The regulation of cognitive enhancement devices: extending the medical model
Identifieur interne : 000046 ( Main/Curation ); précédent : 000045; suivant : 000047The regulation of cognitive enhancement devices: extending the medical model
Auteurs : Hannah Maslen [Royaume-Uni] ; Thomas Douglas [Royaume-Uni] ; Roi Cohen Kadosh [Royaume-Uni] ; Neil Levy ; Julian Savulescu [Royaume-Uni]Source :
- Journal of Law and the Biosciences [ 2053-9711 ] ; 2014.
Abstract
This article presents a model for regulating cognitive enhancement devices (CEDs). Recently, it has become very easy for individuals to purchase devices which directly modulate brain function. For example, transcranial direct current stimulators are increasingly being produced and marketed online as devices for cognitive enhancement. Despite posing risks in a similar way to medical devices, devices that do not make any therapeutic claims do not have to meet anything more than basic product safety standards. We present the case for extending existing medical device legislation to cover CEDs. Medical devices and CEDs operate by the same or similar mechanisms and pose the same or similar risks. This fact coupled with the arbitrariness of the line between treatment and enhancement count in favour of regulating these devices in the same way. In arguing for this regulatory model, the paper highlights potential challenges to its implementation, and suggests solutions.
Url:
DOI: 10.1093/jlb/lst003
PubMed: 25243073
PubMed Central: 4168724
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Neil Levy<affiliation><nlm:aff id="aff4">Australian Research Council Future Fellow, Florey Institute of Neuroscience and Mental Health</nlm:aff>
<wicri:noCountry code="subfield">Florey Institute of Neuroscience and Mental Health</wicri:noCountry>
</affiliation>
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<front><div type="abstract" xml:lang="en"><p>This article presents a model for regulating cognitive enhancement devices (CEDs). Recently, it has become very easy for individuals to purchase devices which directly modulate brain function. For example, transcranial direct current stimulators are increasingly being produced and marketed online as devices for cognitive enhancement. Despite posing risks in a similar way to medical devices, devices that do not make any therapeutic claims do not have to meet anything more than basic product safety standards. We present the case for extending existing medical device legislation to cover CEDs. Medical devices and CEDs operate by the same or similar mechanisms and pose the same or similar risks. This fact coupled with the arbitrariness of the line between treatment and enhancement count in favour of regulating these devices in the same way. In arguing for this regulatory model, the paper highlights potential challenges to its implementation, and suggests solutions.</p>
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