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.

Lehigh Valley Health admits to controlled substances violations in $2.75M settlement
The Pennsylvania-based health system reported drug diversion incidents to authorities involving a pharmacy technician who used employee passwords to steal pills from one of its hospitals.
Sanitation issue forces FDA recall of ventilator suction systems
Ballard Closed Suction Systems will need to be returned to the manufacturer for a refund due to the high risk of a potentially fatal infection stemming from their use.
Medicare now covers TriClip procedures for patients with symptomatic tricuspid regurgitation
CMS has finalized a new national coverage determination for T-TEER, sometimes known as transcatheter tricuspid valve repair. Abbott's TriClip is the only device approved by the FDA for T-TEER, but other treatment options are under development.
Over 100 AI-enabled radiology algorithms added to FDA's list of approvals
The updated list contains 146 newly approved AI devices and, as usual, algorithms tailored to radiology lead the way.
Healthcare AI today: HL7 Int’l opens AI office, Justice Dept. uses AI, epidemiologist harbors AI skepticism, more
HL7 International is open for AI business. The interoperability organization announced the launch of its new AI office July 8.

6 tips for integrating NPPs into imaging practice

The role of non-physician practitioners will inevitably continue to grow in healthcare, but how will their presence impact radiology?

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.

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.

Scientific misconduct and bias in cardiovascular imaging research among concerns reported in new survey

The data, published in Clinical Imaging, reveal that more than 20% of respondents have witnessed scientific fraud within their department and more than 85% reported the issue of publication bias.

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.

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.

Policy & Regulations

Lehigh Valley Health admits to controlled substances violations in $2.75M settlement

Sanitation issue forces FDA recall of ventilator suction systems

Medicare now covers TriClip procedures for patients with symptomatic tricuspid regurgitation

Over 100 AI-enabled radiology algorithms added to FDA's list of approvals

Healthcare AI today: HL7 Int’l opens AI office, Justice Dept. uses AI, epidemiologist harbors AI skepticism, more