A Concept for a Japanese Regulatory Framework for Emerging Medical Devices with Frequently Modified Behavior

A Concept for a Japanese Regulatory Framework for Emerging Medical Devices with Frequently Modified Behavior

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 developme...

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Bibliographic Details
Published in:Clinical and translational science Vol. 13; no. 5; pp. 877 - 879
Main Authors: Ota, Nagomi, Tachibana, Keisuke, Kusakabe, Tetsuya, Sanada, Shoji, Kondoh, Masuo
Format: Journal Article
Language:English
Published: United States John Wiley & Sons, Inc 01-09-2020
John Wiley and Sons Inc
Wiley
Subjects:
Algorithms
Artificial intelligence
Behavior
Deep learning
Designers
Engineers
Innovations
Internet
Machine learning
Marketing
Medical device industry
Medical equipment
Mini‐Review
Personal health
Pharmaceuticals
Quality management
Regulation
Reviews
Japan
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Summary: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.
Bibliography:ObjectType-Article-2
SourceType-Scholarly Journals-1
ObjectType-Feature-3
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ObjectType-Review-1
ISSN:1752-8054
1752-8062
DOI:10.1111/cts.12784