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 · Medical Device Cybersecurity
Genomic sequencing cybersecurity protects diagnostic results, instrument software, and connected workflows. Learn FDA scope, SBOM evidence, and test limits.
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Post · Compliance
Vulnerability management metrics for medical device makers: which KPIs to track, how to set targets by risk, and how they support FDA 524B postmarket plans.
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Post · Risk Management
Benefit-risk analysis weighs medical device benefits against residual risks. Learn how ISO 14971, FDA pathways, and cybersecurity evidence fit together.
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Post · Compliance
Does the FDA care about stolen PHI from a medical device? How confidentiality fits security risk, when it reaches ISO 14971 harm, and what HIPAA covers.
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Post · Risk Management
Medical device cybersecurity should scale with device risk. Christian Espinosa argues why meeting only the Section 524B minimum leaves patients and submissions exposed.
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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 FDA guidance recommends 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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