Findings
The US regulatory landscape is more suitable for promoting innovation in digital health compared to Europe.
Traditional regulatory approaches are not keeping pace with technological advancements.
There is a lack of specific guidance on the use of wearables and software in clinical drug trials.
The US has a more advanced regulatory framework for drug development tools than Europe.

Recommendations
Use approved solutions or consider early qualification of drug development tools.
Engage early with FDA and EMA to define evidentiary standards and regulatory pathways.
Ensure correct regulatory classification of digital tools.
Engage early with regulatory authorities to navigate the regulatory landscape.

Regulatory Considerations
Digital tools must be fit-for-purpose for their intended use.
Sponsors must ensure conformity with GxP and local data privacy and cybersecurity laws.
Data from digital tools must deliver reliable data with tangible clinical benefits.
The context of use drives the benefit-risk assessment and evidentiary criteria for regulatory acceptability.