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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Healthcare AI today: Hurry up and slow down, AI playbook, docs over bots, more

A slow but sure approach to governance can keep AI champions focused on improving patient care when—and even after—the technology builds unstoppable momentum seemingly of its own accord.

Radiologists fear new $100,000 visa fee could exacerbate specialty’s staffing shortages

The Trump administration first announced this change via a presidential proclamation, with the added charge taking effect on Sept. 21. 

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FDA approves labeling changes for fenofibrates due to lack of cardiovascular benefits

The FDA listened to physician feedback and updated its labeling requirements for fenofibrates. These drugs have not been linked to any significant cardiovascular benefits, and clinicians should act accordingly.

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Patients from poorer neighborhoods travel farther for MRIs, show up in worse condition

A twofold increase in distance traveled from home to an imaging center resulted in substantially higher severity in these patients’ conditions, researchers detailed in JACR. 

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Medicare contractors mull restricting coverage for key image-guided pain procedure

Five of the seven MACs recently released proposed local coverage determinations, pertaining to peripheral nerve blocks. 

Harrison.ai cofounders Tran

Imaging artificial intelligence firm Harrison.ai scores FDA breakthrough device designations

The agency has granted this designation to the Australia-based company's Comprehensive Care triage and prioritization solution for obstructive hydrocephalus. 

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TrumpRx now online as AstraZeneca becomes second pharmaceutical company to join

Details are still unclear. However, the administration—along with Pfizer and AstraZeneca, the two companies to sign on—promises the storefront will offer deeply discounted drugs directly to Americans. The deal allows the manufacturers to avoid import tariffs. 

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FDA details Class I recalls for more than 1 million pacemakers—software update required

The FDA has finalized new Class I recalls related to ongoing safety concerns with Boston Scientific’s Accolade family of pacemakers. A software update is now available to help address the issue, and an additional update is already in the works.