STRIDE Threat Model
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.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.- •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
Cross-references
Used by
Related terms
Shared paths + categoryA structured analysis that identifies how an attacker could compromise a medical device and what controls mitigate each threat.
The bundle of cybersecurity artifacts a sponsor includes in a 510(k), De Novo, PMA, or HDE submission for a cyber device.
The federal statute that gives FDA explicit premarket authority over cybersecurity for cyber devices.
A documented, risk-based set of processes that build cybersecurity into a medical device across its full lifecycle.
AAMI Technical Information Report providing MedTech-specific guidance on cybersecurity risk management.
A machine-readable inventory of all software components, including open-source and third-party libraries, used to build a medical device.
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Primary references
3 sources- 1Microsoft Threat Modeling - STRIDEVerifiedMicrosoftlearn.microsoft.com
- 2FDA Cybersecurity Guidance (Sept 2023)VerifiedFDAfda.gov
- 3MDCG Cybersecurity GuidanceVerifiedMDCGhealth.ec.europa.eu
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