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The U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) reminds you that, like other electronics, medical devices can be vulnerable to security breaches, potentially impacting the safety and effectiveness of the device.
Informed by patient voices and collaborations with industry, government agencies, and health care delivery organizations, the FDA will continue to drive and refine medical device cybersecurity policy.
Before Cybersecurity Awareness Month ends, check out these recent publications that may be generally informative to help keep medical devices operating safely.
Recent Publications
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Data Normalization Challenges and Mitigations in Software Bill of Materials (SBOM) Processing White Paper
- The FDA contracted with MITRE to develop a publication that discusses normalization challenges and mitigations for generating and digesting SBOMs, and advantages of using a standard nomenclature and formats to ensure that data from various sources is consistent.
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Digital Certificate Management for Medical Devices
- This article, published in the Journal of Clinical Engineering, provides health care delivery organizations and clinical engineers an introduction to the role of digital certificates to secure and manage access to medical devices, including discussion of potential issues. The contents of this journal article represent the views of the authors and do not necessarily represent the official views of, and are not an endorsement by, U.S. Food and Drug Administration (FDA)/Department of Health and Human Services (HHS) or the U.S. Government. The views, findings, and interpretations contained in this document do not constitute FDA guidance, position on this matter, or legally enforceable requirements.
Questions?
If you have questions about cybersecurity and medical devices, email CyberMed@fda.hhs.gov.
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