Drug Evaluation Committee Challenges and Prospects for Efficient Clinical Trials through Standardization of Medical Information with HL7 FHIR as the Axis and Linkage of Electronic Data Capture (EDC) and Other Data
Data Science Subcommittee
June 2023
The Data Science Subcommittee of the Drug Evaluation Committee has been identifying the current status and issues and recommending measures for two eSources, DDC and electronic medical records, in FY 2019 and FY 2021.
In recent years, the movement toward standardization of medical information in Japan has become even more active, and expectations for expanding the use of medical information using HL7 FHIR, the next-generation standard for medical information exchange, are extremely high.
In response to these expectations, this year we focused on electronic medical records among eSource and investigated trends in medical information standardization and FHIR and related information to move forward from the recommendations for FY2021, and considered the future image of data linkage between electronic medical records and EDC, and summarized issues and The report summarizes the issues and action recommendations for the spread of EDC and electronic medical records.
We hope that this report will help in understanding and resolving issues for the dissemination and development of data linkage between electronic medical records and EDC, etc., and accelerate the improvement of operational efficiency at clinical development sites such as medical institutions.
Japan Pharmaceutical Manufacturers Association, Committee on Drug Evaluation
Data Science Subcommittee Task Force 1-2 for FY2022
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