Traditional and digital biomarkers - two worlds apart?

The identification and application of biomarkers in the clinical and medical fields has an enormous impact on society. The increase of digital devices and the rise in popularity of health-related mobile apps has produced a new trove of biomarkers in large, diverse, and complex data. However, the unclear definition of digital biomarkers, population groups, and their intersection with traditional biomarkers, hinders their discovery and validation. We identify current issues in the field of digital biomarkers and put forth suggestions to address them during the DayOne Workshop with participants from academia, industry and regulatory agencies. We find similarities and differences between traditional and digital biomarkers in order to synchronize semantics, define unique features, review current regulatory procedures and describe novel applications that enable precision medicine