Insights

Field notes from the MedTech security trenches.

Deep dives on FDA expectations, threat modeling, penetration testing, SDLC, and the standards your team is being asked to meet.

Standards· Jan 22, 2024

AAMI TIR57 Risk Management for Medical Devices

A practical guide to AAMI TIR57 (R2023) and how it supports FDA’s Feb 2026 cybersecurity guidance - risk analysis, controls, and evidence.

#Standards#Risk

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Networking· Jan 21, 2024

Securing Communication Protocols in Medical Devices

This guide emphasizes securing communication protocols in medical devices and provides actionable insights for manufacturers to enhance safety and privacy.

#Networking

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Primer· Jan 21, 2024

MedHacking and MedJacking

In this post we're diving into a critical yet often shadowed aspect of healthcare cybersecurity – MedHacking and its various forms, including Medjacking

#Primer

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Audits· Jan 19, 2024

Conducting a Medical Device Security Audit

This post outlines the key steps to perform a comprehensive cybersecurity risk assessment and testing of medical devices.

#Audits#Quality

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Primer· Jan 19, 2024

Risks of Cyber Threats in Medical Devices

In this post, we unravel this complex issue of cyber threats in medical devices and discuss what manufacturers can do to make their devices more secure.

#Primer#Risk

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Primer· Jan 18, 2024

5 Steps to Secure Medical Devices

The post reviews a vital yet often overlooked topic: securing medical devices from cyber threats and what steps can be taken to ensure medical device security.

#Primer

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Risk· Jan 18, 2024

ISO 14971 Risk Management for Medical Device Security

Learn how ISO 14971 risk management applies to medical device cybersecurity - identify cyber hazards, control residual risk, and align with FDA expectations.

#Risk#Standards

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Standards· Jan 18, 2024

ISO 14971 + AAMI TIR57: The Connection

This article discusses the relationship between ISO 14971 and AAMI TIR57, and how they help address risks in the production and use of medical devices.

#Standards

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Primer· Jan 15, 2024

Cybersecurity Concerns with HL7

Updated April 15, 2025 Health Level 7 (HL7) is a vital cog in the machinery of healthcare information technology. It is the backbone for data exchange across various healthcare systems, facilitating improved patient care and efficient administration. However, the extensive adoption of HL7 also bring

#Primer

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FDA· Jan 15, 2024

20 Common Medical Device Protocols

This post covers the purposes, security risks, & regulatory guidance for medical device protocols for manufacturers, healthcare providers, & regulatory bodies.

#FDA

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Testing· Jan 15, 2024

7 Software Testing Principles for Medical Devices

Learn the 7 software testing principles and how to apply them to medical device software and cybersecurity - risk-based testing, evidence, and common pitfalls.

#Testing

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Threat Intel· Jan 14, 2024

Top 10 Ways Cybercriminals Monetize Medical Device Cybersecurity Breaches

Discover the 10 ways cybercriminals monetize medical device breaches. Get expert advice from Blue Goat Cyber to protect patient data, safety, and compliance.

#Threat Intel#Incident Response

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