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Clinical Evidence for Mobile Health Applications

Thursday May 22, 2025 10:20 - 10:40 Innovation area

Lecturer: Przemek Grzywa

Track: Innovation Area

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.

Language

English

Topic

• Process Analysis and Redesign

Seminar type

Live + On site

Lecture type

Presentation

Objective of lecture

Orientation

Level of knowledge

Intermediate

Target audience

Management/decision makers
Technicians/IT/Developers
Researchers
Care professionals
Healthcare professionals
Patient/user organizations

Keyword

Actual examples (good/bad)
Patient centration
Innovation/research
Test/validation
Apps
Patient safety
Information security
Usability

Lecturers

Profile image for Przemek Grzywa

Przemek Grzywa Lecturer

Co-founder
REVOLVE HEALTHCARE

With over seven years of experience in medical software development, I am the co-founder and co-CEO of Revolve Healthcare, a company that helps life science and healthcare companies design, build and certify (ISO/MDR/CE) their digital health products.

We have extensive experience working with international tech companies and startups, and we are certified with an ISO 13485 for "Software design and development services for the medical devices industry". Our services are also compliant with both EN IEC 62304 and EN IEC 62366 standards.

My passion for healthcare stems from my personal and family background.