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.

Major pharmacy group criticizes FTC decision on PBMs

FTC failed to reach a consensus on a study looking into PBM practices.

M&A mergers and acquisitions business deal

M&A activity was down in 2021, but 'mega-mergers' spiked

Last year saw the largest percentage of mega transactions over the past six years at 16.3%, nearly double that of 2020.

AMA releases new toolkit with 5 steps to achieve racial, health equity

The "Racial and Health Equity: Concrete STEPS for Health Systems toolkit is the latest addition to a collection of more than 70 other toolkits that cover transformative medical practice solutions.

Health-tech companies back new legislation introduced to modernize ‘outdated’ health privacy laws

Teladoc Health, IBM, Epic and others all support the bipartisan Health Data Use and Privacy Commission Act.

With patient safety slipping, CDC and CMS turn focus to more resilient approaches

COVID-19 has led to a quick and steep decline in patient safety across the entire American healthcare system.

Appeals court revives lawsuit alleging misordered CT scan led to patient’s death

Lynda Newman, MD, claimed she ordered imaging with contrast, suspecting aortic dissection, but a rad tech performed CT without, leading to a missed diagnosis.

HHS awards $55 million to expand virtual healthcare access

The awards will enhance telehealth, digital patient tools and health information technology to support underserved communities.

American College of Radiology urges FDA to use discretion in ‘point-of-care’ 3D printing oversight

Anatomic models pose significantly less danger than surgical guides or implanted devices and should be regulated differently, the ACR said in recent public comments.

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