Presentation Title: “Personal data in medical research: ethical, legal, and social issues”

Abstract:

The expectations for the utilization of personal health data are increasing worldwide. Furthermore, there are movements towards proposing and implementing new frameworks to promote the utilization of personal health data. In Japan, since the late 2010s, there have been multiple enactments and revisions of laws aimed at utilizing medical data for research and development in the healthcare field. The proposal of the European Health Data Space (EHDS), announced last year in Europe, has gained attention in Japan as well, leading to active discussions on the introduction of a system modeled after EHDS. One of the backgrounds to these trends is the strengthening of regulations in the field of data protection, exemplified by the implementation of GDPR in 2018. Therefore, most of the discussion has been focused on the legal, technical, and procedural aspects of utilizing data. There has been a lack of discussion regarding the societal and ethical expectations for the utilization and protection of personal health data in Japan. It is necessary to engage in sufficient discussions on the values related to what is needed to have confidence that societal and ethical expectations regarding the utilization and protection of personal data are being met. In this presentation, I will examine the ethical expectations for the utilization and protection of personal health data, and explore the appropriate approaches for utilizing and safeguarding data.