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Biobanking between the EU and Third Countries - Can Data Sharing Be Facilitated via Soft Regulatory Tools?
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics. Lund Univ, Fac Law, Lund, Sweden; Riga Stradins Univ, Fac Law, Riga, Latvia.
2018 (English)In: European Journal of Health Law, ISSN 0929-0273, E-ISSN 1571-8093, Vol. 25, no 5, p. 517-536Article in journal (Refereed) Published
Abstract [en]

In biobanking, collaboration and data sharing contribute to building genomic research capacity, and have the potential to further scientific advances that ultimately can result in advances in clinical care. However, in the absence of common applicable legal frameworks that enable collaboration, capacity building is hindered. With the applicability of the General Data Protection Regulation, the obstacles to data sharing which involve export of data from European Union Member States to third countries are expected to grow, rendering the collaboration between the EU and third countries even more challenging. This article examines how, if at all, data sharing in biobank research between the EU and third countries could be facilitated via the use of soft regulatory tools. It argues that although the existing soft tools might not in itself be suitable for meeting all the GDPR requirements, they could be the basis on which to raise the area-specific data protection bar globally.

Place, publisher, year, edition, pages
BRILL ACADEMIC PUBLISHERS , 2018. Vol. 25, no 5, p. 517-536
Keywords [en]
biobanking, data protection, data sharing, soft law, soft rules
National Category
Law and Society
Identifiers
URN: urn:nbn:se:uu:diva-376839DOI: 10.1163/15718093-12550397ISI: 000456044100004OAI: oai:DiVA.org:uu-376839DiVA, id: diva2:1287855
Available from: 2019-02-12 Created: 2019-02-12 Last updated: 2019-02-12Bibliographically approved

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