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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FDA issues Class I recall of brain fluid drain kits after 15 injuries

Two lines of Medtronic Neurosurgery EDMS kits are at risk of developing cracks that could expose patients to pathogens or cause cerebrospinal fluid to leak. 

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UnitedHealthcare in dispute with maternity practice over $1M in claims

Axia Women’s Health has accused the insurer of failing to honor continuity of care agreements for 2,100 patients, while questions remain over fair pricing and appropriate care delivery.

FDA greenlights first non-opioid treatment for severe pain in 20 years

Journavax was shown in clinical trials to be safe and effective, with no addictive potential. 

Nina Kottler, MD, Radiology Partners, offers overview of the U.S. AI regulatory landscape as government and radiologists work on ways to ensure artificial intelligence is not bias and works properly.

Overview of the regulatory landscape of AI in radiology

Nina Kottler, MD, associate CMO for clinical AI at Radiology Partners, explains the movement toward greater regulation of artificial intelligence and the need to test for bias. 

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. 

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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. 

Around the web

The American College of Cardiology has sent a letter to HHS Secretary Robert F. Kennedy Jr. that outlines some of the organization’s central priorities and concerns. 

One product is being pulled from the market, and the other is receiving updated instructions for use.

If the Trump administration continues taking a laissez-faire stance toward AI—including AI used in healthcare—why not let the states go it alone on regulating the technology?