Development of personal data handling policy in human genome research: A historical perspective in Japan

Abstract

An analysis of the policy, research and historical documents was performed to better understand the regulatory context within which the Japanese government has come to address the social control of human genome research and the measures it has taken, with regard to the handling of personal data, an area where innovations in the life sciences and in information and communication technology overlap. Our study revealed a shift in policy over time from a rigid to a more collaborative approach to regulation. From the 1980s to the 2000s, security control measures were developed to prevent leakage of personal data to external entities, using methods such as anonymisation, which can be applied in a linkable or unlinkable fashion. However, by the 2010s, de-identification measures have been introduced. They make it possible to utilise personal data that is de-identified (not completely, but specific individuals cannot be easily identified) in certain types of genomic research. This also involved the establishment of an independent data protection authority that controls the utilisation of data in collaboration with other stakeholders. Through this process, bioethics policy has become an established science and technology policy in Japan; and in recent years, bioethics policy has also gained relevance in areas outside the life sciences.