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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Florida cardiology practice, 10 cardiologists pay $2M to settle fraud allegations

The practice and many of its cardiologists allegedly submitted false claims to Medicare, Medicaid, TRICARE and the Federal Employee Health Benefits Program. 

HHS issues guidance as COVID-19 PHE winds down

The guidance clarifies what will and will not be impacted by the sunset of the PHE on May 11.

 

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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.

Around the web

If passed, this bill would help clinician-led clinical registries explore Medicare data for research purposes. The Society of Thoracic Surgeons and American College of Cardiology both shared public support for the bipartisan legislation. 

Cardiologists and other physicians may soon need to provide much more information when ordering remote patient monitoring for Medicare patients.

Why are so many cardiovascular devices involved in Class I recalls? One possible reason could be the large number of devices hitting the market without undergoing much premarket clinical testing. 

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