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When Will Death Be? Legal Considerations and Regulatory Safeguards in Predictive Modelling Applications for End-of-Life Care. 何时死亡?临终关怀预测模型应用中的法律考虑因素和监管保障。
Q2 LAW Pub Date : 2023-12-01
Hui Yun Chan, Bernadette Richards

Advance care planning (ACP) is generally considered as valuable in guiding treatments that are aligned with patients' preferences. Despite its benefits, there are some practical and legal difficulties in its implementation. Predictive modelling is increasingly used in clinical decision-making, for example, in predicting patients' life expectancy, thus enabling clinicians to initiate timely ACP conversations. This development could transform the way end-of-life conversations are implemented. In this article we advocate for the use of predictive modelling in assisting clinicians to initiate ACP conversations provided several safeguards are in place to address ethical concerns that arise. Predictive modelling applications resolve several practical and legal difficulties in conducting end-of-life conversations. Ethical concerns such as explicability, accountability, trustworthiness and reliability of these models in clinical settings are important considerations. However, safeguards are needed to address these ethical concerns to ensure the models are appropriately supportive of patient needs and interests.

人们普遍认为,预先护理计划(ACP)在指导治疗方法与患者的偏好相一致方面很有价值。尽管它有很多好处,但在实施过程中也存在一些实际和法律上的困难。预测建模越来越多地应用于临床决策,例如预测患者的预期寿命,从而使临床医生能够及时启动 ACP 对话。这一发展可能会改变生命末期谈话的实施方式。在这篇文章中,我们主张使用预测建模来协助临床医生启动 ACP 对话,但前提是必须采取一些保障措施来解决出现的伦理问题。预测建模的应用解决了进行生命末期谈话时的一些实际和法律难题。这些模型在临床环境中的可解释性、责任性、可信性和可靠性等伦理问题都是重要的考虑因素。然而,需要采取保障措施来解决这些伦理问题,以确保这些模型能够适当地支持病人的需求和利益。
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引用次数: 0
Family Veto in Organ Donation. 器官捐赠中的家庭否决权。
Q2 LAW Pub Date : 2023-12-01
David Ernest

A current inconsistency in organ donation is the ability for a family to veto a valid consent for organ donation by a deceased individual; yet the family is unable to veto a valid refusal. Reasons proposed for accepting or rejecting family veto include concerns regarding distress (individual's family vs potential recipients), impact on organ donation rates, and regard for the deceased individual's autonomy. Advance care directives (ACDs) provide an ethical and legal framework for documenting medical treatment decisions which allow an individual to provide directives and to appoint a medical treatment decision-maker to act on their behalf. I argue that consent for organ donation as an ACD under the Medical Treatment Planning and Decisions Act 2016 (Vic) addresses the arguments in support of family veto. This may be an effective ethical and legal framework for managing family veto to meet the needs of the individual, family and community more effectively.

目前,器官捐献中的一个不一致之处是,家属可以否决已故者器官捐献的有效同意;但家属却不能否决有效的拒绝。接受或拒绝家属否决的理由包括对痛苦的担忧(个人家属与潜在接受者)、对器官捐献率的影响以及对死者自主权的考虑。预先护理指示(Advance Care Directives,ACD)为记录医疗决定提供了一个伦理和法律框架,允许个人提供指示,并指定一名医疗决策者代表他们行事。我认为,根据《2016 年医疗计划和决定法》(维多利亚州),器官捐赠同意书作为一种 ACD,解决了支持家庭否决权的论点。这可能是管理家庭否决权的有效伦理和法律框架,以更有效地满足个人、家庭和社区的需求。
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引用次数: 0
Conscientious Objection and Institutional Objection to Voluntary Assistance in Dying: An Ethico-legal Critique. 对临终自愿协助的良心反对和机构反对:伦理-法律批判》。
Q2 LAW Pub Date : 2023-12-01
Ian Kerridge, Cameron Stewart, Jackie Leach Scully, Mary Chiarella, Julie Hamblin, Adam Johnson, Christopher Ryan, Linda Sheahan, George Skowronski

This column examines conscientious objection and institutional objection in Australian voluntary assistance in dying. It reviews the current legislative regimes and then examines these practices from an ethical perspective, and raises particular concerns and suggestions with how conscientious objection and institutional objection should be operationalised.

本专栏探讨了澳大利亚自愿临终关怀中的良心反对和机构反对。它回顾了当前的立法制度,然后从伦理学的角度对这些做法进行了研究,并就如何实施良心反对和机构反对提出了特别关注的问题和建议。
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引用次数: 0
Artificial Intelligence in Medicine: Issues When Determining Negligence. 人工智能在医学中的应用:确定过失时的问题。
Q2 LAW Pub Date : 2023-12-01
Paul Nolan, Rita Matulionyte

The introduction of novel medical technology, such as artificial intelligence (AI), into traditional clinical practice presents legal liability challenges that need to be squarely addressed by litigants and courts when something goes wrong. Some of the most promising applications for the use of AI in medicine will lead to vexed liability questions. As AI in health care is in its relative infancy, there is a paucity of case law globally upon which to draw. This article analyses medical malpractice where AI is involved, what problems arise when applying the tort of negligence - such as establishing the essential elements of breach of duty of care and causation - and how can these can be addressed. Product liability under Australian Consumer Law is beyond the scope of this article. In order to address this question, the article: (1) identifies the general problems that black box AI causes in the health care sector; (2) identifies the problems that will arise in establishing breach and causation due to the "black box" nature of AI, with reference to the Civil Liability Act 2002 (NSW) and common law through two hypothetical examples; and (3) considers selected legal solutions to the problems caused by "black box" AI.

在传统临床实践中引入人工智能(AI)等新型医疗技术会带来法律责任方面的挑战,当出现问题时,诉讼当事人和法院需要正视这些挑战。人工智能在医疗领域的一些最有前景的应用将导致棘手的责任问题。由于人工智能在医疗领域的应用尚处于起步阶段,全球范围内可借鉴的判例法并不多。本文分析了涉及人工智能的医疗事故,在适用过失侵权时会出现哪些问题--例如确定违反护理责任和因果关系的基本要素--以及如何解决这些问题。澳大利亚消费者法》规定的产品责任不在本文讨论范围之内。为了解决这个问题,本文将(1)确定黑盒人工智能在医疗保健领域造成的一般问题;(2)参照《2002 年民事责任法》(新南威尔士州)和普通法,通过两个假设的例子,确定由于人工智能的 "黑盒 "性质而在确定违约和因果关系时会出现的问题;以及(3)考虑针对 "黑盒 "人工智能造成的问题所选择的法律解决方案。
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引用次数: 0
Disability Law Reform in Australia: Principles, Pragmatism and Politics. 澳大利亚残疾法改革:原则、实用主义和政治。
Q2 LAW Pub Date : 2023-12-01
Ian Freckelton

This editorial reviews two landmark contributions to disability reform in Australia, both published in 2023 - the 12 volume report of the Royal Commission into Violence, Abuse, Neglect and Exploitation of People with Disability and the important Commonwealth Government of Australia report on the operation of the 10-year-old National Disability Insurance Scheme. It contends that each leaves Australia with major steps that need to be taken to enable persons with disability to live in a fairer, safer and more inclusive environment in which their human rights are genuinely respected. The reports contain many challenges where a balance needs to be orchestrated between implementation of principled reform and what is financially feasible. If Australia's governments are to adopt the recommendations in the reports, politics will need to be set aside and collaboration between Federal and State governments will be essential. Attitudes and practices will have to change in government and the general community, laws, protocols and even institutions will need to be reformed, accountability mechanisms will need to be tightened, and considerable sums of money will have to be spent.

这篇社论回顾了 2023 年出版的两份对澳大利亚残疾人改革具有里程碑意义的报告--皇家残疾人暴力、虐待、忽视和剥削问题委员会(Royal Commission into Violence, Abuse, Neglect and Exploitation of People with Disability)的 12 卷报告,以及澳大利亚联邦政府(Commonwealth Government of Australia)关于实施 10 年之久的国家残疾人保险计划(National Disability Insurance Scheme)的重要报告。报告认为,这两份报告都给澳大利亚留下了需要采取的重大措施,以使残疾人能够生活在一个更公平、更安全、更具包容性的环境中,使他们的人权得到真正的尊重。这些报告包含了许多挑战,需要在实施原则性改革与财政可行之间取得平衡。如果澳大利亚政府要采纳报告中的建议,就必须摒弃政治因素,联邦政府和州政府之间的合作至关重要。政府和社会各界的态度和做法必须改变,法律、协议甚至机构都必须改革,问责机制必须加强,还必须花费大量资金。
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引用次数: 0
Expert Evidence of "Risk Assessments" and the Preventive Detention of "Dangerous Prisoners". 风险评估 "和预防性拘留 "危险囚犯 "的专家证据。
Q2 LAW Pub Date : 2023-12-01
Russ Scott, Ian Coyle, Ian Freckelton

The Dangerous Prisoners (Sexual Offenders) Act 2003 (Qld) provides for the preventive detention of a prisoner if there is "acceptable, cogent evidence" to a "high degree of probability" that the prisoner is a "serious danger to the community" because of an "unacceptable risk" that the prisoner will commit a "serious sexual offence". In preventive detention cases courts rely on the expert opinion of psychiatrists and psychologists who often use actuarial risk assessment instruments. In Black v Attorney-General (Qld) [2022] QCA 253 the Queensland Court of Appeal considered a decision to detain an offender who had a history of possessing and trading child sexual exploitation material but who had not previously been proved to have committed a contact offence against a child. This article analyses the reasoning of the Court of Appeal and critically examines the reliability of probabilistic risk assessment tools and the validity of expert evidence about risk in the preventive detention context.

2003 年《危险囚犯(性罪犯)法》(昆士兰州)规定,如果有 "可接受的确凿证据 "证明囚犯 "极有可能 "因 "不可接受的风险 "而实施 "严重的性犯罪",从而 "对社区构成严重威胁",则可对囚犯实施预防性拘留。在预防性拘留案件中,法院依靠精神科医生和心理学家的专家意见,他们通常使用精算风险评估工具。在 Black 诉总检察长(昆士兰)[2022] QCA 253 一案中,昆士兰上诉法院审议了一项拘留罪犯的决定,该罪犯有持有和买卖儿童性剥削材料的前科,但此前未被证实对儿童实施过接触性犯罪。本文分析了上诉法院的推理,并批判性地研究了概率风险评估工具的可靠性以及预防性拘留情况下专家风险证据的有效性。
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引用次数: 0
Investigating Investigation Powers under the Health Practitioner Regulation National Law. 调查《国家卫生从业人员管理法》规定的调查权力。
Q2 LAW Pub Date : 2023-12-01
Chris Corns

Investigators and inspectors appointed under the Australia Health Practitioner Regulation National Law play important roles by gathering and assessing evidence used in disciplinary proceedings and/or criminal prosecutions. In performing these roles, investigators and inspectors exercise "police-like" powers including coercive questioning and entry onto private property with or without a search warrant. The investigation process can add additional stress and anxiety for health practitioners who are subject to disciplinary proceedings. It is difficult for an aggrieved party to challenge the lawfulness of the exercise of an investigation power in a tribunal as tribunals lack jurisdiction to rule on the legality of an investigation power or the admissibility of evidence. This article explores the range of powers possessed by investigators and inspectors under the National Law and a number of issues relating to the exercise of those powers.

根据《澳大利亚卫生从业人员管理国家法》任命的调查员和检查员在收集和评估用于纪律处分程序和/或刑事诉讼的证据方面发挥着重要作用。在履行这些职责时,调查员和检查员会行使 "类似警察 "的权力,包括强制询问和在有或没有搜查证的情况下进入私人住宅。调查过程会给受到纪律处分的医疗从业人员增加额外的压力和焦虑。受害方很难在法庭上质疑行使调查权的合法性,因为法庭无权裁定调查权的合法性或证据的可采性。本文探讨了《国家法》赋予调查员和检查员的一系列权力,以及与行使这些权力有关的一些问题。
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引用次数: 0
Work Stress, Vicarious Trauma and the Public Mental Health Framework: Kozarov v Victoria [2022] HCA 12 and Its Aftermath. 工作压力、继发性创伤和公共心理健康框架:Kozarov 诉维多利亚州 [2022] HCA 12 案及其后果》。
Q2 LAW Pub Date : 2023-12-01
Kay Wilson, Ian Freckelton

The Public Mental Health Framework argues that law and policy are important in preventing mental ill-health and promoting wellbeing. Therefore, the 2022 decision of the Australian High Court in Kozarov v Victoria (Kozarov), in which a lawyer from the Office of Public Prosecutions (OPP) who worked in the Specialist Sex Offences Unit successfully claimed damages for vicarious trauma, has significant implications for the legal profession and those who are employed in emotionally demanding work. This article provides commentary on the Kozarov decision, within the context of other Australian case law including subsequent cases. It explores the significance of Kozarov and post-Kozarov authority for the development of (1) the law in "work stress" cases; (2) employers in the wake of the decision, including the OPP; and (3) the Public Mental Health Framework in relation to work stress and sexual violence as social determinants of health and mental health.

公共心理健康框架认为,法律和政策对于预防心理疾病和促进身心健康非常重要。因此,澳大利亚高等法院 2022 年对 Kozarov 诉维多利亚州(Kozarov)一案的判决(在该案中,一名在性犯罪专案组工作的检察院(OPP)律师成功地就替代性精神创伤提出了损害赔偿要求)对法律界和那些受雇从事情绪要求较高工作的人具有重大影响。本文结合澳大利亚其他案例法(包括后续案例)对 Kozarov 案的判决进行了评述。文章探讨了 Kozarov 案和 Kozarov 案之后的权威对以下方面发展的重要意义:(1)"工作压力 "案件中的法律;(2)判决后的雇主,包括检察官办公室;以及(3)与作为健康和心理健康社会决定因素的工作压力和性暴力有关的公共心理健康框架。
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引用次数: 0
Supporting the Involvement of Adults with Cognitive Disabilities in Research: The Need for Reform. 支持有认知障碍的成年人参与研究:改革的必要性》。
Q2 LAW Pub Date : 2023-07-01
Shih-Ning Then, John Chesterman, Yuu Matsuyama

This article examines current legal and ethical requirements concerning research about adults with cognitive disabilities. These requirements, the article argues, are complex, difficult to navigate, and inevitably act as a disincentive for research to be conducted. These requirements also do little to encourage active involvement by adults with cognitive disabilities in deciding whether to participate in research. The article argues that reforms are needed for State and Territory laws to require, wherever possible, adults to be supported to make their own decisions about research participation. State and Territory law reform is also required to clarify when, and on what basis, others may be appointed to make research participation decisions on behalf of adults with cognitive disabilities. The article concludes by seeking complementary reform of the National Health and Medical Research Council National Statement on Ethical Conduct in Human Research, which would result in it being more human rights compliant and simpler to apply.

本文探讨了当前有关认知障碍成人研究的法律和伦理要求。文章认为,这些要求既复杂又难以驾驭,不可避免地会阻碍研究的开展。此外,这些要求也不利于鼓励认知障碍成人积极参与决定是否参与研究。文章认为,需要对各州和地区的法律进行改革,要求尽可能支持成年人自己决定是否参与研究。各州和地区的法律也需要改革,以明确何时以及在什么基础上可以指定他人代表有认知障碍的成年人做出参与研究的决定。文章最后寻求对《国家健康与医学研究委员会关于人类研究伦理行为的国家声明》进行补充改革,使其更加符合人权要求,应用起来更加简单。
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引用次数: 0
The Patent Landscape for CRISPR Genome Editing in Australia. 澳大利亚 CRISPR 基因组编辑的专利情况。
Q2 LAW Pub Date : 2023-07-01
Naomi Foo, Olumayowa Adesanya, Jane Nielsen, Dianne Nicol

Although Australia has a proud record of health and medical research, it finds less traction when it comes to innovative product development. Patent filings are recognised as one of the measures of national innovation, and this is one measure where Australian innovators are falling short. We examined whether there may be discrete pockets of innovation in particular areas of technology where Australian researchers are making significant contributions. This study used patent filings as a measure of innovation and used clustered regularly interspaced short palindromic repeat (CRISPR) genome editing as a case study. We found a rich patent landscape, with filings for general methods and compositions and for specific diseases. However, the contribution by Australian applicants was small, with only four out of 519 filings. This indicates that navigating the CRISPR patent landscape to secure freedom to operate is likely to be complex for Australian innovators in this field.

尽管澳大利亚在健康和医学研究方面有着令人骄傲的记录,但在创新产品开发方面却少有建树。专利申请被认为是衡量国家创新能力的标准之一,而这正是澳大利亚创新能力不足的一个方面。我们研究了在澳大利亚研究人员做出重大贡献的特定技术领域中,是否存在离散的创新区。本研究使用专利申请作为衡量创新的标准,并以聚类规则间隔短回文重复(CRISPR)基因组编辑技术作为案例研究。我们发现了丰富的专利申请情况,既有针对一般方法和组合物的专利申请,也有针对特定疾病的专利申请。然而,澳大利亚申请人的贡献却很小,在519件申请中只有4件。这表明,对于该领域的澳大利亚创新者来说,要想在 CRISPR 专利领域获得运营自由,可能会非常复杂。
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引用次数: 0
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Journal of Law and Medicine
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