Findings
Scarcity of reliable and frequent ground truth labels in real-world conditions.
Challenges in extracting clinically meaningful information from digital device data.
Lack of standardized methods for data collection, storage, organization, curation, and analysis.
Issues with participant diversity and digital literacy affecting patient engagement and adherence.
Need for alignment on methods to establish reliability and validity of DHT measures.

Recommendations
Focus on clinically meaningful outcomes for patients in PD drug development.
Build consensus on data and metadata standards for data exchangeability.
Develop open-source platforms for analysis across device types and studies.
Engage early and often with regulatory agencies via consortia.
Align with FDA review divisions and utilize EMA qualification methodologies.

Regulatory Considerations:
Align with regulatory science pathways to ensure scientific rigor and clinical validity.
Engage with regulatory agencies like FDA and EMA early in the process.
Adhere to standardized data collection and analytical approaches.