Skip to main content
QMSQMS
QMS
  • Welcome to your QMS
  • Quality Manual
  • Procedures
  • Records
    • GP-001 Documents and records control
    • GP-002 Quality planning
    • GP-003 Audits
    • GP-004 Vigilance system
    • GP-005 HR and training
    • GP-007 Post-market surveillance
    • GP-009 Sales
      • R-009-001 Implementation plans
        • 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
    • GP-010 Suppliers
    • GP-012 Design, Redesign and Development
    • GP-018 Infrastructure and facilities
    • GP-019 Software validation
    • GP-023 Change control management
    • GP-050 Data Protection
    • GP-051 Security violations
    • GP-052 Data Privacy Impact Assessment (DPIA)
    • GP-200 Remote Data Acquisition in Clinical Investigations
  • Legit.Health Plus Version 1.1.0.0
  • Legit.Health Plus Version 1.1.0.1
  • Licenses and accreditations
  • External documentation
  • Records
  • GP-009 Sales
  • R-009-001 Implementation plans
  • R-009-001 US J&J 20250612

R-009-001 US J&J 20250612

  • Deal Id: 37180301935

Goals​

Goals for the 1st year​

The customer implements Legit.Health's medical device to achieve the following goal(s):

GoalMetricTarget
Ensure the reliable delivery, support, and integration of Legit.Health’s APASI (local) severity assessment algorithm via secure APIs to power patient-led disease tracking in the Aptar-developed J&J Psoriasis support patient app.Integration100%
J&J provides dermatological services to Psoriasis patientsPatients9,000
Patient submits 1 photo of a given body area every per week: 9,000 patients x 1 photo per week (=1 body area) x 4 weeks = at least 36,000 diagnostic reports per monthDiagnostic reports / month36,000

License terms and usage specifications​

  • Validity: One year or TBD uses/reports.
  • License Extension: In case a higher number of uses is needed due to increased demand, the possibility to extend the license will be available.

Project timeline and milestones​

To achieve the goals, the parties agree on the following timeline.

Q&A to understand the Customer's Objective​

Project Scope & objectives​

QuestionExpected Answer / InstructionsCustomer's Answer
What is the primary objective of this project?e.g.,
[X] Quality control of images received in teledermatology
[ ] Support for Primary Care diagnosis
[ ] Support for Dermatology diagnosis
[X] Support for HCP in automatic severity measurement
[X] Support for patients in automatic severity measurement
[ ] Appropriateness of referrals
[ ] Clinical validation
[ ] Improve diagnosis
[ ] HCP satisfaction
[ ] Operational efficiency
[ ] Other
Do you want your users to interact with Legit.Health’s solution through your own software?[X] Yes
[ ] No
[ ] Not sure yet
Which features do you need?
(you can select multiple)
[X] Image quality analysis
[ ] Diagnostic support
[X] Automatic severity assessment
[ ] Other
Which conditions/pathologies are you interested in evaluating?List of dermatological conditions relevant to your project
e.g.,
[ ] Inflammatory Diseases
[ ] Infectious Diseases
[ ] Autoimmune Diseases
[ ] Genodermatoses
[ ] Vascular Diseases
[ ] All
[ ] All but with focus on x, y, z.
Psoriasis
Which languages do you need the solution to support?EnglishEN
Do you already have a project definition?[ ] Yes
[ ] No
[X] In progress

Technical Setup & Integration​

QuestionExpected Answer / InstructionsCustomer's Answer
What type of integration do you need?
(you can select multiple)
[X] I will send images programmatically and need results in JSON format
[ ] I need a UI for uploading images
[ ] I need a UI to display results
[ ] Sync with internal database
Do you plan to integrate Legit.Health into your own software platform?[X] Yes
[ ] No
[ ] Other
Who will upload the images to Legit.Health?[ ] Healthcare professional
[X] Patient
[ ] Both
[ ] Other
How would you like to receive the Legit.Health results?[X] JSON
[ ] PDF
[ ] Web interface
[ ] Other
Who will access to the Legit.Health results?[ ] Healthcare professional
[X] Other (Patient)

Timeline & Users​

QuestionExpected Answer / InstructionsCustomer's Answer
When would you like to start the integration and go live?Estimated date (YYYY-MM-DD)Service deployment date: 2026-03
Estimated duration of the projectIn months or years1 year
How many dermatologists will use the solution?Estimated numberN/A
How many primary care physicians will use the solution?Estimated numberN/A
How many patients do you estimate will use the solution?Estimated number1st year: 9,000
3rd Year: up to 91,000
Number of medical centers involvedEstimated numberN/A
Estimated number of diagnostic reports per monthApproximate volumeAssumption is 1 photo of a given body area every per week: 9,000 patients x 1 photo per week (=1 body area) x 4 weeks = at least 36,000 diagnostic reports per month

Comments & Open Questions​

QuestionExpected Answer / InstructionsCustomer's Answer
Do you foresee any challenges we should be aware of?e.g., Internal resources, approvals, data access
General comments or questionsOpen field

Customer's Objective Summary​

  • Primary Objective: APASI Local severity assessment for Psoriasis in the J&J patient app
  • Integration Type: JSON Only API integration (/severity-assessment endpoint)
  • Features Needed: Image quality analysis, Automatic severity assessment (APASI Local)
  • Conditions of Interest: e.g., Inflammatory Diseases, Infectious Diseases
  • Languages Supported: English
  • Project Definition: TBD
  • Integration Needs: Yes
  • Timeline: Service deployment date: 2026-03
  • Other comments: Surface Area Input: Manual by patient, not automated or percentage-based.

Project tasks​

🧭 Definition & planning​

TaskDescriptionResponsibleStatus
Project conception and initiationInitial ideation and opportunity scoping with all key stakeholders.Deal Owner, JD-013✅ Completed
Definition and planningDefine project details: scope, key deliverables, timelines, success metrics, and required resources.Deal Owner, JD-013⏳ Pending
Implementation plan definedProject scope, key deliverables, timelines, success metrics, and required resources are defined and clearDeal Owner & JD-003 or JD-013 or JD-007⏳ Pending

📝 Contracting​

TaskDescriptionResponsibleStatus
Offer SentFormal offer/proposal shared with the customer for review.Deal Owner, JD-002⏳ Pending
Offer ApprovedCustomer reviews and approves the proposed scope, terms, and pricing.⏳ Pending
Contract ReviewAlign on deliverables, timelines, legal and data terms.⏳ Pending
Contract SigningFinalize and sign all contractual agreements.⏳ Pending

🔌 Integration workflow​

TaskDescriptionTimelineStatusDependencies
Technical onboardingProvide comprehensive API documentation, technical walkthroughs, and UI/UX guidance for both patient and HCP views.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 UI mockups for surface input, scoring feedback, and reports.TBD⏳ Pending
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
Launch Readiness & Go/No-GoFinal checklist review, rollback plan, support contact escalation paths, and stakeholder sign-off.TBD⏳ PendingOptional, depending on work order
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 stakeholders (e.g., medical teams, patients, HCPs) on the app and scoring system.JD-021, JD-016⏳ Pending
Customer Support EnablementSetup and activate helpdesk or in-app support systems.JD-021, JD-016⏳ Pending
Data AnalysisPerform statistical and clinical analysis on severity scores and patient usage.JD-021, JD-016, JD-014⏳ 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-019, JD-021Sales Manager, Business Development Manager, Account Manager
Legit.HealthJD-003, JD-013Design and Development Manager, Project 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
Legit.HealthJD-016Customer Success Manager
Legit.HealthJD-021Account Manager
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

Last updated: 2025-06-11

Previous
R-009-001 US Johnson & Johnson 20250505
Next
GP-010 Suppliers
  • Goals
    • Goals for the 1st year
  • License terms and usage specifications
  • Project timeline and milestones
  • Q&A to understand the Customer's Objective
    • Project Scope & objectives
    • Technical Setup & Integration
    • Timeline & Users
    • Comments & Open Questions
  • Customer's Objective Summary
  • 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.)