Regulatory status
Kanzen is not a medical device. This page says precisely what that means.
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Intended purpose
Kanzen helps an adult collect, structure, review and control the sharing of their own health information. It supports entry by the person, uploaded documents, visible provenance, limited sharing with chosen recipients, and clearly labelled informational summaries.
That is the whole of it. The purpose is information management, not clinical decision-making.
What the product does not do
- It does not diagnose, and it does not present a probability as a diagnosis.
- It does not prescribe, change or stop treatment, and it does not recommend medicines.
- It does not triage, and it does not promise an emergency response.
- It does not confirm extracted clinical facts without a person accepting them.
- It does not monitor in the clinical sense of the word.
Why this matters
Under EU rules, software becomes a medical device largely because of the purpose its maker assigns to it — including in marketing. A single sentence promising interpretation or clinical benefit would change what the product legally is.
So the boundary is not a disclaimer bolted on at the end. It decides what we are allowed to build and what we are allowed to say, and every claim on this site is checked against it.
Emergencies
If you have urgent symptoms or an immediate risk to life, call 112 or your local emergency number. Kanzen is not an emergency service and must never be used as one.
Where the service is offered
The service is offered to adults in the EU/EEA. Outside that area the applicable regime differs, and we do not offer the service there rather than assume the rules are the same.
If you think we have crossed the line
If you find a claim on this site or in the application that reads as a clinical promise, tell us at zen@kanzenkai.org. We would rather correct a sentence than defend it.