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Product Requirements Document (PRD)

1. Overview

An HF monitoring application that ingests passive/active signals, computes ambient QoL domain scores, and provides clinician dashboards and trial exports. Phase 1 targets KCCQ‑adjunct validation; Phase 2 adds passive signals and trial‑grade pipelines.

2. Users & Jobs

  • Patients: Easy weekly check‑in; optional 20–30s speech prompt; background sensing.
  • Clinicians: Track trends, receive safety alerts, view domain breakdown; document actions.
  • Research/Trials: Export curated endpoints to EDC; lock versions per protocol.
  • Ops/Admin: Manage cohorts, permissions, audits, and integrations.

3. Core Features

  1. Micro Check‑In (Weekly): 6–8 items (Likert + dyspnea/fatigue), 20–30 seconds.
  2. Speech Capture: Optional short reading or free speech; on‑device feature extraction where possible.
  3. Passive Sensing (opt‑in): steps, HR/HRV, sleep, home/away, routine regularity, noise/light.
  4. Ambient QoL Scoring: Five domain scores + composite, with uncertainty bands.
  5. Alerts: Rule‑based initial policies; tiered (FYI, Review, Urgent); clinician acknowledgement required.
  6. Clinician Console: Timeline, sparkline trends, last KCCQ vs ambient QoL deltas, alert feed.
  7. Trial Exports: Subject visits, locked score versions, JSON/CSV + FHIR MeasureReport.
  8. EHR Integration: SMART‑on‑FHIR launch; read vitals/meds/problems; write PDFs/notes and DiagnosticReport.
  9. Privacy/Security: Consent, data minimization, redaction; audit log.

4. Non‑Functional

  • Availability ≥99.5%; Latency <300ms p95 for API reads.
  • Security: Encryption at rest/in transit; secret rotation; RBAC/ABAC; audit.
  • Compliance: HIPAA/GDPR principles; DPA/BAA‑ready.
  • Model Governance: dataset versioning, drift monitoring, fairness metrics.

5. Metrics

  • Patient: weekly completion rate, time‑to‑complete, passives opt‑in rate.
  • Clinical: alert acknowledgement time, false‑alert rate, intervention time.
  • Outcomes: correlation to KCCQ, hospitalization rates, urgent call reductions.

6. Constraints/Assumptions

  • iOS/Android with background tasks; supports major wearables (HealthKit, Google Fit).
  • Early versions avoid continuous audio storage; compute features locally when possible.