Mid-Atlantic Health Law TOPICS
Did You Know? Fall 2026
AI Class Action: Did you know that two major health care providers are facing a class action lawsuit over allegations that they used Artificial Intelligence (AI) to record and transcribe patient conversations without consent? Sutter Health and MemorialCare, both based in California, allegedly used Abridge AI to capture physician-patient conversations in patient examination rooms. Abridge’s software then transmitted the audio to external servers and generated clinical notes that were added to patient health records. Patients argue that they did not receive clear notice that conversations would be recorded, transmitted outside the clinical setting, or processed through third-party systems, all of which violate California privacy laws.
Proposed Modified HIPAA Rules: Did you know that in January 2025, HHS proposed new HIPAA rules? The proposals would: (1) strengthen cybersecurity protections for ePHI by requiring additional technical controls and administrative safeguards; (2) address widespread noncompliance with risk analyses, technical safeguards, and incident response by implementing new contingency planning requirements; (3) expand business associate oversight; and (4) require annual organization-wide internal audits.
FDA Proposal on Compounded GLP-1s: Did you know that the U.S. Food and Drug Administration (FDA) proposed removing key weight loss drugs from its list of active ingredients that outsourcing facilities may use to make compounded medicines? On April 30, 2026, the FDA stated that it did not identify a clinical need for outsourcing facilities to compound semaglutide (the active ingredient of Novo Nordisk’s Wegovy and Ozempic), tirzepatide (the active ingredient for Eli Lilly’s Zepbound and Mounjaro), and liraglutide from bulk substances. If finalized, outsourcing facilities would generally be barred from compounding these drugs unless there is a recognized drug shortage, significantly narrowing when compounded versions can be made.
Kennedy M. Hagens
410-576-4146 • khagens@gfrlaw.com