Bridging the European Data Sharing Divide in Genomic Science.
| Title: | Bridging the European Data Sharing Divide in Genomic Science. |
|---|---|
| Authors: | Molnár-Gábor F; Faculty of Law, University of Heidelberg, Heidelberg, Germany.; Beauvais MJS; Centre of Genomics and Policy, Faculty of Medicine and Health Sciences, McGill University, Montreal, QC, Canada.; Faculty of Law, University of Toronto, Toronto, ON, Canada.; Bernier A; Centre of Genomics and Policy, Faculty of Medicine and Health Sciences, McGill University, Montreal, QC, Canada.; Jimenez MPN; Research group in social and legal sciences applied to the new technosciences IT 1541-22, Faculty of Law, University of the Basque Country, Basque University System, Bilbao, Spain.; Recuero M; Research group in social and legal sciences applied to the new technosciences IT 1541-22, Faculty of Law, University of the Basque Country, Basque University System, Bilbao, Spain.; Knoppers BM; Centre of Genomics and Policy, Faculty of Medicine and Health Sciences, McGill University, Montreal, QC, Canada. |
| Source: | Journal of medical Internet research [J Med Internet Res] 2022 Oct 19; Vol. 24 (10), pp. e37236. Date of Electronic Publication: 2022 Oct 19. |
| Publication Type: | Journal Article; Research Support, Non-U.S. Gov't |
| Language: | English |
| Journal Info: | Publisher: JMIR Publications Country of Publication: Canada NLM ID: 100959882 Publication Model: Electronic Cited Medium: Internet ISSN: 1438-8871 (Electronic) Linking ISSN: 14388871 NLM ISO Abbreviation: J Med Internet Res Subsets: MEDLINE |
| Imprint Name(s): | Publication: : Toronto : JMIR Publications; Original Publication: [Pittsburgh, PA? : s.n., 1999- |
| MeSH Terms: | Computer Security* ; Biomedical Research*; Humans ; European Union ; Genomics ; Information Dissemination |
| Abstract: | In this viewpoint, we argue for the importance of creating data spaces for genomic research that are detached from contexts in which fundamental rights concerns related to surveillance measures override a purpose-specific balancing of fundamental rights. Genomic research relies on molecular and phenotypic data, on comparing findings within large data sets, on searchable metadata, and on translating research results into a clinical setting. These methods require sensitive genetic and health data to be shared across borders. International data sharing between the European Union (EU) or the European Economic Area and third countries has accordingly become a cornerstone of genomics. The EU General Data Protection Regulation contains rules that accord privileged status to data processing for research purposes to ensure that strict data protection requirements do not impede biomedical research. However, the General Data Protection Regulation rules applicable to international transfers of data accord no such preferential treatment to international data transfers made in the research context. The rules that govern the international transfer of data create considerable barriers to international data sharing because of the cost-intensive procedural and substantive compliance burdens that they impose. For certain jurisdictions and select use cases, there exist practically no lawful mechanisms to enable the international transfer of data because of concerns about the protection of fundamental rights. The proposed solutions further fail to address the need to share large data sets of local and regional cohorts across national borders to enable joint analyses. The European Health Data Space is an emerging federated, EU-wide data infrastructure that is intended to function as an infrastructure bringing together EU health data to improve patient care and enable the secondary use of health-related data for research purposes. Such infrastructure is implementing new institutions to support its functioning and is being implemented in reliance on a new enabling law, the regulation on the European Health Data Space. This innovation provides the opportunity to facilitate EU contribution to international genomic research efforts. The draft regulation for this data space provides for a concept of data infrastructure intended to enable cross-border data exchange and access, including access to genetic and health data for scientific analysis purposes. The draft regulation also provides for obligations of national actors aimed at making data widely available. This effort is laudable. However, in the absence of further, more fundamental changes to the manner in which the EU regulates the secondary use of health data, it is reasonable to believe that EU participation in international genomic research efforts will remain impeded.; (©Fruzsina Molnár-Gábor, Michael J S Beauvais, Alexander Bernier, Maria Pilar Nicolas Jimenez, Mikel Recuero, Bartha Maria Knoppers. Originally published in the Journal of Medical Internet Research (https://www.jmir.org), 19.10.2022.) |
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| Contributed Indexing: | Keywords: data protection; genomics; international data transfer; safe data spaces; scientific research |
| Entry Date(s): | Date Created: 20221019 Date Completed: 20221021 Latest Revision: 20221106 |
| Update Code: | 20260130 |
| PubMed Central ID: | PMC9631173 |
| DOI: | 10.2196/37236 |
| PMID: | 36260387 |
| Database: | MEDLINE |
Journal Article; Research Support, Non-U.S. Gov't