Standards
Standards
What the product stands on: the format of the document, the signature, cryptography, registration, the processing of data and terminologies.
What backs it up
The document
The conclusion comes out as an instrumental examination protocol — a structured medical document of type SEMD-224 Rev. 5 in the CDA R2 format. The text of the protocol is built out of the findings of the analysis instead of being typed anew, so a divergence between what is visible in the signal and what is written in the document is excluded by construction.
What backs it up
The physician’s signature
The document is authorized by a physician with their qualified electronic signature — under Federal Law 63-FZ and order No. 947n of the Ministry of Health. The frozen bytes of the document are signed, and the signature is verified over those same bytes; the verification follows Russian national cryptographic standards. The signing key stays on the physician’s side.
What backs it up
Registration
The document is formed and signed in the same window; submission to the registry of electronic medical documents — once the operator’s loop is ready. The completeness of the mandatory fields is checked before submission: a missing field is named by name instead of coming back as a rejection from the registry after the fact.
What backs it up
Data
Processing takes place inside the perimeter of the medical organization or in a cloud on Russian territory — under Federal Law 152-FZ. The data do not go into the training of third-party models.
Dictionary
Terminologies
The dictionary of the cardiology dialect is bound to the electrocardiographic subsets of LOINC and SNOMED CT. The binding goes to the descriptors of the analysis: every finding has a term it relates to.
Limits
The regulatory limit
HealthOS Cardio is not a medical device: the product prepares a draft of a medical document, and the diagnosis is authorized by a physician.
Order No. 193n of the Ministry of Health of 11.04.2025, in force since 1 September 2025, permits the use of clinical decision support systems based on artificial intelligence in deferred consultations — but only for systems that hold medical-device registration (ConsultantPlus). Our position is a tool for producing documents: the pipeline prepares the draft, and the physician takes the decision.