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. 

Luigi Mangione Mugshot Pennsylvania

Mangione now faces federal charges, death penalty in murder of UHC CEO

After Luigi Mangione, the man accused of killing UnitedHealthcare CEO Brian Thompson, was extradited to New York, federal prosecutors unsealed a new set of murder charges. 

FDA issues Class I recall on counterfeit infusion pump batteries

ICU Medical alerted customers to knockoff batteries being circulated by suppliers. Due to a risk of the batteries not holding a charge, the recall has been given the FDA’s most serious designation. 

FDA warning alert exclamation computer

FDA issues alert on PCNL sheath safety after patient death

Trokamed sent a letter to customers warning them to never use its Mini PCNL Sheaths for suction and irrigation, due to a risk of kidney rupture. 

CVS Health announces $10.6B acquisition of Oak Street Health

DOJ sues CVS over unlawful opioid prescriptions and reimbursement

The U.S. Department of Justice said policies at CVS Health forbade pharmacists from discussing patients and providers who may be prescribing opiates in violation of the Controlled Substance Act. 

artificial intelligence pharmaceutical industry

FDA says years-long tirzepatide shortage is resolved, will give limited leeway to compounders

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.

doctor examines patient data on their tablet

Advancing AI for vascular surgery will require a commitment to data integrity

For artificial intelligence to truly transform care, the healthcare industry must address certain challenges. Jens Eldrup-Jorgensen, MD, a veteran vascular surgeon and member of the Society for Vascular Surgery, explains in a guest editorial. 

From Capitol Hill to a hospital near you? 5 federal recommendations for healthcare AI policy

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. 

Luigi Mangione Mugshot

Mangione charged with terrorism-related murder in UnitedHealthcare CEO killing

A grand jury in New York has indicted Luigi Mangione, 26, on 11 charges, including murder in the first degree. 

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.