The paper covers international experience in regulating the use of medical data for the development of artificial intelligence systems (AI) using machine learning methods. High-quality medical data sets are required for successful implementation of AI in medical practice and for higher efficiency of clinical and managerial decision-making. Such data sets are impossible to acquire, store and use without appropriate legal and regulatory framework that takes into account the interests of all participants at each stage of the development and use of AI.

The review of foreign legislations was carried out for the countries — leaders of the macro-regions, which were selected based on the higher metrics of the AI market. Today, there are different approaches to protecting medical data, with the most well-known being industry and cross-industry approaches (USA and EU respectively). In order to keep a proper balance between patient safety and the possibility of collecting medical data for developers, a regulatory framework for both crossbeing industry and cross-industry regulation needs to be formed.