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 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.

executive order on artificial intelligence

What they’re saying about the White House’s executive order on AI

In the Biden administration’s latest push to encourage beneficial AI innovation while discouraging hazardous AI risk-taking, the president on Monday announced an executive order fleshing out that coupled call.

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President Biden issues ‘landmark’ executive order on artificial intelligence

The Medical Imaging & Technology Alliance, which represents device manufacturers, praised the president's announcement.

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Around the web

Cardiovascular Business
FDA says years-long tirzepatide shortage is resolved, will give limited leeway to compounders

The tirzepatide shortage that first began in 2022 has been resolved. Drug companies distributing compounded versions of the popular drug now have two to three more months to distribute their remaining supply.

AI in Healthcare
From Capitol Hill to a hospital near you? 5 federal recommendations for healthcare AI policy

The 24 members of the House Task Force on AI—12 reps from each party—have posted a 253-page report detailing their bipartisan vision for encouraging innovation while minimizing risks. 

Cardiovascular Business
Merck spends up to $2B to license new weight loss drug with potential heart benefits

Merck sent Hansoh Pharma, a Chinese biopharmaceutical company, an upfront payment of $112 million to license a new investigational GLP-1 receptor agonist. There could be many more payments to come if certain milestones are met.