AI & Governance
Health & FDA-Safe Positioning
How we scope products to avoid unintended medical-device classification.
Scope & positioning
Some of our work sits near health and wellbeing—most notably Remu EdTech's role in student support. We are deliberate about scoping these products so they support care and coordination without becoming clinical or diagnostic tools.
- Not a medical or diagnostic device. Our products do not diagnose, treat, or make clinical determinations. They support documentation, routing, and coordination under human authority.
- Support, not substitution. Where wellbeing is involved, our systems assist counselors, educators, and qualified professionals rather than standing in for them.
- Health-grade confidentiality. When information is health-adjacent, we design our handling around the confidentiality principles associated with HIPAA-governed contexts.
- Careful about classification. We scope features intentionally to avoid unintended medical-device classification, and we revisit that scoping as products evolve.
This reflects our current design intent and is not legal or regulatory advice or a statement of certification.
Questions
Contact contact form.