New Delhi, March 10 The Union Health Ministry has launched the Strategy for AI in Healthcare in India (SAHI) and the Benchmarking Open Data Platform for Health AI (BODH) to promote the secure and evidence-based deployment of artificial intelligence in the country's healthcare ecosystem, the Rajya Sabha was informed on Tuesday.
In a written reply, Minister of State for Health Anupriya Patel said the initiatives were launched during the India AI Impact Summit.
She said SAHI is a national guidance framework for the safe, ethical, evidence-based, and inclusive adoption of artificial intelligence (AI) across India's healthcare system, while BODH, developed in partnership with IIT Kanpur, provides a structured mechanism for testing and validating AI solutions before deployment at scale.
The Ayushman Bharat Digital Mission (ABDM) provides a sandbox environment and integration toolkits that allow health technology developers to integrate their applications/software, including AI screening tools, she added.
Patel, in her reply, further said that the Central Drugs Standard Control Organisation (CDSCO) has a pathway for the regulation of all medical devices, which covers AI-enabled medical devices.
The technical documentation requirements for high-risk medical devices are prescribed under the provisions of the Medical Devices Rules, 2017, she said.
For AI-enabled medical devices, the applicant is required to submit comprehensive technical documentation in accordance with the prescribed rules, she added.
The key technical documentation requirements include an essential principles checklist to demonstrate conformity with applicable safety and performance requirements, verification and validation documentation.
This includes software, risk analysis and control documents, clinical evidence in support of safety, performance and effectiveness; quality management system documents and software version release certificates, if any, the minister said.
Chapters IV and V of the Medical Devices Rules, 2017 contain provisions relating to the grant of manufacturing licences and import licences, respectively, for the commercialisation of medical devices in the country, she added.
The timeline for each activity is clearly prescribed under the Medical Devices Rules, 2017, she said.