FDA SIR: Architecturally-Integrated Hazard Analyses for Medical Application Platforms

这项研究的目的是为基于医疗应用平台(MAP)概念的下一代集成医疗系统开发新形式的工具支持的安全分析。MAP是一个安全和安全关键的实时计算平台，用于(A)通过通信基础设施集成不同的设备、医疗IT系统和信息显示，以及(B)托管通过从集成的设备、IT系统和显示器获取信息和更新/控制集成的设备、IT系统和显示器来提供医疗实用的应用程序(APP)。该项目的智力价值在于开发新形式的危险分析(安全关键系统中使用的主要分析形式之一)，其能够克服基于地图的系统带来的独特挑战。该项目将开发工具支持，以(A)将危险分析与地图系统的建筑模型结合起来，并(B)提供分析步骤的重大自动化。在与美国食品和药物管理局(FDA)的工程师协商后，该项目将构建与地图应用程序相关的模拟风险管理和监管文物。这项工作的影响主要集中在帮助FDA工程师了解与MAP相关的架构和安全问题，并确定可导致基于MAP的医疗系统的高度保证的最佳实践。此外，该项目还将提供具体的危险分析实例，为设计新的监管办法和行业安全标准提供科学依据，以支持对不同种类的多供应商地图系统的组成监管。

The objective of this research is to develop new forms of tool-supported safety analyses for next-generation integrated medical systems that are based on the concept of medical application platforms (MAP). A MAP is a safety- and security- critical real-time computing platform for (a) integrating heterogeneous devices, medical IT systems, and information displays via a communication infrastructure and (b) hosting application programs ("apps") that provide medical utility via the ability to both acquire information from and update/control integrated devices, IT systems, and displays.The intellectual merit of the project lies in developing novel forms of hazard analyses (one of the primary forms of analysis used in safety critical systems) that can overcome the unique challenges posed by MAP-based systems. The project will develop tool support that will(a) integrate hazard analyses with architectural models of MAP-based systems and (b) provide significant automation of analysis steps. Inconsultation with engineers from the Food and Drug Administration (FDA), the project will construct mock risk management and regulatoryartifacts associated with MAP apps. The impact of this work centers around helping FDA engineers understand the architectural and safety issues associated with MAPs and identifying best practices that can lead to high assurance of MAP-based medical systems. Additionally, the project will produce concrete hazard analysis examples that will provide science-based inputs into the design of a new regulatory approach and industry safety standards that support compositional regulation of heterogeneous multi-vendor MAP-based systems.