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. 

Reprocessed EP catheters recalled due to contamination risk

The FDA has announced seven Class I recalls related to this issue. Customers are urged to destroy the devices immediately instead of returning them to the manufacturer. 

Robert Wachter MD

5 takeaways from Dr. Wachter’s ‘Giant Leap’ with AI in healthcare

Someday the computerization of medicine will be recognized as the game-changing, paradigm-shifting, everything-upending “disruptive innovation” that so many healthcare watchers and stakeholders have been waiting for. “Today,” however, “it’s often just plain disruptive.”

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Patients cite prior authorization as top healthcare burden, KFF finds

In a new poll, more insured adults listed receiving coverage approval for treatment and medications as the single largest burden they face when navigating the U.S. healthcare system than any other issue. KFF found that 47% experienced “denied, delayed or altered” patient care over the last two years. 

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Safety update: New recommendations for managing patients with high-risk defibrillation leads

HRS has shared an updated guidance on managing Boston Scientific defibrillation leads at risk of experiencing a significant malfunction. The issue, first reported in July 2025, is believed to impact approximately 350,000 leads still being used today.

Medicare

Medicare testing new breast cancer screening cost measure

The federal payment program and its third-party partner, Acumen LLC, are now sending surveys to imaging groups that administered 10 or more screening mammograms in 2024. 

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Las Vegas hospital loses mammography accreditation after inspection unearths quality issues

Summerlin Hospital recently sent letters to patients who received breast scans there sometime between October 2023 and December 2025. 

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US senators introduce bipartisan bill to boost pay for radiation therapy providers

Sens. Tim Kaine, D-Va., and John Boozman, R-Ark., have introduced legislation to lift "arbitrary" caps on compensation for therapeutic and diagnostic medical physicists working in the VA. 

somatom x.ceed

App issue triggers voluntary recall of some Siemens Healthineers CT systems

Siemens self-reported a problem with software being inadvertently delivered to U.S. systems when the applications have not yet been cleared for use by the FDA.