디지털 헬스케어 및 보건의료데이터 활용 관련 법안의 의미와 주요 쟁점

Digital healthcare means to the convergence of health care, information and communication, and digital technology. The major element of digital healthcare is healthcare data. While each country efforts steadily to utilize and foster digital healthcare and healthcare data around the world, related bills were also proposed and discussed in Korea. Considering that policies for sharing and linking healthcare data and revitalizing industries are being promoted as primary national tasks of the Yoon government, it is expected that related advanced bills will be discussed during the 22nd National Assembly. This study reviewed the background and major contents of legislation, focusing on two bills initiated by the Ministry of Health and Welfare on the use of digital healthcare and healthcare data, and contemplated issues to be considered in the next legislative process. At the end of the study, the necessity of following three things were confirmed that the scope of healthcare data, enacting a separate legislation, and defining the concept of digital healthcare and health care data. Especially, it is needed that the necessity of guaranteeing personal and property rights of doctors who contribute to the production of medical data. Regarding the processing of pseudonyms, it is required that the necessity of handling separately based on the degree of ambiguity and sensitivity of the concept of pseudonym medical data and the necessity of measures to realize rights through the design of the consent system of the data subject. The right to transmission should be legislated to ensure overall consistency after reviewing the ways for protecting, utilizing, and realizing the rights of the data subject. Regarding the scope of transmission targets, separated approaches are needed for each data by differentiating the value of observed and collected data belonging to judgment. It is also necessary to consider the transmission target for each type of information in the medical record, related rights, safety measures for transmission, and differentiation of regulatory measures. In this study, sufficient discussion on the above issues should be made in the next legislative process to establish a legal basis for promoting public health and securing industrial competitiveness through the use of digital healthcare and healthcare data.