Digital Twin Based Software Design in eHealth - A New Development Approach for Health / Medical Software Products

摘要

The already presented digital twin concept for information management of health and medical software products is further elaborated with respect to regulatory requirements, the FDA and EU unique device identification (UDI) system, and software product lifecycle management. The concept builds on (1) a personal digital twin as a Gemini of the patient, (2) a group digital twin modelling the designated user group of the software, and (3) a system digital twin for the software product itself. Beside the elaboration of the digital twin concept, we present the strengths and limitations of a digital twin based software design and development approach for health and medical software. The approach deliberately entails a better support of agile development techniques in comparison to the V-model based classic software development in this field of application.