SERAI

Increasingly, regulatory requirements arise from the comprehensive perspective of ethical aspects. Their proactive consideration is therefore becoming increasingly important in order to achieve sustainable positive social effects on the one hand and resilient value creation on the other. However, efficient methodologies appropriate to the working environment are required to ensure this in complex projects and under time and cost pressure.

The project involves the development of model-based tools for value-driven, ethical innovation in the field of AI-based medical technology. The tools should integrate seamlessly into model-based development processes supported by systems engineering.

Integrating ethical requirements into systems engineering-based requirements management is a way to enrich methodological stringency from everyday development with ethical reflection and allows this to happen in methodological contexts familiar in engineering. In the project, best practices of integrating ethical reflection into the development process, as well as existing and emerging standards and norms are condensed and reviewed for their ability to be integrated into systems engineering. An ideal-typical vision of integrated ethical reflection is compared with the possibilities of ethics requirements management. To address anticipated differences between ideal and practice, suggestions for processual consideration as an accompaniment to model-based integration of ethical requirements and evaluations will be developed. For a practice-oriented embedding and the consideration of industrial requirements, the project will be designed in close cooperation with a company experienced in systems engineering and as well as a research-related partner in science transfer right from the beginning, in order to enable the transfer into regionally leading medical technology development.

The result is a method for the transparent consideration and evaluation of ethical implications in engineering. Its seamless and pragmatic integration strengthens the awareness of development teams and enriches the industrial value creation process through efficiency and synergy. The findings are presented in the form of a freely available report including guidelines and a description of an accompanying process, as well as teaching materials, making them easily communicable.

• Institute of Medical Informatics

• Fraunhofer IMTE
• ThinkSono GmbH