Limits
Limits and responsibility
This page says what we sell and what we do not.
Limits
What is sold and what is not
| Sold | Not sold |
|---|---|
| A completed case of functional diagnostics: the study, the draft, authorization by the physician, a structured medical document, registration | A diagnosis made by a machine |
| A producible evidence chain behind every finding | Autonomous interpretation without a physician |
| A flow of a patient’s recordings that reaches the physician structured | A medical device: there is no registration today |
| Reproducibility: a versioned rule, and a new recording means a new version of the document | A substitute for a Holter monitor, a patch or an implantable monitor |
| For a person — a case summary and a conclusion as an informational draft | For a person — a diagnosis, a prescription, or round-the-clock supervision |
Limits
Regulatory status
The product is not yet a medical device: it prepares a draft of a medical document, and the diagnosis is authorized by a physician.
Limits
Who is responsible
No finding becomes a document without a physician’s signature. A draft always stays a draft; the document’s authority comes only from the physician’s qualified electronic signature. This is not a lawyer’s caveat but a load-bearing structure: the bytes of the document are signed, and the physician’s signature is verified over them whenever it is needed.
The machine does not make a diagnosis and does not sign the document.
What backs it up
Submission to the registry
The document is formed and signed in the same window; submission to the registry — once the operator’s loop is ready.
Position
Accuracy, effect, terminologies, data
- Accuracy. We answer for the provability of the output, not for a place in a comparison of accuracies.
- Effect. The figures for time saved and for acceptance by the registry will be obtained in the first pilot, by a method approved in advance.
- Terminologies. The electrocardiographic subsets of international terminologies, bound to the descriptors of the analysis.
- Data. There are no trainable models in the decision path; the product has no training set.
Who this is for
On the patient’s side
The conclusion on your own recording is an informational draft, a reason to see a physician. It is not a physician’s diagnosis and not a service that watches over a person’s condition.
A question about the limits of the product or about responsibility?
Write to us