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2016 ; 24
(7
): 956-60
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Big Data in medical research and EU data protection law: challenges to the
consent or anonymise approach
#MMPMID26554881
Mostert M
; Bredenoord AL
; Biesaart MC
; van Delden JJ
Eur J Hum Genet
2016[Jul]; 24
(7
): 956-60
PMID26554881
show ga
Medical research is increasingly becoming data-intensive; sensitive data are
being re-used, linked and analysed on an unprecedented scale. The current EU data
protection law reform has led to an intense debate about its potential effect on
this processing of data in medical research. To contribute to this evolving
debate, this paper reviews how the dominant 'consent or anonymise approach' is
challenged in a data-intensive medical research context, and discusses possible
ways forwards within the EU legal framework on data protection. A large part of
the debate in literature focuses on the acceptability of adapting consent or
anonymisation mechanisms to overcome the challenges within these approaches. We
however believe that the search for ways forward within the consent or anonymise
paradigm will become increasingly difficult. Therefore, we underline the
necessity of an appropriate research exemption from consent for the use of
sensitive personal data in medical research to take account of all legitimate
interests. The appropriate conditions of such a research exemption are however
subject to debate, and we expect that there will be minimal harmonisation of
these conditions in the forthcoming EU Data Protection Regulation. Further
deliberation is required to determine when a shift away from consent as a legal
basis is necessary and proportional in a data-intensive medical research context,
and what safeguards should be put in place when such a research exemption from
consent is provided.