Which Chapters and Topics Should Be Included in a Safety Case?

The research presented in this paper highlights the need for updating and expanding the chapters and content of safety cases to accommodate the evolving technological and regulatory landscape, particularly with the integration of AI in safety-critical systems. We have evaluated the relevant topics and chapters for a safety case based on studying relevant safety standards, safety regulations, the EU AI Act, current literature, and interviews with safety experts. As a basis, we have used EN 50129 for railway, which divides safety cases into six parts. We suggest four new parts being included. We included an introduction part (0) to establish scope and context since our solution includes several domains. Due to recent developments in AI, AI regulations and AI standards (RQ1) we have established two new parts: Part 7 “The AI safety report” and Part 8 “Human aspects and oversight”. To ensure that our safety case solution can be used in different domains (RQ2), we have also established two new parts: Part 2, “Operational design domain,” and Part 3, “Concept of operation.” In addition, our AI and cross-domain evaluations resulted in several new and improved subchapters, as shown in the table below. We elaborate on the content of the suggested new parts and which subchapters require improvements.