Drug Evaluation Committee Current Status and Issues of IoT Utilization in Drug Development
Electronic Standard for Medical Information Expert Committee
March 2018
In recent years, the rapid spread of smartphones and other mobile technologies has led to the development and utilization of a variety of devices and applications in the medical and healthcare fields. The "Revitalization Strategy of Japan 2016" specifically plans to enhance and strengthen health and medical services utilizing the Internet of Things (IoT), in which sensors and other devices embedded in everything around us are connected to the Internet and can communicate with each other. In addition, there are increasing reports of research and clinical trials of new medical findings using data acquired by IoT devices, mainly from overseas.
The Drug Evaluation Committee Electronic Standard for Medical Information Expert Committee Task Force 3, with the aim of promoting the use of IT in clinical trials and drug development-related work, conducted a questionnaire survey to confirm the status of IoT use in clinical trials by Japanese pharmaceutical companies, and surveyed specific examples of IoT use and related domestic and overseas laws and regulations, and summarized current issues, Since the use of IoT is a new initiative, we hope that not only those in charge of drug development but also those who formulate corporate strategies and business plans will find this report useful.
Current Status and Issues of IoT Utilization in Drug Development (798KB)