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Demystifying Schrems II for the cross-border transfer of clinical research data
The Courts of Justice of the European Union (CJEU) held in its July 2020 Schrems II decision that, in order for entities in other countries to import personal data from the European Economic Area (EEA), the importer must be able to provide data protections ‘essentially equivalent’ to those the EEA o...
Autores principales: | , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Oxford University Press
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8541704/ https://www.ncbi.nlm.nih.gov/pubmed/34703612 http://dx.doi.org/10.1093/jlb/lsab032 |
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author | Liss, Joseph Peloquin, David Barnes, Mark Bierer, Barbara E |
author_facet | Liss, Joseph Peloquin, David Barnes, Mark Bierer, Barbara E |
author_sort | Liss, Joseph |
collection | PubMed |
description | The Courts of Justice of the European Union (CJEU) held in its July 2020 Schrems II decision that, in order for entities in other countries to import personal data from the European Economic Area (EEA), the importer must be able to provide data protections ‘essentially equivalent’ to those the EEA offers under its General Data Protection Regulation. The CJEU expressed particular concern that United States’ national security intelligence gathering laws prevent U.S.-based entities from providing such protections. This decision has sharply limited the sharing of clinical research data from the EEA to the United States. After describing the pertinent aspects of the Schrems II decision, this article evaluates U.S. national security intelligence gathering frameworks, including Section 702 of the Foreign Intelligence Surveillance Act and Executive Order 12333. The article then leverages recent draft guidance from the European Data Protection Board to explain how entities may be able to adopt widely used contractual and technical measures, such as data pseudonymization, to provide ‘essentially equivalent’ protections in the clinical research context. |
format | Online Article Text |
id | pubmed-8541704 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | Oxford University Press |
record_format | MEDLINE/PubMed |
spelling | pubmed-85417042021-10-25 Demystifying Schrems II for the cross-border transfer of clinical research data Liss, Joseph Peloquin, David Barnes, Mark Bierer, Barbara E J Law Biosci Essay The Courts of Justice of the European Union (CJEU) held in its July 2020 Schrems II decision that, in order for entities in other countries to import personal data from the European Economic Area (EEA), the importer must be able to provide data protections ‘essentially equivalent’ to those the EEA offers under its General Data Protection Regulation. The CJEU expressed particular concern that United States’ national security intelligence gathering laws prevent U.S.-based entities from providing such protections. This decision has sharply limited the sharing of clinical research data from the EEA to the United States. After describing the pertinent aspects of the Schrems II decision, this article evaluates U.S. national security intelligence gathering frameworks, including Section 702 of the Foreign Intelligence Surveillance Act and Executive Order 12333. The article then leverages recent draft guidance from the European Data Protection Board to explain how entities may be able to adopt widely used contractual and technical measures, such as data pseudonymization, to provide ‘essentially equivalent’ protections in the clinical research context. Oxford University Press 2021-10-23 /pmc/articles/PMC8541704/ /pubmed/34703612 http://dx.doi.org/10.1093/jlb/lsab032 Text en © The Author(s) 2021. Published by Oxford University Press on behalf of Duke University School of Law, Harvard Law School, Oxford University Press, and Stanford Law School. https://creativecommons.org/licenses/by/4.0/This is an Open Access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | Essay Liss, Joseph Peloquin, David Barnes, Mark Bierer, Barbara E Demystifying Schrems II for the cross-border transfer of clinical research data |
title | Demystifying Schrems II for the cross-border transfer of clinical research data |
title_full | Demystifying Schrems II for the cross-border transfer of clinical research data |
title_fullStr | Demystifying Schrems II for the cross-border transfer of clinical research data |
title_full_unstemmed | Demystifying Schrems II for the cross-border transfer of clinical research data |
title_short | Demystifying Schrems II for the cross-border transfer of clinical research data |
title_sort | demystifying schrems ii for the cross-border transfer of clinical research data |
topic | Essay |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8541704/ https://www.ncbi.nlm.nih.gov/pubmed/34703612 http://dx.doi.org/10.1093/jlb/lsab032 |
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