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.

Over 300 groups urge Senate GOP to reject Medicaid cuts
In an open letter, advocacy groups said the budget proposal passed by the U.S. House of Representatives would “shred our nation’s social safety net.”
HHS to cut 10,000 jobs during 'dramatic restructuring'
The agency said it plans to reduce staff by 25% and consolidate 28 divisions into 15. However, it said Medicare and Medicaid will remain operational.
Trump selects GOP general counsel for HHS Inspector General
Thomas March Bell has been officially nominated and now faces the Senate for confirmation. Bell has a decades-long history working as a Republican staffer.
ACC urges RFK Jr. to make Medicare reform a priority, warns against mass layoffs
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.
ISIS is not launching terrorist attacks against hospitals, FBI says
Trade groups released a statement denying the claim's credibility, but they fear some may be inspired by a widely shared social media post.

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.

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.

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 Once it's published to the federal register on March 3, the 1971 Richardson Waiver will be officially repealed.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.

FDA announces recall of endoscope sheaths after 26 injuries

While there have been no reported deaths, certain lots of Olympus single-use guide sheath kits are to be quarantined immediately.

The late-breaking U.S. multicenter admIRE clinical trial at the Heart Rhythm Society 2024 meeting, showed positive data on the long-term safety and effectiveness of the the Biosense Webster Varipulse pulsed field ablation (PFA) system in patients with paroxysmal atrial fibrillation. #HRS #HRS2024 #PFA

FDA announces catheter recall for Johnson & Johnson PFA system due to stroke risk

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.

Request for an American Board of Cardiovascular Medicine denied—cardiology groups ‘deeply disappointed’

The ACC, AHA, HFSA, HRS and SCAI all worked together to try and make the new board a reality. Though their proposal has been denied, the groups say they are not done fighting.

Around the web

Cardiovascular Business

ACC urges RFK Jr. to make Medicare reform a priority, warns against mass layoffs

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.

Radiology Business

FDA announces recall of Medtronic interventional radiology devices after 17 injuries, 4 deaths

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

AI in Healthcare

What federal regulators can learn from the states about AI oversight

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?