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Top Threat Modeling Resources for Medical Device Cybersecurity

Top Threat Modeling Resources for Medical Device CybersecurityPhoto from Unsplash

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Threat modeling is critical to cybersecurity and FDA submissions. With the latest guidelines, a comprehensive threat model is now a mandatory component of an FDA submission. There are many different ways to perform threat modeling, each with advantages and disadvantages. Using a wide range of resources to encompass as many techniques as possible and achieve maximum coverage can be good.



What Is Threat Modeling?



Threat modeling, as per the “MITRE Medical Device Threat Modeling Playbook,” aims to answer the following questions:

  • What are we working on?
  • What can go wrong?
  • What are we going to do about it?
  • Did we do a good job?

These questions become further refined and build upon each other as the unique situation is analyzed. Threat modeling can be difficult, especially when it comes to medical devices. A new area that is not always common in other areas of cybersecurity is often introduced: patient safety. This is the first and foremost concern with medical device threat modeling.



Of course, while patient health is the primary concern, typical cybersecurity threats still often apply to medical devices. Hackers show boundless creativity, so defenders have to do the same. Understanding the scope of a device in depth is critical to properly securing it. Answering questions about how it should and should not be used can act as a good starting point for understanding more about what problems can happen.



The end goal of threat modeling is to prevent any attacks before they happen. To do this effectively, threats must have appropriate compensating controls tied in. Compensating controls need to be rigorously tested to ensure no bypasses are available, and if any are identified, they need to have controls as well. One often overlooked aspect of threat remediation is the functionality impact that security may have. Perfect security often means that a device will be completely unusable. This is where the expertise of the testing team comes into play, as they will be able to craft appropriate solutions without overly disrupting the device’s normal operations.



Top Threat Modeling Tools And Resources



Blue Goat employs various techniques and tactics when it comes to threat modeling. There is no one-size-fits-all solution since everything must be custom-tailored to the unique environment and challenges the client presents. To accomplish this, Blue Goat relies on a wide range of tools, frameworks, methodologies, and resources when performing threat modeling. Here are some of our go-to resources for the threat modeling process:

  • OWASP Threat Dragon – Threat Dragon is an open-source threat modeling tool provided by the OWASP (Open Web Application Security Project) foundation. It’s designed to be easy to use and focuses on creating data flow diagrams for software applications, including medical devices. It helps identify potential security threats in the design phase and suggests mitigations to improve security posture. Its visual interface and drag-and-drop functionality make it accessible for both technical and non-technical users involved in medical device development and security.
  • Microsoft Threat Modeling Tool – A comprehensive tool developed by Microsoft aimed at helping security and development teams identify and mitigate security risks early in the software development lifecycle, including the development of medical devices. It uses a structured approach to identify potential threats by analyzing the data flow in system architectures and suggesting relevant security controls. Its use in medical device cybersecurity ensures that devices are designed with security in mind from the ground up.
  • STRIDE Framework – An acronym for Spoofing, Tampering, Repudiation, Information Disclosure, Denial of Service, and Elevation of Privileges. STRIDE is a threat modeling framework used to identify potential security threats in software systems, including medical devices. It helps categorize and think about the different types of threats that could impact the confidentiality, integrity, and availability of device data and functionality, guiding the development of strategies to mitigate these threats.
  • CIA Triad – A widely-used model for guiding information security policies within organizations, including those involved in developing and maintaining medical devices. The CIA Triad stands for Confidentiality, Integrity, and Availability. It emphasizes the importance of ensuring that medical device data is kept confidential, accurate and trustworthy (integrity), and readily available to authorized users when needed. The model helps prioritize cybersecurity efforts and design systems that safeguard patient information and device functionality.
  • MITRE Medical Device Threat Modeling Playbook – Developed by MITRE, a not-for-profit organization that operates research and development centers sponsored by the federal government. This playbook is a specialized guide for identifying and mitigating cybersecurity threats specific to medical devices. It provides a structured approach to threat modeling, drawing from real-world scenarios and vulnerabilities identified in medical devices. The playbook aims to standardize the process of threat modeling within the healthcare sector, making it easier for manufacturers and healthcare providers to understand and address potential cybersecurity risks.

Check out our medical device cybersecurity FDA compliance package.

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