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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'Cybersecurity vulnerability' spurs FDA recall of GE HealthCare image viewers

The recall is due to an issue with the software that could make the viewer vulnerable to security threats and data manipulation. 

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Radiologists support bipartisan bill to fund new residency programs in rural areas

The American College of Radiology, alongside over 30 other organizations, voiced “strong support” for the bill on March 16. 

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Telix submits new brain imaging agent for FDA review following previous rejection

The Australia-based company has resubmitted its New Drug Application for Pixclara, an investigational PET product. 

Telehealth company admits to sharing medical records with law firms as Epic’s lawsuit heats up

GuardDog admitted to accessing medical histories from patients stored on Epic’s platform, selling some of them to law firms engaged in unrelated civil litigation. The primary defendant in Epic’s lawsuit, Health Gorilla, maintains it did nothing wrong and accuses Epic of stifling interoperability.

Trump’s EPA wants to roll back Biden-era pollution limits for medical device sterilization

Ethylene oxide is an odorless gas used to sterilize pacemakers, leads, stents and many other medical devices. Long-term exposure, however, can cause cancer. The Biden administration made it a priority to reduce ethylene oxide emissions, but many critics thought those cuts were too extreme.  

Squatter patient refuses to leave hospital room five months after discharge, lawsuit claims

In its complaint, Tallahassee Memorial HealthCare said it cleared an unnamed female patient for discharge on Oct. 6, 2025. Despite setting her up with transportation and coordinating with family, she refused to leave. 

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.

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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.