Drug Evaluation Committee Consideration of Pseudonym Processing Techniques when Preparing Processed Pseudonym Information, etc.
Data Science Subcommittee
December 2024
In recent years, attention has been focused on the advancement and efficiency of clinical development through the secondary use of real-world data from Japan and overseas and clinical trial data of similar drugs that have been conducted in the past. The 2023 amendment of the Next Generation Medical Infrastructure Act (Revised Next Generation Medical Infrastructure Act) established a mechanism to utilize pseudonymized medical information, which has less stringent processing standards than anonymous processing, and medical information can now be used for a wider range of research. Pseudonymous processing is expected to improve the usefulness of data, not only because the processing method is easier than anonymous processing, but also because there is less loss of information due to data processing. In addition to an outline of the revised Next Generation Medical Infrastructure Act, this report assumes a situation in which an authorized user obtains pseudonymized medical information for the purpose of pharmaceutical application from an authorized creator, and discusses the design goals, pseudonymization policy, and pseudonymization technology for pseudonymized medical information based on overseas reports that are necessary in this case. We hope that this report will be of some help in the future utilization of pseudonymized information.
Japan Pharmaceutical Manufacturers Association, Committee on Drug Evaluation
Data Science Subcommittee FY2023 Ongoing Task Force 2
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