FDA SIR: Risk Assessment Techniques for Apps & Devices within Interoperable Medical Frameworks

1343468 Hatcliff，John M.在之前的NSF FDA SIR工作中，PI对如何应用SAE标准架构和分析设计语言(AADL)来指定ICE应用程序和ICE设备的架构、接口和高级行为进行了初步调查。最近，软件工程研究所(SEI)的研究人员为AADL开发了一个错误建模框架(EMv2)，该框架能够对不同类型的故障、单个系统组件的故障行为、影响相关组件的故障传播进行建模，以及对系统体系结构中预期的容错策略进行规范。在这份提案中，PI将展示AADL EMv2如何为安全/风险分析活动提供半自动支持，这些活动可用于ICE应用程序和设备的监管提交。它们将(A)定义与MDCF应用程序和设备相关的常见错误/故障库；(B)说明驱动常见风险分析技术(如故障树分析、故障模式、影响和危害性分析以及功能风险分析)所需的信息如何根据带有错误模型信息的AADL架构进行形式化；(C)说明设备行为和可能出现错误、传播和缓解错误的条件的正式接口规范的好处；以及(D)制定建议，说明如何将这些活动产生的人工制品作为ICE组件监管提交的一部分进行呈现。

1343468 Hatcliff, John M. In previous NSF FDA SIR work, the PIs conducted an initial investigation of how the SAE standard Architecture and Analysis Design Language (AADL) might be applied to specify the architecture, interfaces, and high-level behavior of ICE apps and ICE devices. Recently, researchers at the Software Engineering Institute (SEI) developed an Error Modeling framework (EMv2) for AADL that enables modeling of different types of faults, fault behavior of individual system components, modeling of fault propagation affecting related components, as well as specification of fault tolerance strategies expected in the system architectures. In this proposal the PIs will demonstrate how AADL EMv2 can provide semi-automated support of safety / risk analysis activities that can be used in regulatory submissions for ICE apps and devices. They will (a) define libraries of common errors / faults relevant to MDCF apps and devices, (b) illustrate how information needed to drive common risk analysis techniques such as Fault Tree Analysis, Failure Modes, Effects, and Criticality Analysis, and Functional Hazard Analysis can be formalized in terms of AADL architecture annotated with Error Model information, (c) illustrate the benefits of formal interface specifications of device behavior and conditions under which errors may arise, be propagated, and be mitigated and (d) develop recommendations for how the artifacts resulting from these activities might be presented as part of regulatory submissions for ICE components.