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. 

microsoft building

Microsoft: Ransomware hit nearly 400 healthcare entities this year—a 300% rise since 2015

A study from Microsoft on the impact of ransomware found unaffected nearby hospitals see a rise in stroke and cardiac arrest cases, in addition to an influx of patients. 

UnitedHealth Group - 2

Feds make it official: Change data breach was the largest in healthcare history, impacting 100M

Updated reporting from HHS shows UnitedHealth Group's estimate that roughly one-third of people in the U.S. would be affected was correct. 

phenylephrine FDA

FDA approves first RSV vaccine for adults

Pfizer's Abrysvo vaccine can now be prescribed to all adults 18 and older at high risk for severe RSV complications, including pregnant women. 

Chicago - Circa May 2018: Blue Cross Blue Shield headquarters signage and logo.

Blue Cross Blue Shield of New York sued over ‘ghost networks’

Thousands of patients have filed a class-action lawsuit against the insurer for issuing directories of providers who were out-of-network and did not take BCBS health plans. 

artificial intelligence partnership on AI global cooperation

Partnership on AI valiantly trying to wrap arms around the world

It’s going to take a multinational effort for the global AI community—such as it is—to avoid the emergence of a “fragmented AI landscape.” 

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Q&A: Why are cardiovascular devices involved in so many recalls? FDA policies may be to blame

Cardiovascular devices are more likely to be in a Class I recall than any other device type. The FDA's approval process appears to be at least partially responsible, though the agency is working to make some serious changes. We spoke to a researcher who has been tracking these data for years to learn more. 

child in shock from noise trauma

Surprise active shooter drill at children’s psychiatric hospital results in $13M for victims

The Michigan Department of Health and Human Services failed to notify staff and law enforcement that a simulation at the state-run facility was taking place, resulting in chaos. 

DOJ U.S. Department of Justice HQ

CMS contractor takes $1.2M loss after data breach, DOJ lawsuit

Federal Data Solutions allegedly failed to encrypt screenshots of patient data, stored on a server being paid for with Medicare funds.

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.