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. 2020 Feb 7;4(1):1-12.
doi: 10.1159/000505289. eCollection 2020 Jan-Apr.

Translation of Digital Health Technologies to Advance Precision Medicine: Informing Regulatory Science

Joan E Adamo  1 , Robert V Bienvenu Ii  2 , Felipe Dolz  3 , Michael Liebman  4 , Wendy Nilsen  5 , Scott J Steele  6
Affiliations

Translation of Digital Health Technologies to Advance Precision Medicine: Informing Regulatory Science

Joan E Adamo et al. Digit Biomark. .

Abstract

The proliferation of digital technologies and the application of sophisticated data analysis techniques are increasingly viewed as having the potential to transform translational research and precision medicine. While digital technologies are rapidly applied in innovative ways to develop new diagnostics and therapies, the ultimate approval and adoption of these emerging methods presents several scientific and regulatory challenges. To better understand and address these regulatory science gaps, a working group of the Clinical and Translational Science Awards Program convened the Regulatory Science to Advance Precision Medicine Forum focused on digital health, particularly examining gaps in the use, validation, and interpretation of data from sensors that collect and tools that analyze digital biomarkers. The key findings and recommendations provided here emerged from the Forum and include the need to enhance areas related to data standards, data quality and validity, knowledge management, and building trust between all stakeholders.

Keywords: Digital biomarkers; Precision medicine; Regulatory science; Translational science.

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Conflict of interest statement

The authors have no conflicts to disclose.

Figures

Fig. 1
Fig. 1
Key attributes for digital measures to support regulatory decisions, where the intersection of these areas will advance the development of real-world evidence.
See this image and copyright information in PMC

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