Standards

This page describes standards and regulatory references used by the HealthOS Onco architecture. The statements below are not a claim of full conformance, clinical validation, regulatory clearance, or medical certification.

Data Planes

HealthOS Onco is not an autonomous oncology decision engine and does not assign therapy. Patient preparation depends on other planes: document collection, fact provenance, completeness checking, risk warnings, indicative cost, and doctor report.

Data path to the doctor report, with a breakdown of disputed or incorrect facts and evidence of errors.
Documents and the questionnaire form the initial fact set. Each fact receives a link to its source document. The completeness check surfaces gaps and risk warnings. Disputed or incorrect facts are flagged with explicit warnings. Facts and completeness feed directly into the final report. The price snapshot adds a dated cost context.

Price snapshot is a dated set of indicative price data for the selected region, scope of medical care, and stages of the patient pathway. It supports transparent calculation and discussion with a doctor or coordinator, but it is not the final cost of medicines or medical care.

Source document link is a pointer to the uploaded file, discharge note, pathology report, lab result, certificate, or other document from which a specific fact was taken.

Questionnaire answer is information entered manually by the patient or trusted person: for example medicines, allergies, prior therapy, region, or case clarifications.

Plane	What It Includes	Verifiable Result
Data collection	PDF, discharge notes, pathology, imaging, questionnaire, medicines, allergies, prior therapy	Drafts are separated from confirmed facts
Provenance	Source document link or questionnaire answer, document versions, confirmation date	Patient and doctor can see where a fact came from
Completeness and risks	Readiness status, critical gaps, risk warnings, doctor questions	Gaps, limits, and discussion topics are shown explicitly
Cost	Cost region, price snapshot, calculation components	Cost remains indicative and dated
Export	Doctor report, version history, activity audit	The report is reproducible and usable for consultation

Interoperability and Data

Reference	How It Is Used
HL7 FHIR R4	Medical data exchange model: patient, observations, conditions, medicines, allergies, documents, questionnaire answers, and provenance
FHIR DocumentReference	Future model for document identity and source links
FHIR DiagnosticReport and Observation	Future model for pathology, lab, biomarker, imaging-summary, and other clinical facts
FHIR Provenance	Recording data origin, sources, versions, and actions
FHIR AuditEvent	Access, event, and report operation log

Oncology Reference Frame

Reference	Role in the Product
ESMO patient and guideline materials	Reference frame for plain-language oncology preparation and international comparison
RUSSCO practical recommendations	Reference frame for Russian oncology terminology and breast cancer context
ASCO guidelines	International comparator for guideline language and evidence framing
MONDO, NCIT, OncoTree	Future terminology anchors for disease identity and tumor subtype normalization
GLOBOCAN and national oncology statistics	Market and burden context, not a patient instruction

Patient Interface Safety

HealthOS Onco is not an autonomous clinical decision system. The following product limits are therefore important:

the report is labeled as informational;
the comparison does not contain controls for ordering or selecting treatment;
cost does not rank directions above risk and data completeness;
unknown data are explicitly marked;
unsupported tumor modules do not imitate a ready comparison board;
doctor consultation remains a required part of the pathway.

Personal Data

The personal cabinet must provide user consent, access control, event logging, document storage, report storage, and repeated access. The public site does not accept medical documents and does not collect user medical information.

Regulatory References

Reference	How It Is Applied	Public Site Limitation
FDA Clinical Decision Support Software Guidance	Helps formulate the principle of independent review of the basis for an output	The site is not a medical device and does not replace product assessment
IMDRF SaMD Key Definitions	Used as vocabulary to distinguish informational support from medical purpose	Formal classification requires jurisdiction-specific analysis
ISO 14971	Risk management frame for product implementation	The full risk management dossier is not published on the site
IEC 62304	Software lifecycle reference for productization	The prototype site does not claim certification
IEC 82304-1	General health software safety frame	Conformance must be confirmed by a separate product assessment