The Ropes & Gray Decoding Digital Health podcast series discusses the digital health industry and related legal, business and regulatory issues. In this episode, Digital Health Initiative co-lead and health care partner, Christine Moundas, interviews health care partner and member of the digital health group, David Peloquin. They discuss the legal challenges and potential solutions
Since the decision of the Court of Justice of the European Uon (“CJEU”) in the Schrems II case in mid-2020, organizations have not…
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 The article then leverages recent draft guidance from the European Data Protection Board to explain how entities may be able to adopt widely used contractual and technical measures, such as data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.
Continue Reading Demystifying Schrems II for the Cross-Border Transfer of Clinical Research Data
Law360 (October 4, 2021, 5:30 PM EDT) —
On June 29, Florida Gov. Ron DeSantis signed into law H.B. 833, known as the Protecting DNA Privacy Act.
The act took effect on Oct. 1, and applies to the collection, use, retention, maintenance and disclosure of a DNA sample collected from an individual in Florida as well as the results of any subsequent DNA analysis. The act is self-executing and took effect without the need for creation of implementing regulations.
The act clarifies the extent to which individuals own their genetic information, and it creates new crimes for the unlawful collection, retention, analysis, disclosure or sale of an individual’s DNA sample and the results of a DNA analysis, subject to certain limited exemptions, such as use for specified clinical or research purposes.
The act also has important implications for secondary uses of data by health care providers and others that perform genetic testing and analyze genetic information.…