Ethics and law

A lack of clear protocols elevates risks for clinicians for the consequences of decisions that they have a professional duty to make in the interests of their community Clinicians, ethicists and lawyers have long debated the parameters of triage in response to the inevitable disasters that sporadically overwhelm the health care system. Almost universally, they have advocated for open, transparent and consultative triage protocols, guidelines and legislation to combat biases and to support clinicians making unavoidable decisions in the interests of the community as a whole. The coronavirus disease 2019 (COVID‐19) pandemic has highlighted the importance of transparent triage. While there is considerable debate about ethical aspects of triage protocols, including concerns that the traditional focus on utilitarianism is discriminatory, largely missing from this discussion in Australia is that triage protocols are also important from a legal perspective — as a mechanism to promote lawful decision‐making processes and as a justification or defence to support clinicians’ decisions if a matter is litigated. The purpose of this article is twofold. First, after providing an overview of current COVID‐19 triage policies in Australia, we assess their legal status. Second, we argue that beyond ethics, transparent policies are needed so their compliance with law can be tested, and to enable practitioners to better understand their obligations before making sometimes “impossible” decisions. Australian COVID‐19 triage policies Australian clinicians have seen numerous ethical and professional guidance documents addressing COVID‐19 triage.1,2,3 These documents anticipate that if Australia’s health care system is overwhelmed as in other countries, clinicians will need guidelines to allocate limited resources, including ventilators, beds and highly trained personnel. The umbrella term “triage policy” denotes: (i) broad ethical or operational guidelines with suggested decision‐making principles;1,2,3 and (ii) more specific triage protocols,4 with set inclusion and exclusion criteria, and a process to prioritise individual patients when the system is overwhelmed. Many Australian COVID‐19 triage policies are ethical guidelines, but some Australian hospitals have also developed triage protocols.5 Internationally, the availability and content of such protocols varies widely. In a study from the United States, over half of responding institutions lacked a COVID‐19 triage protocol.6 In 2020, Mitchell and colleagues exposed insufficient transparency and significant variation in Victorian protocols.5 In Australia, primary responsibility for the administration of hospital services lies with the states, which have the power to promote a statewide approach to triage. Although every Australian state and territory has disaster management plans,7 publicly available COVID‐19 triage protocols are lacking. From March 2020 to 27 November 2020, the lead author (EC) regularly searched health department websites for COVID‐19 triage policies, examining both the websites’ content dedicated to COVID‐19 and searching keywords alone and in various combinations (COVID; intensive care; critical care; ICU; triage; framework; guidelines; policy; ethical). These searches revealed few relevant documents (Box 1). New South Wales is the only state to mention a triage guideline, but its COVID‐19 framework does not link to it.8 Queensland Health released an extensive ethical framework for COVID‐19 in April 2020,5 which has since been removed.9 Western Australia has a four‐page ethical framework but no publicly accessible protocol.10 The Commonwealth Government’s COVID‐19 strategy indicates the Commonwealth will work with state and territory governments to “agree on novel coronavirus triage criteria (if required)”,11 but there are no such criteria to date. Given constitutional arrangements, there is no expectation that the Commonwealth Government would provide these. The National Health and Medical Research Council has conducted consultation on an ethics framework for pandemics, but this is limited to ethical guidance. Legal status of COVID‐19 triage policies The prospect of deciding between patients who would benefit from life‐sustaining treatment is distressing. Compounding this is the potential for legal liability. Many of the legal issues that arise in pandemic triage are untested, and various areas of law may be engaged and applied in complex, fact‐specific ways. As other work has detailed, health authorities have wide discretion in making resource allocation decisions, which are generally respected by the courts.12,13 However, in some circumstances, clinicians (and institutions) may be found liable, and decisions may also be challenged on public law grounds (Box 2).13,14,15 These concerns are not merely academic; after Hurricane Katrina one doctor faced possible murder charges and civil lawsuits after several patients died during a hospital evacuation.16 Overseas, some governments have enacted immunity or indemnity laws to protect clinicians making COVID‐19 triage decisions.14,15 No such laws exist in Australia, and they do not appear to have been considered. Absent such laws, triage protocols may provide the next strongest legal defence. Under civil liability legislation, a clinician will generally not be negligent if acting in a manner widely accepted in Australia by peer professional opinion as competent medical practice (professional practice defence).12,13 Concrete advice on the legal significance of triage policies is difficult because the relationship between law and professional guidance is complex and each case is evaluated according to its unique facts. Whether the professional practice defence applies generally depends on the guideline’s nature, author and purported authority.17,18 A policy may create additional obligations beyond those imposed by law (eg, a specific hospital COVID‐19 triage protocol that must be followed by its clinicians), which may inform the legal standard of care.18 However, policy is not necessarily determinative of the standard of care, especially when couched as broad guidance (eg, COVID‐19 ethical guidelines from a professional college).18 Rigid adherence to policy can also be problematic; to meet the standard of care (and broader public decision‐making standards), clinicians must use judgment appropriate to the circumstances.17 Moreover, while policy can establish obligations in addition to the law, law may also impose more onerous obligations than a policy.18 When this occurs the legal standard will prevail. In other words, COVID‐19 triage policies can shape a regulatory response but only within the boundaries of the law. COVID‐19 triage policies may infringe laws in various nuanced ways.14 Liddell and colleagues note that the utilitarian “save the most lives possible” principle underlying most triage policies can infringe patients’ legal rights, many of which are unchanged in a disaster.14 In the United Kingdom, a legal challenge to the National Institute for Health and Care Excellence (NICE) COVID‐19 critical care protocol was initiated on the basis that its heavy reliance on the Clinical Frailty Scale constituted unlawful discrimination.19 In response, NICE revised the protocol to reduce reliance on the Clinical Frailty Scale for some patients. These issues have significant implications for clinicians: Absent a COVID‐19 triage policy, not providing beneficial life‐sustaining treatment is potentially risky because it may be harder to establish the professional practice defence in a negligence action. An institution’s failure to promulgate a policy could also result in claims. Additionally, a triage protocol (with its greater degree of specificity) would generally provide more legal protection than ethical guidelines. While it is lawful for governments and professional bodies to issue COVID‐19 triage policies, these policies should rely on appropriate evidence and must comply with specific jurisdictional laws, such as guardianship and human rights legislation (Box 2). Triage policies promote quality and consistency in decision making and guide clinicians to consider appropriate factors. However, clinicians must still exercise judgment which is reasonable and responsive to individual circumstances. Policies should provide guidance for when an individual is denied life‐sustaining treatment, since the duty to exercise reasonable care remains. Where reasonably possible, this may include communicating to the patient (or family) the reasons for the decision, providing appropriate palliative care, and information about complaints or dispute resolution processes. Transparency — not just about ethics From an ethical perspective, legitimate triage decisions require “accountability for reasonableness” — a fair process based on relevant criteria, a publicly accessible rationale, and (to the extent possible given the urgency of decisions) mechanisms for appeal, review and enforcement.20 Transparency is also important from a legal perspective because it subjects triage policies to public scrutiny before public health emergencies reach crisis levels. While internal legal advice on triage policies may have been sought, the NICE example illustrates that public scrutiny, consultation and litigation play an important role in testing legal boundaries. In addition to protecting individual patients, this promotes rigorous policy development and evaluation, and also benefits clinicians who are then not relying on policy later found to be deficient.17 It may also alleviate stress caused by uncertainty about protocols. Disclosure of triage policies also delivers a measure of natural justice by providing notice to patients and their families of decision‐making criteria and processes. Conclusion So far, Australia has avoided the scale of pandemic that has overwhelmed health systems elsewhere. While in this context, governments’ reluctance to develop and/or release triage protocols until a crisis has arrived is politically understandable, such a course of action carries significant risks. Public confidence is enhanced when governments have the political courage to embark on these difficult public debates in advance of need. Prioritising some individuals over others when the demand for resources exceeds supply is confronting for clinicians and the community alike, and challenges us to reflect on our deeply held values as a society. When clinicians are allocating scarce resources, they need standards to support their decisions which have been subject to public consultation and rigorous legal review. Australia’s successful management of the COVID‐19 pandemic is offering us the luxury of time to consult and reflect. [Corrections added on 9 June 2021 after first online publication: an additional row was added to Box 1.] Box 1 – Australian triage protocols and ethical guidelines for resource allocation during the coronavirus disease 2019 (COVID‐19) pandemic Jurisdiction COVID‐19 triage protocol or ethical guidelines Type of guidance Publicly available Commonwealth Australian Health Ethics Committee of the National Health and Medical Research Council: An ethics framework for pandemics (in development). Ethical guidelines Anticipated Australian Capital Territory None located on ACT Health website (https://health.act.gov.au). New South Wales NSW Health provides a COVID‐19 framework entitled “NSW adult intensive care services pandemic response planning”.8 The framework indicates that the NSW guideline for resource‐based decision making includes the “use of allocation frameworks and tools” with a reference (but no link to) a document entitled the “NSW Health COVID‐19 intensive care guidance drawn from principles in the NSW Health Influenza Pandemic Plan (PD2016_016). Sydney: NSW Health; 2020”. This 2020 document is based on the NSW Health Influenza Pandemic Plan (PD2016_016), which references the NSW Health policy “Influenza Pandemic – Providing Critical Care (PD2010_028)”. PD2010_028 contains a triage tool (https://www1.health.nsw.gov.au/pds/Pages/a-z.aspx). However, as the updated COVID‐19 intensive care guidance is not publicly available, we cannot confirm that it contains the same guidance as PD2016_016 or the PD2010_028 triage tool. Triage protocol and ethical and operational guidelines No Northern Territory None located on the NT Health Department website (https://health.nt.gov.au). Queensland On 20 April 2020, Queensland Health released a comprehensive ethical framework (developed in consultation with numerous stakeholders) but this has since been removed from its website.9 Ethical guidelines No (initially available but subsequently recalled) South Australia None located on the SA Health website (https://www.sahealth.sa.gov.au). Tasmania None located on the Tasmanian Department of Health website (https://www.health.tas.gov.au). Victoria None located on the Victorian Department of Health and Human Services website (https://www.dhhs.vic.gov.au/clinical-guidance-and-resources-covid-19). Western Australia The WA Health Department website includes a framework to guide decision making on the appropriateness of intensive care management during the COVID‐19 pandemic (last updated 26 June 2020) in its section on COVID‐19 guidance for health professionals.10 Ethical guidelines Yes Box 2 – Examples of potential areas of legal risk in response to pandemic triage decisions* Civil law Withholding or withdrawing beneficial life‐sustaining treatment from one patient to provide it to a patient with a better prognosis could amount to a breach of the duty of care and liability in negligence (subject to the peer professional practice defence for clinicians and the resource allocation defence in the case of hospitals). Criminal law Withdrawing a ventilator from one patient who is stable to provide it to another patient with a greater chance of survival could lead to charges of murder or manslaughter if the first patient dies as a result (charges would be subject to prosecutorial discretion and jurisdiction‐specific defences such as necessity). Commonwealth and state antidiscrimination laws A triage protocol could violate state and territory antidiscrimination legislation if the decision was made on the basis of a protected attribute such as age, disability or race (although specific protections may apply under the legislation for decision makers). Guardianship legislation This applies to patients who lack decision‐making capacity; for example, because they are unconscious, sedated or have cognitive impairment. At common law, medical practitioners have no legal duty to provide treatment that is non‐beneficial. However, the Guardianship and Administration Act 2000 (Qld) makes it an offence to withhold or withdraw life‐sustaining treatment from patients who lack capacity without the consent of an appropriate decision maker, even if providing that treatment would be “inconsistent with good medical practice” (ie, even if that treatment is non‐beneficial). This may preclude some triage decisions in Queensland. A decision to withhold or withdraw beneficial life‐sustaining treatment from a patient who lacks capacity to provide it to someone with a better prognosis may violate state or territory guardianship legislation, which requires health care decisions to be made in a person’s best interests. (This could also result in an emergency application to the Supreme Court to intervene in its parens patriae jurisdiction to protect the patient’s best interests.) * This is a non‐exhaustive list of examples. For an expanded discussion of legal challenges in Australia, see Close et al.13 See further Liddell et al14 for the UK context, which has some similarities to Australia.

Eliana Close · Lindy Willmott · Tina Cockburn · Simon Young · Will Cairns · Ben P White

The COVID‐19 pandemic has necessitated rapid uptake and use of telehealth, unmasking a number of concerns potentially not previously contemplated by clinicians, patients and legislators In the physical distancing climate of coronavirus disease 2019 (COVID‐19), the ubiquity of virtual communications in medical practice generates a number of challenges. Consultation via telehealth allows for creation of audiovisual documentation of the clinical interaction as well as observation by unseen parties from each participant’s perspective, either in real time or subsequently via review of any recordings. It is necessary for clinicians to i) obtain informed consent for clinician‐led recordings, ii) be aware of potential patient‐generated recordings (both declared and undeclared), and iii) meet legal, privacy and storage requirements pertaining to health information arising from a virtual consultation. Consent to participation Observing next of kin or third parties to a virtual telehealth consultation must be introduced to the treating clinician in a manner consistent with an in‐person consultation, whereby such an individual would, with the patient’s consent, attend the consultation with the patient. In considering the clinician’s screen, consent for clinician participation is implied, but should be specifically broadened where appropriate to allow for the presence of clinical observers. Indeed, the clinician’s duty of confidentiality still applies to telehealth consultations, necessitating awareness of others within earshot or visual proximity to the consultation. Implications of virtual participation The benefits of a virtual consultation include participation and collaboration with members of the patient’s family previously unable to participate, as well as increased access to health care for patients with particular physical challenges or vulnerabilities, including vulnerability to infection with COVID‐19. Interviewing a patient in their home adds rare insights for a clinician not typically engaged in home visits, including opportunities for environmental observation, which may be of clinical value. The home setting allows for involvement of parties (seen and unseen) potentially contrary to the patient’s best interests. Pertinent examples include family violence or elder abuse contexts, where presence of offenders may jeopardise the clinical encounter and may pose direct risks to the patient in the periconsultation period and subsequently via covert audio or video footage. A 2020 article provided insights on screening questions for detecting and navigating potential abuse during telehealth consultations in the setting of a COVID‐19‐related domestic violence epidemic secondary to government‐imposed social restrictions.1 Beyond clinical value, novel forms of documentation (including audiovisual recording) generated within the consultation may benefit research, education, billing and coding, subject to appropriate ethical and consent obligations. The content of a traditional clinical consultation episode is limited to the parties in the room and, to a defined extent, other parties (via review of written documentation). In the telehealth context, a wide audience can potentially review video footage of the consultation, as if they were there, for an indefinite period. This may have implications for the practicalities and duration of storage required of such material, its latent role as discoverable documentary evidence in future litigation (particularly given the persuasive nature of audiovisual documentation), and in substantiation of episodic care funding. Clinical interactions may incorporate questions or discussions that, while appropriate sequentially, may appear inappropriate, deficient, discourteous or misleading if taken out of context or distilled to a single statement or query. Recordings, and their potential edits, could be used by patients in a maladaptive manner, engender abnormal illness behaviour, or make a participant consciously or unconsciously feel the need to perform or otherwise change clinical interactions. Recordings by the patient The likelihood of a patient recording a clinical encounter is much higher in the age of telehealth, when secret recording is increasingly possible. The legality of recording a private conversation without consent depends on the state or territory where the person undertaking the recording resides, as surveillance legislation is largely a matter for these jurisdictions (Box 1). In New South Wales, South Australia, Tasmania, Western Australia and the Australian Capital Territory, it is an offence to record a private conversation. This was upheld in NSW in Toth v Director of Public Prosecutions, where it was held that a patient secretly recording a consultation with a general practitioner was an offence.2 However, in Victoria, Queensland and the Northern Territory, it is lawful to record a private conversation without consent if you are a party to the conversation.3,4,5 In all jurisdictions, it is generally not permissible to publish or communicate information secretly recorded. However, exceptions exist; for example, in Victoria, the prohibition on publication or communication of information secretly recorded does not apply to subsequent use in the course of legal or disciplinary proceedings.6 Courts may be more receptive to the notion of undisclosed recordings for defensive purposes where there is a reasonable belief that a recording might be necessary to address a substantive harm. Thus, in certain jurisdictions, patients can secretly record a consultation without the consent of the clinician and this recording may be used in legal or disciplinary proceedings. These risks are best described as emerging given the widespread use of telehealth and the paucity of reported examples of recording. It should also be stressed that when practitioners are behaving professionally and meeting the appropriate standard of care, the medico‐legal risk of patient recordings is minimal. Practical measures to prevent patients from secretly recording screens include disabling the in‐built recording functions in telehealth platforms, using platforms lacking this recording option, and employing programs preventing screen recording or superimposing watermarks including publication preclusion. However, such measures will not prevent another party from recording a consultation with an additional device. Provision of documented restrictions to the patient at the time of any patient‐generated recording and co‐recording by the clinician (to ensure record integrity) may be of value. However, an automated message before consultation commencement expressly stating the clinician does not consent to screen recording (intending to effect a licence agreement or permit a gag order) is unlikely to achieve this in jurisdictions allowing patients to record without the clinician’s permission. Recordings by the clinician Key to understanding and managing both consent and any recordings is the status of these recordings at law. The definition of health information as defined by the Privacy Act 1988 (Cth) s 6FA is broad, including not only information pertaining to someone’s health but also personal information collected to provide, or in providing, a health service to an individual.7 Interpreted literally, any information pertaining to a patient that is recorded, irrespective of consent, may be considered health information with requirements for storage in compliance with the relevant state or territory health records and/or freedom of information legislation (Box 2). In Australia, under the Privacy Act 1988 (Cth) as well as relevant state and territory legislation, a patient’s medical records will generally be held and owned by the clinician or health care organisation, but patients are entitled to access and take a copy of their records. However, concepts of data sovereignty are changing.8 Patient‐driven and centralised health records (such as collaborative digital hospital files and My Health Record) are contemporary examples of this, with reduced clarity about the roles and responsibilities of potential contributors (including the patient) to a medical record as well as the ownership of that information. Various jurisdictions within Australia legislate minimum periods for medical record‐keeping, generally 7 years from the date of the last record entry for adults and until the age of 25 years for children. Many variations exist, based on state or territory, whether the records reside in a public or private institution, or relate to public health, quality improvement, disability, implants or artificial devices, sexual assault counselling, or child protection. Efficient and safe storage of electronic health information by clinicians, including telehealth recordings, is increasingly challenging. Considerations include provisions regulating onshore versus offshore and cloud‐based storage technicalities, including encryption inherent in the platform of choice, preventing evolving real‐time threats to health information security (including via insurance and strategic risk mitigation), and compliance with legislated security requirements. The omnipresence of personal digital devices, including smartphones, has irrevocably altered the role and prevalence of clinical photography, videography and digital team communication tools, constantly generating much data, not all of which are routinely stored by health services or clinicians relying on them to guide clinical decisions. Clear documentation of consent to recording of digital information by clinicians is important, and that consent should extend to the purpose of the recording. When the patient provides their consent, the use of the recording should be limited to that purpose.9 Recording of telehealth discussions between health care workers, including multidisciplinary meetings and case conferences, engenders further challenges. Recordings may be helpful for updating absent clinicians, minute taking, education or documentation. However, such recordings constitute health information, necessitating compliance with management and storage requirements applicable to a virtual consultation. In the public sector, patients may have access to recordings under freedom of information legislation, potentially resulting in significant alterations to the dynamic and tone of the discussion. This is a complex area of law which varies among jurisdictions but is worth keeping in mind. Where there is uncertainty, proactive discussion with medical indemnity providers may be invaluable, especially given the heterogeneity of legal obligations upon clinicians across jurisdictions. Conclusion In Australia, the COVID‐19 pandemic has necessitated rapid uptake and use of telehealth. This has unmasked a number of concerns potentially not previously contemplated by legislators, patients and clinicians, particularly concerning the recording of clinical consultations and thereby the creation of health information, with extensive associated data management and security compliance challenges. Recording of clinical conversations or processes may enhance patient and clinician participation, self‐reference, research, education and funding. In certain jurisdictions, however, clinical consultations or meetings may be lawfully recorded with or without participants’ knowledge, and may later be accessible to the patient, including for use in future legal or disciplinary proceedings, potentially stifling candid discussion. This and the challenging obligations relating to data management technicalities represent real risks for clinicians and health services. It is incumbent upon health care providers and lawmakers alike to consider these issues in a practical context, ensuring that telehealth is not only a useful tool but a safe and effective one. Box 1 – Legislation governing covert recordings State or territory Legislation pertaining to recording Australian Capital Territory Listening Devices Act 1992 (ACT) New South Wales Surveillance Devices Act 2007 (NSW) Northern Territory Surveillance Devices Act 2007 (NT) Queensland Invasion of Privacy Act 1971 (QLD) South Australia Listening and Surveillance Devices Act 1972 (SA) Tasmania Listening Devices Act 1991 (TAS) Victoria Surveillance Devices Act 1999 (VIC) Western Australia Surveillance Devices Act 1998 (WA) Box 2 – Legislation governing health information management Jurisdiction Legislation governing health information management (not including legislated regulations) Federal Privacy Act 1988 (Cth); Personally Controlled Electronic Health Records (Consequential Amendments) Act 2012 (Cth); My Health Records Act 2012 (Cth); Freedom of Information Act 1982 (Cth) State or territory Australian Capital Territory Health Records (Privacy and Access) Act 1997 (ACT) New South Wales Health Records and Information Privacy Act 2002 (NSW) Northern Territory Health Services Act 2014 (NT); Information Act 2002 (NT) Queensland Information Privacy Act 2009 (QLD); Right to Information Act 2009 (Qld); Public Records Act 2002 (QLD) South Australia Freedom of Information Act 1991 (SA); State Records Act 1997 (SA) Tasmania Personal Information Protection Act 2004 (TAS); Right to Information Act 2009 (TAS) Victoria Health Records Act 2001 (VIC); Privacy and Data Protection Act 2014 (VIC); Freedom of Information Act 1982 (VIC); Public Records Act 1973 (VIC) Western Australia Freedom of Information Act 1992 (WA); State Records Act 2000 (WA)

Caitlin C Farmer · Sam C Pang · Dev Kevat · Jessica Dean · Danielle Panaccio · Patrick D Mahar

There is little legal recourse in Australia for someone who is denied care on resource grounds, particularly in the context of a pandemic

Michelle A Gunn · Fiona J McDonald

Difficulty in achieving proper informed consent for a complex screening test and the varying phenotypic outcomes leaves pregnant women in a precarious situation when results are abnormal The combined first trimester screening test for Down syndrome, involving a nuchal translucency scan and biochemistry at 11–13 weeks, improved detection rates to 90% when compared with the sensitivity of screening by age‐related a priori risk of around 30% for a false positive rate of 5%.1 The advent of non‐invasive prenatal testing (NIPT) in 2010 as a screening test for the common trisomies was revolutionary, with sensitivity, specificity and detection rates unmatched by the combined first trimester screening programs. NIPT was found to achieve a detection rate for Down syndrome of 99.7%, with a false positive rate of 0.04%.2 However, some NIPT providers now additionally offer extended panels and low resolution whole genome sequencing (WGS) including sex chromosome aneuploidies, rare autosomal aneuploidies, and subchromosomal deletions, duplications and recurrent microdeletions. This comes at a cost of a higher false positive rate and lower positive predictive value.3 Moreover, the expanded panels and WGS NIPT raise issues of clinical utility and ethical concerns.4,5 Clinical utility Screening not diagnosis NIPT is based on the detection of cell‐free fetal DNA in the maternal circulation. The placental origin of cell‐free fetal DNA means that NIPT can only be a screening test and is not diagnostic.6 NIPT findings can be confounded by confined placental mosaicism, cell‐free fetal DNA from a demised co‐twin placenta, maternal chromosomal changes or malignancy.6,7 Moreover, a NIPT result will be issued even if the fetus is demised. The current NIPT tests available are for specific chromosomal aneuploidy, extended panels of targeted conditions and low resolution WGS. Targeted and low resolution WGS NIPT Targeted NIPTs (Box 1) interrogate specific chromosomes: standard (usually 13, 18, 21, X and Y) or extended (specific recurrent microdeletions associated with known syndromes, such as 22q11.2 microdeletion [DiGeorge syndrome]).8 Many abnormalities that can be detected by targeted NIPT have varying clinical outcomes (eg, sex chromosome abnormalities and DiGeorge syndrome). Each of these conditions has varying sensitivity, specificity and positive predictive value. Other NIPTs interrogate every chromosome (by low resolution WGS). These tests can potentially screen for aneuploidy of every chromosome (all 22 autosomes and the sex chromosomes), and for subchromosomal gains and losses on every chromosome. There is potential utility in detecting rare or novel large subchromosomal imbalances, as they are likely to be associated with abnormal clinical phenotype when present in the fetus, and may indicate a familial balanced rearrangement. The clinical utility of screening for rare autosomal aneuploidies is less certain. Most rare autosomal aneuploidies (95%) are confined to the placenta, and those which are present in the fetus as well as the placenta often result in early fetal demise.9 The resolution of WGS NIPT is likely to increase as deeper sequencing becomes viable and cost‐effective. Whereas prenatal microarray testing of amniotic fluid in Australia is primarily used in the context of a fetal structural abnormality, higher resolution NIPT could become a general screening test. This would, however, increase both the number of variants of uncertain significance and the likelihood that they are detected in an apparently phenotypically normal fetus.3,10 Ethical concerns Respect for maternal autonomy is an important ethical principle in clinical guidelines for prenatal screening. Recommendation 2 of the Royal Australian and New Zealand College of Obstetricians and Gynaecologists guidelines states: “Screening or diagnostic testing for fetal chromosomal and genetic conditions is voluntary and should only be undertaken as an informed decision by the pregnant woman”.11 In light of the issues surrounding clinical utility and complexity of expanded panels and WGS NIPT, care needs to be taken to ensure that autonomy is respected. Moreover, consent alone cannot be expected to do the ethical heavy lifting, because of (i) the challenges in providing adequate information arising from complexity of the tests; (ii) the risk of power imbalances and “normalisation” of testing; (iii) anxiety resulting from complex and potentially unnecessary medical decisions; (iv) the problem of screening for “normality” and genetic reductionism; and (v) the doctor’s responsibility in determining which NIPT test is clinically indicated. Complexity endangers informed consent Respect for autonomy requires that informed consent is obtained. From a medico‐legal perspective, consent must be given voluntarily. The individual must also be sufficiently informed regarding a test or procedure, including the associated risks and benefits. The requisite extent of information provision is generally determined in accordance with what information a reasonable person, in that person’s circumstances, would expect to receive. From an ethical perspective, however, it is the understanding of information that is important, not merely that a person was given the legally required information. Given the complexity of extended panels and WGS NIPT, ensuring understanding means that significant time needs to be invested. Power imbalances and normalisation Two additional factors could ethically undermine consent for all NIPT options. First, the power imbalance between a doctor and patient, whereby a patient simply agrees because “doctor knows best” and, second, the impression that NIPT is a normal part of care that it would be foolish to reject.12 The anxiety caused by uncertain results It is tempting to respect autonomy by being non‐paternalistic and non‐directive in counselling by giving parents all the information from prenatal testing regardless of its nature. However, this shifts the burden of the uncertain results and the resultant anxiety to the parents. Qualitative and quantitative research shows higher levels of decisional regret among parents whose results identified variation of uncertain significance. At least some parents would not have consented to the test if they had known what this would entail. The lack of certainty by clinicians about what these results might actually mean for a future child increased parental distress.13 The meaning of screening and the danger of genetic reductionism According to the synthesis of screening criteria offered by Andermann and colleagues (Box 2), screening should be used to identify an individual who is high risk for a specific disease or need, thereby filling the perceived gap between standard screening and invasive diagnostics.14 Screening is then followed up with diagnostic tests and appropriate treatment. The availability of extended panels and WGS NIPT (Box 1) increases the tendency away from screening for diseases guided by public health screening principles. It is difficult to identify a recognised need or define the objectives of the screening beyond merely looking to see if there is anything abnormal. Even if these principles were met, one may be detecting placental pathology, or clinical conditions with highly variable outcomes for the fetus. As the resolution of WGS NIPT increases, so does the likelihood of detecting variants of uncertain significance. Provision of extended panels and WGS NIPT should be seen in light of the bigger question of how we see genetic information in our society.15 Research shows that many genetic tests are in effect screening for “normality”, which partly explains the anxiety when variants of uncertain significance are reported.13 This approach potentially changes the purpose of screening from screening for a specific disease to screening for normality by identifying any abnormality in the genome. The error in this thinking is that it assumes that genetic variation is abnormal. Just because a genetic anomaly can be identified does not necessarily mean that it would be phenotypically expressed. Similarly, detection of genes associated with adult onset disease does not necessarily equate to disease, and the possible future development of therapies for currently untreatable conditions cannot be ruled out. Consent is not sufficient to justify a procedure of questionable clinical utility Screening should be recommended or chosen only if there is likely to be a proportionate benefit, and there is no disproportionate burden. What is proportionate rests on a number of objective and subjective factors, but the aforementioned public health screening principles provide a good starting point. We agree with national guidelines that recommend against routine screening for recurrent microdeletions, and recommend provision of in‐depth counselling before screening for sex chromosome abnormalities.11 Recommendations The following recommendations may address the clinical and ethical concerns outlined above. Informed consent is required for all NIPT tests, especially in the context of extended panels and WGS NIPT. Clinicians must understand the different abnormalities targeted by extended NIPT panels and be able to assess and communicate the clinical utility of screening in accordance with a particular patient’s needs, desires and circumstances (Box 1). If ordering WGS NIPT, given that there may be significant uncertainty as to the actual phenotypic or functional manifestation of a genetic variation in a particular child, the consent process should include helping to contextualise limitations and risks in the broader context of the human experience of risk and uncertainty. Genuine shared decision‐making models can empower patient autonomy by helping them to understand the implications of their possible decisions in relation to their values.16 Moreover, decision tools and algorithms that align a variety of scenarios with personal values can facilitate a high quality informed consent process. Higher resolution WGS NIPT should only be used for research purposes until we have robust data regarding its clinical utility. Box 1 – Non‐invasive prenatal testing (NIPT) options: current availability and main advantages and disadvantages CPM = confined placental mosaicism; PPV = positive predictive value; WGS = whole genome sequencing. Box 2 – Synthesis of screening criteria12 The screening program should respond to a recognised need. The objectives of screening should be defined at the outset. There should be a defined target population. There should be scientific evidence of screening program effectiveness. The program should integrate education, testing, clinical services and program management. There should be quality assurance, with mechanisms to minimise potential risks of screening. The program should ensure informed choice, confidentiality and respect for autonomy. The program should promote equity and access to screening for the entire target population. Program evaluation should be planned from the outset. The overall benefits of screening should outweigh the harm.

Joseph Thomas · James Harraway · David Kirchhoffer

Should medically significant genetic results be offered to research participants or their at‐risk relatives? Australian research studies now generate genetic information on thousands of participants. Some genetic results, present in a small portion of participants (< 5%), are considered medically actionable, meaning they are associated with increased risk of adult‐onset diseases, where effective risk management, prevention or treatment exists (eg, inherited cancer or cardiac disorders).1 The National Statement on Ethical Conduct in Human Research,2 which considers genomic research at Chapter 3.3, now requires an ethically defensible plan for return (or non‐return) of genetic research results. Box 1 summarises the guidelines that are relevant to the return of genetic results to research participants.2 Returning genetic research results can be life‐saving, alerting participants to preventive steps that they would not otherwise have taken. Most participants identified in research studies have no clinical features or family history of the indicated disease, are unaware of their genetic risk, and would not qualify for publicly funded clinical criteria‐based genetic testing. Among the international genomics community, there is growing consensus that medically actionable genetic research results should be made available to participants.3 The American College of Medical Genetics and Genomics published a list of genes related to medically actionable conditions, in which results should be returned if identified during clinical testing.1 This gene list has been used to guide the return of research results in some United States studies,4 but has not been adopted by the National Health and Medical Research Council or other Australian bodies. However, the National Statement makes it clear at 3.3.41 that “researchers have an obligation to have a process in place for the return of findings that are of proven validity and of health significance to the participant, or relative, subject to participant consent”.2 However, even where participant consent has been obtained, not all Australian studies are returning medically actionable results, due to varying ethical and practical challenges. For example, research participants may provide samples for altruistic reasons, before research analysis, without expectation of re‐contact. Should results be returned to these individuals, especially those unaffected by indicated disease? Is there a legal or ethical requirement to make results available or liability for withholding them? The National Statement provides some guidance (Chapter 3.3) regarding which results should be returned,2 but ultimately researchers determine whether to return results. As the National Statement indicates, return of results should be limited to those genes with validity and utility (3.3.29 and 3.3.41).2 However, pathogenic variants in medically actionable genes are not fully penetrant, meaning that not all at‐risk variant carriers develop the disease.5 Risk estimates for many genes are still uncertain, complicating decisions around medical actionability and the time frame for returning results. Some participants may experience surprise or distress on learning about genetic risks. Returning results may also raise the possibility of out‐of‐pocket medical costs or increased insurance liabilities for younger participants. Genetic results should be delivered by a medical professional, with genetic counselling and clinical support provided, as noted by the National Statement (3.3.31 and 3.3.32).2 This requires time and resources, which are often limited. Thus, despite clear guidance in the National Statement, some research studies do not return results even where results are clinically valid and of undisputed relevance to participants’ and family members’ health, and the participant has consented to receive such results. To assist with these challenges, a national service to support the return of genetic results from research studies has recently been developed6 and is now operational. Research cohort case studies Here, we present two case studies from Australian epidemiological research (Box 2). Lifepool,7 a large community‐based study of women in the general population, and ASPREE (ASPirin in Reducing Events in the Elderly),8 a large cohort study of healthy older people, have both commenced genetic analysis and have been faced with decisions regarding the return of genetic results. These case studies highlight the challenges and opportunities related to this complex issue. ASPREE's older population particularly raises unique challenges.9 Lifepool has shown that return of genetic results prompts preventive interventions for women with variants in high risk breast cancer genes, most of whom would not have been identified through current clinical criteria‐based testing.7 To date, Lifepool has contacted 73 women previously unaware of their high risk variants. None of the women identified with a cancer‐causing variant would have been eligible for publicly funded testing through the Australian clinical system. Most women took proactive steps to mitigate risk after receiving genetic results. Of the 73 women, 23 so far have undergone risk‐reducing surgery (bilateral oophorectomy), mitigating their cancer risk.11 This could be life‐saving, given the high lifetime risk and low survival rates for ovarian cancer associated with high risk variants. The shared nature of DNA means genetic results are also relevant to participants’ blood relatives. Beyond participants who directly received results, 63 relatives were also tested through cascade testing, 32 of whom were also found to have a high risk variant. These relatives were, on average, substantially younger than the original participants (Box 3), making this information even more valuable for prevention. ASPREE biobank participants consented to re‐contact regarding genetic results relevant to personal or family health. In accordance with the National Statement (3.3.36 and 3.3.37),2 an ethically defensible plan outlining the return of genetic results was approved by the Alfred Hospital Human Research Ethics Committee in 2015.9 However, there is ongoing debate about the most appropriate strategy, given the age of the cohort (average, 75 years) and primary purpose of the study — an aspirin prevention trial (as opposed to genetic research study). ASPREE has returned other types of (non‐genetic) medically actionable research results, including abnormal magnetic resonance imaging, blood pathology and cognitive assessments. However, genetic results have been treated differently, with unique challenges. Many older ASPREE participants who carry medically actionable variants have seemingly outlived their increased risk, displaying no signs of indicated disease at 75 years of age and older.12 Is the information still medically actionable? Do participants still want to know? Should results be returned for the benefit of younger, potentially high risk family members? What about ASPREE participants who are in cognitive decline or deceased? Is ASPREE obliged to contact these individuals, or their relatives, to provide genetic results? Despite having detected genetic information through research analysis that is clinically valid and of clear relevance to personal or family members’ health, ASPREE has not yet commenced returning genetic results, seeking to achieve an appropriate harm–benefit balance.9 The applicable Human Research Ethics Committee recently discussed a possible strategy of offering results via an opt‐in model, where participants register interest following a newsletter notification. Although well intended, this approach is problematic. First, only a fraction of participants would receive or read the newsletter article, limiting the number who would be informed. Second, only about 1% of the cohort will have a medically actionable variant, meaning the likelihood that those participants will have opted‐in is very small. Finally, ASPREE participants have already consented to re‐contact on the basis of medically actionable genetic results, so re‐consent is not required. The proposed opt‐in model compromises equity in ensuring high risk participants are contacted and offered results ethically. The consequences of a passive approach to returning results are notable. For example, two male ASPREE participants were found through the study analysis to have high risk breast cancer variants. Neither participant had any relevant personal cancer history. Analysis of collected family history data showed that both had daughters (who have a 50% chance of having the same pathogenic variant) who developed breast cancer under the age of 50 during the ASPREE trial. These women did not have a family history of breast cancer required to prompt clinical genetic testing through clinical services. Yet their fathers’ results, if known, may have prompted genetic testing or high risk breast cancer screening for the daughters. This information was clinically significant and relevant to family health, despite its questionable health benefit to the male participants. Although the time for prevention has passed for those participants’ daughters, ASPREE must now consider the return of results to other participants with medically actionable results. Currently, there is no Australian legal requirement to inform research participants of medically actionable genetic results — any imperative to offer results is ethical. Whether any ethical imperative extends to preventing disease in participants’ relatives is unclear,13 although it is contemplated by the National Statement (3.3.32 and 3.3.41).2 A concern arising when considering return of results in ASPREE is that elderly research participants may not want to know about genetic results. However, other studies suggest that most research participants do want to receive genetic information, even if only for their family members’ benefit.14,15 A recent international survey on preferences for genetic results14 showed no significant difference between elderly and younger groups. Evidence suggests that older participants may be more interested in genetic results, especially if family members may benefit.14 Another challenge arises where participants with medically actionable genetic results are deceased or in cognitive decline. In these circumstances, the benefit of returning results to next‐of‐kin is for relatives. Several Australian research studies return genetic results purely for family members’ benefit, demonstrating the acceptability of this approach. The Australian Ovarian Cancer Study commenced returning genetic results of deceased women to next‐of‐kin more than ten years ago.16 Recently, the TRACEBACK study archived DNA samples of women who died from ovarian cancer, to identify genetic risk variants and notify at‐risk relatives.17 These programs conduct genetic testing on DNA of deceased people who cannot derive personal benefit, for the benefit of at‐risk relatives. Conclusion There is a growing consensus on the ethical imperative to offer research participants medically actionable genetic results. Studies show high acceptability for receiving genetic results, and the preventive health benefits are clear. Although the National Statement provides guidance, questions remain regarding the legal obligations and disclosure methods, particularly when research participants lack the capacity to make decisions about receiving genetic information. As genetic information becomes more pervasive and valuable to preventive medicine, the return of medically actionable genetic results will become increasingly important from ethical, legal and medical perspectives. Box 1 – National Statement on Ethical Conduct in Human Research: guidelines relevant to return of genetic results2 Guideline Content 3.3.26 In considering whether to return results of research, researchers should distinguish between individual research results and overall research results. Researchers should consider how these results will be provided to participants, how the process of returning results will be managed, and the risks of the return of individual research results and overall research results. 3.3.27 Return of findings and results relating to an individual participant depends on the contextual relevance of the findings; some genomic research findings must be returned, some findings may be returned, and some findings should not be returned. 3.3.29 Once there is sufficient evidence and agreement that a finding or result is clinically significant, participants should be advised that research results or findings that may be returned will first need to be confirmed according to applicable guidelines; eg, at a National Association of Testing Authorities accredited laboratory. 3.3.31 Any plan to return individual research results should include linkage with a clinical service and access to genetic counselling. The plan should specify any expertise to which the project team might require access. 3.3.32 The return of results or findings of significance for the health of the participant or relative is the responsibility of the appropriate clinical service or, where such a service is not available, the participant's clinician in consultation with the research team. 3.3.36 Researchers must prepare and follow an ethically defensible plan to manage the disclosure or non‐disclosure of genomic information of potential importance for the health of research participants or their relatives. 3.3.37 The ethically defensible plan must be approved by a Human Research Ethics Committee. Step 1: Determination of whether findings will be returned Genomic research falls into three categories: research with findings that must be returned; research with findings that may be returned; and research with findings that should not be returned. The relevant factors to be considered to determine whether findings must, may or should not be returned include: analytic (scientific) and clinical validity; significance to the health of the participants/relatives; and clinical utility. 3.3.41 Where there will be any return of findings to participants, they should be advised as to which findings will be returned and which will not be returned, as follows: that researchers have an obligation to have a process in place for the return of findings that are of proven validity and of health significance to the participant or relative, subject to participant consent; that if researchers plan to return findings during the project that are of proven validity but are not of health significance to the participant or relative, they will need to justify this plan; that there is no obligation on researchers to look at or assess findings outside of the scope of the research; and that there is no ongoing responsibility on researchers to review findings of a research project after the project has been completed in order to discover or assess findings that may have become returnable due to later scientific advances. Box 2 – Research cohort case studies Lifepool study7 ASPREE study8 Australian study aiming to improve women's health, particularly with respect to breast cancer Randomised, placebo‐controlled Australian trial for daily low‐dose aspirin, and ongoing observational cohort study of ageing Participants 50 000 women 19 000 healthy older men and women aged > 70 years Consent for genetic testing and return of results DNA samples were contributed to a “pool” of data and consent given for unspecified future research Participants were informed they would be contacted if information relevant to their health was found DNA samples were contributed to a biobank with consent for future genetic research Participants were informed they may be contacted if information relevant to their health was found An ethically defensible plan for re‐contacting participants with medically actionable results was approved by the applicable HREC9 Genetic testing conducted 14 799 samples were tested for changes in high risk breast cancer genes, which confer significantly increased risk of breast and ovarian cancer Risk can be mitigated through breast screening10 and/or preventive surgery11 13 131 samples were tested for changes in medically actionable genes, including high risk cancer genes Personal and family (first degree relatives) history of cancer was collected throughout the study Genetic results of relevance Following notification of women with high risk results: 97% made an appointment with a familial cancer centre to discuss results further 97% proceeded with confirmatory genetic testing 60% have undergone risk reducing oophorectomy An average of 3.3 relatives were tested per index case 51% of relatives tested also had the genetic variant 53 participants had a medically actionable result in high risk cancer genes12 No genetic results have been returned as yet At an estimated minimum of 3.3 cascade cases per index case,7 offering the return of results to 53 participants could reach a minimum of 175 Australians at high risk of developing familial cancer ASPREE = ASPirin in Reducing Events in the Elderly. Box 3 – Distribution of age among family members accepting cascade testing through a familial cancer centre (FCC) compared with index cases identified through Lifepool6 Although index cases identified through Lifepool often approach the age at which genetic risk is less relevant, a large proportion of the family members identified are considerably younger, at an age where preventive benefits can be maximised.

Jane Tiller · Alison H Trainer · Ian Campbell · Paul A Lacaze

There are legal considerations for both clinicians and patients when recording health care consultations Studies show that patients often have inaccurate recall of health care events and diagnoses.1 Concentration during a medical consultation may be “hampered by unspoken anxieties or pain, making it difficult to recall detail”.2 Audio recordings of consultations can be useful for patients and clinicians to assist memory and understanding. They have mainly been evaluated in oncology and paediatrics.3,4 Patients report that listening to their consultation recording increases knowledge and understanding of their illness, and recordings can assist with treatment decision making, increasing a sense of empowerment.5 Sharing recordings with family can facilitate support and understanding. Clinicians likewise recognise recordings’ benefits for patients and for improving the quality and efficiency of their care.6 Research in the United Kingdom found that 69% of patients wish to record consultations.7 Increasingly, patients are using smartphones to record consultations, either with permission or covertly.7,8 Recording systems have been developed by health services themselves, transformed by the ubiquitous use of smartphones and other flexible technologies.9,10,11 Examples include the Open Recording Automated Logging System (ORALS) software in the United States9 and telephone‐based digital recording in Denmark.11 In Australia, the Second Ears smartphone app, developed at the Victorian Comprehensive Cancer Centre in 2018, is designed to make recordings available to both the patient and the hospital health information management service.6,10 Patients can choose whether to download and use the app (either before their appointment or in the clinic), access the recordings on their smartphone, and share them with family and friends.6,10 Common design features of such health service‐led recordings address data security, file storage and patient consent. Whether the clinician or the patient controls the recording process may differ across technology platforms; for instance, in the Danish example above, the clinician initiated the recordings, whereas with Second Ears the patient would do so. The use of consultation recordings often raises legal questions.5,7,10,12 In this article, we compare the legal implications of overt and covert recordings of health care consultations and address key concerns identified by clinicians, notably the requirement for consent to record and share the recording, and the use of recordings in negligence claims.8,13,14,15 We distinguish between three recording types: Overt patient‐led recordings: for example, a patient recording a consultation with the clinician's consent. These recordings are akin to a patient's handwritten notes. Overt health service‐led recordings: for example, the Second Ears app, where both clinician and patient consent (actively or impliedly) to the recording; the app is facilitated by the health service and the primary version of the recording stored on their system. Covert patient‐led recordings: for example, a patient recording without the clinician's knowledge or consent. As each legal question is identified, we consider the law in the context of the Second Ears app. This article is general in nature and does not constitute legal advice. References to legislation are current at 13 October 2020. References to state or territory laws relate to the location of the recording or the place at which the sharing of the recording originated. We do not address the issue of intentional recording of private conversations by third parties, either overtly or covertly. Consent to record a consultation Clinician consent to patient‐led recordings Clinicians consider that their consent to be recorded is a key issue. Perhaps surprisingly, at law in many Australian jurisdictions, the patient need not obtain explicit consent from the clinician. In Victoria, Queensland and the Northern Territory, the law does not consider a recording of a conversation that is made by one of the parties (as opposed to a third party). In New South Wales, Tasmania and the Australian Capital Territory, patients can record their consultation without the clinician's consent (or, by extension, their knowledge) if the recording is only for the patient's own use (ie, to listen back to the recording later), or to protect their lawful interests (such as in a negligence claim). In South Australia and Western Australia, clinician consent is required (ie, two‐party consent) for recording a consultation for later listening‐back by the patient (Box 1). Patient consent to health service‐led recordings Where the recording is made on an app like Second Ears with data stored by the health service, this is an act of health information collection about an individual that requires the patient's express or implied consent. The patient's decision to download and install the app can act as implied consent; the app's terms and conditions could also include a clear statement about patient consent. Consent of other people captured incidentally in any overt recording A consultation recording — whether patient‐led or health service‐led — might accidentally capture another conversation, for instance from the clinic's reception desk. No consent of the third party is needed in this case, because they are not a party to the recorded conversation. Typically, Australian surveillance device laws do not regulate recordings of conversations occurring in circumstances in which the parties ought reasonably to expect to be overheard, such as in public or an open hospital ward. This means that if a patient is overtly recording their own consultation while in a curtained cubicle, their inadvertent capture of another clearly heard conversation in the next cubicle would not require the consent of those having that conversation. Consent when someone else joins any overt recording If another person, such as the patient's relative or another clinician, enters a room where a consultation is being recorded, but does not join in the conversation, the new person is not a party to it and that person's consent is therefore not needed. However, if the new person does join the conversation, they become a party to it. Box 1 indicates when that new party's consent to be recorded is required. In SA and WA it is usually required. In NSW, the ACT and Tasmania it is required if the patient makes the recording intending to share it with anyone else, but not if the recording is intended only for the patient to listen to. Consent, when required, can be either express or implied. An example of how this situation might be addressed could be a health service policy to have a door sign stating prominently that a recording is in progress and that by entering the room the new participant consents to be recorded. A person entering the room could then signal their non‐consent by verbally requesting the recording be stopped. This applies to health service‐led and patient‐led recordings. Covert recordings by patients Covert recording by patients is not uncommon; a survey conducted in the UK found that 15% of respondents self‐reported recording clinical encounters without permission. A further 35% of respondents would consider covert recordings in the future.7 In the US, a similar survey found that far fewer respondents recorded covertly (2.7%);8 possibly because some health services routinely provided permission for recording. Currently, the proportion of Australian patients who record covertly is unknown; anecdotally, however, clinicians report that it is occurring.16 Covert recording has been described as a topic of “significant legal ambiguity”.17 In Australia, as noted above, the law varies significantly by jurisdiction. Only SA and WA require two‐party consent and thus prohibit patients covertly recording for their own use (Box 1). Covert recordings: legal penalties Not all consultation recordings require consent. In SA and WA, where two‐party consent is required, a person making a covert recording for their own use is subject to legal penalties; for example, in SA, fines of up to $15 000 or imprisonment for up to 3 years. In Toth v DPP (NSW) [2014] NSWCA 133, a case concerning a patient's illegal covert recording, the magistrate imposed an 18‐month good behaviour bond. Dealing with unwanted recording If their consent is legally required but the clinician does not want to be recorded, they can simply ask the patient to discontinue the recording. Regardless of whether the act of recording legally requires their consent, a clinician's refusal to be recorded, or the exposure of covert recording by a patient, may lead to breakdown of the therapeutic relationship,14 necessitating transfer of care to another clinician as per the Medical Board of Australia's code of conduct (https://www.medicalboard.gov.au/codes-guidelines-policies/code-of-conduct.aspx). While discontinuing a relationship may be appropriate in the context of misuse of an audio recording or its use with malicious intent, it would be a drastic response to a simple request by the patient to record, given the benefits of doing so. Health service‐led systems such as Second Ears may overcome this problem by incorporating clear frameworks around participation, consent and sharing. Sharing recordings with others Health care organisations sharing recordings Recordings made by the health service with the patient's consent (eg, via the Second Ears app) form part of the medical record and the organisation can lawfully share the recording in various ways, which are broadly similar across Australian states and territories. These include: with the person's consent; without the person's consent for a directly related purpose as long as the person would “reasonably expect” the disclosure (eg, in transferring care to another provider at the same service: F v Medical Specialist [2009] PrivCmrA 8); to defend a legal claim; for research in the public interest (if certain privacy guidelines are met, such as those set out by the National Health and Medical Research Council18); and with an immediate family member of the patient for compassionate reasons or to provide the patient with care when the patient is incapable of providing consent. This mirrors other parts of the medical record such as written notes and scans. If the recording is de‐identified (which may be difficult because voice patterns are distinctive and health information discussed during consultations is often reasonably identifiable), it can usually be used without patient consent for communication training within the health service. Consent may provide a more appropriate legal basis for such use. Patients sharing recordings Apps such as Second Ears facilitate patients’ sharing of recordings with family and others for treatment decision making and care. The law relating to such sharing of recordings with third parties varies between jurisdictions and also turns upon the question of whether the original recording was overt or covert. Separate legislative provisions address the act of recording compared with the recordings’ subsequent use. Two‐party consent is generally, but not always, required for patients to lawfully share recordings with third parties (Box 2). In Queensland, Tasmania and the ACT, there is a distinction between patients sharing a recording with immediate family (which can be done without the clinician's consent to share) and sharing with the wider world (which requires the clinician's consent). In NSW, unusually, a recording that is originally lawfully made with only one party's consent but with no intention to share can be subsequently shared without restriction (eg, on social media) (Surveillance Devices Act 2007 (NSW), section 11). Clear communication and consent remain the most desirable mechanisms to frame patients’ expectations and choices around the sharing of recordings with others, even where consent is not legally required. For the avoidance of doubt, an agreement to create a recording — whether a clinician's oral agreement for a patient to record on their smartphone, or the terms and conditions built into an app — should explicitly address the extent to which a patient can share the recording with others. Such an agreement might, for instance, permit the patient to share the recording with family but not publish it at large, for example, on public social media. This could override any legislative entitlement to share a recording openly. If a patient distributed the recording in violation of the terms and conditions, the health service could pursue a legal claim for breach of contract. We are not aware of previous such claims. Health services would need to weigh up the financial and reputational costs of pursuing such a claim. The use of recordings in legal proceedings Recording the consultation does not change clinicians’ medico‐legal obligations to patients. Such recordings provide transparency of the discussion and could be used as evidence of appropriate information sharing with patients, thus meeting the clinician's required standard of care. Clinicians have a duty to provide sufficient information on inherent risks of treatment and alternative treatments, to enable patients to exercise a meaningful choice. A claim may lie in negligence if the patient can demonstrate a “failure to warn”, where the clinician did not meet the appropriate standard of care and the patient consequently made an uninformed choice about treatment which resulted in harm. The importance of patient‐centred communication was highlighted in the UK decision of Montgomery v Lanarkshire [2015] UKSC 11 and the Australian case Rogers v Whitaker [1992] HCA 58. In a claim for negligent non‐disclosure, where the patient states that the clinician did not provide information concerning material risks about the proposed procedure, the recording could be used to provide evidence of the consultation. In most states and territories, whether the recording itself was taken with both parties’ consent or by one party covertly does not affect its admissibility in court. In jurisdictions where covert recording is not lawful (Box 1), an exception typically exists permitting a person to covertly record a private conversation to protect their lawful interests. An example is where there is a serious dispute between two parties regarding different versions of an arrangement (Georgiou Building v Perrinepod [2012] WASC 72). The relevant lawful interest must exist at the time of the recording (Marsden v Amalgamated Television Services [2000] NSWSC 465). The recording's lawfulness is a separate issue to its admissibility. It has been established that tape recordings are admissible to provide primary evidence of the conversation or sounds recorded on the tape. In the case of Butera v Director of Public Prosecutions (Vic) [1987] HCA 58, it was held that the tape is “a part of the machinery by which the evidence is produced”. It would follow that the recording on an app such as Second Ears provides evidence of the conversation that took place between the clinician and patient. Such a recording is admissible in court if the content is relevant and otherwise admissible, the voices are properly identified, and the recording has provenance — it is authentic, accurate and has not been tampered with. In this instance, the voices recorded would fall within the category of hearsay evidence — that is, representations made out of court that are led as evidence of the truth of the fact. As audio recordings fall within the definition of “document” in the Evidence Act 1995 (Cth) (which is uniform with most state and territory Acts), they may be admissible if they conform to the statutory requirements. As an example, in Victoria courts have the discretion to admit recordings as evidence if the evidence is relevant (Evidence Act 2008 (Vic), sections 55 and 56) and if the desirability of admitting the evidence outweighs the undesirability of doing so (Evidence Act, section 138). The recording will form only part of the record of information flow between clinician and patient. Contemporaneous notes and other non‐recorded conversations will also be relevant to determine if the standard of care has been met. There is no evidence that audio or video recordings of consultations increase litigation.19,20 A study evaluating the provision of consultation video recordings to patients found that in the high risk specialty of neurosurgery, none of the 2807 patients recorded used the video in a legal action.19 Recordings might actually reduce conflict and litigation because they overcome differences in recollection between two parties.21 Ownership of recordings Traditionally, the law has not conceived of information as property (Boardman v Phipps [1967] 2 AC 46). In Australia, patients have no proprietary interest in a doctor's medical notes (Breen v Williams [1996] HCA 57) (although legislation provides a right to access them). Nor do doctors have any proprietary interest in a patient's handwritten notes, or by extension, an overt patient‐led recording. However, a health service‐led recording such as one made using the Second Ears app could be said to be jointly created. As there are two copies of it, one held by the patient and one by the health service, it could be argued that each has some proprietary interest. A recent exploration of this position posited that there may be multiple rights holders of health data.22 This view has yet to be tested in the courts. It is appropriate to focus instead on the obligations of the different parties to protect and store the recording data. Data security and storage of overt recordings A recording made on a system such as Second Ears forms part of the medical record and the organisation must take reasonable steps to protect it from misuse, loss and unauthorised access or disclosure. Any contract with a third‐party organisation (eg, a cloud storage provider) should also reflect these requirements and address issues of security and access. Health records must be retained for a specified period; in Victoria, NSW and the ACT, this is 7 years after the patient last received care from the organisation, after which the records should be destroyed if they are no longer needed. By comparison, patients need neither keep nor protect their own copy of a recording. If the recording is made using a third‐party app, the terms and conditions of that app are relevant, adding further complexity in relation to custodianship and data protection. Conclusion Health service‐led recording technologies, of which Second Ears is an example, can draw on a framework that makes explicit all parties’ rights and responsibilities, and ensure that an authenticated version of the recording is maintained securely. Such an approach promotes shared expectations between patients and clinicians and is likely to reduce miscommunication. Our analysis found surprising diversity in Australian legislation pertaining to consultation recording, leading us to conclude that, to avoid confusion, expressly articulated permissions around the act of recording and the extent of sharing recordings are desirable. While covert recording is not uniformly unlawful in Australia, transparency promotes trust and enhances the clinician–patient relationship. There is some evidence that concerns about a heightened litigation risk as a consequence of recording are unfounded; rather, the existence of a recording should minimise conflicting recollections and enhance a sense of collaboration. While the act of recording does not alter a clinician's duty to disclose relevant information to a patient, communication skills training may be a way to alleviate concerns about being recorded.10 Box 1 – Patient‐led recordings: when is consent from the other party required for the act of recording? Jurisdiction Patient makes recording for unspecified purpose Patient makes recording intending it for personal use only Patient makes recording that is reasonably necessary for the protection of their own lawful interests Legislation Victoria, Queensland, Northern Territory Consent not required Consent not required Consent not required Surveillance Devices Act 1999 (Vic): no relevant provision Invasion of Privacy Act 1971 (Qld), s 43(2)(a) Surveillance Devices Act 2007 (NT): no relevant provision New South Wales, Australian Capital Territory, Tasmania Consent required Consent not required Consent not required Surveillance Devices Act 2007 (NSW), s 7(3) Listening Devices Act 1992 (ACT), s 4(1)(b), (3) Listening Devices Act 1991 (Tas), s 5(1)(b), (3)(b) South Australia, Western Australia Consent required Consent required Consent not required Surveillance Devices Act 2016 (SA), s 4 Surveillance Devices Act 1998 (WA), s 5 Box 2 – Can a patient share their lawfully made recording with third parties for general purposes* without the clinician's consent for the sharing? Jurisdiction Sharing with immediate family and friends† Sharing with public at large Legislation Victoria, Northern Territory No (clinician consent for sharing required) No (clinician consent for sharing required) Surveillance Devices Act 1999 (Vic), s 11(2)(a) Surveillance Devices Act 2007 (NT), s 15(2)(a) Western Australia No (clinician consent for sharing required) No (not even with clinician consent) Surveillance Devices Act 1998 (WA), s 9(2)(a)(ii), (3) Queensland, Tasmania, Australian Capital Territory Yes‡ No (clinician consent for sharing required) Invasion of Privacy Act 1971 (Qld), s 45(2)(a), (d) Listening Devices Act 1991 (Tas), s 10(2)(a), (d) Listening Devices Act 1992 (ACT), s 5(2)(b), (e) New South Wales, South Australia Yes§ Yes§ Surveillance Devices Act 2007 (NSW), ss 7(3)(b), 11(1). Surveillance Devices Act 2016 (SA), ss 4(2)(a)(i), 12(1). * Legislation usually deals separately with the sharing of recordings for different purposes, such as “in the public interest”, for protecting the “lawful interests” of the person who is sharing the recording, “in the course of legal proceedings”, “in the performance of a duty”, or as authorised by law. This table solely addresses when clinician consent is required for the sharing of a recording with a family member or with the public at large when the purpose of the sharing is not specified. This may include for the patient's health and wellbeing. It does not address sharing for other purposes. † This is typically expressed in legislation as: persons who have, or are believed on reasonable grounds by the person who is communicating or publishing the recording to have, such an interest in the private conversation (ie, the health care consultation) as to make the sharing reasonable under the circumstances. ‡ In these jurisdictions, the original recording may be lawfully made covertly by the patient for their own use, and then shared with family, without the clinician's consent. § Section 11 of the Surveillance Devices Act 2007 (NSW) is silent about the sharing (publication or communication) of recordings that were made lawfully. A recording that is made by one party without an original intention that the recording be published or otherwise disseminated is lawful in NSW: section 7(3)(b)(ii). Section 12 of the Surveillance Devices Act 2016 (SA) is silent about the sharing of recordings that were made lawfully, such as a recording made with the consent of both parties under section 4(2)(a)(i).

Megan Prictor · Carolyn Johnston · Amelia Hyatt

A recent High Court decision directs and reassures medical and other practitioners in clinical and community settings that no parent or individual can compel this unlawful procedure

Ben Mathews · Elizabeth Dallaston

Publicly funded reproductive carrier screening programs must weigh up a number of ethical considerations Reproductive genetic carrier screening (RCS) is undertaken by individuals or couples to determine their likelihood of having a child with particular autosomal recessive or X‐linked genetic conditions. It can be undertaken by anyone of reproductive age who wishes to have it, regardless of their family history or ancestry, and either before or during pregnancy.1 Some forms of RCS are currently available in Australia on a user‐pays basis, costing around $400–$500 per person. It is usually accessed via general practitioners but can also be accessed directly from testing companies.2 People who receive an increased chance result are offered genetic counselling to explore their reproductive options, which might include steps to avoid having a child with a genetic condition. Taking the test before pregnancy gives those with an increased chance result a wider range of reproductive options compared with prenatal testing.3 The Australian Reproductive Genetic Carrier Screening Project (Mackenzie's Mission), announced by federal Health Minister Greg Hunt in 2018, is a research project offering RCS to 10 000 Australian couples. Recruitment via participating health professionals commenced in late 2019. Mackenzie's Mission is gathering evidence — including clinical, laboratory, psychosocial, health economic and ethical aspects — to inform how publicly funded screening could be operationalised in Australia within ten years.4 Here, we reflect on the ethical implications of RCS in Australian health care.5 While the issues raised apply to all types of RCS, we focus on aspects relating to large scale, publicly funded initiatives like Mackenzie's Mission. Ethics and the goals of RCS A central ethical issue for large scale RCS initiatives is how their goals are described. Two main foci for articulating the goals of such programs are (i) outcomes for individuals and their families, such as reproductive autonomy; and (ii) outcomes for populations, such as reduced incidence of certain genetic conditions. It has been argued that a goal of seeking to reduce the population incidence of babies who will develop severe genetic conditions is inappropriate for RCS.6 This line of reasoning draws partly on concerns about perceived coercion; when RCS is offered routinely, couples may perceive that participating is the right thing to do, even if testing is optional.7 Additionally, such a goal might be interpreted as implying that couples who receive an increased chance result are then obliged to take action to avoid the birth of an affected child. Any future national program must be delivered as a genuinely optional intervention, respecting couples’ values and preferences. It has also been argued that the goal of reducing the incidence of certain genetic conditions in the population expresses an unfavourable judgement about the value of the lives of people who currently live with such a condition.8 Therefore, in the case of RCS it is considered more ethically acceptable for a program's stated aim to be aligned with the first set of outcomes mentioned above; namely, to support couples’ reproductive autonomy through provision of relevant information to enable choices that are consistent with their values.1 RCS programs are also motivated, at least in part, by the desire to mitigate harms that couples who have parented a baby or child with a severe or fatal genetic condition experience. These harms include the grief of losing a child or witnessing one's child suffering. RCS might enable some parents to avoid such distressing experiences. Emphasising the severity of a condition included in a screening program arguably lessens any implied negative judgement about people living with genetic conditions screened for. However, ethical debate on what constitutes a severe or serious condition remains ongoing.9 Ethical aspects of gene selection A significant component of designing a publicly funded RCS program is determining which genes warrant inclusion for testing.10 Since screening can be stigmatising for people living with the genetic conditions screened for, it is considered most ethically defensible to screen only for genes associated with severe childhood‐onset conditions.1,3 However, because perceptions surrounding seriousness and severity are not purely objective,9 any RCS program must carefully weigh the diverse ways in which a condition can present, as well as the implications of that condition for the person and their family. There are also ethical aspects regarding the classification of gene variants identified during the testing process.11 There can be a degree of uncertainty as to how strongly a particular variant is associated with a genetic condition, an issue compounded in population screening because there is no index case (proband) to facilitate interpretation. This has ethical implications because reporting a variant as disease‐causing when it is not may mean a couple will experience additional uncertainty and perhaps go through unnecessary tests or interventions. On the other hand, not reporting a variant that does turn out to be disease‐causing means a couple may go on to have a child with a serious condition despite receiving a low chance result from RCS. This issue will remain important for some time, especially as variant databases are still developing. Consent for RCS: enabling meaningful choices Whether and how to gain consent can be contentious in many public health screening programs.12 While both consent and pre‐test education are important for RCS,1 determining how best to do this can be complex. It has been argued that when screening is perceived as routine, people will be less likely to reflect critically on whether it is appropriate for them, or to consider whether the results will be relevant to their decision making.7 Support for pre‐test decision making such as educational videos and decision aids can help couples consider the implications of an increased chance result and their options for reproduction. Mackenzie's Mission is one of several large scale population‐based RCS initiatives globally that have curated large panels of genes to test using a couple‐based model.5,10,13 It is important for participants to understand that RCS is designed to provide the couple with information that might help with decisions about reproduction, rather than to convey genetic risk information for their own health. Participants will also be encouraged and supported to reflect on their values and their goals for testing, to help them decide whether this screening will be useful or important for them.14 Reporting results: ethical implications Results of any genetic test can be complex and might be uncertain.15 As such, results from RCS need to be provided in a way that is meaningful and useful. To optimise the utility of their results, participants will require a basic understanding of key concepts such as what it means to carry a recessive genetic condition, and the implications of an increased chance finding. It is also important to ensure that participating in screening is not interpreted as guaranteeing that someone will have a healthy child. Publicly funded population RCS globally is tending towards reporting couple‐based findings. Evidence suggests that participants understand and accept this approach and that it is feasible as a population screening model.5,13,16 Mackenzie's Mission participants will be informed when they both carry the same disease‐causing variant for an autosomal recessive condition, or when the genetic mother is found to carry one of the X‐linked conditions screened for. Reporting only couple‐based findings is justifiable from an implementation perspective, for both programmatic and pragmatic reasons. Programmatically, RCS aims to inform reproductive choices, so it provides couples with information relevant to those choices. Any potential for false reassurance can be carefully addressed during the pre‐ and post‐test education processes. Pragmatically, publicly funded RCS would be prohibitively expensive to offer if it reported individual carrier results, as the majority of individuals screened are likely to be a carrier for something.16 Each of these people would then need individual follow‐up, despite their future offspring having a very low chance of actually having that autosomal recessive condition, even if they were to re‐partner.17 Moreover, this information has no clinical utility for the individual's own health. It also has the potential to provoke anxiety. As such, it is premature and potentially inequitable to provide individuals with information relating to their individual carrier status without providing further support. Further research will inform considerations of the ethical and psychosocial aspects of using an RCS framework to report individual results, including the possibility of offering individual results for a limited number of the more prevalent conditions on the panel. Public funding How RCS is funded is also ethically relevant, not least due to the perceived endorsement of screening by the state when a program is publicly funded. A formal, publicly funded, screening program may have advantages,18 but public funding might also carry tacit value implications. Experience with antenatal screening suggests that blame and guilt can be associated with declining an offer of screening.19 Funding models can also reinforce routinisation, where a screening offer might be perceived as encouraging or even coercing couples to terminate a pregnancy if a genetic condition is identified in the fetus.7 Within public funding structures, ethical issues also arise from the mode of offer of RCS, either in the context of a formal population screening program (likely to be delivered by centralised, publicly funded entities) or via a Medicare item number. Provision via Medicare will allow any provider who can meet the item number requirements to offer the test, and as such is likely to attract a greater commercial presence in RCS. The resulting fragmentation might constitute a lost opportunity for uniform evaluation of program effectiveness and might also give rise to inconsistencies in aspects of test provision, such as counselling. On the other hand, provision through Medicare may also enable RCS to be rolled out more quickly than establishing a formal population screening program. Cost‐effectiveness of population‐wide RCS has not yet been established conclusively by the existing evidence;11 however, one of the aims of Mackenzie's Mission is to generate such evidence for the Australian health care system. RCS and community values Underlying these ethical considerations is the question of how RCS reflects societal values. While most people are likely to agree on core principles such as respecting couples’ choices about whether to participate in screening, there will also be variations in preferences between communities, families and individuals.20 Future delivery of a national RCS program in Australia will need to recognise and respond to this diversity, while also upholding the values that motivate the program. The central values for RCS in Australia are good health outcomes for families and communities, alongside respect for all Australians, equity in program design and delivery, and reproductive autonomy.

Lisa Dive · Ainsley J Newson

Professional codes of conduct expressly proscribe entering into a sexual relationship with a current patient, but the position is less clear concerning former patients

Jenni Millbank

This case study highlights some important legal and ethical considerations related to advance care planning A 71‐year‐old man with vascular risk factors including hypertension and hypercholesterolaemia lived at home with his wife and enjoyed reading, listening to music and discussing global issues. Immediately on disembarkation from a long flight, he experienced a sudden reduction in consciousness with accompanying right hemiplegia and neglect. He was diagnosed with a large left middle cerebral artery infarct and underwent thrombolysis. Following the procedure, he was haemodynamically unstable, with further investigation revealing massive pulmonary emboli. He was anticoagulated and his condition stabilised. Over subsequent days, his hemiplegia improved, and it was felt that with time and ongoing therapy he would be able to stand independently and mobilise with assistance. Unfortunately, he remained severely globally dysphasic and this was considered unlikely to improve. He was unable to feed himself but was easily fed thickened fluids by nursing staff. He had documented an advance care plan (ACP) 5 years before his stroke. His ACP stated that in the event of impairment rendering him “incapable of rational existence” he would not want to be kept alive via artificial means but rather be allowed to die free of pain and distress. About 3 months before his stroke, he updated his ACP to include an advance care directive (ACD) stating what mattered most to him, as well as his worries for the future. His greatest concern was that he might “linger on in a home, with unacceptable quality of life”. He stated that “acceptable quality of life has at its core the ability to understand one's circumstances, to be able to communicate with other people, the ability to be mobile and not being reliant on others for the basics of life such as having to be washed, dressed and fed”. If he was not able to do these things, his wishes were that he be allowed to die as quickly and peacefully as possible. His ACD specifically stated that if he was “in advanced stages of Alzheimer's disease or other incurable, advanced dementing disease and if my appointed health care agent concludes after consultation with my primary health care provider that I am unable to make informed decisions about my health care, and I am unable to feed myself, continuing life would have no value for me”. In that situation, he directed that all life‐prolonging therapies should be withdrawn, including “the provision of nutrition and hydration whether provided artificially or medically or by hand or by assisted feeding”. The ACD was even more explicit about this as it included the directive that “if I am suffering from advanced dementia and appear willing to accept food and fluid by hand offered by assisted or hand feeding, my instructions are that I do NOT want to be fed by hand even if I appear to cooperate in being fed by opening my mouth”. When his lack of cognitive recovery was apparent, his wife, as his appointed medical treatment decision maker, was concerned that his wishes, as specified in the ACD, were not being honoured and queried whether he should continue to be fed by hand. Given the complexity of the situation, a palliative care consultation was sought, along with guidance from representatives of the hospital's clinical ethics committee, including the Chief Medical Officer, legal counsel and representatives from involved clinical teams. Ultimately, the decision was made in close consultation with his wife to respect his ACD. His anticoagulation was ceased and food and fluid discontinued. He died 4 days later, about one month after his stroke. Discussion Our patient had a very clear, and as it transpired, remarkably prophetic ACD. The question as to whether his desire to refuse oral intake was something his treating teams were legally and ethically obligated to follow is worthy of further consideration. The Medical Treatment Planning and Decisions Act 2016 (Vic) came into effect in Victoria in March 2018.1,2 The Act seeks to provide a single framework to ensure that medical treatments align with an individual's preferences in the event that they are unable to make decisions for themselves. The Act supports ACPs that can incorporate the creation of an ACD, as well as the appointment of a medical treatment decision maker to act as a surrogate decision maker should decision‐making capacity be lost. An ACD can contain: instructional directives, which, if a person lacks decision making capacity, take effect as if the person had consented to or refused a specific medical treatment; and/or values directives, which are broader and can encompass desires, worries and acceptable outcomes. Palliative care is defined in the Act to include medical treatments aimed to relieve suffering, as well as the reasonable provision of food and water, which is generally accepted to exclude artificial hydration or enteral feeding.3 To ensure that dying patients receive appropriate end‐of‐life care, the Act distinguishes palliative care from other medical treatments in two ways. First, it specifically prohibits making an instructional directive refusing palliative care. Any statement in an ACD relating to palliative care is given the status of a values directive, meaning the statement can guide but not mandate decisions. Second, the Act allows a clinician to provide palliative care even if this may not align with a patient's wishes and/or the medical treatment decision maker does not agree. Following his stroke, our patient was assessed to lack decision‐making capacity in relation to feeding. His apparent acceptance of supported feeding was therefore not considered an informed decision and thus his ACD and medical treatment decision maker provided the most appropriate guide to future health care management. When considering whether his treating teams were legally obligated to follow his directives in relation to refusal of oral intake, the following would seem pertinent. His wishes in relation to oral input were very specific and labelled as instructional. Although these statements were written in relation to deterioration in the setting of dementia, it would be difficult to argue that his wishes would not also apply in the context of his stroke with its resulting profound disability and dependence. Despite being designated instructional, the directives probably constituted a refusal of reasonable food and water and thus of palliative care. Under the Act, these can be values directives only, and while the team must take patient preferences into account, the directive would not be binding. Although the Act does therefore appear to allow the treating team to override an individual's wish not to be fed, the law provides little assistance regarding the circumstances in which this would be ethically permissible. Published guidance for clinicians faced with this specific situation is very limited. Although there is literature discussing the clinical and ethico‐legal issues associated with voluntarily stopping eating and drinking,4,5,6,7,8 this is typically in the context of someone whose decision‐making capacity was intact at the time of commencement. There is conflict in the literature regarding the ethics and legality of ACDs that request the cessation of handfeeding in progressive dementia.5,9,10,11 In our patient's case, although the directives were not legally binding, the health care team felt that the ACD, along with his wife's input, was the best guide to appropriate care provision, particularly when it became increasingly likely that he would not regain his previous cognitive abilities. Ultimately, regardless of the instructional or values‐based designation of his written instructions, there was uniform agreement that he could not have made his wishes any clearer, and accordingly this was respected. This case holds some important lessons for patients writing ACDs and for their health care providers. First, had our patient's directives been less detailed, or had he been admitted to an alternative health care setting with different ethical or religious values, support for his refusal of feeding may not have been regarded as acceptable practice. This might have led to mandated ongoing oral feeding, which may have led to significant conflict between the health service and our patient's wife, and considerable distress for all involved. Second, the case highlights the importance of adequate education for clinicians guiding, and the public completing, ACPs. Third, while the law provides some guidance to clinicians regarding the refusal of palliative care, including food and water, each case will require careful individual consideration and reflection on the different ethical issues at play. Finally, while every state and territory of Australia recognises ACDs in either legislation or case law, differences exist across jurisdictions in how they are recognised and interpreted. Importantly, although there is scope to give effect to an ACD created in another jurisdiction, had our patient's flight arrived in a different state than where he resided and completed his ACD, this would have added another layer of legal complexity given that Australia does not have a unifying legal framework for the application and interpretation of ACDs.12

Peter Eastman · Danielle Ko · Brian H Le

Differences between general practice and hospital settings have ethical and legal implications for teachers and learners

Michaela Kelly · Nancy Sturman · David Pakchung

Variation in Australian law concerning self-binding directives for mental illness is unnecessarily complex for clinicians

Katrine Del Villar · Christopher J Ryan

Section 8 is an unwarranted infringement on communication between health practitioners and their patients

Bryanna Moore · Courtney Hempton · Evie Kendal

Victoria's voluntary assisted dying law will soon come into effect; a remaining challenge is effective clinical implementation

Ben P White · Lindy Willmott · Eliana Close

By establishing well functioning internal procedures and by informing patient expectations as to how their information is managed and by whom, the aftermath of a data breach may be reduced in severity

David J Carter · Samuel Hartridge

Clinicians should be aware of the particular physical and psychological risks of haematopoietic stem cell donation in the paediatric setting, and the varying laws between states and territories

Shih-Ning Then · Ian H Kerridge · Michael Marks

Recent Victorian legislation is ethically defensible but will need to be closely monitored

Xavier Symons

Recent developments regarding abortion law in NSW and Queensland carry significant implications for doctors

Heather Douglas · Caroline M de Costa

Clinical photographs can enhance patient care, but carry privacy risks for patients and medicolegal risks for doctors

Paul Stevenson LLB · Anna R Finnane PhD · H Peter Soyer MD

A new approach affects medical practitioners who give expert evidence

Bill Madden BA LLB(Hons), FAAL · Tina Cockburn LLM, LLB(Hons), BCom

A wide-ranging national debate in Australia is needed regarding the ethics and law of paid surrogacy across international borders

Ainsley J Newson PhD(Bioethics), LLB(Hons), BSc(Hons)

A change in the law is needed to allow procurement after circulatory death to maximise organ procurement

James Tibballs MD, MHlth · Neera Bhatia LLB(Hons), LLM, PhD

Sexual harassment in medicine has implications for employers, professional colleges and associations, and regulators

Ben Mathews PhD, LLB, BA · Marie M Bismark MB ChB, LLB, MPH

Is it ever ethically appropriate for health care workers to decline to care for patients with Ebola, and how should treatment decisions be made?

Thomas Solano MB BS, FRACP, FCICM · Gwendolyn L Gilbert MB BS, FRACP, FRCPA · Ian H Kerridge BA, FRACP, FRCPA · Vineet Nayyar MB BS, FRACP, FCICM · Angela Berry BAppSc(Nurs), MAppSc, PhD

Health practitioners who close a practice have immediate and ongoing legal obligations to their patients

David J Carter LLM(Res), LLB(Hons), BAComm