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Healthcare & Pharma

AI governance for clinical and diagnostic AI systems

Clinical AI, diagnostic tools, and patient data processing require rigorous documentation of model behaviour, bias testing, and data handling. Anverith generates audit-ready evidence.

Challenges we solve for Healthcare & Pharma

CDSCO AI requirements

Central Drugs Standard Control Organisation is developing requirements for AI-assisted medical devices. Get ahead with ISO 42001 and AI Impact Assessment.

Clinical model validation docs

Hospitals and health systems demand evidence of model validation, bias testing, and performance monitoring before deploying clinical AI.

Patient data under DPDP

Health data is sensitive personal data under DPDP 2023. Manage DSRs, breach notifications, and DPAs with built-in tracking.

EU AI Act for medical AI (Class III)

Medical AI systems are classified as high-risk under the EU AI Act. If your AI affects EU patients, you need a documented conformity assessment.

Frameworks we cover for you

ISO 42001:2023
ISO 42005 (AIIA)
DPDP 2023
EU AI Act
ISO 27001

What you get

  • AI Impact Assessment (AIIA) for clinical AI risk evaluation
  • Model Cards documenting training data, validation, and bias testing
  • DPDP compliance for patient health data
  • Evidence Vault with clinical validation documentation
  • EU AI Act high-risk system compliance tracking

Document your clinical AI governance

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