Regulations/Legal
Federal pushback on CHAI exposes rifts over who should set healthcare AI rules
Editor's Note Federal officials’ public rebuke of the Coalition for Health AI (CHAI) highlights mounting tensions over who should shape guardrails for artificial intelligence (AI) in healthcare, Modern Healthcare October 10 reports. As hospitals accelerate AI adoption, industry leaders, regulators, and developers are clashing over how to ensure the technology’s…
FDA issues Class I alert for Abiomed Impella heart device over cybersecurity risks
Editor's Note The Food and Drug Administration (FDA) on October 10 classified a cybersecurity correction involving Abiomed’s Automated Impella Controller as a Class I recall, the most serious type, according to the FDA Medical Device Recalls and Early Alerts database. While devices are not being removed from clinical settings, the…
Study finds Medicare paid nearly $2 billion for unnecessary back surgeries
Editor's Note More than 200,000 older Americans underwent back surgeries they likely did need, costing Medicare and Medicare Advantage a combined $1.9 billion, Axios October 9 reports. The findings, based on an analysis by the Lown Institute, raise new concerns about overuse of high-cost procedures with limited benefit, as federal…
FDA accelerates medical device safety alerts to reach public within days
Editor's Note The Food and Drug Administration (FDA) has expanded its early alert recall program to include all medical devices, speeding up how quickly the public learns about high-risk safety issues, Modern Healthcare October 9 reports. The initiative allows the FDA to post early alerts within days of manufacturers notifying…
California’s worsening nurse shortage fuels burnout, safety concerns amid management tensions
Editor's Note The nursing shortage in California is deepening, with RN vacancies projected to grow from 3.7% in 2024 to 16.7% by 2033, HealthLeaders and KFF Health News October 8 report. The researchers cite inadequate training and retention pipelines, while nurses on the front lines say mismanagement, understaffing, and profit…
AI is turning medical devices into learning systems, Google Cloud exec says
Editor's Note Artificial intelligence (AI) is driving medical technology from reactive tools to adaptive learning systems, Medical Device Network October 6 reports. Shweta Maniar, Google Cloud’s global director of healthcare and life sciences, said that advances in agentic AI are enabling medtech devices to anticipate patient needs, simplify operations, and…
OR Manager Conference delivers ready-to-use solutions for perioperative leaders
Editor's Note This year, the OR Manager Conference promises playbooks attendees can put to work the day they return home. The event, being held in Anaheim on October 28–30, targets the system-level goals perioperative leaders are accountable for: capacity, cost, culture, and safety across multi-site enterprises. Attendees will get concrete…
The Joint Commission set to spotlight hospitals’ strengths with new SAFEST initiative
Editor's Note The Joint Commission will launch a new initiative in January 2026 to highlight high-performing practices observed during accreditation surveys, according to an October 1 release from the organization. Called Survey Analysis For Evaluating STrengths (SAFEST), the program aims to provide more balanced feedback to accredited organizations while building…
FDA has begun requiring electronic De Novo submissions for new medical devices
Editor's Note Beginning October 1, the Food and Drug Administration (FDA) is mandating that all De Novo classification requests be submitted electronically using its eSTAR system, according to a final rule and guidance issued by the agency. As detailed in the September 30 release, the shift marks a procedural change…
Study: Outpatient surgery costs hinge on site of care, network status
Editor's Note Patients and insurers pay far less for outpatient surgical procedures performed at in-network ambulatory surgery centers (ASCs) than at hospital outpatient departments (HOPDs), the American Journal of Managed Care October 6 reports. This study, led by Xiaoxi Zhao, PhD, Christopher Whaley, PhD, and colleagues, analyzed commercial claims data…
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