Regulations/Legal

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March 2025
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Healthcare employment up in January

Editor's Note Healthcare employment in the US rose by 70,300 from January to February, according to the latest report from the Bureau of Labor Statistics, released on February 2. That is compared to an overall monthly gain of 353,000 in January—similar to the 333,000 gained in December—for a total of…

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By: Brita Belli
February 9, 2024
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FDA announces urgent chest drain recall

Editor's Note The FDA has announced a recall of the Atrium Express Dry Suction Dry Seal Chest Drain, a disposable device used to remove air and/or fluid from the chest cavity or mediastinum and to aid in lung expansion and breathing. The drain is being recalled by maker Maquet Cardiovascular,…

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By: Brita Belli
February 9, 2024
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Session: What to expect from healthcare policy, regulation in 2024

Editor's Note Since the pandemic, the view of the healthcare industry in congress has essentially gone from “hero to zero” – a shift with potentially big implications for the healthcare business leaders gathered at yesterday’s closing session from Soumi Saha, PharmD, JD, senior vice president of government affairs at Premier…

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By: Matt Danford
February 8, 2024
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Session: Imminent supply chain disruptors—What's your business continuity plan?

Editor's Note “Can cost and resiliency co-exist?” Michael Schiller, CMRP, executive director (interim) of the Association for Healthcare Resources and Materials Management—a professional membership group of the American Hospital Association—asked this session’s audience on the last day of the OR Business Management Conference. “They can co-exist,” he said, “but resiliency…

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By: Tarsilla Moura
February 8, 2024
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Session: How value-based care will impact surgical services

Editor's Note Understanding the impact of value-based care on the surgical suite (VBC) will be essential for hospitals to understand as payers begin to seek partners in new payment models. In a conference session yesterday, Lauren Cricchi, associate principal, financial services at Avalere Healthcare and Katie Sullivan, senior vice president,…

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By: Matt Danford
February 7, 2024
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Session: What are the legal implications of AI in healthcare?

Editor's Note How will healthcare regulators deal with artificial intelligence? How will malpractice law change, and who will be liable for harm derived from AI diagnosis and treatment recommendations? What can be done about bias in AI? Even amid a surge in algorithms cleared by the FDA, all of these…

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By: Matt Danford
February 7, 2024
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Congressional hearing focuses on bill to protect healthcare workers from violence

Editor's Note Nearly 100 house and senate staff attended a January 30 briefing on the Safety from Violence for Healthcare Employees (SAVE) Act, a bill under congressional consideration that aims to protect healthcare workers from assault or intimidation while on the job. In addition to criminalizing these acts, the bill…

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By: Brita Belli
February 2, 2024
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New Joint Commission requirements for total hip, knee replacements focus on opioids, diabetes

Editor's Note The Joint Commission has released revised requirements for the advanced disease-specific care certification for total hip and total knee replacement (THKR). The requirements, which are designed to align with the updated AAOS clinical practice guidelines, go into effect July 1, 2024 and focus largely on addressing opioids and…

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By: Brita Belli
February 1, 2024
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FDA updates safety recall of certain saline, sterile water medical products

Editor's Note The US Food and Drug Administration (FDA) on January 24 updated its safety recall communication from November 6 to add to the voluntary recalls of saline and sterile water medical products associated with Nurse Assist, LLC. The FDA recall notice lists various water-based medical products manufactured by Nurse…

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By: Tarsilla Moura
January 31, 2024
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Impending sale of federal helium reserve raising concerns over supply chain disruptions

Editor's Note The US government's sale of the Federal Helium Reserve, a large underground helium stockpile in Amarillo, Texas, has raised concerns about the supply of helium for critical healthcare applications, especially MRI machines, NBC News reported January 25. The Federal Helium Reserve reportedly provides up to 30% of the…

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By: Tarsilla Moura
January 31, 2024
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