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.

Respected radiologist under investigation for rampant sexual misconduct
Investigators say the doctor “committed sexual acts with almost all the women who entered his office alone."
FDA approves popular ultrasound enhancing agent for pediatric patients
Unlike other UEA options, GE HealthCare's Optison does not contain polyethylene glycol. The FDA approved its use for adult patients back in 1997.
FDA gives AI-powered blood test for obstructive CAD breakthrough device designation
The FDA clearly sees significant potential in a new multi-protein blood test from Prevencio. The company's goal is to gain full approval and get the test in the hands of emergency departments all over the United States.
Healthcare AI newswatch: FDA’s ‘rush’ to the AI altar, AI and Medicare Advantage, OpenAI benchmarks healthcare AI
For some, the FDA is moving too fast in its drive to adopt generative AI agency-wide.
Physicians urge Trump administration to exempt radiopharmaceuticals from tariffs
The American Society of Nuclear Cardiology wants the feds to protect these vital imaging products from tariffs, highlighting barriers to U.S. production.

Certificate-of-need exemption fuels hospital’s outpatient imaging expansion in growing market

West Virginia carved out a CON concession for certain diagnostic imaging services in 2023, with Valley Health capitalizing on the law change.

Healthcare AI newswatch: Bill Gates detractors, structured medical timelines, helpful China tariffs, more

Bill Gates wasn’t just wrong to suggest AI will make physicians unnecessary. He was reckless.

Sen. Warren fears $10B private equity buyout of Walgreens will create ‘pharmacy deserts’

The Massachusetts senator is asking buyer Sycamore Partners for certain assurances, including that it won’t saddle the struggling pharmacy chain with even more debt and indiscriminately close retail locations.

Supreme Court sides with HHS in hospital payment dispute

In a 7-2 vote, the Supreme Court affirmed the formula used by the federal government to calculate Disproportionate Share Hospital (DSH) payments is legal and consistent with the law passed by Congress.

Congress Money washington DC legislation coverage payment

Bipartisan bill would require insurers to cover supplemental breast imaging nationwide

UPDATED: The Access to Breast Cancer Diagnosis Act aims to eliminate a financial barrier to imaging access, patient advocates say.

Trump’s pharma tariffs could raise prices by 12.9%, report shows

A leaked report from Ernst & Young says President Donald Trump’s proposed 25% tariff on drugs would stifle domestic manufacturing and force the industry to take on an additional $51 billion in annual costs.

Is AI just what the doctor ordered for the radiologist shortage? Yes and no

AI shines in radiology when tasked with interpreting images of patients whose odds of illness are either very high or very low. In these cases, the technology could help mitigate burnout and supplement staffing.

OmniaSecure defibrillation lead for placement within a patient’s right ventricle

Medtronic receives FDA approval for smallest defibrillation lead of its kind

Medtronic emphasized that this device should be especially valuable when treating younger patients or those with a small anatomy.

Policy & Regulations

Respected radiologist under investigation for rampant sexual misconduct

FDA approves popular ultrasound enhancing agent for pediatric patients

FDA gives AI-powered blood test for obstructive CAD breakthrough device designation

Healthcare AI newswatch: FDA’s ‘rush’ to the AI altar, AI and Medicare Advantage, OpenAI benchmarks healthcare AI

Physicians urge Trump administration to exempt radiopharmaceuticals from tariffs