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Glossary Term
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ISO/TR 80001 (Application of Risk Management to IT Networks Incorporating Medical Devices)

Definition

ISO/TR 80001 is a technical report that outlines risk management practices for healthcare organizations and manufacturers when medical devices are connected to IT networks. It focuses on ensuring the safety of patients, the integrity of data, and the availability of critical systems in networked environments.

Relevance to the MedTech Industry

ISO/TR 80001 ensures that risks arising from integrating medical devices with IT networks are systematically managed. This includes mitigating cybersecurity threats, addressing interoperability issues, and maintaining patient safety, particularly as medical technologies increasingly rely on interconnected systems.

Additional Information & Related Terms

Key Components of ISO/TR 80001

  1. Risk Management in IT Networks

    • Provides a systematic approach to identifying, evaluating, and mitigating risks related to IT network integration.

  2. Key Risk Areas

    • Focuses on three primary risk categories:

      • Patient Safety: Ensuring network integration does not create hazards that harm patients.

      • Data Integrity: Protecting the accuracy and reliability of patient and operational data.

      • System Availability: Ensuring critical systems remain operational and accessible when needed.

  3. Roles and Responsibilities

    • Defines the roles of healthcare organizations, device manufacturers, and IT service providers in managing risks.

  4. Lifecycle Approach

    • Emphasizes managing risks throughout the device and network lifecycle, from initial integration to decommissioning.

  5. Documentation and Communication

    • Requires detailed documentation of risk management activities and effective communication between stakeholders.


Examples of Applications

  • Networked Patient Monitors: Ensuring real-time data from bedside monitors is transmitted securely to electronic health records (EHR).

  • Infusion Pumps: Managing risks associated with networked infusion pumps that can be remotely programmed or monitored.

  • Diagnostic Imaging Systems: Ensuring secure and reliable transfer of imaging data between devices and PACS (Picture Archiving and Communication Systems).

  • Wearable Medical Devices: Mitigating risks for devices that transmit patient data wirelessly to healthcare IT systems.

Related Terms

  • ISO 14971: Risk management principles for medical devices, integrated into ISO/TR 80001 for network-specific risks.

  • Cybersecurity for Medical Devices: Closely aligned with ISO/TR 80001 for addressing threats to networked devices.

  • Interoperability: A critical focus area for ensuring compatibility between medical devices and IT systems.

  • Data Integrity: A core component of ISO/TR 80001, ensuring accurate and reliable data transmission.

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