[Start! DTx Era]③ "Paving the Way with Regulation, Guiding with Support"

The Unsung Hero Behind the Birth of the 'No.1 DTx'
Interview with the Ministry of Food and Drug Safety's Digital Health Regulation Support Division
"Following AI, We Will Also Establish International Guidelines for DTx"

[Asia Economy Reporter Chunhee Lee] "New regulations are needed for new industries. We aim to pave new regulatory roads and provide guidance to help them run smoothly."

Kang Young-gyu, Director of the Digital Health Regulation Support Division at the Ministry of Food and Drug Safety (right), and Han Young-min, Officer, are being interviewed by Asia Economy.
[Photo by Lee Chun-hee]

Those we met while covering the birth of the 'first digital therapeutic device (DTx)' unanimously emphasized "the significant role of the Ministry of Food and Drug Safety (MFDS)." While most industries call for 'regulatory reform,' the medical industry demands increased personnel at the MFDS and stronger regulations. This is due to the nature of the medical industry, where product launches are impossible without proper regulations, and low regulatory standards can actually degrade product quality.

The first DTx is widely regarded as impossible without the 'DTx Approval and Review Guidelines' issued by the MFDS in August 2020, the world's first of its kind. Unlike overseas cases where approvals were forced to fit into existing software medical device (SaMD) regulations, Korea was the first government to create dedicated approval guidelines for DTx, which led to Korea being recognized internationally as a leader in DTx regulation. At that time, the task was handled by the Digital Health Device Task Force (TF) of the MFDS’s Food and Drug Safety Evaluation Institute. Recognizing this achievement, the official Digital Health Regulatory Support Division was established at the end of 2021. On the 17th, Asia Economy interviewed Kang Young-gyu, the manager, and Han Young-min, the officer, who were the hidden heroes behind the birth of the first DTx.

Manager Kang said about the first DTx, "It is the fruition of creating the DTx approval and review guidelines and two and a half years of effort," adding, "It feels like a farmer finally tasting the fruit after sowing and nurturing seeds proactively by creating regulations and continuously cooperating with developers, related agencies, research institutes, and academia." Regarding the approval process, Officer Han explained, "Since cognitive behavioral therapy (CBT) for insomnia is already widely used in practice, we focused on how well it was implemented as a mobile application," and "We also concentrated on reviewing the efficacy to see if actual therapeutic effects appeared."

"Following AI, we will make Korea's DTx regulations an international guideline"

Not only DTx but also in the field of artificial intelligence (AI) medical devices, Korea is evaluated as having world-class regulations. The MFDS published the world's first AI medical device approval and review guidelines in 2017, and starting with Vuno’s 'VunoMed BoneAge' approval the following year, 139 AI medical devices had been approved by September last year. Notably, Korea chaired the AI Working Group of the International Medical Device Regulators Forum (IMDRF), leading the development of international guidelines for AI medical devices.

Manager Kang said, "It is very meaningful that we proactively created guidelines, quickly completed regulations for these products to enter the market, and that our guidelines have become international standards, placing us shoulder to shoulder with the US and Europe in the digital health regulatory field," adding, "We plan to strive to make DTx an international guideline as well." This confidence stems from not only the approval and review guidelines but also the ongoing creation of tailored regulations such as the 'DTx Safety and Performance Evaluation and Clinical Trial Protocol Preparation Guidelines' for five indications including insomnia, alcohol and nicotine use disorders, panic disorder, and depression. There is also a plan to add guidelines for eight indications by 2027. Officer Han said, "We are developing guidelines focusing on indications close to commercialization among ongoing national research projects," and "We aim to develop guidelines for attention deficit hyperactivity disorder (ADHD) and eating disorders within this year."

In November last year, Han Young-min, an officer from the Digital Health Regulatory Support Division of the Ministry of Food and Drug Safety, is presenting at the '1st DTx Asia' held at the Novotel Ambassador Hotel in Gangnam-gu, Seoul.
[Photo by Lee Chun-hee]

Along with establishing regulations, regulatory reform is also ongoing. Recently, together with the Ministry of Health and Welfare, the previously scattered innovative medical device designation procedures across the Korea Health Industry Development Institute, Health Insurance Review & Assessment Service, and Korea Institute of Health and Medical Technology Assessment were unified into the 'Innovative Medical Device Integrated Review and Evaluation System.' The first beneficiaries included AimMed’s 'SOMZZ,' the first DTx, Welt’s insomnia treatment DTx 'PillowRx,' and JLK’s brain infarction diagnostic support software 'JBS-01K.' Officer Han said, "The intention was to improve regulations so that at least products applying AI and digital technologies could be quickly used in medical practice, even if not all products," adding, "All related agencies agreed and worked together."

Leading proactive regulation and regulatory innovation is also why this division is called the 'Regulatory Support Division' rather than just 'Regulatory Division.' Manager Kang explained, "When pioneering new fields, there are often cases where existing systems do not fit well," and "Our goal is to pave new regulatory roads and provide guidance and support so that these roads can be traveled smoothly." He added, "As the digital health industry continues to grow, government efforts such as increasing personnel are urgently needed to provide richer and more in-depth support."

Although the first DTx has been released, many regulatory challenges remain. For example, how to approve similar products like generic drugs in pharmaceuticals, and how to regulate frequent software updates require new regulations. Manager Kang said, "The important thing is therapeutic effect," and "To prove that similar products have equivalent therapeutic effects to existing DTx, clinical trials are ultimately necessary, so they should undergo full clinical trials like biosimilars." However, he added, "If a simpler alternative evaluation method that can prove effectiveness is found, it could be utilized."

Regarding updates, Officer Han explained, "Software inevitably undergoes frequent changes, but previously, even defect fixes and security enhancements required about 42 days for change approval," and "Since July last year, except for changes in intended use, analysis methods, development environment, and communication functions, changes are considered 'minor' and regulated through a post-reporting system." This means that for general updates, not upgrades such as applying a DTx approved for insomnia to depression, developers can respond autonomously.