Navigating through regulatory frameworks for digital therapeutics and biomarkers.
PMID: 41067729 ·
Cinja Koller, Marc Blanchard, Thomas Hügle
JournalHealth informatics journal
Year
PMID41067729
Abstract
Background: Digital health technologies are often subject to regulatory requirements. Regulatory auditing processes are complex but necessary to guarantee quality, efficacy and safety of patients. Evolvements such as digitalized clinical trials, and digital biomarkers require a constant adaption of regulatory frameworks. Objective: This review aims to provide an overview on current regulations and standards for digital therapeutics and digital biomarkers, from technical development to market acc
Official Source
View on PubMed →Data sourced from PubMed / NCBI. For the full text and most current information, always refer to the official record.