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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Price shopping transparency

CMS to punish hospitals sooner for price transparency noncompliance

Several studies have found that compliance is low with the government's new price transparency regulations. CMS hopes these newly announced changes can make a difference. 

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Supreme Court upholds full access to abortion pill

The Supreme Court issued a stay on April 21 that keeps mifepristone on the market without restrictions––for now.

Infusion system recalled for possible leaks after multiple complaints

The recall includes more than 1,500 devices distributed to customers from October 2021 to January 2023. 

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OTC Narcan will cost less than $50

The drug's manufacturer said it is working with retailers to get the drug on U.S. shelves and online for purchase by late summer.

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Judge halts all lawsuits related to J&J talc formula

A U.S. judge halted all lawsuits against Johnson & Johnson over allegations that its talc formula products and baby powder contained cancer-causing asbestos, stopping any trials as the company has agreed to settle all claims for billions of dollars.

DOJ targets COVID-related healthcare fraud

One official described it as the 'largest-ever coordinated law enforcement action' of its kind.

GE Healthcare solution, billed as a 'unified approach to patient monitoring,' gains FDA clearance

GE Healthcare received clearance from the U.S. Food and Drug Administration (FDA) for its patient monitoring platform, Carescape Canvas.

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Supreme Court delays final decision on abortion pill for 2 more days

A common abortion pill, mifepristone, is still in grave danger of being pulled off the market. 

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Around the web

Cardiovascular Business
Q&A: Why are cardiovascular devices involved in so many recalls? FDA policies may be to blame

Cardiovascular devices are more likely to be in a Class I recall than any other device type. The FDA's approval process appears to be at least partially responsible, though the agency is working to make some serious changes. We spoke to a researcher who has been tracking these data for years to learn more. 

Cardiovascular Business
Cardiologist compensation still rising, especially in invasive and interventional cardiology

Updated compensation data includes good news for multiple subspecialties. The new report also examines private equity's impact on employment models and how much male cardiologists earn compared to females.

Cardiovascular Business
FDA’s tirzepatide decision creates uncertainty for patients—and leads to a lawsuit

When drugs are on the FDA’s shortage list, outsourcing facilities can produce their own compounded versions. When the FDA removed tirzepatide from that list with no warning, it created a considerable amount of chaos both behind the scenes and in pharmacies all over the country. 

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