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 approves first therapy for very rare lipid storage disorder

Ctexli (chenodiol) can now be prescribed to patients with cerebrotendinous xanthomatosis, a condition caused by a genetic mutation that leads to cholesterol buildup around vital organs. 

FDA announces Class I recall of Boston Scientific pacemakers—replacement may be necessary

These safety issues have been linked to more than 800 injuries and two deaths. It is possible, the FDA warned, that some patients may require a device to be removed and replaced. 

FDA ends semaglutide shortage, closing the door on compounded Wegovy, Ozempic

The years-long shortage of Wegovy and Ozempic, two popular prescription-only semaglutide injections, is officially over. 

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American Heart Association highlights importance of NIH as battle over Trump funding cuts continues

“Now more than ever, we must recognize that our country’s leadership in groundbreaking medical research spurs scientific innovation, improves public health and creates new innovations that save and improve lives nationwide,” Joseph C. Wu, MD, PhD, explained in a statement. 

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Federal judge sides with FTC; case against PBMs to move forward

A federal court dismissed a counterclaim from CVS, UnitedHealth and Cigna that sought to halt the case on constitutional grounds.

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Doctor responsible for $742K ‘residency prep’ scheme gets 3-year sentence

Sonny Saggar, MD, a physician working for St. Louis General Hospital, billed Medicare and Medicaid for patient visits his unqualified assistants conducted. He pleaded guilty to conspiracy. 

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Cardiologist questions FDA’s approval process for high-risk medical devices

The technology used to diagnose, treat and manage cardiovascular disease is always evolving, keeping FDA officials quite busy. But have the agency's standards been slipping in recent years? A cardiologist with Cedars-Sinai Medical Center explored that very question.

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Data trove of 1.6M patient records discovered online

A cybersecurity researcher made the discovery. The database, in the care of a clinical trials company, was not password protected or encrypted. 

Around the web

The American College of Cardiology has sent a letter to HHS Secretary Robert F. Kennedy Jr. that outlines some of the organization’s central priorities and concerns. 

One product is being pulled from the market, and the other is receiving updated instructions for use.

If the Trump administration continues taking a laissez-faire stance toward AI—including AI used in healthcare—why not let the states go it alone on regulating the technology?