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. 

Instylla Embrace Hydrogel Embolic System

New liquid embolic agent for hypervascular tumors gains FDA’s premarket approval

Instylla's Embrace Hydrogel Embolic System minimizes bleeding risks during the embolization of hypervascular tumors in the peripheral arteries.

Blue Cross Blue Shield Association BCBS

Radiologists opt out of $2.8B Blue Cross Blue Shield settlement to pursue own litigation

Plaintiffs in the complaint include Radiology Partners and its affiliates, the Arkansas-based Highlands Oncology Group and Harvard Medical Faculty Physicians. 

Reprocessed Supreme Fixed Electrophysiology Catheter

FDA announces new recall of reprocessed EP catheters due to risk of contamination

Customers with these devices on hand are asked to return them right away. No serious injuries have been reported at this time, but the presence of residual particulates can lead to such side effects as pulmonary embolism and deep vein thrombosis.

UnitedHealthcare HQ Sign

It’s official: Breach of Change Healthcare impacted 193M people

The number is almost double initial estimates. With final data breach notifications now sent, UnitedHealthcare said its investigation into the February 2024 ransomware attack is coming to a close.

HHS ends support for mRNA vaccines in favor of ‘novel platforms’

Secretary of Health and Human Services Robert F. Kennedy Jr. says the agency is winding down support for mRNA as it looks to "whole virus" vaccines that offer broad protection against seasonal illnesses such as COVID-19 and influenza.

Watchman TruSteer Access System

FDA says Watchman access systems may increase risk of air embolism—17 deaths reported

Because of this risk, which has been associated with 120 serious injuries, Boston Scientific is updating the instructions for use of several Watchman access systems.

U.S. FDA Sign

FDA details defibrillation lead issue linked to 386 injuries, 16 deaths

Boston Scientific manufactured these devices from 2002 to 2021, and approximately 354,000 are still in use. It is recommended that clinicians look for early signs of this issue during scheduled follow-up appointments.

tech person

Healthcare AI today: Whom to sue, invite into AI governance and altogether avoid (unless you want a new religion)

The question of legal responsibility for AI gone wrong in healthcare remains unsettled. The only sure thing is a lot of finger pointing.