Melbourne Law School - Research Publications
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ItemEssentially Ours: Assessing the Regulation of the Collection and Use of Health-related Genomic Information(Centre for Law and Genetics, University of Tasmania, 2021)Essentially Ours provides an account of the current modes of regulation of health-related genomic samples and data in Australia. This Occasional Paper revisits some of the issues addressed in the 2003 Report, Essentially Yours, authored jointly by the Australian Law Reform Commission and Australian Health Ethics Committee pursuant to a reference from the Commonwealth Government ('Essentially Yours'). Essentially Yours emphasised 'that fundamental human dignity requires that individuals have a high level of control over their own genetic material… and that human genetic information is personal, sensitive, and deserving of a high level of legal protection'. The information presented in this Occasional Paper differs from Essentially Yours in two important ways, largely resulting from the technological and societal changes that have occurred in the intervening years. The first is that the term genetics has been replaced by the term genomics. Genomics refers to the study of the whole genome whereas genetics tends to focus on individual genes. Rapid technological advances mean that genomics is now the most common form of analysis. Secondly, although genomics provides increased clinical and research opportunities, it also raises particular individual and group-member risks. These changes demand reconsideration of the ethical, legal and social implications of and regulatory responses to advances in health-related genomics in Australia. Although the focus of this Occasional Paper is descriptive-that is, to account for the manner in which current laws apply to genomic samples and data-it necessarily brings to light regulatory gaps and fissures. In particular, traditional regulatory frameworks focus on controls at the level of the individual, either through consent or through efforts to strip genomic information of its identifiers. In the genomic era, these fail to recognise the essential nature of genomic samples and data as inherently identifiable and as shared within families, communities, and populations. This points to the need for a reorientation in the way genomic information is regulated in order to find a balance between ‘yours’ and 'ours'. We trust that Essentially Ours will provide a rigorous description of the regulatory landscape relevant to genomics in Australia and a tool for future legal analysis and law reform.
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ItemConsent for Data Processing under the General Data Protection Regulation: Could ‘Dynamic Consent’ be a Useful Tool for Researchers?(Henry Stewart Publishing, 2019)The General Data Protection Regulation (GDPR) sets the bar high for consent for the processing of personal data. In the UK, researchers have been directed to rely on legal bases other than consent for processing personal data for research purposes. Informed consent, nonetheless, and despite certain shortcomings, holds a central position in ethical research practice, as well as at common law, and in a range of other legislation dealing with research involving humans. This paper evaluates the place of informed consent in research following the GDPR’s implementation, arguing that a fresh approach to consent — specifically the concept known as ‘dynamic consent’ — could provide a way for researchers to meet the new European regulatory requirements for data processing while adhering to the highest ethical standards for research conduct. It analyses dynamic consent according to specific GDPR requirements and reflects on practical examples that could inform future implementation of the approach, while remaining aware of the need for further empirical research.
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ItemClinical Decision Support Systems and Medico-Legal Liability in Recall and Treatment: A Fresh Examination(Thomson Reuters, 2020)Clinical decision support systems (CDSSs) provide a valuable tool for clinicians to aid in the care of patients with chronic disease. Various questions have emerged about their implications for the doctor’s legal duty of care to their patients, in terms of recognition of risk, recall, testing and treatment. In this article, through an analysis of Australian legislation and international case law, we address these questions, considering the potential impact of CDSSs on doctors’ liability in negligence. We conclude that the appropriate use of a well-designed CDSS should minimise, rather than heighten, doctor’s potential liability. It should support optimal patient care without diminishing the capacity of the doctor to make individualised decisions about recall, testing and treatment for each patient. We foreshadow that in the future doctors in Australia may have a duty to use available well-established software systems in patient care.
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ItemTowards optimising chronic kidney disease detection and management in primary care: Underlying theory and protocol for technology development using an Integrated Knowledge Translation approach(SAGE PUBLICATIONS INC, 2021)Worldwide, Chronic Kidney Disease (CKD), directly or indirectly, causes more than 2.4 million deaths annually with symptoms generally presenting late in the disease course. Clinical guidelines support the early identification and treatment of CKD to delay progression and improve clinical outcomes. This paper reports the protocol for the codesign, implementation and evaluation of a technological platform called Future Health Today (FHT), a software program that aims to optimise early detection and management of CKD in general practice. FHT aims to optimise clinical decision making and reduce practice variation by translating evidence into practice in real time and as a part of quality improvement activities. This protocol describes the co-design and plans for implementation and evaluation of FHT in two general practices invited to test the prototype over 12 months. Service design thinking has informed the design phase and mixed methods will evaluate outcomes following implementation of FHT. Through systematic application of co-design with service users, clinicians and digital technologists, FHT attempts to avoid the pitfalls of past studies that have failed to accommodate the complex requirements and dynamics that can arise between researchers and service users and improve chronic disease management through use of health information technology.
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ItemInsight or Intrusion? Correlating Routinely Collected Employee Data with Health Risk(MDPI AG, 2019)The volume, variety and velocity of data available to companies about their employees is already significant and likely to increase. Employers hold data about employees that could be used to explore the relationship between workplace practice in their organisation and risks to employee health. However, there is significant uncertainty about whether employers subject to English law are permitted to use this data for this purpose, and even whether they may be under a legal obligation to do so. In this article, the question of whether employers are legally permitted or legally obliged to use employee data to identify associations between workplace practice and risk to employee health is answered through an analysis of two spheres of English Law: data protection law, and health and safety law. The authors establish a hypothetical case study concerning a company that wishes to use employee data in this way, to illuminate a set of detailed legal issues. In particular, the question of whether a reasonable and prudent employer is under an obligation under health and safety law to use the data and analytic tools at his or her disposal to assess risk and inform his or her actions is considered. Also addressed is the question of whether such processing would satisfy the data protection law principles of “lawful, fair, and transparent” processing and that of “purpose limitation”. A complex picture emerges. The analysis reveals that data protection legislation may not support a trend towards the re-use of employee data to enhance workplace health and safety; nor is there currently a clear mandate that responsible employers use data in this way. The line between useful insight into workplace practices and intrusion into employees’ privacy remains blurred.
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ItemNo Preview AvailableIf Privacy is Increasing for My Health Record data, it Should Apply to all Medical Records(The Conversation Media Group, 2018)In response to the public outcry against the potential for My Health Record data to be shared with police and other government agencies, Health Minister Greg Hunt recently announced moves to change the legislation. The laws underpinning the My Health Record as well as records kept by GPs and private hospitals currently allow those records to be shared with the police, Centrelink, the Tax Office and other government departments if it’s “reasonably necessary” for a criminal investigation or to protect tax revenue. If passed, the policy of the Digital Health Agency (which runs the My Health Record) not to release information without a court order will become law. This would mean the My Health Record has greater privacy protections than other medical records, which doesn’t make much sense.
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ItemUnited Kingdom: transfers of genomic data to third countries(SPRINGER, 2018-08)In the United Kingdom (UK), transfer of genomic data to third countries is regulated by data protection legislation. This is a composite of domestic and European Union (EU) law, with EU law to be adopted as domestic law when Brexit takes place. In this paper we consider the content of data protection legislation and the likely impact of Brexit on transfers of genomic data from the UK to other countries. We examine the advice by regulators not to rely upon consent as a lawful basis for processing under data protection law, at least not when personal data are used for research purposes, and consider some of the other ways in which the research context can qualify an individual's ability to exercise control over processing operations. We explain how the process of pseudonymization is to be understood in the context of transfer of genomic data to third parties, as well as how adequacy of data protection in a third country is to be determined in general terms. We conclude with reflections on the future direction of UK data protection law post Brexit with the reclassification of the UK itself as a third country.
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ItemNo Preview AvailableData security in the spotlight(The University of Melbourne, 2018)New legislation means you should, in certain instances, be notified if your data is breached. But will it really keep your personal details safe?