Article | REF: TE7504 V2

International Regulation and Standardisation in bodies of e-Health equipments

Author: Daniel BATTU

Publication date: February 10, 2020

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ABSTRACT

Managing natural disasters and major epidemics could be complex if global regulations and standards had not been prepared. The availability of new electronic health equipment required an overall effort to rationalize. This article summarizes the role and relationships of various agencies involved in defining these materials and in the related regulations. The World Health Organization brings its specificity to the many bodies for standardizing these materials. The aspects of medical data exchange, as well as drug standards and regulations, are briefly discussed.

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AUTHOR

  • Daniel BATTU: Honorary Telecommunications Consultant (ECTI), Rennes, France

 INTRODUCTION

Information and communication technologies (ICT) are helping to support the development and management of conventional medicine. They offer an excellent opportunity to rationalize the organization of care by medical specialty on a national scale, and to demonstrate the economic profitability of the most appropriate structures and methods.

The World Health Organization (WHO), supported by the United Nations and a number of charitable foundations, defines research programs, coordinates terminology and the use of regulatory standards and principles. It presents evidence-based intervention options, with technical support for the poorest countries.

Thanks to the close collaboration established between the many standardization bodies set up around the world, analysis and research work on human health and physical well-being is progressing rapidly. This work brings together the medical and ICT worlds, while respecting generally accepted moral rules and good practices relating to transaction security. Transfers of personal health information are carried out in complete confidentiality. The manufacture of pharmaceutical products is governed by strict standards that international regulations attempt to maintain in all regions of the world.

In every country, ICTs can help reduce healthcare costs while improving the quality of healthcare systems. By describing the landscape of regulatory and standardization bodies involved, this article attempts to objectively indicate the division of responsibilities currently assumed at national and international levels. Global or national management of the healthcare field is probably the most important human activity, and the continuous evolution of the technologies involved means that precise and constant adaptation is essential.

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Regulation and standardization of electronic equipment in the healthcare sector
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