Medical device vendor Boston Scientific announced that it has “identified a cybersecurity incident affecting certain information technology systems that resulted in a network outage and disruption to the company’s operations.” It stated that it immediately activated incident response protocols and “began an investigation to assess and contain the threat with…
In an opinion piece called “Keeping Our Defenses Up Against Cyberattacks,” American Hospital Association (AHA) President and CEO Rick Pollack links cybersecurity to patient safety. Mr. Pollack notes that there has been a “troubling increase in cyber threats perpetrated by international cyber gangs and state-sponsored hackers this summer” who are…
Leaders of the “Five Eyes” cybersecurity agencies from Australia, Canada, New Zealand, the United Kingdom, and the United States have united to issue a “call to action” that “the evolving landscape of artificial intelligence (AI) is rapidly transforming cyber risk, and we must act swiftly to remain ahead.” The agencies…
The Health Sector Coordinating Council (HSCC) Cybersecurity Working Group, “a platform for collaboration among healthcare industry leaders and the government for more than a decade to address the most pressing security and resiliency challenges to the healthcare sector,” has published its Health Industry AI Cybersecurity Governance Framework Implementation Guide. HSCC…
Two ASCs publicly reported data security incidents over the last week. Covenant Health’s Advanced Family Surgery Center, formally known as Surgery Center of Oak Ridge (Tenn.), LLC, stated that “on or around November 26, 2025,” it “became aware of a network intrusion that affected a limited number of systems” and…
A Feb. 19 cyberattack took down the University of Mississippi Medical Center’s (UMMC) IT systems, including access to its EMR, resulting in the cancelation of outpatient and ambulatory surgeries and the closure of all of its clinics. Yesterday, UMMC announced that the closures and cancelations will continue through at least…
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…
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…
Editor's Note Serious cybersecurity vulnerabilities remain in healthcare despite significant improvements in recent years, according to a July 16 MedCity News report on recent data from cybersecurity firm Fortified Health Security. Fortified’s research, which reportedly draws on NIST CSF data and first–hand experience from the field, assesses the state of…
Editor's Note The Centers for Medicare & Medicaid Services (CMS) just proposed sweeping changes to the Medicare Shared Savings Program and Physician Fee Schedule for calendar year 2026, including extensive changes to outpatient Medicare policy such as payment increases, expanded procedural access, and new quality reporting updates, as outlined in…
