GAO Calls for Stronger FDA Oversight of Third-Party Medical Device Reviews
A federal watchdog report highlights audit delays exceeding six months for accredited organizations handling 510(k) reviews for low-to-moderate risk devices.
Category: Standards
Standards
Latest
Standards
Latest
The Next Healthcare Cyberattack May Start With a Trusted Vendor
Growing reliance on vendors, remote access, and connected technologies is expanding healthcare’s cyber risk and putting greater emphasis on third-party oversight and continuity planning.
Standards
Latest
FDA Clears Wearable Platform for Parkinson’s Symptom Monitoring
The system uses clinical-grade wearables and algorithms to provide objective data on tremors, sleep, and medication compliance.
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FDA Issues Alert for GE HealthCare Patient Monitoring Software Issue
The issue involves the Portrait Mobile Monitoring Solution and could lead to patients being removed from the system or alarm settings resetting during updates.
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You Can’t Patch Everything, So Own the List That Decides What Gets Fixed First
Hospitals can’t address every medical device vulnerability at once, making clear ownership of the priority list—and HTM’s role in shaping it—critical.
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FDA Issues Early Alert for Becton Dickinson Convenience Kits
Certain procedure trays contain recalled sodium chloride ampules that may pose a risk of infection or organ failure.
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FDA Seeks Input on Generative AI Medical Device Regulation
The agency released a discussion paper to address the unique risks and potential of generative artificial intelligence in the healthcare ecosystem.
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Healthcare Leaders Report Network Security and Disruptions Impact Patient Care
A survey of more than 300 professionals indicates that cybersecurity is a top concern as technical teams struggle with system complexity.
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Securing the Biomedical Network: Building a Foundation for Safe, Connected Healthcare
A layered cybersecurity strategy can help healthcare organizations protect connected medical devices without disrupting clinical operations.
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IBM Report Finds AI-Enabled Data Breaches Cost Organizations Average of $6 Million
Malicious attacks using artificial intelligence increased 56% over the previous year, according to the 2026 Cost of a Data Breach Report.
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Baxter Identifies Cybersecurity Incident Involving Third-Party Applications
The company reports no impact on manufacturing, patient services, or medical technology safety.
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CHAI Forms New Group to Address Artificial Intelligence Cyber Threats
The work group will develop playbooks and risk assessment tools to help healthcare organizations defend against advanced model risks.
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HANYS Marketplace and ECRI Partner to Improve Patient Safety in New York Hospitals
The collaboration provides health systems with evidence-based solutions to address medical device safety, infection control, and medication practices.
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Joint Commission International Launches Clinical Certification Program
The certification provides a framework for specific service lines and does not require prior organizational accreditation.
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