人体生物样本库与健康信息数据库跨库整合的伦理与法律思考

Ethical and Legal Thinking on Integration of Human Biobank and Health Information Database

因应生命科技的发展愿景与需求,人体生物样本库和健康信息数据库的跨库整合成为未来发展趋势。这种跨库整合将进一步挖掘样本资源的价值,推动精准医疗战略规划的实现。跨库整合的实现并非简单的数据链接,而是通过数据分析探寻其间的关联性或相关性。因此,人体生物样本库和健康信息数据库应充分关注跨库整合过程中的知情同意、隐私保护等问题,探究和规划具备合理性和适配性的伦理指南和法律规范。

Coping with the development of life science and technology,the linkage between biobanks and electronic health records or health information databases become the future trend.This kind of database linkage or integration will help to tap the value of biobank resources,promote the realization of the Accurate Medical Plan.The implementation of cross-database linkage or integration is not a simple data linkage,but a data analysis to explore the correlation between datasets.Therefore,attention should be paid to informed consent,privacy protection and other issues during the process of cross-database linkage or integration,and how to formulate legal and ethical norms that are rational and adaptive.