Sources

This page lists public sources used as the reference frame for the site, standards, market validation, and safe product positioning. Internal working documents are not published as user-facing links.

Sources do not mean an automatic claim of full conformance. They define the product language: verifiable grounds, explicit boundaries, traceable facts, indicative cost, and separation of patient preparation from medical ordering.

Source	Status	How it is used
ESMO Breast Cancer Guide for Patients	reference standard	Plain-language oncology preparation context; not imported as a medical recommendation engine.
ESMO Clinical Practice Guideline: Early Breast Cancer	reference standard	Authorized international professional clinical practice guideline for early breast cancer (updated November 2023); the EN-zone counterpart to the Minzdrav-approved Russian clinical recommendation.
RUSSCO breast cancer practical recommendations	reference standard	Reference frame for breast cancer data fields and doctor discussion topics.
Minzdrav-approved clinical recommendation “Breast Cancer” (ID 379_4)	reference standard	The specific, currently active clinical recommendation (ICD-10 C50, D05) approved by the Ministry of Health’s Scientific and Practical Council, underlying the product’s first module; includes the official patient-information appendix.
ASCO guidelines	reference standard	International comparator for guideline language; not a patient instruction.
HL7 FHIR R4	architectural reference	Compatibility model for documents, observations, medicines, allergies, questionnaire answers, provenance, and audit.
MONDO Disease Ontology	architectural reference	Stable disease identity frame for future oncology terminology normalization.
NCI Thesaurus / NCI Enterprise Vocabulary Services	architectural reference	Oncology-native terminology frame for tumor concepts and mappings.
OncoTree	architectural reference	Clinical tumor taxonomy frame for future subtype routing.
FDA Clinical Decision Support Software Guidance	regulatory reference	Used to frame independent review of the basis for outputs and boundaries around medical ordering.
IMDRF SaMD Key Definitions	regulatory reference	Vocabulary for distinguishing informational preparation from medical-purpose software claims.
ISO 14971:2019 — Medical devices — Risk management	regulatory reference	Frame for hazards such as automation bias, incomplete data, price over safety, and report misinterpretation.
IEC 62304:2006+AMD1:2015 — Medical device software lifecycle	regulatory reference	Future frame for product software development, testing, and change control.
IEC 82304-1 — Health software product safety	regulatory reference	General safety frame for health software; the public site does not claim certification.
GLOBOCAN 2022 / Global Cancer Observatory	market reference	Cancer burden context for oncology module sequencing.
Global cancer statistics 2022	market reference	Global epidemiology reference for breast, lung, colorectal, and prostate cancer prioritization.
Cancer care in Russia 2024, Herzen Institute / NMRC Radiology	market reference	Russian oncology care context for product positioning and patient preparation need.
Order No. 103n official publication	regulatory reference	Reference for clinical recommendation structure and evidence-grade language in Russia.
Clinical Recommendations Rubricator, Russian Ministry of Health	reference standard	Official registry of approved Russian clinical recommendations; frames the local clinical-guideline structure alongside RUSSCO and ASCO.
Federal Law No. 323-FZ “On the Fundamentals of Protecting the Health of Citizens in the Russian Federation”	regulatory reference	Russian legal frame for patient information rights, informed consent, and the boundary between information and medical care.
Federal Law No. 152-FZ “On Personal Data”	regulatory reference	Russian personal data law framing consent, storage, and access control for documents held in the personal cabinet.
Government Decree No. 1684 — medical device state registration rules	regulatory reference	Current Russian medical device registration framework (in force since 1 March 2025, superseding Decree No. 1416); the Roszdravnadzor-supervised counterpart to FDA CDS guidance and IMDRF SaMD definitions.
Ottawa Hospital Research Institute: Decision Aids Research Group	category reference	Reference for patient decision-support tools as a category without importing medical recommendations.