← India RegulationsSectoral Analysis

Healthcare
AI Regulation.

Regulated by CDSCO. Focus on diagnostic AI liability and the Unified Health Interface (UHI).

Primary Applications

Use Cases

01

Diagnostic AI

02

SaMD

03

Triage

Regulatory Framework

Key Instruments

Health Data Policy

SaMD Guidelines

Applicable Regulations

Statutory Instruments

billproposed2025-01-15

AI Ethics & Regulation Bill, 2025 (Proposed)

The definitive horizontal statute for AI. Establishes the National AI Authority and a 4-tier risk classification system, mandating ex-ante vetting for critical-risk neural architectures.

Frontier ModelsHigh-Risk AIAutonomous Systems
lawin_force2023-08-11

DPDP Act, 2023: Algorithmic PbD

Bypasses general privacy for 'Privacy-by-Design' (PbD) in AI. Section 10 mandates Significant Data Fiduciaries (SDF) to undergo independent audits of neural training sets.

Personal DataNeural WeightsSDFs

Comprehensive Compliance.

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