EU-US data transfers for health research remain a particularly thorny issue in view of the stringent rules of the EU General Data Protection Regulation (GDPR) and the challenges related to US mass surveillance programs, particularly the manner in which US law enforcement and national security agencies can access personal data originating from the EU. Since the entry into force of the GDPR, evidence of impeded collaborations is increasing, particularly in the case of sharing data with US public institutions. The adoption of a new EU-US adequacy decision in July 2023 does not hold the promise for a long-lasting solution due to the risks of being challenged and invalidated - yet again - at the Court of Justice of the EU. As the research community is calling for answers, the new proposal for a European Health Data Space regulation may hold a key to solving some of the existing issues. In this paper, we critically discuss the current rules and outline a possible way forward for transfers between public bodies.
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http://dx.doi.org/10.1038/s41746-024-01205-6 | DOI Listing |
J Law Biosci
September 2024
Centre for Advanced Studies in Bioscience Innovation Law, University of Copenhagen, Karen Blixens Plads 16, DK-2300 Copenhagen S.
In July 2023, the United States and the European Union introduced the Data Privacy Framework (DPF), introducing the third generation of cross-border data transfer agreements constituting adequacy with respect to personal data transfers under the General Data Protection Regulation (GDPR) between the European Union (EU) and the US. This framework may be used in cross-border healthcare and research relationships, which are highly desirable and increasingly essential to innovative health technology development and health services deployment. A reliable model meeting EU adequacy requirements could enhance the transfer of patient and research participant data.
View Article and Find Full Text PDFNPJ Digit Med
August 2024
Clinical Pharmacology and Pharmacotherapy, Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium.
EU-US data transfers for health research remain a particularly thorny issue in view of the stringent rules of the EU General Data Protection Regulation (GDPR) and the challenges related to US mass surveillance programs, particularly the manner in which US law enforcement and national security agencies can access personal data originating from the EU. Since the entry into force of the GDPR, evidence of impeded collaborations is increasing, particularly in the case of sharing data with US public institutions. The adoption of a new EU-US adequacy decision in July 2023 does not hold the promise for a long-lasting solution due to the risks of being challenged and invalidated - yet again - at the Court of Justice of the EU.
View Article and Find Full Text PDFCytotherapy
October 2023
Faculty of Health Sciences, University of Brasília (UnB), Brasília, Brazil.
Background Aims: Advanced therapy medicinal products (ATMPs) are a class of biological products for human use that are based on gene, tissues or cells. ATMPs have peculiar characteristics when compared with traditional medicines. In this regard, long-term safety and efficacy follow-up systems of individuals treated with ATMPs have become necessary and may present unique challenges, because unlike conventional drugs and biologics, these products can exert their effects for years after administration.
View Article and Find Full Text PDFJ Prev Alzheimers Dis
June 2023
D. Angioni, Gerontopole of Toulouse, Alzheimer's Disease Research and Clinical Center, Toulouse University Hospital, Toulouse, France,
Regul Toxicol Pharmacol
August 2023
European Chemicals Agency (ECHA), Telakkakatu 6, 00150, Helsinki, Finland. Electronic address:
A new IUCLID database is provided containing results from non-clinical animal studies and human information for 530 approved drugs. The database was developed by extracting data from pharmacological reviews of repeat-dose, carcinogenicity, developmental, and reproductive toxicity studies. In the database, observed and no-observed effects are linked to the respective effect levels, including information on severity/incidence and transiency/reversibility.
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