Russia to Develop Artificial Intelligence Standards in Healthcare


Project:  Technical Committee 164 “Artificial Intelligence” (TC 164)

In 2020, the first versions of national standards in the field of artificial intelligence in healthcare will be developed in Russia. The development will be coordinated by the Technical Committee for Standardisation “Artificial Intelligence” (TC 164), created based on the RVC.

Under the long-term work plan of the Technical Committee until 2027, it is planned to develop about 50 standards in the field of artificial intelligence in healthcare in certain areas, including general requirements and classification of AI systems in clinical medicine, radiation and functional diagnostics, remote monitoring systems, histology, support systems medical decision-making, image reconstruction in diagnoses and treatment, big data in healthcare, medical analytics systems, and forecasting studies, educational programs in healthcare.

Revision of the first six national standards will be prepared in 2020, among them:

  • Artificial Intelligence Systems in Clinical Medicine. Part 1. Clinical investigations;
  • Artificial Intelligence Systems in Clinical Medicine. Part 2. Program and method of technical tests;
  • Artificial Intelligence Systems in Clinical Medicine. Part 3. Application of quality management to pre-training programs. Algorithm Change Protocol;
  • Artificial Intelligence Systems in Clinical Medicine. Part 4 Assessment and control of operational parameters of retrained algorithms;
  • Artificial Intelligence Systems in Clinical Medicine. Part 5. Requirements for the structure and procedure for using the data set for training and testing algorithms;
  • Artificial Intelligence Systems in Clinical Medicine. Part 6. General requirements for operation.

“Healthcare is one of those areas in which the standardisation of artificial intelligence technologies is most relevant. This is explained, firstly, by the danger of the consequences of using AI systems with unwarranted quality in clinical practice, and secondly, by the high technological maturity of developments in this area. In our country alone, several dozen companies are offering highly advanced intelligent medical information processing systems, and the lack of an adequate regulatory framework is a deterrent to the effective implementation of these systems,” said Sergey Garbuk, chairman of the Artificial Intelligence Technical Committee.

To coordinate the unification and standardisation of requirements for AI systems in healthcare, as well as the installation of certification requirements for medical devices, by the order of Rosstandart, a subcommittee “Artificial Intelligence in Healthcare” (PK01 / TC164) was created as part of TC 164. The subcommittee is formed based on the Centre for Diagnostics and Telemedicine. He was headed by a chief freelance specialist in instrumental and radiation diagnostics at the Moscow Department of Health and the Russian Ministry of Health in the Central Federal District, director of the Centre for Diagnostics and Telemedicine, doctor of medical sciences, professor Sergey Morozov.

“National standards will regulate key aspects of the application of artificial intelligence in healthcare and its role in making medical decisions. Without uniform technical standards approved by the professional community by consensus, the practical implementation of artificial intelligence in the healthcare sector is impossible. I want to underline that the main emphasis in our work will be placed on practical healthcare. We will not touch upon pharmaceuticals,” said Sergey Morozov.

The Artificial Intelligence Technical Committee was created in 2019 at the initiative of the RVC with the support of the Ministry of Industry and Trade of the Russian Federation and Rosstandart. TC 164 under the National Strategy will carry out AI standardisation work in critical sectors of the economy for the Development of Artificial Intelligence for the period until 2030. It provides for the creation of unified systems for standardisation and conformity assessment of technological solutions developed based on artificial intelligence, the development of international cooperation on standardisation and the provision of certification of products based on AI.

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