Drug Evaluation Committee Challenges and Prospects for Efficient Clinical Trials through Standardization of Medical Information Based on HL7 FHIR and Linkage of Electronic Data Capture (EDC) and Other Data
June 2023
In fiscal years 2019 and 2021, the Data Science Subcommittee of the Drug Evaluation Committee assessed the current status and challenges of two eSources—DDC and electronic medical records—and proposed countermeasures.
In recent years, efforts toward the standardization of medical information in Japan have become increasingly active, and expectations are running very high for the expanded use of medical information utilizing HL7 FHIR, the next-generation standard for medical information exchange.
In light of these developments, this fiscal year’s report focuses on electronic health records (EHRs) as one of the eSource components. To build upon the recommendations from fiscal year 2021, we investigated trends in healthcare information standardization and FHIR, as well as related information; examined the future of data integration between EHRs and EDCs; and compiled a list of challenges to widespread adoption along with proposed actions.
We hope this report will contribute to understanding and resolving challenges related to the adoption and development of data integration between EHRs and EDCs, thereby accelerating operational efficiency in clinical development settings at medical institutions and other organizations.
Japan Pharmaceutical Manufacturers Association (JPMA) Drug Evaluation Committee
Data Science Subcommittee FY2022 Task Force 1-2