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. 

artificial intelligence in healthcare

FDA clears AI triage tool that detects acute infarcts on noncontrast CT scans

Unlike many stroke detection applications on the market, this model covers six vascular territories and mechanisms of infarct. 

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FTC seeks more time to settle insulin pricing lawsuit with remaining PBM defendants

The request to the court comes a month after the agency settled with Express Scripts, under the condition the company change its wholesale buying practices, pass on manufacturer rebates and support TrumpRx.gov. Now it's up to CVS Caremark and UnitedHealth’s Optum Rx to make deals of their own. 

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Blood filtration company fined $5.7M, executive charged, for covering up patient deaths

The U.S. Department of Justice said ExThera cooperated with the investigation into a failure to file adverse event notices with the Food and Drug Administration after two cancer patients who used its blood filtration systems in Antigua died shortly after returning home. The California-based company’s former chief regulatory officer has agreed to plead guilty and could serve prison time. 

FDA issues recall of imaging systems

FDA shares details about reprocessed catheter recall

Back in February, the FDA expanded a recall of several reprocessed EP and ultrasound catheters due to a risk of contamination. The agency 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.

claire perimeter medical imaging

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).