Findings
Limited use of BYOD in clinical trials and evolving regulatory guidance.
Potential biases due to participant preselection based on technology access and literacy.
Challenges in technology availability for generating study endpoints.

Recommendations
Ensure appropriate technology selection to meet study objectives.
Address potential biases in study population and data variability.
Implement mitigation strategies like provisioned technologies to avoid digital divide.
Develop a comprehensive statistical analysis plan for BYOD data.
Engage stakeholders early in the study design process.

Regulatory Considerations
Manage interactions with regulatory authorities on trial design and approval.
Prepare evidence dossiers for novel assessments via digital health technology.
Ensure compliance with guidelines like those from the Agency for Health Research and Quality.