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

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00216224%3A14610%2F25%3A00142009" target="_blank" >RIV/00216224:14610/25:00142009 - isvavai.cz</a>

Výsledek na webu

<a href="https://academic.oup.com/eurpub/article/35/Supplement_3/iii25/8250090?login=true" target="_blank" >https://academic.oup.com/eurpub/article/35/Supplement_3/iii25/8250090?login=true</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1093/eurpub/ckaf070" target="_blank" >10.1093/eurpub/ckaf070</a>

Jazyk výsledku

angličtina

Název v původním jazyce

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

Popis výsledku v původním jazyce

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.

Název v anglickém jazyce

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

Popis výsledku anglicky

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.

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

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OECD FORD obor

30304 - Public and environmental health

Projekt

—

Návaznosti

R - Projekt Ramcoveho programu EK

Rok uplatnění

2025

Kód důvěrnosti údajů

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Název periodika

EUROPEAN JOURNAL OF PUBLIC HEALTH

ISSN

1101-1262

e-ISSN

1464-360X

Svazek periodika

35

Číslo periodika v rámci svazku

Supplement_3

Stát vydavatele periodika

GB - Spojené království Velké Británie a Severního Irska

Počet stran výsledku

7

Strana od-do

25-31

Kód UT WoS článku

001568831600005

EID výsledku v databázi Scopus

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