SleepQ, a digital therapeutic for insomnia developed through collaboration between Handok and WELT, received ISO 27001 certification on November 27 from KSR Certification Center, an ISO-accredited body. This certification officially confirms that SleepQ manages critical data, including patient information, in a structured and secure manner. With this achievement, SleepQ now meets global regulatory requirements for data protection, facilitating expansion into overseas markets, including Europe.

ISO 27001 is an international standard for information security management systems established by the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC). It is regarded as the most authoritative certification in the field of information security. To obtain certification, organizations must meet approximately 90 detailed criteria across four domains—organizational operations, personnel management, physical security, and technical controls—and pass a rigorous audit.

Eunjeong Choi, Executive Director of Handok’s Digital Healthcare Division, stated:
“Providing effective digital therapeutic services while safeguarding sensitive medical information is essential. SleepQ will continue to strengthen information security management to ensure it remains a trusted digital therapeutic solution.”

SleepQ is Korea’s first integrated review-approved innovative medical device for insomnia treatment, authorized by the Ministry of Food and Drug Safety. It digitizes cognitive behavioral therapy for insomnia, previously available only in clinical settings, and delivers it via a smartphone app. Treatment is prescribed by healthcare professionals, and patients undergo a six-week program to fundamentally improve sleep habits. SleepQ collects patient data and analyzes sleep patterns to provide personalized therapy, including sleep restriction, stimulus control, cognitive restructuring, relaxation techniques, and sleep hygiene education.

Clinical trial results demonstrated that SleepQ significantly improved sleep efficiency in patients with insomnia. At week seven, patients treated with SleepQ showed an approximate 15.14% improvement in sleep efficiency compared to baseline. Sleep efficiency is an objective, quantitative metric based on patient sleep data.