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

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.

Why it matters

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.

Sources

Microsoft Threat Modeling - STRIDE · Microsoft
FDA Cybersecurity Guidance (Sept 2023) · FDA
MDCG Cybersecurity Guidance · MDCG

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Quality systems - QSR vs ISO 13485, QMSR vs QSR.
Software classification - SaMD vs SiMD, Locked vs adaptive AI.
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MedTech Terms is a vendor-neutral community resource sponsored by Blue Goat Cyber. Definitions are written for educational use and are not legal or regulatory advice.