Blue Goat Cyber insights
Posts, playbooks, and reference guides on securing connected medical devices.
Featured post · Standards
MDS2 form explained: what HIMSS/NEMA HN 1-2019 requires, who completes it, how hospitals use it, common mistakes, and how it relates to SBOM and FDA rules.
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Post · SBOM & Supply Chain
VEX resources for medical device teams: a document guide, SBOM comparison, and common assessment mistakes, with evidence-based status and regulatory context.
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Post · Threat Modeling
Medical device cybersecurity for nanotech neurostimulation: a fictional STRIDE threat model linking controller risks, patient harms, controls, and testing.
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Post · FDA Compliance
PreSTAR vs eSTAR explained: PreSTAR is the voluntary FDA template for Q-Submissions, eSTAR is required for 510(k) and De Novo. How cybersecurity carries across.
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Post · FDA
Medical device cybersecurity at each study stage: rodent, large animal, primate, and human trials, and what the FDA expects before your IDE and marketing submission.
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Post · Postmarket
What a medical device security advisor does after FDA clearance: keeping the threat model and SBOM current, rating vulnerabilities, and answering hospitals.
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Post · AI Security
Threat modeling AI-enabled medical devices: how to add the model, training pipeline, and updates to your threat model, with a worked example of a fictional AI dosing advisor.
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Post · AI Security
AI training data security for medical devices: how to track where data comes from, control who can change it, and show the FDA your training pipeline is protected.
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Post · AI Security
AI model integrity for medical devices: how to stop model files from being stolen or swapped, sign model updates, and show the FDA the model that runs is the one you validated.
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Post · AI Security
Hospital security questions for AI medical devices: what reviewers ask about models, patient data, outside AI services, and updates, and how to answer with evidence.
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Post · Startups
What investors ask medical device founders about cybersecurity during a raise, what good answers look like, and how to prepare a diligence-ready package.
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Post · Compliance
Medical device data sovereignty explained: where patient data lives, what HIPAA and GDPR transfer rules require, and how to answer hospital security questionnaires.
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Post · AI Security
Generative AI medical device security: how prompt injection, data leakage, and unsafe outputs threaten LLM features in devices, and the controls and tests the FDA will look for.
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