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      • R-009-001 Implementation plans
        • R-009-001 BR J&J 20250822
        • R-009-001 US Johnson & Johnson 20251031
        • R-009-001 ES Novartis 20251104
        • R-009-001 Iderma 20230301
        • R-009-001 Sermas 20230301
        • R-009-001 Galderma 20230727
        • R-009-001 Boehringer Ingelheim 20240207
        • R-009-001 Hospital del Mar 20240709
        • R-009-001 ES Boehringer Ingelheim 20241223
        • R-009-001 ES Generalitat Valenciana licitacion contrato menor 20250107
        • R-009-001 ES Licitación SESPA 20250101
        • R-009-001 US Sagimet ICON 20250113
        • R-009-001 ES Sandoz 20250407
        • R-009-001 US Johnson & Johnson 20250505
        • R-009-001 US J&J 20250612
        • R-009-001 BR J&J 20250822
        • R-009-001 ES Aptima 20250911
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  • R-009-001 US Johnson & Johnson 20251031

R-009-001 US Johnson & Johnson 20251031

  • Deal Id: 45489188014
  • Contract sign date: YYYY MM DD (YYYY MM DD)
  • Deal name: US J&J Retrospective study - AD and Psoriasis

Goals​

Goals for 1st year​

GoalMetricTarget
  • TO DO: success metrics?

Project definition details summary​

  • Overview:

    • J&J has an internal dataset of approximately 85,000 clinical images, focused on lesions in patients with Atopic Dermatitis (AD) and Psoriasis. Each patient has around 43 images capturing different lesion perspectives.
    • This project aims to explore the potential of Legit.Health (LH) models to complement or accelerate their current capabilities, providing global and local severity scores and identifying clinical visual signs efficiently across their dataset.
    • The goal is to apply Legit.Health (LH) models to generate global and local severity scores and identify clinical visual signs.

  • Primary Objective:

    • Assess the feasibility and added value of using Legit.Health's AI models on J&J's internal clinical images, comparing performance against existing internal models. The goal is to determine whether J&J should invest time and resources in developing their own solution or leverage LH models to accelerate analysis.
    • Evaluate the performance of Legit.Health's AI models in assessing disease severity and identifying clinical visual signs in J&J's retrospective dataset of clinical images.

  • Conditions of Interest:

    • Atopic Dermatitis (AD)
    • Psoriasis

  • Scoring Systems:

    • EASI (Eczema Area and Severity Index) for Atopic Dermatitis
    • ASCORAD (Atopic Dermatitis Clinical Outcome Research Investigator Global Assessment) for Atopic Dermatitis
    • PASI (Psoriasis Area and Severity Index) for Psoriasis

  • Integration Type: API (JSON Only)

  • Translations: No

  • Dashboard: No.

  • Data Transfer: No. API (JSON Only).

  • Timeline: study is expected to start in YYYY-MM-DD.

  • Other comments:

    • Documentation of API endpoints and outputs (/severity-assessment) will be prepared.
    • (if applies) Legal and privacy restrictions will be confirmed with J&J before testing.

Summary of dates​

ConceptStart DateEnd DateApprox. Months
Contract PeriodYYYY-MM-DDYYYY-MM-DDN
Study periodYYYY-MM-DDYYYY-MM-DDN
Technical SupportYYYY-MM-DDYYYY-MM-DDN

JSON-only API Flow for J&J Backend​

Data Flow for Local Severity Assessment via Legit.Health API (JSON Only)​

Request details:​

  • EASI
    • Condition: Atopic Dermatitis (ICD-11 code: EA89)
    • scoringSystem: aeasi
    • questionnaire:
      • Question: Affected area from selected body area (%)
      • Age: Patient age (years), only needed if age below 7 years or above 7 years
  • PASI
    • Condition: Psoriasis (ICD-11 code: EA80)
    • scoringSystem: apasi
    • questionnaire:
      • Question: Affected area from selected body area (% or (0 to 6))

Response visual signs example​

  • AEASI

    • local score
    • Surface area score (*)
    • patient age (*)
    • Redness
    • Thickness
    • Scratching
    • Lichenification

  • APASI

    • local score
    • Body area (*)
    • Surface area score (0 to 6)(*)
    • Desquamation
    • Erythema
    • Induration
Quantification of intensity, count and extent of visible clinical signs​

The device provides quantifiable data on the intensity, count and extent of clinical signs such as erythema, desquamation, and induration, among others; including, but not limited to:

  • erythema,
  • desquamation,
  • induration,
  • crusting,
  • xerosis (dryness),
  • swelling (oedema),
  • oozing,
  • excoriation,
  • lichenification,
  • exudation,
  • wound depth,
  • wound border,
  • undermining,
  • hair loss,
  • necrotic tissue,
  • granulation tissue,
  • epithelialization,
  • nodule,
  • papule
  • pustule,
  • cyst,
  • comedone,
  • abscess,
  • draining tunnel,
  • inflammatory lesion,
  • exposed wound, bone and/or adjacent tissues,
  • slough or biofilm,
  • maceration,
  • external material over the lesion,
  • hypopigmentation or depigmentation,
  • hyperpigmentation,
  • scar

Backend Cloud Infrastructure Flow​

Default data flow diagram​

Note: DPIA it is available upon request.

Note: All data flows are secured using encrypted HTTPS connections to ensure data integrity and confidentiality. Note: we employ the robust OAuth 2.0 authentication mechanisms to ensure that only authorized users can access the API. Role-based access control further restricts user privileges, enhancing data security. All data transmitted between the user and the API is encrypted using industry-standard encryption protocols.

Possible data flow diagram (upon request and contract agreement)​

Note: The client may require that the data not be stored or request its immediate deletion after processing, provided this request is made explicitly and specified in the contract.

Project tasks​

🧭 Definition & planning​

TaskDescriptionStart DateEnd DateStatusNotes
Project conception and initiationInitial ideation and opportunity scoping with all key stakeholders.2025-10-30TBD🚧 WIP
Definition and planningDefine project details: scope, key deliverables, timelines, success metrics, and required resources.TBDTBD⏳ Pending
Implementation plan definedProject scope, key deliverables, timelines, success metrics, and required resources are defined and clearTBDTBD⏳ Pending

📝 Contracting​

TaskDescriptionStart DateEnd DateStatusNotes
Offer SentFormal offer/proposal shared with the customer for review.TBDTBD⏳ Pending
Offer ApprovedCustomer reviews and approves the proposed scope, terms, and pricing.TBDTBD⏳ Pending
Contract ReviewAlign on deliverables, timelines, legal and data terms.TBDTBD⏳ Pending
Contract SigningFinalize and sign all contractual agreements.TBDTBD⏳ Pending

🔌 Integration workflow​

TaskDescriptionTimelineStatusDependencies
Technical onboardingProvide comprehensive API documentation, technical walkthroughs.TBD⏳ PendingKick-off meeting
API AccessAfter contract signed, generate and deliver API keys. Access to both production and testing environments.TBD⏳ PendingContract signed
Professional ServicesExpert support from technicians, consultants, and project managers. Review API input/output structures and align with requirementsTBD⏳ Pending
(Optional) Preproduction environment TestingValidate integration in pre-prod using sample cases; assess scoring accuracy, latency, and input handling.TBD⏳ PendingInterface mapping
Production environment TestingConduct final functional testing with production endpoints using real patient flows and edge cases.TBD⏳ PendingConcordance validation
Customer service deployment into productionOfficially deploy the service to production, ensuring all components are live and operational.2026-03-01⏳ Pending
Post-Launch Support & TuningProvide immediate support coverage, monitor usage patterns, and refine based on real-world feedback.TBD⏳ Pending

🚀 Project Execution​

TaskDescriptionResponsibleStatus
User OnboardingTrain IT managers on the API and scoring system.JD-021, JD-016⏳ Pending
Customer SupportSetup and activate helpdesk or in-app support systems. Comprehensive assistance for complex issuesJD-021, JD-016⏳ Pending

🔁 Follow-up Meetings (Optional)​

TaskDescriptionResponsibleStatus
Follow-up MeetingFormal review of key findings, feedback, and performance.JD-021, JD-016⏳ Pending
Interim ReportSummary report of current status, insights, and recommendations mid-project.JD-021, JD-016⏳ Pending

✅ Project Close​

TaskDescriptionResponsibleStatus
Final ReportAnalyze final outcomes, compare against objectives, and document results.JD-021, JD-016⏳ Pending
Define Next StepsOutline future roadmap, improvements, or additional collaborations.JD-021, JD-016⏳ Pending

Project leads​

TeamCodeLeader of
Legit.HealthJD-002, JD-008, JD-019Sales Manager, Business Development Manager, Sales Development Representative, Digital Health Manager
Legit.HealthJD-027Project Manager Lead
Legit.HealthJD-013Project Manager
Legit.HealthJD-003Design and Development Manager
Legit.HealthJD-016Customer Success Manager
Legit.HealthJD-018Clinical Research Manager
Legit.HealthJD-004Quality Manager & PRRC
Legit.HealthJD-007, JD-010Technology Manager, Software developer
Legit.HealthJD-005, JD-009Machine Learning Manager, Medical Data Scientist
Legit.HealthJD-014Data Analyst
Company NameName SurnameProject Director
Company NameName SurnameProject lead

Signature meaning

The signatures for the approval process of this document can be found in the verified commits at the repository for the QMS. As a reference, the team members who are expected to participate in this document and their roles in the approval process, as defined in Annex I Responsibility Matrix of the GP-001, are:

  • Author: Team members involved
  • Reviewer: JD-003, JD-004
  • Approver: JD-001
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  • Goals
    • Goals for 1st year
  • Project definition details summary
  • Summary of dates
  • JSON-only API Flow for J&J Backend
    • Data Flow for Local Severity Assessment via Legit.Health API (JSON Only)
      • Request details:
      • Response visual signs example
        • Quantification of intensity, count and extent of visible clinical signs
  • Backend Cloud Infrastructure Flow
    • Default data flow diagram
    • Possible data flow diagram (upon request and contract agreement)
  • Project tasks
    • 🧭 Definition & planning
    • 📝 Contracting
    • 🔌 Integration workflow
    • 🚀 Project Execution
    • 🔁 Follow-up Meetings (Optional)
    • ✅ Project Close
  • Project leads
All the information contained in this QMS is confidential. The recipient agrees not to transmit or reproduce the information, neither by himself nor by third parties, through whichever means, without obtaining the prior written permission of Legit.Health (AI LABS GROUP S.L.)