In a Journal of Law and the Biosciences article, health care partners David Peloquin and Mark Barnes (both of Boston) analyze a court decision impacting the cross-border transfer of clinical research data.
The Court of Justice of the European Union (CJEU) held in its 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 (GDPR). The CJEU expressed concern that United States’ national security intelligence gathering frameworks 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 relevant aspects of the Schrems II decision, the authors evaluate U.S. national security intelligence gathering frameworks, including Section 702 of the Foreign Intelligence Surveillance Act (FISA) and Executive Order 12333. Their article then leverages recent 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 de-identification, to provide ‘essentially equivalent’ protections in the clinical research context.
The article was co-authored by Barbara Bierer, MD, a hematologist/oncologist and professor of medicine at Harvard Medical School and the Brigham and Women’s Hospital (BWH) who co-founded and is faculty director of the Multi-Regional Clinical Trials Center of BWH and Harvard.
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