Kim Seok-ju, Chairman of the Korean Academy of Sleep Medicine, stated, “The success of insomnia digital therapy devices depends on the usability by both doctors and patients."

[Interview] "If the first and second products do not succeed, the subsequent products will also face uncertainties. Success cases are crucial."
[관련기사=김석주 수면의학회 이사장 “불면증 디지털 치료기기, 성공 여부는 의사와 환자의 사용성”]

Two digital therapeutic devices for cognitive-behavioral therapy for insomnia received approvals in February and April this year. How would the psychiatrist, who will conduct the research as well as prescribe them, see the outlook of the insomnia digital treatment devices? There is a sense of optimism that the use of software-based digital therapeutic devices, instead of relying on sleeping pills, may increase. However, at the same time, there are concerns about the digitalization of cognitive-behavioral therapy, as it should meet the satisfaction of both doctors and patients. 

Kim Suk-ju, Chairman of the Korean Academy of Sleep Medicine and a professor of psychiatry at Samsung Seoul Hospital, commented as such on the insomnia digital therapeutic devices "SOMZ" by AIMed and "Wellt Eye" by Wellt.

He strongly emphasized that if it is a digital therapeutic device, it should be based on evidence and approved by the Ministry of Food and Drug Safety. He also highlighted the need for a treatment method that is not just superficial but one that doctors are willing to prescribe and patients are willing to pay for. He expressed concerns about wellness-oriented digital therapeutic devices lacking sufficient evidence and potentially not functioning effectively in the market.

According to Chairman Kim Suk-ju, an important issue in sleep health is the problem of sleep deprivation and the misuse of sleeping pills among Koreans. There is significant light pollution in society, and many people work in shift schedules, while students have early school start times. However, cognitive-behavioral therapy for insomnia is not being adequately implemented. The key question now is whether digital therapeutic devices can replace traditional therapy and provide an effective solution to this problem.

Chairman Kim stated, "I do not have a doubt on the effectiveness of digital therapeutic devices. Obtaining medical device approval from the Ministry of Food and Drug Safety also indicates having substantial evidence and certainty." However, he also pointed out that the bankruptcy of Fair Therapeutics in the United States demonstrates that survival can be difficult for companies if they cannot penetrate the insurance system.

He also emphasized if the digital therapeutic devices for insomnia (1st and 2nd products) fail, it may become more challenging to develop digital therapeutic devices for other conditions. Therefore, it is important to encourage digital therapeutic devices that doctors and patients can use from the beginning. Further, he pointed out on the need for government-level support.

Chairman Kim expressed concerns about the pricing of digital therapeutic devices. If the price is too high or not covered by medical insurance, the burden on patients may be significant, and widespread adoption may be challenging. On the other hand, if the price is set too low, it could hinder further development of domestic digital therapeutic solutions. He suggested the need for a reasonable pricing strategy and the inclusion of digital therapeutic devices in medical insurance coverage to ensure accessibility and sustainability in the market.

Chairman Kim emphasized that changing human emotions is not easy; therefore, cognitive-behavioral therapy aims to change thoughts and behaviors of a person. However, when it comes to cognitive-behavioral therapy for insomnia, it requires significant effort from both doctors and patients, and the improvement may not be immediate.

Therefore, for digital therapeutic devices to work effectively, trust between doctors and patients is crucial. As digital therapeutic devices continue to emerge throughout the year, the Korean Academy of Sleep Medicine also plans to actively monitor the situation and advocate for the needs and concerns of the general public at the academy level.

Chairman Kim stated, "The academy should disseminate expert knowledge to the general public, from individual clinics to nationwide awareness campaigns. Even if we cannot provide immediate economic incentives, the role of the academy is to identify what is needed for sleep health among the entire population."

By Sol Im