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

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

Author information

1
Computational Health Informatics Program, Boston Children's Hospital, Boston, MA.
2
Food and Drug Administration, Silver Spring, MD.

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.

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.

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