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. 

Robert F. Kennedy Jr. RFK HHS secretary

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. 

doctor in handcuffs after being arrested

Radiologist arrested for secretly recording female patient's breasts during imaging

The accused has fessed up to secretly recording a patient with his smartphone while she underwent medical imaging. 

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 Once it's published to the federal register on March 3, the 1971 Richardson Waiver will be officially repealed.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

the words "FDA recall" on a board

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.