Findings
The EMA emphasizes early engagement to align on regulatory pathways and qualification processes for DHTs.
Context of Use (CoU) is critical in assessing digital technologies, requiring clear justification for their application in clinical trials.
The selection of digital endpoints must demonstrate clinical relevance, reliability, and sensitivity to change.
Validation of digital biomarkers must include data supporting their relationship to clinical outcomes of interest.
Changes to technology during development require a risk-based management approach to maintain the validity of data.

Recommendations
Begin early consultations with the EMA to determine the most suitable regulatory pathways and to define the Context of Use.
Ensure that qualification submissions provide robust evidence on clinical validity, reliability, and sensitivity to change.
Develop best practice guides for the implementation of digital technologies in clinical trials, including training for users and compliance monitoring.
Use an iterative approach for technology qualification, allowing adjustments based on emerging data and findings.
Provide clear risk management strategies for handling technology updates and assessing their impact on data integrity.

Regulatory Considerations
Adhere to applicable regulations, including the Medical Devices Regulation (MDR) and ISO standards, for technologies used in medicinal product development.
Implement data protection measures compliant with EU regulations, ensuring the integrity and security of sensitive health data.
Submit validation documentation demonstrating compliance with Good Clinical Practice (GCP) and Computer System Validation (CSV) standards.
Incorporate statistical planning aligned with ICH guidelines, including pre-planned analyses for endpoints supported by digital technologies.
Engage with multidisciplinary teams and potentially parallel processes with other regulatory agencies (e.g., FDA, PMDA) for a comprehensive qualification process.