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.

Imaging manufacturer will pay $18M to settle federal investigation, plus more radiology vendor news

Also, Insightec earns Medicare coverage for MR-guided treatment, a new AI tool to assist with COVID imaging, and Xact Robotics earns FDA clearance to market new product.

American College of Radiology selects new Harvey L. Neiman Health Policy Institute chief

Elizabeth Rula, PhD, will replace Executive Director Danny Hughes, PhD, who has led the institute since its inception in 2012.

HHS allocates over $4B in relief to hospitals hit hard by the pandemic

One billion of the total will go toward specialty rural hospitals, urban hospitals with certain rural Medicare designations and providers in small metropolitan areas, the administration announced recently.

ACR: Congress should include delay of ‘controversial’ USPSTF breast cancer screening in final funding bill

Draft legislation recently passed by a House subcommittee ensures the recommendations would be pushed back until 2025.

Trump’s move to withdraw from WHO puts America’s health at ‘grave risk,’ leading medical groups warn

Leaders of the American Medical Association, American Academy of Pediatrics, American Academy of Family Physicians and American College of Physicians all cautioned against the president's plan.

RapidAI receives ‘groundbreaking’ FDA clearance for its neuroimaging stroke platform

The system, known as Aspects, is the first neuroimaging solution in the FDA’s computer-assisted diagnostic software category to receive this designation.

Are 14 hospitals too many for Vermont?

An influential writer in the Green Mountain State who’s lived there since the 1940s is calling for the culling of its hospital network.

Community hospital issues fix after FDA declares mammography services ‘serious risk to human health’

An Oklahoma provider is resuming breast imaging this week following concerns from the Food and Drug Administration tied to the quality of its services.

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