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. 

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A majority of medical devices involved in Class I recalls were never required by the U.S. Food and Drug Administration (FDA) to undergo premarket or postmarket clinical testing, according to new research published in Annals of Internal Medicine.[1]

Answering key follow-up questions after the FDA approved TAVR in asymptomatic patients

The approval of certain TAVR valves to be used in asymptomatic patients is expected to make a significant impact on patient care going forward. 

Prescription drugs pharmacy law

Michigan sues PBMs, alleging unlawful collusion created ‘pharmacy deserts'

State Attorney General Dana Nessel is suing Express Scripts and Prime Therapeutics, accusing the two PBMs of manipulating rebate pricing, "crippling small, independent pharmacies and restricting access to lifesaving medications in the process."

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Incidental findings evident in 70% of lung screening exams, but few reported

Despite this, consensus is lacking on whether radiologists should be required to report on findings that are not relevant to the exam. 

Tariffs will cost Philips Healthcare up to $340M

U.S.-China tariffs will have a $226M to $340M net impact on its bottom line in 2025, even after substantial mitigation efforts, the imaging manufacturer estimates. 
 

doctor comparing the costs of different medical treatments

Hospital transparency efforts fail to curb rising imaging prices

However, health policy efforts initiated in 2021 appear to be reducing variation in imaging costs, experts contend. 

artificial intelligence AI in healthcare

Healthcare AI newswatch: UnitedHealth hearts AI, agentic AI again, healthcare AI dependency, more

Give healthcare workers AI to do their jobs and you might make them AI-dependent. Give them AI anyway?

Gavin Newsom

19-state coalition sues HHS over restructuring, mass firings

The states argue the Department of Health and Human Services is failing to perform basic functions, in violation of the Constitution, as the agency and its programs are authorized by Congress. 

U.S. FDA Sign

FDA reverses course on some layoffs, rehires FOIA staff

According to a media report, workers managing records on medical device and tobacco regulations are returning to work after the agency missed court-ordered deadlines for Freedom of Information Act responses. 

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