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. 

Video of SNMMI President Cathy Cutler explaining the efforts to get U.S. production started for Mo-99 for a domestic supply of nuclear imaging isotopes. #RSNA #SNMMI #RSNA24 #RSNA2024 #isotopeshortage

U.S. moves closer to establishing domestic supply of Mo-99 for nuclear imaging

Society of Nuclear Medicine and Molecular Imaging President, Cathy Cutler, explains the long road to jump-starting a new U.S. domestic supply of imaging isotopes.

Surgeons in Houston have performed the world’s first successful human implant of BiVACOR’s Total Artificial Heart (TAH) technology. The procedure was completed July 9, 2024, at The Texas Heart Institute at Baylor St. Luke’s Medical Center. It was part of an early feasibility study (EFS) first approved by the U.S. Food and Drug Administration (FDA) back in December 2023.

‘Incredibly rewarding’: FDA expands total artificial heart study after early success

An additional 15 patients will now receive BiVacor's titanium total artificial heart technology as they wait for a permanent transplant.

Congress dome capitol Washington

Congress reaches deal to partially blunt Medicare pay cut, ditches prior authorization reform

UPDATED Dec. 23: Lawmakers have now ditched the previously agreed-upon deal and passed a slimmed-down version at the urging of President-elect Trump. 

Luigi Mangione Mugshot

Mangione charged with terrorism-related murder in UnitedHealthcare CEO killing

A grand jury in New York has indicted Luigi Mangione, 26, on 11 charges, including murder in the first degree. 

HeartBeam, a California-based healthcare technology company, has received U.S. Food and Drug Administration (FDA) clearance for its cable-free, credit card-sized heart monitor that produces 12-lead electrocardiograms (ECGs).

FDA clears credit card-sized heart monitor

The new device was designed to help patients evaluate their own heart health in real time.

artificial intelligence ai in healthcare

Industry Watcher’s Digest

Will the second Trump Administration manage AI’s risks—or ‘unshackle’ AI’s potential? 

Roger Marshall Senate Congress Durbin

Senators introduce radiologist-backed bill to punish payers for ignoring No Surprises Act rulings

Sens. Roger Marshall, MD, and Michael Bennet have unveiled the NSA Enforcement Act after representatives proposed a similar House bill in September. 

artificial intelligence AI healthcare regulation FDA

Healthcare AI regulation needs nuance, balance: Research review

When regulating AI-equipped medical devices, the FDA might take a page from the Department of Transportation’s playbook for overseeing AI-equipped vehicles. These run the gamut from assisting human drivers to fully taking the wheel.