In the era of advancements in artificial intelligence (AI) and machine learning, the healthcare industry has become one of the major areas where such technologies are being actively adopted and utilized. The global health care sector generated more than 2.3 zettabytes of data worldwide in 2020. Analysts estimate that the global market for artificial intelligence (AI) in medicine will grow to $13 billion by 2025, with a significant increase in newly established companies. Artificial intelligence in medicine is used to predict, detect and diagnose various diseases and pathologies. The sources of data can be various results of medical research (EEG, X-ray images, laboratory tests, e.g. tissues, etc.). At the same time, there are understandable concerns that AI will undermine the patient-provider relationship, contribute to the deskilling of providers, undermine transparency, misdiagnose or inappropriately treat because of errors within AI decision-making that are hard to detect, exacerbate existing racial or societal biases, or introduce algorithmic bias that will be hard to detect. Traditional research methods, general and special ones, with an emphasis on the comparative legal method, were chosen. For the AI to work it needs to be trained, and it’s learning from all sorts of information given to it. The main part of the information on which AI is trained is health data, which is sensitive personal data. The fact that personal data is qualified as sensitive personal data indicates the significance of the information contained, the high risks in case it’s leaking, and hence the need for stricter control and regulation. The article offers a detailed exploration of the legal implications of AI in medicine, highlighting existing challenges, the current state of regulation, and proposes future perspectives and recommendations for legislation adapted to the era of medical AI. Given the above, the study is divided into three parts: international framework, that will focus primarily on applicable WHO documents; risks and possible ways to minimize them, where the authors have tried to consider various issues related to the use of AI in medicine and find options to address them; and relevant case-study.