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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Americans getting more and more dissatisfied with abortion policies

A record high of 69% of U.S. adults are dissatisfied with abortion laws––the highest percentage since 2001, according to a recent Gallup poll.

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Atrium Health and CEO indicted in $407M healthcare fraud scheme

The scheme allegedly included cheating employees, committing mail fraud, providing inadequate care to residents and more. 

DiA Imaging Analysis, an Israel-based healthcare technology company, has gained U.S. Food and Drug Administration (FDA) clearance for LVivo IQS, a new software solution designed to help users acquire high-quality echocardiography images.

FDA clears new AI-powered cardiac imaging solution

The newly approved software uses artificial intelligence to provide users with real-time feedback related to image quality.

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Feds may block Amazon’s acquisition of One Medical

Amazon announced its intent to acquire One Medical in July 2022, and the $3.9 billion deal came under fire right away, with critics voicing their concerns about Amazon’s growing size and reach.

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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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Around the web

Cardiovascular Business
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. 

Cardiovascular Business
Cardiologist compensation still rising, especially in invasive and interventional cardiology

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.

Cardiovascular Business
FDA’s tirzepatide decision creates uncertainty for patients—and leads to a lawsuit

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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