▲ (from the left) Professor Hangsik Shin and Dr. Changwon Wang

A research team, led by Professor Hangsik Shin from the Department of Convergence Medicine, and Dr. Changwon Wang from the Biomedical Engineering Research Center at Asan Medical Center, has recently published research results proposing essential prerequisites for the development and commercialization of digital therapeutics (DTx), a subset of Software as a Medical Device (SaMD).

Through a comprehensive analysis of DTx-related literature, DTx manufacturers and commercial products, as well as medical device regulatory organizations in 11 countries and international platforms, the research team confirmed that no clear international consensus or standards had been established for the definition, regulatory criteria, and safety and performance evaluation methods for DTx. One notable observation was that, unlike medications, DTx could only be applied to patients with an understanding and cognitive ability to operate digital devices, necessitating sufficient user training during the development and conduct of clinical trials.

Furthermore, the study highlighted the critical importance of measures to prevent information leakage by regulatory organizations, as patient data is stored in a digital format. In addition, the research team emphasized the need for ongoing research and validation based on real-world evidence (RWE) to confirm the potential benefits and risks of DTx, even after evidence from randomized clinical trials has been established.

Professor Shin said, “We look forward to the successful establishment of DTx by reaching international consensus on the definition and regulations of DTx, building a close collaboration system among researchers, manufacturers, and governments, and continuously carrying out research and clinical verification.”

The research findings were recently published in the international academic journal, ‘npj Digital Medicine.’