Rules and Regulations
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…
Hospitals, health groups criticize CMS pay proposals
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…
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…
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…
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…
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…
FDA announces Class 1 recalls for ventilators, LVAS monitors
Editor's Note The US Food and Drug Administration has announced class 1 recalls—the most severe category indicating risk of serious injury or death—for Abbot Medical’s HeartMate System Monitor and Philips Respironics OmniLab Advanced+ (OLA+) ventilator. According to the agency’s June 28 report, the recall of the HeartMate System Monitor, part…
Study: Federal antitrust action minimal relative to number of hospital mergers
Editor's Note Federal regulation of hospital mergers is inadequate, according to an April antitrust enforcement study scheduled to be published by the American Economic Association. According to a June 14 report in Modern Healthcare, researchers at universities including Harvard and Yale analyzed insurance claims data from Aetna, Humana, and UnitedHealthcare,…
Change Healthcare issues notifications of patient data stolen in cyberattack
Editor's Note Change Healthcare has started to notify health care providers about patient data stolen in the February cyberattack and announced plans to mail affected individuals as well. A unit of UnitedHealth Group, the organization issued the update June 20. “CHC is providing this notice now to help individuals understand…
Scaling standards from sterile processing department to clinic
Reforming instrument reprocessing practices does not always end with the main sterile processing department (SPD). Holding clinics to the same standard adds to the challenge, whether they are associated with hospitals or operate independently. Nonetheless, standardization is just as essential to maintaining efficiency and quality standards. Establishing and maintaining best…
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- Routine preop tests catch hidden risks in outpatient cosmetic surgery, Canadian study finds
- Study: Hospital same‑day knee replacements match ASC outcomes, even in higher‑risk patients
- FDA clears AI platform for real-time surgical measurements
- Study: MRI contrast agent causes harmful metal buildup in some patients
- Dissolvable pacemaker delivers temporary cardiac support without wires, surgery
- CSA taps Milagro’s AI coding to accelerate revenue cycle across ASC network
- Study: Cannabis use complicates sedation, cancer care
- Medication vial coring incidents prompt patient safety concerns
- First single-port robotic renal vein transposition surgery treats nutcracker syndrome
- Study: Mortality prediction models fail to recognize severe patient injuries