A government official said Korea’s first homegrown digital therapeutic would get marketing approval within this year.

Kang Young-kyu, director of the Digital Health Devices Division at the Ministry of Food and Drug Safety (MFDS), said 10 digital therapeutics (DTx) were in clinical trials. At least one of them will obtain authorization within this year.

If a digital therapeutic gets the nod this year, it will pave the way for software-based disease treatment in Korea.

In rehabilitation and diagnosis assistance, products using cutting-edge technologies such as AI and 3-D printing have obtained the nod and are used in clinical care.

As companies continued to develop digital health products, the MFDS set up a new Digital Health Devices Division to manage products and nurture the related industry.

Korea Biomedical Review met with Kang to learn about the government’s blueprint for digital health.

Question: What kind of tasks does the Digital Health Devices Division do?

Answer: Established on Feb. 28, the Digital Health Devices Division has two roles: reviewing digital health devices and regulatory support. Regulatory support refers to the government’s support for companies to quickly commercialize software products using AI or VR by giving them regulatory information and speeding up the approval process. In other words, our division aims to promote the commercialization of safe and excellent products by preparing appropriate regulations reflecting the characteristics of digital health-related devices and preemptively providing regulatory information related to licensing to developers and companies.

Q: Are there any organizations that play a similar role in other countries?

A: The U.S. government has the “Digital Health Unit,” and Canada has a similar agency. Like us, they specialize in reviewing products developed based on AI, cyber security, and VR. Establishing a government agency exclusively dealing with digital health products is a global trend. The U.S. is leading in this area, but Korea is one of the leading countries.

Q: With growing interest in digital health, more companies have jumped into this industry. So, the need for approval for those products is expected to spike. I wonder if the Digital Health Devices Division has enough personnel for this. The shortage of review personnel at the MFDS has been a chronic problem.

A: It takes even more time to evaluate digital health products because they use new technologies. Fortunately, the MFDS has nurtured related professionals at the High-Tech Medical Devices Division. But if there are more reviewers, we can evaluate the products more quickly. It will also benefit the Korean people and the industry. Our division has nine workers. Among them, five are full-time, regular employees and the four are civilian workers assisting government officials in policy research. Only with them, it is not easy to keep up with social and industrial needs. We plan to hire more staff.

Q: Earlier, the MFDS announced guidelines for winning approval for AI-powered and big data-using medical devices, which drew a favorable response. Do you have any plan to announce approval guidelines for digital health products?

A: In the wake of Covid-19, we noted the need for contactless patient care and expected that related medical devices would grow. So, our division will prepare criteria so that telemedicine-related products can be managed safely. We will make safety guidelines.

We are also preparing guidelines for the usability of software medical devices. There were only 13 software items classified as medical devices in the past. But in 2020, the number went up to 90. So, we needed to categorize them and create a standard for classification. If we include that in the guideline, companies may find it helpful when they predict a product registration. Also, companies will be able to decide whether clinical trial data is necessary, whether winning approval is possible only with performance data, and what is the classification criteria, and simplify the process of changing approval conditions.

Q: Your division is known to communicate with industry officials actively. Did you have any difficulty in communication with the industry?

A: Companies want to win approval quickly through a simple procedure. Some of them even request a clinical trial exemption. But the MFDS has to check whether the product will be safe and effective for the Korean people. That doesn’t mean that we always say no to the industry. We tell them that the product could improve little by little. Most industry officials do not make unreasonable requests. We have just a slight difference in judgment on whether the product can be used now or not, and we are working to narrow this down.

Q: What is the difference in clinical trials or quality control between hardware and software medical devices?

A: In the case of software medical devices, it is possible to conduct not only a typical, prospective trial but a retrospective trial where the software can be used with medical records, medical images, and biometric data. A software device’s risk to patients is relatively low because it is not directly contacted or inserted into the human body. It is intangible and differs from existing hardware medical devices in manufacturing processes, storage facilities, sales forms, and management.

Q: Although you say software medical devices are relatively safe, it would also be hard to say there will be no side effect risk.

A: Software medical devices are also managed by the GMP criteria. But, unlike hardware devices, we cannot force companies to conduct post-marketing surveillance on software devices. There is no written regulation. So, the MFDS provides related guidelines. The Guidelines for Evidence of Use of Medical Devices include analyzing the product after the marketing and which data is advantageous when changing approval conditions later.

Most of the DTx focuses on a diagnosis. If these products are used only in hospitals, it will be possible to manage them. But if a product for the general public's use comes out, it will not be easy to conduct a follow-up. Those products may not cause fatal side effects, but it is also unpredictable what kind of adverse events they will cause. I wish we could trust companies to manage side effects autonomously. But as they are new products that no one has ever experienced, there should be a legal framework for a follow-up. As it is impossible to force a PMS on software devices, we recommended it in the approval guidelines. Companies also agree on this.

Q: Some raised concerns that the efficacy of DTx at approval might be different from that at commercial use.

A: That is why DTx needs clinical trials. But some companies making health management products demand we exempt clinical trials. The MFDS wants to investigate the product more thoroughly before commercialization because it is difficult to control it after the market release.

Q: With the advent of software medical devices, the medical device industry seems to be more aware of the security issue.

A: We are also taking it seriously. Cyber security is being emphasized more than ever. This is probably because people use various medical devices in telemedicine. The MFDS is paying particular attention to this.