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Medical Device Cybersecurity Resource Updated

The FDA has announced that a new Medical Device Cybersecurity Regional Incident Preparedness and Response Playbook is now available.

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In collaboration with the FDA, MITRE has updated the Medical Device Cybersecurity Regional Incident Preparedness and Response Playbook, a resource to help healthcare organizations prepare for cybersecurity incidents. The playbook focuses on preparedness and response for medical device cybersecurity issues that impact device functions.

  • Updates to the playbook include:
    • Emphasizing the need to have a diverse team participating in cybersecurity preparedness and response exercises—including clinicians, healthcare technology management professionals, IT, emergency response, risk management, and facilities staff.
    • Highlighting considerations for widespread impacts and extended downtimes during cybersecurity incidents, which benefit from the use of regional response models and partners.
    • Adding a resource appendix, making it easier to find tools, references, and other resources to help healthcare organizations prepare for and respond to medical device cybersecurity incidents (including ransomware).

As part of the playbook update, a Quick Start Companion Guide was developed to orient new playbook users and help all users quickly identify the key parts of the playbook to turn to during a cyber incident.

To download the updated Medical Device Cybersecurity Regional Incident Preparedness and Response Playbook, click here.

MITRE is a company that was established to advance national security in new ways and serve the public interest as an independent adviser. It continues to deliver on that promise, applying its systems-thinking approach to provide solutions that enhance national security.


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