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.

FDA announces full recall of Baxter Life2000 ventilators over cybersecurity flaw
All models and lot numbers of the units are subject to the recall. The security vulnerability could allow an unauthorized person to access and control the pumps, posing a serious health risk to patients.
Reimbursement for AI-based plaque assessments is improving
A growing number of private insurers are now covering these advanced technologies. Roosha Parikh, MD, told Cardiovascular Business that the hard work of SCCT and other groups has helped make this happen.
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.
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.

FDA announces full recall of Baxter Life2000 ventilators over cybersecurity flaw

All models and lot numbers of the units are subject to the recall. The security vulnerability could allow an unauthorized person to access and control the pumps, posing a serious health risk to patients.

The Society of Cardiovascular Computed Tomography (SCCT) is seeing major progress in its long-running push to secure broad reimbursement for artificial intelligence (AI)-enabled coronary CT angiography (CCTA) plaque analysis. According to Roosha Parikh, MD, FACC, FSCCT, associate director of Cardiac CT at St. Francis Heart Hospital, Long Island, New York, and a member of the SCCT Health Policy and Practice Committee, both Medicare and a growing number of private insurers are now covering the technology.

Reimbursement for AI-based plaque assessments is improving

A growing number of private insurers are now covering these advanced technologies. Roosha Parikh, MD, told Cardiovascular Business that the hard work of SCCT and other groups has helped make this happen.

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.

U.S. News & World Report children’s hospitals cardiology heart surgery

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.

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.

chatgpt artificial intelligence healthcare

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.