Work

Challenges and potential of using digital biomarkers in healthcare and clinical trials

Year: 2026

Type: article

Abstract: Digital biomarkers use sensors and analytics, to offer continuous monitoring and personalized medicine. In this Perspective, we describe real-world use cases, such as glucose tracking to optimise insulin dosing and wearables to measure heart rhythms to de-risk cardiovascular trials. We also discuss the issues preventing most candidate biomarkers from reaching clinical practice. Evidence generation is costly, regulatory reviews can be redundant, commercial incentives fall short, and data silos can be biased and/or nonrepresentative. By combining harmonized qualification pathways, value-based reimbursement, modular extensions for single-trial biomarkers, and adaptive post-market evidence loops, we propose a path from experimental signal to standard of care.

Source: Communications Medicine

DOI: 10.1038/s43856-026-01450-8

Authors: Johann K. Lieberwirth, Mirja Mittermaier, Ariel Dora Stern

Institutions: Hasso Plattner Institute, University of Potsdam, Humboldt-Universität zu Berlin, Charité - Universitätsmedizin Berlin, Icahn School of Medicine at Mount Sinai

Language: English

Topic: Mobile Health and mHealth Applications

Subfield: General Health Professions

Field: Health Professions

Domain: Health Sciences

SDG: Good health and well-being

Open Access status: gold

Estimated APC paid: $3,690