Often there is a lot of attention paid to the Centers for Medicare & Medicaid Services (“CMS”) Inpatient Prospective Payment System (“IPPS”), Outpatient Prospective Payment System (“OPPS”), and Medicare Physician Fee Schedule...more
Katten's Privacy, Data and Cybersecurity Quick Clicks is a monthly newsletter highlighting the latest news and legal developments involving privacy, data and cybersecurity issues across the globe....more
On June 18, 2025, the U.S. Food and Drug Administration (“FDA”) announced an immediate review of new clinical trials that export American citizens’ biological materials to countries of concern, such as China, for genetic...more
On June 5, 2025, the U.S. Food and Drug Administration (“FDA”) issued draft guidance (the “510(k) Transfer Guidance”) related to the transfer of a Premarket Notification (510(k)) Clearance. The 510(k) Transfer Guidance...more
In 2024, the U.S. Department of Health and Human Services’ (“HHS”) implemented a new privacy rule under the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) that applied specifically to reproductive...more
On June 10, 2025, the Commissioner of the FDA, Dr. Martin Makary, and Dr. Vinayak Prasad, the Director of the FDA’s Center for Biologics Evaluation and Research, published an article in JAMA discussing the “Priorities for a...more
Important changes are coming to 42 CFR Part 2 (Part 2), which deals with the confidentiality of patients’ substance use disorder (SUD) records. On April 16, 2024, the US Department of Health and Human Services (HHS) published...more