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Product Vision

Why

Heart failure (HF) remains a leading driver of disability and utilization. Patients care about how they feel and function more than abstract survival metrics. Today’s gold‑standard QoL instrument (KCCQ) is episodic (2‑week recall), sensitive to bias, and shows ceiling/floor effects. We will provide continuous, contextual, ambient quality‑of‑life (QoL) monitoring that complements KCCQ initially and can evolve into a validated trial‑grade endpoint.

Vision Statement

Deliver a regulator‑ready, AI‑powered QoL layer for HF that: - Captures passive (sensors, activity, environment) and low‑friction active (micro check‑ins, brief speech prompts) signals. - Converts them into interpretable scores aligned to five domains: Physical, Emotional/Cognitive, Social/Behavioral, Symptom Burden, Environmental. - Produces actionable alerts and trial‑grade endpoints with auditable lineage and bias controls. - Integrates with EHR (SMART on FHIR) and trial platforms (ePRO / EDC).

Success Criteria (North‑Star)

  • Improves detection of decompensation ≥7 days earlier than standard care.
  • Demonstrates non‑inferiority to KCCQ for change detection; later superiority on responsiveness.
  • Achieves ≥80% weekly engagement with micro check‑ins and ≥70% speech snippet capture.
  • Gains IRB approval and pilot validation with statistically significant correlation to KCCQ subscales.
  • Passes independent privacy & security assessments (SOC2‑ready posture).

Principles

  1. Clinically grounded: build with cardiology input; align to guideline pathways.
  2. Lightweight for patients: minutes per week, not hours.
  3. Transparent AI: model cards, bias checks, versioning, and human‑interpretable outputs.
  4. Interoperable: FHIR resources, standard questionnaires (KCCQ-12), export to EDC.
  5. Safety first: conservative alert thresholds; clinician in the loop.