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. 

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.

Bipartisan group of 233 House members call for Medicare reform

In a letter, the undersigned asked Congress to halt cuts to Medicare reimbursement and enact a permanent system to adjust rates to inflation. 

Wartime powers enacted to address nationwide IV fluid shortage

The Biden Administration has invoked parts of the Defense Production Act to address shortages that stem from Hurricane Helene damaging a Baxter production facility in North Carolina. 

HeartFlow Plaque Analysis Example

New Category I CPT code issued for AI-enabled coronary plaque analysis software

The news comes just days after CMS confirmed these technologies would start receiving expanded Medicare coverage in November. HeartFlow and other AI vendors have already shared their excitement over the decision. 

doctors nurses ai in healthcare fda oversight

How the FDA sees its role vis-à-vis AI in healthcare

The U.S. Food and Drug Administration has its hands full making sure medical AI products are safe, efficacious and trustworthy before they hit the market. The rise of ever-more-innovative iterations of the technology—not least generative AI—is only adding to the burden. 

Texas hospitals to begin asking patients about citizen status

The Texas Hospital Association said answering the question, which stems from an executive order from Gov. Greg Abbot, will not impact patient care.

cyberattack cybersecurity IT

Homeland Security warns healthcare organizations of hackers using 'password spraying' tactic

The agency said cybercrime cells in Iran are using brute force to breach and maintain covert access to IT systems. 

Around the web

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. 

Updated compensation data includes good news for multiple subspecialties. The new report also examines private equity's impact on employment models and how much male cardiologists earn compared to females.

When drugs are on the FDA’s shortage list, outsourcing facilities can produce their own compounded versions. When the FDA removed tirzepatide from that list with no warning, it created a considerable amount of chaos both behind the scenes and in pharmacies all over the country. 

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