The Hyge AI skin check is a class I medical device, according to Art. 5 of the Medical Device Regulation, in conjunction with Directive 93/42/EEC.
Hyge AI skin check Version 1.0
Purpose
Warden AI LAB SIA (Hyge AI) offers an online service that allows the user to make a paid medical inquiry about a specific dermatological condition. When creating a query on the platform, the user answers a series of automated questions about their symptoms. The specific questions are matched to the user's input by a medical algorithm, and the patient submits photos of the affected skin areas.
From this query, a case dossier is created and sent to a dermatologist (physician) for evaluation. The doctor makes a medical diagnosis and a treatment recommendation (recommended course of action), which is sent to the user digitally, usually by e-mail.
Hyge AI NOT does not automatically diagnose health conditions and diseases - no direct diagnosis is made. Diagnoses and therapy recommendations are only made with the involvement of a doctor and are only presented in the corresponding recommendations for action that the doctor sends to the user. The responsibility for the diagnosis and the subsequent medical procedure lies solely with the physician.
Consultations via the Hyge AI platform do not replace a visit to a doctor. Medical decisions regarding diagnosis and treatment may require the user to see a doctor in person or go directly to an emergency room.
Warnings
Data collected through the Hyge AI platform is evaluated and reviewed exclusively by dermatologists licensed in the EU and EEA. The Hyge AI skin check does not make its own diagnosis from the collected data, nor does it make its own diagnosis suggestion to the dermatologist.
Medical consultations via the Hyge AI skin check should not and cannot replace every visit to the doctor. For some symptoms and diseases, or for a meaningful diagnosis and comprehensive treatment and therapy plan, the user may need to see a doctor in person or go directly to an emergency room. The Hyge AI skin check is not intended for emergencies or urgent treatment needs. It is not intended for immediate monitoring of illness or medical procedures. In such cases, please contact your dermatologist immediately.