Journal of Law Medicine & Ethics最新文献_第2页

The EHDS Regulation: Health Data at the Crossroads of Patient Autonomy, Data Protection, and Innovation. EHDS法规：处于患者自主、数据保护和创新十字路口的健康数据。

IF 1.3 4区哲学

Journal of Law Medicine & Ethics Pub Date : 2026-09-22 DOI: 10.1017/jme.2026.10284

Elisabeth Steindl

{"title":"The EHDS Regulation: Health Data at the Crossroads of Patient Autonomy, Data Protection, and Innovation.","authors":"Elisabeth Steindl","doi":"10.1017/jme.2026.10284","DOIUrl":"https://doi.org/10.1017/jme.2026.10284","url":null,"abstract":"Digitalization and data-driven research are widely recognized as key drivers of innovation in healthcare, with the potential to improve clinical outcomes, accelerate research, and support evidence-based policymaking. Nevertheless, across jurisdictions, obstacles such as fragmented data governance, limited interoperability, and tensions between data protection and data reuse continue to hinder the effective use of health data. The Regulation on the European Health Data Space (Regulation (EU) 2025/327) represents a significant shift in EU health data governance. It seeks to create a single European market for health data by introducing harmonized rules, shared technical standards, and new institutional structures, while simultaneously reinforcing patients' rights, access to their data, and control over its use. This paper aims to provide a clear and systematic account of the Regulation for a broad international and interdisciplinary audience. It situates the legal piece within its broader political and legal context, highlighting the factors that shaped its design and providing a comprehensive analysis of its core concepts. Using the patient opt-out regime as a case study, the paper critically examines the enduring tensions between safeguarding fundamental rights, ensuring patient autonomy, and fostering innovation and economic objectives, all while accommodating national preferences.","PeriodicalId":50165,"journal":{"name":"Journal of Law Medicine & Ethics","volume":" ","pages":"1-12"},"PeriodicalIF":1.3,"publicationDate":"2026-09-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149018704","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Fifty Years After Estelle v. Gamble - Where Does Carceral Health Law Go from Here? 埃斯特尔诉甘布尔案50年后——医疗保健法将何去何从？

IF 1.3 4区哲学

Journal of Law Medicine & Ethics Pub Date : 2026-09-14 DOI: 10.1017/jme.2026.10273

James René Jolin, Jenean Docter, Benjamin A Barsky

引用次数: 0

Restoring Trust in Health Care: Public Scholarship Based Certification of Key Opinion Leaders with Non-Profit Shared Academic-Patient Governance. 恢复对医疗保健的信任：基于公共奖学金的关键意见领袖认证与非营利性共享学术-患者治理。

IF 1.3 4区哲学

Journal of Law Medicine & Ethics Pub Date : 2026-09-14 DOI: 10.1017/jme.2026.10279

Kim Thompson, Ryan Masotti, Kenneth Carter, Deepa Das Acevedo, Gerard Vong, Michael Winkler

{"title":"Restoring Trust in Health Care: Public Scholarship Based Certification of Key Opinion Leaders with Non-Profit Shared Academic-Patient Governance.","authors":"Kim Thompson, Ryan Masotti, Kenneth Carter, Deepa Das Acevedo, Gerard Vong, Michael Winkler","doi":"10.1017/jme.2026.10279","DOIUrl":"https://doi.org/10.1017/jme.2026.10279","url":null,"abstract":"Collaboration between physician Key Opinion Leaders (KOLs) and the health care industry accelerates the adoption of new therapies, but public awareness of industry payments and research linking such payments to prescribing behaviors has fueled a sharp decline in trust. Meanwhile, for-profit, industry-aligned credentialing programs have begun to define and train KOLs with little public accountability. Without independent alternatives, these models may entrench standards that serve corporate interests over the public good. We review the evolution of the KOL role, from early communication theory to its integration into pharmaceutical marketing and examine the rise of Public Scholarship (PS) as an academic movement grounded in beneficence, transparency, and civic accountability. From this analysis, we propose a Key Opinion Leader Public Scholarship Certification (KOL-PSC) program, governed jointly by academics and patient advocates, to align KOL influence with public interests. The KOL-PSC model includes a skills-based curriculum in ethical science communication, patient engagement, and conflict-of-interest management, culminating in a public-facing capstone project. Governance safeguards will ensure independence from commercial influence while offering industry the reputational benefits of working with certified experts. This voluntary, non-regulatory credential offers a proactive means to restore public trust in physician-industry collaboration, thereby benefitting patients, physicians, academia, and industry.","PeriodicalId":50165,"journal":{"name":"Journal of Law Medicine & Ethics","volume":" ","pages":"1-12"},"PeriodicalIF":1.3,"publicationDate":"2026-09-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148963860","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Planetary Health: A Framework for Expanding the Boundaries of Global Health Law. 行星健康：扩大全球卫生法边界的框架。

IF 1.3 4区哲学

Journal of Law Medicine & Ethics Pub Date : 2026-08-27 DOI: 10.1017/jme.2026.10263

Marlies Hesselman, Benjamin Mason Meier, Judith Bueno De Mesquita, Luciano Bottini Filho, Tsung-Ling Lee, Kriti Sharma, Sam Halabi, Monique van Cauwenberghe, Dominique Mollet, Gian Luca Burci

引用次数: 0

Antimicrobial effectiveness within a new paradigm of infrastructure. 一种新的基础设施模式下的抗菌效果。

IF 1.3 4区哲学

Journal of Law Medicine & Ethics Pub Date : 2026-08-10 DOI: 10.1017/jme.2026.10275

Tom Ashfield, Lucy Victoria Naga, Brett Frischmann, David Jenkins, Adam Dixon, Michael Corley, Saverio Peter Borriello

{"title":"Antimicrobial effectiveness within a new paradigm of infrastructure.","authors":"Tom Ashfield, Lucy Victoria Naga, Brett Frischmann, David Jenkins, Adam Dixon, Michael Corley, Saverio Peter Borriello","doi":"10.1017/jme.2026.10275","DOIUrl":"https://doi.org/10.1017/jme.2026.10275","url":null,"abstract":"Antimicrobials form the backbone of modern medicine and represent a foundational pillar of economic productivity. Overuse and misuse have led to a rising trend of antimicrobial resistance (AMR), depleting the efficacy of existing antimicrobials, necessitating conservation through stewardship and renewal through innovation. Poor global access exacerbates these challenges. We introduce the concept of antimicrobial effectiveness (AME) as a system in which antimicrobials are clinically and microbiologically efficacious against infectious pathogens and accessible for appropriate use. We frame AME as a global economic infrastructure, demonstrating its role as a key input to health, social, and economic outcomes and driver of positive spillovers. We investigate the balance between capacity constraints imposed by AMR and the benefits of maximizing non-discriminatory sharing of AME, exploring how a sustainable management approach comprised of infection prevention, universal access, stewardship, surveillance, and innovation can conserve AME. We explore economic mechanisms such as internalized healthcare overheads and hypothecated taxes to align contributions with benefits, ensuring that patients, hospitals, and businesses who rely on AME help to conserve it. Through identifying social value, patterns of payoffs, and downstream beneficiaries of AME, infrastructure framing provides a coherent axis to structure action, align incentives, and mobilize investment across sectors and scales.","PeriodicalId":50165,"journal":{"name":"Journal of Law Medicine & Ethics","volume":" ","pages":"1-9"},"PeriodicalIF":1.3,"publicationDate":"2026-08-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148702569","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Supreme Court Impacts in Public Health Law: 2025-2026. 最高法院对公共卫生法的影响：2025-2026。

IF 1.3 4区哲学

Journal of Law Medicine & Ethics Pub Date : 2026-08-04 DOI: 10.1017/jme.2026.10272

James G Hodge, Taylor Brown

引用次数: 0

The Sufficiency of Disclosure in Medical AI Patents: Evidence from 865 Granted Patents Across the US, China, and the EU. 医疗人工智能专利披露的充分性：来自美国、中国和欧盟865项授权专利的证据

IF 1.7 4区哲学

Journal of Law Medicine & Ethics Pub Date : 2026-04-20 DOI: 10.1017/jme.2026.10256

Ruyi Xiao, Jin Zhang

{"title":"The Sufficiency of Disclosure in Medical AI Patents: Evidence from 865 Granted Patents Across the US, China, and the EU.","authors":"Ruyi Xiao, Jin Zhang","doi":"10.1017/jme.2026.10256","DOIUrl":"https://doi.org/10.1017/jme.2026.10256","url":null,"abstract":"The rise of health care AI raises concerns over whether patent disclosure supports reproducibility and legal validity. This study analyzes 865 granted medical AI patents (2015-2025) from the US, China, and the EU using a five-dimensional framework (algorithm transparency, training data accessibility, model reproducibility, result verifiability, and mathematical support) implemented through NLP-assisted expert scoring. Results suggest limited technical transparency; approximately 40% of patents score zero in at least two dimensions. Performance varies significantly: algorithm transparency is relatively strong (>60% score 2), while training data accessibility is less prevalent (4.6% score 2) and mathematical support is frequently omitted (39.4% score 0). Statistical testing indicates US patents significantly outperform Chinese patents (p < 0.001), while EU results remain exploratory (N = 31, mean 6.2). These patterns appear associated with institutional factors, strategic applicant behaviour, and technical complexity. Such limitations may pose risks to enforceability and market development, highlighting the need for targeted disclosure improvements. This study contributes a replicable framework for translating legal standards into measurable indicators, providing cross-jurisdictional evidence to guide examination, litigation, and policy refinement in medical AI governance.","PeriodicalId":50165,"journal":{"name":"Journal of Law Medicine & Ethics","volume":" ","pages":"1-14"},"PeriodicalIF":1.7,"publicationDate":"2026-04-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147724173","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Syringe Services Program Legal Restrictions Are Counter to Public Health and the Experience of People Who Use Drugs. 注射器服务计划的法律限制与公共卫生和吸毒者的经历背道而驰。

IF 1.3 4区哲学

Journal of Law Medicine & Ethics Pub Date : 2026-01-01 Epub Date: 2026-04-16 DOI: 10.1017/jme.2026.10233

Amy Lieberman, Corey Davis, Alison Newman

引用次数: 0

It's Getting Hot Out There: The Need for and Development of Law and Policy Strategies to Reduce Health Risks of Extreme Heat. 外面越来越热：法律和政策策略的需要和发展，以减少极端高温的健康风险。

IF 1.3 4区哲学

Journal of Law Medicine & Ethics Pub Date : 2026-01-01 Epub Date: 2026-04-16 DOI: 10.1017/jme.2026.10239

Joanne Pérodin, Betsy Lawton, Caleb Smith

引用次数: 0

Trust, Transparency, and the Fragile Promise of Data Governance in the Era of Modernization. 信任、透明度和现代化时代数据治理的脆弱承诺。

IF 1.3 4区哲学

Journal of Law Medicine & Ethics Pub Date : 2026-01-01 Epub Date: 2026-04-16 DOI: 10.1017/jme.2026.10234

Fallon Julia Cochlin, Regen Weber-Fares, Jami Crespo, William Sage, Cason Daniel Schmit

{"title":"Trust, Transparency, and the Fragile Promise of Data Governance in the Era of Modernization.","authors":"Fallon Julia Cochlin, Regen Weber-Fares, Jami Crespo, William Sage, Cason Daniel Schmit","doi":"10.1017/jme.2026.10234","DOIUrl":"10.1017/jme.2026.10234","url":null,"abstract":"Public health data modernization in the United States has accelerated since COVID-19 exposed systemic weaknesses in fragmented data infrastructure and governance. Technical solutions have advanced, but legal and relational barriers still complicate data sharing across jurisdictions. Traditionally, interjurisdictional data sharing has relied on individually negotiated Data Use Agreements (DUAs), a process that is both resource-heavy and often opaque. To address this, the Centers for Disease Control and Prevention have proposed a Core DUA to standardize terms and reduce administrative burden. However, its success depends on trust - a fragile foundation increasingly strained by politicization, perceived lack of transparency, and controversial federal actions involving sensitive data. Jurisdictional concerns about compliance, security, and misuse underscore the need for governance frameworks that prioritize clarity, reciprocity, and accountability. Coercive approaches risk deepening fragmentation and undermining collaborative governance. Ultimately, modernization efforts will fail without supporting trust as the cornerstone of public health data governance. This article examines legal variation, transactional friction, and evolving jurisdictional perspectives to illuminate the critical role of trust in shaping the future of public health data systems.","PeriodicalId":50165,"journal":{"name":"Journal of Law Medicine & Ethics","volume":"54 S1","pages":"10-14"},"PeriodicalIF":1.3,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147693415","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0