EFPIA：2025年关于EMA认证新方法的提案报告（英文版）

Digital measure: an obtained value using a test, tool, or instrument derived from data captured by digital health technology (DHT). A digital measure can be used to derive a variable that can be used as an endpoint in the context of a clinical trial. ● Digital biomarker: a defined characteristic or set of characteristics that is measured as an indicator of normal biological processes, pathogenic processes, or responses to an exposure or intervention and is derived from data captured by a