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Through a broad literature review, analysis of EU, USA and Ukraine regulation acts, scientific researches and opinions of progressive-minded people in this sphere this paper provide a guide to understanding the essence of stand-alone software as a medical device and specifics of its regulation. It is based on dialectical, comparative, analytic, synthetic and comprehensive methods. The aim To systematize and bring the reader closer to knowledge about the occurrence of sexual disorders in people after heart transplantation based on a