Skip Navigation
Skip to contents

JYMS : Journal of Yeungnam Medical Science

Indexed in: ESCI, Scopus, PubMed,
PubMed Central, CAS, DOAJ, KCI
FREE article processing charge
OPEN ACCESS
SEARCH
Search

Articles

Page Path
HOME > J Yeungnam Med Sci > Ahead-of print > Article
Review article
Digital therapeutics in Korea: current status, challenges, and future directions – a narrative review
Hee Jun Shin1orcid, Ik Tae Cho2orcid, Wan Suk Choi1orcid, Hong Rae Kim1orcid, Min Bong Kang3orcid, Won Jong Yang2orcid

DOI: https://doi.org/10.12701/jyms.2024.01004
Published online: November 18, 2024

1Department of Physical Therapy, Kyungwoon University, Gumi, Korea

2Department of Physical Medicine and Rehabilitation, Daegu Medical Foundation K Hospital, Daegu, Korea

3Department of Physical Therapy, Musculoskeletal Center, Daegu Medical Foundation K Hospital, Daegu, Korea

Corresponding author: Won Jong Yang, MD Department of Physical Medicine and Rehabilitation, Daegu Medical Foundation K Hospital, 357 Chilgokjungang-daero, Buk-gu, Daegu 41452, Korea Tel: +82-53-310-7114 • E-mail: louis.yang.rm@gmail.com
• Received: September 3, 2024   • Revised: October 2, 2024   • Accepted: October 9, 2024

© 2024 Yeungnam University College of Medicine, Yeungnam University Institute of Medical Science

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (https://creativecommons.org/licenses/by-nc/4.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

  • 331 Views
  • 18 Download
  • Digital therapeutics (DTx) are emerging as a transformative innovation in healthcare offering evidence-based digital interventions for the treatment, management, and prevention of various diseases and disorders. In Korea, DTx have gained significant attention as potential solutions to the increasing burden of chronic diseases and mental health conditions. However, the Korean DTx market faces several challenges that hinder its widespread adoption and integration into the national healthcare system. This study provides a comprehensive analysis of the current state of the DTx market in Korea, identifies the key challenges impeding its growth, and proposes strategies for overcoming these obstacles. This study utilized a literature review and market analysis approach to examine the latest research, industry reports, and regulatory documents related to DTx. The analysis focused on three primary areas: (1) the current regulatory landscape, (2) technological advancements and challenges, and (3) economic and commercial factors influencing DTx adoption in Korea. A comparative analysis of global regulatory practices was also conducted to identify best practices. The findings revealed that while Korea has made significant strides in supporting DTx development, the market remains in its early stages. The key challenges include underdeveloped regulatory frameworks, issues with data quality and security, and a lack of established reimbursement pathways. We recommend developing tailored regulatory frameworks for DTx, enhancing policy support for small and medium-sized enterprises involved in DTx development, and increasing investments in technological infrastructure. By addressing these challenges, Korea could position itself as a leader in the global DTx market, delivering innovative and effective treatments to enhance patient care and outcomes.
Digital therapeutics (DTx) have emerged as a transformative innovation in the healthcare field, providing digital interventions designed to treat, manage, and prevent diseases and disorders through evidence-based software applications [1]. Unlike traditional therapies that often rely on pharmaceutical compounds or medical devices, DTx leverage digital platforms to deliver therapeutic outcomes, making them a critical component of the modern healthcare landscape [2]. These interventions are particularly noteworthy for their ability to offer personalized treatment plans, often by integrating real-time patient data with advanced algorithms to optimize therapeutic efficacy [3].
Recently, DTx have gained significant attention worldwide with a growing body of evidence supporting their effectiveness in managing chronic diseases, mental health conditions, and other complex medical issues [4]. The advent of technologies, such as artificial intelligence (AI), machine learning (ML), and big data analytics, has further enhanced DTx capabilities, enabling more precise and adaptive treatment strategies [5]. These advancements have positioned DTx as key players in the movement towards personalized medicine, where treatment plans are tailored to the individual characteristics of each patient [6].
In Korea, the importance of DTx is being increasingly recognized, leading to various research initiatives and commercialization efforts aimed at integrating these technologies into the national healthcare system. The Korean government has been proactive in supporting the development of DTx, recognizing their potential to address significant public health challenges, such as the aging population and rising prevalence of chronic diseases [7]. However, despite these efforts, the DTx market in Korea is still in its nascent stage and faces numerous challenges related to regulations, technology, and market acceptance [8].
The regulatory environment is one of the most pressing challenges. DTx, which is fundamentally different from traditional medical products, requires a regulatory framework that reflects its unique characteristics. However, the current regulatory landscape in Korea is still evolving, and there is a significant need for clear guidelines and robust regulatory support to facilitate the growth of the DTx industry [9]. The absence of well-defined regulatory pathways can create uncertainty for developers and hinder widespread adoption of DTx solutions.
Economically, DTx face additional challenges in Korea. The country’s health insurance system is primarily designed for traditional medical treatments and pharmaceuticals, leaving a gap in the reimbursement structures for innovative DTx products [10]. This lack of financial support poses a significant barrier to the commercialization of DTx, as companies may struggle to achieve profitability in the absence of adequate reimbursement policies. Consequently, this economic challenge not only affects companies developing DTx but also limits patient access to these potentially life-changing therapies [11].
Technologically, the integration of DTx into Korea’s healthcare system remains challenging. DTx rely heavily on cutting-edge technologies such as AI, big data, and the Internet of Things, all of which require robust infrastructure and high-quality data to function effectively. However, the pace of technological advancement in Korea, particularly in areas such as data quality, security, and interoperability, has not yet fully met the demands of DTx [12]. This technological gap hinders the full realization of the potential of DTx and delays their widespread adoption [13].
Furthermore, there is a need for increased awareness and education regarding DTx among healthcare providers and the public [14]. Many healthcare professionals remain unfamiliar with DTx, leading to hesitation in adopting these new technologies [15]. Simultaneously, patients may be skeptical about the efficacy and safety of digital treatments, particularly when compared with more traditional therapies [16]. Addressing these issues is crucial for successful integration of DTx into mainstream healthcare systems.
Thus, although DTx offer promising opportunities to revolutionize healthcare, particularly in Korea, substantial challenges need to be addressed. These challenges span the regulatory, economic, technological, and educational domains, each of which plays a critical role in the successful implementation of DTx. This study aimed to explore these challenges in depth, analyze the status of DTx in Korea, and propose actionable strategies to overcome these obstacles and ensure the sustainable integration of DTx into the Korean healthcare system.
1. Definition and scope
DTx are a subset of digital health interventions that utilize software programs to deliver evidence-based therapeutic interventions. These interventions are designed to prevent, manage, or treat medical conditions either independently or in conjunction with conventional therapies. Unlike general health and wellness applications, DTx undergo rigorous clinical testing to ensure their safety and efficacy and are often subject to regulatory approval processes similar to those of pharmaceuticals and medical devices [17,18]. The scope of DTx is broad and encompasses a wide range of applications from chronic disease management and mental health treatment to lifestyle modification and preventive care.
DTx operate primarily through digital platforms, such as mobile applications, desktop software, and integrated wearable devices, providing personalized treatment plans based on real-time data collection and analysis. For instance, a DTx application for diabetes management may continuously monitor a patient’s blood glucose levels by adjusting treatment recommendations based on daily fluctuations and long-term trends. This capacity for real-time adaptation and personalization is one of the key features distinguishing DTx from traditional therapeutic approaches, making them particularly effective for managing chronic conditions that require the ongoing adjustment of treatment protocols [19] (Fig. 1).
The scope of DTx continues to expand with the emergence of new technologies. Advances in AI, ML, and big data analytics have enabled the development of sophisticated DTx products that can deliver highly tailored interventions based on genetic makeup, lifestyle, and environmental factors. These technologies allow DTx to move beyond simple symptom management, offering the potential for preventive care and early intervention strategies that can significantly improve patient outcomes [20-22].
2. Key features of digital therapeutics
The defining characteristics of DTx include their digital nature, evidence-based design, and ability to integrate with other aspects of healthcare delivery. First, DTx are inherently digital and rely on software and data analytics to deliver therapeutic outcomes. This digital foundation enables continuous updates and improvements to the therapy, ensuring that it remains aligned with the latest medical research and technological advancements [18,23]. For example, an application designed to manage anxiety could be updated regularly to include new coping strategies or mindfulness exercises based on recent psychological studies.
Another important feature of DTx is their evidence-based design. Before a DTx product can be introduced to the market, it must undergo rigorous clinical testing to demonstrate its safety and effectiveness. This process is similar to that for traditional pharmaceuticals and involves multiple phases of clinical trials to assess the impact of a product on patient health outcomes. This commitment to evidence-based practice ensures that DTx products deliver tangible benefits to patients, as supported by scientific research [17,24].
Additionally, DTx products are often integrated with other healthcare technologies, such as electronic health records (EHRs) and telemedicine platforms, to provide a comprehensive and coordinated approach to patient care. This integration allows healthcare providers to monitor patient progress in real time, adjust treatment plans as necessary, and ensure that all aspects of patient care are aligned and optimized. For instance, a DTx platform for managing heart disease might be linked to a patient’s EHR, allowing cardiologists to track the patient’s progress and make informed decisions regarding medication adjustments or lifestyle changes [21,22].
Scalability is another significant advantage of DTx. Unlike traditional therapies that require significant resources to scale, DTx can be distributed to large populations at relatively low incremental costs. This scalability makes DTx an attractive option for public health initiatives aimed at addressing widespread health issues such as obesity, smoking cessation, and mental health disorders. The ability to deliver these interventions on a large scale, while maintaining a high level of personalization, is a key factor driving growth of the DTx market [19,20].
3. Global and Korean market trends
The global market for DTx is experiencing rapid growth driven by an increasing demand for innovative healthcare solutions that can reduce costs, improve outcomes, and enhance patient engagement. As of 2022, the global DTx market was valued at approximately $3 billion, with projections suggesting that it will continue to expand at a compound annual growth rate of >20% through 2028. This growth is fueled by the rising prevalence of chronic diseases, increased adoption of digital health technologies, and growing recognition of the benefits of personalized medicine [23,24].
In Korea, the DTx market is still in its early stages but shows significant potential for expansion. The Korean government has been supportive of digital health innovations and has implemented policies that encourage the development and integration of DTx into the national healthcare system. For example, the Ministry of Health and Welfare launched several initiatives aimed at promoting digital health, including funding programs for startups and research institutions and efforts to streamline the regulatory approval process for DTx products.
Korea’s advanced digital infrastructure, characterized by high smartphone penetration and robust internet connectivity, provides a strong foundation for the adoption of DTx. The country is well-positioned to become a leader in the DTx market, particularly as it continues to integrate AI and big data analytics into healthcare delivery [25]. These technologies are expected to play crucial roles in the development of next-generation DTx products that offer personalized and effective interventions.
However, the Korean DTx market faces several challenges that must be addressed to fully realize its potential. These include regulatory uncertainties, the need for more clinical evidence to support the efficacy of DTx, and the need to educate healthcare providers and patients on the benefits of these technologies. Addressing these challenges is crucial for continued growth and success of the Korean DTx market.
1. Key application areas and examples

1) Chronic disease management

In Korea, DTx are currently utilized in various medical fields, with a particular emphasis on chronic disease management. Diabetes management is a prominent area in which DTx have a significant impact. Given the high prevalence of diabetes in Korea, digital platforms that offer real-time glucose monitoring, personalized diet recommendations, and activity tracking have become indispensable tools for both patients and healthcare providers. For instance, the DTx platform “Diabetes Care” has been widely adopted in Korea, providing comprehensive care through continuous monitoring and AI-driven insights, which assist in better managing blood sugar levels and reducing the risk of complications [26].

2) Mental health and sleep disorders

Mental health is another area in which DTx have shown great potential in Korea. The rising incidence of stress-related disorders, depression, and anxiety exacerbated by the coronavirus disease 2019 pandemic has led to a growing demand for accessible mental health solutions. DTx platforms offering cognitive behavioral therapy, mindfulness exercises, and stress management programs have gained popularity. These platforms allow patients to access mental healthcare discreetly and conveniently, thereby reducing the stigma associated with seeking help [27].
Insomnia treatment has emerged as a key focus area, with two of the first four Korean Ministry of Food and Drug Safety (MFDS)-approved DTx products targeting this condition.

(1) Somzz by AIMMED (Seoul, Korea)

On February 15, 2023, Somzz was approved as the first DTx in Korea, utilizing Cognitive Behavioral Therapy for Insomnia (CBT-I) through a mobile application over a 6-week to 9-week treatment period [28].

(2) WELT-I by WELT Corp. (Seoul, Korea)

On April 19, 2023, WELT-I was approved as the second DTx in Korea, also employing CBT-I principles. It uses patient-inputted “sleep diary” data to provide personalized interventions over a 6-week program [29].

3) Neurological disorders and rehabilitation

DTx are also being explored for use in rehabilitation, particularly in patients with stroke or neurological disorders. Digital platforms utilizing virtual reality (VR) and gamification techniques are being developed to support the rehabilitation of motor functions and cognitive abilities [30].
A notable example in this category is VIVID Brain by Neurophet Inc. (Seoul, Korea), approved on April 19, 2024 as the third DTx in Korea. This cognitive therapy software uses VR technology to improve the visual field defects caused by brain disorders through 12 weeks of repetitive visual perception training [31].

4) Respiratory rehabilitation

The fourth MFDS-approved DTx product, EasyBreath by Share & Service (Busan, Korea), targets respiratory conditions. Approved on April 19, 2024, EasyBreath offers an 8-week personalized respiratory rehabilitation program for patients with chronic obstructive pulmonary disease, asthma, or lung cancer. The software focuses on improving aerobic exercise capacity and alleviating respiratory distress symptoms [32].
2. Patient perspectives on digital therapeutics in Korea

1) Patient adoption rates and demographics of digital therapeutics users in Korea

The adoption of DTx in Korea has been steadily increasing, particularly among younger tech-savvy populations. A recent survey found that approximately 15% of smartphone users in Korea have used at least one DTx application, with higher adoption rates among those aged 20 to 40 years [15]. The demographic profile of DTx users tends to skew towards urban dwellers with higher education levels and income, suggesting a potential digital divide that needs to be addressed for more equitable access [33].

2) Patient-reported outcomes and satisfaction with digital therapeutics products

Early studies on the patient-reported outcomes of DTx in Korea have shown promising results. A retrospective analysis of mental health app users reported that 65% of patients experienced improved symptoms after a 6-week program [34]. However, long-term adherence remains a challenge, with many individuals discontinuing use after the initial novelty wanes [16].

3) Barriers to adoption from the patient’s perspective

Despite the growing interest in DTx, several barriers to their adoption persist from the patient’s perspective. A qualitative study identified three primary concerns: privacy and data security, skepticism about effectiveness compared with traditional treatments, and difficulty navigating complex user interfaces (UIs), especially among older adults [35]. In addition, the lack of reimbursement for many DTx products poses financial barriers for some patients [8].

4) Patient feedback on specific digital therapeutics products approved in Korea

User reviews and feedback on DTx products approved in Korea have been mixed. While some users reported high satisfaction with the personalized features and ease of use, others expressed frustration with technical issues and the need for more comprehensive support [36]. This highlights the need for a more robust post-market surveillance of DTx products.

5) Patient preferences for features and functionalities in digital therapeutics

Korean patients have expressed a strong preference for DTx applications that offer personalized treatment plans, real-time feedback, and integration with other health monitoring devices [37]. Gamification elements and social features that allow users to connect with others who are managing similar conditions have also been well-received [38].

6) Cultural factors influencing patient acceptance of digital therapeutics in Korea

Cultural factors play a significant role in shaping patient acceptance of DTx in Korea. The country’s strong techno-positive culture and high smartphone penetration rate have facilitated the rapid adoption of digital health solutions [39]. However, traditional beliefs about health and healing, particularly among older generations, sometimes conflict with the digital approach of DTx [40].

7) Patient perspectives on integration of digital therapeutics with traditional healthcare

Many Korean patients view DTx as a complement to, rather than a replacement for, traditional healthcare. A survey found that most patients were interested in using DTx alongside conventional treatments, but few considered using DTx as a standalone therapy [25]. The patients expressed a strong desire for their healthcare providers to be involved in recommending and monitoring their use of DTx.

8) Patient-reported challenges and suggestions for improvement

Patients have reported several challenges in the use of DTx, including difficulties in maintaining long-term engagement, concerns about the accuracy of data collected by DTx applications, and a lack of clear guidance on how to interpret and act on the information provided [41]. To address these issues, patients have suggested improvements, such as more intuitive UIs, better integration with EHRs, and the development of hybrid models that combine digital interventions with periodic in-person consultations.
Thus, although patient perspectives on DTx in Korea are generally positive, there are significant opportunities for improvement in areas such as user experience (UX), data privacy, and integration with traditional healthcare systems. Understanding and addressing these patient-centric concerns are crucial for the continued growth and success of the DTx market in Korea [42].
3. User and market demand analysis
The demand for DTx in Korea is growing, driven by an aging population and increasing prevalence of chronic diseases. Korea’s rapidly aging society has led to a surge in the prevalence of chronic conditions, such as diabetes, hypertension, and heart disease, all of which require continuous management. DTx offer promising solutions for this growing healthcare burden by providing tools that allow patients to manage their conditions more effectively and with greater convenience [43].
Moreover, there is a growing recognition of the benefits of DTx among healthcare providers and patients. Healthcare providers are increasingly adopting DTx to enhance patient care, improve treatment outcomes, and reduce the overall cost of care. Patients are drawn to the convenience and accessibility of DTx as well as the personalized nature of the interventions. This has led to a surge in the demand for DTx solutions, particularly among younger, tech-savvy populations who are more comfortable with digital health tools [44].
However, challenges such as lack of awareness and skepticism among healthcare providers remain significant barriers to wider adoption. Many healthcare providers are still unfamiliar with DTx and hesitate to adopt these new technologies because of concerns regarding their efficacy and safety. Additionally, there is a need for more clinical evidence to support the use of DTx in various healthcare settings and for greater education and training of healthcare providers on how to effectively integrate DTx into their practice [45].
1. Compatibility with existing regulatory frameworks
DTx in Korea face significant challenges when it comes to integrating with existing regulatory frameworks primarily developed for traditional pharmaceuticals and medical devices. Traditional frameworks are adept at assessing the safety and efficacy of physical products such as drugs or medical devices, which are typically based on chemical or biological components. However, DTx, which are software-based, introduce complexities that these frameworks were not initially designed to handle. DTx often involve mobile applications, wearable devices, or online platforms that achieve therapeutic effects through behavioral modifications or cognitive interventions rather than physical means. This fundamental difference necessitates a reevaluation of the regulation of these products.
In Korea, traditional medical device regulations focus on physical hardware, which poses challenges when applying these rules to software-based DTx. Traditional medical devices are evaluated based on their physical and functional characteristics, whereas DTx, which are purely software, require a different approach. The dynamic nature of DTx, which involve continuous updates and improvements, is something that existing regulatory frameworks have struggled to accommodate. Additionally, the real-time data collection and personalized treatment aspects of DTx further complicate its classification and regulation under traditional frameworks, which are more static and less adaptable to the evolving nature of digital products.
Recognizing these challenges, the Korean MFDS has initiated efforts to establish a regulatory framework tailored to DTx. In 2020, the MFDS introduced the category of “digital therapeutics,” which includes DTx, and began developing specific approval criteria for these products. However, this regulatory framework is still in its early stages and further refinement is necessary to fully address the unique characteristics of DTx. There is a need for new clinical trial methodologies that account for the dynamic updates and continuous improvements typical of DTx, ensuring that these products remain safe and effective throughout their lifecycle [36,46].
2. Major regulatory issues and challenges
DTx regulations in Korea face several significant challenges, particularly in terms of safety and efficacy validation, data protection, and regulatory flexibility. Validating the safety and efficacy of DTx is inherently more complex than that of traditional therapies. Traditional pharmaceuticals are tested in static clinical trials to evaluate their safety and efficacy as fixed products. In contrast, DTx software may undergo frequent updates, leading to changes in its functionality and therapeutic outcomes over time. This dynamic nature requires a new approach to clinical validation that can accommodate ongoing software updates and evolving algorithms [47].
Data protection and privacy are also critical issues in DTx regulation. As DTx often rely on real-time data collection from users, there is a heightened need for stringent data protection measures. Korea has strict data protection laws, such as the Personal Information Protection Act, but additional regulations specific to DTx may be necessary. These regulations would need to address the secure storage and transmission of health data and ensure that user data are collected with informed consent and used transparently. Strong encryption and security protocols are essential for protecting sensitive health information, and regulatory oversight must ensure that these standards are rigorously applied [48,49].
Regulatory flexibility is another critical issue. The rapid pace of technological advancements in the field of DTx means that regulatory frameworks must be adaptable and responsive to new developments. Traditional regulatory processes, which can be slow and cumbersome, may not be well suited to the fast-moving nature of digital health technologies. To address this issue, the Korean regulatory bodies must work closely with industry stakeholders to develop a more agile regulatory framework that can quickly adapt to new technologies and innovations. This may include the implementation of conditional approvals or post-market surveillance mechanisms that allow for continuous monitoring and improvement of DTx products even after they have been approved for commercialization [50,51].
1. Regulatory improvements and policy recommendations
Regulatory improvements are essential for DTx to become sustainable and innovative treatments within the Korean healthcare system. The current regulatory framework, which is primarily designed for traditional medical devices and pharmaceuticals, does not fully accommodate the unique characteristics of DTx. Therefore, regulatory improvements and policy recommendations are necessary to promote the efficient development and commercialization of DTx in Korea.

1) Tailored regulatory framework

There is a need for regulatory framework specifically tailored for DTx. Current regulations do not adequately reflect the unique nature of DTx, leading to uncertainty among developers and companies during the product development process. As DTx products are software-based, they require a different approach from traditional medical devices or drugs. This includes new approval procedures that continuously assess the safety and efficacy of software as it undergoes updates and algorithm changes. In addition, regulations related to data protection must be established to ensure that patient data used in real time by DTx products are securely managed [52,53].

2) Enhanced policy support

DTx require major support throughout their life cycle, from initial development to clinical trials, regulatory approval, and market entry. This is particularly true for small and medium-sized enterprises and startups, which often lack the resources and infrastructure of larger companies. The government should expand its financial support programs to ensure that DTx products are included in the national health insurance system. This would make DTx more accessible to a broader range of patients, improve healthcare quality, and promote market growth [52,54].

3) Regulatory flexibility

Given the rapid pace of technological advancements in DTx, the regulatory framework must be sufficiently agile to respond swiftly to these changes. This requires close collaboration between regulatory bodies and industry to support the rapid entry of new technologies and products into the market. The regulatory system should be progressively improved based on empirical data to ensure that DTx continue to innovate. Given the frequent technical changes in DTx such as software updates, a flexible regulatory framework that can adapt to these changes is necessary [5,54].
2. Technological advancements and innovation opportunities
The success of DTx relies heavily on technological advancements, making the adoption of new technologies and innovative approaches essential for their future development. The effectiveness of DTx can be maximized by integrating cutting-edge technologies such as AI, big data, and cloud computing.

1) Artificial intelligence and machine learning

The use of AI and ML has become increasingly important. DTx focus on providing personalized treatments by analyzing large amounts of data. AI and ML can automate this data analysis, monitor patient conditions in real time, and suggest personalized treatments, making them powerful tools for DTx. For example, algorithms can be developed to analyze patient behavioral patterns and biometric signals, adjust treatments in real time to improve effectiveness, and deliver personalized healthcare [54,55].

2) Big data and data integration

The importance of big data and data integration will be further emphasized. DTx requires integration and analysis of data from various sources. Big data technologies are essential for effectively integrating and analyzing such data. Big data analysis can provide a comprehensive understanding of a patient’s health status and predict long-term health outcomes. Furthermore, enhancing the interoperability of data across various medical devices and digital platforms can ensure consistency of patient data and lead to better treatment outcomes. National-level data standardization efforts are necessary to support the efficient operation of DTx [52,53].

3) User experience and interface design

Innovations in UX and UI design are crucial for the success of DTx. Because DTx products involve software with which patients interact directly, user satisfaction and ease of use are critical factors. An intuitive and simplified UI/UX design is especially necessary for older adults or users who are less familiar with technology. These innovations can enhance patient engagement and maximize the effectiveness of DTx by providing a user-friendly design. For example, the incorporation of voice recognition technology or simple touch interfaces can create an environment where users can easily access and engage with DTx. Additionally, incorporating gamification elements can encourage users to engage more consistently and enjoyably with their treatment process [54].
3. Strategies for strengthening global competitiveness
Strategic approaches are necessary to ensure that Korea’s DTx industry remains competitive in the global market. The global healthcare market is rapidly embracing DTx. For Korean companies to succeed, they must secure differentiated competitive advantages.

1) Global regulatory standards

Developing products that meet global regulatory standards is essential. As DTx approval processes vary across countries, entering the global market requires meeting various regulatory requirements. This necessitates obtaining internationally recognized certifications and strengthening collaborations with global regulatory bodies. In particular, the development of products that meet the standards of major regulatory bodies, such as the U.S. Food and Drug Administration and the European Medicines Agency, is crucial. This will enable Korean DTx products to become competitive in the global market [52,53].

2) International cooperation and partnerships

Success in the global market requires collaborations between companies and research institutions in other countries. International cooperation in technology development, clinical trials, and market-entry strategies can help Korean DTx products enter global markets more quickly. Collaborating with local partners who understand the market and have established networks is essential for accelerating market entry and reducing risk [52,53].

3) Global marketing strategies

Strengthening global marketing strategies is necessary. Because DTx products combine information technology and healthcare, they require marketing strategies that differ from those of traditional medical devices and pharmaceuticals. Marketing strategies that emphasize product innovation, user convenience, and clinical effectiveness are required to succeed in the global market. This includes tailored marketing approaches that consider the cultural and social characteristics of each country and effectively convey the product value. In addition, using online platforms and social media for digital marketing will play a significant role in increasing brand awareness in the global market [52].
Thus, regulatory improvements, technological innovation, and strategies for enhancing global competitiveness are essential for Korea’s DTx industry to achieve sustainable and innovative development. These efforts will ensure that DTx are recognized treatment methods not only in Korea but also globally.
This study provides a comprehensive analysis of the current state of the DTx market in Korea, highlighting the key challenges and suggesting future directions for development. DTx represent a significant innovation at the intersection of healthcare and technology, offering new possibilities for managing chronic diseases, improving mental health, and supporting rehabilitation. Despite its potential, the Korean DTx market remains in its early stages and faces various regulatory, technological, and economic challenges that must be addressed to foster its growth and integration into the healthcare system.
From a regulatory perspective, DTx require a new framework that reflects their unique characteristics that are distinct from those of traditional medical devices and pharmaceuticals. The need for tailored regulations is critical for ensuring the safety and efficacy of DTx products while supporting innovation. On the technological front, the integration of advanced technologies, such as AI, big data, and user-centered design, is crucial for the success of DTx. However, the current pace of technological advancement and challenges related to data quality, security, and interoperability present significant barriers to the widespread adoption of DTx.
The lack of established reimbursement pathways for DTx in Korea poses a major economic challenge. Without adequate financial support from the healthcare system, the commercialization of DTx products will likely be difficult, limiting their accessibility to patients. Moreover, there is a need for greater awareness and education among healthcare providers and patients to build trust and confidence in these new digital interventions.
In summary, addressing these challenges requires coordinated efforts from regulators, industry stakeholders, and the healthcare community. By improving regulatory frameworks, fostering technological innovation, and enhancing global competitiveness, Korea can position itself as a leader in the global DTx market, delivering innovative and effective treatments to patients, both domestically and internationally. Successful integration of DTx into the Korean healthcare system has the potential to transform patient care, making it more personalized, accessible, and efficient.

Conflicts of interest

No potential conflict of interest relevant to this article was reported.

Funding

This study was supported by a Research Grant from Kyungwoon University in 2024 (grant number: Kw-2024-0199).

Author contributions

Conceptualization: all authors; Data curation: HJS, WSC; Formal analysis, Supervision: HJS, WSC, WJY; Funding acquisition, Validation: HRK, MBK, WJY; Methodology: HJS, HRK, MBK; Project administration: ITC, WJY; Investigation: ITC, HRK, MBK; Resources, Software, Visualization: WSC; Writing-original draft: WSC; Writing-review & editing: MBK.

Fig. 1.
Schematic depicting examples of traditional treatment approaches and digital therapeutics (DTx). Created with Flaticon (flaticon.com).
jyms-2024-01004f1.jpg
  • 1. Sverdlov O, van Dam J, Hannesdottir K, Thornton-Wells T. Digital therapeutics: an integral component of digital innovation in drug development. Clin Pharmacol Ther 2018;104:72–80.ArticlePubMedPDF
  • 2. Mathews SC, McShea MJ, Hanley CL, Ravitz A, Labrique AB, Cohen AB. Digital health: a path to validation. NPJ Digit Med 2019;2:38.ArticlePubMedPMCPDF
  • 3. Torous J, Firth J. The digital placebo effect: mobile mental health meets clinical psychiatry. Lancet Psychiatry 2016;3:100–2.ArticlePubMed
  • 4. Patel NA, Butte AJ. Characteristics and challenges of the clinical pipeline of digital therapeutics. NPJ Digit Med 2020;3:159.ArticlePubMedPMCPDF
  • 5. Jiang F, Jiang Y, Zhi H, Dong Y, Li H, Ma S, et al. Artificial intelligence in healthcare: past, present and future. Stroke Vasc Neurol 2017;2:230–43.ArticlePubMedPMC
  • 6. Schork NJ. Artificial Intelligence and Personalized Medicine. Cancer Treat Res 2019;178:265–83.ArticlePubMedPMC
  • 7. Lee SM, Lee D. Healthcare wearable devices: an analysis of key factors for continuous use intention. Serv Bus 2020;14:503–31.ArticlePDF
  • 8. Park YT. Emerging new era of mobile health technologies. Healthc Inform Res 2016;22:253–4.ArticlePubMedPMCPDF
  • 9. Lee D, Yoon SN. Application of artificial intelligence-based technologies in the healthcare industry: opportunities and challenges. Int J Environ Res Public Health 2021;18:271.ArticlePubMedPMC
  • 10. Kwon S. Thirty years of national health insurance in South Korea: lessons for achieving universal health care coverage. Health Policy Plan 2009;24:63–71.ArticlePubMed
  • 11. Joo JH, Lee JE, Kwon OT. Review of the concept of digital therapeutic devices and the possibility of applying them to health insurance. Wonju, Korea: Health Insurance Review and Assessment Service; 2021.
  • 12. Lee CH, Yoon HJ. Medical big data: promise and challenges. Kidney Res Clin Pract 2017;36:3–11.ArticlePubMedPMC
  • 13. Choi DJ, Park JJ, Ali T, Lee S. Artificial intelligence for the diagnosis of heart failure. NPJ Digit Med 2020;3:54.ArticlePubMedPMCPDF
  • 14. Choi MJ, Kim H, Nah HW, Kang DW. Digital therapeutics: emerging new therapy for neurologic deficits after stroke. J Stroke 2019;21:242–58.ArticlePubMedPMCPDF
  • 15. Byambasuren O, Sanders S, Beller E, Glasziou P. Prescribable mHealth apps identified from an overview of systematic reviews. NPJ Digit Med 2018;1:12.ArticlePubMedPMCPDF
  • 16. Torous J, Nicholas J, Larsen ME, Firth J, Christensen H. Clinical review of user engagement with mental health smartphone apps: evidence, theory and improvements. Evid Based Ment Health 2018;21:116–9.ArticlePubMedPMC
  • 17. Orsolini L, Longo G, Volpe U. Practical application of digital therapeutics in people with mood disorders. Curr Opin Psychiatry 2024;37:9–17.ArticlePubMedPMC
  • 18. Shah AM, Shah SV. Digital therapeutics: a new era in health care. Natl J Physiol Pharm Pharmacol 2023;13:2190–6.Article
  • 19. Negricea C, Purcărea IM. Adequately managing digital marketing, considering the new consumer behaviors driven including by the daily health news. Holist Mark Manag J 2020;10:11–26.
  • 20. Klemperer K, Chapman S. Digital libraries: a selected resource guide. Inf Technol Libr 1997;16:126–31.
  • 21. Biskupiak Z, Ha VV, Rohaj A, Bulaj G. Digital therapeutics for improving effectiveness of pharmaceutical drugs and biological products: preclinical and clinical studies supporting development of drug + digital combination therapies for chronic diseases. J Clin Med 2024;13:403.ArticlePubMedPMC
  • 22. Chen X, Luo Y. Digital therapeutics in migraine management: a novel treatment option in the COVID-19 era. J Pain Res 2023;16:111–7.ArticlePubMedPMCPDF
  • 23. Johnson N, deHaan J. Enhancing the scenario: emerging technologies and experiential learning in second language instructional design. Int J Learn 2012;18:321–33.Article
  • 24. Aapro M, Bossi P, Dasari A, Fallowfield L, Gascón P, Geller M, et al. Digital health for optimal supportive care in oncology: benefits, limits, and future perspectives. Support Care Cancer 2020;28:4589–612.ArticlePubMedPMCPDF
  • 25. Ryu S. Telemedicine: opportunities and developments in member states: report on the second global survey on eHealth 2009 (Global Observatory for eHealth Series, Volume 2). Healthc Inform Res 2012;18:153–5.ArticlePMC
  • 26. Kim HE, Kim E, Kim G. The effects of diabetes management programs using mobile app: a systematic review and a meta-analysis. J Korea Contents Assoc 2015;15:300–7.Article
  • 27. Kim SH, Park HE, Lee DH. Trends and implications of digital therapeutics (DTx) in the mental health field. Korean J Couns Psychother 2022;34:1401–30.
  • 28. Shin J, Kim S, Lee J, Gu H, Ahn J, Park C, et al. Efficacy of mobile app-based cognitive behavioral therapy for insomnia: multicenter, single-blind randomized clinical trial. J Med Internet Res 2024;26:e50555.ArticlePubMedPMC
  • 29. Park KM, Lee SE, Lee C, Hwang HD, Yoon DH, Choi E, et al. Prediction of good sleep with physical activity and light exposure: a preliminary study. J Clin Sleep Med 2022;18:1375–83.ArticlePubMedPMC
  • 30. Kim Y, Kim M, Kim J, Song TJ. Smartphone-based speech therapy for poststroke dysarthria: pilot randomized controlled trial evaluating efficacy and feasibility. J Med Internet Res 2024;26:e56417.ArticlePubMedPMC
  • 31. Sun J, Li M, Chen Z, Moens MF. NeuroCine: Decoding vivid video sequences from human brain activities [Preprint]. arXiv; 2024 Feb [cited 2024 Nov 10]. https://arxiv.org/abs/2402.01590.
  • 32. Kim C, Choi HE, Rhee CK, Song JH, Lee JH. Efficacy of digital therapeutics for pulmonary rehabilitation: a multi-center, randomized controlled trial. Life (Basel) 2024;14:469.ArticlePubMedPMC
  • 33. Ma KPK, Stephens KA, Geyer RE, Prado MG, Mollis BL, Zbikowski SM, et al. Developing digital therapeutics for chronic pain in primary care: a qualitative human-centered design study of providers’ motivations and challenges. JMIR Form Res 2023;7:e41788.ArticlePubMedPMC
  • 34. Firth J, Torous J, Nicholas J, Carney R, Pratap A, Rosenbaum S, et al. The efficacy of smartphone-based mental health interventions for depressive symptoms: a meta-analysis of randomized controlled trials. World Psychiatry 2017;16:287–98.ArticlePubMedPMCPDF
  • 35. Kim BY, Lee J. Smart devices for older adults managing chronic disease: a scoping review. JMIR Mhealth Uhealth 2017;5:e69.ArticlePubMedPMC
  • 36. Sim B, Ju JH, Kim B, Lee JY. Stakeholders' Perceptions Regarding Digital Therapeutics Reimbursement in South Korea: Qualitative Study. JMIR Mhealth Uhealth 2023;11:e47407.ArticlePubMedPMC
  • 37. Lee K, Kwon H, Lee B, Lee G, Lee JH, Park YR, et al. Effect of self-monitoring on long-term patient engagement with mobile health applications. PLoS One 2018;13:e0201166.ArticlePubMedPMC
  • 38. Son JH, Yang SH, Jeong IY. Current status and prospects of digital therapeutics. Seoul: Korea Insurance Research Institute; 2023. Report No. 2023-03.
  • 39. Lee J, Kim B. Social impacts of the continuous usage of digital healthcare service: a case of South Korea. Innov Mark 2021;17:79–89.ArticlePDF
  • 40. Suh H, Shahriaree N, Hekler EB, Kientz JA. Developing and validating the User Burden Scale: a tool for assessing user burden in computing systems. In: Proceedings of the 2016 CHI Conference on Human Factors in Computing Systems (CHI ’16). New York, NY: Association for Computing Machinery; 2016. p. 3988-99.
  • 41. Lee K, Shin S. Validity of instrument development research in Korean nursing research. J Korean Acad Nurs 2013;43:697–703.ArticlePubMed
  • 42. Kim J, Park HA. Development of a health information technology acceptance model using consumers’ health behavior intention. J Med Internet Res 2012;14:e133.ArticlePubMedPMC
  • 43. Kukreja P, Saxena K, Santra S. Digital therapeutics and their integration into healthcare systems: a public health perspective. HPHR J 2023;75.Article
  • 44. Carrera A, Manetti S, Lettieri E. Rewiring care delivery through Digital Therapeutics (DTx): a machine learning-enhanced assessment and development (M-LEAD) framework. BMC Health Serv Res 2024;24:237.ArticlePubMedPMCPDF
  • 45. Madeo G, Sanna A, Golinelli D, Foggi A, Cocchi F, Nante N. The increasing use of digital therapeutics of insomnia and other sleep disorders: a systematic review. Eur J Public Health 2023;33(Suppl 2):ckad160–1212.ArticlePDF
  • 46. Miao BY, Sushil M, Xu A, Wang M, Arneson D, Berkley E, et al. Characterisation of digital therapeutic clinical trials: a systematic review with natural language processing. Lancet Digit Health 2024;6:e222–9.ArticlePubMedPMC
  • 47. Wang C, Lee C, Shin H. Digital therapeutics from bench to bedside. NPJ Digit Med 2023;6:38.ArticlePubMedPMCPDF
  • 48. Kim DH, Park DH. Automated decision-making in South Korea: a critical review of the revised Personal Information Protection Act. Humanit Soc Sci Commun 2024;11:974.ArticlePDF
  • 49. Shahrullah RS, Park J, Irwansyah I. Examining Personal Data Protection Law of Indonesia and South Korea: the privacy rights fulfilment. Hasanuddin Law Rev 2024;10:1–20.ArticlePDF
  • 50. Jeon SJ, Go MS, Namgung JH. Use of personal information for artificial intelligence learning data under the Personal Information Protection Act: the case of Lee-Luda, an artificial-intelligence chatbot in South Korea. Asia Pac Law Rev 2023;31:55–72.Article
  • 51. Kemalasari NP, Putra IP. Protection of medical record data as a form of legal protection of health data through the Personal Data Protection Act. J Digit Law Policy 2023;2:111–8.ArticlePDF
  • 52. Kim SY, Moon JY, Shin J, Sim JY, Kim M, Jang J. Survey for government policies regarding strategies for the commercialization and globalization of digital therapeutics. Yonsei Med J 2022;63(Suppl):S56–62.ArticlePubMedPMCPDF
  • 53. Chung J, Shin J, Ryu G. Policy proposals to revitalize Korea digital therapeutics market: focused on the institutional analysis in other countries. HIRA Res 2023;3:130–41.Article
  • 54. Choi H, Kim B, Kim I, Kang JG, Lee Y, Lee H, et al. Analysis of the status and future direction for digital therapeutics in children and adolescent psychiatry. Soa Chongsonyon Chongsin Uihak 2023;34:192–203.ArticlePubMedPMC
  • 55. Sun TH, Yeom JW, Choi KY, Kim JL, Lee HJ, Kim HJ, et al. Potential effectiveness of digital therapeutics specialized in executive functions as adjunctive treatment for clinical symptoms of attention-deficit/hyperactivity disorder: a feasibility study. Front Psychiatry 2023;14:1169030.ArticlePubMedPMC

Figure & Data

References

    Citations

    Citations to this article as recorded by  

      Figure
      • 0
      Digital therapeutics in Korea: current status, challenges, and future directions – a narrative review
      Image
      Fig. 1. Schematic depicting examples of traditional treatment approaches and digital therapeutics (DTx). Created with Flaticon (flaticon.com).
      Digital therapeutics in Korea: current status, challenges, and future directions – a narrative review

      JYMS : Journal of Yeungnam Medical Science
      TOP