Genomic data sharing in research across Europe: legal
challenges and upcoming opportunities within the European
Health Data Space

J 2025

Genomic data sharing in research across Europe: legal challenges and upcoming opportunities within the European Health Data Space

ROYO, Romina; Eva GARCIA; Irene SCHLÜNDER; Christina HILMARSEN; Mette KIELSHOLM THOMSEN et al.

Základní údaje

Originální název

Genomic data sharing in research across Europe: legal challenges and upcoming opportunities within the European Health Data Space

Autoři

Vydání

EUROPEAN JOURNAL OF PUBLIC HEALTH, OXFORD UNIV PRESS, 2025, 1101-1262

Další údaje

Jazyk

angličtina

Typ výsledku

Článek v odborném periodiku

Obor

30304 Public and environmental health

Stát vydavatele

Velká Británie a Severní Irsko

Utajení

není předmětem státního či obchodního tajemství

Odkazy

URL

Impakt faktor

Impact factor: 3.900 v roce 2024

Označené pro přenos do RIV

Ano

Kód RIV

RIV/00216224:14610/25:00142009

Organizační jednotka

Ústav výpočetní techniky

DOI

https://doi.org/10.1093/eurpub/ckaf070

UT WoS

001568831600005

Klíčová slova anglicky

informed consent heterogeneity ethics committees genome european continental ancestry group principles of law and justice data sharing

Štítky

rivok

Příznaky

Mezinárodní význam, Recenzováno

Změněno: 25. 3. 2026 15:08, Mgr. Eva Špillingová

Anotace

V originále

The European Health Data Space (EHDS) will help researchers use health data across EU Member States (MS). Currently, cross-border research faces heterogeneous data access processes. Using a real-world use case, this paper analyses challenges and opportunities brought by the upcoming implementation of the EHDS, assessing the situation before and after the regulation comes into force. The use case focused on metastatic colorectal cancer, analysing the relations between mutational signatures and clinical trajectories while addressing data access procedures across MS. The regulatory landscape and the challenges that need to be addressed for the EHDS to enable the secondary use of health data, particularly genomic data, are complex and heterogeneous across MS. We describe the pathway from data application to access to pseudonymized data in secure processing environments, emphasizing the legal requirements, including the role of ethics committees. Finally, we analyse the success factors for achieving access to the data and the reasons for access denial to support shaping the upcoming EHDS implementation. Several challenges remain unaddressed for cross-border data use, especially in the context of genomic data, where the complexity and heterogeneity of informed consent can impact or even impede data-sharing efforts. While EHDS can simplify processes across MS, it is crucial to ensure that additional safeguards do not negatively impact or block access to health data and that EHDS infrastructure is ready for effective and affordable processing of large volumes of genomic and other data.

Návaznosti

101079839, interní kód MU

Název: Pilot for a European Health Data Space on secondary use of health data

Investor: Evropská unie, Pilot for a European Health Data Space on secondary use of health data

Citovat

ROYO, Romina; 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 a Salvador CAPELLA-GUTIERREZ. Genomic data sharing in research across Europe: legal challenges and upcoming opportunities within the European Health Data Space. EUROPEAN JOURNAL OF PUBLIC HEALTH. OXFORD UNIV PRESS, 2025, roč. 35, Supplement_3, s. 25-31. ISSN 1101-1262. Dostupné z: https://doi.org/10.1093/eurpub/ckaf070.

@article{2517957,
   author = {Royo, Romina and Garcia, Eva and Schlünder, Irene and Hilmarsen, Christina and Kielsholm Thomsen, Mette and Cauët, Emilie and Kok Jensen, Simon and Giardina, Simona and Hebrant, Aline and Raicevic Toungouz, Gordana and Van Den Bulcke, Marc and Arenas, Juan and Fynbo Christiansen, Christian and Hovig, Eivind and Holub, Petr and Valencia, Alfonso and CapellaandGutierrez, Salvador},
   article_number = {Supplement_3},
   doi = {https://doi.org/10.1093/eurpub/ckaf070},
   keywords = {informed consent heterogeneity ethics committees genome european continental ancestry group principles of law and justice data sharing},
   language = {eng},
   issn = {1101-1262},
   journal = {EUROPEAN JOURNAL OF PUBLIC HEALTH},
   title = {Genomic data sharing in research across Europe: legal challenges and upcoming opportunities within the European Health Data Space},
   url = {https://academic.oup.com/eurpub/article/35/Supplement_3/iii25/8250090?login=true},
   volume = {35},
   year = {2025}
}

TY  - JOUR
ID  - 2517957
AU  - Royo, Romina - Garcia, Eva - Schlünder, Irene - Hilmarsen, Christina - Kielsholm Thomsen, Mette - Cauët, Emilie - Kok Jensen, Simon - Giardina, Simona - Hebrant, Aline - Raicevic Toungouz, Gordana - Van Den Bulcke, Marc - Arenas, Juan - Fynbo Christiansen, Christian - Hovig, Eivind - Holub, Petr - Valencia, Alfonso - Capella-Gutierrez, Salvador
PY  - 2025
TI  - Genomic data sharing in research across Europe: legal challenges and upcoming opportunities within the European Health Data Space
JF  - EUROPEAN JOURNAL OF PUBLIC HEALTH
VL  - 35
IS  - Supplement_3
SP  - 25-31
EP  - 25-31
PB  - OXFORD UNIV PRESS
SN  - 11011262
KW  - informed consent heterogeneity ethics committees genome european continental ancestry group principles of law and justice data sharing
UR  - https://academic.oup.com/eurpub/article/35/Supplement_3/iii25/8250090?login=true
N2  - The European Health Data Space (EHDS) will help researchers use health data across EU Member States (MS). Currently, cross-border research faces heterogeneous data access processes. Using a real-world use case, this paper analyses challenges and opportunities brought by the upcoming implementation of the EHDS, assessing the situation before and after the regulation comes into force. The use case focused on metastatic colorectal cancer, analysing the relations between mutational signatures and clinical trajectories while addressing data access procedures across MS. The regulatory landscape and the challenges that need to be addressed for the EHDS to enable the secondary use of health data, particularly genomic data, are complex and heterogeneous across MS. We describe the pathway from data application to access to pseudonymized data in secure processing environments, emphasizing the legal requirements, including the role of ethics committees. Finally, we analyse the success factors for achieving access to the data and the reasons for access denial to support shaping the upcoming EHDS implementation. Several challenges remain unaddressed for cross-border data use, especially in the context of genomic data, where the complexity and heterogeneity of informed consent can impact or even impede data-sharing efforts. While EHDS can simplify processes across MS, it is crucial to ensure that additional safeguards do not negatively impact or block access to health data and that EHDS infrastructure is ready for effective and affordable processing of large volumes of genomic and other data.
ER  -

ROYO, Romina; Eva GARCIA; Irene SCHLÜNDER; Christina HILMARSEN; Mette KIELSHOLM THOMSEN; Emilie CAU$\backslash$''ET; 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 a Salvador CAPELLA-GUTIERREZ. Genomic data sharing in research across Europe: legal challenges and upcoming opportunities within the European Health Data Space. \textit{EUROPEAN JOURNAL OF PUBLIC HEALTH}. OXFORD UNIV PRESS, 2025, roč.~35, Supplement\_{}3, s.~25-31. ISSN~1101-1262. Dostupné z: https://doi.org/10.1093/eurpub/ckaf070.

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