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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Industry Watcher’s Digest

Having released the latest version of Llama in December, Meta is telling the world that open-source AI is the future of AI in healthcare. 

4 ways HHS plans to help shape a national strategy for healthcare AI

HHS has thought through the ways AI can and should become an integral part of healthcare, human services and public health. Last Friday—possibly just days ahead of seating a new secretary—the agency released a detailed plan for getting there from here.

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Johnson & Johnson buys depression drug and its manufacturer for $15B

The drug Caplyta, owned by Intra-Cellular Therapies, is being used to treat bipolar disorder and schizophrenia. In 2024, it brought in more than $481 million in sales. 

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FDA announces recall after Philips heart monitor software failed to send alerts—multiple deaths reported

Philips is recalling the software associated with its Mobile Cardiac Outpatient Telemetry devices after certain high-risk ECG events were never routed to trained cardiology technicians as intended. The issue, which lasted for two years, has been linked to more than 100 injuries. 

HRS President Ken Ellenbogen, MD, FHRS, explains the need for the Heart Rhythm Advocates lobby group in Washington, D.C. to push for policies in Congress over reimbursements.

Why electrophysiologists needed a champion in Washington

Heart Rhythm Society President Kenneth A. Ellenbogen, MD, detailed a new advocacy group focused on improving EP reimbursements, patient care and access. “If you’re not at the table, you’re on the menu," he said.

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Hundreds of radiologists urge Senate to reject RFK Jr. as next HHS secretary

“As physicians who care deeply about the health and safety of our patients and communities, we are appalled by Donald Trump's reckless decision to appoint Robert F. Kennedy Jr.," over 19,000 docs wrote. 

Dual Energy ThermoCool SmartTouch SF Catheter

Johnson & Johnson gains CE mark approval for catheter capable of radiofrequency, PFA ablation

A new catheter from Johnson & Johnson MedTech is now approved to treat cardiac arrhythmias in Europe. Could FDA approval be on the horizon? 

FDA has approved over 1,000 clinical AI applications, with most aimed at radiology

Diagnostic imaging leads the way in AI product approvals by a mile, accounting for more than 70% of all applications on the list.