Supporting Cybersecurity Risk Management for Medical Devices via the SECUMAN Ontology and Shapes

Medical devices are becoming more software-intensive, connected, and AI-enabled. Their development requires risk-management evidence aligned with ISO 14971 and, for software, IEC 62304. This evidence must be kept consistent across requirements, design decisions, software changes, verification results, complaints, and post-market data. These tasks are costly and depend on scarce safety and domain experts. Large language models (LLMs) may reduce parts of this effort because medical-device safety work is highly document-based. However, current LLM-based safety-engineering studies often address isolated methods, rely on generic prompting or public examples, and provide limited support for source links, traceability, uncertainty handling, lifecycle updates, and recorded expert review. This limits their use in regulated medical-device development. This paper argues that the central research problem is not safety-text generation, but source-linked safety-knowledge support. We propose an evidence-grounded framework that connects device artifacts, controlled knowledge storage and retrieval, method-specific generation of candidate safety items, critique and uncertainty checks, and recorded expert review. The framework prepares, links, checks, and updates candidate safety artifacts for expert decision-making. It does not decide whether a device is safe and does not provide regulatory approval. We also outline an evaluation strategy using non-public or newly built medical-device case studies and expert reference analyses to assess coverage, correctness, relevance, traceability, duplicate rate, unsupported claims, and review effort.

Regulated cybersecurity workflows lack a runtime substrate that enforces organization-level scope across retrieval, tool calls, memory, findings, reports, and audit while remaining model-agnostic and locally deployable. Recent large language model (LLM) agent systems report strong results on isolated cybersecurity tasks, yet they do not by themselves define an auditable platform architecture for regulated security operations centre (SOC) and compliance workflows, where a single analyst may trigger actions that bind the organization, and where the runtime must integrate with existing SIEM/XDR stacks as a primary source of context and alert-driven triggers rather than operate as a standalone analytical layer. This paper proposes an organization-scoped LLM agent runtime architecture for financial cybersecurity. The contribution is a typed Security Context that is created at every entry point, including SIEM/XDR notifications ingested as first-class triggers, and enforced at every component boundary, combined with a shared Runtime Core, logical specialist subagents, a governed Tool Adapter Layer exposing SIEM/XDR query, enrichment, and response primitives under uniform policy and audit, structured findings with evidence references, tiered human-in-the-loop (HITL) gates, and append-only audit. Model Context Protocol (MCP), extended telemetry, digital twins for pentesting, graph retrieval, and federated knowledge sharing are treated as optional extension paths rather than mandatory runtime assumptions. We describe an implementable slice as the architecture's testability surface, and we propose a falsifiable evaluation plan with metric-level pass criteria for architecture readiness, security-policy enforcement, evidence traceability, output quality, and operational observability.

The rapid evolution of digital health technologies is redefining healthcare services worldwide. The integration of wireless communication and Internet-enabled medical devices within Internet of Medical Things (IoMT) networks enables continuous, real-time patient monitoring. However, this increased connectivity raises cybersecurity and patient safety risks due to increasingly sophisticated cyberattacks. This paper proposes a novel on-device, interpretable Tsetlin Machine (TM)-based Intrusion Detection System (IDS) to identify various phases of cyberattacks in IoMT environments. The TM is a rule-driven and transparent machine learning (ML) approach that represents attack patterns using propositional logic. Extensive evaluations on the MedSec-25 dataset, encompassing various phases of realistic cyberattacks, show that the proposed model outperforms ML models, attaining an F1-score (macro) of 97.83%. Moreover, the proposed model offers explicit explanations of its decisions to enhance transparency using feature-level contributions, class-wise vote scores, and clause activation heatmaps. Edge deployment (Raspberry Pi) further supports real-time on-device inference and intrusion detection. The combination of interpretability and high performance makes the proposed model well-suited for IoMT healthcare, where trust, reliability, safety, and timely decision-making are critical.