Regulations/Legal

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June 2024
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FDA recalls BrightView SPECT systems

Editor's Note The FDA has issued a Class I recall of Philips’ BrightView, BrightView X and BrightView XCT Single Photon Emission Computed Tomography (SPECT) scanners due to a component failure that could result in the system’s detector falling on patients. Philips sent all affected customers an Urgent Medical Device Correction…

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By: Matt Danford
February 15, 2024
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The Joint Commission, NFQ announce 2023 Eisenberg Award recipients

Editor's Note The Joint Commission and National Quality Forum (NQF) on February 14 announced the recipients of the 2023 John M. Eisenberg Patient Safety and Quality Awards. The Awards recognize major achievements by individuals and organizations to improve patient safety and healthcare quality. This year’s recipients are: National Level Innovation…

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By: Tarsilla Moura
February 15, 2024
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Expected CDC COVID-19 isolation guidance revisions exclude those with mild symptoms, no fever

Editor's Note This spring, The Centers for Disease Control and Prevention (CDC) is expected to announce that individuals who test positive for COVID-19 no longer need to isolate if they’ve been fever-free for 24 hours and symptoms are mild or improving. Current guidelines, in place since 2021, recommend isolating for…

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By: Matt Danford
February 14, 2024
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Study examines high emergency department use by transgender Medicare patients

Editor's Note A study showing greater likelihood for transgender (TGD) Medicare patients to use the emergency department highlights the need to train staff in transgender-inclusive care, the authors argue. Conducted by the Brown University School of Public Health, the study was published February 13 in JAMA Internal Medicine. As reported…

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By: Brita Belli
February 13, 2024
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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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