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The current status of breakthrough devices designation in the United States and innovative medical devices designation in Korea for digital health software
Published in Expert Review of Medical Devices, 2022
Jae Hyun Woo, Eun Cheol Kim, Sung Min Kim
Digital technologies enable homogenization and storage of significant data using big data analytics or advanced tools and techniques for storing, processing, and analyzing large amounts of data. Digitization in healthcare is facilitated by new technologies contributing to safe and high-quality care [4,5]. It has led to new developments such as self-tracking, big data predictive analytics, e-health, mobile health, participatory medical research, e-patient communities, and shared decision making in diagnosis and treatment [6].