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How AI challenges the medical device regulation: patient safety, benefits, and intended uses J Law Biosci (IF 3.4) Pub Date : 2024-04-09 Daria Onitiu, Sandra Wachter, Brent Mittelstadt
This article examines whether the EU Medical Device Regulation (MDR) adequately addresses the novel risks of AI-based medical devices (AIaMDs), focusing on AI medical imaging tools. It examines two questions: first, does the MDR effectively deal with issues of adaptability, autonomy, bias, opacity, and the need of trustworthiness of AIaMD? Second, does the manufacturer’s translation of the MDR’s requirements
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Implementing the human right to science in the context of health-related data processing J Law Biosci (IF 3.4) Pub Date : 2024-03-16 Fruzsina Molnár-Gábor
This paper contributes to the exploration of the potential application of duties related to the diligent anticipation of the (imminent) harms and (potential) benefits to humans that scientific innovation engenders to health-related contexts. In particular, it addresses the intersection between the human right to science and health-related data processing, which plays a key role in the production, translation
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U.S. public perceptions of the sensitivity of brain data J Law Biosci (IF 3.4) Pub Date : 2024-01-21 Shenyang Huang, Umika Paul, Shikhar Gupta, Karen Desai, Melinda Guo, Jennifer Jung, Beatrice Capestany, William D Krenzer, Dylan Stonecipher, Nita Farahany
As we approach an era of potentially widespread consumer neurotechnology, scholars and organizations worldwide have started to raise concerns about the data privacy issues these devices will present. Notably absent in these discussions is empirical evidence about how the public perceives that same information. This article presents the results of a nationwide survey on public perceptions of brain data
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The regulation of health data sharing in Africa: a comparative study J Law Biosci (IF 3.4) Pub Date : 2024-01-21 Annelize G Nienaber McKay, Dirk Brand, Marietjie Botes, Nezerith Cengiz, Marno Swart
The sharing of health data is an essential component in the provision of healthcare, in medical research, and disease surveillance. Health data sharing is subject to regulatory frameworks that vary across jurisdictions. In Africa, numerous factors complicate the regulation of health data sharing, including technological, motivational, economic, and political barriers, as well as ethical and legal challenges
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Leading with the trailing edge: facilitating patient choice for insulin products J Law Biosci (IF 3.4) Pub Date : 2023-12-13 Robin Feldman
Insulin prices have risen sharply, despite a century since its introduction. Against this backdrop, companies have discontinued dozens of insulin products. Discontinuation could relate to safety or effectiveness, or to the overwhelming benefits of newer products. On the other hand, discontinuation could suggest strategic behavior hampering competition and supporting prices. To test these theories,
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Cryopreservation and current legal problems: seeking and selling immortality J Law Biosci (IF 3.4) Pub Date : 2023-11-11 Alexandra Mullock, Elizabeth Chloe Romanis
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
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‘The law is very, very outdated and not keeping up with the technology’: novel forms of assisted gestation, legal challenges, and perspectives of reproductive rights advocates in England and Wales J Law Biosci (IF 3.4) Pub Date : 2023-11-07 Elizabeth Chloe Romanis
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
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Neuroethics guidance documents: principles, analysis, and implementation strategies. J Law Biosci (IF 3.4) Pub Date : 2023-10-26 Matthew R O'Shaughnessy,Walter G Johnson,Lucille Nalbach Tournas,Christopher J Rozell,Karen S Rommelfanger
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
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Implementing the human right to science in the regulatory governance of artificial intelligence in healthcare J Law Biosci (IF 3.4) Pub Date : 2023-10-18 Calvin W L Ho
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
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The right to terminate pregnancy (abortion): reflections from Turkey. J Law Biosci (IF 3.4) Pub Date : 2023-09-03 Hatice Kübra Ercoşkun Şenol,Pelin Ercoşkun
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
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Doctors' duty to provide abortion information. J Law Biosci (IF 3.4) Pub Date : 2023-09-01 Michelle Oberman,Lisa Soleymani Lehmann
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
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Genetic data are not always personal-disaggregating the identifiability and sensitivity of genetic data. J Law Biosci (IF 3.4) Pub Date : 2023-07-24 Johanna Rahnasto
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
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Open science in play and in tension with patent protections J Law Biosci (IF 3.4) Pub Date : 2023-07-20 Anna Nuechterlein, Ari Rotenberg, Jeff LeDue, Paul Pavlidis, Judy Illes
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
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Patent term extension and test data protection obligations: identifying the gap in policy, research, and practice of implementing free trade agreements J Law Biosci (IF 3.4) Pub Date : 2023-07-19 Bryan Mercurio, Pratyush Nath Upreti
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
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Terms and conditions apply: an ethical analysis of mobile health user agreements in research J Law Biosci (IF 3.4) Pub Date : 2023-07-14 Luke Gelinas, Walker Morrell, Barbara E Bierer
Mobile health (mHealth) technologies raise unique risks to user privacy and confidentiality that are often embedded in lengthy and complex Privacy Policies, Terms of Use, and End User License Agreements. We seek to improve the ethical review of these documents (‘user agreements’) and their risks in research using mHealth technologies by providing a framework for identifying when these risks are research
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Policy options to facilitate cancer genomic variant data sharing: outcomes of a modified policy Delphi J Law Biosci (IF 3.4) Pub Date : 2023-07-14 Jill O Robinson, Amira Daoud, Janis Geary, Vasiliki Rahimzadeh, Juli Bollinger, Christi J Guerrini, Robert Cook-Deegan, Amy L McGuire, Mary A Majumder
Sharing cancer gene variant and relevant clinical data could accelerate progress in cancer genomics. However, data sharing is currently impeded by issues related to financial sustainability, equity, incentives, privacy and security, and data quality. Evidence-based policy options to facilitate data sharing in these domains, and ultimately improve interpretation of cancer-associated genomic variants
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Payer reimbursement practices and incentives for improving interpretation of germline genetic testing J Law Biosci (IF 3.4) Pub Date : 2023-07-11 Patricia Deverka, Janis Geary, Charles Mathews, Matan Cohen, Gillian Hooker, Mary Majumder, Zuzana Skvarkova, Robert Cook-Deegan
Germline genetic testing for inherited cancer risk has shifted to multi-gene panel tests (MGPTs). While MGPTs detect more pathogenic variants, they also detect more variants of uncertain significance (VUSs) that increase the possibility of harms such as unnecessary surgery. Data sharing by laboratories is critical to addressing the VUS problem. However, barriers to sharing and an absence of incentives
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How penalizing substance use in pregnancy affects treatment and research: a qualitative examination of researchers’ perspectives J Law Biosci (IF 3.4) Pub Date : 2023-07-11 Seema K Shah, Leishla Perez-Cardona, Khrystyna Helner, Suena H Massey, Ashish Premkumar, Renee Edwards, Elizabeth S Norton, Cynthia E Rogers, Emily S Miller, Christopher D Smyser, Matthew M Davis, Lauren S Wakschlag
Introduction Laws regulating substance use in pregnancy are changing and may have unintended consequences on scientific efforts to address the opioid epidemic. Yet, how these laws affect care and research is poorly understood. Methods We conducted semi-structured qualitative interviews using purposive and snowball sampling of researchers who have engaged pregnant people experiencing substance use.
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Is benefit sharing with research participants lawful in South Africa? An unexplored question in the governance of genomics research J Law Biosci (IF 3.4) Pub Date : 2023-06-29 Donrich Thaldar, Bonginkosi Shozi
Despite advocacy in favour of benefit sharing with research participants in genomics research that is conducted in South Africa, there has been little critical legal engagement with this concept. That is what this article provides by posing the hitherto unexplored—but foundational—question: Is benefit sharing with research participants lawful in South Africa? The answer is clearly ‘no’. South African
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Should Canada adopt managed access agreements in Canada for expensive drugs? J Law Biosci (IF 3.4) Pub Date : 2023-06-16 Melanie McPhail, Tania Bubela
Drugs are increasingly authorized based on less mature evidence, leaving payors faced with significant clinical and cost-effectiveness uncertainties. As a result, payors must often choose between reimbursing a drug that may not turn out to be cost-effective (or may even be unsafe) or delaying the reimbursement of a drug that is cost-effective and offers clinical benefit to patients. Novel reimbursement
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Confidentiality, public interest, and the human right to science: when can confidential information be used for the benefit of the wider community? J Law Biosci (IF 3.4) Pub Date : 2023-06-14 Edward S Dove
This article explores whether the human right to science can support the public interest as a legal basis to use and disclose confidential information. The contextual focus is scientific research; the jurisdictional focus is England. The human right to science, as reflected in the Universal Declaration of Human Rights (Article 27) and the International Covenant on Economic, Social and Cultural Rights
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Ectogestation and the Good Samaritan Argument J Law Biosci (IF 3.4) Pub Date : 2023-06-08 Christopher Stratman
Philosophical discussions concerning ectogestation are trending. And given that the Supreme Court of the United States overturned Roe v. Wade (1973) and Casey v. Planned Parenthood (1992), questions regarding the moral and legal status of abortion in light of the advent of ectogestation will likely continue to be of central importance in the coming years. If ectogestation can intersect with or even
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Legal personhood and frozen embryos: implications for fertility patients and providers in post-Roe America J Law Biosci (IF 3.4) Pub Date : 2023-05-21 Gerard Letterie, Dov Fox
The demise of Roe v. Wade has prompted some state lawmakers to try to redefine legal personhood to begin before birth and even before pregnancy. The sweeping abortion bans passed and pending in the wake of Dobbs pose a threat to reproductive rights that extends beyond abortion. That threat spills over into in vitro fertilization (IVF) and other assisted reproductive technologies (ART). If legislatures
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The United Nations convention on the rights of persons with disabilities, neuroscience, and criminal legal capacity J Law Biosci (IF 3.4) Pub Date : 2023-05-19 Benjamin A Barsky, Michael Ashley Stein
The United Nations Convention on the Rights of Persons with Disabilities requires states parties to ‘recognize that persons with disabilities enjoy legal capacity on an equal basis with others in all aspects of life.’ This mandate has sparked debate about the interpretation of legal capacity, including within the criminal context as applied to the retrogressively named ‘insanity defense.’ Yet, under-examined
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Who would own the HeLa cell line if the Henrietta Lacks case happened in present-day South Africa? J Law Biosci (IF 3.4) Pub Date : 2023-05-19 Donrich W Thaldar
The HeLa cell line was created in 1951 without consent from Henrietta Lacks, the person whose tissue sample was used. In 2021, the descendants of Henrietta Lacks sued a well-known biotechnology company for the profits it made from the HeLa cell line. In this article, ownership of the cell lines is investigated from a South African legal perspective by considering three possible contemporary scenarios
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The various faces of vulnerability: offering neurointerventions to criminal offenders. J Law Biosci (IF 3.4) Pub Date : 2023-05-06 Sjors Ligthart,Emma Dore-Horgan,Gerben Meynen
In recent years, we have witnessed considerable progress in neurotechnologies that visualize or alter a person's brain and mental features. In the near future, some of these technologies could possibly be used to change neural parameters of high-risk behavior in criminal offenders, often referred to as neurointerventions. The idea of delivering neurointerventions to criminal justice populations has
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Lessons from Canada’s notice of compliance with conditions policy for the life-cycle regulation of drugs J Law Biosci (IF 3.4) Pub Date : 2023-04-13 Melanie McPhail, Howard Zhang, Zohra Bhimani, Tania Bubela
Innovative health technologies are not well regulated under current pathways, leading regulators to adopt contextual, life-cycle regulatory models, which authorize drugs based on earlier clinical evidence subject to the conduct of post-market trials that confirm clinical benefit and safety. In this paper, we evaluate all drugs authorized in Canada under the Notice of Compliance with conditions (NOC/c)
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The legal personhood of human brain organoids J Law Biosci (IF 3.4) Pub Date : 2023-04-03 Masanori Kataoka, Tsung-Ling Lee, Tsutomu Sawai
Research using three-dimensional neural tissues derived from human pluripotent stem cells—known as ‘human brain organoids’—has progressed rapidly in recent years. Although related ethical issues have been intensively discussed, legal issues have only been sparsely examined compared with the related ethical issues. In this paper, we explore a fundamental issue concerning the legal status of human brain
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Allocating organs through algorithms and equitable access to transplantation-a European human rights law approach. J Law Biosci (IF 3.4) Pub Date : 2023-03-31 Audrey Lebret
Digitization in transplantation is not a new phenomenon. Algorithms are being used, for example, to allocate organs based on medical compatibility and priority criteria. However, digitization is accelerating as computer scientists and physicians increasingly develop and use machine learning (ML) models to obtain better predictions on the chances of a successful transplant. The objective of the article
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FDA preemption of conflicting state drug regulation and the looming battle over abortion medications J Law Biosci (IF 3.4) Pub Date : 2023-03-15 Peter Grossi, Daphne O’Connor
Over the past 25 years, Congress and the FDA have determined the safest and most beneficial way to regulate the use of mifepristone (Mifeprex), the medication that accounts for the majority of abortions in the United States. The Dobbs decision has renewed the importance of those scientific determinations, especially FDA's decisions implementing the Risk Evaluation and Mitigation Strategy (REMS) provisions
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Governing nonconventional genetic experimentation J Law Biosci (IF 3.4) Pub Date : 2023-03-09 Maxwell J Mehlman, Ronald A Conlon, Alex Pearlman
A large and highly heterogeneous group of individuals conducts genetic and genomic research outside of traditional corporate and academic settings. They can be an important source of innovation, but their activities largely take place beyond the purview of existing regulatory systems for promoting safe and ethical practices. Historically the gene-targeting technology available for non-traditional genomic
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Pathogen dematerialization and the ABS loophole. J Law Biosci (IF 3.4) Pub Date : 2023-03-04 Abbie-Rose Hampton
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Rules for robots, and why medical AI breaks them J Law Biosci (IF 3.4) Pub Date : 2023-02-16 Barbara J Evans
This article critiques the quest to state general rules to protect human rights against AI/ML computational tools. The White House Blueprint for an AI Bill of Rights was a recent attempt that fails in ways this article explores. There are limits to how far ethicolegal analysis can go in abstracting AI/ML tools, as a category, from the specific contexts where AI tools are deployed. Health technology
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Vaccination of individuals lacking decision-making capacity during a public health emergency J Law Biosci (IF 3.4) Pub Date : 2023-01-16 G Owen Schaefer, Tess Johnson, Ryan Friets, Sumytra Menon, Julian Savulescu
This paper explores the ethical challenges in deciding whether to vaccinate individuals lacking the decision-making capacity needed to provide informed consent during a public health emergency like COVID-19. The best interests standard ordinarily governs such decisions, which under the law in jurisdictions like England, Wales and Singapore takes into account the individual’s past wishes and present
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Mifepristone, preemption, and public health federalism J Law Biosci (IF 3.4) Pub Date : 2022-12-22 Patricia J Zettler, Annamarie Beckmeyer, Beatrice L Brown, Ameet Sarpatwari
On June 24, 2022, the Supreme Court issued an opinion in which five justices voted to overturn Roe v Wade. Even before the final opinion issued, scholars and advocates had begun to consider legal strategies that might mitigate the decision’s anticipated harmful consequences. One such strategy involves challenging state restrictions on Food and Drug Administration (FDA)-approved pregnancy termination
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Deconstructing age(s): an analysis of the different conceptions of age as a legal criterion for access to assisted reproductive technologies. J Law Biosci (IF 3.4) Pub Date : 2022-12-15 Andrea Martani,Eva De Clercq,Christian De Geyter,Guido Pennings,Tenzin Wangmo,Bernice Simone Elger
Whether there should be restrictions for access to Assisted Reproductive Technologies (ART) is a matter of continuous medical, societal, and ethico-legal debate. One of the most controversial topics in this context is the use of parental age as a criterion to limit access to ART. Views are divided on whether there should be an upper age limit for one or both parents and on where such limits should
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Exploring access to genomic risk information and the contours of the HIPAA public health exception J Law Biosci (IF 3.4) Pub Date : 2022-12-10 Jennifer K Wagner, Juhi K Tanniru, Courtney A Chane, Michelle N Meyer
Considerable resources have been invested in research to identify pathogenic and likely pathogenic variants that cause morbidity and mortality and also in returning these results to patients. The public health impact and cost-effectiveness of these efforts are maximized when probands’ relatives are informed of their risk and offered testing. However, such ‘Traceback’ cascade testing programs face multiple
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Digital Sequence Information between Benefit-Sharing and Open Data J Law Biosci (IF 3.4) Pub Date : 2022-11-23 Irma Klünker, Heiko Richter
Currently, parties to the Convention on Biological Diversity (CBD) are negotiating a strategic plan to save biodiversity. One crucial element of an agreement is the question of whether and how digital sequence information (DSI) is subject to access and benefit-sharing from the utilization of genetic resources, one main instrument of the CBD. In the EU, the Open Data Directive (ODD) of 2019 and the
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The body of law: boundaries, extensions, and the human right to physical integrity in the biotechnical age. J Law Biosci (IF 3.4) Pub Date : 2022-10-31 Christoph Bublitz
The body is precondition of human existence and reference point of many legal norms. But the law only rarely asks what the body is more precisely. Answers might appear evident, but commonsensical conceptions of the body have been cast into doubt by feminists, artists, and disability theorists. Drawing on polyphonic arguments, they suggest social or post-human reconceptualizations with potential legal
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Prescribing unproven cancer drugs: physician perspectives on expanded access and right to try. J Law Biosci (IF 3.4) Pub Date : 2022-10-25 Haley Manley,Bryan A Sisk,Zubin Master,Christopher Thomas Scott
Background For gravely ill patients who have no treatment options and who are ineligible for clinical trials, the US Food and Drug Administration (FDA) established the Expanded Access Program (EAP). Motivated by efforts to weaken FDA regulation and sold as providing greater access to experimental drugs, the federal Right to Try Act (RTT) was passed in 2017. It reduces FDA oversight by not requiring
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Digital pills for the remote monitoring of medication intake: a stakeholder analysis and assessment of marketing approval and patent granting policies. J Law Biosci (IF 3.4) Pub Date : 2022-10-18 Katerina Sideri,Julian Cockbain,Wim Van Biesen,Marc De Hert,Johan Decruyenaere,Sigrid Sterckx
This article explores whether 'digital pills' that track medication intake should be used to enhance adherence. We concentrate on psychiatric conditions since these pose unique challenges. We analyze two public policies that potentially encourage the development of systems for remote monitoring of intake, namely the granting of patents and marketing authorization, and identify key stakeholders and
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Why uterine transplantation requires us to rethink the role of the pre-conception welfare principle J Law Biosci (IF 3.4) Pub Date : 2022-10-11 Laura O’Donovan
Uterine transplantation (UTx) is a programme of treatment aimed at providing a unique solution to absolute uterine factor infertility, enabling patients to have children as a result of their own pregnancies. As a transplant procedure performed for fertility purposes it may be thought obvious that the welfare of any children created should be assessed prior to treatment provision. However, major concerns
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Value choices in European COVID-19 vaccination schedules: how vaccination prioritization differs from other forms of priority setting. J Law Biosci (IF 3.4) Pub Date : 2022-09-26 Karolina Wiśniowska,Tomasz Żuradzki,Wojciech Ciszewski
With the limited initial availability of COVID-19 vaccines in the first months of 2021, decision-makers had to determine the order in which different groups were prioritized. Our aim was to find out what normative approaches to the allocation of scarce preventive resources were embedded in the national COVID-19 vaccination schedules. We systematically reviewed and compared prioritization regulations
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On CAR-Ts, decentralized in-house models, and the hospital exception. Routes for sustainable access to innovative therapies. J Law Biosci (IF 3.4) Pub Date : 2022-09-23 Luca Arnaudo
Chimeric Antigen Receptor T cells, or CAR-Ts, are a novel class of gene and cell 'one-shot' therapies based upon collecting, reprogramming, and using patients' own immune cells to treat their cancer. The article discusses the status, prospects, and some relevant legal issues of this frontier of personalized medicine. In particular, it explores the legitimacy of 'in-house' CAR-Ts, ie treatments manufactured
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Forensic DNA phenotyping in Europe: How far may it go? J Law Biosci (IF 3.4) Pub Date : 2022-09-14 Martin Zieger
The fast evolution of genetic sequencing techniques led to new applications in forensic genetics, one of these being the prediction of the physical appearance of a possible perpetrator from biological traces found at the crime scene. Some European countries recently changed their legislations, to permit this technique, also known as Forensic DNA Phenotyping (FDP). The phenotypical traits that may be
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Ethicolegal considerations of screening for brain injury in women who have experienced intimate partner violence J Law Biosci (IF 3.4) Pub Date : 2022-09-08 Quinn Boyle, Judy Illes, Deana Simonetto, Paul van Donkelaar
The vast majority of women who experience physical intimate partner violence (IPV) will likely suffer a brain injury (BI) as a result of the abuse. Accurate screening of IPV–BI can ensure survivors have access to appropriate health care and other supports, but screening results may also impact them receiving fair and equitable treatment in the legal system, and the justice they deserve. We used semi-structured
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Addressing privacy risk in neuroscience data: from data protection to harm prevention. J Law Biosci (IF 3.4) Pub Date : 2022-09-04 Anita S Jwa,Russell A Poldrack
A recent increase in the amount and availability of neuroscience data within and outside of research and clinical contexts will enhance reproducibility of neuroscience research leading to new discoveries on the mechanisms of brain function in healthy and disease states. However, the uniquely sensitive nature of neuroscience data raises critical concerns regarding data privacy. In response to these
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Biological patent thickets and delayed access to biosimilars, an American problem J Law Biosci (IF 3.4) Pub Date : 2022-09-02 Rachel Goode, Bernard Chao
Our study seeks to determine whether patent thickets covering biologic drugs are responsible for delayed biosimilar market entry. We compare patent assertions against the same biosimilar drugs across three countries. On average nine to twelve times more patents were asserted against biosimilars in the United States than in Canada and the United Kingdom. Biosimilars also enter the Canadian and UK markets
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The oversight of autonomous artificial intelligence: lessons from nurse practitioners as physician extenders J Law Biosci (IF 3.4) Pub Date : 2022-08-10 Walker Morrell, Carmel Shachar, Anthony P Weiss
The development of autonomous artificial intelligence (A-AI) products in health care raises novel regulatory challenges, including how to ensure their safety and efficacy in real-world settings. Supplementing a device-centered regulatory scheme with a regulatory scheme that considers A-AI products as a ‘physician extender’ may improve the real-world monitoring of these technologies and produce other
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Skating the line between general wellness products and regulated devices: strategies and implications J Law Biosci (IF 3.4) Pub Date : 2022-07-14 David A Simon, Carmel Shachar, I Glenn Cohen
Health technology is advancing at a rapid clip, with many of these technologies appearing on consumer products like smartphones and tablets. Federal regulators have responded to these changes with a flexible approach that allows firms to manufacture a ‘general wellness product’ (‘GWP’) without being subject to regulation typically applied to ‘devices’ that diagnose or treat a disease or condition.
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An ethico-legal assessment of intellectual property rights and their effect on COVID-19 vaccine distribution: an Australian case study J Law Biosci (IF 3.4) Pub Date : 2022-07-13 James Scheibner, Jane Nielsen, Dianne Nicol
This article posits that Australia, as an affluent country with increasing capacity to manufacture vaccines, has an obligation to assist its regional (and global) counterparts in implementing vaccination programs that protect their populations. First, the article explores the capacity of high-income nations to meet their obligations, assist their neighbours and refrain from vaccine nationalism. This
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The death of Roe and the future of ex vivo embryos J Law Biosci (IF 3.4) Pub Date : 2022-07-04 Henry T Greely
This article examines the possible effects of the end of a federal constitutional right to abortion on clinical practice and research involving ex vivo human embryos. It first analyzes the likely outcomes of Dobbs v. Mississippi, concluding the Supreme Court will either overrule the federal constitutional abortion right or restrict it in a way that leads to its rapid disappearance. Next, the article
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Biomodifying the ‘natural’: from Adaptive Regulation to Adaptive Societal Governance J Law Biosci (IF 3.4) Pub Date : 2022-07-02 Miranda Mourby, Jessica Bell, Michael Morrison, Alex Faulkner, Phoebe Li, Edison Bicudo, Andrew Webster, Jane Kaye
Biomodifying technologies—such as gene editing, induced pluripotent stem cells, and bioprinting—are being developed for a wide range of applications, from pest control to lab-grown meat. In medicine, regulators have responded to the challenge of evaluating modified ‘natural’ material as a therapeutic ‘product’ by introducing more flexible assessment schemes. Attempts have also been made to engage stakeholders
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What the harm principle says about vaccination and healthcare rationing J Law Biosci (IF 3.4) Pub Date : 2022-06-27 Christopher Robertson
Clinical ethicists hold near consensus on the view that healthcare should be provided regardless of patients’ past behaviors. In classic cases, the consensus can be explained by two key rationales—a lack of acute scarcity and the intractability of the facts around those behaviors, which make discrimination on past behavior gratuitous and infeasible to do fairly. Healthcare providers have a duty to
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Framing vaccine mandates: messenger and message effects J Law Biosci (IF 3.4) Pub Date : 2022-06-24 Christopher Buccafusco, Daniel J Hemel
In September 2021, President Biden announced that the Occupational Safety and Health Administration (OSHA) would require large employers to ensure workers are vaccinated against Covid-19 or tested weekly. Although widely characterized as ‘Biden’s vaccine mandate’, the policy could be described with equal accuracy as ‘OSHA’s testing mandate’. Some commentators speculated that reframing the policy as
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Can we do that here? An analysis of US federal and state policies guiding human embryo and embryoid research. J Law Biosci (IF 3.4) Pub Date : 2022-06-09 Kirstin R W Matthews,Daniel Morali
Recent technological advances have helped scientists understand early human development. However, scientists' ability to fully explore their potential comes in conflict with national and state-level policies in the USA. In 2016, for the first time, researchers were able to grow human embryos in culture up to 14 days but stopped because of scientific and legal limits. Other researchers have used stem
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Ethics-by-design: efficient, fair and inclusive resource allocation using machine learning. J Law Biosci (IF 3.4) Pub Date : 2022-04-28 Theodore P Papalexopoulos,Dimitris Bertsimas,I Glenn Cohen,Rebecca R Goff,Darren E Stewart,Nikolaos Trichakis
The distribution of crucial medical goods and services in conditions of scarcity is among the most important, albeit contested, areas of public policy development. Policymakers must strike a balance between multiple efficiency and fairness objectives, while reconciling disparate value judgments from a diverse set of stakeholders. We present a general framework for combining ethical theory, data modeling
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Addressing choice of law challenges in multi-state precision medicine research: experts' assessment of key factors. J Law Biosci (IF 3.4) Pub Date : 2022-04-27 Leslie E Wolf,Erin Fuse Brown,Roxanne Greeson,Catherine Hammack-Aviran,James W Hazel,William Rencher,Laura M Beskow
Precision medicine research implicates numerous state laws that may affect participants' rights and protections and are not preempted by federal law. The choice of which state's laws apply, and under what circumstances, can have significant impact on research design and oversight. But neither of the traditional approaches to choice of law issues-contractual agreement or determination by a court after
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What will and won’t happen when abortion is banned J Law Biosci (IF 3.4) Pub Date : 2022-04-25 Michelle Oberman
For the past 50 years, abortion opponents have fought for the power to ban abortion without little attention to how things might change when they won. The battle to make abortion illegal has been predicated on three nebulous assumptions about how abortion bans work. First, supporters believe banning abortion will deter it. Second, they hope bans will send a message about abortion—specifically, that
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Mental data protection and the GDPR J Law Biosci (IF 3.4) Pub Date : 2022-04-22 Marcello Ienca, Gianclaudio Malgieri
Although decoding the content of mental states is currently unachievable, technologies such as neural interfaces, affective computing systems, and digital behavioral technologies enable increasingly reliable statistical associations between certain data patterns and mental activities such as memories, intentions, and emotions. Furthermore, Artificial Intelligence enables the exploration of these activities