Regulations/Legal

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May 2025
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FDA issues early alerts for intravascular catheters

Editor's Note The US Food and Drug Administration (FDA) warned of safety risks resulting from manufacturing issues with two varieties of intravascular catheter—Conavi Medical’s Novasight Hybrid line and BD’s PowerPICC intravascular devices—in separate early alerts April 18. In one reported incident, the sheath of a Novasight Hybrid catheter—a device used…

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By: Matt Danford
April 21, 2025
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Market volatility threatens hospitals’ liquidity as tariff-driven costs rise

Editor's Note Tariff-fueled market volatility is jeopardizing the investment returns that nonprofit hospitals rely on to bolster liquidity, manage debt, and weather ongoing operational headwinds, according to an April 16 report in Fierce Healthcare. As detailed in the article, hospitals face a dual threat: higher direct costs on supplies and…

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By: Matt Danford
April 18, 2025
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OAS CAHPS compliance soars to 96% among ASCs, vendor satisfaction also improves

Editor's Note Ambulatory surgery centers (ASCs) across the US have quickly adapted to the new federal requirement mandating participation in the Outpatient and Ambulatory Surgery Consumer Assessment of Healthcare Providers and Systems (OAS CAHPS) Survey, according to a March 2025 "60-Second Survey" from ASCA. The survey captured responses from 261…

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By: Tarsilla Moura
April 16, 2025
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Health system mega-mergers fall short amid cost, quality concerns

Editor's Note Chasing size through mega-mergers no longer guarantees sustainability for health systems, according to an April 15 article in HealthLeaders. Many of the nation’s largest systems are reporting significant losses, while emerging evidence links consolidation to stagnant or declining care quality and worsening workforce challenges. The article highlights financial…

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By: Matt Danford
April 15, 2025
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Strengthening healthcare cyber defenses challenged by third-party, asset-related risks

Editor's Note Healthcare organizations are improving their ability to respond to cyberattacks but continue to fall short on preventing them—particularly when it comes to managing third-party and asset-related risks. That’s the key takeaway from the 2025 Healthcare Cybersecurity Benchmarking Study conducted by KLAS Research and partner organizations. Surveying 69 healthcare…

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By: Matt Danford
April 15, 2025
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CMS vision shifts as agency halts funding for state programs

Editor's Note The Centers for Medicare & Medicaid Services (CMS) will no longer approve federal matching funds for designated state health programs (DSHPs) and designated state investment programs (DSIPs) that are not directly related to Medicaid services. According to the April 10 announcement, the decision aims to preserve the core…

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By: Matt Danford
April 11, 2025
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GAO urges HHS to improve drug shortage response coordination

Editor's Note The Government Accountability Office (GAO) has called on the Department of Health and Human Services (HHS) to implement a formal mechanism for coordinating efforts to address ongoing drug shortages, which continue to jeopardize patient care nationwide. In a report released April 9, 2025, the GAO highlighted the critical…

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By: Matt Danford
April 10, 2025
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FDA clears AI platform for real-time surgical measurements

Editor's Note What is reportedly the first technology to allow dynamic, 3D, segmental visualization of anatomy during surgery earned a second 510(k) clearance from the US Food and Drug Administration, according to an April 8 press release from developer Proprio. Designed to let surgeons measure progress during surgery without scrubbing…

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By: Matt Danford
April 9, 2025
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The Joint Commission revises volume criteria for cardiac, stroke certifications

Editor's Note The Joint Commission announced significant updates taking effect immediately to the eligibility requirements for its cardiac and stroke certifications, developed in collaboration with the American Heart Association (AHA) and the American Stroke Association (ASA). According to the April 2 announcement,  key revisions involve the removal of percutaneous coronary…

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By: Tarsilla Moura
April 2, 2025
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FBI investigates as Oracle health data breach exposes patient information

Editor's Note Cybercriminals breached a legacy server at Oracle Health, stealing patient data from multiple hospitals and health systems, according to a March 31 article in Healthcare Executive. The breach, discovered around February 20, occurred before Oracle migrated the affected server from Cerner's system to Oracle Cloud. According to the…

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By: Matt Danford
April 1, 2025
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