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. 

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. 

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

Blue Cross settles largest healthcare antitrust case in history for $2.8B

The settlement also includes an agreement for operational changes at all of the insurer's 33 independent partners.

The iCardio.ai EchoMeasure AI software to automate measurements for cardiac echo imaging. It was FDA cleared in October 2024.

FDA approves AI startup’s new software for echo assessments

iCardio.ai, co-founded by a cardiologist, is part of the Cedars-Sinai Accelerator program. The startup has already announced new partnerships with Viz.ai, Abbott and others in the cardiac health space. 

Employee parking lot is a sea of mud and storm debris at the the Baxter North Cove facility. Photo by Aerial Lens.

Baxter begins importing IV supplies as 86% of providers report shortages

Hurricane Helene severely damaged Baxter's plant near Asheville, North Carolina, leading to a nationwide shortage of IV fluid bags. 

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Conspiracy at Chicago safety net hospital leads to fourth indictment

Three executives at Loretta Hospital were allegedly receiving cash bribes from a local businessman who operated medical supply companies.

HeartFlow Plaque Analysis

CMS updates Medicare coverage for AI-powered coronary plaque assessments

The new policy goes into effect in November, improving Medicare coverage for a technology that has rapidly gained momentum in recent years.

Around the web

The American College of Cardiology has shared its perspective on new CMS payment policies, highlighting revenue concerns while providing key details for cardiologists and other cardiology professionals. 

As debate simmers over how best to regulate AI, experts continue to offer guidance on where to start, how to proceed and what to emphasize. A new resource models its recommendations on what its authors call the “SETO Loop.”

FDA Commissioner Robert Califf, MD, said the clinical community needs to combat health misinformation at a grassroots level. He warned that patients are immersed in a "sea of misinformation without a compass."

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