Characteristics and Future Perspectives of Available Electronic Health Record Databases in Japan

Area of Science:

• Health Informatics
• Regulatory Science
• Data Management

Background:

• Global regulatory agencies increasingly use real-world data (RWD) for drug approval and surveillance.
• Japan's Pharmaceuticals and Medical Devices Agency (PMDA) actively promotes RWD utilization.
• Electronic health record (EHR) databases are a key source of RWD in Japan.

Purpose of the Study:

• To characterize Japanese EHR databases.
• To identify challenges in using EHR data for regulatory decision-making.

Main Methods:

• Conducted Google searches for 'electronic medical record database' in Japan.
• Performed online interviews with eight Japanese EHR database companies.
• Summarized database characteristics, utilization challenges, and future perspectives.

Main Results:

• EHR databases offer broad patient data and lab values but lack inter-hospital data linkage.
• Data collection is primarily retrospective, with potential information loss during abstraction.
• A critical limitation is the lack of standardization across Japanese EHR databases.

Conclusions:

• Japanese EHR data are used for observational studies on efficacy/safety and post-marketing surveillance.
• Addressing operational, technical, and methodological challenges is crucial for regulatory use.
• Multi-stakeholder collaboration is essential to overcome EHR data limitations for regulatory approval.