A3 Refereed book chapter or chapter in a compilation book

Comparative Review of National Regulatory Frameworks in the Context of Secondary Use of Data for Research Across Europe




AuthorsTzortzatou-Nanopoulou, Olga; Ziaka, Alexandra; Barbosa, Carla; Chassang, Gauthier; Duardo-Sánchez, Aliuska; Elunurm, Silja; Dalebø Gjerdevik, Christine; Halouzka, Radek; Hartlev, Mette; Holst, Ragnhild Angell; Krekora-Zajac, Dorota; Kuráň, Jan; Lalova—Spinks, Teodora; Lavitrano, Maria Luisa; Macilotti, Matteo; Makri, Marina; Mežinska, Signe; Molnár-Gábor, Fruzsina; Rebers, Susanne; Reichel, Jane; Slokenberga, Santa; Southerington, Tom; Falzon, Ruth Vella

EditorsSeoane, José-Antonio; Vergara, Oscar

Publication year2024

Book title The Discourse of Biorights: European Perspectives

Series titleThe International Library of Bioethics

Number in series109

First page 243

Last page269

ISBN978-3-031-66803-6

eISBN978-3-031-66804-3

ISSN2662-9186

eISSN2662-9194

DOIhttps://doi.org/10.1007/978-3-031-66804-3_16

Web address https://link.springer.com/chapter/10.1007/978-3-031-66804-3_16

Self-archived copy’s web addresshttps://su.diva-portal.org/smash/get/diva2:1941997/FULLTEXT01.pdf


Abstract

Scientific research is a crucial tool for advancing healthcare and public health. In cross-border research collaborations, researchers need to navigate a complex pool of different requirements, which potentially hamper scientific research. This chapter aims to map the current legal landscape in seventeen Member States of the European Economic Area in the context of the secondary processing of health and genetic data for scientific research purposes. It critically assesses the transposition of GDPR in the national legal order of each State and its interplay with other applicable legislations. Our research findings show that only a handful examined Member States have a dedicated Act on secondary use, as the majority rely on provisions of different laws. Consent, which has been traditionally relied upon for the processing of health and genetic data for scientific research purposes, still remains the most commonly used legal basis. However, there is an increasingly common stance among experts towards the lack of appropriateness of consent as legal basis and a preference over using it as additional safeguard. Most Member States have enabled the derogation from the exercise of data subject rights under art 89(2) GDPR, while providing a series of appropriate safeguards, mostly including anonymisation, pseudonymisation and encryption.


Funding information in the publication
This publication was funded within B1MG project that has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No. 951724.


Last updated on 2025-26-06 at 13:40