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. 

Medical malpractice gavel diagnostic error mistake stethoscope

Referrer fails to order CT that could have caught man’s deadly lung cancer weeks earlier

An octogenarian visited the emergency department three times in August 2019 complaining of chest pain, with doctors instead diagnosing angina via X-ray. 

August 15, 2023
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CMS officially drops fee for independent dispute resolution back to $50

The agency has not yet announced the reopening of the Federal IDR portal to submit new disputes, with the feds hoping to do so "soon." 

August 15, 2023
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Google Health, radiology vendor seek regulatory approval of AI as independent mammography reader

"We hope to not only alleviate the increasing burdens on radiologists worldwide but also reduce disparities in healthcare," one Google AI leader said. 

August 14, 2023
The Society for Cardiovascular Angiography and Interventions (SCAI) has issued a new statement urging the American Board of Internal Medicine (ABIM) to rethink its maintenance of certification (MOC) policies. The organization, home to more than 4,500 interventional cardiologists, says some of its members have seen their privileges “threatened and even revoked” despite passing the necessary exams and reporting procedural volumes as required. Stamp | Certification

Interventional cardiologists call out ABIM for ‘unfair and unjustified’ certification policies

“This situation unacceptably exacerbates the interventional cardiology workforce shortage and threatens to directly impact the care of patients," SCAI wrote in a new statement. 

August 11, 2023
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‘Unstoppable’ radiologist keeps practicing despite millions in fines, mounting investigations

James McGuckin, MD, most recently made the news in May when the DOJ filed suit against him and his affiliated practices. 

August 11, 2023
Product Recall

FDA announces fourth recall of 2023 for troubled heart devices

This latest recall was brought on by electrical failures and includes more than 4,500 devices. There have been 26 complaints due to the issue but no reported injuries or deaths. 

August 10, 2023
The U.S. Food and Drug Administration (FDA) has issued a new draft guidance designed to help applicants add clinically relevant information about QTc interval prolongation to the labeling of non-antiarrhythmic drugs

FDA highlights importance of including heart rhythm risks on drug labels

The agency has shared a new draft guidance focused on the inclusion of information related to QTc interval prolongation. 

August 10, 2023
Boston Scientific’s POLARx Cryoablation System to treat atrial fibrillation gained FDA approval in August 2023. It is compatible with two balloon sizes, 31 and 28 mm to fit different sized anatomies.

FDA approves Boston Scientific’s new cryoablation system for AFib

The system includes an expandable cryoablation balloon catheter compatible with multiple balloon sizes. 

August 9, 2023