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Cross-Border Health Data Transfer for Scientific Research Purposes in China: Legislation, Practice, and Challenges

  • Zhangyu Wang,
  • Li Du

摘要

Diverse health data has played an important role in advancing biomedical science, developing advanced drugs and therapies, and facilitating the safe and efficient integration of artificial intelligence in biomedical research and healthcare. This study examines the existing regulatory frameworks in ChinaChina concerning the sharing and cross-border transfer of health data, uncovering a multi-layered and intricate system riddled with notable restrictions. These constraints are enforced by three primary types of laws: general data protection laws, human genetic resources laws, and laws concerning health data derived from medical and healthcare institutions. The study reveals how localized data storage requirements for health records, rigorous administrative procedures for human genetic data sharing, and the need for informed consent collectively increase legal compliance obligations and impede the cross-border flow of health data. To mitigate these obstacles, the paper suggests two approaches: revoking localized data storage rules related to scientific research activities and simplifying regulatory procedures, and launching a National Data Analytics PlatformNational Data Analytics Platform to permit global, legal access to Chinese health data. The enactment of these proposals could encourage international collaborative research and promote progress in data-driven biomedical research.