Build First, Govern Next, Then Scale: A Three-Layer Governance Framework for India’s Digital Health Ecosystem

Abstract India has rapidly built one of the world's largest digital health ecosystems through the Ayushman Bharat Digital Mission (ABDM). More than one billion health records are linked to the Ayushman Bharat Health Account (ABHA), and a standardised, longitudinal, interoperable Electronic Health Records (EHR) built on ABHA as the common patient identifier is now being consolidated. Safe and equitable use of artificial intelligence (AI) in health therefore depends on first building and governing this record, then the secondary use of health data for research and AI, and finally the AI tools before deployment. This narrative review synthesised Government of India policy documents, statutory instruments, programme reports, and peer-reviewed literature from PubMed and official sources published between 2018 and 2026, identified using the terms digital health, electronic health records, artificial intelligence governance, and India, and synthesised into a three-layer governance framework. The framework proposes three sequential governance layers. The first establishes a standardised, interoperable EHR on ABHA, supported by legal and interoperability standards. The second governs the secondary use of health data for research and AI through risk-based classification, consent, and access controls. The third governs AI tools through risk-proportionate validation and oversight before deployment. Recent national initiatives, including Strategy for Artificial Intelligence in Healthcare for India (SAHI) and Benchmarking Open Data Platform for Health AI (BODH), have strengthened this enabling infrastructure. India has a valuable and timely opportunity to align governance with deployment as these technologies mature. A governance-first, whole-of-government approach, supported by public and private health systems, can strengthen trust, enable responsible innovation, and offer a scalable model for other countries.