Digital Health Initiatives in Rare Disease Management: A Roadmap for India's Orphan Drug Ecosystem

India faces significant challenges in managing rare diseases and providing access to orphan drugs.This study explores the potential of digital health initiatives to transform rare disease management and orphan drug development in India.We analyze the current landscape of digital health in India, focusing on its application to rare diseases.Through a comprehensive review of global best practices and India's unique healthcare context, we propose a roadmap for integrating digital health solutions into India's orphan drug ecosystem.Our findings suggest that telemedicine, Artificial Intelligence (AI)-powered diagnostics, digital patient registries, and mobile health applications can significantly improve rare disease diagnosis, treatment, and research in India.However, challenges such as digital literacy, data privacy, and infrastructure limitations need to be addressed.We conclude that a strategic implementation of digital health initiatives, tailored to India's healthcare landscape, can substantially enhance rare disease management and accelerate orphan drug development.