의료 분야에서의 개인정보보호 - 유럽연합과 미국의 법제를 중심으로 -

Abstract

Although personal information protection in the medical field is important for privacy protection and smooth implementation of medical practice, the scientific/economic usefulness of personal health information cannot be disregarded. Finding an appropriate balance point between the ‘protection’ and ‘use’ of personal health information is an urgent task of now. This study is aimed to examine the present situation of personal information protection in the medical field in the European Union and the USA to derive implications for South Korea. The two legislative systems were compared with each other based on ① protected information, ② consent, and ③ reasons for exemptions from consent, which are basic concepts that constitute personal information protection regulations. European Union’s legislative system for personal information protection was changed drastically when the General Data Protection Regulation (GDPR) was established in 2016. With regard to protected information, breaking from the existing dichotomy of personal information and anonymous information, the concept of pseudonymized information was introduced for the first time. Pseudonymized information is a device that reduces the risk of data subjects while relieving the obligations of data controllers. With regard to consents, an interpretation that, for use of personal information for research, data subjects’ ‘broad consents’ may be valid instead of their specific consents was stated clearly in the GDPR Recital with a view to facilitating secondary use of personal health information. With regard to reasons for exemptions from consents, it could be seen that relatively wide ranges of the use of sensitive data for medical purposes, public health related purposes and research purposes are exempted from data subjects’ consents. In the USA, a law regarding personal health information protection (HIPAA) has been separately enacted. First, with regard to protected information, the said is characteristic in that it has specific regulations for de-identification methods, which are the ‘expert determination method’ and the ‘safe harbor method.’ In addition, the concept of ‘limited data set’ is separately set forth to partially relax the regulation. With regard to reasons for exemptions from consents, the law opens up possibilities to use personal health information for research purposes without data subjects’ consents on approval of a waiver of authorization from Institutional Review Boards, etc. Based on the above discussion, implications for South Korean legislative systems were derived. First, the 『personal information de-identification action guidelines』 established by the government have limitations in ensuring stable use of personal health information because they have no legal binding force and specifying de-identification methods with a ground for delegation in a law is desirable. Second, in light of recent streams to interpret requirements for consents toward relaxation, in the case of consents for research purposes, broad consents that are not limited to specific studies but are reusable for follow-up studies or related studies will be allowed. Third, legislative improvement is necessary toward giving exemption from consents to the use of sensitive data for research purposes is exemption from consents.