Fit for purpose? The GDPR and the governance of European digital health

August 07 17:39 2020 Print This Article

The introduction of the General Data Protection Regulation (GDPR) in 2018 served as the cornerstone of the new data governance regime of the European Union. Informed by principles and values such as privacy, accountability, transparency, and fairness, the GDPR is premised on the objective to balance the protection of individual privacy and the promotion of a thriving European data economy. Still, shortcomings of this regulatory effort have been noted by recent ethical, socio-political, legal, and policy scholarship. Focusing on the deployment of digital health technologies and big data practices within the European digital health ecosystem, this article draws upon these bodies of literature to chart the main lines of tension emerging between the current GDPR-based data governance regime and the broader societal shifts coming along with the expansion of digital health. Central aspects of the GDPR–i.e. key underlying data protection principles and regulatory categories, the reliance on the “notice-and-consent” model, the (narrow) remit of the Regulation vis-à-vis possible harms and discriminations–are misaligned with the surge in digital health. This throws into doubt whether the Regulation is fully fit for the purpose of governing current developments in this field, while also calling for swift and adequate policy responses.

KEYWORDS: General Data Protection Regulation (GDPR), digital health technologies, big data, data governance, European Union
Additional information
This work was supported by the European Union’s Horizon 2020 research and innovation program, under the Marie Sklodowska-Curie grant agreement number 753531 (LM), and the Research Foundation Flanders (FWO), under the Odysseus Project ‘Postgenomic Solidarity. European Life Insurance in the Era of Personalised Medicine’ [grant number 3H140131, IVH] and the PhD Fellowship Fundamental Research [grant number 11C8520N, EL].
The authors would like to thank Barbara Prainsack and the anonymous reviewers for their insightful and constructive comments that helped improving the argument and flow of the article.

Disclosure statement
No potential conflict of interest was reported by the author(s).

Notes on contributors
Luca Marelli (PhD, 2016) is a Marie Skłodowska-Curie Fellow with the Life Sciences & Society Lab at the Centre for Sociological Research (KU Leuven). He also holds appointments as a Visiting Research Fellow at the Department of Experimental Oncology (European Institute of Oncology, Milan) and an Adjunct Professor of Bioethics at the Department of Medical Biotechnologies and Translational Medicine (University of Milan). His main research activities, at the intersection of Science & Technology Studies (STS), data governance and biomedical research policy, focus on the ethical, legal, and social aspects of contemporary data-intensive biomedicine in the European Union. As the Scientific Secretary of the ACC GDPR Committee, established under the aegis of the Italian Ministry of Health, Marelli is presently involved in devising binding guidelines for the implementation of national and European legislation on data protection for the processing activities of Italian research hospitals (IRCCS, Istituti di Ricovero e Cura a Carattere Scientifico).

Elisa Lievevrouw is an FWO PhD Fellow with the Life Sciences & Society Lab at the Centre for Sociological Research (KU Leuven). Her doctoral research, at the intersection between Foucauldian, Science & Technology, and socio-legal studies, focuses on the social aspects of digital health policymaking in the United States and the European Union.

Ine Van Hoyweghen is a Research Professor at the Centre for Sociological Research (KU Leuven) where she directs the Life Sciences & Society Lab. She is a leading and internationally renowned researcher in sociology of biomedicine, science and technology studies (STS), and governance of health care innovation. Her main research activities concentrate on the ethical, legal and social implications of biomedical innovations (genomics, digital health, personalized medicine, artificial intelligence). Van Hoyweghen is the author of many books, including Risks in the Making. Travels in Life Insurance and Genetics (Amsterdam University Press, 2007), Making Global Health Care Innovation Work. Standardization and Localization (2014, Palgrave, with Engel, N. & Krumeich, A.), Citizen Science (2019, with Gijsel, L. & Huyse, T.) and Shifting Solidarities. Trends and Developments in European Societies (2020, Palgrave, with Pulignano, V. & Meyers, G.).

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Luca Marelli
Luca Marelli

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