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Artificial Intelligence Needs Data: Challenges Accessing Italian Databases to Train AI 人工智能需要数据:访问意大利数据库以训练人工智能所面临的挑战
IF 1.3 Q3 ETHICS Pub Date : 2024-06-13 DOI: 10.1007/s41649-024-00282-9
Ciara Staunton, Roberta Biasiotto, Katharina Tschigg, Deborah Mascalzoni

Population biobanks are an increasingly important infrastructure to support research and will be a much-needed resource in the delivery of personalised medicine. Artificial intelligence (AI) systems can process and cross-link very large amounts of data quickly and be used not only for improving research power but also for helping with complex diagnosis and prediction of diseases based on health profiles. AI, therefore, potentially has a critical role to play in personalised medicine, and biobanks can provide a lot of the necessary baseline data related to healthy populations that will enable the development of AI tools. To develop these tools, access to personal data, and in particular, sensitive data, is required. Such data could be accessed from biobanks. Biobanks are a valuable resource for research but accessing and using the data contained within such biobanks raise a host of legal, ethical, and social issues (ELSI). This includes the appropriate consent to manage the collection, storage, use, and sharing of samples and data, and appropriate governance models that provide oversight of secondary use of samples and data. Biobanks have developed new consent models and governance tools to enable access that address some of these ELSI-related issues. In this paper, we consider whether such governance frameworks can enable access to biobank data to develop AI. As Italy has one of the most restrictive regulatory frameworks on the use of genetic data in Europe, we examine the regulatory framework in Italy. We also look at the proposed changes under the European Health Data Space (EHDS). We conclude by arguing that currently, regulatory frameworks are misaligned and unless addressed, accessing data within Italian biobanks to train AI will be severely limited.

人口生物库是支持研究的日益重要的基础设施,也将成为提供个性化医疗所急需的资源。人工智能(AI)系统可以快速处理和交叉链接大量数据,不仅可用于提高研究能力,还可根据健康状况帮助进行复杂的疾病诊断和预测。因此,人工智能有可能在个性化医疗中发挥关键作用,而生物库可以提供大量与健康人群相关的必要基线数据,从而促进人工智能工具的开发。要开发这些工具,就需要获取个人数据,尤其是敏感数据。这些数据可以从生物库中获取。生物库是一种宝贵的研究资源,但获取和使用生物库中的数据会引发一系列法律、伦理和社会问题(ELSI)。这包括对样本和数据的收集、储存、使用和共享进行管理的适当同意,以及对样本和数据的二次使用进行监督的适当管理模式。生物库已经开发了新的同意模式和管理工具,以解决与 ELSI 相关的一些问题。在本文中,我们将考虑这种管理框架是否能使生物库数据的使用成为可能,从而开发人工智能。由于意大利是欧洲对基因数据使用限制最严格的监管框架之一,我们对意大利的监管框架进行了研究。我们还研究了欧洲健康数据空间(EHDS)下的修改建议。最后,我们认为目前的监管框架存在偏差,如果不加以解决,意大利生物库中用于训练人工智能的数据将受到严重限制。
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引用次数: 0
Using Artificial Intelligence in Patient Care—Some Considerations for Doctors and Medical Regulators 在患者护理中使用人工智能--医生和医疗监管机构的一些考虑因素
IF 1.3 Q3 ETHICS Pub Date : 2024-06-13 DOI: 10.1007/s41649-024-00291-8
Kanny Ooi

This paper discusses the key role medical regulators have in setting standards for doctors who use artificial intelligence (AI) in patient care. Given their mandate to protect public health and safety, it is incumbent on regulators to guide the profession on emerging and vexed areas of practice such as AI. However, formulating effective and robust guidance in a novel field is challenging particularly as regulators are navigating unfamiliar territory. As such, regulators themselves will need to understand what AI is and to grapple with its ethical and practical challenges when doctors use AI in their care of patients. This paper will also argue that effective regulation of AI extends beyond devising guidance for the profession. It includes keeping abreast of developments in AI-based technology and considering the implications for regulation and the practice of medicine. On that note, medical regulators should encourage the profession to evaluate how AI may exacerbate existing issues in medicine and create unintended consequences so that doctors (and patients) are realistic about AI’s potential and pitfalls when it is used in health care delivery.

本文讨论了医疗监管机构在为在患者护理中使用人工智能(AI)的医生制定标准方面发挥的关键作用。鉴于监管机构的职责是保护公众健康和安全,因此有责任在人工智能等新兴和棘手的实践领域为行业提供指导。然而,要在一个新领域制定有效而有力的指导意见是极具挑战性的,尤其是监管机构正在探索一个陌生的领域。因此,监管者本身需要了解什么是人工智能,并在医生使用人工智能护理病人时努力应对其伦理和实际挑战。本文还将论证,对人工智能的有效监管不仅限于为该行业制定指导意见。它包括紧跟人工智能技术的发展,并考虑其对监管和医疗实践的影响。在这方面,医疗监管机构应鼓励医疗行业评估人工智能可能如何加剧医疗领域的现有问题并造成意想不到的后果,从而使医生(和患者)对人工智能在医疗保健服务中的应用潜力和隐患有现实的认识。
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引用次数: 0
Scoping Review Shows the Dynamics and Complexities Inherent to the Notion of “Responsibility” in Artificial Intelligence within the Healthcare Context 范围界定审查显示了医疗保健领域人工智能 "责任 "概念的动态性和复杂性
IF 1.3 Q3 ETHICS Pub Date : 2024-06-11 DOI: 10.1007/s41649-024-00292-7
Sarah Bouhouita-Guermech, Hazar Haidar

The increasing integration of artificial intelligence (AI) in healthcare presents a host of ethical, legal, social, and political challenges involving various stakeholders. These challenges prompt various studies proposing frameworks and guidelines to tackle these issues, emphasizing distinct phases of AI development, deployment, and oversight. As a result, the notion of responsible AI has become widespread, incorporating ethical principles such as transparency, fairness, responsibility, and privacy. This paper explores the existing literature on AI use in healthcare to examine how it addresses, defines, and discusses the concept of responsibility. We conducted a scoping review of literature related to AI responsibility in healthcare, searching databases and reference lists between January 2017 and January 2022 for terms related to “responsibility” and “AI in healthcare”, and their derivatives. Following screening, 136 articles were included. Data were grouped into four thematic categories: (1) the variety of terminology used to describe and address responsibility; (2) principles and concepts associated with responsibility; (3) stakeholders’ responsibilities in AI clinical development, use, and deployment; and (4) recommendations for addressing responsibility concerns. The results show the lack of a clear definition of AI responsibility in healthcare and highlight the importance of ensuring responsible development and implementation of AI in healthcare. Further research is necessary to clarify this notion to contribute to developing frameworks regarding the type of responsibility (ethical/moral/professional, legal, and causal) of various stakeholders involved in the AI lifecycle.

人工智能(AI)日益融入医疗保健领域,带来了一系列涉及各利益相关方的伦理、法律、社会和政治挑战。这些挑战促使各种研究提出了解决这些问题的框架和指南,强调人工智能开发、部署和监督的不同阶段。因此,"负责任的人工智能 "这一概念已广为流传,其中包含了透明、公平、责任和隐私等伦理原则。本文探讨了有关人工智能在医疗保健领域应用的现有文献,以研究其如何处理、定义和讨论责任概念。我们对与医疗保健中的人工智能责任相关的文献进行了一次范围审查,在 2017 年 1 月至 2022 年 1 月期间检索了数据库和参考文献列表中与 "责任 "和 "医疗保健中的人工智能 "及其衍生词相关的术语。经过筛选,共纳入 136 篇文章。数据被分为四个主题类别:(1)用于描述和解决责任问题的各种术语;(2)与责任相关的原则和概念;(3)利益相关者在人工智能临床开发、使用和部署中的责任;以及(4)解决责任问题的建议。研究结果表明,医疗保健领域缺乏对人工智能责任的明确定义,并强调了确保在医疗保健领域负责任地开发和实施人工智能的重要性。有必要开展进一步研究,以澄清这一概念,从而为制定人工智能生命周期中各利益相关方的责任类型(伦理/道德/专业、法律和因果关系)框架做出贡献。
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引用次数: 0
The Fourth Industrial Revolution: Its Impact on Artificial Intelligence and Medicine in Developing Countries 第四次工业革命:第四次工业革命:对发展中国家人工智能和医学的影响》。
IF 1.3 Q3 ETHICS Pub Date : 2024-05-25 DOI: 10.1007/s41649-024-00284-7
Thalia Arawi, Joseph El Bachour, Tala El Khansa

Artificial intelligence (AI) is the ability of a digital computer or computer-controlled robot to perform tasks commonly associated with intelligent beings. Artificial intelligence can be both a blessing and a curse, and potentially a double-edged sword if not carefully wielded. While it holds massive potential benefits to humans—particularly in healthcare by assisting in treatment of diseases, surgeries, record keeping, and easing the lives of both patients and doctors, its misuse has potential for harm through impact of biases, unemployment, breaches of privacy, and lack of accountability to mention a few. In this article, we discuss the fourth industrial revolution, through a focus on the core of this phenomenon, artificial intelligence. We outline what the fourth industrial revolution is, its basis around AI, and how this infiltrates human lives and society, akin to a transcendence. We focus on the potential dangers of AI and the ethical concerns it brings about particularly in developing countries in general and conflict zones in particular, and we offer potential solutions to such dangers. While we acknowledge the importance and potential of AI, we also call for cautious reservations before plunging straight into the exciting world of the future, one which we long have heard of only in science fiction movies.

人工智能(AI)是指数字计算机或计算机控制的机器人执行通常与智能生物相关的任务的能力。人工智能既是福也是祸,如果不小心使用,可能会成为一把双刃剑。虽然人工智能为人类带来了巨大的潜在利益,特别是在医疗保健领域,它可以帮助治疗疾病、进行手术、保存记录以及减轻病人和医生的生活负担,但滥用人工智能也有可能造成伤害,如偏见、失业、侵犯隐私和缺乏责任感等。本文将讨论第四次工业革命,重点关注这一现象的核心--人工智能。我们概述了什么是第四次工业革命,它的基础是人工智能,以及它如何渗透到人类生活和社会中,类似于一种超越。我们重点关注人工智能的潜在危险及其带来的伦理问题,特别是在发展中国家,尤其是冲突地区,并为这些危险提供潜在的解决方案。虽然我们承认人工智能的重要性和潜力,但我们也呼吁在直接进入这个令人兴奋的未来世界(我们长期以来只在科幻电影中听说过这个世界)之前持谨慎的保留态度。
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引用次数: 0
When can we Kick (Some) Humans “Out of the Loop”? An Examination of the use of AI in Medical Imaging for Lumbar Spinal Stenosis 我们何时才能将(某些)人类 "踢出 "循环?人工智能在腰椎管狭窄症医学影像中的应用研究
IF 1.3 Q3 ETHICS Pub Date : 2024-05-15 DOI: 10.1007/s41649-024-00290-9
Kathryn Muyskens, Yonghui Ma, Jerry Menikoff, James Hallinan, Julian Savulescu

Artificial intelligence (AI) has attracted an increasing amount of attention, both positive and negative. Its potential applications in healthcare are indeed manifold and revolutionary, and within the realm of medical imaging and radiology (which will be the focus of this paper), significant increases in accuracy and speed, as well as significant savings in cost, stand to be gained through the adoption of this technology. Because of its novelty, a norm of keeping humans “in the loop” wherever AI mechanisms are deployed has become synonymous with good ethical practice in some circles. It has been argued that keeping humans “in the loop” is important for reasons of safety, accountability, and the maintenance of institutional trust. However, as the application of machine learning for the detection of lumbar spinal stenosis (LSS) in this paper’s case study reveals, there are some scenarios where an insistence on keeping humans in the loop (or in other words, the resistance to automation) seems unwarranted and could possibly lead us to miss out on very real and important opportunities in healthcare—particularly in low-resource settings. It is important to acknowledge these opportunity costs of resisting automation in such contexts, where better options may be unavailable. Using an AI model based on convolutional neural networks developed by a team of researchers at NUH/NUS medical school in Singapore for automated detection and classification of the lumbar spinal canal, lateral recess, and neural foraminal narrowing in an MRI scan of the spine to diagnose LSS, we will aim to demonstrate that where certain criteria hold (e.g., the AI is as accurate or better than human experts, risks are low in the event of an error, the gain in wellbeing is significant, and the task being automated is not essentially or importantly human), it is both morally permissible and even desirable to kick the humans out of the loop.

人工智能(AI)吸引了越来越多的关注,无论是正面的还是负面的。它在医疗保健领域的潜在应用确实是多方面的和革命性的,在医学成像和放射学领域(这将是本文的重点),通过采用这项技术,可以显著提高准确性和速度,并显著节省成本。由于它的新颖性,在部署人工智能机制的地方,让人类“参与其中”的规范在某些圈子里已经成为良好道德实践的代名词。有人认为,出于安全、问责制和维护机构信任的原因,让人类“参与其中”很重要。然而,正如本文案例研究中机器学习在腰椎管狭窄(LSS)检测中的应用所揭示的那样,在某些情况下,坚持将人类置于循环中(或者换句话说,对自动化的抵制)似乎是没有根据的,并且可能导致我们错过医疗保健中非常真实和重要的机会-特别是在资源匮乏的环境中。重要的是要承认在这种情况下抵制自动化的机会成本,因为在这种情况下可能没有更好的选择。使用一个基于卷积神经网络的人工智能模型由NUH /新加坡国立大学医学院的一个研究小组在新加坡进行自动检测和分类的腰椎运河,横向休会,和神经孔的缩小在脊柱MRI检查诊断LSS,我们的目标是证明在特定条件(例如,AI是准确或比人类专家,风险很低在发生错误时,获得的幸福很重要,被自动化的任务本质上或重要上不是人类的),把人类踢出这个循环在道德上是允许的,甚至是可取的。
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引用次数: 0
Cross-jurisdictional Data Transfer in Health Research: Stakeholder Perceptions on the Role of Law 健康研究中的跨司法管辖区数据传输:利益相关者对法律作用的看法
IF 1.3 Q3 ETHICS Pub Date : 2024-05-11 DOI: 10.1007/s41649-024-00283-8
Hui Yun Chan, Hui Jin Toh, Tamra Lysaght

Large data-intensive health research programmes benefit from collaboration amongst researchers who may be located in different institutions and international contexts. However, complexities in navigating privacy frameworks and data protection laws across various jurisdictions pose significant challenges to researchers seeking to share or transfer data outside of institutional boundaries. Research on the awareness of data protection and privacy laws amongst stakeholders is limited. Our qualitative study, drawn from a larger project in Singapore, revealed insights into stakeholders’ perceptions of the role of law in cross-national health data research. Stakeholders in our study demonstrated a range of perceptions regarding the role of data protection law in governing the collection and transfer of health data for research. The main criticisms included inadequate legal protection to data and lack of uniformed data protection standards. Despite these criticisms, participants recognised the importance of data protection law in supporting cross-border data transfers and proposed measures to improve perceived limitations of existing laws. These measures include strengthening existing legal framework, establishing contractual agreements and imposing severe punishments for data misuse.

大型数据密集型健康研究计划受益于研究人员之间的合作,这些研究人员可能位于不同的机构和国际环境中。然而,不同司法管辖区的隐私框架和数据保护法律的复杂性,给寻求在机构边界之外共享或转移数据的研究人员带来了巨大挑战。有关利益相关者对数据保护和隐私法认识的研究非常有限。我们的定性研究来自新加坡的一个大型项目,揭示了利益相关者对法律在跨国健康数据研究中的作用的看法。在我们的研究中,利益相关者对数据保护法在管理用于研究的健康数据的收集和传输方面的作用有不同的看法。主要的批评意见包括对数据的法律保护不足以及缺乏统一的数据保护标准。尽管有这些批评意见,与会者还是认识到数据保护法在支持跨境数据传输方面的重要性,并提出了一些措施来改善现有法律的局限性。这些措施包括加强现有法律框架、制定合同协议以及对滥用数据行为实施严厉惩罚。
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引用次数: 0
An Update on the Ethical Breadth of the Human Rights Concept 人权概念的伦理广度最新情况
IF 1.3 Q3 ETHICS Pub Date : 2024-04-24 DOI: 10.1007/s41649-024-00288-3
Steven B. Rothman, Karina Dyliaeva, Nader Ghotbi

The Universal Declaration of Human Rights (UDHR) approved by the United Nations (UN) in 1948 includes the most widely accepted list of individual rights all over the world. Although it has been a catalyst in the pursuit of a universal ethic for human rights, it has not been updated for over 75 years during which significant progress has been made in the recognition of more human rights. It is time to examine whether the current global society aspires for more/other human rights that are not reflected in previous declarations. We offer a review of literature on the potential areas that human rights may be extended to in the current sociocultural atmosphere and share the results of a survey at an international university in Japan which examines the views of 232 young Asian students from Japan, Korea, Vietnam, Thailand, China, Indonesia, etc. regarding the human rights declaration items and their implications, as well as new hypothetical items that they would like to see recognized as human rights. The results demonstrate stronger support for 15 out of the 21 surveyed items by all respondents, as well as stronger support for 10 out of the 21 items by female respondents. These results suggest a variable expansion in the breadth of the human rights concept which is worthy of further research. Also, gender inequality may be the basis for the stronger support of certain human rights by female respondents.

联合国(UN)于 1948 年批准的《世界人权宣言》(UDHR)列出了全世界最广泛接受 的个人权利清单。尽管它在追求普遍人权伦理方面发挥了催化剂的作用,但 75 年多来一直没有更新,而在此期间,在承认更多人权方面取得了重大进展。现在是审查当前全球社会是否渴望更多/其他人权的时候了,这些人权在以前的宣言中没有得到体现。我们回顾了有关在当前社会文化氛围下人权可能扩展的领域的文献,并分享了在日本一所国际大学进行的一项调查的结果,该调查研究了来自日本、韩国、越南、泰国、中国、印度尼西亚等国的 232 名亚洲青年学生对人权宣言项目及其影响的看法,以及他们希望被承认为人权的新的假设项目。结果表明,在 21 个调查项目中,所有受访者对其中 15 个项目的支持度较高,而在 21 个调查项目中,女性受访者对其中 10 个项目的支持度较高。这些结果表明,人权概念的广度在不断扩大,值得进一步研究。此外,性别不平等也可能是女性受访者更支持某些人权的原因。
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引用次数: 0
Navigating the Landscape of Digital Twins in Medicine: A Relational Bioethical Inquiry 探索医学中的数字双胞胎:关系生物伦理探究
IF 1.3 Q3 ETHICS Pub Date : 2024-04-23 DOI: 10.1007/s41649-024-00280-x
Brandon Ferlito, Michiel De Proost, Seppe Segers

This perspective article explores the use of digital twins (DTs) in medicine, highlighting its capacity to simulate risks and personalize treatments while examining the emerging bioethical concerns. Central concerns include power dynamics, exclusion, and misrepresentation. We propose adopting a relational bioethical approach that advocates for a comprehensive assessment of DTs in medicine, extending beyond individual interactions to consider broader structural relations and varying levels of access to power. This can be achieved through two key relational recommendations: acknowledging the impact of uneven relational structures on access to medical care and promoting social justice by evaluating resource allocation. While DTs in medicine offer promising advancements, a relational bioethical lens may provide a nuanced understanding, fostering equitable, inclusive and responsible integration of DTs into medical practice.

这篇透视文章探讨了数字孪生(DTs)在医学中的应用,强调其模拟风险和个性化治疗的能力,同时探讨了新出现的生物伦理问题。关注的核心问题包括权力动态、排斥和歪曲。我们建议采用一种关系生物伦理方法,主张全面评估 DTs 在医学中的应用,超越个体互动,考虑更广泛的结构关系和不同程度的权力获取。这可以通过两个关键的关系建议来实现:承认不均衡的关系结构对获得医疗服务的影响,以及通过评估资源分配来促进社会公正。虽然 DTs 在医学中的应用提供了大有希望的进步,但关系生物伦理视角可以提供一种细致入微的理解,促进 DTs 公平、包容和负责任地融入医疗实践。
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引用次数: 0
Ethics Review of Biomedical Research in Uzbekistan: Policy and Program Gaps 乌兹别克斯坦生物医学研究的伦理审查:政策与计划差距
IF 1.3 Q3 ETHICS Pub Date : 2024-04-17 DOI: 10.1007/s41649-023-00273-2
Dilfuza Aniyozova, Martin A. Strosberg

We describe the national health research ethics review system of Uzbekistan and identify policy and program gaps that impede the protection of human research subjects. We find that the National Ethic Committee (NEC), functioning at the national level, is solely responsible for conducting research ethics review. There is little evidence that regional ethics committees work as intended, and there is no research ethics review at medical institutes and research centers even though they conduct CDTs (clinical drug trials). There is no national policy for the ethical review of non-clinical trials. We recommend the establishment of institutional review boards (IRBs) at medical institutes and research centers while at the same time building capacity at the national level to oversee and support the research ethics review system of the entire country.

我们介绍了乌兹别克斯坦的国家健康研究伦理审查系统,并找出了妨碍人类研究对象保护的政策和计划漏洞。我们发现,国家伦理委员会 (NEC) 在国家层面运作,全权负责进行研究伦理审查。几乎没有证据表明地区伦理委员会按计划开展工作,而医疗机构和研究中心即使开展 CDT(临床药物试验),也没有进行研究伦理审查。目前还没有对非临床试验进行伦理审查的国家政策。我们建议在医疗机构和研究中心设立机构审查委员会 (IRB),同时在国家层面进行能力建设,以监督和支持整个国家的研究伦理审查制度。
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引用次数: 0
Transnational Health and Self-care Experiences of Japanese Women who have taken Oral Contraceptives in South Korea, including Over-the-counter Access: Insights from Semi-structured Interviews 在韩国服用口服避孕药(包括非处方药)的日本妇女的跨国健康和自我保健经历:半结构式访谈的启示
IF 1.3 Q3 ETHICS Pub Date : 2024-04-11 DOI: 10.1007/s41649-024-00293-6
Seongeun Kang, Kazuto Kato

In an increasingly globalized world, the accessibility of healthcare and medication has expanded beyond local healthcare systems and national borders. This study aims to investigate the transnational health and self-care experiences of 11 Japanese women who have resided in South Korea for a minimum of six months and have utilized oral contraceptives, including those that were acquired over-the-counter (OTC). Data were gathered through semi-structured interviews and analyzed by utilizing the NVivo software. The analysis yielded three significant thematic categories, namely (1) experiences and perceptions of obtaining and utilizing contraceptive pills, including OTC access; (2) individual and social perceptions of pills and their accessibility in Japan, insights from actual users; and (3) enhancing pill accessibility, transnational health and self-care experiences and perspectives. Participants acknowledged that oral contraceptives are a global product and experienced communication challenges with healthcare providers as a result of differing understandings of these medications. Additionally, this study identified transnational strategies, such as purchasing an adequate supply of pills just before departure and seeking pills from local families or acquaintances. This study not only highlights the implications of clinical care for transnational patients but also underscores their critical global perspectives on access to oral contraceptives. Furthermore, it proposes two models for improving accessibility within the Japanese healthcare system, even in prescription-only contexts, by introducing OTC options.

在日益全球化的世界中,医疗保健和药物的可及性已经超越了当地的医疗保健系统和国界。本研究旨在调查 11 名在韩国居住至少 6 个月并使用过口服避孕药(包括非处方药(OTC))的日本女性的跨国健康和自我保健经历。数据通过半结构式访谈收集,并使用 NVivo 软件进行分析。分析得出了三个重要的主题类别,即(1)获得和使用避孕药的经验和看法,包括非处方药;(2)个人和社会对避孕药及其在日本的可及性的看法,来自实际使用者的见解;以及(3)提高避孕药的可及性,跨国健康和自我保健的经验和观点。参与者承认口服避孕药是一种全球性产品,由于对这些药物的理解不同,他们在与医疗服务提供者沟通时遇到了挑战。此外,本研究还发现了一些跨国策略,例如在出发前购买足够的避孕药,以及向当地家庭或熟人寻求避孕药。这项研究不仅强调了为跨国患者提供临床护理的意义,还强调了他们在获取口服避孕药方面的全球视角。此外,本研究还提出了两种模式,通过引入非处方药,改善日本医疗保健系统内的可及性,即使是在仅凭处方的情况下。
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引用次数: 0
期刊
Asian Bioethics Review
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