Cargando…

International transfers of health data between the EU and USA: a sector-specific approach for the USA to ensure an ‘adequate’ level of protection

International health research increasingly depends on collaboration and combination using medical data to advance treatment and drug discovery. The European Union (EU), through its General Data Protection Regulation, has tightened the rules for sharing data across borders to protect individual priva...

Descripción completa

Detalles Bibliográficos
Autores principales: Bradford, Laura, Aboy, Mateo, Liddell, Kathleen
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Oxford University Press 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8249089/
https://www.ncbi.nlm.nih.gov/pubmed/34221424
http://dx.doi.org/10.1093/jlb/lsaa055
_version_ 1783716837619400704
author Bradford, Laura
Aboy, Mateo
Liddell, Kathleen
author_facet Bradford, Laura
Aboy, Mateo
Liddell, Kathleen
author_sort Bradford, Laura
collection PubMed
description International health research increasingly depends on collaboration and combination using medical data to advance treatment and drug discovery. The European Union (EU), through its General Data Protection Regulation, has tightened the rules for sharing data across borders to protect individual privacy. These new rules threaten cooperation between the EU and the USA, the two largest public funders of biomedical research. This article analyzes the primary pathway for sharing research data with the USA, the US–EU Privacy Shield, and argues that the Shield is ill-suited to support complex health studies. Its legitimacy is in question under both EU and US law, and its terms are too restrictive for the variety of exchanges underlying research, treatment, and care. As an alternative, we propose that the USA seek an additional sector-based adequacy determination based on the existing US health privacy law, the Health Insurance Portability and Accountability Act. A sector-specific approach to adequacy for health would avoid many of the most contentious issues that divide the USA and EU on data protection. It could also serve as a model for other third-party jurisdictions and facilitate international harmonization of health research practices.
format Online
Article
Text
id pubmed-8249089
institution National Center for Biotechnology Information
language English
publishDate 2020
publisher Oxford University Press
record_format MEDLINE/PubMed
spelling pubmed-82490892021-07-02 International transfers of health data between the EU and USA: a sector-specific approach for the USA to ensure an ‘adequate’ level of protection Bradford, Laura Aboy, Mateo Liddell, Kathleen J Law Biosci Original Article International health research increasingly depends on collaboration and combination using medical data to advance treatment and drug discovery. The European Union (EU), through its General Data Protection Regulation, has tightened the rules for sharing data across borders to protect individual privacy. These new rules threaten cooperation between the EU and the USA, the two largest public funders of biomedical research. This article analyzes the primary pathway for sharing research data with the USA, the US–EU Privacy Shield, and argues that the Shield is ill-suited to support complex health studies. Its legitimacy is in question under both EU and US law, and its terms are too restrictive for the variety of exchanges underlying research, treatment, and care. As an alternative, we propose that the USA seek an additional sector-based adequacy determination based on the existing US health privacy law, the Health Insurance Portability and Accountability Act. A sector-specific approach to adequacy for health would avoid many of the most contentious issues that divide the USA and EU on data protection. It could also serve as a model for other third-party jurisdictions and facilitate international harmonization of health research practices. Oxford University Press 2020-10-15 /pmc/articles/PMC8249089/ /pubmed/34221424 http://dx.doi.org/10.1093/jlb/lsaa055 Text en © The Author(s) 2020. 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-nc-nd/4.0/This is an Open Access article distributed under the terms of the Creative Commons Attribution NonCommercial-NoDerivs licence (http://creativecommons.org/licenses/by-nc-nd/4.0/ (https://creativecommons.org/licenses/by-nc-nd/4.0/) ), which permits non-commercial reproduction and distribution of the work, in any medium, provided the original work is not altered or transformed in any way, and that the work properly cited. For commercial re-use, please contact journals.permissions@oup.com
spellingShingle Original Article
Bradford, Laura
Aboy, Mateo
Liddell, Kathleen
International transfers of health data between the EU and USA: a sector-specific approach for the USA to ensure an ‘adequate’ level of protection
title International transfers of health data between the EU and USA: a sector-specific approach for the USA to ensure an ‘adequate’ level of protection
title_full International transfers of health data between the EU and USA: a sector-specific approach for the USA to ensure an ‘adequate’ level of protection
title_fullStr International transfers of health data between the EU and USA: a sector-specific approach for the USA to ensure an ‘adequate’ level of protection
title_full_unstemmed International transfers of health data between the EU and USA: a sector-specific approach for the USA to ensure an ‘adequate’ level of protection
title_short International transfers of health data between the EU and USA: a sector-specific approach for the USA to ensure an ‘adequate’ level of protection
title_sort international transfers of health data between the eu and usa: a sector-specific approach for the usa to ensure an ‘adequate’ level of protection
topic Original Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8249089/
https://www.ncbi.nlm.nih.gov/pubmed/34221424
http://dx.doi.org/10.1093/jlb/lsaa055
work_keys_str_mv AT bradfordlaura internationaltransfersofhealthdatabetweentheeuandusaasectorspecificapproachfortheusatoensureanadequatelevelofprotection
AT aboymateo internationaltransfersofhealthdatabetweentheeuandusaasectorspecificapproachfortheusatoensureanadequatelevelofprotection
AT liddellkathleen internationaltransfersofhealthdatabetweentheeuandusaasectorspecificapproachfortheusatoensureanadequatelevelofprotection