Legal and Ethical Challenges on Health and Genomic Data Transfer: A South Korean Perspective

Abstract

The legal and governance frameworks in South Korea for trans-border health and genomic data sharing are multifaceted and evolving. The Constitutional right to self-determination of personal information is upheld, emphasizing privacy and human dignity, although full alignment with international human rights norms remains a challenge. The Personal Information Protection Act (PIPA)Personal Information Protection Act (PIPA) comprehensively governs the processing and safeguarding of individual data. It includes cross-border data transfers, aligning with international standards, as affirmed by recent EU adequacy decision. The Bioethics and Safety Act (BSA)Bioethics and Safety Act (BSA) regulates ethical practices in genomic data research, mandating oversight by the Institutional Bioethics Committees (IBCs) for international research collaboration. The Data Review Boards (DRBs) further enhance oversight and pseudonymization of genetic data. The governance aims to balance research promotion with privacy, ethical conduct, and international standards in genomic data sharing. Challenges remain in reconciling interpretations of the main legislative text, impacting national security exemptions and lawful processing of personal information across different contexts. Reforms are underway to update frameworks for individual data sharing and governance, yet progress in genetic data sharing has been slow due to limited emphasis on it. Recent amendments of the laws have weighted to less regulate data utilization over risk mitigation. Therefore, achieving the balance between data protection and utilization will be essential for advancing research collaboration, addressing public concerns, and developing ethical standards in a data-intensive society and precision medicine. © The Author(s), under exclusive license to Springer Nature Singapore Pte Ltd. 2024.