Civil Liability Insurance Coverage Certification

Project Details

Project Title: Pilot study for the clinical validation of a medical device for the automatic assessment of severity and remote monitoring of patients with acne.

Project Code: Legit.Health_acne

Sponsor: AI Labs Group S.L.

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Insurance Coverage Statement

This document officially certifies that the above-referenced project is fully covered without exclusion under the Civil Liability Insurance Policy held by Legit.Health for the year 2025.

Policy Information

• Policy Holder: Legit.Health
• Policy Number: [To be completed with specific policy number]
• Policy Period: 2025
• Coverage Limits: [To be completed with specific coverage amounts per occurrence]
• Policy Document: Available at /apps/qms/docs/licenses-and-accreditations/civil-liability-insurance/2025.pdf

Coverage Scope

The project entitled "Pilot study for the clinical validation of a medical device for the automatic assessment of severity and remote monitoring of patients with acne" (Code: Legit.Health_acne) is fully covered without limitation under the terms and conditions of the Civil Liability Insurance Policy for 2025 and 2026, in compliance with RD 1090/2015 and applicable regulatory requirements for clinical device investigations.

This coverage includes:

• Professional liability coverage for the development and validation of the medical device
• Coverage for clinical investigation activities and device validation studies
• Protection for sponsor organization (AI Labs Group S.L.) and Legit.Health during the pilot study execution
• Coverage for potential liabilities arising from the clinical validation activities
• Coverage is not subject to any exclusions or restrictions related to the nature of this clinical device validation study

Exclusions and Limitations

This project is NOT subject to coverage limitations, exclusions, or restrictions related to its classification as a clinical device validation study. The policy provides comprehensive liability protection for all activities conducted under this project code.

Project Duration

This insurance coverage is effective from April 18, 2025 through April 18, 2026, covering the entire duration of the pilot study as conducted under the aforementioned project code and title. This certification is valid as of the date issued and remains effective throughout the policy period, subject to the terms of the insurance policy.

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Acknowledgment

By this certification, it is acknowledged that:

1. The project is registered with Legit.Health quality management system
2. All project activities comply with applicable standards and regulatory requirements, including RD 1090/2015
3. The project is fully insured under the 2025 Civil Liability Insurance Policy without exclusions
4. Any Ethics Committee inquiries regarding insurance coverage for this project should reference this certification document and the policy document available in the organization's documentation system
5. This project maintains continuous insurance coverage for the entire 2025 calendar year

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Authorized Certification

Certified by:

• Department: Legit.Health Quality Assurance or Risk Management
• Date of Certification: December 9, 2025
• Authorized Representative Signature: ********___********
• Name and Title: ********___********

For insurance coverage verification or emergency inquiries, contact: [Quality Assurance or Risk Management department contact information]

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Document Information

• Document Type: Insurance Coverage Certification
• Date of Certification: December 9, 2025
• Document Validity: Valid through April 18, 2026 (policy period)
• Organization: Legit.Health
• Classification: Internal Documentation
• Regulatory Compliance: RD 1090/2015 (Clinical Investigation Regulations)

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For inquiries regarding this certification or insurance coverage details, please contact the Legit.Health Quality Assurance or Risk Management department.