Regulations

法规
  • 文章类型: Journal Article
    和ARP立场声明基于现有的科学证据,并以促进战斗运动运动员的安全和争取清洁运动的进步为目标,Ringside医师协会对大麻的建议如下:●由于未经证实的益处和许多已知的不良反应,不鼓励格斗运动运动员使用大麻或合成大麻素.急性使用会损害认知和复杂的运动功能,这可能会导致在格斗运动中的表现下降。长期使用会增加患心脏和肺部疾病的风险,几种癌症,精神分裂症,并且可以减少男性的睾丸激素并损害生育能力。在大多数情况下,大麻的好处,包括运动表现,还没有被证明。●既不鼓励也不鼓励使用局部纯化的CBD。●由于急性大麻中毒会损害复杂的认知和运动功能,根据临床判断,任何在比赛时涉嫌急性中毒的运动员都应被禁止参加比赛。●基于定量测试的大麻大规模监管在战斗运动中的有用性有限,出于以下原因:○大麻不是麦角性的,很可能是麦角性的。○体液中的浓度与临床效果和使用时机的相关性较差。○各体育组织对测试资源的访问差异很大。
    and ARP Position StatementBased on the available body of scientific evidence and with the goals of promoting safety of combat sports athletes and striving for the advancement of clean sport, the Association of Ringside Physicians recommends the following regarding cannabis:●Use of marijuana or synthetic cannabinoids by combat sports athletes is discouraged due to unproven benefits and many known adverse effects. Acute use can impair cognition and complex motor function, which likely leads to reduced performance in combat sports. Chronic use can increase risk for heart and lung disease, several cancers, schizophrenia, and can reduce testosterone in men and impair fertility. Benefits from cannabis in most contexts, including athletic performance, have not been proven.●Use of topical purified CBD is neither encouraged nor discouraged.●Since acute cannabis intoxication can impair complex cognitive and motor function, any athlete suspected of acute intoxication at the time of competition - based on clinical judgment - should be banned from that competition.●Wide-scale regulation of cannabis based on quantitative testing has limited usefulness in combat sports, for the following reasons:○Cannabis is not ergogenic and is likely ergolytic.○Concentrations in body fluids correlate poorly with clinical effects and timing of use.○Access to testing resources varies widely across sporting organizations.
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  • 文章类型: Journal Article
    生物类似疫苗和免疫治疗是医学研究中的创新方法。本评论解决了不同国家目前在生物仿制药疫苗和免疫治疗产品法规方面的差异。它还导航全球监管协调的好处和可能遇到的挑战。目前不同国家的法规差异,这对生物仿制药疫苗和免疫治疗产品的开发和批准构成了重大挑战。这些差距往往导致市场准入延迟,增加开发成本,阻碍了创新。评注强调,这些障碍可以通过统一的条例来缓解,导致更快的批准,降低医疗成本,改善患者预后。此外,评论探讨了与生物仿制药疫苗和免疫治疗相关的特定复杂性,例如由于其分子组成和免疫原性特性而对生物相似性进行的复杂评估。总之,社论主张共同努力,克服在实现生物仿制药全球监管协调方面的挑战。这包括建立统一标准,促进监管机构之间的国际合作,并促进医疗保健提供者和监管机构的教育举措。最终目标是确保全世界的患者能够及时获得安全、有效,和负担得起的生物类似疗法。
    Biosimilar vaccines and immunotherapeutic are innovative approaches in medical research. This commentary addresses the current disparities in regulations of biosimilar vaccines and immunotherapeutic products across different nations. It also navigates the benefits of global regulatory alignment and challenges that may be encountered. The current discrepancies in regulations across different countries, which pose significant challenges for the development and approval of biosimilar vaccines and immunotherapeutic products. These disparities often lead to delayed market access, increased development costs, and hindered innovation. The commentary stresses that such obstacles could be mitigated through harmonized regulations, resulting in faster approvals, reduced healthcare costs, and improved patient outcomes. Moreover, the commentary explores the specific complexities associated with biosimilar vaccines and immunotherapeutic, such as the intricate evaluation of biosimilarity due to their molecular composition and immunogenic properties. In conclusion, the editorial advocates for collaborative efforts to overcome the challenges in achieving global regulatory harmonization for biosimilars. This includes establishing uniform standards, fostering international cooperation among regulatory agencies, and promoting educational initiatives for healthcare providers and regulators. The ultimate goal is to ensure that patients worldwide have timely access to safe, effective, and affordable biosimilar treatments.
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  • 文章类型: Journal Article
    2021年8月15日,美军从喀布尔撤出,阿富汗的制裁开始了。被通常的问题——无效的,适得其反,笨拙-这些制裁揭示了另外三个难题。首先,尽管基于有针对性的制裁,他们变成了事实上的全面制裁。其次,这种转变是瞬时的,没有提示。第三,几周内发生了近乎饥荒的事件。我做嵌套分析,功能,和解释性论点。分析性的论点是,最好不要将定向制裁理解为国际胁迫的工具,而主要是将其理解为国内法规。职能论点是,外国资产控制办公室(OFAC)使用战术和战略歧义来最大程度地提高其对财务直觉的监管范围,人道主义援助组织,和汇款组织。解释性参数返回到谜题。我认为,没有来自OFAC的任何信号,这是信号,反映了OFAC的监管统治,当塔利班占领喀布尔时,国际金融界,人道主义援助组织,和汇款提供者都脱离了阿富汗,立即生效,对食物权利产生了特别严重的后果。
    On August 15, 2021, American military forces withdrew from Kabul, and the sanctioning of Afghanistan began. Marred by the usual problems-ineffective, counterproductive, unwieldy-these sanctions revealed three additional puzzles. First, although grounded in targeted sanctions, they transformed into de facto comprehensive sanctions. Secondly, that transformation was instantaneous and unprompted. Thirdly, a near-famine followed within weeks. I make nested analytical, functional, and explanatory arguments. The analytical argument is that targeted sanctions are best understood not as tools of international coercion but primarily as domestic regulations. The functional argument is that the Office of Foreign Asset Control (OFAC) uses tactical and strategic ambiguity to maximize its regulatory reach over financial intuitions, humanitarian aid organizations, and money transfer organizations. The explanatory argument returns to the puzzles. I argue that, without any signal from OFAC, which was the signal, and reflecting OFAC\'s regulatory domination, when the Taliban took Kabul, the international financial community, humanitarian aid organizations, and remittance providers all dissociated from Afghanistan with immediate effect and particularly acute consequences on food entitlements.
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  • 文章类型: Journal Article
    背景:肌钙蛋白复合物在调节骨骼和心脏收缩中起着至关重要的作用。先天性肌病可由于编码骨骼肌钙蛋白的基因中的几种突变而发生。此外,关于骨骼肌钙蛋白组成的信息有限。这篇综述专门研究了TNNC基因突变对心脏和骨骼调节的全面回顾。
    方法:肌钙蛋白C(TNNC)与一种新发现的遗传性肌肉疾病有关。编码骨骼肌钙蛋白的基因的遗传变异会损害肌节的功能。已经采用了各种治疗方法来减轻变化的影响,包括使用肌钙蛋白激活剂,通过AAV基因治疗注射野生型蛋白,和肌球蛋白修饰以增强肌肉收缩。编码骨骼肌钙蛋白的基因变异的病理生理意义的过程尚未完全了解。
    结论:本综述将有助于理解人类心肌病与TNNC突变之间的关系,并将指导治疗方法的发展。
    BACKGROUND: The troponin complex plays a crucial role in regulating skeletal and cardiac contraction. Congenital myopathies can occur due to several mutations in genes that encode skeletal troponin. Moreover, there is limited information regarding the composition of skeletal troponin. This review specifically examines a comprehensive review of the TNNC gene mutations on cardiac and skeletal regulations.
    METHODS: Troponin C (TNNC) has been linked to a newly discovered inherited muscle disorder. Genetic variations in genes that encode skeletal troponin can impair the function of sarcomeres. Various treatment approaches have been employed to mitigate the impact of variations, including the use of troponin activators, the injection of wild-type protein via AAV gene therapy, and myosin modification to enhance muscle contraction. The processes responsible for the pathophysiological implications of the variations in genes that encode skeletal troponin are not fully understood.
    CONCLUSIONS: This comprehensive review will contribute to the understanding of the relationship between human cardiomyopathy and TNNC mutations and will guide the development of therapy approaches.
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  • 文章类型: Journal Article
    背景:制定和实施自动驾驶汽车(AV)相关法规对于确保安全的AV部署和所有道路用户的广泛接受是必要的。评估易受伤害的道路用户对AV法规的看法可以告知决策者制定适当的AV法规,以促进多式联运系统中不同用户的安全。
    方法:这项研究评估了行人和骑自行车者对六种AV法规的看法(即,封顶AV速度限制,在敏感区域以手动模式操作AV,在操作AVs时既有飞行员又有副驾驶,和三项数据共享法规)。此外,评估了行人和骑自行车的人对在公共街道上测试AVs的看法。应用统计测试和建模技术来完成研究目标。
    结果:与本研究中评估的其他AV法规相比,确定了对AV相关数据共享法规的大力支持。年龄较大的受访者对公共道路上的AV测试表示更高的认可,对监管AV的支持较少。AV技术的熟悉程度和对AV的安全道路共享观念导致对AV法规的支持较低。
    结论:政策制定者和AV技术开发人员可以开发有效的教育工具/资源,以告知行人和骑自行车的人AV技术的可靠性,并软化他们的立场,特别是在AV法规上,这可能会延迟技术发展。
    结论:这项研究的结果可用于制定知情的AV法规,并制定政策,以改善行人和骑自行车者对规范AV和促进AV技术部署的态度/看法。
    BACKGROUND: Development and implementation of autonomous vehicle (AV) related regulations are necessary to ensure safe AV deployment and wide acceptance among all roadway users. Assessment of vulnerable roadway users\' perceptions on AV regulations could inform policymakers the development of appropriate AV regulations that facilitate the safety of diverse users in a multimodal transportation system.
    METHODS: This research evaluated pedestrians\' and bicyclists\' perceptions on six AV regulations (i.e., capping AV speed limit, operating AV in manual mode in the sensitive areas, having both pilot and co-pilot while operating AVs, and three data-sharing regulations). In addition, pedestrians\' and bicyclists\' perceptions of testing AVs in public streets were evaluated. Statistical testing and modeling techniques were applied to accomplish the research objectives.
    RESULTS: Compared to the other AV regulations assessed in this research, strong support for AV-related data sharing regulations was identified. Older respondents showed higher approval of AV testing on public roadways and less support for regulating AVs. AV technology familiarity and safe road sharing perceptions with AVs resulted in lower support for AV regulations.
    CONCLUSIONS: Policymakers and AV technology developers could develop effective educational tools/resources to inform pedestrians and bicyclists about AV technology reliability and soften their stance, especially on AV regulations, which could delay technology development.
    CONCLUSIONS: The findings of this research could be used to develop informed AV regulations and develop policies that could improve pedestrians\' and bicyclists\' attitudes/perceptions on regulating AVs and promoting AV technology deployments.
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  • 文章类型: Journal Article
    人工智能(AI)在移动健康(mHealth)中的日益突出已经产生了一个不同的应用程序子集,这些应用程序使用用户输入的健康状况和症状信息为用户提供诊断信息-AI支持的症状检查器应用程序(AIShycheck)。虽然这些应用程序可能会增加获得医疗保健的机会,他们提出了相应的道德和法律问题。本文将强调人工智能在医疗保健系统中的使用值得注意的问题,进一步巩固医疗保健系统中现有的偏见和专业问责制问题。对专业义务和责任的偏见和复杂性问题进行深入分析,我们专注于2mHealth应用程序作为例子-巴比伦和阿达。我们选择了这两个应用程序,因为它们在COVID-19大流行期间都广泛分发,并对它们使用人工智能来评估用户症状做出了突出的声明。首先,偏见根深蒂固通常源于用于训练人工智能系统的数据,让人工智能通过垃圾复制这些不平等,“垃圾出”现象。这些应用程序的用户也不太可能在人口统计上代表更大的人口,导致扭曲的结果。第二,鉴于AISymCheck应用程序可靠性的巨大多样性和缺乏监管,专业问责制构成了重大挑战。目前还不清楚这些应用程序是否应该接受安全审查。负责应用介导的误诊,以及这些应用程序是否应该由医生推荐。随着应用程序数量的迅速增加,对卫生专业人员的指导仍然很少。专业机构和宣传组织在解决这些道德和法律差距方面可以发挥特别重要的作用。在这些应用程序中实施技术保障措施可以减轻偏见,人工智能可以主要用中性数据进行训练,应用程序可能会受到监管系统的约束,以允许用户做出明智的决定。在我们看来,至关重要的是,在这些潜在破坏性技术的设计和实施过程中,必须考虑这些法律问题。根深蒂固的偏见和职业责任,在以不同方式操作时,最终加剧了mHealth的不受管制的性质。
    The growing prominence of artificial intelligence (AI) in mobile health (mHealth) has given rise to a distinct subset of apps that provide users with diagnostic information using their inputted health status and symptom information-AI-powered symptom checker apps (AISympCheck). While these apps may potentially increase access to health care, they raise consequential ethical and legal questions. This paper will highlight notable concerns with AI usage in the health care system, further entrenchment of preexisting biases in the health care system and issues with professional accountability. To provide an in-depth analysis of the issues of bias and complications of professional obligations and liability, we focus on 2 mHealth apps as examples-Babylon and Ada. We selected these 2 apps as they were both widely distributed during the COVID-19 pandemic and make prominent claims about their use of AI for the purpose of assessing user symptoms. First, bias entrenchment often originates from the data used to train AI systems, causing the AI to replicate these inequalities through a \"garbage in, garbage out\" phenomenon. Users of these apps are also unlikely to be demographically representative of the larger population, leading to distorted results. Second, professional accountability poses a substantial challenge given the vast diversity and lack of regulation surrounding the reliability of AISympCheck apps. It is unclear whether these apps should be subject to safety reviews, who is responsible for app-mediated misdiagnosis, and whether these apps ought to be recommended by physicians. With the rapidly increasing number of apps, there remains little guidance available for health professionals. Professional bodies and advocacy organizations have a particularly important role to play in addressing these ethical and legal gaps. Implementing technical safeguards within these apps could mitigate bias, AIs could be trained with primarily neutral data, and apps could be subject to a system of regulation to allow users to make informed decisions. In our view, it is critical that these legal concerns are considered throughout the design and implementation of these potentially disruptive technologies. Entrenched bias and professional responsibility, while operating in different ways, are ultimately exacerbated by the unregulated nature of mHealth.
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  • 文章类型: Letter
    暂无摘要。
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  • 文章类型: Journal Article
    虽然支持人工智能(AI)的技术继续快速发展,关于人工智能的有益产出和对医疗保健中人机交互挑战的担忧越来越多。为了解决这些问题,机构越来越多地诉诸于发布医疗保健人工智能指南,旨在使AI与道德实践保持一致。然而,可以分析作为书面语言形式的指南,以识别其文本交流与潜在的社会观念之间的相互联系。从这个角度来看,我们进行了语篇分析,以了解这些指南是如何构建的,口齿清晰,并为医疗保健中的人工智能构建伦理。我们纳入了八项指导方针,并确定了三个普遍和交织的话语:(1)人工智能是不可避免的和可取的;(2)人工智能需要以(某些形式的)原则指导(3)对人工智能的信任是工具性和主要的。这些话语标志着技术理想对AI伦理的过度溢出,比如过度乐观和由此产生的过度批评。这项研究提供了对AI指南中存在的基本思想的见解,以及指南如何影响AI的实践和伦理,legal,和社会价值有望塑造医疗保健领域的人工智能。
    While the technologies that enable Artificial Intelligence (AI) continue to advance rapidly, there are increasing promises regarding AI\'s beneficial outputs and concerns about the challenges of human-computer interaction in healthcare. To address these concerns, institutions have increasingly resorted to publishing AI guidelines for healthcare, aiming to align AI with ethical practices. However, guidelines as a form of written language can be analyzed to recognize the reciprocal links between its textual communication and underlying societal ideas. From this perspective, we conducted a discourse analysis to understand how these guidelines construct, articulate, and frame ethics for AI in healthcare. We included eight guidelines and identified three prevalent and interwoven discourses: (1) AI is unavoidable and desirable; (2) AI needs to be guided with (some forms of) principles (3) trust in AI is instrumental and primary. These discourses signal an over-spillage of technical ideals to AI ethics, such as over-optimism and resulting hyper-criticism. This research provides insights into the underlying ideas present in AI guidelines and how guidelines influence the practice and alignment of AI with ethical, legal, and societal values expected to shape AI in healthcare.
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  • 文章类型: Journal Article
    目标:随着当天在线酒类销售的增加,有必要研究他们的监管。进行了酒精送货上门的测试购买,以衡量是否符合澳大利亚两个司法管辖区的身份检查和无人看管的规定(珀斯,西澳大利亚和吉朗,Victoria),有不同的规定。
    方法:由年龄在18-24岁的研究助理在珀斯(n=34)和吉朗(n=29)进行当天或周五和周六晚上快速(<2小时)的酒精订单。使用观察检查表记录交付交互,特别侧重于在交付时检查带照片的身份证件,以及交付是否无人看管。
    结果:两个站点从订单到快速交付的平均时间不到一小时(珀斯=50分钟;吉朗=36分钟)。在两个地点,超过20%的交付都是在没有身份检查的情况下进行的(珀斯=24%;吉朗=21%)。
    结论:这项初步研究表明,酒精可以在一小时内送到家中,并非所有交付都包括交付点的身份检查。这些发现表明,需要制定政策,授权监管机构和警察进行“神秘购物者”监测,以减少潜在的危害并提高对酒精输送政策的遵守程度。
    OBJECTIVE: With same day online alcohol sales increasing, there is a need to study their regulation. Test purchasing of alcohol home delivery was conducted to measure compliance with regulations for identification checks and unattended deliveries in two Australian jurisdictions (Perth, Western Australia and Geelong, Victoria), which have differing regulations.
    METHODS: Alcohol orders for same day or rapid (<2 hours) delivery on Friday and Saturday nights were made by research assistants aged 18-24 years in Perth (n=34) and Geelong (n=29). An observation checklist was used to record the delivery interaction, with a specific focus on checking of photo identification at time of delivery and whether deliveries were left unattended.
    RESULTS: Average time from order to delivery for rapid deliveries was less than one hour in both sites (Perth = 50 minutes; Geelong = 36 minutes). More than 20% of deliveries were made without an identification check in both sites (Perth = 24%; Geelong = 21%).
    CONCLUSIONS: This pilot study showed alcohol can be delivered to the home within one hour, and not all deliveries include an identification check at point of delivery. These findings indicate a need for policies that empower regulators and police to undertake \'mystery shopper\' monitoring to reduce potential harms and improve compliance with alcohol delivery policy.
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  • 文章类型: Journal Article
    类器官是一种自组织的三维结构,来自模拟结构的干细胞,细胞组成,和特定器官和组织的功能特征,用于评估药物的安全性和有效性以及工业化学品的毒性。类器官技术是一种新的方法,可以替代动物测试,并加速精密和再生医学的发展。然而,实验室之间的生产可能会发生很大的差异,生产过程的可重复性较低,并且没有国际商定的终点质量评估因素标准。为了克服这些阻碍类器官的监管接受和商业化的障碍,韩国于2023年9月与各种利益相关者建立了类器官标准倡议。包括工业,学术界,监管机构,和标准开发专家,通过公共和私人伙伴关系。这制定了类器官制造和质量评估的一般指南,以及用于肝脏类器官特异性制造的质量评估指南,肠子,并通过广泛的证据分析和专家之间的共识。本报告基于通用标准指南v1.0,这是一般的类器官制造和质量评估,以促进类器官的实际使用。本指南不关注特定的类器官或特定的使用环境,但为类器官制造商和用户提供材料指导。程序,以及终点的基本质量评估方法,这些方法对于适用于当前技术水平的类器官生产至关重要。
    An organoid is a self-organized three-dimensional structure derived from stem cells that mimics the structure, cell composition, and functional characteristics of specific organs and tissues and is used for evaluating the safety and effectiveness of drugs and the toxicity of industrial chemicals. Organoid technology is a new methodology that could replace testing on animals testing and accelerate development of precision and regenerative medicine. However, large variations in production can occur between laboratories with low reproducibility of the production process and no internationally agreed standards for quality evaluation factors at endpoints. To overcome these barriers that hinder the regulatory acceptance and commercialization of organoids, Korea established the Organoid Standards Initiative in September 2023 with various stakeholders, including industry, academia, regulatory agencies, and standard development experts, through public and private partnerships. This developed general guidelines for organoid manufacturing and quality evaluation and for quality evaluation guidelines for organoid-specific manufacturing for the liver, intestines, and heart through extensive evidence analysis and consensus among experts. This report is based on the common standard guideline v1.0, which is a general organoid manufacturing and quality evaluation to promote the practical use of organoids. This guideline does not focus on specific organoids or specific contexts of use but provides guidance to organoid makers and users on materials, procedures, and essential quality assessment methods at end points that are essential for organoid production applicable at the current technology level.
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