Digital biomarkers: Convergence of digital health technologies and biomarkers

Srikanth Vasudevan; Anindita Saha; Michelle E Tarver; Bakul Patel

doi:10.1038/s41746-022-00583-z

Digital biomarkers: Convergence of digital health technologies and biomarkers

NPJ Digit Med. 2022 Mar 25;5(1):36. doi: 10.1038/s41746-022-00583-z.

Authors

Srikanth Vasudevan¹, Anindita Saha², Michelle E Tarver³, Bakul Patel⁴

Affiliations

¹ Division of All Hazards Response, Science, and Strategic Partnerships, Office of Strategic Partnerships and Technology Innovation, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, MD, USA.
² Digital Health Center of Excellence, Office of Strategic Partnerships and Technology Innovation, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, MD, USA.
³ Office of Strategic Partnerships and Technology Innovation, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, MD, USA.
⁴ Digital Health Center of Excellence, Office of Strategic Partnerships and Technology Innovation, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, MD, USA. Bakul.Patel@fda.hhs.gov.

Abstract

Increasing digitization across the healthcare continuum has revolutionized medical research, diagnostics, and therapeutics. This digitization has led to rapid advancements in the development and adoption of Digital Health Technologies (DHT) by the healthcare ecosystem. With the proliferation of DHTs, the term ‘digital biomarker’ has been increasingly used to describe a broad array of measurements. Our objectives are to align the meaning of ‘digital biomarker’ with established biomarker terminology and to highlight opportunities to enable consistency in evidence generation and evaluation, improving the assessment of scientific evidence for future digital biomarkers.