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Data Sharing Under the General Data Protection Regulation

Antonia Vlahou 1 Dara Hallinan 2 Rolf Apweiler 3, 4 Angel Argilés 5 Joachim Beige 6 Ariela Benigni 7 Rainer Bischoff 8 Peter Black 9 Franziska Boehm 2 Jocelyn Céraline 10 George Chrousos 11 Christian Delles 12 Pieter Evenepoel 13 Ivo Fridolin 14 Griet Glorieux 15 Alain van Gool 16 Isabel Heidegger 17 John Ioannidis 18 Joachim Jankowski 19 Vera Jankowski 19 Carmen Jeronimo 20 Ashish Kamat 21 Rosalinde Masereeuw 22 Gert Mayer 23 Harald Mischak 24 Alberto Ortiz 25 Giuseppe Remuzzi 7 Peter Rossing 26 Joost Schanstra 27 Bernd Schmitz-Dräger 28 Goce Spasovski 29 Jan Staessen 30 Dimitrios Stamatialis 31 Peter Stenvinkel 32 Christoph Wanner 33 Stephen Williams 34 Faiez Zannad 35, 36, 37, 38 Carmine Zoccali 39 Raymond Vanholder 15, 40
Abstract : The General Data Protection Regulation (GDPR) became binding law in the European Union Member States in 2018, as a step toward harmonizing personal data protection legislation in the European Union. The Regulation governs almost all types of personal data processing, hence, also, those pertaining to biomedical research. The purpose of this article is to highlight the main practical issues related to data and biological sample sharing that biomedical researchers face regularly, and to specify how these are addressed in the context of GDPR, after consulting with ethics/legal experts. We identify areas in which clarifications of the GDPR are needed, particularly those related to consent requirements by study participants. Amendments should target the following: (1) restricting exceptions based on national laws and increasing harmonization, (2) confirming the concept of broad consent, and (3) defining a roadmap for secondary use of data. These changes will be achieved by acknowledged learned societies in the field taking the lead in preparing a document giving guidance for the optimal interpretation of the GDPR, which will be finalized following a period of commenting by a broad multistakeholder audience. In parallel, promoting engagement and education of the public in the relevant issues (such as different consent types or residual risk for re-identification), on both local/national and international levels, is considered critical for advancement. We hope that this article will open this broad discussion involving all major stakeholders, toward optimizing the GDPR and allowing a harmonized transnational research approach.
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Submitted on : Friday, February 19, 2021 - 3:10:15 PM
Last modification on : Tuesday, February 23, 2021 - 3:30:48 PM


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Antonia Vlahou, Dara Hallinan, Rolf Apweiler, Angel Argilés, Joachim Beige, et al.. Data Sharing Under the General Data Protection Regulation. Hypertension, American Heart Association, 2021, pp.HYPERTENSIONAHA12016340. ⟨10.1161/HYPERTENSIONAHA.120.16340⟩. ⟨hal-03147039⟩



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