Regulations/Legal

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November 2025
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FDA draft guidance addresses pulse oximeter accuracy, AI devices

Editor's Note The US Food and Drug Administration (FDA) has issued new draft guidance January 6 providing recommendations improving the use of pulse oximeters and supporting the safety of AI-enabled medical devices, among other topics. Released January 6, draft guidance supporting the safety and effectiveness of AI-enabled devices would, if…

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By: Matt Danford
January 7, 2025
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Health system to pilot AI-powered OR cameras; leaders acknowledge privacy challenges

Editor's Note UC San Diego Health plans to pilot artificial intelligence (AI)-enabled camera systems to enhance patient safety, addressing risks like falls and bedsores, but leaders are also acknowledging challenges related to patient consent, compliance, and privacy. The San Diego Union-Tribune reported the news January 5. According to the article,…

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By: Matt Danford
January 6, 2025
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Report: Healthcare ransomware compromises millions of patient records, costs billions in downtime

Editor's Note Between 2018 and 2024, ransomware attacks on US healthcare organizations compromised nearly 89 million patient records and resulted in downtime costing an estimated total of $21.9 billion, according to a December 18 report from Comparitech. The report tallies 654 total ransomware incidents during this period targeting hospitals, clinics,…

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By: Matt Danford
January 3, 2025
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Proposed tariffs, stricter immigration policies threaten healthcare workforce, supply chain

Editor's Note Immigration and trade policies proposed by President-elect Donald Trump could exacerbate challenges with healthcare staff and medical supply chains, according to recent reporting from Modern Healthcare and The Hill. As detailed by Modern Healthcare, stricter immigration policies could impede efforts to recruit skilled international workers, exacerbating gaps in…

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By: Matt Danford
January 2, 2025
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Mastering CMS regulations: How to ensure a finding-free Joint Commission survey

Takeaways • Requirements for improvement and condition level deficiency findings have been trending up in recent The Joint Commission surveys. • The scoring trends and OR hot spots focus on infection control, medication management, national patient safety goals, post-surgical electronic health record tracers, and transplant (tissue) safety. • Federal regulations,…

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By: Uyen Vo, BSN, MBA
January 1, 2025
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Surgical legislation advocacy focuses on safety, access

“Surgeons are the only people trained to provide surgery—life-saving care," says Carrie Zlatos, chief of legislative and political affairs at the American College of Surgeons (ACS). "They are an essential element of a community-based healthcare system. Regardless of where you live, everyone should have access to full quality surgical care.”…

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By: Brita Belli
January 1, 2025
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FDA designates Class 1 recalls for balloon catheters, radiographic markers

Editor's Note Balloon catheters for atrial fibrillation patients and implantable radiographic markers were the subjects of separate US Food and Drug Administration (FDA) Class 1 recalls—the most severe category indicating risk of serious injury or death—announced on December 18. The first recall involves Boston Scientific’s POLARx Cryoablation devices. Higher-than-anticipated reports…

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By: Matt Danford
December 19, 2024
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Medtronic, Zimmer Biomet challenge Intuitive Surgical’s robotic surgery dominance

Editor's Note Robotic-assisted surgical procedures are no longer futuristic—they are becoming a mainstay in modern ORs. While Intuitive Surgical’s da Vinci system has led the market since 2001, competitors Medtronic and Zimmer Biomet are building innovative portfolios to challenge its dominance, MarketBeat December 12 reports. Medtronic’s Hugo Robotic Assisted Surgery…

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By: Tarsilla Moura
December 18, 2024
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Anthem’s anesthesia time limit policy, reversal sparks new legislation

Editor's Note Anthem Blue Cross Blue Shield recently reversed its controversial plan to impose time limits on anesthesia coverage after intense backlash from the medical community, including anesthesiologists and patient advocates. The policy, aimed at curbing alleged overbilling, would have restricted payments based on average surgery times, a move critics…

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By: Tarsilla Moura
December 18, 2024
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Simple procedure or ‘surgery’? Questionable medical billing practices cause confusion

Editor's Note Certain medical bills reclassifying minor procedures as “surgery” are driving up costs and causing confusion among patients, KFF Health News December 13 reports. Cases such as a $414 charge for a splinter removal with tweezers and a $469 charge for freezing a skin tag highlight how CPT codes…

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By: Tarsilla Moura
December 18, 2024
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