Health management AI service app, mandatory review of applicability of the Medical Device Act.
Article posted in 2024-10-31 15:43:27 | VEAT
Law firm Veat received a request from Company A, an operator of a mobile application providing AI-powered health management services, to thoroughly examine whether its services would be subject to the "Medical Device Act."
Law firm Veat assessed whether AI-driven health information provision could be recognized as a general non-medical health management service and whether it might be classified as a medical device subject to the Medical Device Act, and carefully analyzed the operating method of the client's service, legal regulations, and specific service functions to provide legal advice to minimize legal risks.
Examining Legal Issues Related to AI Services and the Medical Device Act
Under the Medical Device Act, a 'medical device' is defined as a device used for diagnosing or treating diseases and is subject to various regulations depending on its function.
Services like Company A’s, which provides personalized health information through AI analysis, can greatly assist users in their daily health management. However, if such services go beyond providing simple health information and perform medical acts such as predicting or managing diseases, they may be classified as medical devices under the Medical Device Act.
In such cases, medical device approval, reporting, and review must be undergone, which requires considerable time and expense. Therefore, if the service is a healthcare service, it is necessary to consider the possibility of being legally defined as a medical device.
First, there is the issue of interconnection with existing medical devices. If the application uses technologies like Bluetooth or NFC to receive information from existing medical devices or transmit data remotely, it is likely to be classified as a medical device. For example, if it connects to an actual blood glucose meter, analyzes the data, and allows the user to use the results as a basis for disease diagnosis, it may be subject to the Medical Device Act.
Second, there is the purpose of the service. If the service is a non-medical health management service and is used by the user for health management in daily life, it may be excluded from the scope of the Medical Device Act. For example, monitoring the user’s health status to improve their lifestyle habits may not be considered a medical device.
Whether something constitutes a medical device must be reviewed comprehensively, including guidelines from the Ministry of Health and Welfare and the 「Medical Device Act」, and it is recommended to receive legal advice from
Digital healthcare is a rapidly evolving field, merging advanced technology and medical services to provide personalized health management and disease prevention services to users. However, such digital healthcare services need to be provided in compliance with relevant legal regulations, such as the Medical Device Act.
Law firm Veat is providing advice on whether the client’s business model can operate legally, based on its experience and understanding of various cases related to the IT and healthcare industries, and presenting the optimal strategy.
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