Human-In-The-Loop (HITL) Workflow
SmartHeal is designed as a Clinical Decision Support System (CDSS). The AI suggests measurements; the clinician verifies, edits if needed, and decides. All AI-generated findings must be reviewed and confirmed by a qualified healthcare professional before use in clinical documentation.
TGA CDSS Boundary
SmartHeal is built with Australian Therapeutic Goods Administration (TGA) regulatory requirements in mind. It provides objective measurement and documentation support only. It does not diagnose or suggest treatment. We do not claim TGA or FDA approval; the system is designed to align with CDSS regulatory expectations as we progress toward formal assessment.
Data Residency & Sovereignty
100% of SmartHeal data is hosted in AWS Sydney. All processing and storage remain within Australia, supporting Australian data sovereignty and meeting local data protection requirements.
Privacy and data
- Australian Privacy Principles (APPs): Data handling aligns with APP requirements for health information.
CDSS Disclaimer
SmartHeal is a Clinical Decision Support System (CDSS) intended for objective measurement and documentation support only. It does not diagnose or suggest treatment. All AI-generated findings must be reviewed and verified by a qualified healthcare professional.