Pilot study for the clinical validation of a medical device for the automatic triage in teledermatology (Legit.Health_clinical_VH_2025)

Study identification

• EU PAS number:
  EUPAS1000000649
• Study ID:
  1000000649
• Official title and acronym:
  Pilot study for the clinical validation of a medical device for the automatic triage in teledermatology (Legit.Health_clinical_VH_2025)
• DARWIN EU® study:
  No
• Study countries:
  Spain
• Study description:
  Over the past three years, Barcelona’s Vall d’Hebron University Hospital (HUVH) has implemented an innovative teledermatology system that has managed tens of thousands of cases. ; This platform enables primary care physicians to submit referrals complete with images and designated urgency levels. ; However, delays in non‑urgent referrals—combined with a dermatology waiting time averaging 118 days across Catalan hospitals as of October 2023—have led to late diagnoses of malignant and urgent conditions.; ; Legit.Health offers an AI‑driven solution that extracts clinically relevant data from dermatological images. ; This output supports clinicians’ decision‑making and can also automate workflows such as patient prioritisation based on malignancy risk or severity criteria.; ; This project aims to optimise care for patients with skin cancer and serious dermatoses by reducing waiting times, improving the accuracy of skin‑cancer detection, and lowering rates of false positives and negatives. ; To achieve this, we will conduct a detailed analysis of over 30,000 teleconsultations between primary care and dermatology, alongside other pertinent data, to evaluate the tool’s performance. Image quality will be monitored and non‑malignant but urgent conditions—such as toxicodermias and extensive inflammatory dermatoses—will be identified for priority attention.; ; The introduction of Legit.Health at Vall d’Hebron promises to transform dermatological services through its advanced AI capabilities. ; Nonetheless, before full deployment, this study will validate the tool’s clinical utility using real‑world data.; ; ; ; ; ; ; ; ;
• Study status:
  Ongoing

Research institutions and networks

Institutions

University Hospital Vall d’Hebron (HUVH)

Spain

AI Labs Group S.L. (Legit.Health)

Spain

Study timelines

Date when funding contract was signed

Planned:01/03/2025

Actual:07/03/2025

Study start date

Planned:15/03/2025

Actual:28/03/2025

Data analysis start date

Planned:01/08/2025

Date of final study report

Planned:01/09/2025

Sources of funding

No external funding

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable