The Government of India has launched two key frameworks—Strategy for AI in Healthcare in India (SAHI) and Benchmarking Open Data Platform for Health AI (BODH)—to strengthen secure, ethical, and evidence-based deployment of artificial intelligence in the country’s healthcare ecosystem. The initiatives were unveiled during the India AI Impact Summit.
The SAHI framework serves as a national guidance mechanism to ensure the safe, inclusive, and responsible adoption of AI technologies across India’s healthcare system. Meanwhile, the BODH platform, developed in partnership with Indian Institute of Technology Kanpur, provides a structured mechanism for benchmarking, testing, and validating AI solutions before their large-scale deployment in healthcare settings.
The Central Drugs Standard Control Organisation (CDSCO) already has a regulatory pathway for AI-enabled medical devices under the Medical Devices Rules, 2017. According to these rules, applicants seeking approval for AI-enabled medical devices must submit comprehensive technical documentation, including safety and performance compliance checklists, verification and validation records, risk analysis, clinical evidence supporting safety and effectiveness, quality management system documents, and software version release certificates where applicable.
The rules also outline provisions for the grant of manufacturing and import licences for medical devices under Chapters IV and V of the regulations, ensuring clear timelines for commercialization processes.
Additionally, the Ayushman Bharat Digital Mission (ABDM) offers a sandbox environment and integration toolkits that allow health technology developers to integrate their applications, including AI-based screening tools, into the national digital health ecosystem.
The information was shared by **Anupriya Patel, Union Minister of State for Health and Family Welfare, in a written reply in the Rajya Sabha.
The launch of SAHI and BODH marks a significant step toward promoting responsible innovation while ensuring safety, transparency, and reliability in the use of AI technologies within India’s healthcare sector.
Nurturing Creativity – Keekli Charitable Trust, Shimla
