Cited by 13Mobile Health and mHealth ApplicationsHealthcare Technology and Patient MonitoringTechnology and Human Factors in Education and Health

Challenges and Potential of Using Digital Biomarkers in Healthcare and Clinical Trials

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Lieberwirth, Johann K., Mittermaier, Mirja, Stern, Ariel Dora·2026·Communications Medicine

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.

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  1. [10]Mandrola, J. & Foy, A. Downsides of detecting atrial fibrillation in asymptomatic patients. Am. Fam. Physician 99, 354–355 (2019). 30874403
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Authors
Lieberwirth, J. K., Mittermaier, M., & Stern, A. D.
Affiliations
  • Hasso Plattner Institute (DE)
  • Humboldt-Universität zu Berlin (DE)
Corresponding author
Lieberwirth, Johann K.
Venue
Communications Medicine
Published
2026-02-21
Volume
6
Issue
1
ISSN
2730-664X (ISSN-L)
OpenAlex
W7130837187
Cited by
13
References
72
Citations by year
2026: 13
FWCI
23.31
Type
journal article
Language
en
Open access
Locations
  • Communications Medicine (publishedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
Funders
  • Novo Nordisk (NNF23SA0087056)
  • Novo Nordisk Fonden (NNF23SA0087056)
Topics
  • Health Sciences › Health Professions › General Health Professions › Mobile Health and mHealth Applications
  • Health Sciences › Medicine › Surgery › Healthcare Technology and Patient Monitoring
  • Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Technology and Human Factors in Education and Health
Keywords
digital biomarkers, wearable sensors, continuous glucose monitoring, insulin dose, cardiovascular clinical trials, cardiac rhythm monitoring, personalized medicine, regulatory review, value-based payment, data silos

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