Findings
There is a lack of well-established consensus parameters for digitized performance outcomes with thresholds for validation acceptance criteria.
The amount of publicly available data on DHT validation remains limited.
Many DHT validation studies are conducted by single institutions and are not disclosed publicly.
The unique proposition of DHTs presents challenges for measure design, development, and validation.
Regulatory endorsements for DHTs in clinical investigations are limited.

Recommendations
Establish technical validation parameters and technology performance acceptance thresholds in the scientific community.
Develop hardware-agnostic approaches by sharing DHT data and cross-validating different algorithms.
Standardize data and create publicly shared databases to facilitate DHT acceptance in drug development.
Form precompetitive consortia via public-private partnerships and professional societies to advance DHT use.
Focus on data sharing to enable DHT measure development in a technology-agnostic way.

Regulatory Considerations
Validation requirements must include understanding the relationship between DHTs and conventional outcome assessments.
Evidence is needed that digital measures capture meaningful health aspects if they constitute an electronic Clinical Outcome Assessment (eCOA).
Initiatives like the CPP Digital Drug Development Tool can advance regulatory maturity by optimizing studies with multiple stakeholders.