Update on Secure AI in Health Initiative: SAHI and BODH Frameworks Launched

The Central Drugs Standard Control Organisation (CDSCO) maintains a comprehensive regulatory pathway for all medical devices, including artificial intelligence (AI)-enabled medical devices, under the Medical Devices Rules, 2017. Applicants must submit detailed technical documentation demonstrating conformity with safety and performance standards, covering essential principles checklists, software verification and validation, risk analysis, clinical evidence, quality management systems, and software version certificates.
Chapters IV and V of the Medical Devices Rules, 2017, govern manufacturing and import licences for commercialising medical devices, with clearly prescribed timelines for each regulatory activity. This framework ensures AI-enabled medical devices meet stringent safety, performance, and effectiveness requirements before market entry.
The Ministry of Health and Family Welfare launches the Strategy for AI in Healthcare in India (SAHI) and Benchmarking Open Data Platform for Health AI (BODH) on February 17, 2026, during the India AI Impact Summit. SAHI provides a national guidance framework promoting safe, ethical, evidence-based, and inclusive AI adoption across India’s healthcare system. BODH, developed with IIT Kanpur, offers structured testing and validation mechanisms for AI solutions before large-scale deployment.
Ayushman Bharat Digital Mission (ABDM) supports integration of AI tools through its sandbox environment and developer toolkits, enabling health technology applications, including AI screening solutions. Union Minister of State for Health and Family Welfare, Smt. Anupriya Patel shares this update in a written reply in the Rajya Sabha on March 10, 2026.