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Legal Framework and Challenges in Promoting the Utilization of Medical Data in Japan

Abstract:
This paper examines Japan’s legal framework for promoting the utilization of medical data, focusing on the Next-Generation Medical Infrastructure Act and its recent amendments. The Act enables the safe and appropriate use of anonymized and pseudonymized medical data to advance research and development in healthcare. While the framework represents a significant step forward, challenges remain, such as limited participation by small medical institutions and the need for standardized data formats like HL7. Additionally, the current analysis environments re quire improvements to support advanced research, including container-based customization and high-performance computing resources. Comparisons with the European Health Data Space (EHDS) highlight potential strategies for future revisions of the Act. Addressing these issues is essential to ensure comprehensive data collection and utiliza tion, particularly from small clinics and home care settings, to enhance collaborative care for chronic diseases and other long-term health conditions.