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 issues recall of imaging systems

FDA warns public about reprocessed catheter recalls—all devices should be destroyed

Back in February, several reprocessed EP and ultrasound catheters were recalled due to a risk of contamination. The FDA is now sharing additional information with the public.

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American College of Radiology criticizes administration’s push to make higher education more affordable

In January, the Department of Education released a proposed rule seeking to simplify federal student loan repayment, including "commonsense loan caps" and "streamlining repayment options." 

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Two drug suppliers plead guilty in $50M ‘straw purchase’ resale scheme

The two men, Frank Incognito, 46, and Stephen Corba, 50, conspired with doctors in a scheme involving the fraudulent purchase of critical cancer and macular degeneration drugs, which were then diverted and resold for profit. The U.S. Department of Justice said the unlawful pact lasted seven years.

Nonprofit health system, Nuance Communications agree to $5M settlement after data theft

A fired employee of Nuance, a Microsoft subsidiary, is responsible for stealing records on 1.3 million patients from Geisinger Health in Pennsylvania. He has pleaded guilty as part of a deal with prosecutors.

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FDA approves 1st AI-enabled imaging device for breast cancer surgery

Manufacturer Perimeter Medical Imaging announced the news on March 3 after earning premarket approval for “Claire” (formerly the Perimeter OCT B-Series). 

Bayer's MR contrast injection system cleared by FDA for expanded use

The updated clearance expands the system's labeled field strength compatibility; the change will allow MRI suites with scanners up to the 7T range to utilize the system.

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Clover Health becomes first healthcare payer to meet CMS interoperability standard

Meeting the requirements to become a CMS Aligned Network means medical records on its core Medicare Advantage patients will be made available in real-time upon request, facilitated through secure data exchange made possible by Kno2.

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AI-enabled lesion quantification tool earns new CPT code

The software gives clinicians detailed insight into how patients are responding to treatment based on changes in lesion size and metabolic activity, offering earlier opportunities to alter care plans.