| # LIMITATIONS.md — Primordial OS Runtime Prototype |
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| **Created and Developed by Collin D. Weber.** |
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| ## Scope Statement |
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| The Primordial OS Runtime Prototype is **pre-validation architecture**. |
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| It is a runnable user-space prototype demonstrating HIR × OAM runtime concepts. It is intended for the Rice-Facing AI-in-Health Review Showcase as an architectural demonstration only. |
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| ## What This Prototype Is Not |
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| | Category | Status | |
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| | Clinical software | **No** | |
| | Medical device | **No** | |
| | Diagnostic tool | **No** | |
| | Therapeutic tool | **No** | |
| | Treatment system | **No** | |
| | FDA-regulated software | **No** | |
| | CE-marked product | **No** | |
| | IRB-reviewed research tool | **No** | |
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| ## What This Prototype Does Not Do |
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| - Does **not** diagnose any condition, disease, disorder, or health state. |
| - Does **not** treat, cure, or mitigate any condition. |
| - Does **not** make medical decisions or recommendations of any kind. |
| - Does **not** replace or augment the judgment of: |
| - Licensed clinicians |
| - Licensed therapists or counselors |
| - Hospice or palliative care providers |
| - Emergency services or crisis response |
| - Legal counsel |
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| ## Runtime Output Disclaimer |
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| All outputs produced by this runtime are **architectural demonstrations**. |
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| They reflect the behavior of the HIR × OAM prototype model under defined inputs. They have no clinical, diagnostic, therapeutic, or legal standing. |
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| **No output from this system should be used to inform, support, or substitute for any health-related decision.** |
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| ## Stability Metric Disclaimer |
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| The Resonance threshold used in this runtime is a **software stability metric** defined within the prototype architecture. It has no medical, physiological, or clinical meaning. It does not measure any biological, psychological, or health-related state. |
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| ## Data |
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| This prototype does not collect, store, transmit, or process protected health information (PHI) or personally identifiable information (PII) under any circumstance. No data retention occurs beyond the local session in `audit_logs/`. |
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| ## Regulatory |
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| This prototype has not been submitted to, reviewed by, or cleared by the FDA, CE, or any other regulatory body. It is not intended for submission to any regulatory body in its current form. |
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| ## Version |
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| This limitations statement applies to all versions of the Primordial OS Runtime Prototype prior to and including any version tagged as `prototype`. Any future versions that change the scope of this prototype must update this document explicitly and with author approval. |
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| *Last reviewed: 2026-05-02* |
| *Author: Collin D. Weber* |
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