SICAN Insight #08
Digital technology has played a significant role in healthcare for the past few centuries. Electronic health records (EHRs) of patient files came into common practice since the 1990s, and from this developed combined storages and online data space, facilitating analysis, communication, and interprofessional cooperation of medical personnel. Computing and mathematical modelling has also attributed to improving diagnosis precision, prevention of illnesses, and healthcare in rural and underserved communities. Following such advances, the next leap in digital healthcare is Digital therapeutics (DTx).
Digital therapeutics are a digital health category defined by the Digital Therapeutics Alliance as products that “deliver evidence-based therapeutic interventions to patients that are driven by high quality software programs to prevent, manage, or treat a medical disorder or disease.” While digital treatments share the characteristics of drugs in that they verify the effectiveness of treatment through clinical trials and undergo screening by regulatory authorities, the Ministry of Food and Drug Safety uses the term "digital treatment device" because they are technically medical devices. As explained by Park An-sun, a researcher at the Korea Electronics and Telecommunications Research Institute, "Digital therapeutics go through clinical trials, doctors' prescriptions, and insurance applications like ordinary drugs, but there is a difference in that they are intangible software that utilizes ICT technologies such as artificial intelligence, virtual reality, chatbot, and game." For this reason, digital therapeutics are classified as a ‘third-generation’ treatment, ensuing the previous first-generation treatments (pills or capsules) and second-generation treatments (biological agents such as antibodies, proteins, cells, etc.).
The main advantages of digital therapeutics are safety, cost, and accessibility. Digital therapeutics have high safety because it does not act directly in the body, thus having less toxicity and side effects than conventional treatments. Additionally, the feature of software-based treatments naturally leads to savings in time and cost during the development and licensing process. The development of new drugs originally requires a huge amount of time and money to ensure its safety and ethicality. However, such procedural costs are greatly reduced in the development and commercialization of digital therapeutics." Medical expenditure is currently on the rise due to rising incidences of chronic diseases that are difficult to manage with existing medical systems. Digital therapeutics with high cost-effectiveness are prospected to supplement this problem and alleviate the price burden. Furthermore, digital therapeutics using mobile technologies such as smartphones and wearable devices are much more accessible than conventional offline treatments, making monitoring and appropriate intervention easier. Professor Ahn Woo-young at Seoul National University stated in an interview that through pairing digital therapeutics and portable technology, "it is possible to monitor patients in real time and manage medication, and based on the obtained data, patients can manage the disease on their own and doctors can present customized treatments optimized for patients."
The United States is the leading country in the newly emerging digital therapeutics industry. A number of digital treatments have been developed for mental disorders including insomnia and ADHD as well as chronic diseases such as cancer, stroke, and diabetes, and some are already officially prescribed to patients with FDA approval. An example of this are the drug addiction treatments "reSET" and "reSET-O". “reSET” is “a 90-day Prescription Digital Therapeutic (PDT) for Substance Use Disorder (SUD) intended to provide cognitive behavioral therapy (CBT), as an adjunct to a contingency management system” (Pear Therapeutics). The treatments have exceeded 20,000 prescriptions since approval in 2017. On the other hand, it is evaluated that Korea has not yet reached the stage of leading the global digital therapeutics market. Digital treatments under development in Korea include "Nunap Vision," the first clinical licensed digital treatment aimed at treating visual impairment after brain damage, and "efiL Care," a self-health care service for patients with chronic illnesses. However, a clear regulatory system has not yet been established, and it has not reached full-scale commercialization like as in the United States.
ex_nunaps and efiL care
Digital therapeutics may be the next medical and technological breakthrough of the 21st century. Due to its safety, cost, and accessibility, the use of digital therapeutics is constantly increasing, both independently and combined with first- and second-generation treatments. Following COVID-19 and the spatial limitations it imposes, telemedicine and digital healthcare are drawing more attention than ever. In times like these, it would be important for governments and enterprises to lay a strong foundation for digital therapeutics establishment.
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