Digital therapeutics can be classified as medicine and non-medicine at the same time. People regard a drug as a product made from synthetic or natural ingredients, taken orally, or injected. A dictionary defines medicine as “a substance used in treating or preventing diseases or wounds, taken orally or applied or injected.”
Digital therapeutics, however, disrupt this “common sense.” They refer to treatments for patients using software programs based on digital technologies. They exist not only in theory. A digital therapeutic won U.S. license after proving the safety and efficacy in a clinical trial. The U.S. Food and Drug Administration (FDA) granted approval for reSET, a mobile application to treat opioid use disorder, in 2017.
There have been many attempts to use software games and applications to treat a disease. However, digital therapeutics are drawing particular attention today because people can use information quickly using their smartphones, two-way communication became possible, and the environment has matured enough to utilize artificial intelligence and big data.
Plus, many local companies are developing various digital therapeutics, and some of them have already completed the development. The government is also supporting the industry, based on a keen interest in the integration of digital technologies and healthcare.
When can Korean consumers officially use a digital therapeutic, then? How are digital technologies incorporated into the healthcare sector?
To get the answers, Korea Biomedical Review met with Song Seung-jae, CEO of LifeSemantics, which developed a digital therapeutic.
|LifeSemantics CEO Song Seung-jae|
Question: The convergence of digital technologies and healthcare are not new, and it instead became a major trend. How would you evaluate the status of the domestic digital healthcare industry?
Answer: The Korean health insurance system is the envy of the world because every Korean can enjoy high-quality medical services at a low cost. In this process, however, doctors had to sacrifice to a degree, and some people are not satisfied with the medical service. One of the best examples is a healthcare service after treatment. After a patient undergoes surgery, patient care is almost gone two or three years later. There aren't many places to ask questions about the patient’s life and health, such as what kind of care the patient needs and about which part the patient should be careful. This cannot be managed by public insurance. Digital health can be a solution to this problem. Digital health will play a role to manage the public health in the areas where the national healthcare cannot cover.
Q: Do you think it is possible to introduce digital therapeutics in Korea?
A: The government’s “Biohealth Industry Innovation Strategy,” announced in May, included digital therapeutics-related content. I heard that health-related agencies, including the Ministry of Health and Welfare and the Ministry of Food and Drug Safety, were reviewing approval and reimbursement issues. We need the criteria for certification if we want to use digital therapeutics in the Korean healthcare system.
Q: Can Koreans use overseas digital therapeutics such as reSET?
A: Taking medication is simple: we eat it, apply it, or get an injection. In contrast, digital therapeutics needs changes in people’s lifestyles and behaviors for treatment. So, a digital therapeutic needs localization to win approval. The critical issue in digital healthcare is consent on the use of individual information. A cancer patient care service, like reSET, is based on personal information. In Europe, however, it is impossible to move personal information to another country. In Korea, too, people are sensitive about using civilian personal information. So, we need a new program setting if we want to introduce a foreign digital therapeutic. We should check if the program fits Koreans. Insurance systems are different in each country. So, digital therapeutics needs localization.
Q: We heard that LifeSemantics also developed a digital therapeutic. Is that correct?
A: Yes. Our flagship product is efilcare, a cancer patient prognosis management service. It is a mobile application for wellness, and you don’t need a doctor’s prescription to use it. We launched it in January. Its digital therapeutic version is efilcare M. We couldn’t roll it out because the Korean system is not ready for it.
Efilcare provides health information such as exercise, nutrition, and diet according to the current condition of cancer patients, and supports prognosis monitoring through various smart devices. The digital therapeutic version needs a prescription. Cancer patients can receive the help of experts in terms of medication compliance, chemotherapy’s side effects, rehabilitation to prevent postoperative strictures, and medication types and doses. In Korea, it is difficult for patients to listen to the doctor’s explanation because they can’t see the doctor for a long time. So, our service can help in this area.
Q: Do you think that digital therapeutics need reimbursement first to be actively used in Korea?
A: First of all, the government should set up the criteria for software as a medical device (SaMD). To do so, the health authorities should first classify highly-advanced medical devices to set reimbursement rates for digital therapeutics. Also, digital therapeutic needs to get new medical technology evaluation to win reimbursement. The authorities should discuss whether the reimbursement should be fee-for-service or value-based care. We’re trying to create an opportunity to discuss this with the government.
Q: Do you have other digital therapeutics you’re working on?
A: Efil breath is a rehabilitation service for patients with respiratory disorders such as lung cancer, asthma and chronic obstructive pulmonary disease (COPD). This product provides a six-minute gait test based on the patient's condition. The app service offers customized rehabilitation exercises in six stages. The exercise prescription program is classified into a response type, which is set according to the progress of the patient state regardless of the step-by-step exercise sequence, and a fixed type where the phased exercise is sequentially performed. Users can connect the smart healthcare device with the app to measure oxygen saturation, heart rate, and activity, and perform respiratory rehabilitation exercises. We have completed clinical trials and published several papers. The study results confirmed the actual rehabilitation effect.
Q: How do you think digital therapeutics will affect medical institutions?
A: Hospitals and clinics can use digital therapeutics to manage patients. The programs will help them reach patients more and manage them better.
Q: What are your plans?
A: In the digital healthcare business, the earlier you start, the better. If you provide service quickly and meet customers, you can give a better service. The key in this field is algorithms. Korea is not a latecomer in the digital healthcare industry. The country is rather leading. I hope that the government will be able to prepare a system sooner so that digital therapeutics can reach the globe quickly. The government can use a stick and carrot together.
Our company is preparing to go public. If it gets listed, LifeSemantics will be the first among digital therapeutics developers.
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