Editor's Note A joint letter from the American Medical Association (AMA) and more than 100 medical organizations asks Health and Human Services (HHS) Secretary Xavier Becerra to confirm that providers do not bear responsibility for legal reporting requirements for information stolen in the Change Healthcare cyberattack, including personal patient data.…

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Editor's Note The US Food and Drug Administration (FDA) has classified recalls of Abbot’s HeartMate 3 Left Ventricular Assist System (LVAS) implant kits and Phillips Respironics' Trilogy Evo ventilators as class 1, the most serious category indicating risk of serious injury or death. Used while waiting for recovery, a transplant,…

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Editor's Note The US Food and Drug Administration (FDA) has designated Route 92 Medical’s recall of products containing the Tenzing 7 delivery catheters as class 1, the most serious classification indicating risk of serious injury or death. The devices are used to deliver microcatheters to the blood vessels in the…

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Editor's Note Black Basta, reportedly the second most prolific ransomware group in the world, has healthcare organizations firmly in its crosshairs, according to a May 13 article in the Hippa Journal. Citing a May 10 bulletin on the group from Health Information Sharing and Analysis Center Healht-ISAC, the article notes…

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Editor's Note Recognizing that complying with some standards is more difficult than complying with others, The Joint Commission regularly evaluates which areas are most difficult so it can tailor education accordingly. To that end, a May 7 report reveals the top 5 most frequently cited elements of performance (EPs) in…

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Editor's Note A recent data breach at Kaiser Permanente could impact as many as 13.4 million people who are part of the healthcare conglomerate’s Kaiser Foundation Health Plan, according to the Department of Health and Human Services (HHS). Fox Business reported the news April 29. The breach was first reported…

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Editor's Note The number of US Food and Drug Administration (FDA) Class 1 recalls—the most serious classification—for medical devices has been trending upwards. Regulatory News, a publication of the Regulatory Affairs Professional Society (RAPS), reported the news April 25.  According to the report, Anne Reid, program director of the Office…

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Editor's Note Effective July 1, telehealth providers can apply for a new Joint Commission accreditation designed to ensure safe, high-quality care. Announced April 23 by The Joint Commission, the new Telehealth Accreditation Program is designed for organizations that exclusively provide care, treatment and services via telehealth. Hospitals and other healthcare…

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Editor's Note Microscopic stainless steel debris on the insides of biopsy needles prompted the FDA to issue a class 1 recall—indicating risk of death or serious injury—for Elekta Instrument’s Disposable Biopsy Needle Kit, which is used with the Leksell Stereotactic System for brain tissue sampling during neurosurgery, the disposable biopsy…

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Editor's Note Starting in 2025, Medicare-certified ambulatory surgery centers (ASCs) will be required to participate in the Outpatient and Ambulatory Surgery Consumer Assessment of Healthcare Providers and Systems (OAS CAHPS) Survey to comply with the ASC Quality Reporting Program, reports the Ambulatory Surgery Center Association (ASCA) and Outpatient Surgery Magazine…

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