POLICY · GOVERNANCE · LAW · ETHICS
The EHDS Research Library
A living bibliography of scholarly work on European Health Data Space policy, governance, law and ethics.
The collection also includes empirical and interdisciplinary research directly relevant to the design and implementation of the EHDS.
60 publications
Journal articles, scholarly books and chapters, and selected academic preprints.
2022–2026
Grouped by publication year and alphabetically by first author.
Updated regularly
Last updated 27 August 2026. New suggestions are reviewed before inclusion.
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Complete bibliography
Titles and “Open record” links lead to the DOI record. Preprints are identified explicitly. Topic and country filters will be introduced as the collection grows.
2026
28 publications · Alphabetical by first author
JOURNAL ARTICLE
The EU GDPR and secondary use of health and genetic data for research support purposes
Regina Becker, Edward S Dove
International Data Privacy Law, 16(2), ipag001. 2026. DOI: 10.1093/idpl/ipag001 · Open record ↗
JOURNAL ARTICLE
Is Poland ready for the European health data space?
Katarzyna Byszek, Barbara Więckowska, Anna Gawrońska, Katarzyna Luchowska
Health Policy and Technology, 15(3), 101167. 2026. DOI: 10.1016/j.hlpt.2026.101167 · Open record ↗
JOURNAL ARTICLE
The Dilemma between Data Protection and Data Altruism within the Context of Rare Diseases in the European Health Data Space
Laura Centeno Casado
European Journal of Health Law, 33(2), 137–165. 2026. DOI: 10.1163/15718093-bja10169 · Open record ↗
JOURNAL ARTICLE
The European Health Data Space: an opportunity to strengthen citizen rights and engage citizens in health data governance
Patricia Cervera De La Cruz, Teodora Lalova-Spinks, Mahsa Shabani
Frontiers in Medicine, 12, 1699941. 2026. DOI: 10.3389/fmed.2025.1699941 · Open record ↗
BOOK CHAPTER
Austrian EHDS Secure Processing Environment: From Regulation to Reality
Florian Endel, David Würflinger, Alexander Degelsegger
In Studies in Health Technology and Informatics. IOS Press. 2026. DOI: 10.3233/SHTI260080 · Open record ↗
JOURNAL ARTICLE
Stretching Constitutional Boundaries: The European Health Data Space Regulation and Its Impact on the Public Health Integration Process
Anna Fiorentini
European Constitutional Law Review, 22(1), 39–77. 2026. DOI: 10.1017/S1574019625100965 · Open record ↗
BOOK CHAPTER
Training Future Health and Information Technologies Professionals on the European Health Data Space
Sharon Guardado, Woubshet Behutiye, Ornela Bardhi, Saara Kukkohovi, Minna Isomursu
In Studies in Health Technology and Informatics. IOS Press. 2026. DOI: 10.3233/SHTI260649 · Open record ↗
JOURNAL ARTICLE
The right standard for the job? On the limits of standard setting as a tool for governing commercial actors
Klaus Hoeyer, Sara Green
Policy Studies, 47(2), 225–235. 2026. DOI: 10.1080/01442872.2024.2415149 · Open record ↗
JOURNAL ARTICLE
Lessons from federated networks for implementing the European health data space. Empirical study
Magdalena Kogut-Czarkowska, Mahsa Shabani
DIGITAL HEALTH, 12, 20552076261466806. 2026. DOI: 10.1177/20552076261466806 · Open record ↗
JOURNAL ARTICLE
The opt-out right for secondary uses of personal data in the European Health Data Space: Legal basis, scope, and interplay with the GDPR
Pablo Trigo Kramcsák, Iñigo De Miguel Beriain
Computer Law & Security Review, 62, 106367. 2026. DOI: 10.1016/j.clsr.2026.106367 · Open record ↗
JOURNAL ARTICLE
What patients value in data reuse for oncology research: a multi-stakeholder qualitative study to inform the European Health Data Space implementation in Belgium and beyond
Teodora Lalova-Spinks, Ine Van Zeeland, Silke Léonard, Florence Horicks, Brent Taels, Patricia Cervera De La Cruz, Lyzette Bax, Bernard Carton, Willy Dirkx, Mahsa Shabani
Archives of Public Health, 84(1), 96. 2026. DOI: 10.1186/s13690-026-01884-5 · Open record ↗
JOURNAL ARTICLE
Genetic Data Sharing in the European Health Data Space: An Urgent Call for Coordinated Action by the Member States
Guillermo Lazcoz, Giovanni Comandé
BioLaw Journal – Rivista di BioDiritto(1), 165–177. 2026. DOI: 10.15168/2284-4503-4053 · Open record ↗
PREPRINT
Broken Promises? The Ethical Challenge of Making Pre-Existing Datasets Collected on the Basis of Consent Available under the EHDS Regulation
Wenkai Li
SSRN. 2026. DOI: 10.2139/ssrn.6570980 · Open record ↗
JOURNAL ARTICLE
Two-faced Janus? Consent to participate in research and consent to data processing in the EHDS era: a comparative analysis of requirements and standards in eight European countries
Luca Marelli, Ilaria Colussi, Irene Schlünder, Anne Bahr, Isabelle Huys, Dorota Krekora-Zając, Jan Kuráň, Teodora Lalova-Spinks, Deborah Mascalzoni, Mihaela Matei, Pilar Nicolás, Tom Southerington
Journal of Law and the Biosciences, 13(1), lsag016. 2026. DOI: 10.1093/jlb/lsag016 · Open record ↗
JOURNAL ARTICLE
“First, do no harm” in the digital era: examining the practicality of the European Health Data Space proposal and ethical implications of artificial intelligence- A systematic literature review
Margarida Mateus, Irina Alho, Ana Luísa Neves, Henrique Lopes, Mónica Correia
BMC Medical Ethics, 27(1), 35. 2026. DOI: 10.1186/s12910-025-01372-5 · Open record ↗
BOOK CHAPTER
The European Health Data Space Board: challenges, opportunities, and expectations
Susana Navas Navarro
In Research Handbook on Digital Regulatory Agencies, 191–211. Edward Elgar Publishing. 2026. DOI: 10.4337/9781035330898.00020 · Open record ↗
JOURNAL ARTICLE
Guideline for secondary use of health records within Norwegian and EU regulatory frameworks
Dipendra Pant, Thomas Brox Røst, Harald Krüger, Pieter Jelle Toussaint, Øystein Nytrø
npj Digital Medicine, 9(1), 532. 2026. DOI: 10.1038/s41746-026-02784-2 · Open record ↗
JOURNAL ARTICLE
Dynamic Consent for Secondary Use of Health Data: Challenges and Opportunities Under European Law
Sudip Phuyal, Manila Bhandari, Ricardo Correia Bezerra, Rabindra Bista, João Carlos Ferreira
JMIR Medical Informatics, 14, e93348. 2026. DOI: 10.2196/93348 · Open record ↗
JOURNAL ARTICLE
‘Drilling down’ and ‘breaking glass’ – Evolving notions of public service ‘quality’ in the Norwegian health data space
Tanja Plasil, Gunhild Tøndel, Mads Dahl Gjefsen, Odd Morten Mjøen
Big Data & Society, 13(1), 20539517251406095. 2026. DOI: 10.1177/20539517251406095 · Open record ↗
JOURNAL ARTICLE
A qualitative comparison of data infrastructures for COVID-19 health-related data: lessons for the European Health Data Space
Vittoria Porta, Anne-Marie Fors Connolly, Naja Hulvej Rod, Klaus Hoeyer, Ine Van Hoyweghen, Carlo Botrugno, Federica Lucivero, Giuseppe Testa, Luca Marelli
Policy Studies, 47(2), 338–358. 2026. DOI: 10.1080/01442872.2025.2486159 · Open record ↗
JOURNAL ARTICLE
The Role of Social Value in Data‐Intensive Health Research
Tessa I. Van Rijssel, Sam H. A. Muller, Marianne Boenink, Johannes J. M. Van Delden
Bioethics, bioe.70159. 2026. DOI: 10.1111/bioe.70159 · Open record ↗
JOURNAL ARTICLE
Building a national health data ecosystem in Greece: Strategic pathways and readiness for the EHDS
Evangelia Salmatani, Dimitrios G. Katehakis, George Dimitriou, Angelina Kouroubali
Health Policy and Technology, 15(5), 101199. 2026. DOI: 10.1016/j.hlpt.2026.101199 · Open record ↗
JOURNAL ARTICLE
Unlocking Health Data for Research: Legal, Technical, and Organisational Lessons from a Belgian Interdisciplinary Case Study
Audrey Van Scharen, Karen Cruyt, Jeroen Colon, Selene De Sutter, Johnny Duerinck, Ramses Forsyth, Catharina Olsen, Paul Quinn, Konstantina Tzavella, Sonia Van Dooren, Wim Waelput, Arne Witdouck, Pieter Cornu, Jef Vandemeulebroucke, Wim Vranken
Journal of Healthcare Informatics Research, 10(1), 179–208. 2026. DOI: 10.1007/s41666-025-00220-w · Open record ↗
JOURNAL ARTICLE
Embedding ethics in infrastructures for data-intensive health research
Tessa I Van Rijssel, Marianne Boenink
Big Data & Society, 13(3), 20539517261467360. 2026. DOI: 10.1177/20539517261467360 · Open record ↗
JOURNAL ARTICLE
European Health Data Space Regulation: Users’ Free Choice or Maximum Harmonisation?
Antoinette R. Vlieger
European Journal of Health Law, 1–21. 2026. DOI: 10.1163/15718093-bja10177 · Open record ↗
JOURNAL ARTICLE
Operationalising ethics in the EHDS: Tools, principles, and governance mechanisms
Kristina Weishäupl, Beatriz Jacinto Barros, Lisa Ferent, Anne Sofie Skødt Jørgensen, Alexander Leander Knudsen
Open Research Europe, 6, 191. 2026. DOI: 10.12688/openreseurope.23447.1 · Open record ↗
JOURNAL ARTICLE
Balancing Scientific and Commercial Interests: The European Health Data Space Response to Commercial Scientific Research
Xuxin Yao, Zheyuan Sun, Hongjie Man
INQUIRY: The Journal of Health Care Organization, Provision, and Financing, 63, 00469580261420714. 2026. DOI: 10.1177/00469580261420714 · Open record ↗
PREPRINT
Bringing Data Autonomy, Digital Sovereignty to the European Health Data Space
Andrej Zwitter
SSRN. 2026. DOI: 10.2139/ssrn.7200800 · Open record ↗
2025
17 publications · Alphabetical by first author
JOURNAL ARTICLE
The politics of constructing health data spaces: Border work and the stickiness of fragmentation
Heidrun Åm, Lotte Groth Jensen, Rasmus Mølgaard Hansen, Karoliina Snell, Heta Tarkkala, Aaro Tupasela
Big Data & Society, 12(1), 20539517251320012. 2025. DOI: 10.1177/20539517251320012 · Open record ↗
JOURNAL ARTICLE
The European Health Data Space: Will it be emergency-ready?
Jane Arroyo, Hien Vu, Timothy Yu-Cheong Yeung
Health Policy and Technology, 14(2), 100977. 2025. DOI: 10.1016/j.hlpt.2025.100977 · Open record ↗
JOURNAL ARTICLE
Data Sharing in the Internet of Medical Things: Between the Data Act and the EHDS
F. Casarosa, F. Gennari
European Journal of Risk Regulation, 16(3), 1115–1137. 2025. DOI: 10.1017/err.2025.18 · Open record ↗
BOOK CHAPTER
The EHDS and Electronic Health Records
Katharina Ó Cathaoir
In The European Health Data Space, 22–43. Routledge. 2025. DOI: 10.4324/9781003544111-3 · Open record ↗
JOURNAL ARTICLE
Implementation of the European health data space: a qualitative study on expectations of health data experts from 23 countries
Patricia Cervera De La Cruz, Teodora Lalova-Spinks, Mahsa Shabani
Health Policy, 161, 105428. 2025. DOI: 10.1016/j.healthpol.2025.105428 · Open record ↗
JOURNAL ARTICLE
Anticipating ethical and social dimensions of the European Health Data Space: A rapid systematic review
Joseph Donia, Luca Marelli
Health Policy, 162, 105443. 2025. DOI: 10.1016/j.healthpol.2025.105443 · Open record ↗
JOURNAL ARTICLE
“Revolutionize medicine as we know it”: Shaping imaginaries of the European Health Data Space
Desirée Enlund
Big Data & Society, 12(4), 20539517251389842. 2025. DOI: 10.1177/20539517251389842 · Open record ↗
BOOK CHAPTER
Federated networks and secondary uses of health data
Magdalena Kogut-Czarkowska, Mahsa Shabani
In The European Health Data Space, 229–254. Routledge. 2025. DOI: 10.4324/9781003544111-14 · Open record ↗
JOURNAL ARTICLE
Opting Out of Scientific Research with Health Data: The Limits of the EHDS and the GDPR
Maret Kruus
European Journal of Health Law, 32(2), 165–189. 2025. DOI: 10.1163/15718093-bja10141 · Open record ↗
JOURNAL ARTICLE
The European Health Data Space as a Compass for Academic/Industry Collaborations
Gabriela Lenarczyk, Hannah Louise Smith, W. Nicholson Price
The American Journal of Bioethics, 25(12), 55–57. 2025. DOI: 10.1080/15265161.2025.2570659 · Open record ↗
JOURNAL ARTICLE
Access to Health Data, Competition, and Regulatory Alternatives: Three Dimensions of Fairness
Ioannis Lianos
Journal of Competition Law & Economics, 21(4), 595–646. 2025. DOI: 10.1093/joclec/nhaf016 · Open record ↗
JOURNAL ARTICLE
Health Data Access Bodies under the European Health Data Space – A technocratic colossus or rubber stamp forum?
Paul Quinn
Technology and Regulation, 2025, 60–80. 2025. DOI: 10.71265/vbfvpb76 · Open record ↗
JOURNAL ARTICLE
Can personal data be recycled? The reuse and repurposing of data under the EHDS
Vera Lúcia Raposo
International Journal of Law and Information Technology, 33, eaae016. 2025. DOI: 10.1093/ijlit/eaae016 · Open record ↗
BOOK CHAPTER
Administrative tools for balancing societal and individual interests
Jane Reichel
In The European Health Data Space, 207–228. Routledge. 2025. DOI: 10.4324/9781003544111-13 · Open record ↗
JOURNAL ARTICLE
Genomic data sharing in research across Europe: legal challenges and upcoming opportunities within the European Health Data Space
Romina Royo, Eva Garcia, Irene Schlünder, Christina Hilmarsen, Mette Kielsholm Thomsen, Emilie Cauët, Simon Kok Jensen, Simona Giardina, Aline Hebrant, Gordana Raicevic Toungouz, Marc Van Den Bulcke, Juan Arenas, Christian Fynbo Christiansen, Eivind Hovig, Petr Holub, Alfonso Valencia, Salvador Capella-Gutierrez
European Journal of Public Health, 35(Supplement_3), iii25–iii31. 2025. DOI: 10.1093/eurpub/ckaf070 · Open record ↗
BOOK
The European Health Data Space: Examining A New Era in Data Protection
Santa Slokenberga, Katharina Ó Cathaoir, Mahsa Shabani
Routledge. 2025. DOI: 10.4324/9781003544111 · Open record ↗
BOOK CHAPTER
Transforming the secondary use of patient data in the European Health Data Space
Daniela Spajić
In The European Health Data Space, 87–109. Routledge. 2025. DOI: 10.4324/9781003544111-7 · Open record ↗
2024
8 publications · Alphabetical by first author
JOURNAL ARTICLE
The European Health Data Space as a Case Study
Edward S. Dove
Ethics & Human Research, 46(6), 29–35. 2024. DOI: 10.1002/eahr.500228 · Open record ↗
JOURNAL ARTICLE
Health in data space: Formative and experiential dimensions of cross-border health data sharing
Klaus Hoeyer, Sara Green, Andrea Martani, Alexandra Middleton, Clémence Pinel
Big Data & Society, 11(1), 20539517231224258. 2024. DOI: 10.1177/20539517231224258 · Open record ↗
BOOK CHAPTER
Exploring the Potential of Health Data: EHDS, Secondary Utilization, and Stakeholder Perspectives in Czech Healthcare
Petra Hospodková, Martin Budil
In 9th European Medical and Biological Engineering Conference, 62–70. Springer Nature Switzerland. 2024. DOI: 10.1007/978-3-031-61628-0_7 · Open record ↗
JOURNAL ARTICLE
Are EU member states ready for the European Health Data Space? Lessons learnt on the secondary use of health data from the TEHDAS Joint Action
Irini A Kessissoglou, Shona M Cosgrove, Linda A Abboud, Petronille Bogaert, Michael Peolsson, Neville Calleja
European Journal of Public Health, 34(6), 1102–1108. 2024. DOI: 10.1093/eurpub/ckae160 · Open record ↗
JOURNAL ARTICLE
The European Health Data Space: An expanded right to data portability?
Wenkai Li, Paul Quinn
Computer Law & Security Review, 52, 105913. 2024. DOI: 10.1016/j.clsr.2023.105913 · Open record ↗
JOURNAL ARTICLE
Will the GDPR Restrain Health Data Access Bodies Under the European Health Data Space (EHDS)?
Paul Quinn, Erika Ellyne, Cong Yao
Computer Law & Security Review, 54, 105993. 2024. DOI: 10.1016/j.clsr.2024.105993 · Open record ↗
JOURNAL ARTICLE
Anonymisation, Pseudonymisation and Secure Processing Environments Relating to the Secondary Use of Electronic Health Data in the European Health Data Space (EHDS)
Richard Rak
European Journal of Risk Regulation, 15(4), 928–938. 2024. DOI: 10.1017/err.2024.67 · Open record ↗
JOURNAL ARTICLE
Ethical and social reflections on the proposed European Health Data Space
Ciara Staunton, Mahsa Shabani, Deborah Mascalzoni, Signe Mežinska, Santa Slokenberga
European Journal of Human Genetics, 32(5), 498–505. 2024. DOI: 10.1038/s41431-024-01543-9 · Open record ↗
2023
4 publications · Alphabetical by first author
JOURNAL ARTICLE
Towards the European Health Data Space (EHDS) ecosystem: A survey research on future health data scenarios
Rada Hussein, Lucas Scherdel, Frederic Nicolet, Fernando Martin-Sanchez
International Journal of Medical Informatics, 170, 104949. 2023. DOI: 10.1016/j.ijmedinf.2022.104949 · Open record ↗
JOURNAL ARTICLE
Real World Evidence: methodological issues and opportunities from the European Health Data Space
Stelios Kympouropoulos
BMC Medical Research Methodology, 23(1), 185. 2023. DOI: 10.1186/s12874-023-02014-3 · Open record ↗
JOURNAL ARTICLE
The European health data space: Too big to succeed?
Luca Marelli, Marthe Stevens, Tamar Sharon, Ine Van Hoyweghen, Martin Boeckhout, Ilaria Colussi, Alexander Degelsegger-Márquez, Seliem El-Sayed, Klaus Hoeyer, Robin Van Kessel, Dorota Krekora Zając, Mihaela Matei, Sara Roda, Barbara Prainsack, Irene Schlünder, Mahsa Shabani, Tom Southerington
Health Policy, 135, 104861. 2023. DOI: 10.1016/j.healthpol.2023.104861 · Open record ↗
JOURNAL ARTICLE
Interoperability and governance in the European Health Data Space regulation
Petros Terzis, (Enrique) Oe Santamaria Echeverria
Medical Law International, 23(4), 368–376. 2023. DOI: 10.1177/09685332231165692 · Open record ↗
2022
3 publications · Alphabetical by first author
JOURNAL ARTICLE
Lawfulness in secondary use of health data: Interplay between three regulatory frameworks of GDPR, DGA & EHDS
Mahsa Shabani, Sami Yilmaz
Technology and Regulation, 2022, 128–134. 2022. DOI: 10.71265/hawesm05 · Open record ↗
JOURNAL ARTICLE
Scientific research regime 2.0? Transformations of the research regime and the protection of the data subject that the proposed EHDS regulation promises to bring along
Santa Slokenberga
Technology and Regulation, 2022, 135–147. 2022. DOI: 10.71265/h27r4829 · Open record ↗
JOURNAL ARTICLE
Compromises and Asymmetries in the European Health Data Space
Petros Terzis
European Journal of Health Law, 30(3), 345–363. 2022. DOI: 10.1163/15718093-bja10099 · Open record ↗
How publications are selected
Scope
The library focuses on scholarship that directly examines the EHDS or a clearly identifiable aspect of its policy, governance, legal or ethical framework. Relevant empirical and interdisciplinary implementation research is also included.
Publication types
The collection primarily comprises peer-reviewed journal articles, scholarly books and book chapters. Selected academic preprints may be included when directly relevant and are clearly labelled.
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Inclusion is based on relevance rather than agreement with a publication’s conclusions. Listing does not imply endorsement, and EHDS Monitor does not accept payment for inclusion.
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