Journal of Law Medicine & Ethics最新文献

The Impact of Semantics in Medicines Regulation. 语义学对药品监管的影响。

IF 1.3 4区哲学

Journal of Law Medicine & Ethics Pub Date : 2026-10-19 DOI: 10.1017/jme.2026.10293

Enrico Costa, Aaron S Kesselheim

{"title":"The Impact of Semantics in Medicines Regulation.","authors":"Enrico Costa, Aaron S Kesselheim","doi":"10.1017/jme.2026.10293","DOIUrl":"https://doi.org/10.1017/jme.2026.10293","url":null,"abstract":"Words can have inherently multiple meanings; therefore, semantics can directly impact policies and behaviours. In regulatory practice, semantics refers to the specific, actionable meaning behind terminology, and attention to semantics can help ensure that legal frameworks are interpreted accurately. Refining semantics is not a purely theoretical exercise, but a subtle yet powerful element that has the potential to make the regulatory system more efficient in setting priorities and more reliable in meeting societal expectations and needs. When their intended purpose does not align with their true meaning, labels widely used in pharmaceutical regulation such as \"breakthrough,\" \"orphans,\" or \"unmet medical need\" risks undermining the clarity and precision essential to a sound regulatory framework. In addition, differences in definitions, scopes, eligibility criteria, and incentives can obstruct the efficient convergence of efforts in drug development and access. As pharmaceutical investments and clinical research increasingly transcend borders, the adoption of consistent terminology and regulatory definitions becomes crucial. This alignment can enhance cooperation among investors, governments, regulators, researchers, health care practitioners, and patients.","PeriodicalId":50165,"journal":{"name":"Journal of Law Medicine & Ethics","volume":" ","pages":"1-3"},"PeriodicalIF":1.3,"publicationDate":"2026-10-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149221058","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

Navigating Health Information Sharing to Address Social Needs: Practice, Research, and Policy Recommendations from Hospital-Based Violence Intervention. 导航健康信息共享，以解决社会需求：实践，研究和政策建议，从医院为基础的暴力干预。

IF 1.3 4区哲学

Journal of Law Medicine & Ethics Pub Date : 2026-10-19 DOI: 10.1017/jme.2026.10288

Lara Cartwright-Smith, Ruth Abaya

{"title":"Navigating Health Information Sharing to Address Social Needs: Practice, Research, and Policy Recommendations from Hospital-Based Violence Intervention.","authors":"Lara Cartwright-Smith, Ruth Abaya","doi":"10.1017/jme.2026.10288","DOIUrl":"https://doi.org/10.1017/jme.2026.10288","url":null,"abstract":"Hospital-based violence intervention programs (HVIPs) help survivors of violent injury to return to physical, psychological, financial, and social health by addressing a broad range of social determinants of health and reducing the risk of future injury. This work requires connections to a range of providers and services, which often requires the sharing of patient health information. While HIPAA gives providers more discretion to share information to address health-related social needs and care coordination than many providers realize, patients can and should be the ones deciding what health information is shared, with whom it is shared, and under what circumstances. Providers, patients, and programs like HVIPs would benefit from greater clarity on appropriate information-sharing practices. In this article, we consider the real and perceived barriers to information sharing to address social needs and we make recommendations for practice, research, and policy to improve how patient information is shared to address social needs, with relevance for a wide range of interventions.","PeriodicalId":50165,"journal":{"name":"Journal of Law Medicine & Ethics","volume":" ","pages":"1-6"},"PeriodicalIF":1.3,"publicationDate":"2026-10-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149221033","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

Minding the Gap: The Absence of Pennsylvania's Involuntary Commitment Data - CORRIGENDUM. 注意差距：宾夕法尼亚州非自愿承诺数据的缺失-勘误。

IF 1.3 4区哲学

Journal of Law Medicine & Ethics Pub Date : 2026-10-14 DOI: 10.1017/jme.2026.10296

Ari Gluckman, Michele Mekel, Laura Cabrera

引用次数: 0

The Legal Epidemiology Learning Cohort: Reflections and Spotlights After a Decade of Practice-Based Legal Epidemiology Training. 法律流行病学学习队列：基于实践的法律流行病学培训十年后的反思与亮点。

IF 1.3 4区哲学

Journal of Law Medicine & Ethics Pub Date : 2026-10-12 DOI: 10.1017/jme.2026.10286

Katie Hannon Michel, Samantha Bent Weber, Jami Crespo, Madeline Kim, Lauren Tonti, Vicki Collie-Akers, Colin Gerber, Sunbal Virk, Taylor Pinsent, Lyndsey Blair, Diana Leathers, Elizabeth Tennison, Matthew Penn

{"title":"The Legal Epidemiology Learning Cohort: Reflections and Spotlights After a Decade of Practice-Based Legal Epidemiology Training.","authors":"Katie Hannon Michel, Samantha Bent Weber, Jami Crespo, Madeline Kim, Lauren Tonti, Vicki Collie-Akers, Colin Gerber, Sunbal Virk, Taylor Pinsent, Lyndsey Blair, Diana Leathers, Elizabeth Tennison, Matthew Penn","doi":"10.1017/jme.2026.10286","DOIUrl":"https://doi.org/10.1017/jme.2026.10286","url":null,"abstract":"For years, in response to demand from the field, Centers for Disease Control and Prevention's Office of Public Health Law Services (OPHLS) has partnered with outside organizations, including Temple University's Center for Public Health Law Research and ChangeLab Solutions, to operate the Legal Epidemiology Learning Cohort (Learning Cohort). This year-long opportunity offers training and mentorship to health department practitioners and others from public health-adjacent settings on the practical steps of legal epidemiology, which includes collecting, mapping, and evaluating legal texts. Participants work in transdisciplinary teams to design and carry out the foundational work for completing projects on research questions relevant to local public health challenges. Throughout 2023, ChangeLab Solutions and OPHLS coordinated training sessions and provided technical assistance to seven Learning Cohort teams across the country. This paper provides an overview of the Learning Cohort's background, approach, and lessons learned. It also spotlights three recent Learning Cohort teams who describe the projects they completed and the benefits and challenges they found in learning foundational legal epidemiology methods for their public health work. Featured projects demonstrate how legal epidemiology can be used to examine topics like water safety, Tribal access to public health data, and the intersection of state and local law.","PeriodicalId":50165,"journal":{"name":"Journal of Law Medicine & Ethics","volume":" ","pages":"1-9"},"PeriodicalIF":1.3,"publicationDate":"2026-10-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149171294","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

Conformity Between Values and EU Legal Requirements Regarding an AI Clinical Decision Support System (AI-CDSS) for Improved Cardiovascular Risk Management (DECIDE). 关于用于改善心血管风险管理（DECIDE）的人工智能临床决策支持系统（AI- cdss）的价值与欧盟法律要求的一致性

IF 1.3 4区哲学

Journal of Law Medicine & Ethics Pub Date : 2026-10-10 DOI: 10.1017/jme.2026.10289

Tycho J de Graaf, André Krom, Sara Colombo, Myrthe L van de Pavert, Maaike Harbers, Jan H van Staalduinen, Ildikó Vajda, Tijs C Portegies, Niels H Chavannes, María Villalobos-Quesada

{"title":"Conformity Between Values and EU Legal Requirements Regarding an AI Clinical Decision Support System (AI-CDSS) for Improved Cardiovascular Risk Management (DECIDE).","authors":"Tycho J de Graaf, André Krom, Sara Colombo, Myrthe L van de Pavert, Maaike Harbers, Jan H van Staalduinen, Ildikó Vajda, Tijs C Portegies, Niels H Chavannes, María Villalobos-Quesada","doi":"10.1017/jme.2026.10289","DOIUrl":"https://doi.org/10.1017/jme.2026.10289","url":null,"abstract":"The European Union Artificial Intelligence (AI) Act was adopted in 2024 to protect public interests from AI-related harms. We aimed to determine whether the AI Act captures the most relevant values of stakeholders (understood as any person potentially affected by the AI system, including, but not limited to, the direct users) related to a high-risk AI Clinical Decision Support System (CDSS) for cardiovascular disease. This system is intended to be implemented in primary care. A secondary analysis was carried out based on empirical data previously generated using ethics and design methodologies that had identified stakeholder values. These values were translated into the Trustworthy AI requirements of the High-Level Expert Group on AI and then contrasted with the AI Act. These requirements do not capture all identified stakeholder values. We describe three groups of untranslatable values and propose three additional complementary requirements. The AI Act mainly supports the requirements of human agency and oversight; transparency; and diversity, nondiscrimination, and fairness; but only partially, limited by its product safety nature. To address this gap, contractual strategies could provide a more legally robust ground for general practitioners to align the AI-CDSS with stakeholders' values, comply with their duty of care, and promote trustworthy AI-CDSSs.","PeriodicalId":50165,"journal":{"name":"Journal of Law Medicine & Ethics","volume":" ","pages":"1-20"},"PeriodicalIF":1.3,"publicationDate":"2026-10-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149172138","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

The Price of a Cure: Luxturna and the Economic Dilemmas of Precision Medicine. 治疗的代价：Luxturna和精准医疗的经济困境。

IF 1.3 4区哲学

Journal of Law Medicine & Ethics Pub Date : 2026-10-07 DOI: 10.1017/jme.2026.10294

Alex Tabarrok

引用次数: 0

US Food and Drug Administration Officials' Public Statements on Regulatory Flexibility in New Drug Approval, 2021-2024. 美国食品和药物管理局官员关于新药批准监管灵活性的公开声明，2021-2024。

IF 1.3 4区哲学

Journal of Law Medicine & Ethics Pub Date : 2026-10-02 DOI: 10.1017/jme.2026.10290

Tiffany E Jiang, Julia S Etkin, Kennedy Caldwell, Emily Zhang, Sejin Lee, Joseph S Ross, Reshma Ramachandran, Holly Fernandez Lynch

{"title":"US Food and Drug Administration Officials' Public Statements on Regulatory Flexibility in New Drug Approval, 2021-2024.","authors":"Tiffany E Jiang, Julia S Etkin, Kennedy Caldwell, Emily Zhang, Sejin Lee, Joseph S Ross, Reshma Ramachandran, Holly Fernandez Lynch","doi":"10.1017/jme.2026.10290","DOIUrl":"https://doi.org/10.1017/jme.2026.10290","url":null,"abstract":"The US Food and Drug Administration (FDA) has historically exercised substantial regulatory flexibility to adjust the type, amount, and quality of evidence necessary to support drug approval for areas of unmet need. Our objective was to characterize how FDA officials described and justified regulatory flexibility in recent public statements. We conducted a thematic analysis of quotations related to regulatory flexibility from 31 FDA officials published in Pink Sheet and STAT, two leading news sources covering FDA, from January 2021 to June 2024. In these statements, FDA officials typically justified prioritizing patient access to promising treatments over certainty regarding efficacy at the time of approval, even outside the accelerated approval pathway. Regulators also highlighted confirmatory studies conducted after accelerated approval as important for establishing drug efficacy. However, they recognized challenges to their completion, including insufficient industry incentives and FDA enforcement, and were reticent to interpret failed studies as evidence of failed drugs. Overall, in public statements from 2021-2024, FDA officials acknowledged challenges posed by regulatory flexibility but publicly justified its broad use to improve patient access for serious diseases despite even extended uncertainty. Under the Trump Administration, many officials have changed but efforts to advance regulatory flexibility continue.","PeriodicalId":50165,"journal":{"name":"Journal of Law Medicine & Ethics","volume":" ","pages":"1-11"},"PeriodicalIF":1.3,"publicationDate":"2026-10-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149117742","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

Delisted Patents on Pharmaceuticals, 1998-2024. 摘牌药品专利，1998-2024。

IF 1.3 4区哲学

Journal of Law Medicine & Ethics Pub Date : 2026-10-02 DOI: 10.1017/jme.2026.10292

Lily Kirby-Rivera, William Feldman, Myongjin Kim, Georgia Kosmopoulou, Aaron Seth Kesselheim, S Sean Tu

{"title":"Delisted Patents on Pharmaceuticals, 1998-2024.","authors":"Lily Kirby-Rivera, William Feldman, Myongjin Kim, Georgia Kosmopoulou, Aaron Seth Kesselheim, S Sean Tu","doi":"10.1017/jme.2026.10292","DOIUrl":"https://doi.org/10.1017/jme.2026.10292","url":null,"abstract":"Patents listed in the US Food and Drug Administration's (FDA) Orange Book can delay generic competition, yet little is known about how often patents are removed before expiration or why these delistings occur. We reviewed Orange Book records from 1998 through 2024 to identify patents removed before their expiration dates, classified patents according to the subject matter of their claims and assessed potential reasons for delisting using patent litigation and prosecution databases, FDA records, and Federal Trade Commission (FTC) actions. Among 9,980 patents listed during the study period, 535 (5%) were delisted before expiration. Only 71 (13%) claimed active ingredients; most delisted patents instead covered methods of use (177, 38%), formulations (167, 36%), or delivery devices (75, 16%). Potential reasons for delisting included potential invalidation in litigation (226, 42%), product discontinuation (207, 39%), and patent reexamination or reissue (60,11%). Orange Book patent delistings predominantly involved secondary patents rather than active-ingredient patents. Greater clarity and oversight regarding Orange Book listing requirements could reduce questionable listings and unnecessary barriers to generic competition.","PeriodicalId":50165,"journal":{"name":"Journal of Law Medicine & Ethics","volume":" ","pages":"1-4"},"PeriodicalIF":1.3,"publicationDate":"2026-10-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149117721","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

Evaluating State Laws Protecting Access to Gender-Affirming Care: Considerations for Patients and Providers. 评估保护获得性别肯定护理的州法律：对患者和提供者的考虑。

IF 1.3 4区哲学

Journal of Law Medicine & Ethics Pub Date : 2026-09-30 DOI: 10.1017/jme.2026.10287

Ryan Knox, Coral Katave

引用次数: 0

The Henrietta Lacks Case: Ongoing Litigation Seeks Closure. 亨丽埃塔·拉克斯案：正在进行的诉讼寻求了结。

IF 1.3 4区哲学

Journal of Law Medicine & Ethics Pub Date : 2026-09-29 DOI: 10.1017/jme.2026.10291

Allegra Rollo, Shelly Simana, Eli Y Adashi

引用次数: 0