Aligned with the guidelines of the Cybersecurity Act and the existing guidance on cybersecurity for medical devices, ENTRUST envisions 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 has 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 will leverage a series of breakthrough solutions to enhance assurance without limiting the applicability of connected medical devices by enclosing to them cybersecurity features. The project will introduce a novel remote attestation mechanism to ensure the device’s correct operation at runtime regardless of its computational power; will be efficient enough to run in also resource-constrained real-time systems such as the medical devices. This will be accompanied by dynamic trust assessment models capable of identifying the Required Level of Trustworthiness (RTL) per device and function (service) that will then be verified through a new breed of efficient, attestation mechanisms (to be deployed and executed during runtime). This will also enable 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 to be attested during runtime. The motivation behind ENTRUST is 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
PARTICLE contributes to the ENTRUST Project by providing the testbed to support the Use Case involving Patient Transport Services. In ambulance transportation, the vehicle is equipped with a large number of connected medical devices that continuously monitor the patient’s vital signs, collecting data that is valuable for providing adequate medical assistance. In addition, the emergency medical technicians (EMTs) collect medically-relevant information on the patient’s condition. Today, this data is only available at the ambulance for the EMTs to monitor the patient’s status and stability during transport. The Use Case will explore the cybersecurity aspects associated with the real-time exchange of the vehicle’s devices data and patient information to the destination hospital, so as to keep the point-of-care medical team apprised of the patient’s status at all times. This information will support the hospital’s medical intervention and early diagnosis and will allow for a better planning of the resources required to assist the incoming patient. Specifically, ENTRUST will address the security vulnerabilities associated with connected medical devices and the exchange of medical data between an unsecure space (i.e., public communications network) and the secure hospital IT infrastructure and will integrate different cybersecurity tools to validate how the ENTRUST System delivers superior levels of cyber protection, ensuring secure data exchange from connected medical devices, the safeguard of the hospital’s IT infrastructure and the privacy of patient data.
ENTRUST has received funding from the European Union’s Horizon programme under the Grant Agreement No. 101095634