Legal issues

法律问题
  • 文章类型: Journal Article
    孕产妇死亡监测和响应(MDSR)系统旨在不断识别和审查所有孕产妇死亡。它旨在帮助各国了解孕产妇死亡的规模和分布,找出他们的原因,并告知纠正措施以应对挑战。尽管许多低收入或中等收入国家越来越多地采用MDSR,它的实施面临各种挑战,包括合法的。进行此范围审查是为了绘制MDSR实施过程中出现的法律问题和挑战。它采用了Bain和Kongnyuy框架,将法律问题分类为数据,人,使用发现,和法律规制。从七个数据库中检索文献,辅以额外的在线搜索。我们纳入了2010年至2022年11月期间以英文发表的研究报告,报告了实施MDSR过程中出现的法律问题。在筛选的1,174项研究中,31人被选中进行审查。审查强调了研究界对MDSR法律层面的关注有限。它还记录了缺乏有效实施该系统所必需的适当法律框架。对信息隐私的保障不足和缺乏机密性强化了一种普遍的被指责感,主要是卫生工作者。因此,孕产妇死亡原因普遍漏报和故意误报,防御性推荐,并报告了脱离MDSR过程的情况。我们建议实施国通过适当的法律规范MDSR数据的收集和使用,并在法律上确保MDSR数据仅用于预期目的。卫生系统需要适当的投诉处理机制,以防止滥用MDSR。未来关于MDSR实施的研究将受益于法律专家的参与,考虑到MDSR的多方面法律层面。
    The Maternal Death Surveillance and Response (MDSR) system is designed to continuously identify and review all maternal deaths. It aims to assist countries in understanding the scale and distribution of maternal deaths, identifying their causes, and informing corrective measures to address the challenge. Despite the growing adoption of the MDSR by numerous low- or middle-income countries, its implementation faces various challenges, including legal ones. This scoping review was conducted to map legal issues and challenges that arise during the implementation of the MDSR. It adapted the Bain and Kongnyuy framework, categorising legal issues into data, people, use of findings, and legal regulation. Literature was retrieved from seven databases, complemented by additional online searches. We included studies published in English between 2010 and November 2022 that report on legal issues arising during the implementation of MDSR. Out of 1,174 studies screened, 31 were selected for review. The review highlighted the limited attention given to the legal dimension of the MDSR by the research community. It also documented the lack of adequate legal framework essential for the system\'s effective implementation. Inadequate safeguards for informational privacy and the lack of confidentiality reinforce a prevalent sense of being blamed, mainly among health workers. Consequently, widespread underreporting and intentional misattribution of causes of maternal death, defensive referrals, and disengagement from the MDSR process were reported. We recommend that implementing countries regulate the gathering and use of MDSR data through suitable laws and legally ensure that the MDSR data are only used for the intended purpose. Appropriate complaint-handling mechanisms are needed in health systems to prevent the misuse of the MDSR. Future studies on MDSR implementation would benefit from involving legal experts, considering the multifaceted legal dimensions of the MDSR.
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  • 文章类型: Journal Article
    3D打印已被用于某些医疗应用的日常使用。但是更广泛的使用受到了阻碍,除其他外,立法不明确。我们进行了分析,运用法律理论研究和法律信息学,在与医疗3D打印(不包括生物打印或药物打印)相关的四个问题中,相关的欧盟立法和判例法:上市前批准,上市后负债,知识产权,和数据保护。确定了当前立法和解释中的一些差距和不确定性。特别是,我们认为目前的欧盟监管框架是相当有限和不灵活的,体现了欧盟法律中常见的警示方法。尽管人们理解有必要建立高安全标准,以保护作为弱势群体的患者,法律不确定性和过度监管都被视为有害于创新。因此,需要更多的适应性立法,以确保持续的创新努力和提高患者的治疗效果。
    3D printing has been adopted into routine use for certain medical applications, but more widespread usage has been hindered by, among other things, unclear legislation. We performed an analysis, using legal doctrinal study and legal informatics, of relevant EU legislation and case law in four issues relevant to medical 3D printing (excluding bioprinting or pharmacoprinting): pre-market approval, post-market liability, intellectual property rights, and data protection. Several gaps and uncertainties in the current legislation and interpretations were identified. In particular, we regard the current EU regulatory framework to be quite limiting and inflexible, exemplifying a cautionary approach common in EU law. Though the need to establish high safety standards in order to protect patients as a disadvantaged population is understood, both legal uncertainties and overregulation are seen as harmful to innovation. Hence, more adaptive legislation is called for to ensure continuous innovation efforts and enhanced patient outcomes.
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  • 文章类型: Journal Article
    据报道,非自愿治疗是创伤性的,污名化和恐惧,有时甚至是救命。然而,对18岁之前非自愿住院的人的经历几乎没有研究。对此有更多的了解可能有助于我们做出改变,从而改善儿童和年轻人非自愿精神病治疗的经验。LizzieMitchell是一位经验丰富的专家,她16岁时根据《精神健康法案》(MHA)被送往英格兰的一家精神病医院。这里,在与苏珊·沃克的讨论中,一名儿童和青少年精神病医生,Lizzie反思了自己的经历,以及对年轻人非自愿住院的更广泛思考,包括对心理健康的潜在短期和长期影响,教育,友谊,家庭和身份。
    Involuntary treatment has been reported to be traumatic, stigmatising and frightening, as well as sometimes lifesaving. However, there has been little research into the experiences of people who have been hospitalised involuntarily prior to the age of 18. A greater understanding of this may help us to make changes which could improve the experience of involuntary psychiatric treatment for children and young people. Lizzie Mitchell is an expert by experience who was admitted to a psychiatric hospital in England under the Mental Health Act (MHA) when she was 16 years old. Here, in discussion with Susan Walker, a child and adolescent psychiatrist, Lizzie reflects on her own experiences alongside wider reflections around the involuntary hospitalisation of young people, including the potential short and long-term impact on mental health, education, friendships, family and identity.
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  • 文章类型: Journal Article
    全世界所有年龄段的人都受到非自愿精神拘留和治疗,但目前正在讨论这是否符合现代人权法。迄今为止,在儿童和年轻人中使用非自愿精神病住院治疗在很大程度上避免了研究和政策兴趣。在这个辩论部分,我们从英国有儿童心理健康服务经验的人那里听到,美国和低收入和中等收入国家对年轻人使用非自愿治疗的看法。
    People of all ages are subject to involuntary psychiatric detention and treatment worldwide but there is current discussion about whether this complies with modern human rights law. The use of involuntary psychiatric hospitalisation among children and young people has largely eschewed research and policy interest to date. In this debate section, we hear from people with experience of child mental health services in the UK, USA and low- and middle-income countries about their views on the use of involuntary treatment in young people.
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  • 文章类型: Practice Guideline
    几十年来,性传播疾病的发病率在我们的环境中一直在上升。这些感染不仅代表个人问题,但也是公共卫生问题。因此,性病的管理涉及减少社区发病率,这意味着临床实践中的常见问题,如未能出席可能成为一个更复杂的问题,这增加了定位性接触者的困难和微妙的任务,这些接触者将受益于筛查和适当的治疗。另一方面,性病对未成年患者有直接的法律影响,或者涉嫌性侵犯.因此,正确处理这些情况需要了解规范这些情况的法律框架。皮肤科医生经过临床培训,并准备应对这些疾病。尽管如此,涉及的法律问题往往难以解决。本文件是一个简单的参考指南,有助于解决我们在处理性传播疾病时可能遇到的主要法律问题。
    The incidence of sexually transmitted diseases has been on the rise in our setting for decades. These infections represent not only an individual problem, but also a problem of public health. Therefore, the management of STDs involves reducing community incidence, which means that common issues in the clinical practice such as failure to attend may become a more complex problem, which adds to the difficult and delicate task of locating sexual contacts that would benefit from screening and the appropriate treatment. On the other hand, STDs have direct legal implications in cases of underage patients, or suspected sexual assault. Therefore, the correct handling of these scenarios requires knowledge of the legal framework that regulates them. Dermatologists are clinically trained and prepared to deal with these conditions. Nonetheless, the legal issues involved are often difficult to solve. This document stands as a simple reference guide to help solve the main legal issues we may encounter in a consultation when dealing with STDs.
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  • 文章类型: Journal Article
    死亡医疗援助(MAID)立法在加拿大迅速发展,对护理实践产生了重大影响。本文的目的是描述立法背景和实践标准中不断变化的复杂性,这些复杂性会影响执业护士和注册护士对MAID的经验。对来自加拿大各地不同背景的25名注册护士和10名护士从业人员进行了定性访谈。参与者在讨论MAID作为预先护理计划的一部分时描述了他们的做法和考虑因素;他们使用,和挑战,放弃同意;他们在谈判无法合理预见死亡的客户的复杂性时的实践考虑;以及他们对唯一潜在医疗状况是精神疾病的人纳入MAID的道德斗争。调查结果说明了不断发展的立法所固有的道德复杂性,以及健全的健康和社会护理系统对加拿大MAID的法律和道德实施的重要性。
    Medical Assistance in Dying (MAID) legislation has evolved rapidly in Canada with significant impacts on nursing practice. The purpose of this paper is to describe evolving complexities in legislative context and practice standards that influence the experiences nurse practitioners and registered nurses have with MAID. Qualitative interviews were conducted with 25 registered nurses and 10 nurse practitioners from diverse contexts across Canada. Participants described their practices and considerations when discussing MAID as part of advance care planning; their use of, and challenges with, waivers of consent; their practice considerations in negotiating the complexities of clients for whom death is not reasonably foreseeable; and their moral wrestling with the inclusion of MAID for persons whose sole underlying medical condition is mental illness. Findings illustrate the moral complexities inherent in the evolving legislation and the importance of robust health and social care systems to the legal and ethical implementation of MAID in Canada.
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  • 文章类型: Journal Article
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  • 文章类型: Journal Article
    保护面临虐待风险的成年人面临复杂的道德挑战。通过知道什么是成人虐待,认识到成人虐待的迹象,并适当处理可疑的成人虐待,护士有助于保护病人的安全,幸福,自主和尊严。本文讨论了成人虐待的类别和指标,相关立法和标准,成人保护原则和可疑成人虐待的护理评估的关键要素。作者强调,护士需要敏感地处理保护问题,并在保护个人和维护其自主权之间取得平衡。有必要进行持续的教育和培训,以提高护士对保障措施的理解,立法,政策和标准。
    Safeguarding adults at risk of abuse presents complex ethical challenges. By knowing what counts as adult abuse, recognising the signs of adult abuse and appropriately addressing suspected adult abuse, nurses contribute to protecting patients\' safety, well-being, autonomy and dignity. This article discusses categories and indicators of adult abuse, relevant legislation and standards, the principles of adult safeguarding and the key elements of a nursing assessment of suspected adult abuse. The author highlights that nurses need to approach safeguarding concerns sensitively and strike a balance between acting to safeguard the person and preserving their right to autonomy. There is a need for ongoing education and training to enhance nurses\' understanding of safeguarding practices, legislation, policies and standards.
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  • 文章类型: Journal Article
    背景:医疗决定受各种因素的影响,也受法律要求和不确定感的影响,这导致了防御医学这个术语。该研究的目的是从德国全科医生(GP)的角度评估对感知到的法律后果的恐惧对防御性医学实践的影响。
    方法:2022年4月至5月进行了横断面研究。全科医生是通过德国全科医师协会家庭医学继续教育研究所的电子邮件通讯以及德国全科医师和家庭医师学院的在线平台邀请的。对法律恐惧的评估,本研究调查了防御性医学的一般评估以及防御性医学措施的原因和频率。除了描述性分析,采用逐步线性回归分析,探讨主要结局变量"对法律后果的恐惧"对防御性医学实践的潜在关联.
    结果:413名平均年龄为50岁的全科医生(51%为女性)回答。大多数人认为他们对法律后果的担忧低至平均水平,而近三分之一(27%,n=113)恐惧强烈到非常强烈。关于法律的担忧,在48%(n=198)的受访者中,医患关系发挥了相当大的作用.三分之一的人估计在未来10年内被民事起诉的可能性相当高。47%(n=193)的参与者认为,被起诉的风险可以通过防御性医学大大降低。法律上的自我保护是38%的响应者(n=157)经常采取防御性行动的原因。因此,一半的受访者表示,他们每周至少进行一次不必要的实验室检查,40%的受访者表示,他们每月一次转介患者接受放射学诊断,但没有医学指征。
    结论:由于法律恐惧对医疗实践有影响,法律自我保护是防御性行为的常见原因,应通过大学法律教育提高对法律的理解和知识,并对研究生学员和执业医师进行进一步培训。此外,社会对保护和防御医学现象及其后果的更深入的启示可能是减少医生对法律后果的恐惧的可能性。
    Medical decisions are influenced by a variety of factors also by legal requirements and feelings of uncertainty, which results in the term defensive medicine. The aim of the study was to evaluate the influence of fears of perceived legal consequences on the practice of defensive medicine from the perspective of German general practitioners (GPs).
    A cross-sectional study was performed from April to May 2022. GPs were invited via an e-mail newsletter of the Institute for Continuing Education in Family Medicine in the German Association of General Practitioners and via an online platform of the German College of General Practitioners and Family Physicians. The evaluation of legal fears, the general assessment of defensive medicine and reasons for and the frequency of defensive medical measures were surveyed in this study. Beside descriptive analyses, a stepwise linear regression analysis was used to explore potential associations between for the primary outcome variable \'fears of legal consequences\' on the practice of defensive medicine.
    413 general practitioners with an average age of 50 years (51% female) responded. The majority rated their fears of legal consequences as low to average whereas for almost a third (27%, n = 113) the fears were strong to very strong. Regarding legal fears, the physician-patient-relationship played a fairly to very large role for 48% (n = 198) of the respondents. One third estimated the probability of being sued civilly in the next 10 years as rather high to very high. 47% (n = 193) of the participants assumed that the risk of being sued could mostly to very much be reduced by defensive medicine. Legal self-protection was for 38% of the responders (n = 157) quite frequently to very frequently a reason for acting defensively. Consequently, half of the respondents stated that they performed unnecessary laboratory tests at least once per week and 40% indicated that they referred patients for radiological diagnostics without medical indication once per month.
    As legal fears have an influence on medical practice and legal self-protection being a frequent reason for defensive behaviour, understanding and knowledge of the law should be improved by legal education at university and further training of post-graduate trainees and practicing physicians should be implemented. Additionally, a more in-depth enlightenment of society about the phenomenon of Protective and Defensive Medicine and its consequences could be a possibility to decrease the perceived fears of legal consequences on the physicians\' side.
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  • 文章类型: Review
    背景:本范围审查旨在系统地和批判性地描述在提供口腔医疗保健中利用数字口腔健康带来的众多法律挑战。
    方法:进行系统检索。从成立到2023年3月,对以下电子数据库进行了审查:MEDLINE,Embase,Scopus,和LILACS。搜索包括任何英文科学文件和论文,西班牙语,或葡萄牙语关于在口腔医疗保健交付中使用数字健康提出的法律问题。两名审阅者进行了选择过程和数据提取。使用修改后的火星框架分析了有关采用数字健康技术的法律问题。
    结果:共纳入17项研究。大多数文件确定并涵盖了提供数字口腔医疗保健的一般方面(n=11),而没有明确提及任何牙科专业。提到最多的法律问题是数据安全(n=15);责任和渎职(n=14);同意(n=12);和保密(n=12)。在较低的程度上,患者-医生关系(n=11);以及执照和管辖权(n=11)也包括在内.其次是信息隐私(n=10);记录的充分性(n=9);和电子推荐(n=8)。另一方面,关于社交媒体使用的研究较少(n=3),认证(n=2);或电子处方(n=2)。在实施任何数字健康解决方案之前,从业者需要意识到这些技术的引入涉及的许多法律问题,明确责任在哪里,并在遵循国家准则时极其谨慎。当前的文献集中在一些众所周知的法律问题上。围绕身份验证的问题,使用社交媒体,电子处方受到的关注较少。
    BACKGROUND: This scoping review aims to systematically and critically describe the numerous legal challenges brought about by the utilization of digital oral health in the delivery of oral healthcare.
    METHODS: A systematic search was conducted. The following electronic databases were reviewed from inception up to March 2023: MEDLINE, Embase, Scopus, and LILACS. The search included any scientific document and paper in English, Spanish, or Portuguese on legal issues raised using digital health in oral healthcare delivery. Two reviewers conducted the selection process and data extraction. Legal issues raised concerning the adoption of digital health technology were analysed using the modified Mars\' framework.
    RESULTS: Seventeen studies were included. Most of the documents identified and covered generic aspects of delivering digital oral healthcare (n = 11) without explicitly referring to any dental specialty. The most mentioned legal issues were data security (n = 15); liability and malpractice (n = 14); consent (n = 12); and confidentiality (n = 12). To a lower extent, patient-practitioner relationship (n = 11); and license and jurisdiction (n = 11) were also covered. These were followed by privacy of information (n = 10); adequacy of records (n = 9); and e-referrals (n = 8). On the other hand, fewer studies commented on social media use (n = 3), authentication (n = 2); or e-prescriptions (n = 2). Before implementing any digital health solution, practitioners need to be aware of the many legal issues that the introduction of these technologies involves, be clear where the responsibility lies, and apply extreme caution in following national guidelines. Current literature concentrates on a few well-known legal issues. Issues around authentication, use of social media, and e-prescriptions received less attention.
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