Journal of Law and the Biosciences最新文献

Late disclosures of federal funding in US patents. 美国专利的联邦资金披露较晚。

IF 2.5 2区哲学

Journal of Law and the Biosciences Pub Date : 2025-06-11 eCollection Date: 2025-01-01 DOI: 10.1093/jlb/lsaf012

Luis Gil Abinader

{"title":"Late disclosures of federal funding in US patents.","authors":"Luis Gil Abinader","doi":"10.1093/jlb/lsaf012","DOIUrl":"https://doi.org/10.1093/jlb/lsaf012","url":null,"abstract":"Enacted primarily to encourage patents on federally funded inventions, an additional policy objective of the Bayh-Dole Act is to increase visibility around scientific discoveries made with US government support. The Bayh-Dole Act requires federal grantees to disclose subject inventions to funding agencies and declare government support in their patents. Prior research has shown, however, that hundreds of grantees have failed to declare federal funding in biomedical patents, and others have acknowledged government support several years late through certificates of corrections. Combining data from the National Institutes of Health and the Patent and Trademark Office, this study explores the extent to which grantees have declared government support late through certificates of corrections and likely reasons why this occurred. Over 3000 patents covering federally funded inventions have been corrected to acknowledge government support late, most in recent years. Many of these corrections appear to have been driven by high-profile controversies, changes in the Bayh-Dole regulations, and civil society advocacy. These findings call for policies to encourage timely compliance with invention reporting requirements and to increase the visibility of late acknowledgements of US government funding.","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":"12 1","pages":"lsaf012"},"PeriodicalIF":2.5,"publicationDate":"2025-06-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12152413/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144276822","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

Displaying wastewater surveillance data: an ethics framework. 展示废水监测数据：一个伦理框架。

IF 2.5 2区哲学

Journal of Law and the Biosciences Pub Date : 2025-06-09 eCollection Date: 2025-01-01 DOI: 10.1093/jlb/lsaf001

Govind Persad, Anne Barnhill, Douglas MacKay

引用次数: 0

The right to mental integrity in the age of neurotechnology: constructing scope and exploring permissible limitations. 神经技术时代的精神完整权：构建范围和探索允许的限制。

IF 2.5 2区哲学

Journal of Law and the Biosciences Pub Date : 2025-06-03 eCollection Date: 2025-01-01 DOI: 10.1093/jlb/lsaf010

Sjors Ligthart

引用次数: 0

Toward the effective implementation of the Biosafety Protocol: a Chinese regulatory capacity-building perspective. 有效实施《生物安全议定书》：一个中国监管能力建设的视角。

IF 2.5 2区哲学

Journal of Law and the Biosciences Pub Date : 2025-06-03 eCollection Date: 2025-01-01 DOI: 10.1093/jlb/lsaf011

Ancui Liu

{"title":"Toward the effective implementation of the Biosafety Protocol: a Chinese regulatory capacity-building perspective.","authors":"Ancui Liu","doi":"10.1093/jlb/lsaf011","DOIUrl":"https://doi.org/10.1093/jlb/lsaf011","url":null,"abstract":"The capacity-building mechanism in the Biosafety Protocol aims to assist the parties, inter alia, in establishing and implementing national measures concerning genetically modified organisms (GMOs) that are aligned with the objectives of the Biosafety Protocol. Regulatory capacities of developing countries to address environmental risks caused by GMOs remain to be improved. The article takes China as an example to analyze how regulatory capacity-building activities organized under the Biosafety Protocol contributed to and will further influence China's establishment and implementation of GMO laws and regulations. A four-stage analytical framework is established to examine the interaction between capacity-building activities and the development of China's GMO regulation. China has gradually developed its GMO laws and regulations, with each stage having different regulatory needs and capacity-building efforts. External intervention and endogenous regulatory capacity-building activities mutually strengthened China's implementation of the Biosafety Protocol. Endogenous regulatory capacity-building activities are increasing in enhancing China's GMO regulation. The article concludes by proposing ways to enhance China's regulatory capacities regarding GMOs against the backdrop of adopting the Kunming-Montreal Global Biodiversity Framework and China's Biosecurity Law, involving making laws and regulations on GMOs consistent with the Biosecurity Law and reconsidering the regulatory modes on genome-editing techniques.","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":"12 1","pages":"lsaf011"},"PeriodicalIF":2.5,"publicationDate":"2025-06-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12133087/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144217645","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

Advocating distinct regulatory paths for embryos and embryo-like structures. 倡导胚胎和胚胎样结构的独特调控途径。

IF 2.5 2区哲学

Journal of Law and the Biosciences Pub Date : 2025-05-14 eCollection Date: 2025-01-01 DOI: 10.1093/jlb/lsaf008

Emma Cave

{"title":"Advocating distinct regulatory paths for embryos and embryo-like structures.","authors":"Emma Cave","doi":"10.1093/jlb/lsaf008","DOIUrl":"https://doi.org/10.1093/jlb/lsaf008","url":null,"abstract":"Human embryo-like structures (ELSs) are novel entities emulating aspects of embryogenesis to advance understanding of early human life and enable future clinical applications. ELSs frequently fall into a regulatory gap: the laws that govern embryo research do not commonly apply, but nor are there bespoke regulatory schemes. There is international consensus that the gap must be addressed, but disagreement as to when and how this should be achieved. To date ELSs model embryos, mimicking aspects of embryonic development. In 2024 a UK Nuffield Council on Bioethics report recommended that these `stem cell-based embryo models' should be regulated separately to embryos. Building on this report, this paper considers a subset of ELSs that may in future lose their model status because they replicate rather than model embryos. Distinguishing between models and replicas it considers what circumstances, in the UK and internationally, would require regulation as an embryo, the circumstances in which replicas might justifiably be regulated separately to embryos and why maintaining distinct regulatory paths for embryos and ELSs is beneficial.","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":"12 1","pages":"lsaf008"},"PeriodicalIF":2.5,"publicationDate":"2025-05-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12074899/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144082384","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

Regulatory framework of human germline and heritable genome editing in China: a comparison with the United States and the United Kingdom. 中国人类生殖系和可遗传基因组编辑的监管框架：与美国和英国的比较。

IF 2.5 2区哲学

Journal of Law and the Biosciences Pub Date : 2025-05-13 eCollection Date: 2025-01-01 DOI: 10.1093/jlb/lsaf007

Yawen Zou, Yanting Li, Yingshi Tao

{"title":"Regulatory framework of human germline and heritable genome editing in China: a comparison with the United States and the United Kingdom.","authors":"Yawen Zou, Yanting Li, Yingshi Tao","doi":"10.1093/jlb/lsaf007","DOIUrl":"https://doi.org/10.1093/jlb/lsaf007","url":null,"abstract":"Genome editing technology is rapidly advancing and has generated significant controversy, particularly in the field of human heritable genome editing, while also presenting vast potential applications. Following the He Jiankui incident in 2018, there was a global call to reinforce the regulatory frameworks governing human germline and heritable genome editing. China's existing regulatory framework for human genome editing has improved with several laws enacted and updated, but there are shortcomings. These include overlapping responsibilities of multiple governing agencies and limited involvement of patient groups and the public in the legislative process. By drawing insights from regulatory agencies, legislation, and multigroup participation from abroad, especially in the United Kingdom and the United States, we can compare the differences between China and foreign countries and help China enhance its regulatory framework based on international practices. This article proposes recommendations for enhancing China's regulatory framework, such as clarifying the responsibilities of agencies, updating policies in a timely manner, strengthening bioethics education and training, and emphasizing the need for a forward-looking, balanced, meticulous, and adaptable regulatory approach.","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":"12 1","pages":"lsaf007"},"PeriodicalIF":2.5,"publicationDate":"2025-05-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12069028/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144060585","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

Patient-centric federated learning: automating meaningful consent to health data sharing with smart contracts. 以患者为中心的联合学习：通过智能合约自动同意健康数据共享。

IF 2.5 2区哲学

Journal of Law and the Biosciences Pub Date : 2025-04-30 eCollection Date: 2025-01-01 DOI: 10.1093/jlb/lsaf003

Kristin M Kostick-Quenet, Marcelo Corrales Compagnucci, Mateo Aboy, Timo Minssen

{"title":"Patient-centric federated learning: automating meaningful consent to health data sharing with smart contracts.","authors":"Kristin M Kostick-Quenet, Marcelo Corrales Compagnucci, Mateo Aboy, Timo Minssen","doi":"10.1093/jlb/lsaf003","DOIUrl":"https://doi.org/10.1093/jlb/lsaf003","url":null,"abstract":"Federated Learning (FL) promises to enhance data-driven health research by enabling collaborative machine learning across distributed datasets without direct data exchange. However, current FL implementations primarily reflect the data-sharing interests of institutional controllers rather than those of individual patients whose data are at stake. Existing consent mechanisms-like broad consent under HIPAA or explicit consent under the GDPR-fail to provide patients with control over how their data is used. This article explores the integration of smart contracts (SCs) into FL as a mechanism for automating, enforcing, and documenting consent in data transactions. SCs, encoded in decentralized ledger technologies, can ensure that FL processes align with patient preferences by providing an immutable, and dynamically updatable consent architecture. Integrating SCs into FL and swarm learning (SL) frameworks can mitigate ethico-legal concerns related to patient autonomy, data re-identification, and data use. This approach addresses persistent principle-agent asymmetries in biomedical data sharing by ensuring that patients, rather than data controllers alone, can specify the terms of access to insights derived from their health data. We discuss the implications of this model for regulatory compliance, data governance, and patient engagement, emphasizing its potential to foster public trust in health data ecosystems.","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":"12 1","pages":"lsaf003"},"PeriodicalIF":2.5,"publicationDate":"2025-04-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12046574/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144060584","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

Neural personal information and its legal protection: evidence from China. 神经个人信息及其法律保护：来自中国的证据。

IF 2.5 2区哲学

Journal of Law and the Biosciences Pub Date : 2025-04-15 eCollection Date: 2025-01-01 DOI: 10.1093/jlb/lsaf006

Bin Wei, Shuyao Cheng, Yang Feng

引用次数: 0

A review of public comments submitted to the Centers for Medicare and Medicaid Services in response to the 2022 National Coverage Decision on treatment for Alzheimer's disease. 针对2022年阿尔茨海默病治疗的全国覆盖决定，对提交给医疗保险和医疗补助服务中心的公众意见进行了审查。

IF 2.5 2区哲学

Journal of Law and the Biosciences Pub Date : 2025-04-04 eCollection Date: 2025-01-01 DOI: 10.1093/jlb/lsaf004

Kaatje S Greenberg, Holly Fernandez Lynch, Chisom Nwakama, Jonathan Frumovitz, Samarth Setru, Ariel M Johnson, Saloni M Shah, Liliana Schadt, Matthew S McCoy, Allison K Hoffman, Emily A Largent

{"title":"A review of public comments submitted to the Centers for Medicare and Medicaid Services in response to the 2022 National Coverage Decision on treatment for Alzheimer's disease.","authors":"Kaatje S Greenberg, Holly Fernandez Lynch, Chisom Nwakama, Jonathan Frumovitz, Samarth Setru, Ariel M Johnson, Saloni M Shah, Liliana Schadt, Matthew S McCoy, Allison K Hoffman, Emily A Largent","doi":"10.1093/jlb/lsaf004","DOIUrl":"https://doi.org/10.1093/jlb/lsaf004","url":null,"abstract":"Alzheimer's disease (AD) is a neurodegenerative disease with devastating personal and social consequences. In June 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to aducanumab (Aduhelm; Biogen), a first-in-class monoclonal antibody (mAb) for treatment of AD. In July 2021, responding to the significant controversy sparked by aducanumab's approval, the Centers for Medicare and Medicaid Services (CMS) opened a National Coverage Determination (NCD) analysis for mAbs intended for the treatment of AD. CMS received a record number of public comments on the proposed NCD, which included a proposal for coverage with evidence development (CED). We undertook an in-depth qualitative analysis of those comments. Broad themes included: the appropriateness of FDA's approval of aducanumab; the nature of the relationship between CMS and FDA; anticipated downstream effects of CED on innovation and health equity; aducanumab's cost, value, and affordability; and whether aducanumab offered patients hope. The aducanumab controversy occurred at the intersection of multiple contentious issues; in the discussion, we contextualize our findings within these broader debates. Though Biogen pulled aducanumab from the market in early 2024, the effects of the public discourse surrounding its approval and coverage have been long-lasting and far-reaching, affecting health law, policy, and clinical practice.","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":"12 1","pages":"lsaf004"},"PeriodicalIF":2.5,"publicationDate":"2025-04-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11969149/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143797237","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

'Potato potahto'? Disentangling de-identification, anonymisation, and pseudonymisation for health research in Africa. “土豆potahto”?解开非洲卫生研究的去身份化、匿名化和假名化。

IF 2.5 2区哲学

Journal of Law and the Biosciences Pub Date : 2025-03-24 eCollection Date: 2025-01-01 DOI: 10.1093/jlb/lsae029

Aliki Edgcumbe, Marietjie Botes, Dusty-Lee Donnelly, Beverley Townsend, Carmel Shachar, Donrich Thaldar

{"title":"'Potato potahto'? Disentangling de-identification, anonymisation, and pseudonymisation for health research in Africa.","authors":"Aliki Edgcumbe, Marietjie Botes, Dusty-Lee Donnelly, Beverley Townsend, Carmel Shachar, Donrich Thaldar","doi":"10.1093/jlb/lsae029","DOIUrl":"https://doi.org/10.1093/jlb/lsae029","url":null,"abstract":"Effective scientific research relies heavily on data sharing, particularly in collaborative projects spanning multiple African countries. Researchers must be cognisant of data protection laws, especially regarding secondary data use and cross-border data sharing. In this article, we examine how the terms 'anonymisation', 'de-identification', and 'pseudonymisation' are employed in data protection legislation across 12 African nations and compare them with two prominent regulatory frameworks-the Health Insurance Portability and Accountability Act of the United States of America and the General Data Protection Regulation of the European Union. While 10 of the selected African countries have enacted data protection laws, only six explicitly incorporate these terms, often without clear definitions. Despite this, our analysis reveals that the terms 'de-identification' and 'anonymisation' are distinct legal concepts in the selected jurisdictions, underscoring that researchers must employ these terms carefully and not assume they are interchangeable. Our study highlights the necessity for researchers to use terminology which is consistent with an individual African country's choice to ensure internal consistency, legal compliance, and respect for legislative preferences. It is imperative for researchers involved in international health projects to be acutely aware of how terms are interpreted within each jurisdiction and the possible legal ramifications for data sharing.","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":"12 1","pages":"lsae029"},"PeriodicalIF":2.5,"publicationDate":"2025-03-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11932073/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143702290","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