– published in Journal of Medical Internet Research
Summary
Digital Therapeutics RWE Framework
Digital Therapeutics (DTx) offer a scalable, effective future for health, but their complex development requires a structured approach. This article unveils the DTx Real-World Evidence (RWE) Framework—a first-of-its-kind, pragmatic, and iterative model. Derived from behavioral intervention phases, this framework uniquely integrates real-world data (RWD) across the entire DTx life cycle, from design to long-term monitoring. It’s an essential guide for industry, healthcare, and academia seeking to develop and deploy evidence-based DTx solutions.