Vision & outcomes — clear mission, target personas, and measurable KPIs.

User research & personas — methods, journey maps, and acceptance criteria.

Clinical & ethical framework — scope limits, escalation rules, and consent patterns.

Technical architecture — modular stack, on‑device vs cloud tradeoffs, APIs.

Data strategy & governance — classification, retention, audit trails, DPIA checklist.

Privacy by design (GDPR) — layered consent, DPO roles, subject‑rights workflows.

Model selection & fine‑tuning — provenance, local language datasets, safety filters.

Personalization engine — tiered memory, user controls, provenance logging.

Conversational UX & accessibility — multilingual flows, voice, low‑literacy modes.

Safety layers & escalation — classifiers, human‑in‑the‑loop, SLAs, playbooks.

Clinical content pipeline — templated modules, review stages, evidence links.

Testing & validation — adversarial tests, RCT/pilot guidance, CI gates.

Bias, fairness & inclusion — threat model, subgroup audits, remediation steps.

Explainability & transparency — user rationales, provenance metadata, reports.

Security & incident response — threat model, HSMs, tabletop exercises.

Regulatory map & certification — AI Act, MDR considerations, compliance matrix.

Operational playbook — roles, runbooks, onboarding, release and rollback plans.

Monitoring & KPIs — safety, clinical outcomes, engagement, drift detection.

Business & monetization ethics — models, conflict‑of‑interest controls, audits.

Community adoption & improvement — co‑design, pilots, feedback loops, scaling plan.