AI Mental Health Development

Reference architecture

1. Patient Interface
2. Risk & Crisis Classifier
3. Guardrailed LLM / Screening Engine
4. Escalation Router (988 / clinician)
5. Clinician Dashboard + EHR Write-back

A typical AI mental-health system: every patient message passes through a risk and crisis classifier first; low-risk turns continue to the guardrailed LLM and screening engine, while high-risk signals short-circuit straight to the escalation router (988, crisis text, or a live clinician). Screening results and alerts write back to the clinician dashboard and EHR.

Frequently asked questions

• How do you handle a user in crisis or expressing suicidal ideation?+

  We build crisis handling first, before anything else in the product. Every message passes through a risk classifier before the support flow; a self-harm or suicidal-ideation signal short-circuits the conversation and routes immediately to 988, a crisis text line, or a live clinician per your escalation policy. Those escalation patterns are reviewed by your clinical advisor on every build: never-miss-crisis is a design requirement.

• Is an AI mental-health tool FDA-regulated?+

  It depends on the claims. A wellness or support companion generally sits outside FDA oversight, but the moment a product claims to treat or diagnose a condition it can become a regulated Software as a Medical Device or prescription digital therapeutic. We architect your build for the SaMD/DTx pathway from the start, but the formal determination and any clinical-evidence strategy need your FDA regulatory consultant. We’ll tell you honestly where your product sits.

• Will the AI ever give clinical advice or recommend medication?+

  No. The system prompt and guardrail logic enforce that boundary directly. The support layer is CBT/DBT-informed and stays within scope: no diagnosis, no medication guidance, no unsupervised clinical advice. Anything that crosses that line hits a refusal pattern and, where appropriate, a hand-off to a licensed clinician.

• Do you implement validated screening instruments like PHQ-9 and C-SSRS?+

  Yes. We implement PHQ-9, GAD-7, C-SSRS, PCL-5, and similar instruments to their published scoring specs, with correct severity banding and clinician-visible results. We build the instrument faithfully; the interpretation of scores and any clinical action on them stays with your licensed providers.

• How does this augment therapists rather than replace them?+

  The system is built to give clinicians more signal while staying inside a support role. Session-prep summaries, between-visit deterioration alerts, and measurement-based-care dashboards surface what matters before an appointment. High-risk moments route to a human, and the model stays inside a support scope. The licensed clinician remains the one providing care.