디지털 치료기기의 현황 및 발전 방향

Abstract

Background: Digital therapeutics, evidence-based software applications, offer preventive measures for various diseases and enhance healthcare accessibility and change. This article explores the current status and future trajectory of these devices. Current Concepts: Digital therapeutics prioritize a patient-centered approach. Historically, healthcare relied heavily on prescribed treatments during hospital visits. However, these devices provide objective data on patient symptoms through real-time digital monitoring. They also foster advancements in biotechnology and information technology, leading to improved patient care through technologies like artificial intelligence and virtual reality apps. Rigorous clinical trials are crucial for these devices, and integrating digital technology is proving increasingly efficient, particularly for decentralized clinical trials. Despite initial promise, challenges abound. While an international leader in this sector gained U.S. Food and Drug Administration approval, it recently filed for bankruptcy. Similarly, companies employing gaming techniques for attention deficit hyperactivity disorder treatment experienced lackluster performance. In Korea, the domestic digital therapeutics ecosystem stagnates with limited new approvals. High dropout rates and low user engagement remain major hurdles. Addressing these issues requires a design focused on user experience and motivation. Discussion and Conclusion: Digital therapeutic devices, coupled with digital monitoring, are poised to revolutionize healthcare into a patient-centered ecosystem. Establishing this ecosystem demands collaboration among patients, medical professionals, developers, and regulatory agencies. Continuous regulatory innovation, such as shortening the medical device evaluation process from 390 days to 80 days, is vital for progress.