Software as a Medical Device

20/02/2025

Analysis of 2023-2024 data including question additions on SaMD (2024 only) and related questions from all organisations participating in the Scottish Government/COSLA Digital Maturity Assessment demonstrates that, while the infrastructure supporting digital licensing and software asset management can be considered mature, SaMD assets are rarely managed using that infrastructure, and lifecycle management for this class of assets is not yet ubiquitous. 

The distribution of responses points at a lack of organisational awareness around SaMD and related management / governance requirements, which aligns with the recent gain in prominence of devices of this kind

A bar chart showing information about
SaMD capabilities in 2023 and 2024.
 A stacked bar chart showing the
distribution of assessment responses for
questions about SaMD capabilities in 2023 and
2024.

by Rebecca Hawkins


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