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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Medtronic recalls data management software, urging healthcare providers to run update

The error caused incorrect glucose data to be displayed to clinicians. According to Medtronic, any treatment decisions or recommendations based on those data need to be revisited.

Catheters recalled due to defect—FDA highlights risk of stroke or brain damage

The recall was put in place after a hydrophilic coating was discovered on the inside of the devices. According to the FDA, patients treated with the catheters could face a number of significant risks. 

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Radiology societies urge caution when implementing AI in pediatric imaging

Six professional organizations including the Society for Pediatric Radiology made their case in a joint statement published across multiple medical journals Nov. 25. 

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Medicare doubles payment for certain contrast-enhanced ultrasound scans

The federal payment program for seniors revealed the update in its hospital outpatient final rule, published in the Federal Register Nov. 25. 

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Coalition of 36 AGs rejects Congressional push to bar states from regulating AI

The bipartisan group of attorneys general is pushing back against Congressional plans to bar states from regulating AI, machine learning and large language models.

White House announcement on healthcare called off, as GOP rejects ACA subsidies

President Donald Trump's plan included a two-year extension of Affordable Care Act tax credits. But without support from Congress, any such proposal has no chance of being implemented.

Abbott’s FreeStyle Libre 3 integrated continuous glucose monitoring (iCGM) system

Abbott shares safety concerns with millions of CGM sensors—7 deaths reported

Approximately 3 million FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors need to be replaced due to a risk of incorrect glucose readings. Abbott has received reports of 736 severe adverse events and seven deaths that may be related to this issue.

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Cardiology groups share new recommendations for performing safe, effective cardiac ablations in ASCs

The timing of this new guidance from the Heart Rhythm Society and American College of Cardiology could not have been better—the document went live just as CMS finalized its decision to cover cardiac ablation procedures performed in ASCs.