IEEE/ISO 11073-40101-2022

Within the context of secure plug-and-play interoperability, cybersecurity is the process and capability of preventing unauthorized access or modification, misuse, denial of use, or the unauthorized use of information that is stored on, accessed from, or transferred to and from a PHD/PoCD. The process part of cybersecurity is risk analysis of use cases specific to a PHD/PoCD. For PHDs/PoCDs, this standard defines an iterative, systematic, scalable, and auditable approach to identification of cybersecurity vulnerabilities and estimation of risk. This iterative vulnerability assessment uses the Spoofing, Tampering, Repudiation, Information Disclosure, Denial of Service, and Elevation of Privilege (STRIDE) classification scheme and the embedded Common Vulnerability Scoring System (eCVSS). The assessment includes system context, system decomposition, pre-mitigation scoring, mitigation, and post-mitigation scoring and iterates until the remaining vulnerabilities are reduced to an acceptable level of risk.

The purpose of this document is to define a common approach to cybersecurity assessment in PHDs/PoCDs and define an iterative, systematic, scalable, and auditable vulnerability assessment appropriate for use in the design of PHDs/PoCDs..

Adoption Standard - Active. For Personal Health Devices (PHDs) and Point-of-Care Devices (PoCDs), an iterative, systematic, scalable, and auditable approach to identification of cybersecurity vulnerabilities and estimation of risk is defined by this standard. The standard presents one approach to iterative vulnerability assessment that uses the Spoofing, Tampering, Repudiation, Information Disclosure, Denial of Service, and Elevation of Privilege (STRIDE) classification scheme and the embedded Common Vulnerability Scoring System (eCVSS). The assessment includes system context, system decomposition, pre-mitigation scoring, mitigation, and post-mitigation scoring and iterates until the remaining vulnerabilities are reduced to an acceptable level of risk.