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. 

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.

california usa

Healthcare AI newswatch: California AI hoping, the jagged AI frontier, agents bumping off bots, more

California has moved assertively to legislate guardrails around AI in healthcare. Will other states follow? 

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. 

dollar money finance debt decrease

Changes to practice-expense RVU component could spell ‘detrimental consequences’ for radiology

Radiology experts are warning that reimbursements for certain imaging services are not enough to cover expenses, putting specialists in a precarious position. 

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.

What mycoplasma pneumonia looks like on imaging.

Mycoplasma pneumonia: Experts highlight imaging findings linked to the pediatric diagnosis

Following a recent surge of mycoplasma pneumoniae pneumonia cases, experts have issued new guidance to help providers quickly identify and treat the condition, with imaging playing a prominent role.