DTC基因检测法律规制的域外经验与启示  

Overseas experience and enlightenments of laws and regulations of direct-to-consumer(DTC)genetic testing

作　　者：赵杰 霍增辉[1] ZHAO Jie;HUO Zenghui(School of Humanities,Beijing University of Chinese Medicine,Beijing 102488,China)

机构地区：[1]北京中医药大学人文学院,北京102488

出　　处：《卫生软科学》2025年第3期89-94,共6页Soft Science of Health

摘　　要：基因测序技术的飞速进步催生了直面消费者型基因检测(Direct-To-Consumer Genetic Testing,以下简称“DTC基因检测”)服务的普及,这一趋势引发了一系列关于基因信息安全和对检测结果科学性不足的担忧。我国目前在DTC基因检测领域的立法尚不完善,文章通过比较研究法,总结美国、韩国和英国在该领域的立法经验与监管实践,为我国DTC基因检测服务的法律规制提供借鉴,提出:确立基于中间主义的监管原则,确保检测的科学有效性;完善基因检测程序的制度建设,提高其规范性和透明度;加强基因信息法律保护的机制构建,确保个人信息安全等建议。The rapid advances in genomic sequencing technologies have led to the popularization of direct-to-consumer(DTC)genetic testing services.This trend has sparked a series of concerns regarding the security of genetic information and not scientific enough results.At present,China s legislation in the field of DTC genetic testing is imperfect.This paper summarizes the legislative experience and regulatory practice of the United States,South Korea and the United Kingdom in this field through comparative research to provide the reference for laws and regulations of DTC genetic testing services in China.Suggestions are proposed to establish the regulatory principles based on intermediate position to ensure the accuracy and validity of testing,improve the institutional construction of genetic testing procedures to improve standardization and transparency,and strengthen the mechanism of legal protection for genetic information to ensure the security of personal information.

关 键 词：DTC基因检测 法律规制 域外经验 中间主义监管 

分 类 号：Q-3[生物学] D92[政治法律—法学]