Melbourne Law School - Research Publications

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    Data Breach Notification Laws—Momentum Across the Asia-Pacific Region
    Prictor, M (Springer Science and Business Media LLC, 2023)
    In late 2022, leading Australian health insurer Medibank Private experienced a catastrophic cyber- a ack that saw the data – including highly-sensitive health information – of close to 10 million current and former clients stolen. The data were subsequently published on the dark web a/er Medibank refused to pay a US$10 million ransom. The published records contained identifiable information about people’s HIV status, drug and alcohol treatment and reproductive care. Compared to breaches of purely financial or even identity information, health information hacks like this may cause significant personal distress and stigma that are hard to remedy. The Medibank hack is now subject to several class actions, from both shareholders and affected customers.
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    Evaluation of CTRL: a web application for dynamic consent and engagement with individuals involved in a cardiovascular genetic disorders cohort
    Haas, MA ; Madelli, EO ; Brown, R ; Prictor, M ; Boughtwood, T (SPRINGERNATURE, 2024-01)
    There has been keen interest in whether dynamic consent should be used in health research but few real-world studies have evaluated its use. Australian Genomics piloted and evaluated CTRL ('control'), a digital consent tool incorporating granular, dynamic decision-making and communication for genomic research. Individuals from a Cardiovascular Genetic Disorders Flagship were invited in person (prospective cohort) or by email (retrospective cohort) to register for CTRL after initial study recruitment. Demographics, consent choices, experience surveys and website analytics were analysed using descriptive statistics. Ninety-one individuals registered to CTRL (15.5% of the prospective cohort and 11.8% of the retrospective cohort). Significantly more males than females registered when invited retrospectively, but there was no difference in age, gender, or education level between those who did and did not use CTRL. Variation in individual consent choices about secondary data use and return of results supports the desirability of providing granular consent options. Robust conclusions were not drawn from satisfaction, trust, decision regret and knowledge outcome measures: differences between CTRL and non-CTRL cohorts did not emerge. Analytics indicate CTRL is acceptable, although underutilised. This is one of the first studies evaluating uptake and decision making using online consent tools and will inform refinement of future designs.
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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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    Ethics guidelines use and Indigenous governance and participation in Aboriginal and Torres Strait Islander health research: a national survey
    Burchill, LJ ; Kotevski, A ; Duke, D ; Ward, JE ; Prictor, M ; Lamb, KE ; Kennedy, M (WILEY, 2023-02-06)
    OBJECTIVES: To assess the use of NHMRC Indigenous research guidelines by Australian researchers and the degree of Aboriginal and Torres Strait Islander governance and participation in Indigenous health research. DESIGN, SETTING, PARTICIPANTS: Cross-sectional survey of people engaged in Indigenous health research in Australia, comprising respondents to an open invitation (social media posts in general and Indigenous health research networks) and authors of primary Indigenous health research publications (2015-2019) directly invited by email. MAIN OUTCOME MEASURES: Reported use of NHMRC guidelines for Indigenous research; reported Indigenous governance and participation in Indigenous health research. RESULTS: Of 329 people who commenced the survey, 247 people (75%) provided responses to all questions, including 61 Indigenous researchers (25%) and 195 women (79%). The NHMRC guidelines were used "all the time" by 206 respondents (83%). Most respondents (205 of 247, 83%) reported that their research teams included Indigenous people, 139 reported dedicated Indigenous advisory boards (56%), 91 reported designated seats for Indigenous representatives on ethics committees (37%), and 43 reported Indigenous health research ethics committees (17%); each proportion was larger for respondents working in Indigenous community-controlled organisations than for those working elsewhere. More than half the respondents reported meaningful Indigenous participation during five of six research phases; the exception was data analysis (reported as apparent "none" or "some of the time" by 143 participants, 58%). CONCLUSIONS: Indigenous health research in Australia is largely informed by non-Indigenous world views, led by non-Indigenous people, and undertaken in non-Indigenous organisations. Re-orientation and investment are needed to give control of the framing, design, and conduct of Indigenous health research to Indigenous people.
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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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    Where does responsibility lie? Analysing legal and regulatory responses to flawed clinical decision support systems when patients suffer harm
    PRICTOR, MEGAN (OXFORD UNIV PRESS, 2023-02-27)
    Clinical decision support systems (CDSSs) are digital healthcare information systems that apply algorithms to patient data to generate tailored recommendations. They are designed to support, but neither dictate nor execute, clinical decisions. CDSSs can introduce new risks, both by design features that heighten clinician burden and by outright errors that generate faulty recommendations for care. In the latter instance, if such unintercepted recommendations were to result in harm to the patient, novel legal questions emerge. Does legal responsibility for this harm lie with the clinician, the software developer or both? What is the clearest path to a remedy? Further, how does the Australian regulatory framework provide for oversight and redress? This article analyses the potential forms of legal redress in negligence, contract and under statutory consumer law, for the patient and the clinician. It also examines the Australian regulatory framework, specifically in relation to the Australian Competition and Consumer Commission and the Therapeutic Goods Administration, and reflects on the framework's adequacy to protect patients and clinicians. It finds that the regulatory approach and the contour of legal risk still centre upon the clinician's duty to exercise decisional autonomy and to intercept flawed recommendations generated by algorithmic errors within CDSSs.
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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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    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.