Rules and Regulations

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November 2024
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Feds warn of increased healthcare cyber threats from Iranian actors

Editor's Note Iranian cyber actors employing techniques such as brute force, password spraying, and multifactor authentication (MFA) "push bombing" to compromise healthcare and other critical infrastructure sectors, the American Hospital Association (AHA) reported October 17. The report cites an October 16 joint advisory issued on October 16 by the FBI,…

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By: Matt Danford
October 21, 2024
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OR “megafloor” combines inpatient, outpatient procedures

Editor's Note A newly constructed surgical “megafloor” that connects inpatient and outpatient ORs promises to aid workflow and add flexibility for perioperative teams at The University of California Irvine (UCI) Health—Irvine campus, Healthcare Design reported October 7. As detailed in the article, the academic center must accommodate a variety of…

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By: Matt Danford
October 21, 2024
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Outpatient, ASC clinicians share perspectives on upcoming NOPAIN Act implementation

Editor's Note On October 14, Anesthesiology News published a monograph featuring clinical perspectives on how “those working in the trenches of postsurgical pain management” are preparing for the Non-Opioids Prevent Addiction in the Nation (NOPAIN) Act, which outlines new, separate Medicare reimbursement for certain non-opioid analgesics in outpatient and ambulatory…

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By: Matt Danford
October 16, 2024
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FDA designates Class 1 recall for infusion pumps due to air bubble risk

Editor's Note The US Food and Drug Administration (FDA) has deemed Zyno Medical’s recall of Z-800, Z-800F, Z-800W, and Z-800WF infusion pumps a Class 1, the most severe designation indicating serious risk of injury or death. According to FDA’s October 11 announcement, the recall was due to  a defect in…

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By: Matt Danford
October 14, 2024
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CMS proposes $2 Drug List Model to reduce out-of-pocket costs for Medicare recipients

Editor's Note CMS has taken the next steps in making prescription drugs more affordable for Medicare recipients, according to an October 9 report from The US Department of Health and Human Services (HHS). The proposed Medicare $2 Drug List Model, developed in line with President Biden’s Executive Order 14087, aims…

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By: Matt Danford
October 9, 2024
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AAMI, CTA partners to develop healthcare AI standards

Editor's Note The Association for the Advancement of Medical Instrumentation (AAMI) has entered into a partnership with the Consumer Technology Association (CTA) to develop new standards for the integration of artificial intelligence and machine learning in healthcare, according to an October 1 report in DOTmed. Formalized through a memorandum of…

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By: Matt Danford
October 3, 2024
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Vice presidential debate highlights healthcare, abortion policy differences

Editor's Note The October 1 vice presidential debate showcased sharp divisions between the candidates on healthcare policy, focusing primarily on the future of the Affordable Care Act (ACA) and reproductive rights. A summary published October 2 in Stat details how Sen. JD Vance (R-Ohio) proposed changes that could allow insurers…

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By: Matt Danford
October 2, 2024
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FDA designates Class 1 recalls for infusion pump software, ventilator software

Editor's Note The US Food and Drug Administration (FDA) designated software-related recalls for Fresenius Kabi USA’s Iveni Infusion Systems and Philips Respironics Triology Evo ventilators as class 1, the most severe category indicating serious risk of injury or death. According to FDA’s October 1 announcement, Fresenius recalled the Ivenix Infusion…

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By: Matt Danford
October 2, 2024
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Deadline looms for CMS patient safety reporting requirements

Editor's Note Starting October 1, US hospitals participating in Medicare's Inpatient Quality Reporting Program will need to report adherence to 25 patient safety best practices, as mandated by the Centers for Medicare & Medicaid Services (CMS). According to a September 4 report from the Association of Health Care Journalists, the…

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By: Matt Danford
September 26, 2024
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HHS announces $75 million investment in rural healthcare

Editor's Note The Health Resources and Services Administration (HRSA), part of the US Department of Health and Human Services (HHS), has announced nearly $75 million in funding to address critical challenges in rural health, including opioid treatment, maternal health care in the South, and supporting the financial stability of rural…

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By: Matt Danford
September 25, 2024
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