[Reporter’s Notebook] Challenges in the DTx Era

Finally, the First DTx Approved
Challenges Remain... Overcoming Them with 'Trust'

[Asia Economy Reporter Lee Chun-hee] "So what is it exactly?" This was the reaction most people showed to the news on the 15th about the approval of Korea's first domestic digital therapeutic device (DTx). Even though DTx development has been underway for over four years, many still did not understand the basic concept, with responses such as "Is it about sending digital signals into the body?" or "Are they talking about telemedicine?" Even the media sometimes confused electronic medicine or explained DTx using the broader concept of digital healthcare. As a reporter who has been paying attention to and covering DTx through projects like the 'DTx Era' series, the 'Good Brain International Conference,' and 'DTx Asia,' I felt a mix of anticipation and concern.

If the perception barriers encountered right from the start are not overcome, patients may not use DTx properly even with a doctor's prescription. Overseas, concerns about the DTx industry continue as half of patients drop out during treatment due to usability issues.

The effectiveness of DTx is clear. It enables access to treatment anytime and anywhere, transcending time and space. Although there are concerns that its efficacy may be lower compared to face-to-face consultations, it is likely to be much more affordable. The benefit perceived by patients is expected to be greater with DTx. DTx could be a good alternative to the pain points faced by telemedicine. Assuming a doctor's prescription, DTx can be a boon for patients in areas where frequent visits to doctors are difficult by providing real-time monitoring of their condition, while doctors can closely observe the status of patients who are far away.

However, the path to commercialization is still long. It is not yet decided who will prescribe, how follow-up care will be managed, or how fees will be set. The foremost regulatory framework has already been elevated to world-class standards by the Ministry of Food and Drug Safety. For Korea to lead the DTx era, progressive fee policies must be introduced by institutions such as the Health Insurance Review and Assessment Service, and the medical community must establish a ‘trust linkage’ to deliver DTx to patients.