Regulations/Legal
Feds warn of increased healthcare cyber threats from Iranian actors
Editor's Note Iranian cyber actors employing techniques such as brute force, password spraying, and multifactor authentication (MFA) "push bombing" to compromise healthcare and other critical infrastructure sectors, the American Hospital Association (AHA) reported October 17. The report cites an October 16 joint advisory issued on October 16 by the FBI,…
OR “megafloor” combines inpatient, outpatient procedures
Editor's Note A newly constructed surgical “megafloor” that connects inpatient and outpatient ORs promises to aid workflow and add flexibility for perioperative teams at The University of California Irvine (UCI) Health—Irvine campus, Healthcare Design reported October 7. As detailed in the article, the academic center must accommodate a variety of…
Outpatient, ASC clinicians share perspectives on upcoming NOPAIN Act implementation
Editor's Note On October 14, Anesthesiology News published a monograph featuring clinical perspectives on how “those working in the trenches of postsurgical pain management” are preparing for the Non-Opioids Prevent Addiction in the Nation (NOPAIN) Act, which outlines new, separate Medicare reimbursement for certain non-opioid analgesics in outpatient and ambulatory…
Feds take action on Hurricane-wracked medical supply chain with wartime powers, drug compounding guidance
Editor's Note The Biden administration has invoked wartime powers to speed rebuilding of intravenous fluid (IV) manufacturing capacity, CBS News reported October 15, four days after the US Food and Drug Administration (FDA) took steps to combat drug shortages. Both efforts are in response to devastation wrought by Hurricane Helene,…
FDA designates Class 1 recall for infusion pumps due to air bubble risk
Editor's Note The US Food and Drug Administration (FDA) has deemed Zyno Medical’s recall of Z-800, Z-800F, Z-800W, and Z-800WF infusion pumps a Class 1, the most severe designation indicating serious risk of injury or death. According to FDA’s October 11 announcement, the recall was due to a defect in…
Medicare policy on prior authorization falls short on shifting outpatient surgery trends
Editor's Note A Medicare policy introduced in 2020, which requires prior authorization for certain procedures done at hospital outpatient departments (HOPDs), has not significantly reduced the volume of surgical procedures being done at these facilities, reports a study by Michigan Medicine, University of Michigan, published on October 9. The policy,…
DEA registration validation changes challenge healthcare accreditation
Editor's Note Since February 2024, changes to the Registrant Validation Toolset from the Drug Enforcement Administration (DEA) have introduced new hurdles for healthcare organizations, MedTrainer October 2024 reports. The updates, which aim to prevent fraud by adding multi-factor authentication, are causing compliance challenges during primary source verification (PSV). Credentialers are…
CMS proposes $2 Drug List Model to reduce out-of-pocket costs for Medicare recipients
Editor's Note CMS has taken the next steps in making prescription drugs more affordable for Medicare recipients, according to an October 9 report from The US Department of Health and Human Services (HHS). The proposed Medicare $2 Drug List Model, developed in line with President Biden’s Executive Order 14087, aims…
FDA announces Class 1 recall for pediatric resuscitator
Editor's Note The US Food and Drug Administration (FDA) has deemed Mercury Medical’s recall of Neo-Tee Resuscitators a Class 1, the most severe category indicating serious risk of injury or death. According to the agency’s October 7 announcement, the recall was motivated by potential for the inline controller to come…
AAMI, CTA partners to develop healthcare AI standards
Editor's Note The Association for the Advancement of Medical Instrumentation (AAMI) has entered into a partnership with the Consumer Technology Association (CTA) to develop new standards for the integration of artificial intelligence and machine learning in healthcare, according to an October 1 report in DOTmed. Formalized through a memorandum of…
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