- Published
- Updated
A wearable firmware update may generate different outputs from the same underlying movement. Recording only the device model may not explain which algorithm or configuration produced a measurement used in a clinical study.
Preserve the meaning of data
Link relevant device, application and processing versions to data provenance. Assess whether a change affects presentation alone or the production of measurements. Manufacturer release notes inform this assessment but do not automatically establish suitability for the study’s intended use. Plan separately for automatic updates that the research team cannot directly control.
Worked example
For example, an update changes how brief interruptions contribute to daily activity totals. Differences before and after the update might appear to reflect participant behaviour. The team links version-transition dates to participant records, refers comparability questions to relevant scientific experts, and separately checks the consistency of the technical transfer.
Review checks
- Check that device and processing versions accompany relevant measurements.
- Compare output definitions and known limitations when a version changes.
- Define how reports distinguish data generated under mixed versions.
Acceptance and boundaries
Acceptance means the technical context of a measurement can be reconstructed and the change impact has a reasoned assessment. An update does not automatically invalidate data, but absence of impact should not be assumed. Document scientific suitability separately from transfer correctness. Preserve relationships between original outputs, any reprocessing and the rules used to create revised results.
Frequently asked questions
- Is manufacturer approval sufficient?
- Manufacturer information matters, but the effect on the specific study measurement and intended use needs separate assessment.
- Can historical data be processed with a newer algorithm?
- It may be considered for a defined purpose, while preserving traceability between raw data, earlier outputs and revised outputs.