Healthcare technologies combine complex automation, human operation, and software-driven control, introducing safety challenges that conventional risk methods often miss. This presentation demonstrates how Systems-Theoretic Process Analysis (STPA) can be applied to proactively identify hazards, missing requirements, and unsafe control interactions during system design.

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Several key themes emerge from this work: (1) requirements and gap identification, revealing incomplete or ambiguous specifications that can lead to unsafe outcomes; (2) human–system interaction, analyzing operator control actions, automation, and feedback mechanisms; (3) system modeling, using control structures to visualize interactions and expose vulnerabilities.

 

A representative Electronic Health Record (EHR) example is used to illustrate how these principles apply to healthcare equipment and software. The session concludes with practical guidance for integrating STPA into the medical device and health technology development process to improve safety, usability, and system resilience.