Digital Health / 1 min read
AI and Software as a Medical Device
Design considerations for AI-enabled digital health and SaMD solutions where safety, traceability and evidence matter.
AI-enabled healthcare software requires an explicit safety and evidence strategy from the first architectural decisions.
The product must make risk controls, traceability, validation and post-market learning part of the delivery lifecycle. This is especially important when generative AI is introduced into clinical or operational workflows.
The opportunity is significant, but the architecture has to respect the domain: explainability where needed, clear human oversight and a robust quality management mindset.