Policy & Regulations

This channel includes news coverage of healthcare policy and regulations set by Congress, the states, Centers for Disease Control and Prevention (CDC), the Department of Health and Human Services (HHS), U.S. Food and Drug Administration (FDA), and medical associations and societies. 

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FDA announces supplement recall over risk of heart attack or stroke

Silintan is a dietary supplement marketed as a treatment for joint and body aches. According to a recent analysis by the FDA, however, all lots contained undeclared meloxicam, creating an increased risk of adverse events.

Nirat Beohar, MD, director, cardiac catheterization laboratory, medical director of the structural heart disease program, Mount Sinai Medical Center in Miami Beach, Florida, and a professor at the Columbia University Division of Cardiology, explains the financial landscape of the cath lab, what is ahead, and why cardiologists need to become more business savvy. #TCT

The business of cardiology is changing—and cath labs are working to keep up

Financial literacy is no longer optional for physicians. “If you're not financially viable, you can't function,” explained Nirat Beohar, MD. “The business education is probably just as important as learning a new procedure.”

AI Avalanche

The ‘AI avalanche’ descends on surgery, ChatGPT goes healthcare-specific and more AI news & views not to miss

AI is an icy landslide sweeping through healthcare. Even surgeons must choose between two stark options: Ride the crest of the powder cloud now or dig yourselves out of a deep runout zone later. 

Lawsuit alleges AFP imported unsafe HIV drugs from Turkey through gray market supply chains

Numerous “alternative funding programs” are named as defendants in what is a larger challenge of the right of these third-party organizations to import drugs from overseas, bypassing FDA regulations. 

Jefferson Health

Large nonprofit health system sues PBMs, drug companies over insulin prices

Philadelphia-based Jefferson Health has accused the three biggest PBMs—Caremark, Express Scripts and Optum Rx—of a de facto collusion scheme involving the primary makers of insulin, Eli Lilly, Novo Nordisk and Sanofi. The lawsuit alleges rebates offered by the manufacturers unfairly burden self-insured and public health plans, like the one the health system uses for its employees.

Hologic issues safety alert for breast biopsy needles

The safety notice was issued due to the risk of pieces of the needles dislodging into tissue during procedures. 

70cm bore Magnetom Flow platform

Siemens Healthineers' latest 'helium-free' MRI nabs FDA clearance

The health tech company announced the news Thursday, noting that the platform should help facilities address the growing demand for imaging.

AI healthcare doctor surgery procedure artificial intelligence

FDA clears next-generation platform for AI-enabled ECG evaluations

AccurECG 2.0 was designed to interpret a total of 13 different rhythm classifications, including atrial fibrillation, atrial flutter and ventricular tachycardia.