10/22/2025 10:32:55 PM California Tightens Oversight of PE Involvement in Physician Platforms By Anthony Del Rio Caitlin Kierum California has enacted two new laws—AB 1415 and SB 351—effective January 1, 2026, that will materially affect private equity ownership...
10/16/2025 9:33:54 PM New Joint Commission Guidance On The Use Of Artificial Intelligence In Healthcare By Paul DeMuro Brandon von Kriegelstein Taylor Stilwell On September 17, 2025, the Joint Commission, in collaboration with the Coalition for Health AI (“CHAI”), issued its first high-level...
10/8/2025 1:25:05 PM FDA Launches New ANDA Prioritization Pilot to Support U.S.-Based Generic Manufacturing By Kate Hardey The U.S. Food and Drug Administration (FDA) has introduced a new pilot program to prioritize Abbreviated New Drug Applications (ANDAs)...
10/6/2025 6:11:57 PM FDA Seeks Stakeholder Feedback on AI-Enabled Medical Device Performance By Kate Hardey The U.S. Food and Drug Administration (FDA) is offering an opportunity for stakeholders to provide feedback to “advance a broader...
9/18/2025 7:19:06 PM New Texas Law on Storage of Health Care Data By Lisa Prather Brandon von Kriegelstein Texas is imposing new rules for the storage of electronic health records (“EHR”). Recently enacted Senate Bill 1188 (“SB 1188”) requires...
9/12/2025 8:00:32 PM FDA's AI-Powered Crackdown on Alleged Deceptive Drug Promotions By Kate Hardey On September 9, 2025, the U.S. Food and Drug Administration (FDA) announced it is launching a targeted initiative to combat deceptive...
9/8/2025 3:54:53 PM Getting the Green Light: FDA's New Safeguards for GLP-1 Imports By Kate Hardey On September 5, 2025, the U.S. Food and Drug Administration (FDA) announced the establishment of a "green list" import alert (Import...
9/4/2025 3:11:33 PM CMS Releases FAQ Discussing New WISeR Model By Ramana Rameswaran Joe Lecroy As a follow-up to its recent announcement of the new Wasteful and Inappropriate Service Reduction (WISeR) Model (which we have previously...
8/18/2025 9:01:59 PM Potential Changes Coming to Medicare Provider Enrollment and DMEPOS Accreditation By Ramana Rameswaran Brandon von Kriegelstein Often there is a lot of attention paid to the Centers for Medicare & Medicaid Services (“CMS”) Inpatient Prospective Payment System...
8/11/2025 4:07:56 PM FDA PreCheck: Fast-Lane Approval to Boost U.S. Drug Manufacturing and Supply Chain Security By Kate Hardey On August 7, 2025, the Food and Drug Administration announced a voluntary “FDA Pre-Check” program to encourage and expedite domestic drug...
8/1/2025 2:18:26 PM USDA Ramps Up Food Safety Strategy By Kate Hardey Katy Pollitt On July 15, the U.S. Secretary of Agriculture, Brooke L. Rollins, announced a “comprehensive plan to bolster U.S. Department of...
8/1/2025 12:46:24 PM FTC Request for Information Regarding Gender Affirming Care By Kate Hardey Katy Pollitt On July 9, 2025, the Federal Trade Commission (“FTC”) hosted a workshop to discuss unfair and/or deceptive trade practices in gender...
7/25/2025 7:24:32 PM Texas and Louisiana Serve Up New Laws on Food Product Labels and Disclosures By Kate Hardey Daniel Walbright In a significant move toward greater labeling transparency and state oversight of food policy, Texas and Louisiana have enacted new laws...
7/3/2025 12:53:41 PM The Joint Commission’s 2025 Accreditation Overhaul: What Healthcare Organizations Need to Know By Kenya Scott Woodruff Katy Pollitt Taylor Stilwell On June 30, the Joint Commission announced it is transforming its accreditation process, promising a more streamlined, relevant, and...
7/2/2025 1:58:24 PM CMS Unveils New Prior Authorization “WISeR Model” for Electrical Nerve Stimulators, Skin and Tissue Substitutes and Knee Arthroscopy By Ramana Rameswaran Joe Lecroy CMS recently announced a new model it will be using to pilot the use of artificial intelligence and machine learning in reviewing prior...
6/30/2025 3:07:58 PM FDA Scrutinizes Clinical Trials Exporting U.S. Genetic Material By Kate Hardey Brandon von Kriegelstein On June 18, 2025, the U.S. Food and Drug Administration (“FDA”) announced an immediate review of new clinical trials that export American...