IRHAI Policy Document 001: Patient as Central Axis

IRHAI-POL-001: Patient-Centric Governance Policy Explorer
Policy Reference Document

Patient-Centric Governance Policy for Healthcare AI

Author: Dr. Sharad Maheshwari

Date: 03.02.2026 | Version: 0.9 (Draft)

3. Core Principle

"The patient is the primary stakeholder."

All AI governance decisions must prioritize patient safety, outcome, and dignity over operational efficiency or innovation speed.

2. Scope of Application

🩺

CDS Systems

Clinical Decision Support for clinicians.

🔬

Diagnostic AI

Imaging and lab analysis tools.

📋

Workflow AI

Systems influencing triage or pathways.

⚖️

High Impact

Direct influence on patient care urgency.

4. Governance Framework Alignment

The IRHAI-POL-001 framework adopts the six-pillar RATSe governance model as its authoritative backbone. The following table maps these canonical pillars to the operational requirements used in clinical environments.

RATSe Pillar (Canonical) Operational Requirement (IRHAI-POL-001)
Responsibility Clinical Ownership (4.1)
Accountability Accountability (4.1)
Transparency Transparency (4.3)
Safety Determinism (4.2) + Oversight (4.4)
Ethics & Equity Oversight (4.4)
Environment & Sustainability Lifecycle (4.5)

Operational Requirements Details

RATSe Pillar Coverage

Visualization of operational alignment

Operational Context: ...

4.5 Lifecycle Governance

Ensures "Environment & Sustainability" by managing the system from ideation to safe decommissioning.

💡

Ideation

Clinical impact assessment.

🚀

Deployment

Clinical owner assignment.

Runtime

Continuous monitoring.

🛑

Retirement

Secure decommissioning.

5. Explicit Non-Claims

Does NOT certify systems or clinical use.
Does NOT replace regulatory obligations.
Does NOT transfer liability.

6. Global Alignment

NIST AI RMF OECD AI Principles EU AI Act India DPDP Act

Institute for Responsible Healthcare AI

Authored by Dr. Sharad Maheshwari | 03.02.2026

IRHAI-POL-001 | v0.9 (Draft) | Non-binding Reference Standard

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