Journal of Law and the Biosciences最新文献_第9页

Ethicolegal considerations of screening for brain injury in women who have experienced intimate partner violence. 对遭受亲密伴侣暴力的妇女进行脑损伤筛查的伦理法律考虑。

IF 3.4 2区哲学

Journal of Law and the Biosciences Pub Date : 2022-09-07 eCollection Date: 2022-07-01 DOI: 10.1093/jlb/lsac023

Quinn Boyle, Judy Illes, Deana Simonetto, Paul van Donkelaar

{"title":"Ethicolegal considerations of screening for brain injury in women who have experienced intimate partner violence.","authors":"Quinn Boyle, Judy Illes, Deana Simonetto, Paul van Donkelaar","doi":"10.1093/jlb/lsac023","DOIUrl":"https://doi.org/10.1093/jlb/lsac023","url":null,"abstract":"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 interviews, combined with a contrastive vignette that described a realistic but hypothetical scenario involving IPV with or without BI, to explore the impact of BI on parenting disputes. Participants were lawyers (n = 12) whose focus is family law. Results highlight the potential adverse consequences of a positive BI screen that are influenced by the legal responsibility of counsel, the legal aid status of the woman, ongoing family dynamics, and the expectations of society while the focus on the best interests of the child is retained. Taken together, the findings reflect the legal vulnerability of women in decision-making about their capacity to parent after a BI. We conclude with recommendations for the future of IPV-BI screening aimed at mitigating risk and equipping women to navigate a legal system that has disadvantaged them, both historically and in the current context.","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":" ","pages":"lsac023"},"PeriodicalIF":3.4,"publicationDate":"2022-09-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/37/26/lsac023.PMC9452684.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"33461588","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}

引用次数: 1

Biological patent thickets and delayed access to biosimilars, an American problem. 生物专利丛生，生物仿制药迟迟不能上市，这是美国的一个问题。

IF 3.4 2区哲学

Journal of Law and the Biosciences Pub Date : 2022-09-01 eCollection Date: 2022-07-01 DOI: 10.1093/jlb/lsac022

Rachel Goode, Bernard Chao

{"title":"Biological patent thickets and delayed access to biosimilars, an American problem.","authors":"Rachel Goode, Bernard Chao","doi":"10.1093/jlb/lsac022","DOIUrl":"https://doi.org/10.1093/jlb/lsac022","url":null,"abstract":"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 more quickly than they do in the United States following regulatory approval. Later market entry is not a problem when the brand name drug company is asserting high quality patents (i.e. patents covering significant advances). Consequently, we drilled down into the U.S. patent portfolio of one major biologic, Abbvie's Humira drug, and found that it was made up of roughly 80% non-patentably distinct (duplicative) patents linked together by terminal disclaimers, which is permitted under United States Patent and Trademark Office (USPTO) rules. In contrast, there were far less non-duplicative European patents that covered Humira. Patent thickets can allow brand name drug companies to delay biosimilar entry by relying on the high cost of challenging many duplicative patents instead of the quality of their underlying patents. Accordingly, we suggest several policy interventions that may thin these biologic patent thickets.","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":" ","pages":"lsac022"},"PeriodicalIF":3.4,"publicationDate":"2022-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/6e/20/lsac022.PMC9439849.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"33448647","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}

引用次数: 10

The oversight of autonomous artificial intelligence: lessons from nurse practitioners as physician extenders. 自主人工智能的监督:从护士从业者作为医师扩展者的经验教训。

IF 3.4 2区哲学

Journal of Law and the Biosciences Pub Date : 2022-08-11 eCollection Date: 2022-07-01 DOI: 10.1093/jlb/lsac021

Walker Morrell, Carmel Shachar, Anthony P Weiss

{"title":"The oversight of autonomous artificial intelligence: lessons from nurse practitioners as physician extenders.","authors":"Walker Morrell, Carmel Shachar, Anthony P Weiss","doi":"10.1093/jlb/lsac021","DOIUrl":"https://doi.org/10.1093/jlb/lsac021","url":null,"abstract":"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 benefits, such as increased access to the services offered by these products. In this article, we review the three approaches to the oversight of nurse practitioners, one type of physician extender, in the USA and extrapolate these approaches to produce a framework for the oversight of A-AI products. Under the framework, the US Food and Drug Administration would evaluate A-AI products and determine whether they are allowed to operate independently of physician oversight; required to operate under some physician oversight via a 'collaborative protocol' model; or required to operate under direct physician oversight via a 'supervisory protocol' model.","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":" ","pages":"lsac021"},"PeriodicalIF":3.4,"publicationDate":"2022-08-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/d5/3e/lsac021.PMC9366091.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40698473","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}

引用次数: 0

Skating the line between general wellness products and regulated devices: strategies and implications. 一般健康产品和管制设备之间的界限:策略和影响。

IF 3.4 2区哲学

Journal of Law and the Biosciences Pub Date : 2022-07-14 eCollection Date: 2022-07-01 DOI: 10.1093/jlb/lsac015

David A Simon, Carmel Shachar, I Glenn Cohen

{"title":"Skating the line between general wellness products and regulated devices: strategies and implications.","authors":"David A Simon, Carmel Shachar, I Glenn Cohen","doi":"10.1093/jlb/lsac015","DOIUrl":"https://doi.org/10.1093/jlb/lsac015","url":null,"abstract":"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. Using currently available medical products and devices from across a spectrum of diseases, we describe how firms can use this existing regulatory framework to develop innovative products by 'skating the line' between mostly unregulated GWPs and regulated devices. On the one hand, we find that skating the line offers a variety of benefits, including potential improvements to product development, innovation, and patient access to medical technologies. On the other hand, we show that this technique has potential costs to patient safety, competition, and data sharing. Skating the regulatory line between GWP and devices, in other words, offers important benefits but is not without risks. Any further regulatory action to address such risks should be careful to leave significant unregulated space for product development.","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":" ","pages":"lsac015"},"PeriodicalIF":3.4,"publicationDate":"2022-07-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/98/51/lsac015.PMC9280986.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40606435","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}

引用次数: 7

An ethico-legal assessment of intellectual property rights and their effect on COVID-19 vaccine distribution: an Australian case study. 知识产权的伦理-法律评估及其对COVID-19疫苗分发的影响:澳大利亚案例研究。

IF 3.4 2区哲学

Journal of Law and the Biosciences Pub Date : 2022-07-12 eCollection Date: 2022-07-01 DOI: 10.1093/jlb/lsac020

James Scheibner, Jane Nielsen, Dianne Nicol

{"title":"An ethico-legal assessment of intellectual property rights and their effect on COVID-19 vaccine distribution: an Australian case study.","authors":"James Scheibner, Jane Nielsen, Dianne Nicol","doi":"10.1093/jlb/lsac020","DOIUrl":"https://doi.org/10.1093/jlb/lsac020","url":null,"abstract":"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 inquiry involves an analysis of the optimal ethical strategy for distributing vaccines globally, and the role that Australia might play in this distribution strategy. Secondly, the article examines the intellectual property landscape for vaccines in Australia, focusing on the patents that cover vaccine compositions and manufacturing techniques (recognizing the potential for know-how and access to materials as well as patents to affect manufacturing capacity). This article then discusses the strategies the Australian Government has at its disposal to counter potential intellectual property impediments whilst complying with existing obligations under the Agreement on Trade-related Aspects of Intellectual Property Rights (TRIPS), as an ethically appropriate response to the pandemic. This article also considers whether a so-called TRIPS waiver could provide better options and concludes that the challenge of compelling disclosure of know-how remains.","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":" ","pages":"lsac020"},"PeriodicalIF":3.4,"publicationDate":"2022-07-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/f5/05/lsac020.PMC9278044.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40608442","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}

引用次数: 2

The death of Roe and the future of ex vivo embryos. Roe的死亡和体外胚胎的未来。

IF 3.4 2区哲学

Journal of Law and the Biosciences Pub Date : 2022-07-03 eCollection Date: 2022-07-01 DOI: 10.1093/jlb/lsac019

Henry T Greely

引用次数: 4

Vaccination of individuals lacking decision-making capacity during a public health emergency. 在突发公共卫生事件中为缺乏决策能力的个人接种疫苗。

IF 3.4 2区哲学

Journal of Law and the Biosciences Pub Date : 2022-07-01 DOI: 10.1093/jlb/lsac030

G Owen Schaefer, Tess Johnson, Ryan Friets, Sumytra Menon, Julian Savulescu

{"title":"Vaccination of individuals lacking decision-making capacity during a public health emergency.","authors":"G Owen Schaefer, Tess Johnson, Ryan Friets, Sumytra Menon, Julian Savulescu","doi":"10.1093/jlb/lsac030","DOIUrl":"https://doi.org/10.1093/jlb/lsac030","url":null,"abstract":"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 preferences. However, in a public health emergency, the interests of third parties become more salient: those whom the unvaccinated individual might expose to infection have an interest in the individual's being vaccinated. While current mental capacity law has not been interpreted to take such public health considerations into account, we argue that such considerations are nevertheless ethically relevant, and can legitimately be weighed up alongside other considerations such as the preferences of the individual and impacts on their health. This is most relevant for individuals lacking decision-making capacity who have previously declined or presently resist vaccination. The public health impact of vaccination may in some instances be enough to outweigh preferences of the individual and justify providing vaccination against their past or present wishes.","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":"9 2","pages":"lsac030"},"PeriodicalIF":3.4,"publicationDate":"2022-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/17/e9/lsac030.PMC9584342.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9082201","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}

引用次数: 1

Prescribing unproven cancer drugs: physician perspectives on expanded access and right to try. 处方未经证实的抗癌药物:医生对扩大获取和试用权的看法。

IF 3.4 2区哲学

Journal of Law and the Biosciences Pub Date : 2022-07-01 DOI: 10.1093/jlb/lsac031

Haley Manley, Bryan A Sisk, Zubin Master, Christopher Thomas Scott

{"title":"Prescribing unproven cancer drugs: physician perspectives on expanded access and right to try.","authors":"Haley Manley, Bryan A Sisk, Zubin Master, Christopher Thomas Scott","doi":"10.1093/jlb/lsac031","DOIUrl":"https://doi.org/10.1093/jlb/lsac031","url":null,"abstract":"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 physicians to report safety data and foregoes approval of protocols by local institutional review boards.Methods: This study explored the views of 17 neuro-oncologists from 15 different academic medical centers with varying experience with EAP and RTT using convenience sampling. We conducted semi-structured interviews and qualitative analysis to identify emerging themes.Results: Most oncologists were confused between the two pathways, had little familiarity with RTT, and had little knowledge about experimental medicine available through either pathway. Oncologists reported a preference of enrolling patients in clinical trials over off-trial preapproval pathways with scant data. As a result, oncologists revealed concerns over properly evaluating risks for their patients.Conclusion: Our findings suggest that neuro-oncologists need better resources and clearer mechanisms at their institutions to help navigate EAP and RTT in order to counsel patients interested in experimental medicine.","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":"9 2","pages":"lsac031"},"PeriodicalIF":3.4,"publicationDate":"2022-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/03/17/lsac031.PMC9596169.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9146699","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}

引用次数: 0

Exploring access to genomic risk information and the contours of the HIPAA public health exception. 探索获得基因组风险信息和HIPAA公共卫生例外的轮廓。

IF 3.4 2区哲学

Journal of Law and the Biosciences Pub Date : 2022-07-01 DOI: 10.1093/jlb/lsac034

Jennifer K Wagner, Juhi K Tanniru, Courtney A Chane, Michelle N Meyer

{"title":"Exploring access to genomic risk information and the contours of the HIPAA public health exception.","authors":"Jennifer K Wagner, Juhi K Tanniru, Courtney A Chane, Michelle N Meyer","doi":"10.1093/jlb/lsac034","DOIUrl":"https://doi.org/10.1093/jlb/lsac034","url":null,"abstract":"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 obstacles, including perceived or actual legal and regulatory hurdles. Here, using genetic cancer syndromes as a test case, we explore the contours of the Public Health Exception to the HIPAA Privacy Rule to assess whether it is a viable pathway for implementing a Traceback program. After examining the Privacy Rule as well as state laws and regulations for reportable conditions and genetic privacy, we conclude that this is not currently a viable approach for Traceback programs. We conclude by reflecting on ethical considerations of leveraging HIPAA's public health exception to disclose PHI directly to at-risk relatives and offering insights for how legal hurdles to such a Traceback program could be overcome, if desired.","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":"9 2","pages":"lsac034"},"PeriodicalIF":3.4,"publicationDate":"2022-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9740515/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10605033","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}

引用次数: 0

Deconstructing age(s): an analysis of the different conceptions of age as a legal criterion for access to assisted reproductive technologies. 解构年龄:分析将年龄作为获得辅助生殖技术的法律标准的不同概念。

IF 3.4 2区哲学

Journal of Law and the Biosciences Pub Date : 2022-07-01 DOI: 10.1093/jlb/lsac036

Andrea Martani, Eva De Clercq, Christian De Geyter, Guido Pennings, Tenzin Wangmo, Bernice Simone Elger

{"title":"Deconstructing age(s): an analysis of the different conceptions of age as a legal criterion for access to assisted reproductive technologies.","authors":"Andrea Martani, Eva De Clercq, Christian De Geyter, Guido Pennings, Tenzin Wangmo, Bernice Simone Elger","doi":"10.1093/jlb/lsac036","DOIUrl":"https://doi.org/10.1093/jlb/lsac036","url":null,"abstract":"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 be. Although this debate is centered around the issue of 'age' and although age-related limits are present in many legislations, the intrinsic ambiguity of the term `age' is largely overlooked. In this article, we build on gerontological, medical, and sociological literature on the concepts of 'age' and 'aging' to distinguish three conceptions of age that are relevant for ART regulation: the chronological, the biological, and the social-cultural one. Beyond mapping out these conceptions of age, we describe how they relate to ART and reproduction, and illustrate the advantages and disadvantages of relying on each of them as a basis for limiting ART access. Finally, we propose a template for defining legal age limits for ART access in the law, based on the refined understanding of the different conceptions of age that we outline and we discuss two potential objections to our proposal.","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":"9 2","pages":"lsac036"},"PeriodicalIF":3.4,"publicationDate":"2022-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9754082/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10441918","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}

引用次数: 0