Rules and Regulations

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March 2025
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Third-party vendors drive healthcare cybersecurity risks

Editor's Note Cybersecurity threats in healthcare are increasingly driven by third-party vendors, affecting millions of patients and hospital systems globally, experts John Riggi and Richard Staynings emphasized at the HIMSS Healthcare Cybersecurity Forum. Healthcare Finance News reported on the experts’ testimony November 5. According to the article, cyberattacks have surged…

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By: Matt Danford
November 8, 2024
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Trump vs. Harris: Key differences in healthcare proposals for Medicaid, Medicare, private insurance, abortion

Editor's Note When it comes to the 2024 presidential election, “Neither candidate addresses a return to the fundamental tenet of healthcare: the patient-physician relationship,” reads the closing line of an “election guide” from Richard Menger MD MPA. In the preceding paragraph, Menger also argues that both candidates also neglect issues…

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By: Matt Danford
November 4, 2024
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Updated AAMI standard addresses chemical sterilization safety, compliance

Editor's Note New guidance from The Association for the Advancement of Medical Instrumentation (AAMI) addresses regulatory and safety concerns for hospitals using ethylene oxide (EO) for medical device sterilization—a pressing concern due to EO’s effectiveness but associated health risks. ANSI/AAMI ST58:2024, an update on chemical sterilization and high-level disinfection practices…

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By: Matt Danford
November 4, 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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