If a person gets sick, he or she visits a doctor, gets a prescription, takes it to pharmacies, and receives medications.
This is the way by which most people currently gets healthcare service and treat their illnesses. From now on, however, the rapid development of IT technology will bring about a new type of medicine -- digital therapeutics – on the healthcare industry.
Already, global health regulators have given the go-ahead to related software, such as clinical mobile apps and platforms used for medical treatments.
Digital therapies have shown efficacy, especially in the fields of treating brain nervous system, neuropsychiatric disorders, and drug addiction, which are difficult to treat with conventional treatments.
In the United States, where drug addiction is a serious social problem, clinically approved digital treatments have recently been undergoing the fast track system. The scheme allows an investigational drug to receive an expedited review to help speed up the development of medicines that treat a severe or life-threatening condition and fill an unmet medical need.
The first digital treatment that won the nod of the U.S. Food and Drug Administration was a new platform called "reSET," in 2017.
The platform is an application that provides cognitive behavioral therapy, a psychiatric method of treating addiction symptoms. The app offers a way to get rid of loneliness so that the patients are not tempted to take drugs.
The FDA approved the platform after it showed impressive results in its clinical trial on 400 addicts. The trial showed that the patient group applied by conventional medication had an abstinence rate of 17.6 percent. In contrast, the group that used the reSET application displayed an abstinence rate of higher than 40 percent. Since then, various companies have dived into the field of digital therapeutics with the hope of developing new treatments for illnesses that have high unmet medical needs in the U.S.
According to the Biotech Policy Research Center, the market for digital therapeutics in the U.S. is expected to grow from $850 million in 2017 to $4.42 billion in 2023.
Although there are no approved digital treatments in Korea, the field has recently become highly active in recent years.
Experts say that Korea’s healthcare industry can get highly competitive in digital therapeutics, as the nation has a strong IT and game industry. It also has considerable potential as a new industrial sector, as it is just at an early stage of development.
Companies focusing on digital therapies began to emerge here last year. Among more noticeable of them are Nunaps, Welt, and LifeSemantics.
Nunaps is a company based on virtual reality-based treatment technology for treating brain injury sequelae.
The company received approval from the Ministry of Food and Drug Safety to conduct a clinical trial into Nunap Vision, a digital therapeutics for improving visual disorders after brain injury, in July last year. The go-ahead marks Korea's first clinical trial of digital treatment.
Welt is developing a digital therapy for treating sarcopenia. Currently, there is no cure for sarcopenia, and diet and exercise management are the only prevention and management methods.
Welt plans to build and provide an online diminution diagnosis and management platform, as well as routine patient data collection, sarcopenia management, and personalized exercise regimens.
LifeSemantics has launched Efilcare, a cancer patient prognosis management service. It is a mobile application for wellness, which doesn't require a doctor's prescription.
The company has also developed Efilcare M for treatment purposes, but its launch is unclear due to controversy over telemedicine in the local legal system.
As seen in the case of LifeSemantics, there are still various obstacles that the country needs to overcome because digital treatments are mainly based on telemedicine, which is still illegal in Korea. Also, there is a lack of medical information to develop diagnostic devices using artificial intelligence.
Medical information sharing and telemedicine are essential for combining IT and healthcare. Moreover, a bill introducing telemedicine has been drifting in the National Assembly with little progress for 20 years. Another bill to use big data for a medical purpose has also failed to get over the parliamentary threshold for more than a year.
"In the present situation where even the sharing of medical big data is difficult, our hands are tied even if we manage to develop a digital therapy," d a company CEO specializing in digital therapy told Korea Biomedical Review, asking to remain anonymous.
Privacy protection maybe most important, but this area has few side effects, he said, emphasizing that drastic regulatory innovation is needed.
Kim Jae-young, the principal investigator at the AI New Drug Development Support Center, also said, "Algorithms have been built to utilize AI, but the local environment is far from using the data. We don’t have enough data available to use AI in for developing drugs."
Insurance benefits are another barrier to the development of digital therapy, industry executives say.
Due to such an adverse environment, companies with technologies to develop digital therapies are abandoning the local market and are looking to launch their products overseas instead.
"If you complain about it anonymously, there are even rumors that the Ministry of Health and Welfare actively seeks out the origin of the complaint, making it hard even to lodge a grievance," an official from a digital therapy firm said, asking to remain anonymous.
Faced with rising criticism from the industry, the government has recently said that it would improve the situation by introducing new, eased rules.
"Remote monitoring of chronic and neurological diseases, online counseling, and advice based on patient status are controversial as it can be considered as a telemedicine practice, which is banned under national law," said Lee Seung-min, a researcher for Korea Health Industry Development Institute's future industry planning division.
In other countries, companies can get sales approval from a regulatory body after a clinical study, but domestic circumstances are different, she added.
In Korea, even after a medical device item wins regulators’ approval, complicated processes are waiting, such as new medical technology evaluation, reimbursement determination, and price discussion, before its entry into the market, Lee noted.
"There is a need for a parallel, risk-based review and evaluation system for licensing and new medical technology review systems for innovative medical devices," she said.
The post-evaluation system, which will be introduced for in-vitro diagnostic devices, should be expanded to include low-risk innovative medical devices, and the existing review system focusing on systematic literature review, such as the use of real-world evidence, should be improved, Lee added.
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