis or treatment, or to corresponding officers interstate (regulation 10). These authorisations may be general or specific. This creates a significant power imbalance: researchers can access data without the individual's consent if the Chief Health Officer authorises it, as long as the research is ethically approved.

The penalty framework is consistent across the notification and disclosure offences. Regulation 6(2) imposes a maximum fine of $1,000, with a minimum fine that escalates with the number of offences: a first offence carries a minimum fine of $100, a second offence a minimum of $200, and a third or subsequent offence a minimum of $500. The same penalty structure applies to the offence of failing to comply with a Chief Health Officer request for information under regulation 7(2). It also applies to the offence of unauthorised disclosure under regulation 9.

The use of escalating minimum fines signals a legislative intent that repeat non-compliance will be treated more seriously. However, the maximum fine is the same regardless of offence number ($1,000). For a hospital CEO or medical practitioner, a $1,000 maximum fine is relatively low and may not be a strong deterrent, particularly if the administrative cost of compliance is high. The minimum fine for a first offence is only $100, which is trivial for a hospital but might be felt by an individual practitioner.

Enforcement is not detailed in these regulations. There is no reference to infringement notices, compliance officers, or the power to prosecute. The regulations presumably rely on the general enforcement mechanisms under the Health (Miscellaneous Provisions) Act 1911. The Chief Health Officer would need to detect non-compliance, which could happen through audits of hospital records, complaints, or cross-referencing with other data sources such as birth defects registers in other states. However, the six-month notification window gives some leeway. Non-compliance is more likely to go undetected if the condition is not obvious.

The regulation 9 disclosure offence is notable: "A person who has access to the register in the course of the person's duty" must not disclose information except with consent or authorisation. This covers any person, not just the Chief Health Officer or health professionals. It could include administrative staff, researchers granted access, or IT personnel. The penalty structure is identical to the notification offence, but the nature of the wrongdoing is different: unauthorised disclosure of health data is a privacy breach with potentially serious consequences for the individual. A maximum fine of $1,000 for such a breach might be considered low compared to penalties under the Privacy Act 1988 (Cth) or state health privacy laws, but there may be separate professional disciplinary consequences for medical practitioners.

There is no corporate penalty for the hospital itself; only the CEO as the responsible person faces the fine. This creates an interesting incentive: the CEO is personally liable. They may delegate the actual notification task to staff, but if the notification is not made, the CEO faces the penalty. This should encourage CEOs to put robust systems in place. However, a CEO might argue they "caused" the notification to be made if they had reasonable procedures, but the wording "cause the Chief Health Officer to be notified" suggests an outcome obligation, not just a best-endeavours obligation.

These regulations are made under Part IXA of the Health (Miscellaneous Provisions) Act 1911, which is the enabling provision that allows the Governor to prescribe conditions of health for which a register must be kept. Regulation 5 expressly provides that a developmental anomaly is prescribed as a condition of health to which Part IXA applies. That Act provides the overarching legal framework for the register, including any provisions about the Chief Health Officer's powers, the use of information, and the relationship with other health legislation.

The regulations reference two other pieces of Commonwealth legislation. The Australian Institute of Health and Welfare Act 1987 (Cth) establishes the AIHW, which is given a special role as a permitted recipient of register data under regulation 10(1)(b). The National Health and Medical Research Council Act 1992 (Cth) is referenced for the research approval pathway: disclosure for research requires approval in accordance with guidelines issued under section 10 of that Act. That means the NHMRC's National Statement on Ethical Conduct in Human Research forms the benchmark. This imports Commonwealth ethical standards into the WA regulatory framework.

The Health Services Act 2016 (WA) is referenced for definitions of "health service provider" and "hospital". Regulation 3 imports these definitions, so any amendment to those definitions in the Health Services Act will flow through to the regulations. As of the latest amendments (2017), the definitions are current. This interaction ensures consistency across WA health legislation.

There is no express provision about privacy law, but the regulations clearly create a mandatory reporting regime that overrides patient consent in the initial collection of information. The notification duty does not require consent. This likely displaces any common law or statutory duty of confidence or medical ethics obligations that would otherwise prevent disclosure without consent, because the regulations are a valid law requiring the disclosure. However, the disclosure offence under regulation 9 shows that parliament intended a high level of protection for register information once collected, subject to the authorisations. That offence may interact with the Criminal Code (WA) and with professional misconduct provisions under the Medical Board of Australia's registration standards.

The regulations also interact with interstate health registers. The definition of "corresponding officer" allows the Chief Health Officer to share information with other states and territories that have similar registers. This avoids duplication and allows for national epidemiological surveillance. However, the regulations do not require the other jurisdiction to have equivalent privacy protections, which could create a gap if that jurisdiction's laws are less protective.

The interaction with the common law right to privacy and with the Privacy Act 1988 (Cth) is complex. The Privacy Act applies to Australian Government agencies and some private sector organisations. The WA Department of Health is a state authority and is generally exempt from the Privacy Act, unless it is a "health service provider" that is a contracted service provider for the Commonwealth. Most likely, the register is not subject to the Commonwealth Act, but it may be subject to WA's privacy principles or the Freedom of Information Act 1992 (WA). The right to know under regulation 11 provides a more specific access mechanism than FOI.

The regulations were originally gazetted on 7 January 2011 and commenced the next day for all substantive provisions. The regulations were amended twice. The first amendment was by the Health Services (Consequential Amendments) Regulations 2016 (Pt. 5), gazetted 24 June 2016 and commencing 1 July 2016. That amendment updated references in the definitions to the Health Services Act 2016, which replaced the earlier Hospitals and Health Services Act. Specifically, the definition of "health service provider" and "hospital" were updated to refer to section 6 and section 8(4) of the Health Services Act 2016 respectively. This was a machinery amendment to reflect the restructure of WA's hospital governance system.

The second amendment was by the Health Regulations Amendment (Public Health) Regulations 2016 (Pt. 27), gazetted 10 January 2017 and commencing 24 January 2017. This made a number of amendments. Regulation 3 was amended to update the name of the "Australian Institute of Health and Welfare" from its previous name (possibly "Australian Institute of Health and Welfare" was already correct, but the amendment updated the reference to the Commonwealth Act). Regulations 6, 7, 8, 10, 11, and 12 were also amended. The specific changes included updating the title of "Chief Health Officer" (previously perhaps "Executive Director, Public Health" or similar) and updating cross-references. The penalty clause in regulations 6 and 7 was rewritten to include the minimum penalty amounts. The original 2011 version may have had different penalty wording. The current version clearly sets the escalating minimum fines.

The compilation table shows that the regulations are a compilation of the original and the two sets of amendments. There have been no further amendments as of the latest available compilation. The regulations have remained stable since 2017. This suggests they are not a political priority, which could mean they are operating without serious controversy but also could mean they are not being actively enforced or reviewed.

There is no litigation history mentioned in the regulations themselves, and none would be expected for subordinate legislation of this type. The regulations are administrative in nature and have not been the subject of reported legal challenges in Western Australia. Challenges could potentially arise if a person argued that the notification requirement infringes privacy rights or that the authorisation of disclosure for research without consent is ultra vires the parent Act. However, no such cases are identified in the source material. The regulations have been in force since 2011 without apparent judicial scrutiny.

One possible area of litigation would be a prosecution for failure to notify or for unauthorised disclosure. If the Chief Health Officer sought to impose the minimum penalty, a defendant might challenge the interpretation of "developmental anomaly" or "responsible person." The definition of "child" including a human fetus could be contested in the context of terminations. The exclusion of minor anomalies that are not disfiguring or requiring treatment might give rise to disputes about clinical judgement. But again, no cases are cited.

The absence of litigation could indicate that the regulations are either well-understood and complied with, or that they are not actively enforced. Given the low penalties and the difficulty of detecting non-compliance, enforcement action may be rare. The regulations may be more of a formal legal framework for data collection that is already occurring voluntarily or through other mechanisms.

Another angle: regulation 11 provides a right of access, and a person could theoretically seek judicial review if the Chief Health Officer refused to provide a copy of their information or delayed unreasonably. The "as soon as reasonably practicable" standard is not precise, but a court could find that months of delay is unreasonable. Similarly, a refusal to remove identifying information after six years could be challenged. No such challenges appear to have been reported.

The most significant trap is the mandatory notification duty within six months of diagnosis, applied to individual medical practitioners practising outside hospitals. A doctor who diagnoses a child with cerebral palsy at age 4 must notify the Chief Health Officer. The doctor may not know about the register. The penalty applies even if the doctor was unaware of the obligation. There is no defence of ignorance. The duty also applies even if the child has already been diagnosed in another state (regulation 6(3)), so a doctor seeing a recently arrived migrant child with a known condition must still notify WA's register.

Another trap is the definition of "child" including a human fetus. This means that a diagnosis of a developmental anomaly made during pregnancy, or after a stillbirth or termination, must be reported. This could include conditions detected on ultrasound that may not be confirmed later. The responsible person (the hospital or the obstetrician) must notify within six months of the diagnosis. For terminations, the diagnosis might be made well before the termination procedure, so the six-month clock starts from that earlier diagnosis, not the termination.

The six-month notification window is long, but doctors might forget or assume someone else will report. For hospital diagnoses, the CEO is the responsible person, but the attending doctor may not notify the CEO. The doctor may believe the hospital's coding staff will handle it, but if no one does, the CEO is still liable. This creates a need for explicit reporting protocols in every hospital.

The "minor anomaly" exclusion (regulation 4(3)) is a trap because it requires a judgement call. Minor structural, chromosomal, metabolic or functional anomalies are not developmental anomalies unless they are "disfiguring or require treatment." A doctor must determine whether a condition meets this threshold. If the doctor in good faith thinks it is minor and does not notify, but the Chief Health Officer later disagrees, the doctor could be fined. There is no safe harbour for reasonable belief. The term "disfiguring" is not defined, and "require treatment" could include observation or monitoring.

The right to remove identifying information is only available after the information has been kept on the register for six years or more (regulation 12(1)). This means that a person whose condition is recorded at birth cannot have identifying details removed until they are at least six years old. But the request must be made by the person themselves, or by a parent/guardian if under legal disability (regulation 13). For a child who is not under a legal disability (e.g., a mature minor), only the child can request. But if the child is under six, the child cannot request because the information hasn't been kept for six years yet. So effectively, no one can request removal until after six years. And even then, non-identifying information can be retained.

The disclosure authorisation under regulation 10(1)(c) for urgent diagnosis or treatment is available only if "it is not reasonably practicable to obtain the written consent of that person." This is vague. In an emergency, consent may be implied, but the regulation provides a separate pathway. Practitioners should document the impracticality.

The register is kept by the Chief Health Officer, and the Chief Health Officer can determine its manner and form (regulation 8(5)). This means the Chief Health Officer could change the form of notification or the register structure unilaterally, imposing new compliance burdens without further regulation amendment.

For hospital chief executive officers, compliance requires establishing a system that ensures every diagnosis of a developmental anomaly made by any medical practitioner within the hospital is captured and notified to the Chief Health Officer within six months. This system should include: (a) clear definitions of which conditions are notifiable (including the minor anomaly exclusion); (b) training for medical and coding staff; (c) regular audits to ensure no diagnosis is missed; (d) a designated officer to prepare the notification in the form required by the Chief Health Officer; and (e) retention of records showing that notification was sent. The CEO should also be prepared to respond to requests under regulation 7 from the Chief Health Officer for additional information about a child with a developmental anomaly, within 30 days.

For medical practitioners in private practice, the first step is to become aware of the obligation. When diagnosing a condition that falls within regulation 4 (cerebral palsy, congenital malformations, chromosomal anomalies, inborn errors of metabolism, inherited conditions that are not minor, or other structural/functional anomalies present before birth and diagnosed before age 6), the practitioner must notify the Chief Health Officer. The form is determined by the Chief Health Officer, so the practitioner should request the current form. The notification can be made by the practitioner or by a practice manager. The practitioner should keep a copy of the notification and a record of the date it was sent. If the practitioner later receives a request from the Chief Health Officer for further information, they must comply within 30 days, even if they are no longer treating the child.

For researchers wishing to access register data, compliance involves two steps. First, the research must be approved in accordance with NHMRC guidelines (regulation 10(1)(a)). That means obtaining ethics approval from a Human Research Ethics Committee constituted under the National Statement. Second, the researcher must obtain written authorisation from the Chief Health Officer. The authorisation can be general or specific. The researcher must not use the data for any purpose other than the authorised research, and must ensure that anyone with access to the register in the course of duty does not disclose it further other than as authorised (regulation 9). Researchers should also consider whether they want identifying information or only non-identifying information; regulation 10(2) allows disclosure of non-identifying information for statutory purposes without the need for consent from the individual, but still requires Chief Health Officer authorisation.

For individuals who suspect they are on the register, compliance is about exercising rights. To find out, they should make a written request to the Chief Health Officer under regulation 11. They must provide sufficient identifying information for the search. The Chief Health Officer must respond as soon as reasonably practicable. If they find their details and want identifying information removed after six years, they must make another written request under regulation 12. For persons under legal disability, parents or guardians should act on their behalf using regulation 13. These requests should be kept in writing with proof of delivery.

For anyone with access to the register (including the Chief Health Officer's staff, hospital staff, or researchers granted access), the key compliance rule is do not disclose information unless authorised. Written consent from the person concerned is one authorisation; a written authorisation from the Chief Health Officer is another. There is no general exception for internal use within a hospital or government department. Even sharing with a colleague for a legitimate purpose must be checked against the regulations. The penalty is small but the reputational and professional consequences could be much larger. The safest course is to establish internal protocols that require written authorisation before any disclosure, and to maintain a log of disclosures and the authorisation relied upon.