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    STRIDE Threat Model

    A six-category framework for enumerating threats: Spoofing, Tampering, Repudiation, Information disclosure, Denial of service, Elevation of privilege.

    Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026

    Definition

    STRIDE is a threat-classification taxonomy developed by Microsoft in the late 1990s and now the de-facto threat-modeling vocabulary in medical device cybersecurity. The acronym stands for Spoofing identity, Tampering with data, Repudiation, Information disclosure, Denial of service, and Elevation of privilege - six classes of threat that map onto the security properties of authentication, integrity, non-repudiation, confidentiality, availability, and authorization. STRIDE is used to systematically walk every element of a data-flow diagram and ask, for each, which of the six threat classes apply and how they would be mitigated.
    What the regulation says
    FDA's 2023 cybersecurity guidance and AAMI TIR57:2016 both reference STRIDE as an example threat-modeling methodology. FDA does not mandate STRIDE specifically, but reviewers expect the threat model to use a recognized methodology applied systematically - STRIDE is by far the most common in submissions and reviewers are accustomed to its structure.

    What this means in practice

    STRIDE shines when paired with a data-flow diagram (DFD) that shows trust boundaries between subsystems. The team walks each element (process, data store, external entity, data flow) across each STRIDE category, recording threats, likelihood/impact, and mitigations. The output feeds the cybersecurity risk assessment and links to ISO 14971 safety harms.
    Common pitfalls
    • •Applying STRIDE without a current data-flow diagram - there's nothing systematic to walk.
    • •Conflating STRIDE categories (e.g., logging Information disclosure threats as Tampering).
    • •Stopping at threat enumeration without scoring likelihood/impact and selecting mitigations.

    Frequently asked questions

    STRIDE-per-element walks each DFD element through all six categories. STRIDE-per-interaction walks each data flow's source/destination/data combinations. Per-interaction is more thorough; per-element is faster. Most MedTech teams use per-element for breadth and per-interaction on high-risk paths.

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    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-06-20
    Microsoft·1FDA·1MDCG·1
    1. 1
      Microsoft Threat Modeling - STRIDE
      Verified
      Microsoftlearn.microsoft.com
    2. 2
      FDA Cybersecurity Guidance (Sept 2023)
      Verified
      FDAfda.gov
    3. 3
      MDCG Cybersecurity Guidance
      Verified
      MDCGhealth.ec.europa.eu

    Inline markers like [1] jump to the matching reference above.