Findings
Concerns about data accuracy, particularly variability in measurements across different age groups and devices.
Issues with data provenance, as raw data from wearables are often transformed and filtered before storage, making comprehensive analysis difficult.
Regulatory challenges due to lack of specific FDA guidance for clinical trials using wearables and mobile devices.

Recommendations
Improve data accuracy through standardized approaches and expert recommendations.
Enhance data provenance by developing methods to trace data lineage and ensure transparency in data processing.
Develop specific FDA guidance for the use of wearables and mobile devices in clinical trials.
Implement robust security measures to protect data integrity and privacy.
Follow the ePRO Consortium’s recommendations for device suitability in clinical trials.

Regulatory Considerations
The need for FDA guidance specific to clinical trials using mHealth technologies.
Sponsors’ responsibility to validate the reliability of mHealth technology in capturing and transmitting data.
Security vulnerabilities in devices, necessitating adherence to privacy standards and robust security protocols.