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...

Descripción completa

Detalles Bibliográficos
Autores principales: Ota, Nagomi, Tachibana, Keisuke, Kusakabe, Tetsuya, Sanada, Shoji, Kondoh, Masuo
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2020
Materias:
Reviews
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7485956/
https://www.ncbi.nlm.nih.gov/pubmed/32216078
http://dx.doi.org/10.1111/cts.12784
_version_ 1783581249763278848
author Ota, Nagomi
Tachibana, Keisuke
Kusakabe, Tetsuya
Sanada, Shoji
Kondoh, Masuo
author_facet Ota, Nagomi
Tachibana, Keisuke
Kusakabe, Tetsuya
Sanada, Shoji
Kondoh, Masuo
author_sort Ota, Nagomi
collection PubMed
description 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.
format Online
Article
Text
id pubmed-7485956
institution National Center for Biotechnology Information
language English
publishDate 2020
publisher John Wiley and Sons Inc.
record_format MEDLINE/PubMed
spelling pubmed-74859562020-09-18 A Concept for a Japanese Regulatory Framework for Emerging Medical Devices with Frequently Modified Behavior Ota, Nagomi Tachibana, Keisuke Kusakabe, Tetsuya Sanada, Shoji Kondoh, Masuo Clin Transl Sci Reviews 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. John Wiley and Sons Inc. 2020-04-03 2020-09 /pmc/articles/PMC7485956/ /pubmed/32216078 http://dx.doi.org/10.1111/cts.12784 Text en © 2020 The Authors. Clinical and Translational Science published by Wiley Periodicals, Inc. on behalf of the American Society of Clinical Pharmacology and Therapeutics. This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.
spellingShingle Reviews
Ota, Nagomi
Tachibana, Keisuke
Kusakabe, Tetsuya
Sanada, Shoji
Kondoh, Masuo
A Concept for a Japanese Regulatory Framework for Emerging Medical Devices with Frequently Modified Behavior
title A Concept for a Japanese Regulatory Framework for Emerging Medical Devices with Frequently Modified Behavior
title_full A Concept for a Japanese Regulatory Framework for Emerging Medical Devices with Frequently Modified Behavior
title_fullStr A Concept for a Japanese Regulatory Framework for Emerging Medical Devices with Frequently Modified Behavior
title_full_unstemmed A Concept for a Japanese Regulatory Framework for Emerging Medical Devices with Frequently Modified Behavior
title_short A Concept for a Japanese Regulatory Framework for Emerging Medical Devices with Frequently Modified Behavior
title_sort concept for a japanese regulatory framework for emerging medical devices with frequently modified behavior
topic Reviews
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7485956/
https://www.ncbi.nlm.nih.gov/pubmed/32216078
http://dx.doi.org/10.1111/cts.12784
work_keys_str_mv AT otanagomi aconceptforajapaneseregulatoryframeworkforemergingmedicaldeviceswithfrequentlymodifiedbehavior
AT tachibanakeisuke aconceptforajapaneseregulatoryframeworkforemergingmedicaldeviceswithfrequentlymodifiedbehavior
AT kusakabetetsuya aconceptforajapaneseregulatoryframeworkforemergingmedicaldeviceswithfrequentlymodifiedbehavior
AT sanadashoji aconceptforajapaneseregulatoryframeworkforemergingmedicaldeviceswithfrequentlymodifiedbehavior
AT kondohmasuo aconceptforajapaneseregulatoryframeworkforemergingmedicaldeviceswithfrequentlymodifiedbehavior
AT otanagomi conceptforajapaneseregulatoryframeworkforemergingmedicaldeviceswithfrequentlymodifiedbehavior
AT tachibanakeisuke conceptforajapaneseregulatoryframeworkforemergingmedicaldeviceswithfrequentlymodifiedbehavior
AT kusakabetetsuya conceptforajapaneseregulatoryframeworkforemergingmedicaldeviceswithfrequentlymodifiedbehavior
AT sanadashoji conceptforajapaneseregulatoryframeworkforemergingmedicaldeviceswithfrequentlymodifiedbehavior
AT kondohmasuo conceptforajapaneseregulatoryframeworkforemergingmedicaldeviceswithfrequentlymodifiedbehavior

Ejemplares similares