Scope: what ATS-1 is for, and what it must never do
ATS-1 is for research and general wellness only. It does not diagnose, treat, prevent or predict any disease, including any mental health condition.
The scope
ATS-1 defines how to collect, compute and report three-plane measures of a person's everyday state for research and general wellness. Deployment to employers or education providers in the EU is out of scope, because of the EU AI Act's prohibition on emotion recognition in workplaces and education, which has applied since February 2025.
Prohibited outputs
- Clinical severity bands, including PHQ-9 or GAD-7 bands
- Screening cut-offs
- The words "risk", "predict", "detect" or "abnormal"
Outputs may state: "Evaluation by a healthcare professional may be helpful."
The crisis notice
Any participant-facing interface must show: "If you are in crisis, call or text 988 (US) or your local emergency number."
Why the boundary is strict
In the US, the FDA's general wellness guidance, revised on 6 January 2026, keeps non-invasive wearable features such as heart-rate variability within wellness only if they avoid disease references, diagnostic thresholds and labels such as "abnormal" (Covington, 8 January 2026; FDA, General Wellness: Policy for Low Risk Devices). ATS-1 builds those limits into the specification itself. See wellness versus medical device.
Questions
Can a licensee add a diagnostic feature?
Not under ATS-1. Licensees must not make diagnostic, disease or treatment claims based on ATS-1 outputs.
Sources
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The ATS-1 scope: research and general wellness only, the outputs it prohibits, the words it never uses, and the crisis notice every interface must show.