Threat Modeling articles.

FDA AI Cybersecurity Threats: 7 Attacks

The FDA's Feb 3, 2026 guidance names 7 AI cyber threats, data poisoning, model inversion, evasion, leakage, overfitting, bias, drift, as 524B obligations.

TARA for Medical Devices: FDA Premarket

How Threat Analysis and Risk Assessment (TARA) fits FDA premarket cybersecurity, AAMI TIR57, and ISO 14971 for medical device manufacturers in 2026.

Design FMEA for Medical Devices: dFMEA

How to run a design FMEA (dFMEA) for a connected medical device, link it to the ISO 14971 risk file, and hand cyber failure modes to the threat model.

FMEA vs Threat Modeling for Medical

FMEA covers random and systematic failure modes; threat modeling covers adversarial action.

Infusion Pump Cybersecurity: FDA

What the FDA expects from infusion pump cybersecurity submissions in 2026: threat model focus areas, Section 524B evidence, and the deficiencies that.

Data Flow Diagrams for Medical Device

What a DFD is, the five DFD elements, and how data flow diagrams feed STRIDE threat modeling and the FDA's Security Architecture Views in a 2026.

Penetration Test Case Design for Medical

How to design penetration test cases from a medical device threat model, the methodology that bridges STRIDE-style threats and concrete bench test.

Brainjacking: The Real Cyber-Physical Threat to NeuroTech

Brainjacking is unauthorized control of an implanted neurostimulator. We unpack attack vectors, clinical consequences, and what FDA reviewers expect.

Threat Modeling Connected & Implantable Devices

DREAD vs STRIDE vs PASTA Threat Modeling

STRIDE is the preferred threat modeling baseline for medical device cybersecurity. Compare STRIDE, DREAD, and PASTA and when to use each.\

FDA Security Architecture Views

The FDA's four Security Architecture Views for medical devices (global system, multi-patient harm, updateability, security use cases) and how they differ.

Medical Device Threat and Attack Trees

In this post, we explore the differences and similarities between threat trees and attack trees, specifically in the context of medical device FDA.