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 as a structured proposal to harmonize global oversight of SaMD, including AI-enabled systems. GDMP articulates principles for continuous validation, algorithmic transparency, risk-proportionate lifecycle management, and international convergence. By providing an operational reference model grounded in real-world regulatory experience, GDMP seeks to advance a coherent, globally relevant foundation for safe, equitable, and trustworthy digital medicine.

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