IEEE 11073-40102-2020

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 capability part of cybersecurity is information security controls related to both digital data and the relationships to safety and usability. For PHDs/PoCDs, this standard defines a security baseline of application layer cybersecurity mitigation techniques for certain use cases or for times when certain criteria are met. This standard provides a scalable information security toolbox appropriate for PHD/PoCD interfaces, which fulfills the intersection of requirements and recommendations from National Institute of Standards and Technology (NIST) and the European Network and Information Security Agency (ENISA). This standard maps to the NIST cybersecurity framework [B15]; IEC TR 80001-2-2 [B8]; and the Spoofing, Tampering, Repudiation, Information Disclosure, Denial of Service, and Elevation of Privilege (STRIDE) classification scheme. The mitigation techniques are based on the extended CIA triad (Clause 4) and are described generally to allow manufacturers to determine the most appropriate algorithms and implementations.

The purpose of this document is to build a common approach to cybersecurity mitigation on PHD/PoCD interfaces and define a scalable information security toolbox appropriate for the PHD/PoCD data exchange standards.

New IEEE Standard - Active. For Personal Health Devices (PHDs) and Point-of-Care Devices (PoCDs), a security baseline of application layer cybersecurity mitigation techniques is defined by this standard for certain use cases or for times when certain criteria are met. The mitigation techniques are based on an extended confidentiality, integrity, and availability (CIA) triad and are described generally to allow manufacturers to determine the most appropriate algorithms and implementations. A scalable information security toolbox appropriate for PHD/PoCD interfaces is specified that fulfills the intersection of requirements and recommendations from the National Institute of Standards and Technology (NIST) and the European Network and Information Security Agency (ENISA). A mapping of this standard to the NIST cybersecurity framework; IEC TR 80001-2-2; and the Spoofing, Tampering, Repudiation, Information Disclosure, Denial of Service, and Elevation of Privilege (STRIDE) classification scheme is defined.