Designing Trust in Digital Health Technologies: Real-world Evidence as a Sustainable Market Lever in Digital Therapeutics

About

With the increasing usage of digital therapeutics (DTx), as digitally native tools, “real-world data” derived from outside of formal clinical trials (RWD) and “real-world evidence” (RWE) generated from such RWD are becoming essential resources for evaluating the effectiveness of new healthcare technologies. This project investigates how early-stage digital health companies—especially those developing DTx—strategically generate and communicate evidence to shape their market success and adoption.

Focusing on the intersection of entrepreneurial strategy and healthcare innovation, the project explores how firms navigate complex strategic environments and make decisions about what evidence to produce, how to disseminate it, and when to rely on collecting data through traditional clinical trials versus focusing on the use of RWD. With new policies, such as Germany’s upcoming RWE-linked reimbursement for DTx, these strategic choices are more relevant than ever. By comparing digital health firms with traditional pharmaceutical approaches, the project also draws broader lessons for evidence-based policy and innovation management.