Advancing real-world data integration in nursing research: A policy perspective on Japan's next-generation medical infrastructure law and the EU EHDS framework.

aimThis Viewpoint analyzes the policy implications of Real-World Data (RWD) utilization in Japanese nursing research, comparing Japan's revised Next-Generation Medical Infrastructure Law with the European Union's European Health Data Space (EHDS) regulation. The paper explores how data standardization, interoperability, privacy protection, and technological integration can be improved in Japan and proposes actionable policy solutions for RWD integration into nursing practice and health policy.

methodsThe paper draws on a review of empirical studies and policy documents, comparing Japan's fragmented RWD framework with the EU's EHDS regulation. Focus areas include data standardization, interoperability, privacy protection, and technological integration. The review analyzes case studies from chronic disease management, nursing workflow optimization, and predictive analytics.

resultsThe comparison reveals barriers to RWD integration in Japan, such as inconsistent data standards, fragmented IT infrastructure, and lack of centralized data repositories. The EU's EHDS law offers a cohesive framework for cross-border data sharing through standardized data formats, enhanced interoperability, and privacy protections. The paper argues that Japan must adopt similar policies to improve data governance, enhance interoperability, and develop integrated systems for nursing research.

conclusionsJapan must strengthen its data governance frameworks, establish centralized data repositories, and adopt standardized practices to fully capitalize on RWD's potential. By aligning its policies with the EU's EHDS regulation, Japan can improve RWD integration in nursing practice and health policy, leading to better outcomes and more effective interventions.