AI Integration in Indian Healthcare System

Summary of Key Points on AI Integration in Healthcare in India

AI-Enabled Healthcare Solutions

• e-Sanjeevani: India’s telemedicine consultation platform has integrated an AI-enabled clinical decision support system to enhance healthcare delivery.
• Role of AI: AI aids in clinical decisions related to reassurance, referrals, and investigations, raising the need for regulatory framework to ensure patient safety.

Regulatory Framework

• Central Drugs Standard Control Organisation (CDSCO): Issued guidance in July 2026 on the regulation of software in medical devices, clarifying approval pathways for AI-enabled health technologies.
• Definition of MedTech: Encompasses instruments and software for medical purposes not achieving action through pharmacological means (e.g., thermometers, CT scanners).
• Regulatory Backdrop: India regulates medical devices under the Drugs and Cosmetics Act, 1940, with an amendment in 1982 allowing classification of devices as 'drugs'. The Medical Devices Rules, 2017 established a classification system for medical devices.

Software Classification

• Software Categories:
  • Software in a Medical Device (SiMD): Embedded software controlling hardware.
  • Software as a Medical Device (SaMD): Software performing medical functions independently.
• Regulatory framework differentiates based on intended use, severity of clinical situation, and output influence on medical decisions.

AI and Clinical Validation

• CDSCO requires clinical evidence linking software output to medical conditions, performance assessment in the intended population, and unique validation for AI systems.
• Developers must provide diverse datasets for training and validation of AI algorithms, addressing potential biases and performance generalizability.

Policy Framework and Guidelines

• NITI Aayog’s National Strategy for AI: Released in 2018, prioritizing healthcare and addressing ethical considerations.
• Indian Council of Medical Research (ICMR): In 2023, issued guidelines emphasizing accountability and fairness in AI application in healthcare.
• Ministry of Electronics and Information Technology: Released AI Governance Guidelines in November 2025, opting against a separate AI law.

Comparative Global Standards

• FDA (USA): Established AI lifecycle approaches for medical devices, involving change-control plans for updates.
• EU AI Act: Combines medical device regulation with AI-specific regulations, emphasizing risk management and oversight.

Challenges and Considerations

• The guidance raises concerns about reliance on an 80-year-old law versus the need for a dedicated statutory framework for AI in medicine, ensuring trust among patients and clinicians.
• Need for Statutory Framework: To enhance clarity on liability and establish a public registry for AI medical devices with life-and-death implications.

This overview reflects the current landscape of AI integration into Indian healthcare, highlighting the need for rigorous guidelines and a systematic approach to regulation in alignment with technological advancements.