Digital biomarkers: Convergence of digital health technologies and biomarkers

作者：Srikanth Vasudevan, Anindita Saha, Michelle E. Tarver, Bakul Patel · 发表于：npj Digital Medicine · 年份：2022 · DOI：10.1038/s41746-022-00583-z · 被引用次数：180 · 研究领域：Digital Mental Health Interventions、Mobile Health and mHealth Applications

Over the last decade, 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 consumers, researchers, and providers to enable collection of health-related data outside the traditional clinical setting (Box 1 ). With the shift to digitization in healthcare, the term ‘digital biomarker’ has been increasingly used to describe a broad array of measurements. There are currently multiple definitions of the term digital biomarker reported in the scientific literature, and some seem to conflate established definitions of a biomarker and a clinical outcomes assessment (COA). Biomarkers and clinical outcome assessments measure different concepts and both could be useful in understanding the impact of a condition on patients. For example, an investigational product used to treat patients with heart failure could be assessed by measuring a biomarker of the heart’s output (left ventricular ejection fraction) as well as through a COA, a subjective measure of how the patient feels (the Kansas City Cardiomyopathy Questionnaire). Conflating the terms can hamper communication and evidence expectations between medical product developers and regulators. Therefore, a clear definition of the term digital biomarker could potentially facilitate the effective use of a DHT in the evaluation of a medical product, pote...