Findings
Lack of widely accepted tools for digital mobility assessment.
Challenges in technical and clinical validation due to multiple expertise requirements.
Inconsistent testing procedures and variations in norms.
Limitations of current mobility measurement methods.
Need for real-world mobility assessment.

Recommendations
Adopt best practices and innovate with standards and open access tools.
Ensure transparency through regular interaction with stakeholders.
Develop algorithms in an agnostic and fully documented manner.
Make data accessible through a digital data biobank.
Aim for regulatory approval with accurate real-world mobility measurement.

Regulatory Considerations:
Engage in early dialogue with regulatory authorities.
Understand different regulatory requirements based on context of use.
Focus on qualification of new methodologies for safety and efficacy.
Use DMOs to monitor disease progression and as surrogates for secondary endpoints.
Adopt a staged approach to regulatory qualification.