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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FDA announces Class I recall of ventilators after 3 patient injuries

An unexpected nickel coating on the breathing circuits of Percussionaire Phasitron 5 ventilators is being blamed for the recall. The FDA is asking providers to stop using them immediately. 

HeartLung Technologies, a Houston-based artificial intelligence (AI) company, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for new software that assesses chest CT scans for signs of coronary artery disease (CAD) and other potentially fatal heart conditions. The newly cleared offering, AutoChamber, was designed with opportunistic heart evaluations in mind.

FDA clears AI tool that flags signs of heart disease in chest CT scans

The newly cleared offering, AutoChamber, was designed with opportunistic screening in mind. It can evaluate many different kinds of CT images, including those originally gathered to screen patients for lung cancer. 

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Stewardship Health sale to private equity finalized for $245M

The physician group, once part of Steward Health Care, has been rebranded as Revere Medical.

Helene damage to bridge Baxter North Cove facility in North Carolina.

Baxter producing IV solutions ahead of schedule at Asheville-area site

The company said its largest production line at its North Carolina plant is operational, accounting for 25% of total output. The site was damaged by flood waters from Hurricane Helene. 

ransomware cybercrime

Hackers were inside an Iowa hospital’s network for two weeks

St. Anthony Regional Hospital confirmed patient data was taken by cybercriminals, but the August incident is still being investigated.

Bill introduced in Congress would raise physician reimbursement by 1.9%

The Medicare Patient Access and Practice Stabilization Act aims to change the annual Centers for Medicare and Medicaid Services physician fee schedule, which cut reimbursement by 2.8% for 2025. 

AI governance meeting

Good AI governance can spell the difference between smashing success and mere learning experience

Discussions of AI governance may cause many an eye to glass over, but the discipline is as crucial to the ascent of AI in healthcare as big training datasets drawn from diverse patient populations.

private equity corporatization business consolidation

Private equity owns 900 patient care centers in Philadelphia, report finds

Physical therapy practices in greater Philadelphia are of particular interest to private equity firms, with 271 locations owned by six companies. The report comes from the Private Equity Stakeholder Project (PESP). 

 

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Around the web

Cardiovascular Business
Payment cuts and beyond: Key takeaways for cardiologists from the 2025 Medicare Physician Fee Schedule

The American College of Cardiology has shared its perspective on new CMS payment policies, highlighting revenue concerns while providing key details for cardiologists and other cardiology professionals. 

AI in Healthcare
A modest proposal to rally AI regulators around a simple game plan

As debate simmers over how best to regulate AI, experts continue to offer guidance on where to start, how to proceed and what to emphasize. A new resource models its recommendations on what its authors call the “SETO Loop.”

Cardiovascular Business
FDA commissioner urges clinicians to join fight against medical misinformation

FDA Commissioner Robert Califf, MD, said the clinical community needs to combat health misinformation at a grassroots level. He warned that patients are immersed in a "sea of misinformation without a compass."

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