The Union Health Ministry has taken a bold step toward modernising India’s healthcare sector. It launched two landmark initiatives — the Strategy for AI in Healthcare in India (SAHI) and the Benchmarking Open Data Platform for Health AI (BODH) — to promote the secure, ethical, and evidence-based use of artificial intelligence across the country’s health ecosystem. Minister of State for Health Anupriya Patel informed the Rajya Sabha about these developments in a written reply on March 10, 2026.
Both platforms were unveiled at the India AI Impact Summit, marking a significant milestone in India’s push to integrate AI-driven solutions into public health delivery.
What Is SAHI?
A National Framework for Ethical AI Adoption
SAHI — the Strategy for AI in Healthcare in India — serves as a national guidance framework. It promotes the safe, ethical, evidence-based, and inclusive adoption of AI across India’s healthcare system. Rather than leaving individual institutions to navigate AI deployment on their own, SAHI provides structured direction at the national level.
The framework addresses critical concerns around transparency, patient safety, and equitable access. Furthermore, it ensures that AI tools deployed in clinical and administrative settings meet consistent standards before reaching patients.
What Is BODH?
Testing AI Before It Reaches Patients
BODH — the Benchmarking Open Data Platform for Health AI — was developed in partnership with IIT Kanpur. Its core purpose is to provide a structured mechanism for testing and validating AI solutions before large-scale deployment in healthcare settings.
Before any AI tool can be adopted at scale, BODH allows developers and regulators to measure performance, identify gaps, and ensure clinical reliability. This platform directly addresses the global challenge of unverified AI tools entering sensitive medical environments without adequate scrutiny.
Role of ABDM in AI Integration
A Sandbox for Health Tech Developers
The Ayushman Bharat Digital Mission (ABDM) plays a complementary role in this ecosystem. It offers a sandbox environment along with integration toolkits. These tools enable health technology developers to integrate their applications and software — including AI screening tools — into the broader health infrastructure.
This approach lowers the barrier for responsible innovation. Developers can test their solutions within a controlled environment before pursuing full integration, thereby reducing risks for patients and providers alike.
CDSCO Regulation of AI Medical Devices
Bringing AI Under the Regulatory Net
The Central Drugs Standard Control Organisation (CDSCO) already has a clear regulatory pathway for all medical devices — and this now covers AI-enabled medical devices as well. Minister Patel confirmed that CDSCO has the mandate and mechanism to regulate these products.
This is a vital step. As AI-powered diagnostic tools and treatment recommendation systems grow in number, clear regulatory oversight protects patients from unvalidated or unsafe technologies entering the market.
Technical Documentation Requirements
What AI Device Makers Must Submit
For high-risk AI-enabled medical devices, applicants must submit comprehensive technical documentation in accordance with the Medical Devices Rules, 2017. The documentation requirements include:
- Essential Principles Checklist — to confirm conformity with safety and performance standards
- Verification and Validation Documentation — including software testing records
- Risk Analysis and Control Documents — assessing and mitigating potential harms
- Clinical Evidence — supporting the safety, performance, and effectiveness of the device
- Quality Management System Documents — demonstrating process integrity
- Software Version Release Certificates — where applicable
These requirements ensure accountability at every stage of AI device development.
Licensing Under Medical Devices Rules 2017
Clear Timelines for Manufacturers and Importers
Chapters IV and V of the Medical Devices Rules, 2017 contain the provisions governing manufacturing and import licences. These chapters apply to all medical devices intended for commercialisation in India — including AI-powered ones.
Importantly, the timeline for each activity is clearly prescribed under these rules. This gives manufacturers and importers a predictable regulatory roadmap, reducing uncertainty and supporting faster yet compliant market entry
Conclusion
India’s launch of SAHI and BODH signals a maturing approach to healthcare AI. By combining a national strategy, a testing platform, a sandbox environment through ABDM, and a clear regulatory framework under CDSCO and the Medical Devices Rules 2017, the government is building a comprehensive ecosystem for responsible AI adoption in health. Together, these initiatives aim to ensure that AI in Indian healthcare is not only innovative — but also safe, validated, and equitable.
