인문학
사회과학
자연과학
공학
의약학
농수해양학
예술체육학
복합학
지원사업
학술연구/단체지원/교육 등 연구자 활동을 지속하도록 DBpia가 지원하고 있어요.
커뮤니티
연구자들이 자신의 연구와 전문성을 널리 알리고, 새로운 협력의 기회를 만들 수 있는 네트워킹 공간이에요.
초록·키워드
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.
본문·목차
인공지능 문자 인식 모델을 통해 추출된 텍스트로, 일부 오타나 오류가 포함될 수 있으나 지속적으로 개선 중입니다.
오류를 발견하셨다면 해당 부분을 드래그한 후 ' 를 통해 신고해주세요.
오류를 발견하셨다면 해당 부분을 드래그한 후 ' 를 통해 신고해주세요.