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

Abstract: 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. In consultation with engineers from the Food and Drug Administration (FDA), the project will construct mock risk management and regulatory artifacts 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.