Digital biomarkers in healthcare, FHNW School of Life Sciences

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. The identification and application of biomarkers in the clinical and medical fields can have an enormous impact on society. However, the unclear definition of digital biomarkers, population groups, and their intersection with traditional biomarkers, hinders their discovery and validation.

We identified current issues in the field of digital biomarkers and put forth suggestions to address them during a DayOne Workshop, together with participants from academia, industry and regulatory agencies. We found similarities and differences between traditional and digital biomarkers, aiming 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.