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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DOJ asks Supreme Court to lift injunctions, approve DOGE firings

The U.S. Department of Justice is appealing a lower court’s ruling that would see 16,000 federal employees return to work, including many from Veterans Affairs. 

DEA, HHS postpone permanent telehealth prescribing rule—again

The new rule was expected to go into effect on March 21 and would have expanded prescribing practices for buprenorphine, a non-opioid painkiller used to treat addiction.

Edwards Lifesciences Corporation has shared new one-year data on the safety and effectiveness of its Evoque transcatheter tricuspid valve replacement (TTVR) system among patients with tricuspid regurgitation (TR)

CMS approves Medicare coverage for transcatheter tricuspid valve replacement

CMS will cover TTVR for the treatment of symptomatic tricuspid regurgitation on a national level. The agency first proposed such a policy in December, taking time to consider public comments before finalizing its decision.

Bard Peripheral Vascular Rotarex Atherectomy System recall

Safety update: FDA announces Class I recall due to atherectomy devices breaking during use

The FDA shared a warning about these safety issues in February, but said it was still reviewing the evidence. The agency is now saying the devices “may cause serious injury or death” if used without following the updated instructions for use.

agentic AI agents in healthcare

Next-generation AI agents are headed for healthcare. What will they do once they get here?

Healthcare AI agents can be classified as one of four models. In increasing order of autonomy and clinical integration, these are: foundation, assistant, partner and pioneer. 

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FDA issues two serious patient safety alerts

The notices are unrelated, but both require that clinicians adhere to a set of updated use instructions. One patient died as a result of injury. 

FDA announces Class I recall on defective ports used for vein access

There have been two reported injuries linked to the Smiths Medical ProPort Plastic Implantable Ports, many of which are subject to an immediate recall. 

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Report: DOGE to cut federal HIV prevention program

Elon Musk's recommended cuts to the Centers for Disease Control and Prevention (CDC) may effectively end a program designed to monitor and prevent the spread of HIV, sources familiar with the matter told the Wall Street Journal.

Around the web

The American College of Cardiology has sent a letter to HHS Secretary Robert F. Kennedy Jr. that outlines some of the organization’s central priorities and concerns. 

One product is being pulled from the market, and the other is receiving updated instructions for use.

If the Trump administration continues taking a laissez-faire stance toward AI—including AI used in healthcare—why not let the states go it alone on regulating the technology?