"Digital Medical Devices Require Health Insurance Listing Criteria... Regulatory Relaxation Should Be Discussed"

Advice has been given that measures should be prepared to register digital healthcare devices, such as digital medical devices, under health insurance to revitalize the digital healthcare industry. Opinions were also expressed on the need to ease regulations related to digital therapeutics.

The Korea Venture Business Association held a "Discussion Forum on Development Plans for the Digital Healthcare Industry" on the 27th at the 9th Meeting Room of the National Assembly Members' Office Building, together with Hong Seok-jun and Baek Jong-heon, members of the People Power Party.

Participants are sharing their opinions at the Digital Healthcare Industry Development Forum held on the 27th in the 9th Meeting Room of the National Assembly Members' Office Building.
[Photo by Lee Myunghwan]

This forum was organized to share the results of a study on improvement measures after investigating institutional difficulties in the digital healthcare industry over the past year by the Digital Healthcare Policy Committee under the Korea Venture Business Association. In addition, participants discussed future development plans for fostering the digital healthcare industry. Specifically, ▲Healthcare regulatory difficulties ▲Digital healthcare legislation in major foreign countries ▲Measures to resolve digital healthcare regulations were addressed.

Jinsoo Lee, CEO of I& I Research, who delivered the presentation, argued that a plan to register digital therapeutic devices under health insurance is necessary. Regarding the current insurance application procedure for digital therapeutic devices, Lee explained, "Medical acts using medical devices must be recognized for safety and efficacy, and it must be reviewed whether there was an existing similar benefit in terms of existing benefits and usage purposes," adding, "Clinical trials after approval by the Ministry of Food and Drug Safety are minimal but maintain absolute effectiveness, so the level of clinical evidence is higher than that of other medical technologies."

Lee stated, "Since (digital therapeutic devices) need to be compared with existing treatment methods, there needs to be criteria for setting comparison targets," and argued, "A separate benefit registration framework should be established from the initial stage." He also added, "It is necessary to consider a plan to have all digital therapeutic devices used as innovative technologies covered by health insurance."

There was also a suggestion to clarify laws regarding the use of medical personal information and ease regulations. Lee emphasized, "According to the Ministry of Food and Drug Safety’s healthcare data utilization guidelines, there is an interpretation that it is governed by the Personal Information Protection Act," adding, "Depending on how the legal nature of the guidelines is viewed, there can be various opinions on legal binding force, so a clear legal definition is necessary." He also added that essential classification criteria for convergence products, including digital therapeutic devices, should be established.

In the discussion, Seungjae Song, CEO of LifeSemantics and chairman of the Digital Healthcare Policy Committee of the Korea Venture Business Association, served as the moderator and discussed development plans for the digital healthcare industry with key officials from relevant ministries. During the discussion, Youngjin Song, Director of the Bio Convergence Industry Division at the Ministry of Trade, Industry and Energy, explained the Ministry’s digital healthcare research and development (R&D), including a large-scale demonstration project planned for 2025. Director Song emphasized, "To develop the industry, unnecessary regulations must be proactively improved." Gukhwa Lee, Team Leader of Digital Talent Development at the Ministry of Science and ICT, explained this year’s Ministry of Science and ICT’s digital healthcare R&D plans, including AI introduction support projects for public medical institutions, medical artificial intelligence projects, and development projects for autism spectrum digital therapeutics.

Eunkyung Park, Officer of the Medical Information Policy Division at the Ministry of Health and Welfare, explained, "The Ministry of Health and Welfare is promoting the enactment of the Digital Healthcare Act to establish a safe utilization ecosystem for healthcare data and to promote digital healthcare linked with healthcare." The Ministry of Food and Drug Safety, responsible for regulating digital healthcare products, expressed its intention to prepare regulatory plans according to product characteristics. Suntae Joo, Director of the Medical Device Policy Division at the Ministry of Food and Drug Safety, stated, "(The Ministry) plans to exempt clinical trial approval for low-risk products to ensure digital medical products are developed safely and quickly and their use is activated, and to establish a regulatory system tailored to product characteristics from clinical trials to post-market through customized rapid classification and real-world evaluation."

Before the report session, Assemblyman Hong Seok-jun said, "With the advent of the 4th Industrial Revolution era, digital healthcare technology is developing, and the global market size is also showing explosive growth," adding, "As the head of the Regulatory Reform Promotion Team, I will work with the Yoon Seok-yeol administration to improve regulations so that Korea can leap forward as a global hub in the digital health field, improving the quality of medical care and promoting public health."

Seungjae Song, chairman of the Digital Healthcare Policy Committee, said, "The digital health industry is a representative regulated industry that can only grow when supported by the government and led by the private sector," adding, "Since the government and the National Assembly are listening to and reflecting the industry's opinions, we will do our best to create an environment where venture companies can thrive."