This guide provides a structured, system-level understanding of how artificial intelligence is being governed in India’s healthcare ecosystem. Rather than focusing on a single regulation, it brings together the evolving landscape of laws, guidelines, and frameworks that collectively shape how AI is built, tested, deployed, and used in real-world healthcare settings. The guide organizes this landscape into six key layers, guidance, validation, data protection, data exchange, ethics, and regulation, covering frameworks such as SAHI, BODH, DPDP, ABDM, ICMR, and CDSCO. Each layer is examined in terms of its role across the AI lifecycle, its impact on different stakeholders, and how it influences safety, accountability, transparency, and deployment in practice. Moving beyond legal interpretation, the guide adopts a practical lens to decode how these frameworks interact within healthcare systems, where infrastructure variability, data fragmentation, and diverse patient populations shape real-world outcomes. It highlights that governance in healthcare AI is not defined by individual rules, but by how multiple layers work together across workflows, institutions, and decision-making contexts. Designed for clinicians, healthcare leaders, policymakers, product teams, and researchers, this resource simplifies a complex regulatory environment into an accessible and actionable structure. Part of the HealthInnovation Toolbox Innovation Series, it aims to support more responsible, transparent, and system-aware adoption of AI in India’s healthcare ecosystem.
Sonu et al. (Thu,) studied this question.