FDA Announces Release of “Playbook for Threat Modeling Medical Devices”

The U.S. Food and Drug Administration（FDA）is announcing the release of “Playbook for Threat Modeling Medical Devices,” which was developed by MITRE and the Medical Device Innovation Consortium（MDIC）. The playbook is an educational resource that discusses best practices for understanding basic threat modeling and processes, and how to apply them to medical devices.

Threat modeling has become a recognized cybersecurity best practice, both generally and in the medical device subsector specifically. However, threat modeling is complex, and involves a specialized set of knowledge and expertise. The Playbook is an educational resource for the medical device sector to learn how to effectively threat model.

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The playbook can be downloaded for free from the Medical Device Innovation Consortium （MDIC）and MITRE websites.