SKU 2 — MEDTRAC™ Clinical Insight (Research Stage)

Intended Use (Research Phase)

MEDTRAC™ Clinical Insight is an investigational clinical decision-support system intended solely for research and evaluation purposes.

The system is designed to assist licensed healthcare professionals by correlating screening outputs with clinical and physiological data to support diagnostic assessment in a non-interventional, human-in-the-loop context.

During the research phase, outputs generated by MEDTRAC™ Clinical Insight must not be used to inform or influence real-time clinical diagnosis, treatment, or patient management decisions.

✅ Allowed in SKU 2 — Clinical Insight (Research Mode)

Developers may implement (behind research flags):

• Disease-specific correlation models
• Differential diagnosis support
• Diagnostic probability ranges
• Cross-validation against clinical data
• Clinician-adjustable parameters
• Case review and annotation tools
• Shadow-mode analytics
• Retrospective case evaluation

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❌ Forbidden in SKU 2 (Pre-Regulation)

Even in research mode, developers must not:

• Drive live diagnosis
• Influence treatment decisions
• Present outputs to patients
• Integrate into clinical workflow systems
• Remove clinician override
• Market externally