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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More than 1,000 hospitals earn $700M opioid crisis judgment

Drug distributors AmerisourceBergen (Cencora), Cardinal Health, McKesson, Johnson & Johnson, Teva and Allergan do not admit to wrongdoing. However, they have agreed to a settlement which will compensate providers for opioid abuse treatments. 

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VA planning 83,000 layoffs as part of restructuring

The reports are based on a leaked internal memo in which the agency said it’s working closely with Elon Musk’s DOGE to cut jobs.

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HIMSS survey report: Beware insider threats to cybersecurity involving AI

Almost one in three healthcare organizations allow their people to use AI without formal restrictions. 

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HHS spokesperson abruptly resigns, reportedly after clash with RFK

Tom Corry was sworn in as the assistant secretary of public affairs at HHS two weeks ago. He announced his unexpected departure in a LinkedIn post. 

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Hospital faces $3.5M settlement after sharing patient data with Facebook

That number could rise to $6.75 million, depending on the number of patients who sign onto the class-action settlement levied against Virginia Mason Medical Center. The hospital does not admit to wrongdoing. 

Philips pulls endovascular devices from market after safety issues prompt Class I recall

Philips is recalling all sizes of its Tack Endovascular System after 20 patient injuries were reported. Interventional cardiologists are urged to stop using the device immediately. 

Robert F. Kennedy Jr. RFK HHS secretary

HHS retracts Richardson Waiver in change to public comment policy

Robert F. Kennedy unveiled the shift in a policy memo. Once it's published to the federal register on March 3, the 1971 Richardson Waiver will be officially repealed. 

FDA issues Class I recall on newborn resuscitation devices

The recall impacts products from ROi, supplied by Mercury Medical. A defective spring can cause a controller to malfunction, resulting in poor ventilation. 

Around the web

Boston Scientific has announced another significant M&A deal, scooping up an Israeli medtech company focused on RDN technology. 

Harvard’s David A. Rosman, MD, MBA, explains how moving imaging outside of hospitals could save billions of dollars for U.S. healthcare.

The recall comes after approximately 3% of patients treated with the device during the early stages of its U.S. rollout experienced a stroke or transient ischemic attack following surgery. The expected stroke rate is closer to 1%, the FDA explained.