欧盟和澳大利亚电子健康档案信息处理同意原则对我国的启示

Enlightenment of Consent Principle for Electronic Health Records Information Processing in the EU and Australia to China

欧盟电子健康档案数据处理的合法性基于患者对其数据处理的自由、具体、知情且明确的同意。患者亦有权利被医疗机构或医务人员充分告知不同职能数据处理的每个目的,并有权拒绝。在澳大利亚,公民均默认在“我的健康记录”系统上注册,并有权选择退出系统。另外系统设置常设同意,医疗机构在上载患者健康信息之前无需征得其同意,患者有拒绝此类处理的权利。欧盟和澳大利亚电子健康档案信息处理同意原则在保护患者权利与获得系统信息的效用之间各有侧重。我国相关法律条款对电子健康档案信息处理同意原则的同意形式、是否要求具体同意没有明确规定,结合欧盟和澳大利亚电子健康档案信息处理原则,建议我国电子健康档案信息处理信息分类同意、过程分阶段同意。

The legitimacy of the electronic health records information processing in the EU is based on patients'consent on the free,specific,informed and clarified data processing.Patients have the right to be informed by medical institutions or the medical staff with the objectives of data processing for different functions,and they also have the right to reject it.In Australia,citizens are defaulted to register in the system of"My Health Record",and they have the right to choose to have a quit.In addition,the system is defaulted to be set with consent,so the medical institutions have no need to ask for their consent before uploading the health information of the patients,but patients get the right to reject the processing.The consent principle for electronic health records information processing in the EU and Australia would attach difference importance to protecting the right of patients and the utility of obtaining system information.The relevant domestic laws have no clear regulations on the consent form of the electronic health records information processing and whether there should be specific consent.Combined with the consent principle for electronic health records information processing in the EU and Australia,it is suggested that there should be consent on the classification and on the stages during the process in the electronic health records information processing of our country.