Affiliation:
1. 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
2. NATIONAL SECURITY AND DEFENSE COUNCIL OF UKRAINE, KYIV, UKRAINE
Abstract
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.
Reference25 articles.
1. 1. Nicole Wetsman. When it comes to fitness trackers and health apps, the FDA says you figure it out. URL: https://www.popsci.com/fdaregulations- fitness-trackers-apps/ (reference date 01.02.2021)
2. 2. Carroll N., Travers M., Richardson I. “Evaluating multiple perspectives of a connected health ecosystem”, 9th International Conference on Health Informatics (HEALTHINF), Rome,2016, 21-23 February.
3. 3. O’Leary P., Carroll N., Clark, P. and Richardson I. “Untangling the complexity of connected health evaluations”, IEEE International Conference on Healthcare Informatics2015 (ICHI 2015), Dallas, 21-23 October.
4. 4. Richardson I. “Connected health: people, technology and processes”, Lero Technical Report Series Lero-TR-2015-03, University of Limerick.2015.
5. 5. Pashkov V., Kotvitska A., Harkusha A. Legal regulation of the production and trade of medical devices and medical equipment in the EU and US: experience for Ukraine. Wiad. Lek. 2017;70 (3 pt 2):614-618.
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