Open AccessA Concept for a Japanese Regulatory Framework for Emerging Medical Devices with Frequently Modified Behavior
Author(s) -
Ota Nagomi,
Tachibana Keisuke,
Kusakabe Tetsuya,
Sanada Shoji,
Kondoh Masuo
Publication year - 2020
Publication title -
clinical and translational science
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.303
H-Index - 44
eISSN - 1752-8062
pISSN - 1752-8054
DOI - 10.1111/cts.12784
Subject(s) - the internet , computer science , data science , risk analysis (engineering) , business , medicine , world wide web
Recent progress in the Internet of Things and artificial intelligence has made it possible to utilize the vast quantity of personal health records, clinical data, and scientific findings for prognosis, diagnosis, and therapy. These innovative technologies provide new possibilities with the development of medical devices (MDs), whose behaviors can be continuously modified. A novel regulatory framework covering these MDs is now under discussion in Japan. In this review, we introduce the regulatory initiative for MDs and the importance of a paradigm shift from regulation to innovation regarding MDs.