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Walking Backward to Ensure Risk Management of Large Language Models in Medicine. 医学大语言模型风险管理的逆向探索
IF 1.7 4区 哲学
Journal of Law Medicine & Ethics Pub Date : 2025-01-01 DOI: 10.1017/jme.2025.10132
Daria Onitiu, Sandra Wachter, Brent Mittelstadt
{"title":"Walking Backward to Ensure Risk Management of Large Language Models in Medicine.","authors":"Daria Onitiu, Sandra Wachter, Brent Mittelstadt","doi":"10.1017/jme.2025.10132","DOIUrl":"10.1017/jme.2025.10132","url":null,"abstract":"<p><p>This paper examines in what way providers of specialized Large Language Models (LLM) pre-trained and/or fine-tuned on medical data, conduct risk management, define, estimate, mitigate and monitor safety risks under the EU Medical Device Regulation (MDR). Using the example of an Artificial Intelligence (AI)-based medical device for lung cancer detection, we review the current risk management process in the MDR entailing a \"forward-walking\" approach for providers articulating the medical device's clear intended use, and moving on sequentially along the definition, mitigation, and monitoring of risks. We note that the forward-walking approach clashes with the MDR requirement for articulating an intended use, as well as circumvents providers reasoning around the risks of specialised LLMs. The forward-walking approach inadvertently introduces different intended users, new hazards for risk control and use cases, producing unclear and incomplete risk management for the safety of LLMs. Our contribution is that the MDR risk management framework requires a backward-walking logic. This concept, similar to the notion of \"backward-reasoning\" in computer science, entails sub-goals for providers to examine a system's intended user(s), risks of new hazards and different use cases and then reason around the task-specific options, inherent risks at scale and trade-offs for risk management.</p>","PeriodicalId":50165,"journal":{"name":"Journal of Law Medicine & Ethics","volume":" ","pages":"454-464"},"PeriodicalIF":1.7,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144509228","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
Compassionate Release and COVID-19: Analyzing Inconsistent Applications of the First Step Act by Federal Courts. 同情释放与COVID-19：分析联邦法院对第一步法案的不一致适用。
IF 1.7 4区 哲学
Journal of Law Medicine & Ethics Pub Date : 2025-01-01 DOI: 10.1017/jme.2025.10127
Helen Mooney, Kayla Larkin, Mara Howard-Williams
{"title":"Compassionate Release and COVID-19: Analyzing Inconsistent Applications of the First Step Act by Federal Courts.","authors":"Helen Mooney, Kayla Larkin, Mara Howard-Williams","doi":"10.1017/jme.2025.10127","DOIUrl":"10.1017/jme.2025.10127","url":null,"abstract":"<p><p>The COVID-19 pandemic has posed a significant health threat to people in corrections facilities due to communal living, inability to social distance, and high rates of comorbidity among incarcerated populations. Combined with the First Step Act of 2018, which granted incarcerated individuals seeking compassionate release access to the courts, the pandemic increased the number of people in federal prisons petitioning for early release due to health risk. Analysis of federal compassionate release case law throughout the pandemic reveals inconsistent judicial reasoning related to COVID-19-based requests. Inconsistently interpreted compassionate release factors include vaccination status, COVID-19 reinfection, and the \"degree\" of extraordinary circumstances considered. Varied application among federal districts produced inequitable access to compassionate release. Therefore, this analysis provides insight into how an unclear policy can create disparate public health outcomes and considerations for compassionate release determinations in future times of uncertainty, such as a pandemic.</p>","PeriodicalId":50165,"journal":{"name":"Journal of Law Medicine & Ethics","volume":" ","pages":"426-432"},"PeriodicalIF":1.7,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144818063","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
Maintaining the Integrity of the Biomedical Research Record Through Timely, Appropriate Corrective Action. 通过及时、适当的纠正措施维护生物医学研究记录的完整性。
IF 1.7 4区 哲学
Journal of Law Medicine & Ethics Pub Date : 2025-01-01 DOI: 10.1017/jme.2025.10150
Lauren Walsh, Minal Caron, Carolyn T Lye, Mark Barnes, Barbara E Bierer
{"title":"Maintaining the Integrity of the Biomedical Research Record Through Timely, Appropriate Corrective Action.","authors":"Lauren Walsh, Minal Caron, Carolyn T Lye, Mark Barnes, Barbara E Bierer","doi":"10.1017/jme.2025.10150","DOIUrl":"10.1017/jme.2025.10150","url":null,"abstract":"<p><p>Researchers, academic institutions, and journals have an ethical obligation to correct the research record expeditiously and publicly to maintain the integrity of science.</p>","PeriodicalId":50165,"journal":{"name":"Journal of Law Medicine & Ethics","volume":" ","pages":"486-490"},"PeriodicalIF":1.7,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144976880","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
Reflections on Climate Change Policy for Global Health. 对气候变化政策促进全球健康的思考。
IF 1.6 4区 哲学
Journal of Law Medicine & Ethics Pub Date : 2025-01-01 Epub Date: 2025-06-06 DOI: 10.1017/jme.2025.2
David W Patterson
{"title":"Reflections on Climate Change Policy for Global Health.","authors":"David W Patterson","doi":"10.1017/jme.2025.2","DOIUrl":"https://doi.org/10.1017/jme.2025.2","url":null,"abstract":"<p><p>This reflection considers the contribution of Prof Larry Gostin to global health law and the lessons for climate action.</p>","PeriodicalId":50165,"journal":{"name":"Journal of Law Medicine & Ethics","volume":"53 S1","pages":"40"},"PeriodicalIF":1.6,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144235758","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
Reflections on Working with Larry. 与拉里共事的感想。
IF 1.6 4区 哲学
Journal of Law Medicine & Ethics Pub Date : 2025-01-01 Epub Date: 2025-03-21 DOI: 10.1017/jme.2025.29
I Glenn Cohen
{"title":"Reflections on Working with Larry.","authors":"I Glenn Cohen","doi":"10.1017/jme.2025.29","DOIUrl":"10.1017/jme.2025.29","url":null,"abstract":"<p><p>In longer-form writing with Larry Gostin, especially on global health, I have been particularly struck by how careful he is not to lose the narrative voice, especially of the vulnerable. He truly believes that these stories are \"on loan\" to us, and that there is an almost holy reverence and devotion we owe to the lives of those whose stories we tell.</p>","PeriodicalId":50165,"journal":{"name":"Journal of Law Medicine & Ethics","volume":" ","pages":"69"},"PeriodicalIF":1.6,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143674113","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
Reflections on Health and Human Rights. 关于健康与人权的思考。
IF 1.6 4区 哲学
Journal of Law Medicine & Ethics Pub Date : 2025-01-01 Epub Date: 2025-04-14 DOI: 10.1017/jme.2025.23
Tlaleng Mofokeng
{"title":"Reflections on Health and Human Rights.","authors":"Tlaleng Mofokeng","doi":"10.1017/jme.2025.23","DOIUrl":"10.1017/jme.2025.23","url":null,"abstract":"<p><p>Communities and individuals globally continue to suffer the violent impacts of colonialism and racism, in a global system of governance that remains rooted in unequal and hierarchical power imbalances. The interpersonal, societal, and structural violence that persists around the world exists in violation of human rights, and is evidence of a persistent lack of political will to effectively invest in human rights, including the right to health, as a true priority.The demand on States and non-State actors to fulfil the human right to health is imperative. Attacks on civilians during times of conflict and catastrophe, as seen in the latest escalation and display of imperial aggression by Israel in the occupied Palestinian territory, demonstrate the consistent uneven application of human rights and commitment to fulfilling them.Protecting human rights, and specifically the realization of the right to health, is fundamental as it has significant consequences for the realisation of other human rights. Eliminating discrimination requires paying sufficient attention to groups of individuals that suffer historical or persistent prejudice. Fulfilling a commitment to health equity and justice demands creating opportunity and conducive conditions for the dignity for all people.</p>","PeriodicalId":50165,"journal":{"name":"Journal of Law Medicine & Ethics","volume":" ","pages":"16-17"},"PeriodicalIF":1.6,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144003719","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
Reflections on Global Health Law in the COVID-19 Response. COVID-19应对中对全球卫生法的思考。
IF 1.6 4区 哲学
Journal of Law Medicine & Ethics Pub Date : 2025-01-01 Epub Date: 2025-04-14 DOI: 10.1017/jme.2025.26
Helen Clark
{"title":"Reflections on Global Health Law in the COVID-19 Response.","authors":"Helen Clark","doi":"10.1017/jme.2025.26","DOIUrl":"10.1017/jme.2025.26","url":null,"abstract":"<p><p>Over the last three years, Larry Gostin, I, and many others have urged world leaders to open their minds toward specific subsets of reform in the interest of pandemic response, including mechanisms for transparency, accountability, and, crucially, financial buy-in. With negotiations for a new pandemic accord still incomplete, our focus must remain on reaching global agreement, and keeping at top of mind the immense stakes if that is not possible.</p>","PeriodicalId":50165,"journal":{"name":"Journal of Law Medicine & Ethics","volume":" ","pages":"46"},"PeriodicalIF":1.6,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144003807","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
Reflection on the Legacy of Lawrence Gostin in Global Health. 对劳伦斯·高斯廷在全球卫生领域遗产的反思。
IF 1.6 4区 哲学
Journal of Law Medicine & Ethics Pub Date : 2025-01-01 Epub Date: 2025-04-14 DOI: 10.1017/jme.2025.14
Anthony S Fauci
{"title":"Reflection on the Legacy of Lawrence Gostin in Global Health.","authors":"Anthony S Fauci","doi":"10.1017/jme.2025.14","DOIUrl":"10.1017/jme.2025.14","url":null,"abstract":"<p><p>The tenth anniversary of the publication of Lawrence Gostin's seminal treatise Global Health Law affords us the opportunity to reflect on his enduring legacy as a preeminent scholar, and one of the field's founding thought leaders.</p>","PeriodicalId":50165,"journal":{"name":"Journal of Law Medicine & Ethics","volume":" ","pages":"1"},"PeriodicalIF":1.6,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144054436","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 2024 Amendments to the International Health Regulations: A New Era for Global Health Law in Pandemic Preparedness and Response? 2024年《国际卫生条例》修正案：全球卫生法在大流行防范和应对方面的新时代？
IF 1.6 4区 哲学
Journal of Law Medicine & Ethics Pub Date : 2025-01-01 Epub Date: 2025-04-14 DOI: 10.1017/jme.2025.16
Roojin Habibi, Mark Eccleston-Turner, Gian Luca Burci
{"title":"The 2024 Amendments to the International Health Regulations: A New Era for Global Health Law in Pandemic Preparedness and Response?","authors":"Roojin Habibi, Mark Eccleston-Turner, Gian Luca Burci","doi":"10.1017/jme.2025.16","DOIUrl":"10.1017/jme.2025.16","url":null,"abstract":"<p><p>On June 1, 2024, the World Health Assembly reached consensus on a package of amendments to the 2005 International Health Regulations (IHR). These amendments follow nearly two decades of implementation and an intensive multilateral process prompted by the global struggle against COVID-19. This article critically examines whether the amended IHR reflect lessons learned from the pandemic, potentially ushering in a new era for global health law in pandemic preparedness and response, or if they deflect attention from the need for deeper structural reforms. While the IHR remain the only near-universal legal framework for preventing and addressing the international spread of disease, these amendments emphasize equity and solidarity, and potentially shift the IHR from a technical instrument to one focusing on inherently political issues. This analysis examines key IHR amendments and their implications for the future of global health law, particularly in the context of equity, financing, and implementation.</p>","PeriodicalId":50165,"journal":{"name":"Journal of Law Medicine & Ethics","volume":" ","pages":"47-50"},"PeriodicalIF":1.6,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12174786/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144052082","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"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
"Everything is Tuberculosis" - Except the Law? “一切都是肺结核” -除了法律？
IF 1.7 4区 哲学
Journal of Law Medicine & Ethics Pub Date : 2025-01-01 DOI: 10.1017/jme.2025.10128
James G Hodge
{"title":"\"Everything is Tuberculosis\" - Except the Law?","authors":"James G Hodge","doi":"10.1017/jme.2025.10128","DOIUrl":"10.1017/jme.2025.10128","url":null,"abstract":"<p><p>In \"Everything is Tuberculosis,\" author John Green assesses the intricacies of the communicable condition, TB, as a source of significant morbidity and mortality globally over centuries. Despite available vaccines, treatments, and protocols, tens of millions are infected and over a million persons will die from TB in 2025 alone. In searching for answers to mitigate this global scourge, however, Green looks past a key factor - specifically the role of law - as a primary tool for prevention and control.</p>","PeriodicalId":50165,"journal":{"name":"Journal of Law Medicine & Ethics","volume":" ","pages":"475-477"},"PeriodicalIF":1.7,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144477660","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
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