P2621.2 - Standard for Wireless Diabetes Device Security Assurance: Protection Profile for Connected Diabetes Devices
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This standard describes the security requirements, which compose a Protection Profile, for connected diabetes devices (CDDs). This standard includes: 1. Identification of relevant threats to CDDs and derivation of security objectives that counter those threats. 2. Derivation, from the security objectives, of security requirements for CDDs, taking into account the need to balance security and safe clinical application. 3. As part of that balance, differentiation between mandatory and optional requirements and specification of objectives that must be handled by the CDDs deployment environment rather than the CDD itself. 4. As part of that balance, definition of multiple levels of assurance requirements, enabling certification bodies and other stakeholders to apply a level of independent evaluation rigor that meets the collective and often varying needs across disparate situations, deployments, treatment criticality, and device type. 5. In order to be most useful for a broad audience of stakeholders, an informative layperson's explanation of CDD security requirements, in addition to the formal, normative requirements that follow the standardized requirements definition framework of ISO/IEC 15408.
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