Clinical Validation Studies
This section provides full bibliographic references for the clinical validation studies cited in the Clinical Benefits and Performance Claims section. Each study code that appears alongside a performance metric is defined below with its complete study metadata.
Study-to-Benefit Cross-Reference
The following table summarises which clinical benefits each study supports. Clinical benefit codes are defined in the Clinical Benefit Identifiers section.
| Study | Clinical Benefits Supported | Claims |
|---|---|---|
 MC_EVCDAO_2019 | 7GH | 12 |
 COVIDX_EVCDAO_2022 | 5RB3KX | 7 |
| DAO_Derivación_PH_2022 | 7GH3KX | 3 |
 IDEI_2023 | 7GH5RB | 14 |
 SAN_2024 | 7GH3KX | 31 |
 BI_2024 | 7GH | 45 |
| PH_2024 | 7GH3KX | 17 |
| DAO_Derivation_O_2022 | 7GH3KX | 17 |
 AIHS4 2025 | 5RB | 2 |
Study Bibliography
- Title:
- Clinical validation study of a CAD system with artificial intelligence algorithms for early noninvasive in vivo cutaneous melanoma detection
- Investigational site(s):
- Hospital Universitario Cruces and Hospital Universitario Basurto
- Principal investigator(s):
- Dr. Jesus Gardeazabal Garcia and Dr. Rosa Ma Izu Belloso
- Sample size:
- 105
- Study period:
- February 2020 – November 2023
- Ethics committee:
- Comite de Etica de la Investigacion con Medicamentos de Euskadi
- Device under investigation:
- Legit.Health Legacy Device
- Publication status:
- Expected to be sent in May 2025 to the Journal of the European Academy of Dermatology and Venereology Clinical Practice
- Title:
- 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
- Investigational site(s):
- Torrejón University Hospital
- Principal investigator(s):
- Dra. Marta Andreu
- Sample size:
- 160
- Study period:
- April 2022 – October 2023
- Ethics committee:
- Comité de Ética de la Investigación con Medicamentos de los Hospitales Universitarios Torrevieja y Elche-Vinalopó
- Sponsor:
- AI Labs Group S.L.
- Device under investigation:
- Legit.Health Plus
- Publication status:
- Not yet submitted for publication
- Title:
- Project to enhance Dermatology E-Consultations in Primary Care Centres using Artificial Intelligence Tools
- Investigational site(s):
- Pozuelo and Majadahonda Health Centers and Puerta del Hierro Majadahonda University Hospital
- Principal investigator(s):
- Dr. Gastón Roustan Gullón
- Sample size:
- 131
- Study period:
- June 2022 – January 2024
- Ethics committee:
- Comité de Ética de la Investigación con Medicamentos del Hospital Universitario Puerta del Hierro de Majadahonda
- Sponsor:
- Instituto de Investigación Sanitaria Puerta de Hierro
- Device under investigation:
- Legit.Health Plus
- Publication status:
- Not yet submitted for publication
- Title:
- Optimisation of clinical flow in patients with dermatological conditions using Artificial Intelligence
- Investigational site(s):
- Instituto de Dermatología Integral (IDEI)
- Principal investigator(s):
- Dr. Miguel Sánchez Viera
- Sample size:
- 204
- Study period:
- January 2024 – August 2024
- Ethics committee:
- Comité de Ética de la Investigación con Medicamentos de HM Hospitales (Reference: 24.12.2266-GHM)
- Sponsor:
- AI Labs Group S.L.
- Device under investigation:
- Legit.Health Plus
- Publication status:
- Not yet submitted for publication
- Title:
- Multi-Reader Multi-Case Study for Evaluating the Impact of Legit.Health Plus Device on the Healthcare Practitioners' Assessment of Skin Lesions
- Investigational site(s):
- This study was conducted remotely by sending the images to the participating professionals.
- Principal investigator(s):
- Dr. Antonio Martorell Calatayud
- Sample size:
- 29
- Study period:
- June 2024 – October 2024
- Ethics committee:
- This study did not require an Ethics Committee approval because it is observational and non-interventional. All data used consists of fully anonymized images sourced from public dermatology atlases and databases, containing no information permitting patient identification. As such, the research meets the criteria for exemption from ethics committee review under applicable regulatory frameworks.
- Sponsor:
- Sanitas Hospitales SA
- Device under investigation:
- Legit.Health Plus
- Publication status:
- Not yet submitted for publication
- Title:
- Multi-Reader Multi-Case Study for Assessing the Impact of Legit.Health Plus on the Clinical Assessment of Generalised Pustular Psoriasis and Other Skin Conditions by Healthcare Professionals.
- Investigational site(s):
- This study was conducted remotely by sending the images to the participating dermatologists.
- Principal investigator(s):
- Dr. Antonio Martorell Calatayud
- Sample size:
- 100
- Study period:
- June 2024 – September 2024
- Ethics committee:
- This study did not require Ethics Committee approval because it is observational and non-interventional. All data used consists of fully anonymized images sourced from public dermatology atlases and databases, containing no information permitting patient identification. As such, the research meets the criteria for exemption from ethics committee review under applicable regulatory frameworks.
- Sponsor:
- Boehringer Ingelheim
- Device under investigation:
- Legit.Health Plus
- Publication status:
- Not yet submitted for publication
- Title:
- Multi-Reader Multi-Case Study Assessing the Impact of Legit.Health Plus on the Diagnostic Accuracy and Referral Decision-Making of Primary Care Physicians for Skin Lesions.
- Investigational site(s):
- This study was conducted remotely by sending the images to the participating professionals.
- Principal investigator(s):
- Dr. Gastón Roustán Gullon
- Sample size:
- 30
- Study period:
- June 2024 – September 2024
- Ethics committee:
- This study does not require an Ethics Committee approval due to the nature of the images used. The images employed in this study are completely anonymized medical images sourced from public dermatological atlases and freely available public sources. These images are not derived from identifiable patients, and their anonymization makes patient recognition impossible. As these images constitute non-personal data, they do not fall under the scope of regulations requiring ethics committee approval for studies based on fully anonymized, publicly available data.
- Sponsor:
- Instituto de Investigación Sanitaria Puerta de Hierro
- Device under investigation:
- Legit.Health Plus
- Publication status:
- Not yet submitted for publication
- Title:
- Pilot study for the clinical validation of an artificial intelligence algorithm to optimize the appropriateness of dermatology referrals. (Ongoing Study)
- Investigational site(s):
- Health Centre Sodupe-Güeñes, Health Centre Balmaseda, Health Centre Buruaga, and Health Centre Zurbaran
- Principal investigator(s):
- Dr. Jesús Gardeazabal García and Dr. Rosa Mª Izu Belloso
- Sample size:
- 117
- Study period:
- November 2022 – April 2025
- Ethics committee:
- Comité de Ética de la Investigación con Medicamentos de Euskadi
- Sponsor:
- AI Labs Group S.L.
- Device under investigation:
- Legit.Health Plus
- Publication status:
- Not yet submitted for publication
- Title:
- Evaluation of AIHS4 Performance in the M-27134-01 Clinical Trial for Hidradenitis Suppurativa
- Investigational site(s):
- This study was conducted remotely based on clinical trial image evaluations.
- Principal investigator(s):
- Dr. Antonio Martorell Calatayud
- Sample size:
- 2
- Study period:
- June 2024 – July 2024
- Ethics committee:
- This study did not require an Ethics Committee approval due to its observational non-interventional nature.
- Sponsor:
- AI Labs Group S.L.
- Device under investigation:
- Legit.Health Plus
- Publication status:
- Published (May 2023)