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. 

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BioTech company raises $161M in IPO

The company is pursuing treatments that could target diabetes and obesity in a pill form.

An example of an FDA cleared radiology AI algorithm to automatically take a cardiac CT scan and identify, contour and quantify soft plaque in the coronary arteries. The Cleerly software then generates an automated report with images, measurements and a risk assessment for the patient. This type of quantification is too time consuming and complex for human readers to bother with, but AI assisted reports like this may become a new normal over the next decade. Example from Cleerly Imaging at SCCT 2022.

Legal considerations for artificial intelligence in radiology and cardiology

There are now more than 520 FDA-cleared AI algorithms and the majority are for radiology and cardiology, raising the question of who is liable if the AI gets something wrong.

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Interoperability among hospitals is improving

Overall, hospital engagement in three domains of interoperability––receiving data, finding data and integrating data––have significantly increased since 2017.

Global Pharma Healthcare recalls eye drops over possible contamination

The drops were linked to 55 reports of adverse events, including eye infections, permanent loss of vision and one death with a bloodstream infection.

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CMS proposes 2.1% payment increase for MA plans in 2024

The plan, if finalized, increases payments for MA plans by 2.09%, or 1.03% after adjusting for star rating changes.

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Cigna sues CVS over executive’s move

According to Cigna, Amy Bricker left her role as an executive with the company just days before joining CVS Health.

Brent Savoie, MD, JD, vice chair for radiology informatics, section chief of cardiovascular imaging, Vanderbilt University, explains who will get sued when there is a misdiagnosis due to artificial intelligence (AI).

VIDEO: Who gets sued when radiology AI fails?

Brent Savoie, MD, JD, vice chair for radiology informatics, section chief of cardiovascular imaging, Vanderbilt University, explains who will get sued when there is a misdiagnosis due to artificial intelligence (AI).

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Fraud in Florida: Feds bust fake nursing diploma scheme

The scheme led to more than 7,600 fake nursing diplomas issued by three South Florida-based nursing schools.

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Around the web

Cardiovascular Business
FDA says years-long tirzepatide shortage is resolved, will give limited leeway to compounders

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.

AI in Healthcare
From Capitol Hill to a hospital near you? 5 federal recommendations for healthcare AI policy

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. 

Cardiovascular Business
Merck spends up to $2B to license new weight loss drug with potential heart benefits

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.