Introducing Traceability Information Models in Connected Health Projects

Paulo Eduardo e Silva Barbosa, Fábio Luiz Leite, Danilo F. S. Santos, Alex Figueiredo, Kátia Elizabete Galdino · 2018

In software-intensive products, evidences of regulation conformance and failure propagation mitigation are required. The use of Traceability Information Model (TIM) is an important practice to support system engineering artifacts tracing and links, becoming part of a project traceability planning. Despite the relevance of traceability in terms of guaranteeing quality attributes and certification of these products, improvements creating a link between safety and systems engineering artifacts have not been focus of attention in the connected health industry. The lack of reference practices for adequately applying traceability has hindered product certification. In this work, we move towards introducing a TIM practice for integrated functional and safety specifications in connected health projects. To achieve this, we performed a case study involving an infusion control system. Evidences show that considerable advantages can be obtained by introducing a TIM into the modeling process. Therefore, the main contribution of this paper is to present an approach for the connected health industry to start dealing with traceability challenges.

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