일본의 의료정보 활용 관련 법제도에 관한 연구

Abstract

The Japanese government has amended the Personal Information Protection Act to add and establish a new category of special care-required personal information to protect personal information. Medical information fell under such rubric. However, to provide it to a third person, the consent of the principal of the information was required, except for exceptional cases. Therefore, difficulties were experienced in using such information. For this reason, the Japanese government enacted the Commentary on Next Generation Medical Infrastructure Law, as a special law of the Personal Information Protection Act, to utilize medical information actively. The Commentary on Next Generation Medical Infrastructure Law increases the possibility of using medical information by adopting an opt-out procedure that allows its use, unless the principal of the information refuses to consent to its provision. That is, business operators handling medical information (hospitals, pharmacies, etc.) can provide medical information to business operators who produce anonymized medical information, unless the principal of the information refuses to provide it. The business operators who produce anonymized medical information can anonymize such information for R&D purposes and provide it to other business operators (medical institutions, researchers, etc.) who handle such anonymized medical information.