Secondary Use of Personal Health Data: When Is It “Further Processing” Under the GDPR, and What Are the Implications for Data Controllers?

Author:

Becker Regina1ORCID,Chokoshvili Davit2ORCID,Comandé Giovanni3ORCID,Dove Edward S.4ORCID,Hall Alison5ORCID,Mitchell Colin5ORCID,Molnár-Gábor Fruzsina6ORCID,Nicolàs Pilar7ORCID,Tervo Sini8ORCID,Thorogood Adrian2ORCID

Affiliation:

1. ELIXIR-Luxembourg, Luxembourg Centre for Systems Biomedicine, University of Luxembourg Esch-sur-Alzette 4367 Luxembourg

2. Bioinformatics Core, Luxembourg Centre for Systems Biomedicine, University of Luxembourg Esch-sur-Alzette 4367 Luxembourg

3. Sant’Anna School of Advanced Studies Piazza Martiri della Libertà 33, 56127 Pisa Italy

4. School of Law, University of Edinburgh South Bridge, Edinburgh EH8 9YL, Scotland UK

5. PHG Foundation, University of Cambridge 2 Worts Causeway, Cambridge CB1 8RN UK

6. Faculty of Law, BioQuant Centre, Heidelberg University Im Neuenheimer Feld 267, 69120 Heidelberg Germany

7. Faculty of Law, University of the Basque Country Barrio Sarriena, s/n, 48940 Leioa Spain

8. Ministry of Social Affairs and Health Meritullinkatu 8, 00170 Helsinki Finland

Abstract

Abstract Contemporary biomedical research heavily relies on secondary use of personal health data that were obtained in a different clinical or research setting. Under the European Union’s General Data Protection Regulation (GDPR), data controllers processing personal data must comply with the principle of purpose limitation, which restricts further processing of personal data beyond the purpose for which the data were initially collected. However, “further processing” is not explicitly defined, resulting in considerable interpretive ambiguities as to whether “secondary use” of data by researchers constitutes “further processing” under the GDPR. This ambiguity is problematic as it exposes researchers to potential non-compliance risks. In this article, we analyse the term “further processing” within the meaning of the GDPR, elucidate important aspects in which it differs from “secondary use”, and discuss the implications for data controllers’ GDPR compliance obligations. Subsequently, we contextualise this analysis within a broader discussion of regulating scientific research under the GDPR.

Publisher

Brill

Subject

Law,Health Policy

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