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.

Doc groups say payer promises not enough to address care denials
MGMA and others who are part of the “Regulatory Relief Coalition” are urging Congress to continue pushing forward with the Improving Seniors’ Timely Access to Care Act.
Russian researcher strategizes on collaboration with China over healthcare AI
Have you ever wondered what China and Russia would talk about if they were to discuss AI in healthcare? It turns out they do just that—and a newly published academic paper straight out of the Russian Federation offers a glimpse into the dialogue.
10-second brain MRI scans possible with newly FDA-cleared deep learning reconstruction software
The artificial intelligence-enabled software offers accelerated acquisition times, improved image resolution and one-click workflows for technologists.
'Technical issue' prevents providers from receiving alerts on actionable imaging findings for 3 years
The system uses color coded flags to alert general practitioners that a patient's imaging report contains "serious or unexpected” findings.
FDA shares warning after Johnson & Johnson heart pump controllers linked to 3 deaths
Johnson & Johnson MedTech has received reports of its Automated Impella Controller failing to connect properly with Impella heart pumps. If this happens, the FDA warned, it may put patients at risk.

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.

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Cardiologist-supported bill to stop ‘harmful’ Medicare cuts returns to Congress

A bipartisan bill designed to block recent Medicare payment cuts has been reintroduced to Congress after failing to pass in 2024. Will things be any different this time around?

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.

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.

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 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.

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.

Policy & Regulations

Doc groups say payer promises not enough to address care denials

Russian researcher strategizes on collaboration with China over healthcare AI

10-second brain MRI scans possible with newly FDA-cleared deep learning reconstruction software

'Technical issue' prevents providers from receiving alerts on actionable imaging findings for 3 years

FDA shares warning after Johnson & Johnson heart pump controllers linked to 3 deaths