uu.seUppsala University Publications
Change search
CiteExportLink to record
Permanent link

Direct link
Cite
Citation style
  • apa
  • ieee
  • modern-language-association
  • vancouver
  • Other style
More styles
Language
  • de-DE
  • en-GB
  • en-US
  • fi-FI
  • nn-NO
  • nn-NB
  • sv-SE
  • Other locale
More languages
Output format
  • html
  • text
  • asciidoc
  • rtf
Direct-to-consumer Genetic Testing: Changes in the EU Regulatory Landscape
Uppsala University, Disciplinary Domain of Humanities and Social Sciences, Faculty of Law, Department of Law.
2015 (English)In: European Journal of Health Law, ISSN 0929-0273, E-ISSN 1571-8093, Vol. 22, 463-480 p.Article in journal (Refereed) Published
Abstract [en]

Rapid advances in genomics and technology have rendered genetic testing services easily accessible to consumers over the Internet in the form of direct-to-consumer genetic testing. In the EU, the IVD Directive has been animadverted for its inability to tackle the challenges direct-to-consumer genetic testing has posed. Currently, the EU legislation is in a transition state. It is thus, timely to assess, to what extent the proposed IVD Regulation is intended to address the performance requirements and utility of direct-to-consumer genetic tests, which are made available to consumers within the EU over the Internet, and discuss the developments vis-à-vis the IVD Directive. To compare with the IVD Directive, the IVD Regulation presents a major shift in how direct-to-consumer genetic testing is treated in the EU. It remains unclear, whether and how the EU requirements can be applied beyond the EU market.

Place, publisher, year, edition, pages
2015. Vol. 22, 463-480 p.
Keyword [en]
direct-to-consumer genetic testing
National Category
Law Health Sciences
Research subject
Medical Law
Identifiers
URN: urn:nbn:se:uu:diva-292674DOI: 10.1163/15718093-12341363ISI: 26665691OAI: oai:DiVA.org:uu-292674DiVA: diva2:926382
Available from: 2016-05-06 Created: 2016-05-06 Last updated: 2017-05-05Bibliographically approved

Open Access in DiVA

No full text

Other links

Publisher's full text

Search in DiVA

By author/editor
Slokenberga, Santa
By organisation
Department of Law
In the same journal
European Journal of Health Law
LawHealth Sciences

Search outside of DiVA

GoogleGoogle Scholar

Altmetric score

Total: 179 hits
CiteExportLink to record
Permanent link

Direct link
Cite
Citation style
  • apa
  • ieee
  • modern-language-association
  • vancouver
  • Other style
More styles
Language
  • de-DE
  • en-GB
  • en-US
  • fi-FI
  • nn-NO
  • nn-NB
  • sv-SE
  • Other locale
More languages
Output format
  • html
  • text
  • asciidoc
  • rtf