Archive
Wade Emmert
US Enforcement of Emergency Abortion Rule Halted in Texas
From Bloomberg Law, by Mary Anne Pazanowski and Ian Lopez: The Fifth Circuit has ruled that the Biden administration’s guidance document, intended to protect abortion access…
OCR Doubles Down: Two Settlements in Two Months for Two Common Cybersecurity Issues
From Taft Stettinius & Hollister LLP, by Ike Willett & Cory Brennan: On December 7, 2023, the U.S. Department of Health and Human Services, Office for…
FDA Warns Against Unauthorized Fat-Melting Injection Treatments
From NBC News, by Berkeley Lovelace Jr.: The FDA has issued a warning about the dangers of using unauthorized versions of fat-dissolving injections, citing reports of…
FTC Seeks to Put Private Equity Roll-Up Strategies to Sleep With its Case Against U.S. Anesthesia Partners
From Winston & Strawn, by Neely Agin and Hannah Gallagher, writing for AHLA (Subscription): FTC and DOJ have increased regulatory scrutiny on the health care industry,…
Private Investors and Digital Health Attracting Oig Attention: General Compliance Program Guidance to Watch
From McDermott, Will & Emery, by Tony Maida, Dale C. Van Demark, Monica Wallace: The US Department of Health and Human Services (HHS) Office of Inspector…
HHS Finalizes Regulation of Certain AI
From Manatt, Phelps & Phillips, LLP, by Alex Dworkowitz, Alice Leiter, and Randi Seigel: The U.S. Department of Health and Human Services (HHS) has finalized a…
FDA’s Final Rule on Direct-to-Consumer Advertising – Presentation of Risk Information
From Foley & Lardner, LLP, by Kyle Gaget and Jordan Smiley: The FDA has released a final rule regarding direct-to-consumer (DTC) advertising for prescription drugs and…
Feds Levy First-Ever HIPAA Fine for a Phishing Breach
From Govinfo Security, by Marianne Colbasuk McGee: The Department of Health and Human Services has issued the first ever HIPAA fine for a phishing breach, highlighting…
The Growing Causal Divide: But-For Causation in AKS/FCA Actions
From McGuireWoods, by Renee Kumon, Timothy Fry and Brett Barnett: The District of Massachusetts Court recently joined the Sixth and Eighth Circuits in requiring the government…
FDA Issues Revised Off-Label Communications Guidance
From Jones Day, by Anthony Dick, Harrison Farmer, Colleen Heisey, Laura Laemmle-Weidenfeld, Rebecca Martin: The FDA has issued a revised draft guidance on the sharing of…