Supporting Cybersecurity Risk Management for Medical Devices via the SECUMAN Ontology and Shapes
SECUMAN proposes an ontology for structured cybersecurity risk documentation of connected medical devices—potentially useful for NIS2 and MDR compliance automation.
Summary written by editorial AI · Source link below
arXiv:2608.00698v1 Announce Type: new Abstract: We propose the SECUMAN ontology and shapes for representing and analysing cybersecurity risk-management documentation for medical devices. Cybersecurity risks are increasingly relevant for connected medical devices and may have direct consequences for patient safety. Current risk-management files are often maintained as semi-structured natural language text, which makes consistency checking, certification review, and reuse difficult. SECUMAN provi
Editorial Analysis
Standardised, machine-readable risk documentation can cut audit preparation time for medical-device manufacturers navigating overlapping EU cybersecurity and safety regulations.
Pilot ontology-driven risk documentation for connected-device portfolios to identify compliance gaps before NIS2 reporting deadlines.
Structured ontologies for medical-device cybersecurity risk could reduce regulatory documentation burden across product lines.
Forward-looking interpretation drafted by editorial AI under human review — not a reproduction of the source. See methodology.
External link — opens at arXiv Crypto & Security in a new tab.
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