New Publication on the Legal Implications of Clinician-Initiated ‘Opt-Out’ Testing for HIV
Early diagnosis and rapid initiation of treatment lead to better health outcomes for people living with HIV. Achieving these aims supports individual and population health – as both the early detection of HIV and the achievement of undetectable viral load through treatment uptake together support a reduction of HIV transmission in the community, potentially reducing it to zero. This means that access to HIV testing remains a central pillar of HIV health, especially for people and groups who may be at elevated risk of HIV acquisition.
Despite progress towards eliminating HIV transmissions in Australia, an estimated 8% of people living with HIV in Australia in 2022 were undiagnosed, according to recent surveillance data from the Kirby Institute, and the proportion of HIV notifications considered a ‘late diagnosis’ increased by around 10% between 2014 and 2022. In response, the Kirby report called for an increase in HIV testing efforts. New innovations such as HIV self-testing kits, which enable people to test for HIV from home, are aimed at buoying those testing rates. Another innovation is ‘opt-out testing’, an approach that integrates HIV testing into routine primary healthcare settings, and that has been included in National HIV Testing Policy since 2022. Under an opt-out testing model, an HIV test is offered routinely. This is an approach that is already well established in antenatal care in Australia, and is now being trialled and implemented more broadly in other health settings and for different populations.
While ‘opt-out’ HIV testing may result in more people get tested for HIV, it also reopens longstanding ethical and legal questions about consent and patient autonomy. As this shift unfolds, how do healthcare providers navigate informed consent and other legal requirements for HIV testing? What legal obligations do they have? And how does the law operate to ensure that people’s autonomy and consent to HIV testing is maintained?
In our recent article, ‘Clinician-initiated opt-out HIV testing and the law’, published in the CSIRO journal Sexual Health, we examine these questions using a legal doctrinal method. This method seeks to identify and explain the laws and legal frameworks governing a practice such as opt-out HIV testing in Australia, and to explain implications for implementing the practice in contemporary healthcare settings.
The HIV test and the law
Since it became available in 1985, HIV antibody testing has often involved specific legal procedures focused on consent, including legal or policy-mandated pre- and post-test counselling or discussion. These safeguards emerged after a period where non-consensual and coercive testing had been used – which included secretive mass testing of newborns, surgical patients and staff in hospitals, and the use of public health powers to compel testing. In response to these conditions and to significant advocacy from HIV-affected communities and their allies in health care, Australian states and territories introduced HIV-specific consent and counselling requirements to ensure patients understood both the medical and social implications of an HIV test and to guide and protect clinicians and health services in their work.
Recent reforms have removed some of these exceptional provisions. This means that HIV diagnostic testing now falls within the general law that applies to other diagnostic pathology tests and procedures. However, the introduction of opt-out testing makes this a challenging situation, as it introduces an HIV – or blood-borne virus-specific – testing approach that no longer benefits from the specific legislative and policy frameworks that once governed HIV tests. Together, these two changes give rise to a new legal landscape for HIV testing that requires fresh examination.
Opting out
Our doctrinal analysis of the law in this area finds that while the removal of some historical, HIV-specific consent requirements have occurred, in part to support the use of opt-out testing, this does not alter the broader legal obligations surrounding consent and other processes that apply. Foundational to the legal governance of HIV testing, as with any medical procedure, are two principles: first, that the patient consents; and second, that the information provided about the procedure and its risks is adequate according to law. Although these principles often overlap under the concept of ‘informed consent’, they are legally distinct and should not be conflated.
Where opt-out HIV testing has been introduced through legislative change – such as in Victoria – this has removed ‘specific additional consent’ requirements and procedures that applied previously, effectively bringing HIV testing into alignment with other STI testing procedures. However, these changes do not remove or modify the consent requirements under general law that apply to all clinical procedures, including diagnostic pathology. As we discuss in our article, there is something of a gap between the concept of ‘opt-out’ consent and the enduring legal duties of healthcare providers, which risks creating some ambiguity and potential legal risk. While the introduction of opt-out HIV testing, as we argue,
has seen the removal of some legal and policy requirements for administering an HIV test, these reforms do not negate the fundamental legal principles that govern consent to medical procedures. Healthcare practitioners must still obtain consent, they must warn of the risks involved in testing, and they must act in alignment with professional standards and codes.
Removing HIV-specific consent provisions does not diminish the core legal duties that apply to all medical procedures: clinicians must still obtain valid consent, warn of material risks, and act in accordance with professional standards.
Recommendations
To address this ambiguity, our article makes three recommendations:
Scrutinising the implementation of opt-out HIV testing to ensure that, where it happens, it occurs lawfully and healthcare providers are being compliant with legal obligations.
Reframing the model with a name that better reflects both the clinician’s role and the law, such as ‘provider-initiated testing’ – because the language we use matters and the term ‘opt-out’ can imply a passivity that is inconsistent with the active nature of consent under law.
Further implementation research to support clinicians transitioning from historical to new approaches to testing and consent.
Opt-out HIV testing represents a shift in how HIV testing is governed in Australia, with the potential to improve testing rates, but we must implement it cautiously, and with respect for patient autonomy. This must now occur within existing general legal frameworks, rather than HIV-specific legislative or policy guidance, which brings with it its own challenges as clinicians and public health actors attempt to innovate within existing legal structures.
To read these recommendations in detail and to understand more about our analysis of clinician-initiated HIV testing, access our article in Sexual Health here.
Citation: David J. Carter, Dion Kagan, Daniel Storer and Sean Mulcahy (2025), ‘Clinician-initiated opt-out HIV testing and the law’, Sexual Health 22 (6): SH25083. https://doi.org/10.1071/SH25083