보건의료데이터의 공유·활용을 위한 법제 -보건의료데이터심의위원회에 관한 비교법적 검토를 중심으로-

Healthcare data, encompassing patient treatment records, test results, and genetic information, are essential for medical advancement such as research and personalized treatment. However, given that these data contain sensitive personal information, a critical challenge lies in maintaining the balance between data utilization and personal information protection. While existing legislation provides for Institutional Review Boards (IRBs) under the Bioethics and Safety Act, the legal basis for the Healthcare Data Deliberation Committee (DDC), often required for multi-institutional data sharing, remains ambiguous under current laws. DDCs primarily operate based on the non-binding "Healthcare Data Utilization Guidelines" issued by relevant government bodies. This paper analyzes the legal foundation, function, and role of DDCs operating within Korean medical institutions by comparing and reviewing the laws, and cases of the United States, the European Union, and Japan. The analysis reveals that while DDCs serve to review the appropriateness of pseudonymization processes, their vague legal status leads to unclear accountability in cases of data misuse and operational issues such as review delays and biased committee composition. In conclusion, to ensure the safe and effective utilization of healthcare data, it is crucial to clarify the legal basis for the establishment of DDCs through legislation. Furthermore, systemic improvements are needed, such as presenting clear standards for data linkage in the law and strengthening the qualifications and educational requirements for committee members. These enhancements are expected to foster a medical research environment that aligns with the big data era while robustly protecting data subjects' rights.