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

Author:

Pashkov Vitalii M.1,Soloviov Oleksii S.2,Harkusha Yevheniia O.1

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.

Publisher

ALUNA

Subject

General Medicine

Reference25 articles.

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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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