Findings
Rapid development of digital biomarkers through sensors and personal devices.
Lack of established standards for evaluating digital biomarkers.
Challenges in handling large volumes of data, including missing data and outliers.

Recommendations
Improve the quality and reproducibility of research supporting biomarker use.
Ensure rigorous methodology in biomarker assessment.
Foster collaboration across disciplines for biomarker development.
Develop standards for linking digital phenotypes to traditional outcomes.
Address data handling challenges in digital health technologies.

Regulatory Considerations
Substantial validation work required for FDA approval of biomarkers.
Importance of rigorous scientific evidence for regulatory approval.
Need for collaboration in regulatory science to advance biomarker development.