Digital biomarkers in healthcare

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 together 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. 

This viewpoint provides the community with valuable insights into the challenges and possible solutions for the integration of digital biomarkers into healthcare. We are currently engaged in building a thorough and unified review of the existing global regulatory processes for digital biomarkers.