Establishes the general provisions of the set of national standards on “Artificial intelligence systems in clinical medicine”, including: General purposes and objectives. Requirements. Terms and definitions

Provides guidance on the application of GOST ISO 14971-2021 to the development, use, and maintenance of the risk management procedures that affect artificial intelligence systems in clinical medicine at all stages of their life cycle.

Contain terms and definitions used in the predictive analytics systems, classification, goals, objectives, and baseline requirements.

Contains general provisions regarding the ethical aspects of the development and operation of artificial intelligence systems in health care.

Set out the general requirements for the test methods for the Clinical decision support system (CDSS), which include artificial intelligence technologies. This standard can be recommended to the developers of artificial intelligence systems for internal testing, the certified agencies conducting technical trials, and the regulatory bodies.

Contain the key provisions of the national standards for AI-based CDSS and define the goals, main tasks, requirements, terminology, collection of data from electronic medical records (EMR), and generation of data sets for research, routine clinical practice, and machine learning.

A top-tier standard that covers all processes and terminology related to AI in health care.

Establishes methods for de-identifying the datasets used in training and validation of AI in clinical medicine, and ensuring the dataset meets the criteria for the absence of personal data.

Define the general requirements for artificial intelligence systems used in medical imaging, and establish requirements for quality control, operational parameters, output data content, etc.

Contain terms, definitions, goals, objectives, and general requirements for these systems, and sets out the requirements for patient risk stratification based on artificial intelligence technologies.

Establish general requirements for AI-powered digital platforms for education to acquire practical skills in medicine.

Contain the main terms and definitions related to AI-powered telemonitoring systems, classification, main goals and objectives, and the main requirements for these systems.