{"engine_version":"autoimmune-navigator-2026.08","intended_use_statement":"Clinical decision support for suspected systemic lupus erythematosus and connective-tissue disease in adults presenting to primary care or diagnostic laboratories. Outputs an urgency disposition, structured differential considerations, recommended confirmatory investigations, and immunosuppression treatment-safety context. NOT a diagnostic device. NOT autonomous. Every output requires review by a licensed clinician. Not intended for use in patients under 15 years, pregnancy without specialist input, or acute critical illness.","boundaries":{"must_not_output":["final diagnosis (e.g. 'Patient has SLE')","definitive exclusion of tuberculosis or any infection","autoimmune-disease probability without pre-test calibration","prescribing decision without clinician review"],"outputs":["urgency_tier (Red / Amber / Yellow / Abstain)","differential_categories","missing_critical_data","recommended_confirmatory_tests","red_flags_triggered","referral_recommendation","evidence_per_rule","uncertainty_or_abstention_reason","requires_clinician_review: true (always)"],"regulatory_note":"Written CDSCO IVD classification opinion is a precondition of clinical-report sale in India. This module is currently positioned as decision support for clinician workflow inside a regulated pathologist-signed-out report — not as an autonomous IVD."},"clinician_review_required_on_every_output":true}