Medical Law Review最新文献

Artificial Intelligence (AI) is revolutionizing healthcare by enhancing patient care, diagnostics, workflows, and treatment personalization. The integration of AI in healthcare promises significant advancements and better patient outcomes. However, the lack of explainability in many AI models, known as 'black-box AI', raises concerns for patients, doctors, and developers. This issue, termed 'black box medicine', challenges the adoption of AI in healthcare. The demand for explainable AI has grown as AI systems become more complex. The absence of explanations in AI decisions, especially in critical situations like healthcare, has sparked debates and even suggestions to exclude black-box AI from healthcare provision. This article examines the impact and causes of unexplainable AI in healthcare, critically evaluates its performance, and proposes strategies to address this challenge.

Despite extensive literature examining intellectual property rights (IPRs) and access to health, there has been limited examination of how IPRs can potentially impact the development, access to, delivery of, and use of medical devices. This article fills this gap, focusing on patent and copyright protections applicable to elements of medical devices that are attachable to or implanted into the human body, such as prostheses or pacemakers. Although the human body itself is not patentable in Europe (Article 5, Biotechnology Directive), elements of medical devices created outside the body are patentable. Moreover, certain aspects of such medical devices can be subject to copyright, and other types of IPRs. This article provides an overview of the types of IPRs that can apply over attachable and implantable medical devices. Following this, and focusing specifically on copyright and patent rights, it argues that such IPRs, alongside incentivizing technological development in certain contexts, also give rightsholders significant control over key aspects of how individuals use and access IP-protected elements of such devices, with the potential for health-related impacts and bioethical implications. Accordingly, the article argues that greater understanding and scrutiny are needed within the health law and bioethics communities around the potential impacts of IPRs over medical devices.

The UK National Health Service general practice (GP) patient data constitute a rich research resource, but collecting, managing, and sharing patient data present challenges. In May 2021, to address these challenges, substantial changes to the system for processing pseudonymized GP patient data in England were announced. As part of an opt-out process, patient consent to sharing GP data was deemed to have been given. However, when over a million people quickly acted to opt out of the new system, the process was paused, and an engagement exercise commenced, whose aim was to inform a re-designed programme addressing patient concerns. In this article, we present and discuss the findings of the General Practice Data Trust pilot study, which has investigated people's reasons for opting out of sharing their data, and, looking for practical solutions to their concerns, has discussed with participants the concept of a 'data trust' to manage the sharing of patient data. Making a conceptual argument for the use of the (relatively new) charitable incorporated organization as a governance model for a GP data trust, we demonstrate how this could address patients' concerns and represent a more attractive means of stewarding GP data for research and service planning purposes.

It is widely accepted that voluntary assisted dying (VAD) should be regulated but little is known about the most effective way to regulate doctors in this setting. This article reports on empirical research conducted in two Australian states where VAD is lawful (Victoria and Western Australia). Interviews were conducted with 92 participants: one group comprised doctors providing VAD and the other group was regulators in this field. Participants were asked about how best to regulate doctors providing this service. Strikingly, both regulator and doctor participant groups were consistent with each other in their views on what constituted effective regulation. The nature of VAD was perceived by participants to require special regulation, although some felt this was overdone in these states. Reported features of effective regulation included regulators taking an educative approach, regulation being perceived as acceptable by doctors, and it being responsive and nimble to provide the guidance that doctors need. Participants also considered a range of regulatory tools were required to regulate VAD effectively, and some identified a need for these tools to be employed together in a holistic way. This article concludes with a set of principles for effective regulation of VAD, discerned from the views of participants.

System-level decisions around the commissioning and provision of healthcare services in England have contributed to barriers in accessing the National Health Service. In this article, we ask how to better regulate resource allocation to ensure greater equity in access to healthcare services. First, we focus on the Health and Care Act 2022, which, drawing on principles of deliberative regulation to address health inequalities, initiates a shift away from previous regulatory approaches towards a collaborative decision-making model. We then shed light on the systemic factors creating and maintaining access barriers by considering shortcomings in previous regulatory approaches. With these in mind, we consider whether deliberative regulation-providing communities with resources to create normative solutions to intrinsic issues-could help address these systemic challenges. To assess the potential of laws or policies to achieve greater equity in healthcare, we also introduce an evaluative framework based on deliberative principles. We apply this framework to a case study of an Integrated Care System to gauge the extent to which the Health and Care Act 2022 has indeed been effectively adopting a deliberative approach by intentionally engaging marginalized communities in decision-making and devising accountability mechanisms for the allocation of healthcare resources.

Health, mental health, and well-being are not 'natural' but are shaped by social and environmental factors. This article aims to reorient the development of all laws and policies to do more to prevent mental ill-health and promote well-being as a core function of the contemporary state. It introduces a new conceptual and empirical model, the Public Mental Health Framework, based on three areas of research: (i) the social determinants of health and mental health, which include social structures and daily living conditions (such as poverty, inequality, education, employment, discrimination, adverse childhood experiences, and crime); (ii) health and human rights; and (iii) the intermediate social model of disability. It then explains how the Public Mental Health Framework can be incorporated into law and policy development through parliamentary analysis similar to that used for 'statements of compatibility' in the Human Rights Act 1998 (UK) and legislation such as the Wellbeing of Future Generations (Wales) Act 2015 (Wales), interdepartmental administrative structures, proactive strategic planning, and continued advocacy.

Patients harmed by medical mishaps are often driven to litigation because of a lack of apologies and candour rather than a desire for monetary compensation. Despite attempts at clinical negligence reform, patients continue to receive unsatisfactory responses. Physicians have cited fears of legal liability as a key reason for withholding apologies. Apology legislation has been proposed as a possible solution to encourage apologies by rendering them inadmissible as evidence of liability, thereby reducing the legal risks of apologies. Critics, however, contend that apology legislation may encourage strategic formulaic responses instead of compassionate patient-centred support. This article delivers a comprehensive rejoinder to these concerns, and argues that bold legislative change similar to that of Hong Kong's enactment of full apology protection aligns with English and Welsh clinical negligence reform goals. Through a robust comparative legal analysis of various jurisdictions in which apology laws have been enacted, this article explores the legal, ethical, and practical factors that contribute to the proper functioning of such laws. It then recommends concrete ways to improve the effectiveness of such laws in the context of clinical negligence reform, thereby removing barriers to apologetic discourse and breathing ethical and professional life into the doctor's apology.