Findings
Limited research on sleep disturbances in RA due to lack of suitable technologies.
Current assessment methods like PSG are not scalable for large studies.
Clinician-reported outcomes may not accurately reflect patients’ daily lives due to recall bias.

Recommendations
Incorporate patient input early in the development process.
Select appropriate sensors and ensure they are analytically validated against reference standards.
Develop a regulatory-guided pathway for achieving clinical acceptance of NDEs.

Regulatory Considerations
Understand the pathways offered by FDA and EMA for developing NDEs.
Ensure transparency in the qualification process.
Recognize that agencies qualify the measure or endpoint, not the digital health technology tool itself.