Patient access, triage, and agents
SkinVision
AI-powered skin cancer detection app that provides a risk assessment for uploaded skin spots and is CE-certified under EU MDR Class IIa.
Last updated: June 5, 2026
Back to directoryWysa medical AI product profile
Digital mental health platform with an AI conversation space, clinically verified tools, coach or healthcare-professional escalation options, and institution-facing programs.
Patient access, triage, and agents
Best fit
Organizations evaluating supervised digital mental health access, self-guided support, and structured escalation pathways rather than standalone AI therapy.
- Primary use case
- AI-supported mental health coaching, digital front door workflows, structured assessments, human coach or medical-assistant escalation, and institution-sponsored support programs
- Audience
- Employers, institutions, behavioral health programs, care teams, and digital mental health access leaders
- Risk level
- High
- Pricing signal
- Consumer, employer, institution, and clinical-program terms vary; verify the exact Wysa product, region, and contracted service scope.
- Official sources
- 5 official sources
Compare within workflow: Patient access, triage, and agents · comparison shortlist · source index
Regulatory, privacy, evidence, and workflow lens
Product-specific review. These product-specific signals summarize what the cited sources imply before treating Wysa as safe for a local clinical, operational, or research workflow.
| Regulatory / FDA | Treat as high-risk behavioral-health software. Verify the exact product, intended use, population, geography, clinical-program status, and whether any FDA Breakthrough designation has progressed to clearance or authorization for the planned deployment. |
|---|---|
| Privacy | Review conversation data, assessment scores, safety flags, institution reporting, OpenAI/LLM processing, anonymized training and analytics, AWS hosting, fitness-data use, coach or medical-assistant records, and local BAA/DPA terms. |
| Evidence | Review product-specific clinical evidence, crisis and safeguarding performance, PHQ-9/GAD-7 handling, user engagement, human escalation quality, and outcomes for the target population before rollout. |
| Workflow | Best governed as supervised behavioral-health access and support, with clear exclusions, emergency routing, human escalation, institution reporting boundaries, and periodic clinical safety review. |
Where Wysa fits
Wysa describes an AI-powered conversation space, clinically verified tools, human coach and healthcare-professional options, and institutional services; its FDA Breakthrough announcement is limited to a specific CBT tool for adults with chronic musculoskeletal pain and associated depression and anxiety, while privacy and FAQ materials describe AI chatbot data use, safeguards, and limits on diagnosis or medical advice.
Not for: Emergency crisis handling, autonomous diagnosis or treatment, unsupervised care for high-risk patients, or assuming FDA Breakthrough Device Designation applies to every Wysa product.
What to verify before using Wysa
- Which product is in scope: Wysa app, Wysa Assure, institutional digital front door, Wysa Coach, Wysa Medical Assistant, or a region-specific clinical program.
- Whether the FDA Breakthrough Device Designation applies to the intended use, population, region, and product version, and whether the product has marketing authorization.
- Conversation-data processing, anonymized training use, OpenAI or other LLM subprocessors, fitness-data use, institution reporting, retention, hosting region, and consent terms.
- Crisis routing, moderate-to-severe score escalation, clinical handoff, clinician review of summaries, safeguarding rules, and monitoring for unsafe or over-reassuring responses.
Source links
Use these links to confirm current claims, terms, regulatory status, pricing, and deployment requirements.
- www.wysa.com
- blogs.wysa.io / blog / research
- www.wysa.com / faq-clinical-program
- legal.wysa.io / privacy-policy
- legal.wysa.io / assure / privacy-policy
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