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Journal article 326 views

Can Standards and Regulations Keep Up With Health Technology?

Christopher James Vincent, Gerrit Niezen Orcid Logo, Aisling Ann O'Kane, Katarzyna Stawarz

JMIR mHealth and uHealth, Volume: 3, Issue: 2, Start page: e64

Swansea University Author: Gerrit Niezen Orcid Logo

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DOI (Published version): 10.2196/mhealth.3918

Abstract

Technology is changing at a rapid rate, opening up new possibilities within the health care domain. Advances such as open source hardware, personal medical devices, and mobile phone apps are creating opportunities for custom-made medical devices and personalized care. However, they also introduce ne...

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Published in: JMIR mHealth and uHealth
Published: 2015
Online Access: http://mhealth.jmir.org/2015/2/e64/
URI: https://cronfa.swan.ac.uk/Record/cronfa21989
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first_indexed 2015-06-09T02:09:31Z
last_indexed 2018-02-09T05:00:00Z
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spelling 2015-06-08T11:32:48.8904933 v2 21989 2015-06-08 Can Standards and Regulations Keep Up With Health Technology? b200bd681f400f63fce389f13cfa6e33 0000-0003-3787-8194 Gerrit Niezen Gerrit Niezen true false 2015-06-08 SCS Technology is changing at a rapid rate, opening up new possibilities within the health care domain. Advances such as open source hardware, personal medical devices, and mobile phone apps are creating opportunities for custom-made medical devices and personalized care. However, they also introduce new challenges in balancing the need for regulation (ensuring safety and performance) with the need to innovate flexibly and efficiently. Compared with the emergence of new technologies, health technology design standards and regulations evolve slowly, and therefore, it can be difficult to apply these standards to the latest developments. For example, current regulations may not be suitable for approaches involving open source hardware, an increasingly popular way to create medical devices in the maker community. Medical device standards may not be flexible enough when evaluating the usability of mobile medical devices that can be used in a multitude of different ways, outside of clinical settings. Similarly, while regulatory guidance has been updated to address the proliferation of health-related mobile phone apps, it can be hard to know if and when these regulations apply. In this viewpoint, we present three examples of novel medical technologies to illustrate the types of regulatory issues that arise in the current environment. We also suggest opportunities for support, such as advances in the way we review and monitor medical technologies. Journal Article JMIR mHealth and uHealth 3 2 e64 governmental regulations; health services; medical devices; mHealth; mobile phones; open source initiative; software; standards; technology 3 6 2015 2015-06-03 10.2196/mhealth.3918 http://mhealth.jmir.org/2015/2/e64/ COLLEGE NANME Computer Science COLLEGE CODE SCS Swansea University 2015-06-08T11:32:48.8904933 2015-06-08T11:32:48.8904933 Faculty of Science and Engineering School of Mathematics and Computer Science - Computer Science Christopher James Vincent 1 Gerrit Niezen 0000-0003-3787-8194 2 Aisling Ann O'Kane 3 Katarzyna Stawarz 4
title Can Standards and Regulations Keep Up With Health Technology?
spellingShingle Can Standards and Regulations Keep Up With Health Technology?
Gerrit Niezen
title_short Can Standards and Regulations Keep Up With Health Technology?
title_full Can Standards and Regulations Keep Up With Health Technology?
title_fullStr Can Standards and Regulations Keep Up With Health Technology?
title_full_unstemmed Can Standards and Regulations Keep Up With Health Technology?
title_sort Can Standards and Regulations Keep Up With Health Technology?
author_id_str_mv b200bd681f400f63fce389f13cfa6e33
author_id_fullname_str_mv b200bd681f400f63fce389f13cfa6e33_***_Gerrit Niezen
author Gerrit Niezen
author2 Christopher James Vincent
Gerrit Niezen
Aisling Ann O'Kane
Katarzyna Stawarz
format Journal article
container_title JMIR mHealth and uHealth
container_volume 3
container_issue 2
container_start_page e64
publishDate 2015
institution Swansea University
doi_str_mv 10.2196/mhealth.3918
college_str Faculty of Science and Engineering
hierarchytype
hierarchy_top_id facultyofscienceandengineering
hierarchy_top_title Faculty of Science and Engineering
hierarchy_parent_id facultyofscienceandengineering
hierarchy_parent_title Faculty of Science and Engineering
department_str School of Mathematics and Computer Science - Computer Science{{{_:::_}}}Faculty of Science and Engineering{{{_:::_}}}School of Mathematics and Computer Science - Computer Science
url http://mhealth.jmir.org/2015/2/e64/
document_store_str 0
active_str 0
description Technology is changing at a rapid rate, opening up new possibilities within the health care domain. Advances such as open source hardware, personal medical devices, and mobile phone apps are creating opportunities for custom-made medical devices and personalized care. However, they also introduce new challenges in balancing the need for regulation (ensuring safety and performance) with the need to innovate flexibly and efficiently. Compared with the emergence of new technologies, health technology design standards and regulations evolve slowly, and therefore, it can be difficult to apply these standards to the latest developments. For example, current regulations may not be suitable for approaches involving open source hardware, an increasingly popular way to create medical devices in the maker community. Medical device standards may not be flexible enough when evaluating the usability of mobile medical devices that can be used in a multitude of different ways, outside of clinical settings. Similarly, while regulatory guidance has been updated to address the proliferation of health-related mobile phone apps, it can be hard to know if and when these regulations apply. In this viewpoint, we present three examples of novel medical technologies to illustrate the types of regulatory issues that arise in the current environment. We also suggest opportunities for support, such as advances in the way we review and monitor medical technologies.
published_date 2015-06-03T03:26:08Z
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score 11.013619

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