{"title":"The AI cycle of health inequity and digital ageism: mitigating biases through the EU regulatory framework on medical devices","authors":"Hannah van Kolfschooten","doi":"10.1093/jlb/lsad031","DOIUrl":"https://doi.org/10.1093/jlb/lsad031","url":null,"abstract":"Abstract The use of Artificial Intelligence (AI) medical devices is rapidly growing. Although AI may benefit the quality and safety of healthcare for older adults, it simultaneously introduces new ethical and legal issues. Many AI medical devices exhibit age-related biases. The first part of this paper explains how ‘digital ageism’ is produced throughout the entire lifecycle of medical AI and may lead to health inequity for older people: systemic, avoidable differences in the health status of different population groups. This paper takes digital ageism as a use case to show the potential inequitable effects of AI, conceptualized as the ‘AI cycle of health inequity’. The second part of this paper explores how the European Union (EU) regulatory framework addresses the issue of digital ageism. It argues that the negative effects of age-related bias in AI medical devices are insufficiently recognized within the regulatory framework of the EU Medical Devices Regulation and the new AI Act. It concludes that while the EU framework does address some of the key issues related to technical biases in AI medical devices by stipulating rules for performance and data quality, it does not account for contextual biases, therefore neglecting part of the AI cycle of health inequity.","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":"40 15","pages":""},"PeriodicalIF":3.4,"publicationDate":"2023-12-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138593818","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Cryopreservation and current legal problems: seeking and selling immortality.","authors":"Alexandra Mullock, Elizabeth Chloe Romanis","doi":"10.1093/jlb/lsad028","DOIUrl":"https://doi.org/10.1093/jlb/lsad028","url":null,"abstract":"<p><p>Cryonics, the 'freezing' of the human body after death in the hope of reanimation in the future, remains a remote possibility, and yet it is becoming a more popular choice. There has been much academic discussion of the ethics of cryopreservation; however, the legal problems have received little attention. There are, however, several potential current conflicts that might arise, as was illustrated by the case of <i>JS</i> in England, in which a 14-year-old girl who sought cryopreservation against her father's wishes. In the USA, there have been disputes within families about cryonic preservation, and between cryonics organizations and loved ones of the deceased when there is negligent preservation. Cryopreservation raises questions concerning the law on death and posthumous interests, property in the body, contract law, and (potentially) negligence. We argue that, in the absence of proper regulation, cryonics organizations may be able to exploit the dying and dead. The potential legal problems that we have identified in relation to the law in England and Wales demonstrate that the law is ill-equipped to protect the interests of the dead and their next of kin.</p>","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":"10 2","pages":"lsad028"},"PeriodicalIF":3.4,"publicationDate":"2023-11-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10639002/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89720819","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"<i>'The law is very, very outdated and not keeping up with the technology':</i> novel forms of assisted gestation, legal challenges, and perspectives of reproductive rights advocates in England and Wales.","authors":"Elizabeth Chloe Romanis","doi":"10.1093/jlb/lsad027","DOIUrl":"https://doi.org/10.1093/jlb/lsad027","url":null,"abstract":"<p><p>A growing body of literature examines the ethico-legal challenges resulting from novel forms of assisted gestation like uterus transplantation and artificial placentas (also known as 'artificial wombs'). However, there has not yet been consideration of reproductive rights organizations/advocates' understandings of novel forms of assisted gestation and their challenges. These perspectives provide critical insight into how novel procreative practices are understood and the problems and pressures that might arise from their use. This is the first legal article to engage with reproductive rights organizations/advocates and thus it provides important contextual grounding to existing scholarship about assisted gestation. Focus group discussion epitomized the need for legal reform in key areas surrounding reproduction. Themes were constructed that exemplify what participants highlighted as critical: the need to re-evaluate the fundamentals of legal parenthood, consideration of how novel technologies could further enable the policing of gestation, and the space and time needed for law-making.</p>","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":"10 2","pages":"lsad027"},"PeriodicalIF":3.4,"publicationDate":"2023-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10629861/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"71523522","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Matthew R O'Shaughnessy, Walter G Johnson, Lucille Nalbach Tournas, Christopher J Rozell, Karen S Rommelfanger
{"title":"Neuroethics guidance documents: principles, analysis, and implementation strategies.","authors":"Matthew R O'Shaughnessy, Walter G Johnson, Lucille Nalbach Tournas, Christopher J Rozell, Karen S Rommelfanger","doi":"10.1093/jlb/lsad025","DOIUrl":"10.1093/jlb/lsad025","url":null,"abstract":"<p><p>Innovations in neurotechnologies have ignited conversations about ethics around the world, with implications for researchers, policymakers, and the private sector. The human rights impacts of neurotechnologies have drawn the attention of United Nations bodies; nearly 40 states are tasked with implementing the Organization for Economic Co-operation and Development's principles for responsible innovation in neurotechnology; and the United States is considering placing export controls on brain-computer interfaces. Against this backdrop, we offer the first review and analysis of neuroethics guidance documents recently issued by prominent government, private, and academic groups, focusing on commonalities and divergences in articulated goals; envisioned roles and responsibilities of different stakeholder groups; and the suggested role of the public. Drawing on lessons from the governance of other emerging technologies, we suggest implementation and evaluation strategies to guide practitioners and policymakers in operationalizing these ethical norms in research, business, and policy settings.</p>","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":"10 2","pages":"lsad025"},"PeriodicalIF":3.4,"publicationDate":"2023-10-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10602660/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"71415406","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Implementing the human right to science in the regulatory governance of artificial intelligence in healthcare.","authors":"Calvin W L Ho","doi":"10.1093/jlb/lsad026","DOIUrl":"https://doi.org/10.1093/jlb/lsad026","url":null,"abstract":"<p><p>Artificial intelligence (AI) enables a medical device to optimize its performance through machine learning (ML), including the ability to learn from past experiences. In healthcare, ML is currently applied within controlled settings in devices to diagnose conditions like diabetic retinopathy without clinician input, for instance. In order to allow AI-based medical devices (AIMDs) to adapt actively to its data environment through ML, the current risk-based regulatory approaches are inadequate in facilitating this technological progression. Recent and innovative regulatory changes introduced to regulate AIMDs as a software, or 'software as a medical device' (SaMD), and the adoption of a total device/product-specific lifecycle approach (rather than one that is point-in-time) reflect a shift away from the strictly risk-based approach to one that is more collaborative and participatory in nature, and anticipatory in character. These features are better explained by a rights-based approach and consistent with the human right to science (HRS). With reference to the recent explication of the normative content of HRS by the Committee on Economic, Social and Cultural Rights of the United Nations, this paper explains why a rights-based approach that is centred on HRS could be a more effective response to the regulatory challenges posed by AIMDs. The paper also considers how such a rights-based approach could be implemented in the form of a regulatory network that draws on a 'common fund of knowledges' to formulate anticipatory responses to adaptive AIMDs. In essence, the HRS provides both the mandate and the obligation for states to ensure that regulatory governance of high connectivity AIMDs become increasingly collaborative and participatory in approach and pluralistic in substance.</p>","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":"10 2","pages":"lsad026"},"PeriodicalIF":3.4,"publicationDate":"2023-10-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10581746/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"49685506","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Doctors’ duty to provide abortion information","authors":"M. Oberman, Lisa Soleymani Lehmann","doi":"10.2139/ssrn.4430194","DOIUrl":"https://doi.org/10.2139/ssrn.4430194","url":null,"abstract":"Abstract With abortion remaining legal in over half of the country and a proliferation of websites offering information on how to access abortion medications, for those who know where to look, there are sound options for safely ending an unwanted early-stage pregnancy. But not all patients have equal access to reliable information. This Article addresses the urgent downstream harms caused by the lack of access to abortion information, and argues that in view of these consequences, regardless of abortion’s legal status, clinicians have a duty to provide their patients with abortion information. We begin by documenting clinicians’ hesitation to share abortion information, drawing on our interviews with 25 doctors practicing medicine in a state where abortion is criminalized. Next, we explain why clinicians are duty-bound to provide all-options counseling. We then consider whether such duties shift where abortion is criminalized. After identifying the limited legal risks associated with supplying abortion information, and showing how, by requiring all-options counseling, professional societies might reduce risks to patients and clinicians, we conclude that, regardless of the legal status of abortion, clinicians have a professional responsibility to share basic abortion information – including treatment options and how to access those options.","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":"10 1","pages":""},"PeriodicalIF":3.4,"publicationDate":"2023-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"46834929","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Genetic data are not always personal-disaggregating the identifiability and sensitivity of genetic data.","authors":"Johanna Rahnasto","doi":"10.1093/jlb/lsad029","DOIUrl":"https://doi.org/10.1093/jlb/lsad029","url":null,"abstract":"<p><p>In both the EU and USA, genetic data are recognized as a special category of data that requires heightened privacy protection. Identifiability and sensitivity are central pillars of the regulatory framework in both jurisdictions: the privacy concerns stem from the assumption that genetic data are capable of identifying the individual and reveals sensitive information about them. But not all genetic data are identifiable and sensitive, nor are genetic data necessarily different from other types of big data in terms of these issues. This article argues that a more nuanced approach is needed to assess the threat to privacy interests posed by uses of genetic data. The privacy interests involved should be distinguished in terms of proposed use, the amount of data in question, and its uniqueness and informational content. When these factors are disaggregated, it is clear that both regulatory schemes could better achieve their goals by focusing more on the ways genetic data can be used rather than on their status as a special category of data.</p>","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":"10 2","pages":"lsad029"},"PeriodicalIF":3.4,"publicationDate":"2023-07-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10676748/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138464677","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Anna Nuechterlein, Ari Rotenberg, Jeff LeDue, Paul Pavlidis, Judy Illes
{"title":"Open science in play and in tension with patent protections.","authors":"Anna Nuechterlein, Ari Rotenberg, Jeff LeDue, Paul Pavlidis, Judy Illes","doi":"10.1093/jlb/lsad016","DOIUrl":"10.1093/jlb/lsad016","url":null,"abstract":"<p><p>The open science (OS) movement has garnered increasing support in academia alongside continued financial and reputational incentives to obtain intellectual property (IP) protections over research outputs. Here, we explore stakeholder perspectives about intersections between OS and IP to inform the development of institutional OS guidelines for the neurosciences in Canada. We held six focus groups and three interviews with 29 faculty members from a major research and clinical center in Canada. The semi-structured interview guide probed perspectives on the respective roles of patents and OS in neuroscience-related research. We applied thematic content analysis to the transcript data, and extracted 12 major themes and 30 subthemes. Participants perceived a conflict between OS ideologies and the inherently restrictive nature of patents, and highlighted the importance of autonomy, justice, and respectful, culturally safe research practices in any future adoption of OS. Overall, the data suggest that a hybrid OS-IP policy model supported by local expertise may be best suited to meet the priorities and values of the community while mitigating perceived threats. This model includes expanded education about patenting, incentivized data sharing and collaboration, and tangible resources to support implementation of OS that includes skilled support in digital research infrastructures.</p>","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":"10 2","pages":"lsad016"},"PeriodicalIF":3.4,"publicationDate":"2023-07-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/74/2c/lsad016.PMC10357088.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9858020","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Patent term extension and test data protection obligations: identifying the gap in policy, research, and practice of implementing free trade agreements.","authors":"Bryan Mercurio, Pratyush Nath Upreti","doi":"10.1093/jlb/lsad017","DOIUrl":"10.1093/jlb/lsad017","url":null,"abstract":"<p><p>Much of the academic literature criticizes the inclusion of patent term extensions (PTE) and test data protection into the pharmaceutical provisions and/or intellectual property (IP) chapters of free trade agreements (FTAs), with many arguing that such provisions will increase the cost of pharmaceuticals for the implementing government. Such arguments are often backed by studies conducted prior to the conclusion of the relevant FTA. This is problematic for several reasons, most notably that the studies make assumptions that subsequently turn out not to be false and that the claims are not revisited and supported with empirical data following implementation. This article reviews the experience of two jurisdictions - Canada and Australia - in order to provide an analysis of legislative and judicial practices with a focus on implications and the cost of FTAs. The article examines how Canada and Australia have implemented their FTA obligations domestically and on the hereto ignored but important role of courts. One key finding is how courts in both countries are vigilant in narrowing the scope of obligations under FTAs to accommodate the need of the domestic market. The article ultimately concludes by calling on governments to conduct a detailed analysis of PTE and test data protection so as to better inform and prepare policymakers and, ultimately, improved FTA provisions and health outcomes.</p>","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":"10 1","pages":"lsad017"},"PeriodicalIF":3.4,"publicationDate":"2023-07-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10354413/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9849469","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"The right to terminate pregnancy (abortion): reflections from Turkey.","authors":"Hatice Kübra Ercoşkun Şenol, Pelin Ercoşkun","doi":"10.1093/jlb/lsad023","DOIUrl":"https://doi.org/10.1093/jlb/lsad023","url":null,"abstract":"<p><p>In this article, the right to terminate pregnancy is discussed comparatively in terms of the situation in Turkey and the rest of the world. We have concluded that certain minimum conditions must be met to be able to talk about the full recognition of this right. Recognizing that pregnancy can be terminated voluntarily is the most important of these conditions. Just as the period in which this right can be exercised should not be kept short, it should also be accepted that it can only be used based on the will of a pregnant person who has the power of discernment. In addition, certain obligations must be avoided, such as receiving counseling services before the termination of pregnancy and then waiting for a certain period of time to pass. In cases where pregnancy can be terminated because of an anomaly, a disease, or a crime, it is important to make clear arrangements that will not make practitioners, especially physicians, hesitate to perform such a procedure. Finally, the State must never forget that it is obliged to organize services for the termination of pregnancies in a way that is easily accessible to everyone who may need this procedure.</p>","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":"10 2","pages":"lsad023"},"PeriodicalIF":3.4,"publicationDate":"2023-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10475352/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10161238","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}