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Record linkage of population-based cohort data from minors with national register data : a scoping review and comparative legal analysis of four European countries |
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| Author: | Doetsch, Julia Nadine1,2; Dias, Vasco3; Indredavik, Marit S.4; |
| Organizations: |
1EPIUnit, Instituto de Saúde Pública da, Universidade do Porto (ISPUP), Porto, 4050-600, Portugal 2Laboratory for Integrative and Translational Research in Population Health (ITR), Porto, 4050-600, Portugal 3INESC TEC -Institute for Systems and Computer Engineering, Technology and Science, Campus da Faculdade de Engenharia da Universidade do Porto, Porto, 4050-091, Portugal
4Department of Clinical and Molecular Medicine, Faculty of Medicine and Health Sciences, NTNU – Norwegian University of Science and Technology, Trondheim, NO-7491, Norway
5Finnish Institute for Health and Welfare, Legal Services, Helsinki, Finland 6University of Helsinki, Faculty of Law, Helsinki, Finland 7Faculty of Medicine and Health Sciences, NTNU – Norwegian University of Science and Technology, Trondheim, NO-7491, Norway 8Finnish Institute for Health and Welfare, Population Health Unit, Helsinki and Oulu, Finland 9Departamento de Ciências da Saúde Pública e Forenses e Educação Médica, Faculdade de Medicina, Universidade do Porto (FMUP), Porto, Portugal |
| Format: | article |
| Version: | published version |
| Access: | open |
| Online Access: | PDF Full Text (PDF, 1 MB) |
| Persistent link: | http://urn.fi/urn:nbn:fi-fe2023052547878 |
| Language: | English |
| Published: |
F1000 Research,
2021
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| Publish Date: | 2023-05-25 |
| Description: |
AbstractBackground: The GDPR was implemented to build an overarching framework for personal data protection across the EU/EEA. Linkage of data directly collected from cohort participants, potentially serving as a prominent tool for health research, must respect data protection rules and privacy rights. Our objective was to investigate law possibilities of linking cohort data of minors with routinely collected education and health data comparing EU/EEA member states. Methods: A legal comparative analysis and scoping review was conducted of openly accessible published laws and regulations in EUR-Lex and national law databases on GDPR’s implementation in Portugal, Finland, Norway, and the Netherlands and its connected national regulations purposing record linkage for health research that have been implemented up until April 30, 2021. Results: The GDPR does not ensure total uniformity in data protection legislation across member states offering flexibility for national legislation. Exceptions to process personal data, e.g., public interest and scientific research, must be laid down in EU/EEA or national law. Differences in national interpretation caused obstacles in cross-national research and record linkage: Portugal requires written consent and ethical approval; Finland allows linkage mostly without consent through the national Social and Health Data Permit Authority; Norway when based on regional ethics committee’s approval and adequate information technology safeguarding confidentiality; the Netherlands mainly bases linkage on the opt-out system and Data Protection Impact Assessment. Conclusions: Though the GDPR is the most important legal framework, national legislation execution matters most when linking cohort data with routinely collected health and education data. As national interpretation varies, legal intervention balancing individual right to informational self-determination and public good is gravely needed for health research. More harmonization across EU/EEA could be helpful but should not be detrimental in those member states which already opened a leeway for registries and research for the public good without explicit consent. see all
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| Series: |
Open research Europe |
| ISSN: | 2732-5121 |
| ISSN-E: | 2732-5121 |
| ISSN-L: | 2732-5121 |
| Volume: | 1 |
| Issue: | 58 |
| Pages: | 1 - 40 |
| DOI: | 10.12688/openreseurope.13689.2 |
| OADOI: | https://oadoi.org/10.12688/openreseurope.13689.2 |
| Type of Publication: |
A2 Review article in a scientific journal |
| Field of Science: |
113 Computer and information sciences 3142 Public health care science, environmental and occupational health |
| Subjects: | |
| Funding: |
This research was financially supported by the European Union’s Horizon 2020 research and innovation programme under the grant agreement No [733280] (Research on European children and adults born preterm [RECAP]). This study was also funded by FCT (Portuguese Ministry of Science, Technology and Higher Education), under the Unidade de Investigação em Epidemiologia—Instituto de Saúde Pública da Universidade do Porto (EPIUnit) (UIDB/04750/2020). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. |
| Copyright information: |
© 2021 Doetsch JN et al. This is an open access work distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. |
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https://creativecommons.org/licenses/by/4.0/ |