Background

In 2016, the main theme of the World Economic Forum was ‘Mastering the Fourth Industrial Revolution’ which made a huge wave of the fourth industrial revolution, world widely. Fourth industrial revolution is defined as combination of different fields including ‘Digital’, ‘Bio’, ‘Physics’ and etc.. Advanced countries developed national strategy for the new innovation, at the same time, Korea also established a response system for the new industrial innovation. Korea launched ‘Presidential Committee on the 4th Industrial Revolution’ to deliberate upon and coordinate important policy matters pertaining to the development and acquisition of new science and technology and also new industries and services necessary for Korean society’s adaptation to the 4th industrial revolution. In healthcare field, a special sub-committee to suggest the vision and to discuss action plans for the vision was organized. The special sub-committee decides main agendas and six major projects in healthcare field, and also makes and push forward a response plan for the 4th Industrial Revolution. One of the six major projects is ‘Development and regulatory system improvement regarding smart complex medical devices’. In that project, regulatory system of MFDS (Ministry of Food and Drug Safety), nHTA system and health insurance system of MOHW (Ministry of Health and Welfare) became targets of the system improvement.

The nHTA system uses the evidence-based literature review method in which scientifically and objectively search, analyze and synthesize evidences from the clinical literatures. The main assessment method of nHTA is systematic reviews. Reviewing textbooks or guidelines are also conducted and even expert opinions based on the objective evidence are also reviewed in nHTA. Review system of objective evidences has been pointed out as an inadequate assessment methodology in a situation of rapid and massive development of healthcare technologies with a new concept, such as emerging or complex technologies. NECA conducted a research to develop value-based HTA methodology to the emerging medical technology in 2017. In the study, we investigated the current state of value-based assessment in HTA system and selected value items that could be considered in nHTA system.

Objective

The present study was conducted to develop the new assessment method on innovative or emerging health technology (innovative emerging technology) which has difficulties to applicate evidence-based literature review method. The present study also aimed to present the items to be considered essentially in the nHTA.