Clinical Validation of a Computer-Aided Diagnosis (CAD) System Utilizing Artificial Intelligence Algorithms for Continuous and Remote Monitoring of Patient Condition Severity in an Objective and Stable Manner.

The goal of this observational prospective and analytical study is to evaluate the effectiveness of the device developed by Legit.Health in remotely monitoring the severity of chronic dermatologic pathologies. Secondly, to assess patient satisfaction with the device for remote monitoring. All this in patients diagnosed with any of the specified chronic dermatological conditions that meet the inclusion criteria. These patients are attended at the Dermatology Department of the Hospital Universitario de Torrejón.

The study proceeded as follows:

Patient Selection and Recruitment Visit The recruitment period spanned six months, during which investigators identified eligible patients. The Principal Investigator (PI) or designated collaborating investigators explained the study details to potential participants using the Patient Information Sheet. Patients had the opportunity to seek clarification on any aspects of the study. If a patient chose to participate, they provided informed consent and received a study code. Data collection commenced post-consent. During this initial visit, patients used the device under the supervision of the research team to complete questionnaires and capture photographs associated with their pathology.

Subsequently, the patient autonomously and remotely continued the data collection process at home, as detailed in the following section.

The device was provided at no cost to patients and the research team for the study's duration.

Procedures Performed by the Patient at Home Completion of Questionnaires Patients independently reported on their condition from home, following instructions provided by the research team and the "Patient Information Guide" integrated into Legit.Health, in conjunction with photograph submissions.

Every two months, patients completed the "Patient Satisfaction Questionnaire" addressing general user experience aspects. Additionally, they completed the System Usability Scale (SUS) Questionnaire at the same frequency

Image capture

Patients simultaneously took photographs of the affected areas while completing questionnaires through the app. These photographs were captured using the patient's smartphone from their homes in an autonomous manner. The frequency of photograph submission was determined by the consulting specialist. No specialized camera equipment was required; patients used the camera available on their smartphones. Patients then transmitted these photographs to the research team through a web app Both patients and members of the medical team possessed access credentials.

The manufacturer did not have access to patient accounts or information. Data transfer and photograph storage adhered to the European Regulation 2016/679 of 27 April on the protection of natural persons with regard to the processing of personal data and the free movement of such data, as well as the Organic Law 3/2018 of 5 December on the Protection of Personal Data and guarantee of digital rights.