디지털치료기기 활성화를 위한 정책 수립: 이해당사자 설문을 중심으로

Abstract

Background: Digital therapeutics, a digital medical device that provides evidence-based therapeutic intervention, is expected to be a promising technology. Digital therapeutics provide great potential to improve the experience and outcomes of patients and medical professionals. The purpose of this study was to suggest policies for revitalizing the field of digital therapeutics. Methods: This study conducted an online survey on digital therapeutics with stakeholders such as digital therapeutics companies and medical institutions. The questionnaire for the company consisted of a total of 11 questions, including ones on the current development status of their products, requirements for development, and data exchange. The physicians are asked six questions about the field of interest in digital therapeutics and the clinical validation process. Results: As a result of inquiring about the factors necessary for the development of digital therapeutics on a 5-point scale, the necessity of standard development processes for the product and commercialization guidelines was high (mean±standard deviation [SD]: 4.43±0.76 and 4.14±0.77, respectively). The connectivity between digital therapeutics and electronic medical record/order communication system was in high demand (mean±SD: 4.29±0.73 and 4.21±0.70, respectively). Participants in the companies answered that data exchange such as medical records and results of several tests in clinics are needed. Also, they replied that they could provide the data such as compliance and patients’ behavioral change to medical institutions or governmental regulation organizations. Conclusion: First, a support program for companies developing digital therapeutics is required to help them prepare for approval and registration of the product. There is also a requirement for a platform system in which digital therapeutics can operate well in a medical institution environment. Finally, it is necessary to develop evaluation methods and indicators suitable for digital therapeutics.