Update on Secure AI in Health Initiative

**Executive Summary** The Ministry of Health and Family Welfare has launched the Strategy for AI in Healthcare in India (SAHI) and the Benchmarking Open Data Platform for Health AI (BODH) to strengthen secure, evidence-based AI deployment in India's healthcare ecosystem. These initiatives were unveiled on 17.02.2026. The Central Drugs Standard Control Organisation (CDSCO) outlines regulatory pathways and technical documentation requirements for AI-enabled medical devices, with comprehensive submissions mandated for high-risk devices. **Key Points / Main Content** * **Regulatory Framework for AI-Enabled Medical Devices:** * The CDSCO provides a regulatory pathway for all medical devices, including AI-enabled ones. * Technical documentation requirements for high-risk medical devices are defined by the Medical Devices Rules, 2017. * **Technical Documentation Requirements:** * Applicants for AI-enabled medical devices must submit comprehensive technical documentation. * Key requirements include: * Essential Principles Checklist for safety and performance conformity. * Verification and validation documentation, including software. * Risk analysis and control documents. * Clinical evidence for safety, performance, and effectiveness. * Quality Management System documents. * Software version release certificates, if applicable. * **Licensing for Medical Devices:** * Chapters IV and V of the Medical Devices Rules, 2017, govern manufacturing and import licenses for commercialization. * Timelines for these licensing activities are clearly prescribed. * **Secure AI in Health Initiative:** * The Strategy for AI in Healthcare in India (SAHI) was launched on 17.02.2026 as a national guidance framework for safe, ethical, evidence-based, and inclusive AI adoption in healthcare. * The Benchmarking Open Data Platform for Health AI (BODH) was also launched on 17.02.2026, developed in partnership with IIT Kanpur, providing a mechanism for testing and validating AI solutions. * The Ayushman Bharat Digital Mission (ABDM) offers a sandbox environment and integration toolkits for health technology developers to integrate applications, including AI screening tools. **Impact Analysis** **Health Technology Developers** * **Impact:** Developers of AI-enabled medical devices and AI screening tools will need to comply with new technical documentation requirements and can leverage the ABDM sandbox and BODH platform for testing and validation. * **Action Required:** Submit comprehensive technical documentation as per the Medical Devices Rules, 2017, and utilize SAHI for guidance on ethical and evidence-based AI adoption. **Medical Device Manufacturers and Importers** * **Impact:** The existing licensing processes for manufacturing and import of medical devices remain in place, with defined timelines under the Medical Devices Rules, 2017. * **Action Required:** Adhere to the provisions outlined in Chapters IV and V of the Medical Devices Rules, 2017, for obtaining manufacturing and import licenses. **Regulatory Bodies (CDSCO)** * **Impact:** CDSCO will continue to oversee the regulatory pathway for medical devices, including AI-enabled ones, and review submitted technical documentation. * **Action Required:** Continue to apply the provisions of the Medical Devices Rules, 2017, for the regulation and approval of AI-enabled medical devices.

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