Findings
There is a gap in developing robust and meaningful outcome measures based on DHTT sensor data.
A major challenge is integrating vast amounts of sensor data into meaningful clinical outcome measures.
There is no clear pathway for developing these outcome measures, indicating a need for standardized methods.

Recommendations
Develop roadmaps for data-centric and patient-centric digital outcome measures.
Integrate patient insights into the development of outcome measures.
Ensure statistical robustness and validity in digital outcome measures.
Encourage scientific discourse to reach a consensus on digital outcome measure development.
Combine subjective and objective data for comprehensive patient assessment.

Regulatory Considerations
The field relies on guidance from regulatory authorities like the FDA and EMA.
Regulatory frameworks need to keep pace with the fast-moving nature of DHTTs.
There is a need for consensus on digital outcome measure development that respects established methods.