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 details Class I recalls for more than 1 million pacemakers—software update required
The FDA has finalized new Class I recalls related to ongoing safety concerns with Boston Scientific’s Accolade family of pacemakers. A software update is now available to help address the issue, and an additional update is already in the works.
House Republicans propose reviving shelved imaging appropriate-use criteria program
Reps. Diana Harshbarger and Blake Moore recently introduced the Radiology Outpatient Ordering Transmission (ROOT) Act after bipartisan members of the U.S. Senate did the same in May.
Certificate-of-need law forcing referrers to send patients across state border for radiology services
Massachusetts primary care providers are reportedly sending patients to imaging centers in New Hampshire, which lacks a CON law and offers more affordable options.
600 CDC employees laid off as 700 others mistakenly receive termination notices
The U.S. Department of Health and Human Services said the additional notices were sent in error. A union representing federal workers is challenging the firings, arguing that President Donald Trump lacks the authority to permanently eliminate jobs during a government shutdown.
HHS permanently cuts 1,200 jobs in response to government shutdown
President Donald Trump said the shutdown was an opportunity to cut more federal jobs, and it appears he’s made good on that threat. HHS confirmed that reduction-in-force notices were sent to “nonessential” workers as the agency moves to bare-bones operations.

Abbott has recalled its TactiFlex Ablation Catheter, Sensor Enabled, because of reports that the tip can separate.

Abbott warns EP labs the tip can detach from its TactiFlex ablation catheters

Improper removal of the catheter from the packaging can result in tip damage. Most damaged tips were detected prior to being used, but three tips did separate inside patients.

Chris Kramer ACC president will be moderating a global state of health meeting to help the UN better understand the need for investing in preventive care healthcare workers.

ACC: Global health workforce is in need of investment to combat noncommunicable diseases

The American College of Cardiology has committed to reducing morbidity and mortality from noncommunicable diseases by 30% by 2030, but significant investments will be needed to expand the healthcare workforce.

money maze benjamin franklin reimbursement medicare

Radiologists and other docs express growing frustration with Merit-based Incentive Payment System

Over 30 medical societies including the American College of Radiology recently wrote to CMS Administrator Mehmet C. Oz, MD, MBA, to voice their concerns.

12 charged in Florida as part of ‘Operation Nightingale’ sting on low-quality nursing schools

The defendants include operators and staff at nursing schools that were shut down over accusations they provided pay-for-play degrees that RNs and LPNs used to obtain licenses.

Dana Smetherman, MD, MPH, MBA, FACR, chief executive officer of the American College of Radiology, explains how the consolidation of radiology practices into larger corporate entities now makes up more than 50% of how radiologists are employed. This led to changes in how ACR accredits sites.

ACR changing its accreditation process in response to corporate consolidation

CEO Dana Smetherman, MD, MPH, MBA, explains how the consolidation of radiology practices has shifted how the college thinks about its processes.

FDA highlights risks of evaluating blood pressure with unauthorized medical devices

The agency emphasized that many over-the-counter technologies marketed for this purpose have not been properly evaluated.

Healthcare AI today: Another angle on AI regulation, move fast but don’t break things, WISeR in the real world, more

Getting healthcare AI to fulfill its destiny—can we call it that now?—will require ‘scenario-based’ consideration of every use case.

Repeat imaging rates higher when scans are interpreted by nurse practitioners, physician assistants

The finding is based on an analysis of nearly 1.4 million office-based imaging claims, conducted by the Harvey L. Neiman Health Policy Institute.

Policy & Regulations

FDA details Class I recalls for more than 1 million pacemakers—software update required

House Republicans propose reviving shelved imaging appropriate-use criteria program

Certificate-of-need law forcing referrers to send patients across state border for radiology services

600 CDC employees laid off as 700 others mistakenly receive termination notices

HHS permanently cuts 1,200 jobs in response to government shutdown