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New risks inadequately managed: the case of smart implants and medical device regulation

Many emerging technologies are associated with ‘risk’. While the concept of risk is protean, it is usually conceived of as the potential of something damaging or harmful happening. Thus, risks are a primary target of many regulatory regimes. In this article, after articulating an understanding of ri...

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Detalles Bibliográficos
Autores principales: Harmon, Shawn H.E., Haddow, Gill, Gilman, Leah
Formato: Online Artículo Texto
Lenguaje:English
Publicado: 2015
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5207313/
https://www.ncbi.nlm.nih.gov/pubmed/28058060
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author Harmon, Shawn H.E.
Haddow, Gill
Gilman, Leah
author_facet Harmon, Shawn H.E.
Haddow, Gill
Gilman, Leah
author_sort Harmon, Shawn H.E.
collection PubMed
description Many emerging technologies are associated with ‘risk’. While the concept of risk is protean, it is usually conceived of as the potential of something damaging or harmful happening. Thus, risks are a primary target of many regulatory regimes. In this article, after articulating an understanding of risk, we assess the European medical devices regulatory regime from a risk perspective, focusing on its handling of ‘smart’ implantable medical devices. In doing so, we discuss the empirical evidence obtained from expert participants in the Implantable Smart Technologies Project, which evidence is framed around three risk typologies: materiality, geography and modality. We conclude that none of these risks are sufficiently addressed within the existing regime, which falls down not just from a standards perspective, but also from the perspective of transparency and balance.
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spelling pubmed-52073132017-01-03 New risks inadequately managed: the case of smart implants and medical device regulation Harmon, Shawn H.E. Haddow, Gill Gilman, Leah Law Innov Technol Article Many emerging technologies are associated with ‘risk’. While the concept of risk is protean, it is usually conceived of as the potential of something damaging or harmful happening. Thus, risks are a primary target of many regulatory regimes. In this article, after articulating an understanding of risk, we assess the European medical devices regulatory regime from a risk perspective, focusing on its handling of ‘smart’ implantable medical devices. In doing so, we discuss the empirical evidence obtained from expert participants in the Implantable Smart Technologies Project, which evidence is framed around three risk typologies: materiality, geography and modality. We conclude that none of these risks are sufficiently addressed within the existing regime, which falls down not just from a standards perspective, but also from the perspective of transparency and balance. 2015 /pmc/articles/PMC5207313/ /pubmed/28058060 Text en http://creativecommons.org/licenses/by/4.0/ This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Article
Harmon, Shawn H.E.
Haddow, Gill
Gilman, Leah
New risks inadequately managed: the case of smart implants and medical device regulation
title New risks inadequately managed: the case of smart implants and medical device regulation
title_full New risks inadequately managed: the case of smart implants and medical device regulation
title_fullStr New risks inadequately managed: the case of smart implants and medical device regulation
title_full_unstemmed New risks inadequately managed: the case of smart implants and medical device regulation
title_short New risks inadequately managed: the case of smart implants and medical device regulation
title_sort new risks inadequately managed: the case of smart implants and medical device regulation
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5207313/
https://www.ncbi.nlm.nih.gov/pubmed/28058060
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