Regulatory Alignment
TGA guidance (Australia) — ClinAssist is designed from the ground up to align with the Therapeutic Goods Administration's AI-as-a-Medical-Device framework. Regulatory scoping is a Phase 1 deliverable.
Australian Privacy Act compliance — Data preprocessing pipelines are designed around Australian Privacy Act principles, including de-identification and consent frameworks.
IRB/Ethics approval — Formal ethics clearance for dataset access and any clinician interview or study components will be obtained in Phase 1 prior to data collection.
Our Approach
Clinician-first design: Every architectural decision starts with a single question — will a registrar at 3am be able to act on this? We embed clinician feedback into the design loop from day one, not after the model is built.
Multimodal from the ground up: Rather than bolting imaging or NLP onto a structured-data model, ClinAssist is architected to fuse all three inputs at the inference layer — producing a single, explainable risk output that reflects the full clinical picture.
Validation that measures trust, not just accuracy: AUC alone doesn't predict adoption. Our validation framework measures whether clinicians trust and act on ClinAssist's outputs — using human-factors methods alongside standard ML metrics.
Regulatory alignment from day one: TGA AI-as-a-Medical-Device scoping is a Phase 1 deliverable, not an afterthought. Australian Privacy Act compliance and IRB ethics approval are built into the data pipeline design, not retrofitted.