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. 2019;2(1):14.
doi: 10.1038/s41746-019-0090-4. Epub 2019 Mar 11.

Developing and adopting safe and effective digital biomarkers to improve patient outcomes

Andrea Coravos  1 , Sean Khozin  2 , Kenneth D Mandl  1
Affiliations

Developing and adopting safe and effective digital biomarkers to improve patient outcomes

Andrea Coravos et al. NPJ Digit Med. 2019.

Erratum in

Abstract

Biomarkers are physiologic, pathologic, or anatomic characteristics that are objectively measured and evaluated as an indicator of normal biologic processes, pathologic processes, or biological responses to therapeutic interventions. Recent advances in the development of mobile digitally connected technologies have led to the emergence of a new class of biomarkers measured across multiple layers of hardware and software. Quantified in ones and zeros, these "digital" biomarkers can support continuous measurements outside the physical confines of the clinical environment. The modular software-hardware combination of these products has created new opportunities for patient care and biomedical research, enabling remote monitoring and decentralized clinical trial designs. However, a systematic approach to assessing the quality and utility of digital biomarkers to ensure an appropriate balance between their safety and effectiveness is needed. This paper outlines key considerations for the development and evaluation of digital biomarkers, examining their role in clinical research and routine patient care.

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Conflict of interest statement

Competing Interests KM and SK declare no financial or non-financial competing interests. AC has been developing an open-source pre-competitive digital biomarker catalog, at Elektra Labs, a startup company, with funding from the Harvard Business School, the NSF, and the Mount Sinai School of Medicine.

Figures

Fig. 1
Fig. 1
Digital biomarker products. Five products, all detecting a similar digital endpoint, are constructed with differing, modular approaches. In the first column are five products to detect atrial fibrillation: AliveCor, CardioGram, Apple Watch plus ECG App, Fitbit, and Xiaomi. Across the top, are major software modules comprising the product, from the operating system on the left to the user interface on the right. Some modules are created by the product manufacturer and others by a third party. If the listed organization manufacturers the component, the module is represented in green. If instead it is created by a different party, the color is gray. These differently composed products require different strategies for verification, validation, and likely also regulatory clearance. Figures are reused with permission from the copyright owners, and the Apple watch image is Courtesy of Apple Inc
See this image and copyright information in PMC

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