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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Doctor patient with masks

Should masks still be required at hospitals? Physicians push for a nuanced approach in face of uncertainty

A team of physicians examined the question of continued masking, urging healthcare leaders to work together in a new commentary in Annals of Internal Medicine.

Recor Medical's Paradise Ultrasound Renal Denervation System

FDA panel votes in favor of Recor Medical renal denervation system

A few members of the panel did question the device's efficacy and long-term durability. The FDA will now use these findings to make its final decision related to the system's approval. 

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Lab owner gets 27 years in prison for $463M Medicare fraud scheme

According to the U.S. Department of Justice, LabSolutions took advantage of patients using a telemarketing scheme, with its owner personally pocketing millions in kickbacks.

FDA warning alert exclamation computer

FDA warning letter details quality concerns, violations at Integra facility

The facility in question is responsible for producing collagen-based medical devices primarily used in wound care, soft tissue repair and complex reconstruction surgeries. 

GE Healthcare's Portrait Mobile wireless and wearable monitoring solution

GE HealthCare earns FDA clearance for new remote patient monitoring device

The newly cleared device was designed with patient freedom and flexibility in mind. 

USA China artificial intelligence race

Race for AI dominance: 5 points to ponder about US v. China

AI that’s intended to let cars drive themselves can be repurposed to let tanks level cities. And AI can just as easily weaponize a virus as diagnose it. These are not secrets.

Biden administration invests $100M in strengthening nursing workforce

The funding is a response to the escalating demand for registered nurses, nurse practitioners, certified nurse midwives and nurse faculty throughout the United States. 

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FDA warns public not to use certain pregnancy tests due to safety, accuracy issues

The agency shared a list of 15 diagnostic tests that should not be used by patients going forward. 

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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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