A small interface change can matter
Moving a recommendation from a secondary panel to an interruptive pop-up can alter how often users act on it even if the model is unchanged. That is a meaningful change to the intervention people experience.
Similarly, a revised unit conversion can change inputs without changing the model file.
Keep a complete change record
- What changed and why
- Which users and patients are affected
- Tests performed before release
- Known limitations and monitoring needs
- Rollback or suspension arrangements
The relevant evidence depends on the nature and consequences of the change.
Regulatory plans have a defined scope
FDA guidance describes predetermined change control plans for certain AI-enabled device software functions. An authorized plan covers specified changes and how they will be developed, validated, and implemented. It is not permission for any future modification without review.
Local deployment responsibilities remain important too. A vendor update can arrive after the institution's original evaluation, so contracts and processes should make changes visible.
Versioning is most useful when it connects the software configuration to actual outputs and decisions. A release name alone is insufficient if no one can reconstruct which data processing, threshold, and interface were active at the time.
