Melbourne Law School - Research Publications

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    MANDATORY DATA BREACH NOTIFICATION LAWS AND AUSTRALIAN HEALTH DATA PRIVACY: FRAGMENTS AND FAULT LINES
    Prictor, M (Monash University, 2021)
    Data privacy breaches — unauthorised access to, disclosure, or loss of people’s personal information — are commonplace, particularly in the health sector. In Australia, provisions under the Privacy Act 1988 (Cth) and the My Health Records Act 2012 (Cth) require data breach notification to affected people and the regulator. However, this mandatory notification, as it pertains to health information, has two key problems: fragmentation, and lack of fitness for purpose. In this article, I analyse the goals of the Australian legislative developments and the extent to which these are met in relation to health data. I propose legal and procedural reforms to mend the fragments and fault lines so that breach notification can more effectively address healthcare data breaches in Australia.
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    Toward Universal Eye Health Coverage-Key Outcomes of the World Health Organization Package of Eye Care Interventions A Systematic Review
    Keel, S ; Lingham, G ; Misra, N ; Block, S ; Bourne, R ; Calonge, M ; Cheng, C-Y ; Friedman, DS ; Furtado, JM ; Khanna, R ; Mariotti, S ; Mathenge, W ; Matoto, E ; Mueeller, A ; Rabiu, M ; Rasengane, T ; Resnikoff, S ; Wormald, R ; Yasmin, S ; Zhao, J ; Evans, JR ; Cieza, A (AMER MEDICAL ASSOC, 2022-12)
    IMPORTANCE: Despite persistent inequalities in access to eye care services globally, guidance on a set of recommended, evidence-based eye care interventions to support country health care planning has not been available. To overcome this barrier, the World Health Organization (WHO) Package of Eye Care Interventions (PECI) has been developed. OBJECTIVE: To describe the key outcomes of the PECI development. EVIDENCE REVIEW: A standardized stepwise approach that included the following stages: (1) selection of priority eye conditions by an expert panel after reviewing epidemiological evidence and health facility data; (2) identification of interventions and related evidence for the selected eye conditions from a systematic review of clinical practice guidelines (CPGs); stage 2 included a systematic literature search, screening of title and abstracts (excluding articles that were not relevant CPGs), full-text review to assess disclosure of conflicts of interest and affiliations, quality appraisal, and data extraction; (3) expert review of the evidence extracted in stage 2, identification of missed interventions, and agreement on the inclusion of essential interventions suitable for implementation in low- and middle-income resource settings; and (4) peer review. FINDINGS: Fifteen priority eye conditions were chosen. The literature search identified 3601 articles. Of these, 469 passed title and abstract screening, 151 passed full-text screening, 98 passed quality appraisal, and 87 were selected for data extraction. Little evidence (≤1 CPG identified) was available for pterygium, keratoconus, congenital eyelid disorders, vision rehabilitation, myopic macular degeneration, ptosis, entropion, and ectropion. In stage 3, domain-specific expert groups voted to include 135 interventions (57%) of a potential 235 interventions collated from stage 2. After synthesis across all interventions and eye conditions, 64 interventions (13 health promotion and education, 6 screening and prevention, 38 treatment, and 7 rehabilitation) were included in the PECI. CONCLUSIONS AND RELEVANCE: This systematic review of CPGs for priority eye conditions, followed by an expert consensus procedure, identified 64 essential, evidence-based, eye care interventions that are required to achieve universal eye health coverage. The review identified some important gaps, including a paucity of high-quality, English-language CPGs, for several eye diseases and a dearth of evidence-based recommendations on eye health promotion and prevention within existing CPGs.
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    'As Long as It's Used for Beneficial Things': An Investigation of non-Maori, Maori and Young People's Perceptions Regarding the Research use of the Aotearoa New Zealand Integrated Data Infrastructure (IDI)
    Thabrew, H ; Aljawahiri, N ; Kumar, H ; Bowden, N ; Milne, B ; Prictor, M ; Jordan, V ; Breedvelt, J ; Shepherd, T ; Hetrick, S (SAGE PUBLICATIONS INC, 2022-10)
    The Aotearoa New Zealand Integrated Data Infrastructure (IDI) is a national database containing a wide range of data about people and households. There is limited information about public views regarding its use for research.A qualitative study was undertaken to examine the views of forty individuals attending a large hospital in Auckland, including those of Māori ethnicity and young people. Semi-structured interview data were analysed using Braun and Clarke's method of thematic analysis.Seven key themes emerged: 1) Limited knowledge about medical data held in national databases; 2) Conditional support for the use of the IDI, including for research; 3) Concerns regarding the misuse of IDI data; 4) The importance of privacy; 5) Different views regarding consent for use of data for research; 6) Desire for access to personal data and the results of research; and 7) Concerns regarding third party and commercial use. Young people and those of Māori ethnicity were more wary of data misuse than others.Although there is reasonable support for the secondary use of public administrative data in the IDI for research, there is more work to be done to ensure ethical and culturally appropriate use of this data via improved consent privacy management processes and researcher training.
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    Essentially Ours: Assessing the Regulation of the Collection and Use of Health-related Genomic Information
    McWhirter, R ; Eckstein, L ; Chalmers, D ; Kaye, J ; Nielsen, J ; Otlowksi, M ; Prictor, M ; Taylor, M ; Nicol, D (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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    Impact of Electronic Health Records on Information Practices in Mental Health Contexts: Scoping Review
    Kariotis, TC ; Prictor, M ; Chang, S ; Gray, K (JMIR PUBLICATIONS, INC, 2022-05-04)
    BACKGROUND: The adoption of electronic health records (EHRs) and electronic medical records (EMRs) has been slow in the mental health context, partly because of concerns regarding the collection of sensitive information, the standardization of mental health data, and the risk of negatively affecting therapeutic relationships. However, EHRs and EMRs are increasingly viewed as critical to improving information practices such as the documentation, use, and sharing of information and, more broadly, the quality of care provided. OBJECTIVE: This paper aims to undertake a scoping review to explore the impact of EHRs on information practices in mental health contexts and also explore how sensitive information, data standardization, and therapeutic relationships are managed when using EHRs in mental health contexts. METHODS: We considered a scoping review to be the most appropriate method for this review because of the relatively recent uptake of EHRs in mental health contexts. A comprehensive search of electronic databases was conducted with no date restrictions for articles that described the use of EHRs, EMRs, or associated systems in the mental health context. One of the authors reviewed all full texts, with 2 other authors each screening half of the full-text articles. The fourth author mediated the disagreements. Data regarding study characteristics were charted. A narrative and thematic synthesis approach was taken to analyze the included studies' results and address the research questions. RESULTS: The final review included 40 articles. The included studies were highly heterogeneous with a variety of study designs, objectives, and settings. Several themes and subthemes were identified that explored the impact of EHRs on information practices in the mental health context. EHRs improved the amount of information documented compared with paper. However, mental health-related information was regularly missing from EHRs, especially sensitive information. EHRs introduced more standardized and formalized documentation practices that raised issues because of the focus on narrative information in the mental health context. EHRs were found to disrupt information workflows in the mental health context, especially when they did not include appropriate templates or care plans. Usability issues also contributed to workflow concerns. Managing the documentation of sensitive information in EHRs was problematic; clinicians sometimes watered down sensitive information or chose to keep it in separate records. Concerningly, the included studies rarely involved service user perspectives. Furthermore, many studies provided limited information on the functionality or technical specifications of the EHR being used. CONCLUSIONS: We identified several areas in which work is needed to ensure that EHRs benefit clinicians and service users in the mental health context. As EHRs are increasingly considered critical for modern health systems, health care decision-makers should consider how EHRs can better reflect the complexity and sensitivity of information practices and workflows in the mental health context.
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    Trends and Challenges in Biobanking
    Kaye, J ; Bell, J ; Prictor, M ; Munsie, M ; Freckelton, I ; Petersen, K (Federation Press, 2017)
    The last twenty years have seen the emergence of the phenomena of biobanks, which are now regarded as essential research infrastructure in most countries around the world. However, the very nature of biobanks, as long-term repositories of sample and data that are used for many different research purposes continues to challenge many of the legal requirements for medical research, both in the UK and Australia. This chapter will provide an overview of biobanking and discuss some of the legal challenges that these activities raise by discussing and comparing the UK and Australian legal landscapes.
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    Consent for Data Processing under the General Data Protection Regulation: Could ‘Dynamic Consent’ be a Useful Tool for Researchers?
    Prictor, M ; Teare, H ; Bell, J ; Taylor, M ; Kaye, J (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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    Clinical Decision Support Systems and Medico-Legal Liability in Recall and Treatment: A Fresh Examination
    Prictor, M ; Taylor, M ; Kaye, J ; Emery, J ; Nelson, C ; Manski-Nankervis, J (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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    Consent
    Kaye, J ; Prictor, M ; Laurie, G ; Dove, E ; Ganguli-Mitra, A ; McMillan, C ; Postan, E ; Sethi, N ; Sorbie, A (Cambridge University Press, 2021-06-24)