Parliament Question: Status of secure AI for health initiative

GOVERNMENTOFINDIA MINISTRYOFHEALTH AND FAMILYWELFARE DEPARTMENTOFHEALTH AND FAMILYWELFARE RAJYASABHA UNSTARREDQUESTION NO. 2035 TOBE ANSWERED ON10TH MARCH, 2026 STATUS OFSECURE AI FORHEALTHINITIATIVE 2035.SHRIKARTIKEYASHARMA: Will the Ministerof HEALTH AND FAMILYWELFAREbe pleasedtostate: (a) whether the Central Drugs Standard Control Organisation (CDSCO) has a dedicated regulatory pathway for rapid approval of AI-enabled Class C medical devices for early detectionof breast cancer andtuberculosis; (b) the status of the Secure AI for Health Initiative (SAHI) in benchmarking indigenous mammographyandchest X-ray algorithms using Indianclinicaldata; and (c) whether a roadmap exists to integrate such AI screening tools with the Ayushman Bharat Digital Mission for point-of-care screening and diagnostics at rural Health and Wellness Centres? ANSWER THE MINISTER OFSTATE IN THE MINISTRYOFHEALTH AND FAMILY WELFARE (SMT.ANUPRIYAPATEL) (a): The Central Drugs Standard Control Organisation (CDSCO) has regulatory pathway for regulation of all medical devices which covers Artificial Intelligence (AI)-enabled medical devices. The technical documentation requirements for high-risk medical devices are prescribed underthe provisions of the Medical DevicesRules, 2017. In respect of AI-enabled medical devices, the applicant is required to submit comprehensive technical documentation in accordance with the said rules. The key technical documentationrequirements include: (i) Essential Principles Checklist to demonstrate conformity with applicable safety and performance requirements; (ii) Verificationandvalidationdocumentation includingsoftware; (iii) Risk analysis andcontrol documents; (iv) Clinicalevidenceinsupport of safety, performance andeffectiveness; (v) QualityManagement Systemdocuments(vi) Software version release certificates if any. The 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 commercialization of medical devices in the country. The timeline for each activity is clearly prescribed underthe Medical DevicesRules, 2017. (b): The Ministry of Health and Family Welfare has launched the Strategy for AI in HealthcareinIndia(SAHI)andtheBenchmarkingOpenDataPlatformforHealthAI(BODH) on 17.02.2026 during the India AI Impact Summit. SAHI is a national guidance framework for safe, ethical, evidence-based, and inclusive adoption of Artificial Intelligence across India’s healthcare system. Benchmarking Open Data Platform for Health AI (BODH) has been developed in partnership with IIT Kanpur and provides a structured mechanism for testing andvalidating AIsolutions before deploymentat scale. (c): Ayushman Bharat Digital Mission (ABDM) provides a sandbox environment and integration toolkits that allow health technology developers to integrate their applications/ software includingAI screening tools. **********