Findings
Rigorous evaluation of digital biomarkers is currently lacking, which is necessary for their effective and safe use.
No speech measure has been comprehensively evaluated across verification, analytical validation, and clinical validation.
There is a wide variability in the speech features analyzed across studies, indicating a lack of standardization.
Recommendations
Conduct systematic and rigorous evaluation of digital biomarkers to ensure accurate measurement.
Develop comprehensive evaluations across all necessary categories for speech measures.
Standardize the analysis of speech features across studies.
Apply the recommendations for speech-based biomarkers to other novel digital biomarkers.
Regulatory Considerations
Not mentioned