Health Privacy

On September 17, 2025, the German Supervisory Authorities (Konferenz der unabhängigen Datenschutzaufsichtsbehörden des Bundes und der Länder, DSK) published new guidelines and recommendations addressing the complex requirements for transferring personal data, particularly health data (including health data contained in biomaterials), to countries outside of the European Economic Area for scientific research purposes under the GDPR. These guidelines may be of particular relevance for pharmaceutical, medical device, and other life sciences companies that conduct clinical research.Continue Reading New German Guidelines on GDPR Requirements for International Transfers of Health Data in Medical Research

In late September, plaintiffs announced details regarding Google LLC’s (“Google”) and women’s health app developer, Flo Health Inc.’s (“Flo”) proposed settlements to resolve a class action lawsuit stemming from the Flo app’s allegedly unlawful sharing of health data with Google and others through online tracking technologies.

As part of the proposed settlements, Google agreed to pay $48 million and Flo agreed to pay $8 million, for a combined $56 million to resolve plaintiffs’ claims against these two entities.Continue Reading Flo Health, Google Settle Class Action Privacy Lawsuit for $56 Million

On September 24, Senate Democratic Leader Chuck Schumer (D-N.Y.), Senator Maria Cantwell (D-Wash.), and Senator Ed Markey (D-Mass.) introduced the Management of Individuals’ Neural Data (“MIND”) Act of 2025, which would require the Federal Trade Commission (“FTC”) to conduct a study and provide a report examining the governance of “neural data” under existing law and identify additional areas for federal regulation.  The bill would also require the Office of Science and Technology Policy (“OSTP”) to issue guidance regarding federal agencies’ use of certain neurotechnology.Continue Reading Congress Introduces Neural Data Bill

In a recently announced settlement agreement with the U.S. Department of Justice (“DOJ”), Illumina, Inc. (“Illumina”) agreed to pay $9.8 million to resolve claims arising from alleged cybersecurity vulnerabilities in genomic sequencing systems that the company sold to federal agencies.  The case is the latest in a series of False Claims Act (“FCA”) settlements under the current administration that evidence DOJ’s continued focus on cybersecurity obligations for government contractors, particularly those that maintain sensitive data and personal information on behalf of federal customers.Continue Reading Latest Cybersecurity False Claims Act Settlement with Diagnostics Provider Focuses on Sensitive Health Systems

On June 19, 2025, the U.S. District Court for the Northern District of Texas vacated the majority of the Biden Administration rule (the “2024 Rule”) modifying the Standards for Privacy of Individually Identifiable Health Information (“Privacy Rule”) under the Health Insurance Portability and Accountability Act (“HIPAA”) regarding protected health information (“PHI”) concerning reproductive health.  As discussed in further detail in our previous blog post, the 2024 Rule “limit[ed] the circumstances in which provisions of the Privacy Rule permit the use or disclosure of an individual’s PHI about reproductive health care for certain non-health care purposes.” Continue Reading District Court Enjoins Privacy Rule Modifications Regarding Reproductive Health Care