Regulations/Legal
Supply chain stress fractures demand rock-solid continuity planning
More than 4 years after personal protective equipment production and inventories crashed amid the global COVID-19 pandemic, the “new normal” in healthcare supply chains seems to be “uncertainty.” Although hospital margins are improving and patient volumes are trending upward, “stress fractures continue to remain in place,” says Michael Schiller, CMRP,…
FDA announces class 1 recall for radiographic breast tissue marker
Editor's Note The US Food and Drug Administration (FDA) has designated the recall of Hologic Inc.’s BioZorb Marker a class 1, indicating a risk of serious injury or death. BioZorb is an implantable radiographic marker used to mark soft tissue (such as breast tissue) for future medical procedures. Provided sterile…
Cyberattack-affected Providers seek clarity on stolen data reporting responsibility
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.…
RAND study reveals private payers pay 250% more than Medicare for healthcare services
Editor's Note A recent analysis by the RAND Corporation, a research and analysis nonprofit, revealed a disparity between hospital and ambulatory surgery center (ASC) prices paid by employers and private payers compared to Medicare prices, Revcycle Intelligence May 15 reports. The study, covering data from 2020 to 2022, showed private…
Cybersecurity initiative devotes $50 million to help hospitals combat ransomware
Editor's Note A $50 million initiative to develop cybersecurity tools for hospitals aims to protect providers and patients alike from ransomware, according to a May 20 report in Becker’s Health IT. The Universal PatchinG and Remediation for Autonomous DEfense, or UPGRADE, program was launched the same day by the Advanced Research…
FDA announces class 1 recalls for heart devices, ventilators
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,…
The Joint Commission releases annual Sentinel Event Data Report
Editor's Note According to the annual Sentinel Event Data Report, The Joint Commission received 1,411 reports of sentinel events—an event not related to the natural course of an illness or condition that causes severe harm, permanent harm or death—in 2023. Of that total, 96% of events were voluntary self-reported by…
US News & World Report best ASCs ranking now available
Editor's Note With the goal of helping patients choose if outpatient care is right for them and identify the right ambulatory surgery center (ASC) for their needs, US News & World Report unveiled on May 14 its inaugural ranking of the best ASCs in the US. Reportedly, “fewer than 15%…
FDA issues class 1 recall for medical catheters
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…
Prolific ransomware group targets healthcare, prompts official warning
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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