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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FDA classifies Vyaire recall as ‘most serious’

The FDA has issued a Class I recall for Vyaire Medical respiratory support devices, saying use of older, defective devices could result in injury or death.

physician money payments dollars

Doctors form new coalition focused on reducing private equity’s role in cardiology, other healthcare specialties

More than 5,000 U.S. physicians joined forces to launch the new group. They say they are focused on limiting private equity's involvement and influence in healthcare. 

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HHS to investigate Change Healthcare cyberattack

“Given the unprecedented magnitude of this cyberattack, and in the best interest of patients and health care providers, OCR is initiating an investigation into this incident,” states a “Dear Colleague” letter from OCR director Melanie Fontes Rainer.

John Oliver doctor routine HBO Max

HBO’s John Oliver skewers state medical boards over ‘oopsies!’

"[S]ome states, including—until recently—Texas, even employ an honor-system approach, which relies on physicians to self-report. But guess what? The bad doctors tend not to do that, because they’re bad doctors."

hospital price transparency

Transparency report called ‘irresponsible,’ ‘reckless’

Have hospitals really taken a step backward along their march toward price transparency? Or is the watchdog outfit making the claim playing fast and loose with the facts?

change healthcare cyberattack

Change Healthcare cyberattack: A recap and update in 10 quotes

“This is what happens when everything merges and you only have one option.”

Medicare money payment reimbursement dollar decline george washington

Feds seeking public comment on private equity healthcare spending sprees

A joint announcement from the DOJ, FTC and HHS asks for providers, patients or other industry experts to share their experiences with private equity transactions, including those not typically subject to antitrust review by law.

Dexcom, a global healthcare technology company based out of San Diego, has received U.S. Food and Drug Administration (FDA) clearance for Stelo, a wearable glucose biosensor that can be obtained without a prescription.

FDA clears first over-the-counter wearable device for continuous glucose monitoring

The newly cleared device is worn on the back of the arm and sends data directly to the user's smartphone. 

Around the web

The tirzepatide shortage that first began in 2022 has been resolved. Drug companies distributing compounded versions of the popular drug now have two to three more months to distribute their remaining supply.

The 24 members of the House Task Force on AI—12 reps from each party—have posted a 253-page report detailing their bipartisan vision for encouraging innovation while minimizing risks. 

Merck sent Hansoh Pharma, a Chinese biopharmaceutical company, an upfront payment of $112 million to license a new investigational GLP-1 receptor agonist. There could be many more payments to come if certain milestones are met.