Toward global standards for SaMD: introducing a proposal for Good Digital Medicine Practices (GDMP).

Abstract

Software as a Medical Device (SaMD) has reshaped the technological, regulatory, and clinical landscape of modern healthcare. Yet regulatory approaches remain anchored to assumptions grounded in traditional medical devices: linear development, fixed performance characteristics, and predictable risk profiles. These assumptions no longer hold in an era of adaptive, data-driven, and continuously updating digital systems. This Perspective presents the Good Digital Medicine Practices (GDMP) framework