Findings
Despite progress, DHTs are not yet fully accepted in clinical research.
Challenges include small study samples, unrepresentative samples, lack of normative data sets, feature selection bias, and replication issues due to sensor variability.
There is a need for a framework to identify and mitigate sources of variability in DHTs.

Recommendations
Develop a conceptual framework to identify and mitigate sources of variability.
Consider both active and passive monitoring approaches in study designs.
Align knowledge and data sharing across consortia to improve DHTs.
Emphasize normative data sets to establish ground truths for variability.
Encourage precompetitive collaborations to advance regulatory maturity.

Regulatory Considerations
Collaborative efforts like the 3DT project are essential for regulatory maturity.
Global regulatory agencies encourage data-driven engagement through consortia.