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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Trump’s Commerce Department floats new medical device tariffs to ‘protect national security’

The U.S. Department of Commerce is investigating domestic medical product manufacturing, as well as imports, to gauge how "state-sponsored overproduction" is impacting supply chain security. 

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Fewer than 30% of FDA-cleared AI devices share key safety, adverse event info prior to approval

A new analysis is prompting questions regarding how rigorously many of the AI-enabled tools approved by the U.S. Food and Drug Administration are evaluated prior to their clearance. 

U.S. considering new tariffs for heart valves, imaging equipment and other medical devices

The Department of Commerce is seeking more information about how current trade policies are impacting the U.S. medtech industry. The investigation could lead to the creation of new tariffs. Public comments are being accepted until Oct. 17, and the findings will be presented to President Donald Trump.

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Healthcare AI today: Blind prior-auth pilots, sputtering healthtech romance, solo AI surgeons, more

Meet a robot surgeon who could operate on patients with no human in the room. 

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Radiology societies propose new imaging CPT billing codes for 2027

ACR on Wednesday touted the proposals, which were suggested at the September American Medical Association CPT Editorial Panel meeting. 

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Bipartisan bill would require Medicare Advantage plans to reimburse claims within 2 weeks

The newly introduced Medicare Advantage Prompt Pay Act would require insurance companies to have a 95% timely reimbursement rate or face a reoccurring $25,000 fine.

New GE HealthCare partnership expands access to prostate cancer imaging agent

The product, which is used to detect metastatic or recurrent prostate cancer, was approved by the FDA in 2021. 

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Expert panel develops new breast biopsy guidelines

The recommendations were designed to improve accuracy and safety in diagnosing breast lesions using multiple imaging methods, including DBT, ultrasound and MRI.