Issues Involved in Extracting Data from Maternal and Fetal Electronic Medical Records for Clinical Research in Japan.

Electronic medical records (EMRs) are used as secondary data in clinical research in the healthcare field. This study aims to address issues in the process of extracting maternal and fetal EMRs from EMR storage systems. We described the EMR data extraction process of pregnant Japanese women who gave birth at a university hospital in Tokyo. This study was approved by the ethics committee of Tokyo Women's Medical University (No. 2023-0061). First, to extract the maternal and fetal EMRs, we applied two independent applications to the ethics committee of the university and the hospital's Medical Records Office. Second, some maternal and fetal EMRs are stored separately in independent storage systems in the maternal and fetal wards. Third, some maternal and fetal EMR data storage systems were not connected to the hospital's main EMR storage system. The decentralized EMR data require a comprehensive management approach. Regulatory compliance and streamlined data management are vital for secondary use of EMRs in Japan. This work was supported by Funds for the Development of Human Resources in Science and Technology, Initiative for Realizing Diversity in the Research Environment.