Towards a feature-based regulatory benchmark for user-centred SaMD design in cancer care.

Abstract

Software as a medical device (SaMD) is increasingly central to cancer care, yet current regulatory frameworks from the International Medical Device Regulators, the US Food and Drug Administration and the European Medical Device Regulation lack clear premarket standards for evaluating usability, accessibility and emotional/cultural appropriateness for intended users. This gap is particularly problematic in oncology, where patients, caregivers and clinicians navigate high cognitive load, emotional