An Algorithm for Digital Medicine Testing: A NODE.Health Perspective Intended to Help Emerging Technology Companies and Healthcare Systems Navigate the Trial and Testing Period prior to Full-Scale Adoption.

Over the last several years, there has been rapid growth of digital technologies attempting to transform healthcare. Unique features of digital medicine technology lead to both challenges and opportunities for testing and validation. Yet little guidance exists to help a health system decide whether to undertake a pilot test of new technology, move right to full-scale adoption or start somewhere in between. To navigate this complexity, this paper proposes an algorithm to help choose the best path toward validation and adoption. Special attention is paid to considering whether the needs of patients with limited digital skills, equipment (e.g., smart-phones) and connectivity (e.g., data plans) have been considered in technology development and deployment. The algorithm reflects the collective experience of 20+ health systems and academic institutions that have established the Network of Digital Evidence for Health, NODE. Health, plus insights from existing clinical research taxonomies, syntheses or frameworks for assessing technology or for reporting clinical trials.