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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UnitedHealth faces lawsuit over AI algorithm that allegedly denied care to elderly patients

A lawsuit in federal court claims an AI algorithm used by the insurer systematically denied elderly patients’ claims for extended care.

CVD deaths have increased dramatically, undoing years of progress

The COVID-19 pandemic undid years and years of progress in terms of preventing CVD-related deaths. What can be done to help reverse this trend once and for all? 

FDA announces recall of more than 32 million disposable syringes

The new-look syringes are causing significant issues when used with syringe infusion pumps. This is a Class I recall, which means the FDA believes the products “may cause serious injuries or death.”

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Cardiologist reprimanded for performing surgery after testing positive for COVID-19

He has agreed to pay an administrative fee of $1,100 within the next three months.

take care of maya netflix johns hopkins lawsuit

Hopkins hospital ordered to pay $261M in purported ‘Munchausen’ case made famous by Netflix

The civil case has a very high profile since the story unfolded in excruciating detail in a widely viewed documentary.

American Heart Association ‘enthusiastically’ joins other cardiology groups in push for new, independent medical board

AHA members have voted to throw their full support behind the efforts to establish a new American Board of Cardiovascular Medicine. 

FDA announces Class I recall of nearly 2,000 catheter kits

Medical facilities and distributors have been advised to immediately discontinue the use of these devices due to a significant labeling issue. 

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American Hospital Association sues HHS over IP tracking rule

The AHA is suing HHS over guidance that forbids the use of popular third-party tracking applications.

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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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