ENTRUST

About the project

Aligned with the guidelines of the Cybersecurity Act and the existing guidance on cybersecurity for medical devices, ENTRUST envisioned a Trust Management Architecture intended to dynamically and holistically manage the lifecycle of connected medical devices, strengthening trust and privacy in the entire medical ecosystem. Even from the proposal stage, ENTRUST had identified gaps and necessary revisions of the current guidance (e.g. absence of post-market conformity and certification, real-time surveillance and corrective mechanisms). Towards that ENTRUST leveraged a series of breakthrough solutions to enhance assurance without limiting the applicability of connected medical devices by enclosing to them cybersecurity features. The project introduced a novel remote attestation mechanism to ensure the device’s correct operation at runtime regardless of its computational power; it was efficient enough to run in also resource-constrained real-time systems such as the medical devices. This was accompanied by dynamic trust assessment models capable of identifying the Required Level of Trustworthiness (RTL) per device and function (service) that were then verified through a new breed of efficient, attestation mechanisms (deployed and executed during runtime). This also enabled us to be aligned with the existing standards on defining appropriate Protection profiles per device (especially considering the heterogeneous types of medical devices provided by different vendors with different requirements) including Targets of Validation Properties attested during runtime. The motivation behind ENTRUST was to ensure end-to-end trust management of medical devices including formally verified trust models, risk assessment process, secure lifecycle procedures, security policies, technical recommendations, and the first-ever real-time Conformity Certificates to safeguard connected medical devices.