Six out of 10 technologies that passed the new health technology assessment, which evaluates the safety and effectiveness of new medical technologies, have been introduced into medical settings. Medical technologies in artificial intelligence (AI) and digital health are also growing quickly.
On the 22nd, National Evidence based Healthcare Collaborating Agency (NECA) released an analysis of operational results for the new health technology assessment over the past five years (2021–2025), showing that a total of 610 cases were filed over the past five years, and of the 355 cases for which the assessment was completed, 214 (60.3%) were introduced into medical settings. Among the technologies with completed assessments, 184 (51.8%) were recognized as new health technologies.
The new health technology assessment is a system that evaluates the safety and effectiveness of new medical technologies to determine whether to introduce them into medical settings; if they pass the assessment, they can be used at medical institutions.
During the same period, the number of medical device approvals by the Ministery of Food and Drug Safety totaled 36,191 (an annual average of 7,238). Of these, 610 cases applied for the new health technology assessment as new medical procedures, accounting for 1.7% of all approvals.
By technology type, procedures and interventions were the most common at 263 cases (43.1%), followed by other tests at 190 (31.1%) and in vitro diagnostic tests at 157 (25.7%). Notably, while the share of in vitro diagnostic tests decreased from 41.1% to 17.9%, other tests rose sharply from 16.1% to 41.5%. NECA attributed this to an increase in applications for data-driven medical technologies such as AI-based medical technologies and digital health.
Use of early access programs, such as innovative health technologies and assessment deferrals, also expanded.
A total of 40 innovative health technologies have been designated over the past five years through the innovative health technology assessment and integrated review and assessment of innovative medical devices. The number of medical institutions using these technologies increased about 30-fold from 34 in 2021 to 1,034 this year. Currently, 12 technologies are under study, with 94 participating medical institutions.
Technologies subject to assessment deferral expanded to 56 over the past five years (60 cumulative). They are currently being used at 2,378 medical institutions nationwide, and this year saw the highest number of applications among the past five years, indicating steadily growing demand in medical settings.
Support for corporations and medical institutions also expanded. Over the past five years, a total of 11,485 civil consultation cases were handled, along with 273 literature search supports, 119 clinical trial protocol consultations, and 696 new health technology assessment guide services.
Lee Jae-tae, head of NECA, said, "Over the past five years, many medical technologies have entered clinical settings after undergoing assessment," and added, "We will continue to advance the assessment system and support evidence generation in line with changes in the future medical technology environment, including AI and digital health."