我国手术机器人设计者侵权责任研究  

Research on the Liability for Infringement of Surgical Robot Designers in China

作　　者：朱钟锐 马辉[1] ZHU Zhongrui(School of Medical Humanities,Capital Medical University,Beijing,100069,China)

机构地区：[1]首都医科大学医学人文学院,北京100069

出　　处：《医学与社会》2024年第1期124-129,144,共7页Medicine and Society

基　　金：北京市社会科学基金项目,编号为21FXB005。

摘　　要：相较于普通医疗器械,手术机器人具有更高的自主性和复杂性。研发手术机器人的软件和系统的设计者在设计、生产到使用的整个流程中起着至关重要作用,其地位与生产者、运输者、仓储者、医疗机构等有显著不同。然而,目前手术机器人设计者的特殊性和重要性没有得到充分重视。通过梳理现有法律法规,发现设计者在手术机器人侵权责任承担上面临诸多挑战,如设计者地位的争议、设计缺陷难以认定、责任类型不适用等。对此,应确定手术机器人设计者地位,将其列为侵权责任承担的主体之一,可以采用“风险-效益”的设计缺陷认定标准,明确产品责任的适用类型,完善侵权责任承担规定。In comparison to conventional medical equipment,surgical robots exhibit greater autonomy and complexity.The designers responsible for developing their software and systems play a pivotal role in the entire process including design,production and use,with a distinct position that sets them apart from producers,transporters,warehousing operators,and medical institutions.However,the distinctiveness and significance of surgical robot designers have not received adequate recognition.This study reviews current legal and regulatory frameworks and identifies numerous challenges faced by designers concerning tort liability,including disputes regarding their status,difficulties in design defect identification,and the application of liability types.In response,this paper proposes elevating the status of surgical robot designers to be on par with producers,designating them as key subjects for bearing tort liability.To address these challenges,it recommends establishing a"risk-benefit"standard for identifying design defects,clearly defining the types of applicable product liability,and enhancing provisions for tort liability,resulting in a more equitable distribution of responsibility.

关 键 词：卫生法 侵权责任 手术机器人 设计者 

分 类 号：R-05[医药卫生]