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A Reference Architecture for Secure Medical Devices.

Steven Harp, Todd Carpenter, John Hatcliff

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    |September 28, 2018
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    Summary
    This summary is machine-generated.

    We introduce the ISOSCELES architecture to enhance medical device safety and security. This open-source solution uses advanced software isolation for critical life-saving services.

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    Area of Science:

    • Computer Science
    • Medical Device Engineering
    • Cybersecurity

    Background:

    • Medical devices require robust safety and security measures.
    • Existing architectures may not adequately address evolving cyber-physical threats.
    • Ensuring the integrity of life-critical essential services is paramount.

    Purpose of the Study:

    • To propose a novel reference architecture, ISOSCELES, for enhancing medical device safety and security.
    • To leverage advancements in software component isolation for critical systems.
    • To provide an open-source framework for developing secure and safe medical devices.

    Main Methods:

    • Developed the ISOSCELES architecture based on design principles and software component isolation (hypervisor technology).
    • Utilized Architecture Analysis and Design Language for device instantiation and development processes.
    • Created architecture models supporting safety, security, and risk management analyses.
    • Developed prototypes on low-cost boards for practical application.

    Main Results:

    • The ISOSCELES architecture provides a foundation for intrinsically secure and safe medical devices.
    • Architecture models facilitate safety/security analysis and software skeleton derivation.
    • Prototypes demonstrate the feasibility of the architecture on accessible hardware.
    • The project releases prototypes and artifacts under an open-source license.

    Conclusions:

    • The ISOSCELES architecture offers a viable approach to improving medical device safety and security.
    • Leveraging hypervisor and separation technologies enhances the protection of life-critical services.
    • The open-source nature promotes wider adoption and collaborative development in medical device security.