Medical Device Act Compliance Review for AI Healthcare App

Client Information

Corporate / Service Provider
 

Case Details

The Corporate Practice Group at Decent Law Firm conducted a comprehensive legality review for the new service of Healthcare Startup A, which utilizes AI vision technology to analyze body proportions and provide health management information.

The service in question is an app that analyzes user-uploaded photos to inform users about body ratios and symmetry. Such services tread a fine line between general "Healthcare" and regulated "Medical Practice," creating a significant risk of being misclassified as an unapproved medical device under Korean law.

Consequently, the client retained our firm—specifically our attorneys specializing in the Medical Device Act—to ensure a legally secure business structure prior to the service launch.

Our attorneys provided a tailored solution designed to minimize regulatory risks while effectively maintaining the core value of the service's "body analysis" features.


1. Redefining Terminology

To prevent the service from being mistaken for a medical device by regulatory authorities, we advised replacing sensitive terms such as "normal/abnormal diagnosis" or "examination" with safer alternatives like "comparison with average data" and "ratio calculation." Through this linguistic re-engineering, we clearly defined the service's purpose as providing informational references rather than medical treatment or diagnosis.


2. Designing Data Collection Processes

Adopting a conservative legal approach, we interpreted body photographs as sensitive biometric data. We assisted in constructing a secure UI/UX process at the service entry stage to ensure explicit identity verification and consent collection from users (or their legal guardians), ensuring compliance with data privacy laws.


3. Establishing a Compliant Medical Referral Model

To ensure the hospital recommendation feature did not constitute illegal patient inducement or brokerage, we designed a structure based strictly on consumer-driven choice, precluding any commission fees. We also advised on the inclusion of specific disclaimer clauses in the terms of service to further mitigate legal liability.