DIN-Normenausschuss Gesundheitstechnologien (NAGesuTech),
DIN Standards Committee Health Technologies,
DIN Deutsches Institut für Normung e. V.,
DIN German Institute for Standardization
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Media type:
Standard
Title:
DIN EN ISO 11073-40102
:
Health informatics - Device interoperability - Part 40102: Foundational - Cybersecurity - Capabilities for mitigation (ISO/IEEE 11073-40102:2022); English version EN ISO/IEEE 11073-40102:2022
Other titles:
Früher unter dem Titel: DIN EN ISO 11073-40102 (2021-12)
Medizinische Informatik - Geräteinteroperabilität - Teil 40102: Grundlagen - Cybersicherheit - Möglichkeiten zur Schadensbegrenzung (ISO/IEEE 11073-40102:2022); Englische Fassung EN ISO/IEEE 11073-40102:2022
Informatique de santé - Interopérabilité des dispositifs - Partie 40102: Fondamentaux - Cybersécurité - Capacités d'atténuation (ISO/IEEE 11073-40102:2022); Version anglaise EN ISO/IEEE 11073-40102:2022
Footnote:
Internationale Übereinstimmung mit: EN ISO/IEEE 11073-40102 (2022-03), IDT*ISO/IEEE 11073-40102 (2022-03), IDT
Description:
Within the context of secure plug-and-play interoperability, cybersecurity is the process and capability ofpreventing 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.