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Ethical and social reflections on the proposed European Health Data Space
Inst Biomed, Eurac Res, Bolzano, Italy.;Univ KwaZulu Natal, Sch Law, Durban, South Africa..ORCID iD: 0000-0002-3185-440X
Univ Ghent, Fac Law & Criminol, Ghent, Belgium..
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics. Inst Biomed, Eurac Res, Bolzano, Italy..ORCID iD: 0000-0003-4156-1464
Univ Latvia, Inst Clin & Prevent Med, Riga, Latvia..ORCID iD: 0000-0002-3190-100X
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2024 (English)In: European Journal of Human Genetics, ISSN 1018-4813, E-ISSN 1476-5438, Vol. 32, p. 498-505Article, review/survey (Refereed) Published
Abstract [en]

The COVID-19 pandemic demonstrated the benefits of international data sharing. Data sharing enabled the health care policy makers to make decisions based on real-time data, it enabled the tracking of the virus, and importantly it enabled the development of vaccines that were crucial to mitigating the impact of the virus. This data sharing is not the norm as data sharing needs to navigate complex ethical and legal rules, and in particular, the fragmented application of the General Data Protection Regulation (GDPR). The introduction of the draft regulation for a European Health Data Space (EHDS) in May 2022 seeks to address some of these legal issues. If passed, it will create an obligation to share electronic health data for certain secondary purposes. While there is a clear need to address the legal complexities involved with data sharing, it is critical that any proposed reforms are in line with ethical principles and the expectations of the data subjects. In this paper we offer a critique of the EHDS and offer some recommendations for this evolving regulatory space.

Place, publisher, year, edition, pages
Springer Nature, 2024. Vol. 32, p. 498-505
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Medical Ethics
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URN: urn:nbn:se:uu:diva-549118DOI: 10.1038/s41431-024-01543-9ISI: 001161377400001PubMedID: 38355959OAI: oai:DiVA.org:uu-549118DiVA, id: diva2:1933619
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Marianne and Marcus Wallenberg FoundationAvailable from: 2025-01-31 Created: 2025-01-31 Last updated: 2025-01-31Bibliographically approved

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Mascalzoni, DeborahSlokenberga, Santa

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