Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2022 Jan 13:3:751629.
doi: 10.3389/fdgth.2021.751629. eCollection 2021.

Redefining and Validating Digital Biomarkers as Fluid, Dynamic Multi-Dimensional Digital Signal Patterns

Rhoda Au  1   2   3 , Vijaya B Kolachalama  3   4   5 , Ioannis C Paschalidis  5   6
Affiliations

Redefining and Validating Digital Biomarkers as Fluid, Dynamic Multi-Dimensional Digital Signal Patterns

Rhoda Au et al. Front Digit Health. .

Abstract

"Digital biomarker" is a term broadly and indiscriminately applied and often limited in its conceptualization to mimic well-established biomarkers as defined and approved by regulatory agencies such as the United States Food and Drug Administration (FDA). There is a practical urgency to revisit the definition of a digital biomarker and expand it beyond current methods of identification and validation. Restricting the promise of digital technologies within the realm of currently defined biomarkers creates a missed opportunity. A whole new field of prognostic and early diagnostic digital biomarkers driven by data science and artificial intelligence can break the current cycle of high healthcare costs and low health quality that is being driven by today's chronic disease detection and treatment approaches. This new class of digital biomarkers will be dynamic and require developing new FDA approval pathways and next-generation gold standards.

Keywords: biomarkers; digital; digital biomarkers; fluidic dynamic digital patterns; new regulatory standards; technology.

PubMed Disclaimer

Conflict of interest statement

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

References

    1. Babrak LM, Menetski J, Rebhan M, Nisato G, Zinggeler M, Brasier N, et al. Traditional and digital biomarkers: two worlds apart? Digital biomark. (2019) 3:92–102. 10.1159/000502000 - DOI - PMC - PubMed
    1. FDA Approves Third Amyloid PET Tracer for Alzheimer's,. Medscape. (2021). Available online at: http://www.medscape.com/viewarticle/822370 (accessed December 6, 2021).
    1. Group FNBW, . Glossary. Food Drug Administration (US) (2021). Available online at: https://www.ncbi.nlm.nih.gov/journals/NBK338448/ (accessed December 6, 2021).
    1. Anonymous . Committee for Medicinal Products Human Use (CHMP). European Medicines Agency. https://www.ema.europa.eu/en/committees/committee-medicinal-products-hum... (accessed December 6, 2021).
    1. Xue C, Karjadi C, Paschalidis ICh, Au R, Kolachalama VB. Detection of dementia on voice recordings using deep learning: a Framingham Heart Study. Alzheimer's Res Ther. (2021) 13:146. 10.1186/s13195-021-00888-3 - DOI - PMC - PubMed