This repository is under review for potential modification in compliance with Administration directives.
Every month, ETAI will be sharing a term or concept of the month that is related to ethical issues in biomedical research. The term of the month is part of our module’s milestones relating to engagement and reflection on ethics with the AI-READI team.
Term of October 2024: Digital Biomarker
“A characteristic or set of characteristics, collected from digital health technologies, that is measured as an indicator of normal biological processes, pathogenic processes, or responses to an exposure or intervention, including therapeutic interventions.”
U.S. Food and Drug Administration. Patient-Focused Drug Development: Collecting Comprehensive and Representative Input. Final guidance document https:// www.fda.gov/media/139088/download (2020).