Swedish Law on Personal Data in Biobank Research: Permissible But Complex

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Swedish Law on Personal Data in Biobank Research : Permissible But Complex

Stenbeck, Magnus (author): Karolinska Institute, Department of Clinical Neuroscience

Eaker Fält, Sonja (author): Regional Biobank Centre in Uppsala; Örebro healthcare region

Reichel, Jane (author): Stockholms universitet,Juridiska institutionen,Stockholm University, Faculty of Law

(creator_code:org_t)

2021-01-06
2021
English.
In: GDPR and Biobanking. - Cham : Springer. - 9783030493882 - 9783030493875 ; , s. 379-394-, s. 379-394

Related links:: https://doi.org/10.1...; show more...; https://su.diva-port... (primary) (Raw object); https://link.springe...; https://uu.diva-port... (primary) (Raw object); https://urn.kb.se/re...; https://doi.org/10.1...; https://urn.kb.se/re...; show less...

Book chapter (peer-reviewed)

Abstract Subject headings

This chapter describes the regulatory and organisational infrastructure of biobank research in Sweden, and how the introduction of the GDPR affects the possibilities to use biobank material in future research. The Swedish legislator has chosen a rather minimalistic approach in relation to the research exception in Article 89 GDPR and has only enacted limited general exceptions to the data protection rules. This may be partly explained by the comprehensive right to public access to official documents which gives researchers vast access to information held in registries, albeit conditioned on abiding by secrecy and confidentiality rules. The Swedish legislation implementing the GDPR includes a general exception from the data protection rules in relation to the right to access to official documents, which researchers also benefit from. However, confidentiality rules for different categories of information differ between sectors, which hinders an effective use of the registries in research. The regulatory regime for using biobank and registry data in Sweden thus involves both data protection and secrecy rules, which makes the legal landscape permissible but complex. The operationalisation of the research exception in Article 89 GDPR is analysed against this background. Special attention is given to the possibility to link personal information derived from biobanks with personal information from other data sources, including large national population based statistical registries as well as information from national clinical registers.

Subject headings

SAMHÄLLSVETENSKAP -- Juridik (hsv//swe)
SOCIAL SCIENCES -- Law (hsv//eng)
SAMHÄLLSVETENSKAP -- Juridik -- Juridik (hsv//swe)
SOCIAL SCIENCES -- Law -- Law (hsv//eng)

Keyword

Sweden
Implementation research Exception
minimalistic approach
access to official documents
population based registries
förvaltningsrätt
förvaltningsrätt
Administrative Law

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ref (subject category)
kap (subject category)

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By the author/editor: Stenbeck, Magnus; Eaker Fält, Sonj ...; Reichel, Jane

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SOCIAL SCIENCES: SOCIAL SCIENCES; and Law

SOCIAL SCIENCES: SOCIAL SCIENCES; and Law; and Law

Articles in the publication: GDPR and Biobank ...; GDPR and Biobank ...

By the university: Stockholm University; Uppsala University

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