Requirements: Clinical Quality Service for First Responders (FirstAidIQ)

This document captures the Functional (FR) and Non-Functional (NFR) requirements for each feature in the FirstAidIQ Clinical Quality Service. Requirements are linked to the corresponding Aha.io feature references in product II65.

How to Read This Document

  • FR- prefix denotes a Functional Requirement.
  • NFR- prefix denotes a Non-Functional Requirement.
  • Each requirement block identifies the Aha.io feature it supports.
  • Requirements are numbered sequentially within each feature section.

Phase 1: Foundation & MVP (II65-R-2)


Feature: II65-1 — Clinical Guideline Knowledge Base

Epic: II65-E-1 (Core AI Clinical Decision Support Engine) Aha.io Reference: II65-1

Functional Requirements

IDRequirement
FR-II65-1-01The system SHALL provide an ingestion pipeline capable of importing clinical guideline documents in PDF and structured data formats (JSON, XML).
FR-II65-1-02The system SHALL store version history for every guideline document, recording the version number, effective date, and the identity of the administrator who approved it.
FR-II65-1-03The system SHALL expose a search and retrieval API that the AI engine can query to obtain relevant guideline content given a clinical query string or intent.
FR-II65-1-04The system SHALL provide an administrative interface allowing authorised clinical administrators to upload, review, approve, and retire guideline documents.
FR-II65-1-05The system SHALL enforce an approval workflow for all new and updated guidelines before they become active, requiring sign-off by at least one clinical administrator.
FR-II65-1-06The system SHALL be pre-loaded with the current St John NZ Comprehensive Clinical Procedures and Guidelines on initial deployment.
FR-II65-1-07The system SHALL support guidelines from multiple authoritative sources including St John NZ, American Heart Association (AHA), European Resuscitation Council (ERC), and ILCOR.
FR-II65-1-08The system SHALL allow an administrator to mark a guideline as superseded and automatically route queries to the current active version.

Non-Functional Requirements

IDRequirement
NFR-II65-1-01The guideline search API SHALL return results within 200ms at the 95th percentile under normal operating load.
NFR-II65-1-02The knowledge base SHALL support a minimum of 10,000 structured guideline documents without performance degradation.
NFR-II65-1-03All guideline documents SHALL be stored with AES-256 encryption at rest.
NFR-II65-1-04The ingestion pipeline SHALL maintain an audit log of every document import, including source, timestamp, and importing user.
NFR-II65-1-05The system SHALL achieve 99.9% uptime for the guideline retrieval API, measured monthly.

Feature: II65-2 — AI Voice Guidance Engine

Epic: II65-E-1 (Core AI Clinical Decision Support Engine) Aha.io Reference: II65-2

Functional Requirements

IDRequirement
FR-II65-2-01The system SHALL provide wake word detection that activates the voice interface without requiring any touch interaction.
FR-II65-2-02The system SHALL transcribe spoken clinical queries to text using a speech-to-text engine.
FR-II65-2-03The system SHALL parse the transcribed query to identify clinical intent (e.g., “CPR protocol”, “medication dose”, “airway management”).
FR-II65-2-04The system SHALL generate context-aware clinical guidance responses by querying the Clinical Guideline Knowledge Base (II65-1).
FR-II65-2-05The system SHALL incorporate the active patient record into the context when generating responses (e.g., known allergies, current vitals).
FR-II65-2-06The system SHALL deliver guidance responses via text-to-speech with adjustable volume and playback speed.
FR-II65-2-07The system SHALL fall back to displaying guidance on-screen when audio output is unavailable or disabled.
FR-II65-2-08The system SHALL support interruption of an in-progress audio response when a new wake word is detected.

Non-Functional Requirements

IDRequirement
NFR-II65-2-01Wake word detection SHALL achieve activation within 200ms of the final phoneme being spoken.
NFR-II65-2-02Speech-to-text transcription SHALL achieve accuracy greater than 90% in field environments with ambient noise levels up to 85dB.
NFR-II65-2-03End-to-end latency from query completion to the start of the audio response SHALL be less than 2 seconds at the 95th percentile.
NFR-II65-2-04The voice engine SHALL function in offline mode for pre-cached guidelines with no network connection.
NFR-II65-2-05The voice engine SHALL consume no more than 5% additional battery per hour of active standby on a reference device (iPhone 14).

Feature: II65-3 — Vital Sign Alert & Threshold Engine

Epic: II65-E-1 (Core AI Clinical Decision Support Engine) Aha.io Reference: II65-3

Functional Requirements

IDRequirement
FR-II65-3-01The system SHALL ingest streaming vital sign data including heart rate (HR), oxygen saturation (SpO2), blood pressure (BP), temperature, and ECG waveform from connected wearable devices.
FR-II65-3-02The system SHALL allow clinical administrators to configure alert thresholds per vital sign type, with the ability to set patient-specific overrides.
FR-II65-3-03The system SHALL classify alerts into three severity levels: Warning, Critical, and Life-threatening, based on the degree of threshold breach.
FR-II65-3-04The system SHALL deliver alerts via all three modalities simultaneously: audio (voice announcement), haptic (vibration), and visual (on-screen banner).
FR-II65-3-05The system SHALL perform trend analysis on incoming vital sign streams to detect deterioration trajectories before a threshold is breached.
FR-II65-3-06The system SHALL log every alert event with timestamp, vital sign value, threshold, severity, and acknowledgement action.
FR-II65-3-07The system SHALL suppress duplicate alerts for the same ongoing condition until the condition resolves or the responder acknowledges the alert.

Non-Functional Requirements

IDRequirement
NFR-II65-3-01Alert generation SHALL complete within 1 second from the receipt of the triggering vital sign reading.
NFR-II65-3-02The alert engine SHALL process data from at least 4 simultaneous wearable device streams per patient without dropped readings.
NFR-II65-3-03The threshold configuration interface SHALL enforce validation rules preventing physiologically impossible threshold combinations.
NFR-II65-3-04The system SHALL maintain a false positive rate below 5% for Warning-level alerts during simulated clinical scenario testing.
NFR-II65-3-05Alert data SHALL be retained for a minimum of 7 years to satisfy clinical audit requirements.

Feature: II65-4 — Wearable Device SDK & Integration

Epic: II65-E-2 (Real-Time Telemetry & Wearable Integration) Aha.io Reference: II65-4

Functional Requirements

IDRequirement
FR-II65-4-01The SDK SHALL support device discovery and pairing using Bluetooth Low Energy (BLE) GATT Health Device Profile.
FR-II65-4-02The SDK SHALL support simultaneous connection to a minimum of 4 wearable devices per responder device.
FR-II65-4-03The SDK SHALL provide auto-discovery of certified devices within BLE range without manual configuration by the responder.
FR-II65-4-04The SDK SHALL monitor and report device status including battery level, signal strength, and data quality indicators.
FR-II65-4-05The SDK SHALL buffer wearable data locally during network connectivity gaps and transmit buffered data upon reconnection.
FR-II65-4-06The SDK SHALL include certified profiles for the following initial device set: Polar H10, Apple Watch, Garmin wearables, and generic BLE SpO2 monitors.
FR-II65-4-07The SDK SHALL provide a documented extension API allowing third-party device manufacturers to add certified device profiles.

Non-Functional Requirements

IDRequirement
NFR-II65-4-01Device pairing SHALL complete within 5 seconds from the user initiating connection with a certified device.
NFR-II65-4-02The SDK SHALL not exceed 3% CPU utilisation on the host mobile device when managing 4 simultaneous BLE connections.
NFR-II65-4-03The SDK SHALL tolerate BLE signal interruptions of up to 30 seconds and automatically re-establish connection without user interaction.
NFR-II65-4-04The offline data buffer SHALL retain a minimum of 60 minutes of vital sign data per connected device during connectivity loss.
NFR-II65-4-05The SDK SHALL be distributed as a Swift Package (iOS) with documented integration steps requiring no more than 2 hours for a competent iOS developer.

Feature: II65-5 — 5G/LTE Telemetry Streaming Pipeline

Epic: II65-E-2 (Real-Time Telemetry & Wearable Integration) Aha.io Reference: II65-5

Functional Requirements

IDRequirement
FR-II65-5-01The pipeline SHALL receive real-time vital sign and incident data from mobile field devices via a persistent WebSocket connection.
FR-II65-5-02The pipeline SHALL implement automatic reconnection with exponential backoff when a WebSocket connection is dropped.
FR-II65-5-03The pipeline SHALL support automatic network fallback in the order: 5G → LTE → 3G, buffering data locally during the transition.
FR-II65-5-04The pipeline SHALL store received telemetry data securely and make it available to control centre dashboards (II65-8) and hospital handover systems (II65-9) in real time.
FR-II65-5-05The pipeline SHALL enforce data sovereignty controls that keep New Zealand patient data within NZ-hosted cloud regions.
FR-II65-5-06The pipeline SHALL support multi-region deployment to ensure continued operation in the event of a single-region outage.
FR-II65-5-07All telemetry data in transit SHALL be encrypted using TLS 1.3 minimum.

Non-Functional Requirements

IDRequirement
NFR-II65-5-01End-to-end telemetry latency from device sensor reading to cloud storage SHALL be less than 500ms on a 5G network.
NFR-II65-5-02The pipeline SHALL support a minimum of 1,000 concurrent field device connections without throughput degradation.
NFR-II65-5-03The pipeline SHALL achieve 99.95% uptime, measured monthly, excluding planned maintenance windows.
NFR-II65-5-04Telemetry data SHALL be retained for a minimum of 7 years with a hot-tier retention of 90 days for rapid query access.
NFR-II65-5-05The pipeline architecture SHALL be horizontally scalable, allowing capacity to be doubled within 30 minutes using infrastructure automation.

Feature: II65-6 — FirstAidIQ iOS Application (MVP)

Epic: II65-E-3 (FirstResponder Mobile Application) Aha.io Reference: II65-6

Functional Requirements

IDRequirement
FR-II65-6-01The application SHALL support iOS 16 and above on iPhone 12 and newer hardware.
FR-II65-6-02The application SHALL activate the AI Voice Guidance Engine (II65-2) via a configurable wake phrase.
FR-II65-6-03The application SHALL allow a responder to create a new patient incident record within 3 taps from the home screen.
FR-II65-6-04The application SHALL display live wearable vital signs with colour-coded alert banners reflecting severity levels from II65-3.
FR-II65-6-05The application SHALL operate in offline mode, providing access to cached clinical guidelines without a network connection.
FR-II65-6-06The application SHALL generate a handover report in PDF format containing the complete incident record, interventions, and current vitals.
FR-II65-6-07The application SHALL support quick-capture of a minimum of 10 patient demographic and presenting complaint fields on the incident creation screen.
FR-II65-6-08The application SHALL synchronise all incident and telemetry data to the cloud pipeline (II65-5) when a network connection is available.

Non-Functional Requirements

IDRequirement
NFR-II65-6-01The application SHALL consume less than 15% battery over a 2-hour operational shift with 4 wearable devices connected and voice guidance active.
NFR-II65-6-02The application SHALL launch and reach the home screen within 3 seconds on supported hardware.
NFR-II65-6-03The application SHALL operate within a maximum memory footprint of 200MB under normal use.
NFR-II65-6-04The application SHALL pass Apple App Store review requirements and be distributed via the App Store or enterprise MDM.
NFR-II65-6-05The application SHALL support Dynamic Type accessibility settings for all on-screen text elements.
NFR-II65-6-06Offline cached guidelines SHALL be refreshed automatically whenever the device is connected to a network and an updated guideline is available.

Feature: II65-7 — Patient Incident Record Management

Epic: II65-E-3 (FirstResponder Mobile Application) Aha.io Reference: II65-7

Functional Requirements

IDRequirement
FR-II65-7-01The system SHALL allow a responder to initiate a new patient incident from the home screen in no more than 3 taps.
FR-II65-7-02The incident form SHALL capture patient demographics: full name, date of birth, gender, known medical conditions, current medications, and known allergies.
FR-II65-7-03The system SHALL support AVPU (Alert, Voice, Pain, Unresponsive) and GCS (Glasgow Coma Scale) neurological assessment capture.
FR-II65-7-04The system SHALL allow logging of clinical interventions with timestamps, including CPR, defibrillation, cannulation, and medication administration.
FR-II65-7-05The system SHALL support voice-dictated notes that are transcribed and attached to the incident record.
FR-II65-7-06The system SHALL auto-populate vital sign fields from connected wearable devices (II65-4) in real time.
FR-II65-7-07The system SHALL export completed incident records as HL7 FHIR R4 bundles for integration with hospital EHR systems.
FR-II65-7-08The system SHALL prevent record deletion; incidents may only be archived with an audit trail.

Non-Functional Requirements

IDRequirement
NFR-II65-7-01Incident record save operations SHALL complete within 500ms and SHALL not block the UI thread.
NFR-II65-7-02The HL7 FHIR R4 export SHALL conform to the HL7 FHIR R4 specification and pass validation against the official FHIR validator.
NFR-II65-7-03All patient data SHALL be encrypted at rest on the device using iOS Data Protection (NSFileProtectionComplete).
NFR-II65-7-04Records SHALL be retained locally for a minimum of 30 days before automatic archival to cloud storage.
NFR-II65-7-05The voice dictation transcription accuracy for clinical terminology SHALL exceed 85%, measured against a standardised clinical vocabulary test set.

Feature: II65-11 — Security & Data Privacy Framework

Epic: II65-E-6 (Regulatory Compliance & Security Infrastructure) Aha.io Reference: II65-11

Functional Requirements

IDRequirement
FR-II65-11-01The system SHALL encrypt all patient data at rest using AES-256 and all data in transit using TLS 1.3 as a minimum standard.
FR-II65-11-02The system SHALL implement role-based access control (RBAC) with the principle of least privilege applied to all service accounts and user roles.
FR-II65-11-03All user accounts SHALL require multi-factor authentication (MFA) for login.
FR-II65-11-04The system SHALL maintain a comprehensive, tamper-evident audit log recording every access and modification to patient data, including user identity, timestamp, and action taken.
FR-II65-11-05The system SHALL enforce patient data residency controls, ensuring NZ patient data is stored and processed exclusively within NZ-hosted infrastructure.
FR-II65-11-06The system SHALL implement controls to satisfy the NZ Privacy Act 2020, Australian Privacy Act 1988, and GDPR where applicable.
FR-II65-11-07The system SHALL provide a data export mechanism enabling patient data to be retrieved in a portable format upon subject access request.
FR-II65-11-08The system SHALL provide a documented data deletion/anonymisation process to support the right to erasure where legally applicable.

Non-Functional Requirements

IDRequirement
NFR-II65-11-01The system SHALL undergo a penetration test by a qualified third-party security firm at least annually, with no unresolved high-severity findings permitted at time of release.
NFR-II65-11-02Audit log entries SHALL be available for query within 5 seconds of an auditable event occurring.
NFR-II65-11-03MFA authentication SHALL complete within 10 seconds under normal network conditions.
NFR-II65-11-04Security patches classified as Critical SHALL be applied within 24 hours of vendor disclosure; High-severity patches within 7 days.
NFR-II65-11-05All cryptographic implementations SHALL use industry-standard libraries (e.g., OpenSSL, Apple CryptoKit) and SHALL NOT use custom or deprecated cipher suites.

Phase 2: Validation & Regulatory (II65-R-3)


Feature: II65-8 — Control Centre Live Operations Dashboard

Epic: II65-E-4 (Control Centre & Dispatch Dashboard) Aha.io Reference: II65-8

Functional Requirements

IDRequirement
FR-II65-8-01The dashboard SHALL display the real-time map positions of all active field units alongside each unit’s current incident status.
FR-II65-8-02The dashboard SHALL provide an expandable panel per field unit showing crew details, active incident summary, and a patient vitals summary.
FR-II65-8-03The dashboard SHALL generate audio and visual callout notifications for Critical and Life-threatening alerts received from field units.
FR-II65-8-04The dashboard SHALL support two-way text messaging between control room operators and individual field units.
FR-II65-8-05The dashboard SHALL implement role-based views distinguishing between dispatcher and clinical supervisor access levels.
FR-II65-8-06The dashboard SHALL display the status and alert history for a selected patient in a dedicated panel.
FR-II65-8-07The dashboard SHALL allow operators to acknowledge critical alerts, recording the acknowledgement with timestamp and operator identity.

Non-Functional Requirements

IDRequirement
NFR-II65-8-01The dashboard SHALL support a minimum of 50 simultaneous active field units per control room operator without UI degradation.
NFR-II65-8-02The dashboard SHALL be browser-based and fully functional in current-release Chrome, Firefox, and Safari.
NFR-II65-8-03The map view SHALL refresh field unit positions within 2 seconds of a position update being received from the telemetry pipeline.
NFR-II65-8-04The dashboard SHALL be accessible and usable at 1920×1080 resolution as a minimum, with responsive layout down to 1280×720.
NFR-II65-8-05The dashboard SHALL maintain a connection to the telemetry stream via WebSocket and automatically reconnect within 5 seconds of a connection drop.

Feature: II65-9 — Hospital Pre-Arrival Notification & Handover

Epic: II65-E-4 (Control Centre & Dispatch Dashboard) Aha.io Reference: II65-9

Functional Requirements

IDRequirement
FR-II65-9-01The system SHALL automatically trigger a pre-arrival notification to the receiving hospital when the ambulance ETA is 15 minutes or less.
FR-II65-9-02The notification SHALL initiate a real-time vital signs stream to the hospital ED dashboard for the patient in transit.
FR-II65-9-03The pre-arrival summary delivered to the hospital SHALL include: presenting complaint, interventions performed, current vital signs, and known patient history.
FR-II65-9-04The system SHALL deliver and display a hospital acknowledgement confirmation back to the field team upon ED staff accepting the notification.
FR-II65-9-05The system SHALL integrate with hospital ED information systems via the HL7 FHIR R4 standard.
FR-II65-9-06The system SHALL support configurable integration profiles for target hospital EHR platforms including Epic, Cerner, and locally hosted systems.
FR-II65-9-07The system SHALL allow the field team to manually trigger a pre-arrival notification regardless of ETA if clinically indicated.

Non-Functional Requirements

IDRequirement
NFR-II65-9-01The automated ETA-triggered notification SHALL be sent within 30 seconds of the ETA condition being met.
NFR-II65-9-02The real-time vitals stream to the hospital dashboard SHALL maintain less than 1 second latency under normal network conditions.
NFR-II65-9-03The HL7 FHIR R4 integration SHALL be validated against hospital sandbox environments prior to production go-live at each hospital site.
NFR-II65-9-04The hospital integration SHALL degrade gracefully if the hospital EHR is unavailable, logging the failure and queuing the handover record for manual submission.

Feature: II65-10 — Clinical Quality Reporting & Protocol Adherence

Epic: II65-E-5 (Clinical Quality & Analytics Platform) Aha.io Reference: II65-10

Functional Requirements

IDRequirement
FR-II65-10-01The system SHALL automatically calculate a protocol adherence score for each completed incident, measuring responder actions against the applicable clinical guideline steps.
FR-II65-10-02The system SHALL flag exceptions where a responder deviated from a guideline step, providing the specific step reference and the recorded action.
FR-II65-10-03The system SHALL aggregate adherence data and generate trend reports on weekly, monthly, and quarterly intervals.
FR-II65-10-04The system SHALL provide anonymised peer benchmarking, allowing responders to compare their adherence scores against the organisational average without identifying individuals.
FR-II65-10-05The system SHALL produce exportable reports in both PDF and CSV formats.
FR-II65-10-06The system SHALL de-identify all patient data in reports in compliance with GDPR and the NZ Privacy Act 2020.
FR-II65-10-07The system SHALL allow clinical supervisors to drill down from an aggregate trend report to the individual incident record underlying an exception.
FR-II65-10-08The system SHALL identify responders with a pattern of guideline deviations and surface them in a training needs dashboard.

Non-Functional Requirements

IDRequirement
NFR-II65-10-01Report generation for a quarterly summary across 500 responders SHALL complete within 60 seconds.
NFR-II65-10-02The protocol adherence scoring engine SHALL be auditable, with scoring logic versioned and linked to the guideline version it was derived from.
NFR-II65-10-03Exported reports SHALL be formatted to a professional standard suitable for regulatory submission without further editing.
NFR-II65-10-04All analytics processing SHALL use de-identified data; patient identifiers SHALL NOT be present in the analytics data layer.
NFR-II65-10-05The reporting system SHALL be accessible via the same role-based access control framework defined in II65-11.

Cross-Feature Non-Functional Requirements

These requirements apply across all features unless explicitly overridden at the feature level.
IDRequirement
NFR-GLOBAL-01All system components SHALL be designed for horizontal scalability to support growth from 50 to 5,000 concurrent users without architectural rework.
NFR-GLOBAL-02All APIs SHALL be versioned (e.g. /api/v1/) and SHALL maintain backward compatibility for a minimum of 12 months after a breaking change is announced.
NFR-GLOBAL-03All components SHALL emit structured logs (JSON format) to a centralised logging platform.
NFR-GLOBAL-04The system SHALL provide health check endpoints for all services, used by infrastructure monitoring and load balancers.
NFR-GLOBAL-05All personally identifiable information (PII) and protected health information (PHI) SHALL be governed by the Security & Data Privacy Framework (II65-11).
NFR-GLOBAL-06System documentation SHALL be maintained in version control and kept current with each release.

Feature–Requirement Traceability Matrix

Aha FeatureFeature NameFunctional ReqsNon-Functional Reqs
II65-1Clinical Guideline Knowledge BaseFR-II65-1-01 to FR-II65-1-08NFR-II65-1-01 to NFR-II65-1-05
II65-2AI Voice Guidance EngineFR-II65-2-01 to FR-II65-2-08NFR-II65-2-01 to NFR-II65-2-05
II65-3Vital Sign Alert & Threshold EngineFR-II65-3-01 to FR-II65-3-07NFR-II65-3-01 to NFR-II65-3-05
II65-4Wearable Device SDK & IntegrationFR-II65-4-01 to FR-II65-4-07NFR-II65-4-01 to NFR-II65-4-05
II65-55G/LTE Telemetry Streaming PipelineFR-II65-5-01 to FR-II65-5-07NFR-II65-5-01 to NFR-II65-5-05
II65-6FirstAidIQ iOS Application (MVP)FR-II65-6-01 to FR-II65-6-08NFR-II65-6-01 to NFR-II65-6-06
II65-7Patient Incident Record ManagementFR-II65-7-01 to FR-II65-7-08NFR-II65-7-01 to NFR-II65-7-05
II65-8Control Centre Live Operations DashboardFR-II65-8-01 to FR-II65-8-07NFR-II65-8-01 to NFR-II65-8-05
II65-9Hospital Pre-Arrival Notification & HandoverFR-II65-9-01 to FR-II65-9-07NFR-II65-9-01 to NFR-II65-9-04
II65-10Clinical Quality Reporting & Protocol AdherenceFR-II65-10-01 to FR-II65-10-08NFR-II65-10-01 to NFR-II65-10-05
II65-11Security & Data Privacy FrameworkFR-II65-11-01 to FR-II65-11-08NFR-II65-11-01 to NFR-II65-11-05
GlobalCross-feature requirementsNFR-GLOBAL-01 to NFR-GLOBAL-06