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[The knowledge of medical law among medical students and medical service providers in Switzerland]. [瑞士医科学生和医疗服务提供者的医疗法律知识]。
IF 0.2 Q4 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-10-01 DOI: 10.23785/TU.2024.06.003
Katja Meier, Thomas D Szucs

Introduction: Legal aspects play an increasingly big role in everyday medical practice. This can lead to uncertainties when dealing with medicolegal issues, which could negatively impact the healthcare system and its involved parties. In this study, the medicolegal knowledge of medical students and physicians in Switzerland was examined to give recommendations for undergraduate, postgraduate and further education. A survey was conducted to assess how comfortable individuals feel when dealing with medicolegal issues, and their medicolegal knowledge was tested using case vignettes. Participants generally felt «rather uncomfortable» to be confronted with medicolegal issues. The results of the case vignettes suggest some medicolegal knowledge. However, there were indications of lack of knowledge or incorrect knowledge across almost the entire range of the topics surveyed. In undergraduate, postgraduate and further education, it seems appropriate to focus on the topics insurance and patient rights. Nevertheless, a generally more comprehensive medicolegal education can be considered important. In addition to medicolegal theory, its practical application should be taught as well. A more comprehensive medicolegal education should be seen as one of various approaches to address the uncertainty when facing medicolegal issues.

法律方面在日常医疗实践中发挥着越来越大的作用。这可能导致在处理医学法律问题时的不确定性,这可能对医疗保健系统及其相关方产生负面影响。在这项研究中,对瑞士医学生和医生的医学法律知识进行了调查,以便为本科、研究生和继续教育提供建议。进行了一项调查,以评估个人在处理法医学问题时的舒适程度,并使用案例片段测试了他们的法医学知识。参与者普遍对面对医学法律问题感到“相当不舒服”。案例的结果显示了一些医学法律知识。然而,在调查的几乎整个主题范围内,都有缺乏知识或不正确知识的迹象。在本科、研究生和继续教育中,似乎应该把重点放在保险和患者权利这两个主题上。然而,总体上更全面的医学法律教育是重要的。除了医学法学理论外,还应教授其实际应用。应将更全面的医学法学教育视为解决面临医学法学问题时的不确定性的各种方法之一。
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引用次数: 0
[Criminal law aspects in the medical field]. [医学领域的刑法方面]。
IF 0.2 Q4 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-10-01 DOI: 10.23785/TU.2024.06.008
Brigitte Tag

Introduction: The legal framework in Switzerland regarding medicine and health care is complex. Switzerland doesn't have a specific federal law on medicine or health care. Instead, numerous legal provisions apply to very different medical and health care situations. There are regulations located at different hierarchical legal levels with a variety of international, national and cantonal regulations, as well as the (soft) law of the medical profession. Under federalism and the principle of subsidiarity, the Swiss Federal Parliament is only responsible for the federal legal re-gulations where the Swiss Federal Constitution grants it the power to do so. The 26 cantons of Switzerland are responsible for all other matters. Therefore, the cantons have enacted specific health laws, patient laws and other regulations relevant to the medicine and health care sector. In addition, the Swiss Criminal Code is particularly relevant to medical treatments. The Swiss Criminal Code punishes, among others, assaults on life and physical integrity. Criminal liability is an individual responsibility and is determined by whether the requirements for criminal behavior are met in the individual case.

导言:瑞士关于医药和保健的法律框架是复杂的。瑞士在医药或保健方面没有专门的联邦法律。相反,许多法律规定适用于非常不同的医疗和保健情况。在不同等级的法律层次上有各种各样的国际、国家和州条例,以及医疗专业的(软)法。在联邦制和辅助原则下,瑞士联邦议会只负责瑞士联邦宪法赋予其权力的联邦法律法规。瑞士的26个州负责所有其他事务。因此,各州制定了具体的卫生法、病人法以及与医药和保健部门有关的其他条例。此外,《瑞士刑法》与医疗特别相关。《瑞士刑法典》惩处侵害生命和人身安全的行为。刑事责任是一种个人责任,是根据个案中犯罪行为的条件是否满足而确定的。
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引用次数: 0
[Pharmaceutical Products and Medical Devices: Authorization and Conformity Assessment Procedures, Regulatory Data Protection, Patent Protection and Supplementary Protection Certificate]. 【药品和医疗器械:授权和合格评定程序、监管数据保护、专利保护和补充保护证书】。
IF 0.2 Q4 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-10-01 DOI: 10.23785/TU.2024.06.006
Claudia Seitz

Introduction: Pharmaceutical products and medical devices can pose a potenzial risk to health. They may therefore only be placed on the market if their safety, efficacy and quality have been proven. The safety requirements are not to be understood as absolute. Rather, the safety assessment is based on a risk-benefit assessment. Pharmaceutical products and medical devices are subject to different requirements, whereby pharmaceutical products are subject to an authorization procedure, while medical devices have to undergo a conformity assessment procedure. This article first sets out the basic principles and the system of therapeutic products law and discusses the categorization of pharmaceutical products and medical devices as well as their differentiation from other products, in particular foodstuffs and cosmetics. The main features of placing pharmaceutical products on the market are then presented, with a focus on the authorization procedures for pharmaceutical products. This article also provides a brief overview of the protection rights for pharmaceutical products. In addition to the protection rights under the Therapeutic Products Act, the regulatory data protection, there are also protection rights under intellectual property law. In addition to the patent, intellectual property law grants another protection right for products that require an authorization in order to be placed on the market. The supplementary protection certificate, which is only granted to medicinal products and plant protection products as products that require an authorization, is intended to partially compensate for the lack of possibility of using the patented invention during the approval process. Due to the scope of the medicinal products and intellectual property law regulations mentioned, this article must limit itself to selected areas in an overview.

药品和医疗器械可能对健康构成潜在风险。因此,只有在其安全性、有效性和质量得到证实的情况下,它们才能投放市场。安全要求不应被理解为绝对的。相反,安全性评估是基于风险-收益评估。医药产品和医疗器械有不同的要求,其中医药产品要经过授权程序,医疗器械要经过合格评定程序。本文首先阐述了治疗产品法的基本原则和体系,讨论了药品和医疗器械的分类及其与其他产品,特别是食品和化妆品的区别。然后介绍了将药品投放市场的主要特点,重点是药品的授权程序。本文还简要介绍了医药产品的保护权。除了《治疗产品法》(Therapeutic Products Act)下的保护权利、监管数据保护之外,还有知识产权法下的保护权利。除了专利之外,知识产权法还为需要授权才能投放市场的产品授予另一种保护权利。补充保护证书,仅对医药产品和植物保护产品作为需要授权的产品授予,旨在部分补偿专利发明在批准过程中缺乏使用可能性。由于提及的医药产品和知识产权法律法规的范围,本文必须将自己限制在概述中选定的领域。
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引用次数: 0
[Medicine and Law: an Introduction - Part 2]. [医学与法律:导论-第二部分]。
IF 0.2 Q4 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-10-01 DOI: 10.23785/TU.2024.06.002
Thomas D Szucs

Introduction: Swiss medical law is based on a clear distinction between substantive and procedural law. Substantive law defines the material rights and duties of persons and institutions, while procedural law regulates the procedures for enforcing these rights. In addition, Swiss law distinguishes between objective law, which represents the totality of legal norms, and subjective law, which defines individual rights and powers. Private regulations such as the FMH Code of Professional Conduct or the SAMS guidelines supplement state medical law and set ethical standards. In social insurance law, the definition of illness (Art. 3 para. 1 ATSG) plays a central role, which is substantiated by case law. The interplay of legal requirements, private-law regulations and clear procedural standards ensures high-quality and legally sound medical practice in Switzerland.

导言:瑞士医疗法的基础是明确区分实体法和程序法。实体法规定个人和机构的实质性权利和义务,而程序法规定行使这些权利的程序。此外,瑞士法律区分了代表法律规范总体的客观法和界定个人权利和权力的主观法。私人条例,如FMH职业行为守则或SAMS准则,补充了国家医疗法律并制定了道德标准。在社会保险法中,疾病的定义(第3条第1款)。1 ATSG)发挥核心作用,这是由判例法证实。法律要求、私法条例和明确的程序标准的相互作用确保了瑞士高质量和合法的医疗实践。
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引用次数: 0
[Digital health, telemedicine and law]. [数字卫生、远程医疗和法律]。
IF 0.2 Q4 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-10-01 DOI: 10.23785/TU.2024.06.007
Nicolas Jordi

Introduction: Due to the development of digitalisation and information technology, medicine is subject to constant change. This development raises many new legal questions, most of which are still unanswered. This article first looks at the subarea of telemedicine and its regulation in federal and cantonal law and the question of the extent to which telemedicine is legally permissible. The particular focus here is on the doctor's perspective. Furthermore, this article deals with digital healthcare from the perspective of data protection law. Due to the central position of personal data in medicine, this area has become an integral part of everyday medical practice. This article provides a brief overview of this extensive field and highlights the most important key points of data protection law. Finally, this article uses a case study to address the question of the extent to which digital health applications should be considered medical devices. In practice, it is often very difficult to determine in advance whether such a digital health application is to be considered a medical device and is therefore subject to stricter regulations. The most important conditions in this regard are then presented and analysed.

导读:由于数字化和信息技术的发展,医学不断发生变化。这种发展提出了许多新的法律问题,其中大多数仍然没有答案。本文首先探讨远程医疗的子领域及其在联邦和州法律中的规定,以及远程医疗在法律上被允许的程度的问题。这里特别关注的是医生的观点。此外,本文还从数据保护法的角度讨论了数字医疗保健。由于个人数据在医学中的中心地位,这一领域已成为日常医疗实践中不可或缺的一部分。本文简要概述了这个广泛的领域,并强调了数据保护法的最重要的关键点。最后,本文使用一个案例研究来解决数字健康应用程序应被视为医疗设备的程度的问题。在实践中,通常很难事先确定此类数字健康应用程序是否应被视为医疗设备,因此需要遵守更严格的法规。然后提出并分析了这方面最重要的条件。
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引用次数: 0
[Medical liability and insurance]. [医疗责任和保险]。
IF 0.2 Q4 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-10-01 DOI: 10.23785/TU.2024.06.004
Simon Schönenberger

Introduction: The basic principles of medical liability in Switzerland are the same regardless of whether a physician is self-employed or employed. The first part of this article provides an overview of the jurisdiction of the Federal Supreme Court on the requirements for medical liability under civil law and state liability law, which is aimed at financial compensation for damages suffered by patients. The second part describes the insurance cover and important obligations that the physician has in the event of a claim. The third part of the article contains recommendations developed from the practice of a hospital on what to do after a possible medical error.

导言:在瑞士,无论医生是自雇还是受雇,医疗责任的基本原则都是相同的。本文的第一部分概述了联邦最高法院对民法和州责任法下医疗责任要求的管辖权,旨在对患者遭受的损害进行经济赔偿。第二部分描述了保险范围和医生在索赔事件中的重要义务。文章的第三部分包含从医院的实践中发展出来的关于在可能的医疗错误发生后该怎么做的建议。
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引用次数: 0
[Medical reporting obligations and reporting rights]. [医疗报告义务和报告权利]。
IF 0.2 Q4 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-10-01 DOI: 10.23785/TU.2024.06.005
Esther Schaffner

Introduction: Medical confidentiality protects the patient's privacy and medical data with criminal consequences in the event of a breach. It continues to exist even after the end of professional practice. Exceptions apply with the patient's consent or official authorisation. This paper describes various reporting obligations, e.g. in the case of exceptional deaths, abortions, communicable diseases and significant injuries caused by dogs. There are also reporting rights, e.g. for children or adults who are at risk. Some reports must be made anonymously, others require full patient details to be provided. Violations of the reporting obligations are punishable by law.

简介:医疗保密保护了患者的隐私和医疗数据,一旦违反将产生刑事后果。即使在职业实践结束后,它仍然存在。例外情况适用于患者同意或官方授权。本文描述了各种报告义务,例如在异常死亡、堕胎、传染病和由狗造成的重大伤害的情况下。此外还有报告权,例如针对有风险的儿童或成人。有些报告必须匿名,有些则要求提供病人的详细资料。违反报告义务将受到法律惩罚。
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引用次数: 0
[Medicine and Law: an Introduction - Part 1]. [医学与法律:导论-第一部分]。
IF 0.2 Q4 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-10-01 DOI: 10.23785/TU.2024.06.001
Thomas D Szucs

Introduction: The development of Swiss medical law is closely linked to social and medical development. In the early days and in the Middle Ages, healers and monasteries shaped medical care, with canon law playing an important role. In the early modern period, the first regional regulations for the medical profession emerged. With the founding of the federal state in 1848, the modernisation of medical law began; important laws such as the Factory Act (1877) and the first Health Insurance Act (1911) were introduced. In the 20th century, the introduction of the AHV/IV (1948) and the Health Insurance Act (KVG, 1996) marked the beginning of further professionalisation. Medical law is currently being adapted to meet modern ethical and legal challenges through laws such as the Human Research Act (2014) and remains a dynamic field.

导言:瑞士医疗法的发展与社会和医疗的发展密切相关。在早期和中世纪,治疗师和修道院塑造了医疗保健,教会法发挥了重要作用。在近代早期,出现了第一批区域性的医疗职业规范。随着1848年联邦州的建立,医疗法律的现代化开始了;引入了重要的法律,如《工厂法》(1877年)和第一部《健康保险法》(1911年)。在20世纪,《健康保险法》(1948年)和《健康保险法》(1996年)的出台标志着进一步专业化的开始。医疗法目前正在通过《人类研究法案》(2014年)等法律进行调整,以应对现代伦理和法律挑战,并且仍然是一个充满活力的领域。
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引用次数: 0
[Gout and Nutrition]. [痛风与营养]。
IF 0.2 Q4 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-09-01 DOI: 10.23785/TU.2024.05.005
Barbara Ankli

Introduction: Gout, the most common arthritis worldwide, is closely linked to cardiovascular disease and metabolic syndrome. The most impor-tant risk factor for developing gout is hyperuricemia. Serum uric acid is the end product of purine metabolism and can be partially influenced by dietary changes. Since a quarter of serum uric acid is excreted via the intestine, there is also a connection with diet here - keyword microbiome. Recently, genetic predispositions and drug therapy for gout have come to the fore. However, since cardiovascular comorbidities exist in high frequency, a dietary adjustment also makes sense to improve the comorbidities. Recently, the focus has shifted away from simply reducing purine intake in favor of introducing a largely plant-based diet. Reducing alcohol consumption makes sense for many reasons but does not lead to a significant reduction in serum uric acid. In addition to drug therapy, however, all possibilities should be exploited to enable a rapid reduction in serum uric acid to the target range; a change in diet can contribute to this. A change in diet can also have a positive effect on the frequency of gout flares. Targeted, structured information for patients promotes their knowledge of the disease and motivation to achieve their serum uric acid (SUA) goal. The right diet may be the personal contribution to quickly reaching the SUA target level and freedom from gout flares.

简介:痛风是全球最常见的关节炎,与心血管疾病和代谢综合征密切相关:痛风是全球最常见的关节炎,与心血管疾病和代谢综合征密切相关。罹患痛风最重要的风险因素是高尿酸血症。血清尿酸是嘌呤代谢的最终产物,可受到饮食变化的部分影响。由于四分之一的血清尿酸通过肠道排泄,因此这里也与饮食有关--关键词微生物组。近来,痛风的遗传倾向和药物治疗已成为人们关注的焦点。然而,由于心血管并发症的发生率很高,因此调整饮食结构对改善并发症也很有意义。最近,关注的焦点已经从简单地减少嘌呤摄入量转移到引入主要以植物为基础的饮食。出于多种原因,减少饮酒是有意义的,但这并不能显著降低血清尿酸。不过,除了药物治疗外,还应该利用一切可能的方法,使血清尿酸迅速降至目标范围;改变饮食习惯就能起到这样的作用。改变饮食习惯对痛风复发的频率也有积极影响。为患者提供有针对性、有条理的信息,可以增进他们对疾病的了解,激发他们实现血清尿酸(SUA)目标的动力。正确的饮食可以帮助患者快速达到血清尿酸(SUA)目标水平,避免痛风复发。
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引用次数: 0
[Therapy of gout in 2024]. [2024 年痛风治疗]。
IF 0.2 Q4 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-09-01 DOI: 10.23785/TU.2024.05.004
Adrian Forster

Introduction: The treatment of gout includes anti-inflammatory therapy and prophylaxis of flare-ups on the one hand and measures for long-term uric acid reduction on the other. Acute arthritis urica is best relieved by intra-articular steroids; systemic steroids, NSAIDs and, in exceptional cases, colchicine are also suitable. For the prophylaxis of relapses, long-term use of colchicine, NSAIDs or low-dose steroids is an option. However, the main pillar of gout therapy is pharmacological reduction of uric acid. The xanthine oxidase inhibitors allopurinol and febuxostat are best suited. The goal is a serum uric acid below 360 µmol/l ("treat to target"). The «start low, go slow» strategy reduces the risk of relapses and, in the case of allopurinol, the occurrence of hypersensitivity syndrome. Allopurinol is started at a maximum of 100 mg/d (less in renal insufficiency), followed by a slow upward titration to the required maintenance dose, which may largely exceed 300 mg/d (also in renal insufficiency). Febuxostat is started at a maximum of 40 mg/d and also titrated upwards. The most common cause of insufficient uric acid reduction is unreliable medication intake. In the management of gout, its comorbidities should also be sought and addressed.

导言:痛风的治疗一方面包括抗炎治疗和预防复发,另一方面包括长期降低尿酸的措施。缓解急性尿酸性关节炎的最佳方法是使用关节内类固醇;全身性类固醇、非甾体抗炎药以及在特殊情况下使用秋水仙碱也很合适。为了预防复发,可以长期使用秋水仙碱、非甾体抗炎药或小剂量类固醇。然而,痛风治疗的主要支柱是药物降尿酸。黄嘌呤氧化酶抑制剂别嘌呤醇和非布司他最为适用。目标是使血清尿酸低于 360 µmol/l("目标治疗")。低剂量开始,缓慢治疗 "的策略可降低复发风险,对于别嘌醇来说,还可减少超敏综合征的发生。别嘌醇的起始剂量最高为 100 毫克/天(肾功能不全者剂量更低),然后缓慢递增至所需的维持剂量,维持剂量可能超过 300 毫克/天(肾功能不全者也是如此)。非布索司他的起始剂量最高为 40 毫克/天,也是向上滴定。尿酸降低不足的最常见原因是药物摄入不可靠。在痛风的治疗过程中,还应该寻找并解决其并发症。
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引用次数: 0
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