The regulation of cognitive enhancement devices: extending the medical model
Identifieur interne : 000183 ( Pmc/Curation ); précédent : 000182; suivant : 000184The 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.
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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>Le document en format XML
<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">The regulation of cognitive enhancement devices: extending the medical model</title><author><name sortKey="Maslen, Hannah" sort="Maslen, Hannah" uniqKey="Maslen H" first="Hannah" last="Maslen">Hannah Maslen</name><affiliation wicri:level="4"><nlm:aff id="aff1">Research Fellow in Ethics, Oxford Martin School, University of Oxford and Junior Research Fellow, New College, University of Oxford</nlm:aff><country>Royaume-Uni</country><placeName><settlement type="city">Oxford</settlement><region type="nation">Angleterre</region><region type="région" nuts="1">Oxfordshire</region></placeName><orgName type="university">Université d'Oxford</orgName></affiliation></author><author><name sortKey="Douglas, Thomas" sort="Douglas, Thomas" uniqKey="Douglas T" first="Thomas" last="Douglas">Thomas Douglas</name><affiliation wicri:level="4"><nlm:aff id="aff2">Senior Research Fellow, Oxford Uehiro Centre for Practical Ethics, University of Oxford and Golding Fellow, Brasenose College, University of Oxford</nlm:aff><country>Royaume-Uni</country><placeName><settlement type="city">Oxford</settlement><region type="nation">Angleterre</region><region type="région" nuts="1">Oxfordshire</region></placeName><orgName type="university">Université d'Oxford</orgName></affiliation></author><author><name sortKey="Cohen Kadosh, Roi" sort="Cohen Kadosh, Roi" uniqKey="Cohen Kadosh R" first="Roi" last="Cohen Kadosh">Roi Cohen Kadosh</name><affiliation wicri:level="4"><nlm:aff id="aff3">Wellcome Trust Research Career Development Fellow and University Research Lecturer, Department of Experimental Psychology, University of Oxford</nlm:aff><country>Royaume-Uni</country><placeName><settlement type="city">Oxford</settlement><region type="nation">Angleterre</region><region type="région" nuts="1">Oxfordshire</region></placeName><orgName type="university">Université d'Oxford</orgName></affiliation></author><author><name sortKey="Levy, Neil" sort="Levy, Neil" uniqKey="Levy N" first="Neil" last="Levy">Neil Levy</name><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></author><author><name sortKey="Savulescu, Julian" sort="Savulescu, Julian" uniqKey="Savulescu J" first="Julian" last="Savulescu">Julian Savulescu</name><affiliation wicri:level="1"><nlm:aff id="aff5">Uehiro Chair in Practical Ethics, Oxford Uehiro Centre, University of Oxford, Suite 8, Littlegate House, 16/17, St. Ebbe's Street, Oxford, OX1 1PT, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Uehiro Chair in Practical Ethics, Oxford Uehiro Centre, University of Oxford, Suite 8, Littlegate House, 16/17, St. Ebbe's Street, Oxford, OX1 1PT</wicri:regionArea></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmid">25243073</idno><idno type="pmc">4168724</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4168724</idno><idno type="RBID">PMC:4168724</idno><idno type="doi">10.1093/jlb/lst003</idno><date when="2014">2014</date><idno type="wicri:Area/Pmc/Corpus">000295</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">000295</idno><idno type="wicri:Area/Pmc/Curation">000183</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Curation">000183</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">The regulation of cognitive enhancement devices: extending the medical model</title><author><name sortKey="Maslen, Hannah" sort="Maslen, Hannah" uniqKey="Maslen H" first="Hannah" last="Maslen">Hannah Maslen</name><affiliation wicri:level="4"><nlm:aff id="aff1">Research Fellow in Ethics, Oxford Martin School, University of Oxford and Junior Research Fellow, New College, University of Oxford</nlm:aff><country>Royaume-Uni</country><placeName><settlement type="city">Oxford</settlement><region type="nation">Angleterre</region><region type="région" nuts="1">Oxfordshire</region></placeName><orgName type="university">Université d'Oxford</orgName></affiliation></author><author><name sortKey="Douglas, Thomas" sort="Douglas, Thomas" uniqKey="Douglas T" first="Thomas" last="Douglas">Thomas Douglas</name><affiliation wicri:level="4"><nlm:aff id="aff2">Senior Research Fellow, Oxford Uehiro Centre for Practical Ethics, University of Oxford and Golding Fellow, Brasenose College, University of Oxford</nlm:aff><country>Royaume-Uni</country><placeName><settlement type="city">Oxford</settlement><region type="nation">Angleterre</region><region type="région" nuts="1">Oxfordshire</region></placeName><orgName type="university">Université d'Oxford</orgName></affiliation></author><author><name sortKey="Cohen Kadosh, Roi" sort="Cohen Kadosh, Roi" uniqKey="Cohen Kadosh R" first="Roi" last="Cohen Kadosh">Roi Cohen Kadosh</name><affiliation wicri:level="4"><nlm:aff id="aff3">Wellcome Trust Research Career Development Fellow and University Research Lecturer, Department of Experimental Psychology, University of Oxford</nlm:aff><country>Royaume-Uni</country><placeName><settlement type="city">Oxford</settlement><region type="nation">Angleterre</region><region type="région" nuts="1">Oxfordshire</region></placeName><orgName type="university">Université d'Oxford</orgName></affiliation></author><author><name sortKey="Levy, Neil" sort="Levy, Neil" uniqKey="Levy N" first="Neil" last="Levy">Neil Levy</name><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></author><author><name sortKey="Savulescu, Julian" sort="Savulescu, Julian" uniqKey="Savulescu J" first="Julian" last="Savulescu">Julian Savulescu</name><affiliation wicri:level="1"><nlm:aff id="aff5">Uehiro Chair in Practical Ethics, Oxford Uehiro Centre, University of Oxford, Suite 8, Littlegate House, 16/17, St. Ebbe's Street, Oxford, OX1 1PT, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Uehiro Chair in Practical Ethics, Oxford Uehiro Centre, University of Oxford, Suite 8, Littlegate House, 16/17, St. Ebbe's Street, Oxford, OX1 1PT</wicri:regionArea></affiliation></author></analytic><series><title level="j">Journal of Law and the Biosciences</title><idno type="eISSN">2053-9711</idno><imprint><date when="2014">2014</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><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></div></front></TEI><pmc article-type="research-article"><pmc-dir>properties open_access</pmc-dir>
<front><journal-meta><journal-id journal-id-type="nlm-ta">J Law Biosci</journal-id><journal-id journal-id-type="iso-abbrev">J Law Biosci</journal-id><journal-id journal-id-type="hwp">jlb</journal-id><journal-id journal-id-type="publisher-id">jlb</journal-id><journal-title-group><journal-title>Journal of Law and the Biosciences</journal-title></journal-title-group><issn pub-type="epub">2053-9711</issn><publisher><publisher-name>Oxford University Press</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="pmid">25243073</article-id><article-id pub-id-type="pmc">4168724</article-id><article-id pub-id-type="doi">10.1093/jlb/lst003</article-id><article-categories><subj-group subj-group-type="heading"><subject>Original Article</subject></subj-group></article-categories><title-group><article-title>The regulation of cognitive enhancement devices: extending the medical model</article-title></title-group><contrib-group><contrib contrib-type="author"><name><surname>Maslen</surname><given-names>Hannah</given-names></name><xref ref-type="aff" rid="aff1"><sup>1</sup></xref></contrib><contrib contrib-type="author"><name><surname>Douglas</surname><given-names>Thomas</given-names></name><xref ref-type="aff" rid="aff2"><sup>2</sup></xref></contrib><contrib contrib-type="author"><name><surname>Cohen Kadosh</surname><given-names>Roi</given-names></name><xref ref-type="aff" rid="aff3"><sup>3</sup></xref></contrib><contrib contrib-type="author"><name><surname>Levy</surname><given-names>Neil</given-names></name><xref ref-type="aff" rid="aff4"><sup>4</sup></xref></contrib><contrib contrib-type="author"><name><surname>Savulescu</surname><given-names>Julian</given-names></name><xref ref-type="aff" rid="aff5"><sup>5</sup></xref><xref ref-type="corresp" rid="cor1">*</xref></contrib><aff id="aff1"><label>1</label>Research Fellow in Ethics, Oxford Martin School, University of Oxford and Junior Research Fellow, New College, University of Oxford</aff><aff id="aff2"><label>2</label>Senior Research Fellow, Oxford Uehiro Centre for Practical Ethics, University of Oxford and Golding Fellow, Brasenose College, University of Oxford</aff><aff id="aff3"><label>3</label>Wellcome Trust Research Career Development Fellow and University Research Lecturer, Department of Experimental Psychology, University of Oxford</aff><aff id="aff4"><label>4</label>Australian Research Council Future Fellow, Florey Institute of Neuroscience and Mental Health</aff><aff id="aff5"><label>5</label>Uehiro Chair in Practical Ethics, Oxford Uehiro Centre, University of Oxford, Suite 8, Littlegate House, 16/17, St. Ebbe's Street, Oxford, OX1 1PT, UK</aff></contrib-group><author-notes><corresp id="cor1"><label>*</label>Corresponding author. E-mail: <email>julian.savulescu@philosophy.ox.ac.uk</email>; Tel: +44 1865 286888</corresp></author-notes><pub-date pub-type="ppub"><day>01</day><month>3</month><year>2014</year></pub-date><pub-date pub-type="epub"><day>25</day><month>2</month><year>2014</year></pub-date><volume>1</volume><issue>1</issue><fpage>68</fpage><lpage>93</lpage><permissions><copyright-statement>© The Author 2014. Published by Duke University School of Law, Harvard Law School, Oxford University Press, and Stanford Law School.</copyright-statement><copyright-year>2014</copyright-year><license license-type="creative-commons" xlink:href="http://creativecommons.org/licenses/by/3.0/"><license-p>This is an Open Access article distributed under the terms of the Creative Commons Attribution License (<uri xlink:type="simple" xlink:href="http://creativecommons.org/licenses/by/3.0/">http://creativecommons.org/licenses/by/3.0/</uri>), which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited.</license-p></license></permissions><self-uri xlink:title="pdf" xlink:type="simple" xlink:href="lst003.pdf"></self-uri><abstract><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></abstract><kwd-group><kwd>cognitive enhancement devices</kwd><kwd>Medicines and Healthcare Products Regulatory Agency: medical devices</kwd><kwd>regulation</kwd><kwd>transcranial direct current stimulation</kwd></kwd-group><counts><page-count count="26"></page-count></counts><custom-meta-group><custom-meta><meta-name>cover-date</meta-name><meta-value>March 2014</meta-value></custom-meta></custom-meta-group></article-meta></front></pmc></record>Pour manipuler ce document sous Unix (Dilib)
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