South Korea approves its first digital therapeutic

An app to treat insomnia has become the first digital therapeutics (DTx) to be approved for marketing by the Ministry of Food and Drug Safety (MFDS) in South Korea.

The software as a medical device (SaMD) app – Aimmed’s Sommz – relies on a cognitive behavioural therapy (CBT) approach that has been put through its paces in clinical trials conducted within South Korea.

The app was among a crop of digital therapeutics that were reviewed via a new process for innovative medical devices that was introduced last year, and provides a framework of assessing and approving artificial intelligence (AI), big data, and digital health technologies.

The MFDS works alongside Korea’s Ministry of Health and Welfare, the Korea Health Industry Development Institute, the Health Insurance Review and Assessment Service, and the Korea Health and Medical Research Institute during the review process.

Sommz was given a provisional green light in December along with another insomnia app from Samsung spin-off WELT Corp, called PilLow Rx, as well as an artificial intelligence-powered software to aid in the diagnosis of stroke from medical imaging developed JLK Co.

The three digital health products are from a batch of eight that were filed using the new pathway shortly after it came into effect last October.

Aimmed’s app provides a six- to nine-week course of CBT after an initial consultation to help users improve sleep quality.

CBT is recognised as an effective therapy for insomnia, but in South Korea – like most countries around the world – demand for CBT far outstrips the availability of licensed therapists. The aim is to identify feelings, thoughts, and behaviours that are contributing to poor sleep, and finding ways to circumvent them.

DTx apps that can provide CBT without a therapist being present offer a way to broaden access, and are being rolled out by health services around the world including, for example, in the UK, which cleared NHS use of Big Health’s Sleepio app last year. They can help avoid the use of sleep medicines, which are only recommended for short-term use, can have unwanted side-effects, and do not address the underlying cause of insomnia.

Approval via the new process is, however, only the first hurdle for Aimmed. While the company can now market the app on a paid basis to customers in South Korea, widespread use will rely on securing reimbursement approval, which is still in the early stages for DTx, with a guideline in the final stages of being drawn up by the MFDS.

Minister of Health and Welfare Cho Kyu-hong said last December that the review framework will help South Korea’s digital health sector achieve “global competitiveness” and provide “an opportunity to lead the world in the field of advanced technology”.