DTx Opening the Way for Prescriptions, 'Platform' Essential for Smooth Utilization

Yonsei Medical Center has started prescribing DTx based on the digital therapeutic device (DTx) integrated solution platform ‘Connect-DTx’.

Conceptual Diagram of DTx Integrated Solution Platform 'Connect-DTx'
Photo by Yonsei Medical Center

Severance Hospital announced on the 16th that on the 12th, it prescribed 'Somz,' a cognitive therapy DTx for insomnia improvement based on Connect-DTx, to patient A (26), who developed insomnia during exam preparation. Through Somz, A will receive cognitive behavioral therapy for insomnia improvement, including sleep restriction, stimulus control, cognitive restructuring, muscle relaxation, and sleep hygiene education.

DTx refers to software medical devices that prevent, treat, and manage diseases like pharmaceuticals. In Korea, it is limited to therapeutic specialized software approved by the Ministry of Food and Drug Safety based on clinical trial results, and unlike general health applications, it requires a doctor's prescription. Somz is the first approved DTx in Korea, providing the standard treatment for chronic insomnia patients, cognitive behavioral therapy for insomnia.

Yonsei Medical Center developed the open DTx platform Connect-DTx in 2022 with 7.8 billion KRW support from the Ministry of Trade, Industry and Energy in collaboration with Pi Digital Healthcare. As a DTx integrated solution platform, it connects and utilizes information generated from DTx users, treatment services, products, and locations. The project was carried out under the judgment that for the new treatment method DTx to settle within existing systems, infrastructure guaranteeing convenience and safety for all related users, including medical institutions, government agencies, developers, and patients, must be established first. In addition to Yonsei Medical Center and Wonju Severance Christian Hospital, Seoul St. Mary’s Hospital, Boramae Medical Center, Korea University Anam Hospital, and Seoul National University Bundang Hospital are participating in platform development and preparing for its introduction.

Aimed's digital therapeutic device (DTx) for insomnia, 'Somz' [Photo by Aimed]

By utilizing Connect-DTx, patients can input their personal status in real time while using DTx and receive customized prescriptions accordingly. Medical institutions can provide personalized treatment for each patient in real time by utilizing information linked to the hospital’s electronic prescription and medical record systems, and communicate conveniently with government agencies responsible for insurance claims and reviews. Government agencies such as the National Health Insurance Service and the Ministry of Food and Drug Safety can monitor in real time whether the prescribed DTx shows effective therapeutic effects as in clinical trial results. Developers can also easily connect without individual contact with each medical institution by using the platform.

It is explained that the platform can be used not only for patient treatment but also for additional DTx development. Using the medical big data built through the platform, DTx targeting various diseases such as dementia, Parkinson’s disease, and smoking cessation are currently under development in addition to insomnia.

Im Jun-seok, Director of Digital Health at Yonsei Medical Center, said, “With the development of Connect-DTx, not only patient-tailored treatment but also convenient and safe use of medical data by users such as medical institutions, government departments, and DTx developers has become possible,” adding, “It is expected to be a catalyst for the dawn of an advanced medical era based on big data that systematically analyzes patients’ daily life algorithms and treatment patterns, which are difficult to check in the clinic.”