SBOM Adoption Low as EU Mandate Looms, Report Finds
A new cybersecurity report finds few companies are prepared for the EU’s Cyber Resilience Act, which will require software component lists for connected devices.
Category: Standards
Standards
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Standards
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Hamilton Medical Corrects C6 Ventilators Over Circuit Board Defect
The FDA has issued a Class I recall designation for the correction, which addresses a fault that can cause ventilation to stop unexpectedly.
Pros and Cons of Single-Use Versus Reprocessed Medical Devices
ECRI research examines safety, cost, and environmental tradeoffs of reusing versus discarding medical devices in hospitals.
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Federal Agencies Warn of Interlock Ransomware Targeting Critical Infrastructure
A joint advisory outlines tactics and mitigations for the financially motivated Interlock ransomware, which uses rare methods like drive-by downloads and ClickFix social engineering for initial access.
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White House, CMS Announce Industry Pledges to Support Health IT Interoperability
Federal officials announced voluntary pledges from major tech and healthcare firms to support a national interoperability framework aimed at improving data sharing and easing provider burden.
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Court Upholds DMCA Repair Exemption for Medical Devices
A US District Court has upheld a rule allowing limited circumvention of copyright protections for the repair and maintenance of medical devices.
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Strengthening Industry-Government Relationships Amid Leadership Transitions
Advocacy built on long-term relationships can help HTM professionals stay influential as agency leaders and lawmakers change.
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Playbook for Managing Connected Medical Devices
A seven-step guide to managing and securing connected medical devices across healthcare delivery organizations.
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Baxter’s Life2000 Cyber Recall Draws Attention to FDA’s Focus on Software Safety Risks
A cybersecurity vulnerability that prompted Baxter to recall certain Life2000 ventilators is being seen by some industry experts as part of a broader shift in how the FDA treats software-related risks.Â
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FDA Issues Early Alert on Infusion Pump Issue from Baxter
The FDA issued an early alert under its recall communications pilot citing 79 injuries and two deaths linked to Baxter’s Novum IQ infusion pump.
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BD Recalls Alaris Pump Modules Serviced With Previously Recalled Parts
The voluntary recall involves pump modules that may have been repaired with FR-110 bezels, which the company says can weaken over time and compromise safe infusion delivery.
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SunMed Holdings Removes Adult Manual Resuscitator Devices
The Class I recall involves devices with incorrectly assembled B/V filters.
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BD Recalls Certain Alaris Pump Infusion Sets Over Accuracy Issues
Use with select infusion sets may lead to over- or under-infusion, bolus inaccuracies, and alarm delays, BD warns in recall notice.
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Senate NDAA Includes Right-to-Repair Provision for Military Equipment
Advocacy groups urge the House to adopt similar language in its version of the bill.
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