Integrating Functional Safety into Hazard-Based Safety Engineering: Towards a Comprehensive Framework

As the convergence between hardware and software and the corresponding complexity escalates, the adequacy of safety standards should be reevaluated. The first Hazard-based Safety Engineering (HBSE) standard, IEC 62368-1, despite its comprehensive focus on protection against hazards such as fire, overcurrent, and overtemperature, lacks explicit inclusion of Functional Safety requirements when those safety protections are software-controlled. This paper is a pioneering attempt to present the rationale, assessment process, and nomological validity for incorporating Functional Safety principles into IEC 62368-1 by proposing a potential comprehensive framework that combines HBSE and RBSE, and this will maximize the potential of cutting-edge technologies implemented in ICT products, including the latest generative artificial intelligence (GenAI), and dynamic safety design such as telemetry-based failure prediction.