Increasing digitization across the healthcare continuum has revolutionized medical research, diagnostics, and therapeutics. This digitization has led to rapid advancements in the development and adoption of Digital Health Technologies (DHT) by the healthcare ecosystem. With the proliferation of DHTs, the term ‘digital biomarker’ has been increasingly used to describe a broad array of measurements. Our objectives are to align the meaning of ‘digital biomarker’ with established biomarker terminology and to highlight opportunities to enable consistency in evidence generation and evaluation, improving the assessment of scientific evidence for future digital biomarkers.
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