보건의료데이터 활용의 안정성을 위한 법적 쟁점과 입법방향의 고찰

Efforts have been made to establish a legal basis for the utilization of data in the healthcare field through the revision of the Personal Information Protection Act and the announcement of the "Guidelines for the Utilization of Health and Medical Data." However, the current legislative framework for the utilization of health and medical data faces limitations, including conflicts with existing laws, challenges in ensuring the stability and reliability of data utilization, and competition between the necessity for industrial development. Despite being in the form of guidelines, the regulatory framework for the utilization of health and medical data operates effectively as if it were an actual law. In this study, four major legal issues related to the utilization of health and medical data are identified through a comprehensive examination. To promote the activation of health and medical data, it is crucial to ensure the stability of health and medical data utilization. Therefore, the establishment of an independent law is necessary, with a definition of the concept of health and medical data tailored to the practical characteristics of the health and medical field. Regulations should be put in place in the law regarding pseudonymization and pseudonymization procedures to ensure legal stability. The Data Review Committee should be regulated in a direction that secures a legal basis and expertise. Strengthening the legal status of data utilization agencies through permits and approvals, along with enhanced regulations on responsibilities for violations, is essential. In summary, through swift legislative responses and the establishment of a regulatory system, the foundation for the utilization and responsibility of health and medical data should be secured, ensuring successful integration into our society through effective regulation.