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 recall of insulin delivery pods
Small tears were found on the inside of some of Insulet Corporation's Omnipod 5 pods. The issue was linked to a total of 18 serious adverse events.
New dyslipidemia guideline puts add-on testing, early screening in the spotlight
The updated recommendations represent a collaboration between the American College of Cardiology, American Heart Association and several other U.S. healthcare organizations.
Veterans facing significant challenges accessing radiology services, VA watchdog says
In one instance, a veteran's wife reported difficulty scheduling a critical imaging appointment for her husband amid concern his cancer was spreading.
Data breach on care management company impacts 5K patients at NYC Health
Many of the details are unknown, as an investigation is ongoing. The National Association on Drug Abuse Programs said it became aware of an invasion of its network in January 2026. The nonprofit supports 35,000 people—mainly Medicaid enrollees—in the state of New York.
FDA merges all adverse event reporting systems into new AEMS platform
Adverse event reports for food, drugs, vaccines, dietary supplements and medical devices will soon be available in one place. The U.S. Food and Drug Administration said the change will simplify reporting for consumers and allow it to react in real-time to FOIA requests.

Insulet Corporation has announced a voluntary recall for specific lots of the pods associated with its Omnipod 5 Automated Insulin Delivery System

FDA announces recall of insulin delivery pods

Small tears were found on the inside of some of Insulet Corporation's Omnipod 5 pods. The issue was linked to a total of 18 serious adverse events.

New dyslipidemia guideline puts add-on testing, early screening in the spotlight

The updated recommendations represent a collaboration between the American College of Cardiology, American Heart Association and several other U.S. healthcare organizations.

Veterans facing significant challenges accessing radiology services, VA watchdog says

In one instance, a veteran's wife reported difficulty scheduling a critical imaging appointment for her husband amid concern his cancer was spreading.

Data breach on care management company impacts 5K patients at NYC Health

Many of the details are unknown, as an investigation is ongoing. The National Association on Drug Abuse Programs said it became aware of an invasion of its network in January 2026. The nonprofit supports 35,000 people—mainly Medicaid enrollees—in the state of New York.

FDA merges all adverse event reporting systems into new AEMS platform

Adverse event reports for food, drugs, vaccines, dietary supplements and medical devices will soon be available in one place. The U.S. Food and Drug Administration said the change will simplify reporting for consumers and allow it to react in real-time to FOIA requests.

Prior authorization may reduce access to important heart failure drugs

Researchers noted that these requirements are more common for Black and Hispanic patients, creating a critical barrier to guideline-recommended care.

The Society for Cardiovascular Angiography and Interventions (SCAI) is urging federal policymakers to ensure physicians play a central role in guiding the integration of artificial intelligence (AI) into clinical care, while also raising questions about liability as the technology expands across healthcare.

AI is transforming patient care—and cardiologists have a critical role to play

While the Trump administration is pushing to accelerate clinical AI adoption, SCAI has emphasized that physicians must guide how the technology is implemented and governed.

Selection of stent images captured with the MicroAngioscope from Vena Medical. Images courtesy of Kan et al. and Stroke.

FDA clears intravascular device billed as ‘world’s smallest camera’ as physicians share new data

The new device, which provides users with real-time images in full color, is now approved by the FDA to be used in the peripheral vasculature. Meanwhile, first-in-human data published in Stroke explored its potential in the cerebral vasculature.