CHALLENGES OF CLASSIFICATION OF STAND-ALONE SOFTWARE AS A MEDICAL DEVICE.

Autor: Pashkov VM; POLTAVA LAW INSTITUTE OF YAROSLAV MUDRYI NATIONAL LAW UNIVERSITY, UKRAINE, POLTAVA, UKRAINE; LABORATORY FOR THE STUDY OF NATIONAL SECURITY PROBLEMS IN THE FIELD OF PUBLIC HEALTH OF АCADEMICIAN STASHIS SCIENTIFIC RESEARCH INSTITUTE FOR THE STUDY OF CRIME PROBLEMS, POLTAVA, UKRAINE., Soloviov OS; NATIONAL SECURITY AND DEFENSE COUNCIL OF UKRAINE, KYIV, UKRAINE., Harkusha YO; POLTAVA LAW INSTITUTE OF YAROSLAV MUDRYI NATIONAL LAW UNIVERSITY, UKRAINE, POLTAVA, UKRAINE; LABORATORY FOR THE STUDY OF NATIONAL SECURITY PROBLEMS IN THE FIELD OF PUBLIC HEALTH OF АCADEMICIAN STASHIS SCIENTIFIC RESEARCH INSTITUTE FOR THE STUDY OF CRIME PROBLEMS, POLTAVA, UKRAINE.
Jazyk: angličtina
Zdroj: Wiadomosci lekarskie (Warsaw, Poland : 1960) [Wiad Lek] 2021; Vol. 74 (2), pp. 327-333.
Abstrakt: Through a broad literature review, analysis of EU, USA, Ukraine regulation acts, scientific research, and opinions of progressive-minded people in this sphere, this paper provides a guide to understanding the essence of classification of stand-alone software with medical purpose and specifics of its regulation. This research is based on dialectical, comparative, analytic, synthetic, and comprehensive methods.
Databáze: MEDLINE