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CMS Issues Final Rule Mandating New Minimum Staffing Standards for Long-Term Care Facilities

On April 22, 2024, The Centers for Medicare & Medicaid Services (“CMS”) issued the “Medicare and Medicaid Programs; Minimum Staffing Standards for Long-Term Care Facilities and Medicaid Institutional Payment Transparency...more

Open Up Your Eyes: FDA Expects Real Transparency in ClinicalTrials.gov Disclosures

Based on client inquiries and FDA actions, the Food and Drug Administration is focusing more on companies not submitting data to www.ClinicalTrials.gov. It is taking stronger action against those companies it believes are...more

FDA Announces End of Sales of PFAS Used in U.S. Food Packaging

The U.S. Food and Drug Administration (“FDA”) recently announced that grease-proofing substances containing per and poly-fluoroalkyl substances (“PFAS”) are no longer being sold by manufacturers for food contact use in the...more

Welcome to the Machine: FDA Issues White Paper on AI and Medical Products

For music aficionados, many would agree that the rock band, Pink Floyd, was ahead of its time. “Welcome to the Machine,” from the 1975 album Wish You Were Here, was one of those transformative songs for one of this Bulletin’s...more

OCR Issues Updated Guidance on “Use of Online Tracking Technologies by HIPAA Covered Entities and Business Associates”

The U.S. Department of Health and Human Services Office for Civil Rights (“OCR”) recently released a revised version of its guidance titled “Use of Online Tracking Technologies by HIPAA Covered Entities and Business...more

CMS Announces the Innovation in Behavioral Health Model

Overview - The Centers for Medicare & Medicaid Services (“CMS”) is launching a new model aimed at improving the quality of care and health outcomes for individuals with behavioral health (“BH”) problems. The model, announced...more

(Maybe) I Can See More Clearly Now: FDA Issues Q&A Guidance on DTC Rx Ads

On December 26, 2023, the Food and Drug Administration’s Office of Prescription Drug Promotion (“OPDP”) issued a Questions and Answers Guidance for industry titled “Direct-to-Consumer Prescription Drug Advertisements:...more

I Can See Clearly Now: FDA Issues Final Rule on DTC Rx Ads Relating to Presentation of the Major Statement in TV and Radio Format

In 1972, Johnny Nash sang the catchy song, “I Can See Clearly Now.” A little more than 50 years later, the Food and Drug Administration’s Office of Prescription Drug Promotion issued a Final Rule relating to...more

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