从科学与法律的角度试析药品检验若干问题

目的明确药品检验机构的地位和作用,增强药品检验工作者的法律意识。方法运用史学、法学、管理学的研究思路,对药品检验工作涉及的法律问题进行研究分析。结果与结论药品检验机构是履行公共管理职能的机构,应当确保检验报告书的真实性,并认识到药品检验工作存在的局限性。     

Leveraging non-binding instruments for global health governance: reflections from the Global AIDS Reporting Mechanism for WHO reform

As countries contend with an increasingly complex global environment with direct implications for population health, the international community is seeking novel mechanisms to incentivize coordinated national and international action towards shared health goals. Binding legal instruments have garnered increasing attention since the World Health Organization adopted its first convention in 2003.     

Inverse probability weighting for covariate adjustment in randomized studies

Covariate adjustment in randomized clinical trials has the potential benefit of precision gain. It also has the potential pitfall of reduced objectivity as it opens the possibility of selecting a ‘favorable’ model that yields strong treatment benefit estimate. Although there is a large volume of statistical literature targeting on the first aspect, realistic solutions to enforce objective inference and improve precision are rare. As a typical randomized trial needs to accommodate many implementation issues beyond statistical considerations, maintaining the objectivity is at least as important as precision gain if not more, particularly from the perspective of the regulatory agencies. In this article, we propose a two‐stage estimation procedure based on inverse probability weighting to achieve better precision without compromising objectivity. The procedure is designed in a way such that the covariate adjustment is performed before seeing the outcome, effectively reducing the possibility of selecting a ‘favorable’ model that yields a strong intervention effect. Both theoretical and numerical properties of the estimation procedure are presented. Application of the proposed method to a real data example is presented. Copyright © 2013 John Wiley & Sons, Ltd.     

电子健康档案隐私保护的法律

我国隐私权的法律保护较为滞后.对电子健康档案隐私而言,现有法律法规尚存在诸多不足之处.鉴于此,本文拟就电子健康档案隐私保护的法律困境进行阐述,并据此提出构建电子健康档案隐私保护法律体系的若干建议.     

It Finally Happened to Me

It finally happened to me: I was sued for malpractice by the family of a patient who had died suddenly. My inner turmoil in the aftermath of this traumatic event affected me deeply. While I was an experienced family doctor dedicated to patient-centered medicine, the event challenged my customary approach to my patients. I share three vignettes from my practice that describe my inner dialogue both “preprosecution” and “postprosecution” and explain how I acted in each case.     

《侵权责任法》系列讲座之二:法律适用相关问题

《侵权责任法》试图建立一元化结构的医疗损害责任制度,引致《医疗事故处理条例》(《条例》)的存废之争。作者认为,围绕医患纠纷的民事赔偿法律规制,今后绝不会归于"一元化",而是继续保持甚至愈加"多元化"的态势。《侵权责任法》与《条例》肯定将并行不悖、各有侧重与分工。除《条例》将继续发挥规制作用外,对于《侵权责任法》生效之前诊疗行为结束并已出现损害后果的案例,事发当时有效的其他含有侵权责任规定的法律可能被优先适用,国际公约《经济、社会和文化权利国际公约》第12条及其拓展性文件规定了庞杂的"健康权"相关内容,亦不排除被优先于《侵权责任法》适用的可能性。     

《侵权责任法》系列讲座:概说

《侵权责任法》施行以来,各级卫生行政部门和各级各类医疗卫生服务机构组织从业人员学习、理解和贯彻《侵权责任法》,普法成就斐然。经过一年的研讨,各界就该法的理解达成了许多共识,但在很多环节和关键问题上,仍然歧见纷出,甚至存在着普遍的误读。本文详细阐述侵权责任法的相关概念及立法历程,同时指出其不足之处,并以工作实践为基础,结合法学理论的学习和运用,认为有必要围绕一部《侵权责任法》逐个提出若干重要基础课题,进行深入系统地商兑,以趋利避害,全面地守法、科学地用法。     

强化法律意识在临床实习教学中的意义

在临床实习教学过程中加强医学生法律法规教育对于防范医疗纠纷的发生具有深远的意义.从临床教学过程中缺乏法律法规层面的支持,临床实习教学过程中加强法律意识的必要性、紧迫性及需要性等方面分析了强化法律意识在临床实习教学中的意义.     

药品管理法律责任的制度创新

目的：评析2019年版《药品管理法》中的法律责任制度的创新,明确药品市场主体的主体责任和药品监管者的监管责任,以期减少药品违法事件的发生,保证公众用药安全。方法：对比2001年版《药品管理法》,结合行政法原理,加之比较法的视角,对2019年版《药品管理法》进行解析。结果与结论：2019年版《药品管理法》强化了法律责任的重要性,设定了更为严格的法律责任,通过体系化的制度设计和完善的法律责任机制,提高了违法者的违法成本,有助于遏制和惩戒违法行为。     

医疗机构药师工作的法律责任分析与风险防范

目的：探讨医疗机构药师工作中的法律责任与医疗风险的防范。方法：对已颁布实施的与药学相关的法律法规进行分析,确认风险因素,制定一套风险防范体系。结果与结论：药师工作责任重大,我们要重视药品使用过程中的风险,按法律法规规范自己的行为,预防和规避医疗风险的发生。