Rules and Regulations

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October 2024
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Risks of animal-to-human disease jump remain high despite pandemic lessons

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Editor's Note New findings highlight an urgent need to improve preventive measures against animal-borne diseases jumping to humans and potentially causing another global pandemic, US Today reported on July 21. The article details a study from  Harvard Law School and New York University that examined animal-human interactions in 15 countries,…

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By: Matt Danford
July 22, 2024
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FDA: Ventilator death, injury reports lower than initially reported

Editor's Note:  Problems with Philips’ BiPap V30, BiPAP A30, BiPAP A40 ventilators resulted in only 7 recorded deaths and 10 injuries—far fewer than the 65 deaths and 952 injuries initially reported by the US Food and Drug Administration (FDA). In a July 10 update to the class 1 recall—the most…

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By: Matt Danford
July 18, 2024
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FDA announces Class 1 recalls of ventilator, eye injection kits

Editor's Note The US Food & Drug Administration has designated recalls of Baxter’s Life2000 Ventilator and the I-Pack Injection Kit from Bausch + Lomb and subsidiary Synergetics Inc. as Class 1, the most severe category indicating serious risk of injury or death. According to FDA’s July 15 announcement, the ventilator…

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By: Matt Danford
July 16, 2024
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Trump record, Republican National Convention hint at GOP healthcare policy priorities

Editor's Note As the Republican National Convention meets in Milwaukee to nominate Donald Trump, the party is not expected to unveil a detailed healthcare platform. However, a July 15 report in Modern Healthcare covers what plans and past records reveal about the potential direction of health policy under a GOP…

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By: Matt Danford
July 15, 2024
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FDA announces Class 1 recalls for ventilator software, electrode pads

Editor's Note The US Food and Drug Administration (FDA) has classified recalls by Hamilton Medical and Megadyne as Class 1 events, the most severe category indicating risk of serious injury or death. According to the agency’s July 11 report, Hamilton Medical is correcting software for its HAMILTON-C6 Medical Ventilator to…

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By: Matt Danford
July 12, 2024
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Hospitals, health groups criticize CMS pay proposals

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Editor's Note Hospital groups are criticizing CMS' proposed 2.6% pay increase for 2025, deeming it insufficient for nonprofit hospitals with operating margins near or below zero, according to a July 11 article in Becker’s Hospital CFO Report. The American Hospital Association and America's Essential Hospitals argue the rise won't cover…

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By: Matt Danford
July 12, 2024
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CMS releases proposed Medicare payment rates for outpatient, ASC services

Editor's Note On July 10, CMS proposed Medicare payment rates for hospital outpatient and ambulatory surgery center (ASC) services for 2025.  Published annually, the Hospital Outpatient Prospective Payment System (OPPS) and ASC Payment System Proposed Rule will have a 60-day comment period, which this year ends September 9 prior to…

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By: Matt Danford
July 10, 2024
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FDA announces Class 1 recalls for upper airway stimulation system, MRI components

Editor's Note A manufacturing defect in a critical component of an upper airway stimulation (UAS) system and coils prone to overheating during magnetic resonance imaging scans (MRIs) prompted The US Food & Drug administration to issue two Class 1 recalls June 8. Class 1 is the most severe category, indicating…

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By: Matt Danford
July 10, 2024
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Healthcare industry groups criticize federal cybersecurity reporting rule

Editor's Note Healthcare industry groups are calling for the federal government to streamline and ease the recently proposed cybersecurity incident reporting rule by the Cybersecurity and Infrastructure Security Agency (CISA), Fierce Healthcare reported July 8. According to the report, CISA's proposal imposes enhanced reporting requirements for critical infrastructure entities, including…

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By: Matt Danford
July 9, 2024
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Supreme Court decision could lead to legal challenges to payments, risks to healthcare regulation

Editor's Note Food and Drug Administration (FDA) regulations are at risk, and legal challenges to Medicare payments are likely to rise following the Supreme Court’s overturning of the 40-year-old legal precedent Chevron deference, according to a June 28 report in Becker’s Hospital Review. "Chevron deference is the principle that when…

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By: Matt Danford
July 2, 2024
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