Rules and Regulations

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May 2025
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Chinese medical devices threaten US healthcare cybersecurity

Editor’s Note Backdoors in Chinese-made medical monitors could put patients at risk and compromise hospital networks across the US, according to security agencies quoted in a February 23 report from CNBC. The article cites the popular Contec CMS8000 patient monitor as an example. Both the US Food and Drug Administration…

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By: Matt Danford
February 24, 2025
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Healthcare M&A faces tighter review as FTC retains guidelines

Editor’s Note In a setback for healthcare mergers and acquisitions (M&A), the Federal Trade Commission (FTC) will continue enforcing strict antitrust guidelines established under the Biden administration, Healthcare Dive February 19 reports. Bucking expectations of a more lenient approach under the new administration, FTC Chair Andrew Ferguson confirmed the decision,…

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By: Matt Danford
February 20, 2025
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Healthcare giants prioritize shareholder payouts over patient care

Editor’s Note Shareholder payouts by publicly traded healthcare companies have surged 315% since 2001, raising questions about financial priorities in the sector, according to a February 19 article in Healthcare Finance. A research letter published in JAMA Internal Medicine and co-authored by Yale University researchers found that major healthcare corporations…

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By: Matt Danford
February 20, 2025
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Texas abortion ban linked to spike in pregnancy complications, maternal death

Editor’s Note Pregnancy complications—including life-threatening sepsis—surged in Texas after the state banned abortion in 2021, according to a ProPublica analysis of seven years’ worth of state hospital data. In a February 20 report, the outlet details how sepsis rates for women hospitalized after second-trimester pregnancy loss rose by more than…

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By: Matt Danford
February 20, 2025
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Montana legislators' prior authorization reform push mirrors national trends

Editor's Note Montana legislators are moving to restrict health insurers’ use of prior authorization as frustration over the practice mounts nationwide, KFF News reported February 13. The outlet reports that two Democratic and Republican lawmakers have introduced or are drafting bills for the 2025 Montana Legislature to limit these insurer-mandated…

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By: Matt Danford
February 18, 2025
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Session: Anchors Away: 5 Strategies to Right-Size Your Inventory and Improve Supply Contracts

Editor's Note As executive director of the Association for Health Care Resource & Materials Management (AHRMM), Michael Schiller, CMRP, gets regular insight into strategies employed by healthcare organizations, suppliers, technology leaders and frontline staff—insight he was happy to share with OR business Management Conference attendees in a February 11 presentation.…

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By: Matt Danford
February 13, 2025
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Session: Crew Incentives: 3 Guiding Principles to Leverage Value Analysis Teams

Editor's Note Jasmine Hampton-Nicholson MSN, RN, CNOR, learned the value of a value analysis team (VAT) the hard way. “I thought that we had a very solid process for our value analysis team,” said the VP of perioperative services at Temple University Health System in a presentation at 2025 OR…

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By: Matt Danford
February 12, 2025
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FDA announces Class 1 recall for ventilator system

Editor's Note The US Food and Drug Administration (FDA) designated Baxter Healthcare Corporation’s recall of the Life2000 ventilator system as a Class 1, the most severe category indicating serious risk of injury or death.   According to the agency’s February 5 announcement, a failed operation during manufacturing compromised the operation…

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By: Matt Danford
February 6, 2025
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Moody’s downgrades health insurance outlook as medical costs surge

Editor's Note Moody’s Ratings has shifted the health insurance industry’s credit outlook from stable to negative, according to a February 3 article in Fierce Healthcare. According to the article, the downgrade is due to escalating medical costs that outpace reimbursement rates. Analysts project an 8% rise in commercial market spending…

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By: Matt Danford
February 5, 2025
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FDA approves new non-opioid analgesic

Editor's Note The FDA has approved Journavx (suzetrigine), a first-in-class non-opioid analgesic, for the treatment of moderate to severe acute pain in adults. According to the agency’s January 30 announcement, the drug targets sodium channels in the peripheral nervous system to block pain signals before they reach the brain, representing…

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By: Matt Danford
February 5, 2025
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