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

“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...

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Autores principales: Au, Rhoda, Kolachalama, Vijaya B., Paschalidis, Ioannis C.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8822623/
https://www.ncbi.nlm.nih.gov/pubmed/35146485
http://dx.doi.org/10.3389/fdgth.2021.751629
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author Au, Rhoda
Kolachalama, Vijaya B.
Paschalidis, Ioannis C.
author_facet Au, Rhoda
Kolachalama, Vijaya B.
Paschalidis, Ioannis C.
author_sort Au, Rhoda
collection PubMed
description “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.
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spelling pubmed-88226232022-02-09 Redefining and Validating Digital Biomarkers as Fluid, Dynamic Multi-Dimensional Digital Signal Patterns Au, Rhoda Kolachalama, Vijaya B. Paschalidis, Ioannis C. Front Digit Health Digital Health “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. Frontiers Media S.A. 2022-01-13 /pmc/articles/PMC8822623/ /pubmed/35146485 http://dx.doi.org/10.3389/fdgth.2021.751629 Text en Copyright © 2022 Au, Kolachalama and Paschalidis. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
spellingShingle Digital Health
Au, Rhoda
Kolachalama, Vijaya B.
Paschalidis, Ioannis C.
Redefining and Validating Digital Biomarkers as Fluid, Dynamic Multi-Dimensional Digital Signal Patterns
title Redefining and Validating Digital Biomarkers as Fluid, Dynamic Multi-Dimensional Digital Signal Patterns
title_full Redefining and Validating Digital Biomarkers as Fluid, Dynamic Multi-Dimensional Digital Signal Patterns
title_fullStr Redefining and Validating Digital Biomarkers as Fluid, Dynamic Multi-Dimensional Digital Signal Patterns
title_full_unstemmed Redefining and Validating Digital Biomarkers as Fluid, Dynamic Multi-Dimensional Digital Signal Patterns
title_short Redefining and Validating Digital Biomarkers as Fluid, Dynamic Multi-Dimensional Digital Signal Patterns
title_sort redefining and validating digital biomarkers as fluid, dynamic multi-dimensional digital signal patterns
topic Digital Health
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8822623/
https://www.ncbi.nlm.nih.gov/pubmed/35146485
http://dx.doi.org/10.3389/fdgth.2021.751629
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