What must the underlying sensor and algorithm achieve for digital measurement to gain authority?
A comparable level of rigorous validation to traditional laboratory standards.
Gaining traction in clinical contexts requires that digital measurements earn trust equivalent to established clinical standards. Traditional biomarkers carry inherent authority because they are already validated laboratory standards. For a digital measurement derived from a smartphone or wearable to be accepted, the technology stack—including the sensor hardware and the processing algorithms—must undergo rigorous validation processes to demonstrate accuracy, reliability, and consistency. This validation essentially transforms the technology from being viewed as merely a passive recorder into a validated instrument capable of generating trustworthy clinical evidence.
