Using EHRs to design drug repositioning trials: A devolved approach to data protection

One area where the application of data protection law has proven complex is in relation to the secondary usage of health data in EHRs for medical research. Here the tension between the privacy interests of patients and the risk of harm if such sensitive data are compromised, and on the other side, the potential societal value of utilizing the data for the benefit of medical science, is especially striking. In this paper, we consider the applicable provisions of the EU Data Protection Directive, and outline a general approach to patient data handling for research, which we believe to be compatible with relevant legal and ethical requirements. We then illustrate and apply this by reference to a specific EU FP7 project, involving EHR data processing to select patients for clinical pharmaceutical trials. After introducing the project (PONTE), we explain the ‘devolved’ data protection architecture it employs and provide a legal evaluation.     

反思精神障碍强制医疗的“危险性”原则

很多国家精神卫生立法在强制医疗人院标准方面都适用了“危险性”原则,我国《精神卫生法》也在其列。然而,“危险性”原则是基于三个错误的假设,因此实际上“危险性”原则可能会增加精神疾病对患者的伤害和较大程度增加社区危险的风险。本文呼吁参考Large及Richardson的观点及美国部分州与苏格兰精神卫生立法的实证经验,在“危险性”原则基础上补充“拒绝治疗的能力”评定作为精神障碍者强制医疗入院标准。     

论医疗事故技术鉴定意见的证明力及存在的问题

符合法律规范的医疗事故技术鉴定意见在行政处理医疗纠纷上具有证明力,可以从鉴定人资格和条件、鉴定程序和方法等方面予以印证。但当其作为诉讼中的法定证据鉴定意见使用时,其证据力方面还存在一定问题,尤其与新修订的《民事诉讼法》存在不一致,应予完善,以提高其证据力。     

中医医疗技术损害侵权鉴定中的证据审查分析简

近些年,随着全民养生保健意识的逐步提高,选择中医治疗的患者越来越多,接踵而来的是因中医医疗技术损害引起纠纷的案件数量的攀升。但目前国内外大多数都是按照西医治疗的标准进行鉴定,一直未形成具有针对性、系统性、统一性的中医医疗纠纷鉴定的标准与原则。本文中,作者旨在结合《侵权责任法》中医疗技术损害责任的相关规定,阐述中医辨证论治的特点,审查分析中医医疗技术纠纷鉴定中的相关证据。     

特殊医疗纠纷解决路径研究--对一般医疗纠纷解决路径的反思与突破

特殊医疗纠纷因其医患地位平等性而区别于传统意义上的一般医疗纠纷。在过去,一般医疗纠纷解决主要有合同和侵权两种路径,但以侵权路径为主。之所以如此,是因为合同路径不符合医方的角色定位,且难以帮助患者获得精神损害赔偿。然而,侵权路径亦有劣势,其难以涵盖整个医患关系,且无法解决医患实质平等。综合来看,解决纠纷审判宜采合同路径。主要理由有四:第一,合同路径能够适应特殊医疗纠纷基本特征。第二,合同路径并不排斥精神损害赔偿。第三,选择合同路径有助于《消费者权益保护法》适用的证成。第四,合同路径有利于促进医患形成"命运共同体",缓解医患矛盾。     

医疗损害责任的规制逻辑与适用路径——以《民法典》与“医事法”的协调为视角

为推进对《民法典》的规范阐释,促使其与医事法的衔接、互补,应对"医疗损害责任"的规制逻辑与适用路径进行明晰。"医疗损害责任"整体延续了《侵权责任法》的概念体系和框架结构,在说明义务、责任主体以及责任构成等方面加以创新。其作为《民法典》的具体规范,对总则编之规定予以遵从,是侵权责任编一般规定的特别法;其作为医事法的基本范畴,处于上位效力层级之中,与其他规范条文形成条件关系和并列关系。鉴于此,应遵循"从民法典到医事法"的适用路径,藉由内外在规范的自足与互助,明确规范条文之间的内在关联,实现规范概念的阐明和规范内涵的拓补,以推动《民法典》相关规则的贯彻实施,促进我国医事法学的蓬勃发展。     

医疗废物处置管理的法治应对

医疗废物具有危险性、污染性、毒性等特征,一旦得不到及时、安全、妥善处置,就可能产生二次传染,对环境安全和人民生命健康造成严重威胁。文章针对我国医疗废物处置管理存在的问题,从完善医疗废物处置管理立法体系、法律机制和监督问责制,建立多元机制等方面提出了有效的建议。     

Managing children's and adolescents' medical complaints amid parent conflict: Strategies and tools for professionals

Children and adolescents who are having difficulty coping with stress often present with complaints of physical discomfort. Effective treatment approaches exist for many of these issues. Among high-conflict parents, however, children's medical issues can become another canvas for conflict, with parents focused more on blaming one another for the child's distress than on options for assisting the child. Professionals can be drawn into the conflict to such a degree that they overlook essential steps for addressing and managing these issues. The authors present a research-informed model for managing medical and psychophysiological issues amid parental conflict.     

Why We Need Postmortem Analysis of Cardiac Implantable Electronic Devices

The prevalence of cardiac implantable electronic devices (CIEDs), pacemakers and implantable cardioverter defibrillators (ICDs) is increasing. However, postmortem analysis of CIEDs is not performed routinely. Fourteen consecutive CIEDs were analyzed. The indication for and date of implantation, technical data, CIED reprogramming, heart rhythm disturbances, patient demographics and medical consultations were investigated. Death during the first year after implantation was seen in 54%, whereof 71% consulted a physician within 10 days before death. The time of death was attributed to a particular day in 29%. There was a relationship between CIEDs and cause/manner of death in 50%. Although limited by a small sample size, this study advocates the routine postmortem CIED analysis for forensic and clinical purposes in selected cases. Patients with CIEDs seem to show an increased risk of death during the first year after implantation. The analysis of CIEDs can be helpful in evaluating the time/cause/manner of death.     

原发性脑干损伤及其研究进展

本文综述了原发性脑干损伤的原因、临床表现、诊断与检测 ,重点介绍了其死亡原因和病理形态学 ,尤其是在细胞和分子水平上的改变 ,并对原发性脑干损伤的进一步研究方向进行了展望