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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Data trove of 1.6M patient records discovered online

A cybersecurity researcher made the discovery. The database, in the care of a clinical trials company, was not password protected or encrypted. 

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Commercially insured women less likely to be referred for interventional procedures

“These findings raise the question of whether insurance reimbursement impacts referral patterns for other conditions and specialties, and the extent to which it may outweigh evidence-based care decisions."

Biosense Webster, part of Johnson & Johnson MedTech, shared updated data on its Varipulse pulsed field ablation (PFA) system at AF Symposium 2024 in Boston,

Johnson & Johnson resumes PFA rollout after stopping to review safety concerns

Johnson & Johnson MedTech has resumed the U.S. rollout of its Varipulse PFA system, sharing new warnings to help physicians. 

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Veterans with heart disease often receive better care through VA than they would elsewhere

Military veterans face an increased risk of cardiovascular disease, making it especially important to ensure they receive high-quality care.

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Radiology practices ‘strongly’ urged to seek counsel over Corporate Transparency Act

Enacted as part of the Federal Anti-Money Laundering Act, regulators were slated to begin enforcing penalties under the CTA on Jan. 1. 

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Thousands of staff cut from federal health agencies, including CDC and VA

Elon Musk's Department of Government Efficiency (DOGE) continues to push officials to release workers—and more layoffs could be on the horizon.

SubtleHD receives FDA clearance for AI-powered MRI solutions

FDA clears AI software capable of reducing MRI acquisition times by up to 80%

The product was developed to both improve image quality and shorten image acquisition times. 

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FDA announces new recall of Johnson & Johnson heart pumps over safety concerns

No devices need to be returned at this time. However, the FDA warned, using these heart pumps without reviewing the updated instructions could result in "serious injury or death.”