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20 Democratic AGs sued HHS and DHS for allegedly sharing personal health data with ICE. The complaint alleges that the Centers for Medicare & Medicaid Services—a division of HHS—transferred millions of individuals’ Medicaid...more
Kaiser Permanente is notifying 13.4 million current and former members that their personal information may have been compromised when it was transmitted to tech giants Google, Microsoft Bing and X (formerly Twitter) when...more
Welcome to Vital Signs, a curated compilation of the latest legal and regulatory developments in digital health. Our lead article reports on HHS' recent final rule on the confidentiality of substance use disorder patient...more
On February 8, 2024, the Department of Health and Human Services (HHS) posted a final rule that aims to align 42 CFR Part 2 (Part 2) — which protects certain substance abuse disorder (SUD) records — with the Health Insurance...more
All players in the health and wellness ecosystem should be following developments around the American Data Privacy and Protection Act (ADPPA). If enacted, the ADPPA would be a watershed in the regulation of the privacy and...more
Report on Research Compliance 18, no. 8 (August, 2021) - “As a steward of the nation’s biomedical research enterprise, NIH is dedicated to ensuring that when data and biospecimens are shared, that it is done ethically and...more
In an era of decreasing reimbursement and rapidly expanding opportunities associated with “big data”, healthcare entities may be looking for ways to monetize protected health information (“PHI”) for their own, non-patient...more
On December 19, 2019, the U.S. Department of Health and Human Services (HHS) and the U.S. Department of Education (DOE) provided new joint guidance on the release of certain student records. In summary, this HHS/DOE release...more
On August 26, 2019, the Substance Abuse and Mental Health Services Administration, part of the U.S. Department of Health and Human Services (HHS), published its much-anticipated notice of proposed rulemaking to revise 42...more