RE4CH: Requirements Engineering for Connected Health

摘要

Health information systems are increasing in quantity and complexity. In this sense, projects of health information systems, which are well-fitted for agile, start to face new challenges imposed by regulators, society and suppliers since they start to interact with medical devices. The problem is that the development of medical device software presents requirements that normally are not addressed by agile methodologies. In this paper, we present RE4CH (Requirement Engineering for Connected Health), an agile process focused on the health regulation viewpoint. We introduce its activities and show its application in an open source case study. Choosing to focus on traceability, we take an important step in compliance following agile practices for open source software that is highly regulated and safety-critical.