Korea approves first-ever digital therapeutics device

Mobile application Somzz, the first-ever digital therapeutics device to gain approval from the Ministry of Food and Drug Safety, displayed during a briefing at the ministry's headquarters in Osong, North Chungcheong Province, Wednesday. Yonhap

By Lee Hyo-jin

A domestically developed mobile application that can be used to treat insomnia won regulatory approval, Wednesday, becoming the first-ever digital therapeutics device to be introduced in Korea.

The ground-breaking move is expected to spur the development of the nation's digital therapeutics industry. But some questions remain, such as how the cutting-edge digital software will be included in the state health insurance system, as well as possible confusion over the absence of prescription guidelines.

The Ministry of Drug and Food Safety announced its approval of Somzz, a digital treatment device based on a software application for insomnia patients developed by Aimmed, a digital healthcare company.

Somzz uses cognitive behavioral therapy and analysis of circadian rhythms to treat sleep disorders through an array of treatment methods including sleep habit training, real-time feedback and behavioral intervention. The treatment period lasts for six to nine weeks.

As it is a prescription medical device, patients must consult with a doctor before using the app, the drug ministry said. There are an estimated 670,000 insomnia patients in Korea.

However, the app is not permitted for certain patients such as truck or bus drivers who have to stay alert while operating vehicles, as well as employees who operate machinery on some factory lines, due to associated safety risks.

The drug authorities reviewed clinical trials submitted by Aimmed, conducted for six months in three medical institutions ― Seoul National University Hospital, Korea University Medicine and Samsung Seoul Medical Center. The trials demonstrated improved treatment for severe insomnia. The medical device also passed an assessment by an advisory panel consisting of psychiatrists and doctors of family medicine.

Kim Jae-jin, head of the Korean Society for Digital Therapy, said, "I hope that the approval of No. 1 digital therapeutics will contribute in expanding treatment options for insomnia patients. Digital therapeutics will bring various changes in the clinical paradigm as a new treatment method other than traditional medicines."

Digital therapeutics refers to clinically evaluated software devices used to treat and prevent diseases and disorders. They can be used independently, or with medications and other therapies to treat physical, mental and behavioral health conditions.

Unlike traditional health and wellness apps that mostly track user activities such as sleep or exercise, digital therapeutics entails more sophisticated software that can complement, or even replace prescription drugs in the management of certain health conditions.

Following the landmark approval, Korea has joined some 14 other countries including the U.S., Germany and the U.K. where digital therapeutics devices have been cleared by regulators, according to the drug ministry.

Announcing the approval, the drug ministry expressed hopes that Korean companies will play a vital role in the global digital therapeutics market. According to Allied Market Research, the global digital therapeutics market generated $3.84 billion in 2021, and is projected to reach $22.60 billion by 2031, registering an annual growth rate of 19.4 percent from 2022 to 2031.

The drug ministry also said more than a dozen clinical trials are underway for digital therapeutics on various conditions including Attention Deficit Hyperactivity Disorder (ADHD), developmental disability and mild cognitive impairment.

Minister of Food and Drug Safety Oh Yoo-Kyoung speaks during a briefing in the ministry headquarters in Osong, North Chungcheong Province, Wednesday. Yonhap

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"With the first approval of a digital treatment device, we have opened a new path to the use of digital therapeutics devices for the treatment of various conditions which will contribute to improving public health," Minister of Food and Drug Safety Oh Yoo-kyoung said during a briefing.

"We will widen support for local companies developing digital treatments by enhancing our regulatory guidelines to meet international standards," she added.

However, it is uncertain exactly when Somzz will be available for use, as it is yet to be included in the state health insurance system.

"In the case of Somzz, which has been designated as an innovative medical device, the Ministry of Health and Welfare should be playing a leading role in including it in the state insurance program," said Chae Gyu-han, head of the medical device division at the Ministry of Food and Drug Safety.

Another issue that should be addressed is ensuring cybersecurity and data privacy, as digital treatment devices necessitate the processing of patients' sensitive information.

Regarding this, Oh said, "We have completed a cybersecurity review on Somzz. It is an issue we have been closely watching."