The Global Standard for Medical IT Risk Management
Developed by ISO and IEC, ISO 80001-1 defines best practices for applying risk management to IT networks that include medical devices. It ensures that Health Delivery Organizations (HDOs) can effectively manage:
The standard outlines roles and responsibilities across healthcare providers, IT departments, and medical device manufacturers, enabling coordinated risk controls throughout the lifecycle of medical IT systems.
Because in Connected Healthcare, Risk is Inevitable—Management Isn’t.
As hospitals and clinics adopt interconnected systems, ISO 80001 helps organizations:
✅ Protect Patient Safety
Prevent harm caused by network-related failures of connected medical devices.
✅ Enhance Cybersecurity
Proactively identify and mitigate threats to sensitive health data and device functionality.
✅ Ensure System Reliability
Maintain consistent performance of critical IT infrastructure supporting clinical care.
✅ Support Regulatory Compliance
Meet expectations from authorities like the FDA, EU MDR, and global data protection laws.
✅ Foster Collaboration
Define clear responsibilities for IT, clinical, and vendor stakeholders to manage shared risks.
🌟 For Patients
⚙️ For Healthcare Providers
📊 For Management & Compliance Teams
💰 For the Business
ISO 80001 empowers healthcare organizations to safely operate in a digitally connected world. It strengthens your reputation as a technology-enabled, patient-focused, and risk-aware institution. From reducing vulnerabilities to enabling innovation, ISO 80001 transforms your IT networks into engines of trust and resilience.
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