Melbourne Law School - Research Publications
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ItemWhere does responsibility lie? Analysing legal and regulatory responses to flawed clinical decision support systems when patients suffer harm(OXFORD UNIV PRESS, 2022-07-15)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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ItemImpact of Electronic Health Records on Information Practices in Mental Health Contexts: Scoping Review(JMIR PUBLICATIONS, INC, 2022-05-09)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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ItemClinical Software and Bad Decisions: The "Practice Fusion" Settlement and Its Implications(SPRINGER, 2022-06-01)
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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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ItemDigital Mega-Studies as a New Research Paradigm: Governing the Health Research of the Future(SAGE Publications, 2021-09-09)'Digital Mega-Studies' are entirely or extensively digitised, longitudinal, population-scale initiatives, collecting, storing, and making available individual-level research data of different types and from multiple sources, shaped by technological developments and unforeseeable risks over time. The Australian 'Gen V' project exemplifies this new research paradigm. In 2019, we undertook a multidisciplinary, multi-stakeholder process to map Digital Mega-Studies' key characteristics, legal and governance challenges and likely solutions. We conducted large and small group processes within a one-day symposium and directed online synthesis and group prioritisation over subsequent weeks. We present our methods (including elicitation, affinity mapping and prioritisation processes) and findings, proposing six priority governance principles across three areas-data, participation, trust-to support future high-quality, large-scale digital research in health.
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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, 2021-04-01)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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ItemReflections on dynamic consent in biomedical research: the story so far(SPRINGERNATURE, 2020-11-28)Dynamic consent (DC) was originally developed in response to challenges to the informed consent process presented by participants agreeing to 'future research' in biobanking. In the past 12 years, it has been trialled in a number of different projects, and examined as a new approach for consent and to support patient engagement over time. There have been significant societal shifts during this time, namely in our reliance on digital tools and the use of social media, as well as a greater appreciation of the integral role of patients in biomedical research. This paper reflects on the development of DC to understand its importance in an age where digital health is becoming the norm and patients require greater oversight and control of how their data may be used in a range of settings. As well as looking back, it looks forwards to consider how DC could be further utilised to enhance the patient experience and address some of the inequalities caused by the digital divide in society.
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Item'CTRL': an online, Dynamic Consent and participant engagement platform working towards solving the complexities of consent in genomic research(SPRINGERNATURE, 2021-01-06)The complexities of the informed consent process for participating in research in genomic medicine are well-documented. Inspired by the potential for Dynamic Consent to increase participant choice and autonomy in decision-making, as well as the opportunities for ongoing participant engagement it affords, we wanted to trial Dynamic Consent and to do so developed our own web-based application (web app) called CTRL (control). This paper documents the design and development of CTRL, for use in the Australian Genomics study: a health services research project building evidence to inform the integration of genomic medicine into mainstream healthcare. Australian Genomics brought together a multi-disciplinary team to develop CTRL. The design and development process considered user experience; security and privacy; the application of international standards in data sharing; IT, operational and ethical issues. The CTRL tool is now being offered to participants in the study, who can use CTRL to keep personal and contact details up to date; make consent choices (including indicate preferences for return of results and future research use of biological samples, genomic and health data); follow their progress through the study; complete surveys, contact the researchers and access study news and information. While there are remaining challenges to implementing Dynamic Consent in genomic research, this study demonstrates the feasibility of building such a tool, and its ongoing use will provide evidence about the value of Dynamic Consent in large-scale genomic research programs.
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ItemCulturally Adaptive Governance—Building a New Framework for Equity in Aboriginal and Torres Strait Islander Health Research: Theoretical Basis, Ethics, Attributes and Evaluation(MDPI AG, 2021)Indigenous health inequities persist in Australia due to a system of privilege and racism that has political, economic and social determinants, rather than simply genetic or behavioural causes. Research involving Aboriginal and Torres Strait Islander (‘Indigenous’) communities is routinely funded to understand and address these health inequities, yet current ethical and institutional conventions for Indigenous health research often fall short of community expectations. Typically, mainstream research projects are undertaken using traditional “top-down” approaches to governance that hold inherent tensions with other dominant governance styles and forms. This approach perpetuates long-held power imbalances between those leading the research and those being researched. As an alternative, Indigenous governance focuses on the importance of place, people, relationships and process for addressing power imbalances and achieving equitable outcomes. However, empowering principles of Indigenous governance in mainstream environments is a major challenge for research projects and teams working within organisations that are regulated by Western standards and conventions. This paper outlines the theoretical basis for a new Culturally Adaptive Governance Framework (CAGF) for empowering principles of Indigenous governance as a prerequisite for ethical conduct and practice in Indigenous health research. We suggest new orientations for mainstream research project governance, predicated on translating theoretical and practical attributes of real-world ethics, adaptive governance and critical allyship frameworks to Indigenous health research. The CAGF is being implemented in a national Indigenous multicenter trial evaluating the use of continuous blood glucose monitors as a new technology with the potential to improve diabetes care and treatment for Indigenous Australians—the FlashGM Study. The CAGF is a governance framework that identifies the realities of power, acknowledges the complexities of culture and emerging health technologies, and foregrounds the principle of equity for mainstream Indigenous health research.
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ItemOvert and Covert Recordings of Health Care Consultations in Australia: Some Legal Considerations(Wiley-Blackwell Publishing Asia, 2021)There are legal considerations for both clinicians and patients when recording health care consultations.