2024 Volume 18 Issue 1 Pages 2-10
The utilization of digital devices in the healthcare sector has expanded, and digital health technologies are being employed for health management in the Japanese population. However, there has been a delay in standardizing the evaluation criteria for digital health technologies. In Japan, the evaluation guidelines for digital health technologies are underdeveloped, and the construction of future evaluation standards has become a challenge. In this paper, we have undertaken a comparative study of digital health technology evaluation guidelines across seven countries and one institution, investigating their purpose, evaluation targets, and 16 major evaluation standards that are relevant to the establishment of evaluation standards for digital health technologies. As a result, the objectives of the guidelines can be broadly classified into six categories, ranging from the creation of innovation to the purpose of quality control of medical devices, covering a wide range of purposes. In terms of evaluation targets, significant differences were identified among countries, with guidelines targeting only medical digital devices to those encompassing mobile applications, software, or digital health technologies in general. In the study of 16 major evaluation standards, adoption varied across countries, and disparities were found between guidelines that provide detailed definitions and those that merely mention the terms. Among the eight guidelines reviewed, particular emphasis was placed on equity of access, privacy, and information protection. In future evaluation standards for digital health devices, there may be an expansion in the role of interoperability of devices and information as the digital health market continues to grow.
