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. 

Realheart Total Artificial Heart

Swedish total artificial heart tech granted FDA’s humanitarian use designation

Realheart celebrated the news, noting that multiple preclinical trials focused on the technology's safety and effectiveness are currently underway.

IT AI hardware infrastructure

Industry Watcher’s Digest

Last week’s blastoff of the Chinese AI company DeepSeek struck many like a cold bucket of water in the face.

cybercrime data breaches in healthcare

FDA warns of cybersecurity vulnerabilities in patient monitors

The agency said Contec and Epsimed monitors connected via WiFi are particularly susceptible to cyberattack and could be used to gain access to hospital systems. 

Medicare money payment

Medicare Advantage faces criticism for administrative burdens, pushing doctors to opt out

Medical Group Management Association (MGMA) Senior Vice of Government Affairs, Anders Gilberg, explains the frustration surrounding the Medicare Advantage program.

 

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Blood pressure drug recalled due to black contaminants—FDA highlights safety risks

The recall was put in place after a customer discovered “visible black particulate matter” in a sealed vial. If the contaminant enters a patient's blood vessels, it could lead to serious complications, including a stroke or even death. 

ACR shares guidance to help members deal with confusing White House executive orders

A string of executive orders from the White House created serious concerns among radiologists and other healthcare providers throughout the United States. The American College of Radiology issued a statement to help guide its members through the chaos. 

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Trump backtracks on federal funding pause after Medicaid chaos

A federal judge also halted the order, which instructed federal agencies to “temporarily pause all activities related to obligation or disbursement of all federal financial assistance."

New radiotracers outperform FDA-approved agent for detection of tau tangles.

Radiotracers on FDA’s fast track exceed performance of already approved tau-detecting agent

If approved, the two agents could offer providers greater insight into the process of patients’ neurodegeneration.