Hippo T&C's Depression Treatment Software 'BlueKare' Designated as New Health Technology Assessment Exemption by Ministry of Health and Welfare — Now Available for Prescription and Clinical Use

Hippo T&C (CEO Tai-Myoung Chung) announced that its depression treatment software 'BlueKare' has been designated as a subject of New Health Technology Assessment Exemption (Notification No. 2026-82) by the Ministry of Health and Welfare, securing the institutional foundation for prescription and clinical use in medical settings.

BlueKare is the only digital therapeutic for depression treatment in Korea to have obtained both Class 3 medical device approval and Innovative Medical Device certification from the Ministry of Food and Drug Safety (MFDS), meeting all requirements for medical institution adoption. Prescription rollout is currently underway primarily at major tertiary hospitals, with phased expansion to private clinics planned. Given the limited number of actual prescription cases for digital therapeutics, this notification represents a significant milestone in BlueKare's transition to commercialization.

CEO Tai-Myoung Chung of Hippo T&C stated, "It is highly significant that BlueKare has now established the foundation to be utilized in clinical settings," adding, "We will continue our efforts to bring hope to those suffering from depression."

BlueKare is a Cognitive Behavioral Therapy (CBT)-based mobile Software as a Medical Device (mSaMD) that integrates cognitive and emotional training, record-based self-awareness, and AI-driven personalized feedback to deliver data-driven, individually tailored treatment. In confirmatory clinical trials conducted at three university hospitals, eight weeks of use resulted in an average BDI score reduction of 13.34 points (p < 0.0003), with clear improvements observed not only in depressive symptoms but also across broader mental health indicators including anxiety, stress, life satisfaction, and self-esteem.

Built on an ISO 27001-based information security framework and GMP quality management system, BlueKare is gaining attention as a non-pharmacological treatment option that improves depression through a novel gamified approach rather than relying solely on medication. The company plans to build a reference base centered on tertiary general hospitals and accelerate its expansion in the digital therapeutics market. It also intends to pursue overseas market entry through U.S. FDA 510(k) clearance and global collaborative research.

Source: Electronic Times (Reporter Hyun-Min Kim, minkim@etnews.com)