The presentation will provide a comprehensive overview of how to establish credible clinical evidence for mobile health apps, focusing on both regulatory compliance and real-world application. Attendees will learn about the importance of clinical validation in demonstrating app safety, efficacy, and usability, which are essential for regulatory approval and integration into healthcare systems. 

Key topics include the different types of clinical studies—such as randomized controlled trials and observational studies—that are most effective for digital health validation, along with an examination of metrics commonly used to measure health outcomes in digital applications.

The session will also address specific regulatory requirements and guidelines, such as those from EMA, that mobile health developers should consider when designing their clinical validation plans. Additionally, a real-world case study will highlight successful strategies and common challenges faced in bringing clinically validated apps to market. By the end of the presentation, participants will gain practical insights into building a clinical evidence base that supports both patient trust and healthcare provider adoption.