eprintid: 1469040
rev_number: 51
eprint_status: archive
userid: 608
dir: disk0/01/46/90/40
datestamp: 2015-06-23 15:05:27
lastmod: 2021-09-20 00:31:54
status_changed: 2015-08-11 08:59:07
type: article
metadata_visibility: show
item_issues_count: 0
creators_name: Vincent, JC
creators_name: Niezen, G
creators_name: O Kane, AA
creators_name: Stawarz, K
title: Can Standards and Regulations Keep Up With Health Technology?
ispublished: pub
divisions: UCL
divisions: B02
divisions: C07
keywords: Governmental regulations; Health services; Medical devices; mHealth; Mobile phones; Open source initiative; Software; standards; Technology
note: ©Christopher James Vincent, Gerrit Niezen, Aisling Ann O'Kane, Katarzyna Stawarz. Originally published in JMIR Mhealth and Uhealth (http://mhealth.jmir.org), 03.06.2015.
This is an open-access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR mhealth and uhealth, is properly cited.
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 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.
date: 2015-06-03
official_url: http://dx.doi.org/10.2196/mhealth.3918
vfaculties: VFBRS
oa_status: green
full_text_type: pub
primo: open
primo_central: open_green
article_type_text: article
verified: verified_manual
elements_source: Manually entered
elements_id: 1036402
doi: 10.2196/mhealth.3918
lyricists_name: O'Kane, Aisling
lyricists_name: Stawarz, Katarzyna
lyricists_name: Vincent, Christopher
lyricists_id: AAOKA28
lyricists_id: KSTAW51
lyricists_id: CJVIN31
full_text_status: public
publication: JMIR mHealth uHealth
volume: 3
article_number: e64
citation:        Vincent, JC;    Niezen, G;    O Kane, AA;    Stawarz, K;      (2015)    Can Standards and Regulations Keep Up With Health Technology?                   JMIR mHealth uHealth , 3     , Article e64.  10.2196/mhealth.3918 <https://doi.org/10.2196/mhealth.3918>.       Green open access   
 
document_url: https://discovery.ucl.ac.uk/id/eprint/1469040/1/Vincent%20et%20al.%20Can%20standards%20and%20Regulations.pdf