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. 

3T MRI for neonates approved by FDA

World's first 3T MRI dedicated to neonatal imaging earns FDA clearance

The MR system was designed with smaller spaces in mind, enabling installation in or very near NICUs.

TrumpRx launches with 40 brand-name medications available, including popular weight-loss drugs

Discounts represent out-of-pocket costs and come in the form of direct-to-consumer sales through manufacturer websites or via a coupon. AstraZeneca, Eli Lilly, EMD Serono, Novo Nordisk and Pfizer have all listed some of their most popular drugs on the TrumpRx.gov portal.

surgery

What stakeholders are saying about gender-transition interventions for minors

The more persuasive of the opinions could redound to the reshaping of the principles of pediatric medicine—and of certain policies in public education. Here’s a sampling. 

Cerepak Detachable Coil Systems

FDA announces recall of Johnson & Johnson devices after multiple injuries, 1 death

Several detachable coil systems are being recalled due to a higher-than-expected failure to detach rate. Customers should not use them going forward.

the words "FDA recall" on a board

New recall includes nearly 23K bottles of triglycerides drug used to treat heart disease

New Jersey-based Zydus Pharmaceuticals has recalled nearly 23,000 bottles of its icosapent ethyl capsules due to leakage issues that may have weakened their effectiveness. 

icometrix MRI brain alzheimer's

Medicare contractor proposes denying coverage for AI-based brain MRI technology

If finalized, the decision would impact radiology providers across Illinois, Minnesota, Wisconsin, Connecticut, New York, Maine, Massachusetts, New Hampshire, Rhode Island and Vermont. 

TrumpRx.gov Screenshot

FTC settles lawsuit against Express Scripts in deal that includes TrumpRx support

The Federal Trade Commission was suing the pharmacy benefit manager over allegations it was deliberately inflating the price of insulin. Per the agreement, Express Scripts has agreed to end business practices that involved taking manufacturer rebates on wholesale drug costs without passing them on to patients.

Cybersecurity lock

OIG audit of hospital’s cybersecurity finds vulnerabilities in common web applications

Neither the health system nor the applications were named. Investigators with the U.S. Department of Health and Human Services Office of the Inspector General said they were able to perform a successful phishing attack and breach a portal lacking firewall support. The agency released a report containing the full details.