Drug Evaluation Committee Announcement of the release of "Toward the Utilization of Wearable Devices
Electronic Standard for Medical Information Expert Committee
Wearable devices are attracting increasing attention as a means of continuously and objectively monitoring the health status of patients in the fields of medicine and clinical trials. Especially in recent years, with the promotion of distributed clinical trials (DCT) and the development of digital technology, it is expected that wearable devices will be utilized for data acquisition and remote monitoring under everyday life.
On the other hand, there are multiple challenges in utilizing wearable devices in clinical trials, such as data reliability, device wearability, personal information protection, and compliance with medical device regulations (Pharmaceutical Affairs Law, Radio Law, and Electrical Appliance and Material Safety Law). In addition, operational issues such as lack of know-how on the part of the sponsor and the preparation period and risk assessment when using unapproved devices have also been pointed out.
In light of this background, the Drug Evaluation Committee Electronic Standard for Medical Information Expert Committee Task Force 3-1 has identified issues and concerns when introducing wearable devices into clinical trials, and has organized regulatory compliance, key points for device selection, and operational procedures to be considered for actual use. This document systematically summarizes the items that sponsors should consider, including examples of use in medical and clinical fields, characteristics in each disease area, issues and solutions associated with the introduction of wearable devices, as well as pharmaceutical CSV and regulatory compliance.
We hope that this information will serve as a reference for the establishment of systems, maintenance of operational procedures, and regulatory compliance at each company, and help ensure the smooth introduction of wearable devices.
Japan Pharmaceutical Manufacturers Association Drug Evaluation Committee
Electronic Standard for Medical Information Expert Committee Task Force 3-1