Findings
A well-defined concept of interest (COI) and context of use (COU) are critical to selecting meaningful endpoints.
Digital tools must undergo usability assessments, verification of system performance, and validation against reference standards.
Measurement approaches should be tailored to reflect treatment benefits and detect meaningful changes.
Early and frequent regulatory engagement is essential throughout the development process.
Integration of validation for both the measure and the technology ensures alignment with clinical and operational goals.

Recommendations
Define the target population and conceptualize the treatment benefit and COU early in the development process.
Identify meaningful aspects of health and COIs that are relevant to patients and clinicians.
Evaluate and select digital tools based on evidence of usability, verification, and validation.
Engage with regulators early and often to align endpoints with evidentiary and regulatory requirements.
Finalize endpoint validation, including meaningful change thresholds and data analysis plans, to ensure readiness for pivotal trials.

Regulatory Considerations
Validate the selected digital health technology to meet performance standards for regulatory acceptance.
Demonstrate that the measurement reflects the intended COI and is effective in detecting meaningful change.
Obtain regulatory confirmation that the endpoint is aligned with requirements for pivotal trials and potential label claims.
Address usability and operational concerns, ensuring the DHT is acceptable and feasible for the trial population.
Use prior evidence where applicable, while integrating new validation data to support regulatory engagement.