ENTRUST - ENsuring Secure and Safe CMD Design with Zero TRUST Principles

根据网络安全法案的指导方针和现有的医疗器械网络安全指南，Trusted设想了一个信任管理架构，旨在动态和整体地管理互联医疗器械的生命周期，加强整个医疗生态系统中的信任和隐私。甚至从提议阶段开始，信托基金就发现了不足之处，并对现行指南进行了必要的修订(例如，缺乏上市后符合性和认证、实时监督和纠正机制--见1.2.2)。为了实现这一目标，托拉斯将利用一系列突破性解决方案来增强保障，而不会通过将网络安全功能包含在联网医疗设备中来限制其适用性。该项目将引入一种新的远程证明机制，以确保设备在运行时正确运行，而无论其计算能力如何；将足够高效地运行在资源受限的实时系统中，例如医疗设备。这将伴随着动态信任评估模型，这些模型能够识别每个设备和功能(服务)所需的可信度(RTL)级别，然后将通过一种新的高效证明机制(在运行时部署和执行)进行验证。这还将使我们能够在定义每个设备的适当保护配置文件方面与现有标准保持一致(特别是考虑到不同供应商提供的具有不同要求的不同类型的医疗设备)，包括在运行时要证明的验证属性的目标。Trusted背后的动机是确保医疗设备的端到端信任管理，包括正式验证的信任模型、风险评估流程、安全生命周期程序、安全政策、技术建议和首个实时合规性证书，以保护联网的医疗设备。

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 – see 1.2.2). 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 medical devices.