Au Rhoda, Kolachalama Vijaya B, Paschalidis Ioannis C
Department of Anatomy and Neurobiology, Neurology and Framingham Heart Study, Boston University School of Medicine, Boston, MA, United States.
Department of Epidemiology, Boston University School of Public Health, Boston, MA, United States.
Front Digit Health. 2022 Jan 13;3:751629. doi: 10.3389/fdgth.2021.751629. eCollection 2021.
"Digital biomarker" is a term broadly and indiscriminately applied and often limited in its conceptualization to mimic well-established biomarkers as defined and approved by regulatory agencies such as the United States Food and Drug Administration (FDA). There is a practical urgency to revisit the definition of a digital biomarker and expand it beyond current methods of identification and validation. Restricting the promise of digital technologies within the realm of currently defined biomarkers creates a missed opportunity. A whole new field of prognostic and early diagnostic digital biomarkers driven by data science and artificial intelligence can break the current cycle of high healthcare costs and low health quality that is being driven by today's chronic disease detection and treatment approaches. This new class of digital biomarkers will be dynamic and require developing new FDA approval pathways and next-generation gold standards.
“数字生物标志物”是一个被广泛且不加区分使用的术语，其概念化通常局限于模仿由美国食品药品监督管理局（FDA）等监管机构定义和批准的成熟生物标志物。重新审视数字生物标志物的定义并将其扩展到当前的识别和验证方法之外具有实际紧迫性。将数字技术的前景限制在当前定义的生物标志物范围内会错失良机。由数据科学和人工智能驱动的全新预后和早期诊断数字生物标志物领域，可以打破当前由慢性病检测和治疗方法所驱动的高医疗成本和低健康质量的循环。这类新型数字生物标志物将具有动态性，需要开发新的FDA批准途径和下一代金标准。
