Published by: THE LANCET
31 March 2018
The General Data Protection Regulation will start in May across the European Union, but doubts are being cast on how prepared researchers and clinicians are. Becky McCall reports.
Nigel Hughes and Dipak Kalra from i~HD discuss the GDPR implications for big data research in this interview article in The Lancet. They stress that there are some important grey areas for which we urgently need to agree best practice.
Nigel Hughes, scientific director at Janssen Research and Development, echoes others in highlighting the apparent lack of urgency with respect to guidance on how to best interpret both the GDPR across the EU, and the forthcoming revised Data Protection Act (DPA). He also notes the immense complexity of the regulation, which might partly explain why various parties are dragging their heels in the midst of the intractable Brexit negotiations.
‘The idea that everyone working with data will all be able to respond to an Act or the GDPR without some guidance is very unlikely’, Hughes asserts. ‘We need the relevant authorities to suggest interpretation, implementation, and a whole cascade of guidance in order to be compliant with the law. Furthermore, research is global in nature and therefore GDPRimplementation should be harmonised to avoid fragmentation of legislation.’
Dipak Kalra, president of the European Institute for Innovation through Health Data, says there are specific areas of uncertainty, and he echoes the issues around what comprises the legal anonymity and pseudonymisation raised by Banner. In addition, he believes we need greater clarity on how open-ended consent can be while patients are still adequately informed. ‘This impacts on the ability to build data warehouses that might be used for future research questions that are not known now. I'm also concerned about the right to erasure and the extent to which this might impact on data already held about research subjects, and been analysed and published as research findings.’
Asked for his thoughts on the level of confidence among research communities as GDPR enforcement looms, he remarked that ‘whatever the support intended by the GDPR for big health data research, the uncertainties and anxieties that the research community and data custodians have today about the GDPR are starting to have a negative impact’.Nigel Hughes, Dipak Kalra READ ARTICLE
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