Findings
Mobile sensors provide unique opportunities for objective, real-world data collection but face challenges in achieving regulatory acceptance due to a lack of standardization and validation frameworks.
A comprehensive evidence dossier must address three key components: verification, analytical validity, and clinical validation, to ensure endpoints are fit-for-purpose.
Demonstrating content validity is critical, especially when endpoints are not directly measuring meaningful aspects of health but infer these through related concepts.
Early engagement with regulatory bodies (e.g., FDA, EMA) is recommended to align expectations and address evidentiary gaps.
Usability and feasibility research are vital to ensure patient compliance and data quality in real-world applications.

Recommendations
Develop Comprehensive Dossiers: Include sections on endpoint definition, concept of interest, content validity, clinical validation, analytical validation, and implementation details to support regulatory review.
Ensure Content Validity: Demonstrate a clear relationship between sensor-derived endpoints and meaningful health outcomes, supported by literature, patient interviews, and expert consensus.
Engage with Regulators Early: Discuss the proposed endpoint and its context of use with regulatory agencies to ensure alignment and identify potential challenges.
Standardize Validation Processes: Use rigorous methods for verification, analytical validation, and construct validation to establish the reliability and accuracy of sensor technologies.
Promote Collaboration: Share validation data and methodologies across stakeholders to reduce redundancy and accelerate the adoption of mobile sensor endpoints.

Regulatory Considerations
Verification of Sensor Technologies: Demonstrate that sensors produce accurate, reliable, and consistent raw data under various conditions, including environmental variability.
Analytical Validation: Show that firmware and algorithms used to process raw data maintain high technical performance and align with regulatory standards.
Clinical Validation: Provide evidence that sensor-derived data reliably measure the concept of interest and are responsive to meaningful clinical changes.
Context of Use: Clearly define the intended application of the endpoint, including target populations, trial design, and labeling claims, to guide regulatory evaluation.
Data Security and Privacy: Ensure compliance with data protection regulations, such as 21 CFR Part 11, to secure patient data during collection, transmission, and storage.