J Dent Rehabil Appl Sci.  2020 Dec;36(4):203-210. 10.14368/jdras.2020.36.4.203.

Application of digital software as a medical devices in dental clinic

• Woo K
• Baik S
• Kim ST

• KMID: 2512115
• DOI: http://doi.org/10.14368/jdras.2020.36.4.203

Abstract

By facing the era of the 4th industrial revolution, personalized medical services for patients are expanding with the development of information and communications technology. With these changes, digital medical devices have begun to be used to support diagnosis, patient monitoring, and decision-making of diseases, and recently software medical devices for the purpose of preventing, managing, or treating disorders or diseases have become popular. The aim of this article is to understand the current concept and status of Software as a Medical Device (SaMD), which are actively being carried out in the United States, and to find out what fields can be applied in the future. In addition, it intends to find out the Korean domestic policy trends related to smart healthcare and find out the application of digital software as a medical devices that can be used in dental clinic to keep pace with the upcoming changes in the medical field.

Keyword

digital treatment devices; digital therapeutics; digital based medical device; software as a medical device; dental clinic

Figure

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  Fig. 1 Illustration of the regulatory framework for digital treatment device, as implemented by the KR Ministry of Food and Drug Safety.

Reference

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