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In a Bloomberg Law article, attorneys examined Washington State’s comprehensive new privacy law, the My Health My Data Act, the first state law that specifically safeguards consumer health data.

The article discusses the new law’s scope, applicability, and ensuing company obligations. The Act will apply to many life sciences companies, pharmaceutical and device

On February 28, 2024, President Biden announced an Executive Order directing the Department of Justice to promulgate regulations that restrict or prohibit transactions involving certain bulk sensitive personal data or United States Government-related data and countries of concern or covered persons. The DOJ’s initially identified countries are China (including Hong Kong and Macau), Russia, Iran

On December 20, 2023, the National Institute of Standards and Technology (“NIST”) National Cybersecurity Center of Excellence (“NCCoE”) published its Cybersecurity of Genomic Data report (the “Report”).  The Report aims to assist organizations in protecting against misuse of genomic data and enabling secure collaborative innovations.  Note, however, that the Report is not authoritative with respect to its assessment of the treatment of genomic data under the current U.S. regulatory framework, including with respect to the identifiability of such information.Continue Reading NIST Cybersecurity Center of Excellence – Cybersecurity of Genomic Data Report 

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

On 7 October 2022, the White House issued an Executive Order, as well as an accompanying Fact Sheet, which sets out the foundations for the Transatlantic Data Privacy Framework (“Framework”).

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.Continue Reading What Florida’s DNA Privacy Law Means For Health Care Providers