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. 

ACR joins with Texas Medical Association in declaring an important ‘No Surprises’ win

The American College of Radiology is cheering a Feb. 6 decision by a federal judge in Texas who ruled that parts of the independent dispute resolution (IDR) process in the Surprise Billing Final Rule violate the Administrative Procedure Act.

February 8, 2023

Headlines and ire follow serially sued, disciplined radiologist despite 700-mile move

The radiologist who received, in one patient’s view, a mere “slap on the wrist” for missing a couple dozen breast cancers over several years is back in the news.

February 6, 2023
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.

February 3, 2023

FDA grants passage to autonomous, biology-guided radiotherapy

A therapeutic oncology company has been cleared to market a cancer treatment that that turns a tumor’s own biology into a self-signaling target for radiation therapy.

February 3, 2023
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).

February 2, 2023

Portable orthopedic tomosynthesis cleared for U.S. sales

The FDA has cleared U.K.-based Adaptix to market a 3D X-ray system that, according to the company, images hands, feet and elbows “at a fraction of the radiation dose and per-study cost of traditional CT.”

January 31, 2023
man in prison behind bars

Tesla-crashing radiologist held without bail

Remember the radiologist who drove himself and his family over a rocky California cliff in an alleged—and fortunately failed—suicide-murder attempt? He’s out of the hospital and in jail.

January 30, 2023

EU organizes aggressive anti-cancer action around imaging

The executive branch of the European Union has launched a major project to aggregate cancer imaging data from across the continent so it can be readily tapped by healthcare providers, medical schools and industry innovators.

January 23, 2023

Around the web

"This was an unneeded burden, which was solely adding to the administrative hassles of medicine," said American Society of Nuclear Cardiology President Larry Phillips.

SCAI and four other major healthcare organizations signed a joint letter in support of intravascular ultrasound. 

The newly approved AI models are designed to improve the detection of pulmonary embolisms and strokes in patients who undergo CT scans.

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