IDEAS home Printed from https://ideas.repec.org/a/eee/hepoli/v162y2025ics0168851025001988.html

Anticipating ethical and social dimensions of the European Health Data Space: A rapid systematic review

Author

Listed:
  • Donia, Joseph
  • Marelli, Luca

Abstract

The European Health Data Space Regulation (EHDS) establishes a common governance framework intended to promote the use of health data for clinical care, research, innovation, and policymaking. Academic literature has increasingly focused on anticipating the social and ethical dimensions of the EHDS, but to date, no contributions have systematically reviewed these for their policy relevance. Objectives: This study set out to (a) identify ethical and social issues associated with the EHDS in the multi-disciplinary research literature, and (b) articulate policy recommendations. Methods: A rapid review of the research literature was performed. Results: Seven overarching topics were identified. Most issues relate to secondary use of health data, with disproportionate impacts on member states already facing digitalization challenges. Discussion: We suggest that responsible governance hinges on recognition of different and at-times competing goals, interests, and requirements. A fair, just, or equitable EHDS cannot be understood strictly in terms of fair outcomes in data use, but also requires grappling with contested notions of value. Conclusion: The EHDS’s broader geopolitical significance should be emphasized. This especially includes attending to how local and regional socio-economic goals impact on what comes to be recognized as a priority in data-intensive health systems.

Suggested Citation

  • Donia, Joseph & Marelli, Luca, 2025. "Anticipating ethical and social dimensions of the European Health Data Space: A rapid systematic review," Health Policy, Elsevier, vol. 162(C).
    • Handle: RePEc:eee:hepoli:v:162:y:2025:i:c:s0168851025001988
    DOI: 10.1016/j.healthpol.2025.105443
    as

    Download full text from publisher

    File URL: http://www.sciencedirect.com/science/article/pii/S0168851025001988
    Download Restriction: Full text for ScienceDirect subscribers only
    File URL: https://libkey.io/10.1016/j.healthpol.2025.105443?utm_source=ideas
    LibKey link: if access is restricted and if your library uses this service, LibKey will redirect you to where you can use your library subscription to access this item
    ---><---

    As the access to this document is restricted, you may want to

    for a different version of it.

    References listed on IDEAS

    as
    1. Marelli, Luca & Stevens, Marthe & Sharon, Tamar & Van Hoyweghen, Ine & Boeckhout, Martin & Colussi, Ilaria & Degelsegger-Márquez, Alexander & El-Sayed, Seliem & Hoeyer, Klaus & van Kessel, Robin & Zaj, 2023. "The European health data space: Too big to succeed?," Health Policy, Elsevier, vol. 135(C).
    2. Greenhalgh, Trisha & Robert, Glenn & Macfarlane, Fraser & Bate, Paul & Kyriakidou, Olympia & Peacock, Richard, 2005. "Storylines of research in diffusion of innovation: a meta-narrative approach to systematic review," Social Science & Medicine, Elsevier, vol. 61(2), pages 417-430, July.
    Full references (including those not matched with items on IDEAS)

    Most related items

    These are the items that most often cite the same works as this one and are cited by the same works as this one.
    1. Lijuan Du & Li Xu & Yanping Li & Changshun Liu & Zhenhua Li & Jefferson S. Wong & Bo Lei, 2019. "China’s Agricultural Irrigation and Water Conservancy Projects: A Policy Synthesis and Discussion of Emerging Issues," Sustainability, MDPI, vol. 11(24), pages 1-20, December.
    2. Costa Climent, Ricardo & Haftor, Darek M., 2021. "Business model theory-based prediction of digital technology use: An empirical assessment," Technological Forecasting and Social Change, Elsevier, vol. 173(C).
    3. Alexandra Mudd & Rebecca Feo & Tiffany Conroy & Alison Kitson, 2020. "Where and how does fundamental care fit within seminal nursing theories: A narrative review and synthesis of key nursing concepts," Journal of Clinical Nursing, John Wiley & Sons, vol. 29(19-20), pages 3652-3666, October.
    4. Klara Fischer & Giulia Vico & Helena Röcklinsberg & Hans Liljenström & Riccardo Bommarco, 2025. "Progress towards sustainable agriculture hampered by siloed scientific discourses," Nature Sustainability, Nature, vol. 8(1), pages 66-74, January.
    5. Genus, Audley & Iskandarova, Marfuga, 2018. "Responsible innovation: its institutionalisation and a critique," Technological Forecasting and Social Change, Elsevier, vol. 128(C), pages 1-9.
    6. Jesus Gonzalez-Feliu, 2013. "Vehicle Routing in Multi-Echelon Distribution Systems with Cross-Docking: A Systematic Lexical-Metanarrative Analysis," Post-Print halshs-00834573, HAL.
    7. Thelagavathy Naidu Ramasamy & Shathees Baskaran, 2024. "The Influence of Health Data Spaces, Data Repositories, Data Collectives, Data Natives, and Data Commons on Artificial Intelligence for Clinical Decision-Making Among Physicians," Business Management and Strategy, Macrothink Institute, vol. 15(2), pages 306-321, December.
    8. Gagliardi, Dimitri & Ramlogan, Ronnie & Navarra, Pierluigi & Dello Russo, Cinzia, 2018. "Diffusion of complementary evolving pharmaceutical innovations: The case of Abacavir and its pharmacogenetic companion diagnostic in Italy," Technological Forecasting and Social Change, Elsevier, vol. 134(C), pages 223-233.
    9. Mike Danilovic & Marleen Hensbergen & Maya Hoveskog & Liudmila Zadayannaya, 2015. "Exploring Diffusion and Dynamics of Corporate Social Responsibility," Corporate Social Responsibility and Environmental Management, John Wiley & Sons, vol. 22(3), pages 129-141, May.
    10. Isabella Bonacci & Andrea Mazzitelli & Donato Morea, 2020. "Evaluating Climate between Working Excellence and Organizational Innovation: What Comes First?," Sustainability, MDPI, vol. 12(8), pages 1-29, April.
    11. Hansen, Henrik & Trifkovic, Neda, 2013. "Systematic Reviews: Questions, Methods and Usage," MPRA Paper 47993, University Library of Munich, Germany.
    12. Chaiwichit Chianchana, 2020. "Research Synthesis on Educational Models," GATR Journals gjbssr569, Global Academy of Training and Research (GATR) Enterprise.
    13. Robert Kaba Alhassan & Edward Nketiah-Amponsah & Daniel Kojo Arhinful, 2016. "A Review of the National Health Insurance Scheme in Ghana: What Are the Sustainability Threats and Prospects?," PLOS ONE, Public Library of Science, vol. 11(11), pages 1-16, November.
    14. repec:oup:rseval:v:32:y:2024:i:2:p:286-298. is not listed on IDEAS
    15. Isabel Saz-Gil & Ignacio Bretos & Millán Díaz-Foncea, 2021. "Cooperatives and Social Capital: A Narrative Literature Review and Directions for Future Research," Sustainability, MDPI, vol. 13(2), pages 1-18, January.
    16. Kahiya, Eldrede T., 2018. "Five decades of research on export barriers: Review and future directions," International Business Review, Elsevier, vol. 27(6), pages 1172-1188.
    17. Mathew Azarian & Hao Yu & Asmamaw Tadege Shiferaw & Tor Kristian Stevik, 2023. "Do We Perform Systematic Literature Review Right? A Scientific Mapping and Methodological Assessment," Logistics, MDPI, vol. 7(4), pages 1-32, November.
    18. Ferlie, Ewan & Crilly, Tessa & Jashapara, Ashok & Peckham, Anna, 2012. "Knowledge mobilisation in healthcare: A critical review of health sector and generic management literature," Social Science & Medicine, Elsevier, vol. 74(8), pages 1297-1304.
    19. Prattana Punnakitikashem & Philip Hallinger, 2019. "Bibliometric Review of the Knowledge Base on Healthcare Management for Sustainability, 1994–2018," Sustainability, MDPI, vol. 12(1), pages 1-17, December.
    20. Moxon, Sarah G. & B, Subha Sri & Penn-Kekana, Loveday & Sharma, Sudha & Talbott, Jennifer & Campbell, Oona M.R. & Freedman, Lynn, 2024. "Evolving narratives on signal functions for monitoring maternal and newborn health services: A meta-narrative inspired review," Social Science & Medicine, Elsevier, vol. 352(C).
    21. Deprez, Jana & Leroy, Hannes & Euwema, Martin, 2018. "Three chronological steps toward encouraging intrapreneurship: Lessons from the Wehkamp case," Business Horizons, Elsevier, vol. 61(1), pages 135-145.

    More about this item

    Keywords

    ;
    ;
    ;
    ;
    ;
    ;

    Statistics

    Access and download statistics

    Corrections

    All material on this site has been provided by the respective publishers and authors. You can help correct errors and omissions. When requesting a correction, please mention this item's handle: RePEc:eee:hepoli:v:162:y:2025:i:c:s0168851025001988. See general information about how to correct material in RePEc.

    If you have authored this item and are not yet registered with RePEc, we encourage you to do it here. This allows to link your profile to this item. It also allows you to accept potential citations to this item that we are uncertain about.

    If CitEc recognized a bibliographic reference but did not link an item in RePEc to it, you can help with this form .

    If you know of missing items citing this one, you can help us creating those links by adding the relevant references in the same way as above, for each refering item. If you are a registered author of this item, you may also want to check the "citations" tab in your RePEc Author Service profile, as there may be some citations waiting for confirmation.

    For technical questions regarding this item, or to correct its authors, title, abstract, bibliographic or download information, contact: Catherine Liu or the person in charge (email available below). General contact details of provider: http://www.elsevier.com/locate/healthpol .

    Please note that corrections may take a couple of weeks to filter through the various RePEc services.

    IDEAS is a RePEc service. RePEc uses bibliographic data supplied by the respective publishers.