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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artificial intelligence AI in healthcare

Industry Watcher’s Digest

Healthcare AI proponents say the technology will lower healthcare costs. The assertion has its detractors. 

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Industry concerns over paclitaxel-coated devices may have put PAD patients at risk

Back in 2019, the FDA issued a warning about the use of paclitaxel-coated devices when treating peripheral artery disease. The agency took back that warning in 2023, but it appears to have made a significant impact on patient care. 

FDA Commissioner Robert Califf, MD, explains the U.S. is spending the most on healthcare of any country, but has poorer outcomes than other western nations. He said healthcare reform is needed to change that course. #Healthdisparities #healthequity

FDA commissioner urges health systems to strengthen AI quality oversight

FDA Commissioner Robert Califf, MD, explains the need for hospitals to perform quality assurance checks on clinical artificial intelligence to ensure these technologies don't "drift" from what was originally cleared by the FDA.
 

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Cardiologists to highlight the many benefits of AI-powered CCTA evaluations

Two renowned cardiologists are teaming up to explore the short- and long-term impact of using advanced AI platforms to evaluate coronary CCTA results for signs of coronary artery disease. 

artificial intelligence AI healthcare

Industry Watcher’s Digest

IT departments are budgeting more for AI in 2025 than for any other single area of investment. 

artificial intelligence AI in healthcare

Stanford HAI lookback: Best-read blog posts of 2024

The year 2023 saw a shift toward open-source AI models, surging investments in generative AI and increasing AI regulation.

RSNA Board member Richard Heller, MD, explains issues with Medicare reinburements and the No Surprises Act and Congressional actions that may fix both.

Key Medicare reimbursement and No Surprises Act updates from RSNA 2024

Richard Heller III, MD, RSNA board member and senior VP of policy at Radiology Partners, offers an overview of policies in Congress that are directly impacting imaging.
 

Artivion, an Atlanta-based medical device company, has received a Humanitarian Device Exemption (HDE) from the U.S. Food and Drug Administration (FDA) for its AMDS Hybrid Prosthesis designed to treat DeBakey Type 1 dissections when malperfusion occurs. This HDE ensures select patients can be treated with the device before the FDA makes its final approval decision.

First surgical device of its kind granted key FDA exemption

This update helps ensure Artivion's AMDS Hybrid Prosthesis can be used to treat high-risk patients as the FDA makes its final approval decision. The news came as Artivion works to bounce back from a cybersecurity attack that occurred in November.

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