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QMS
  • Welcome to your QMS
  • Quality Manual
  • Procedures
  • Records
  • Legit.Health Plus Version 1.1.0.0
    • Index
    • Overview and Device Description
    • Information provided by the Manufacturer
    • Design and Manufacturing Information
      • R-TF-012-019 SOUPs
      • R-TF-012-030 Software Configuration Management Plan
      • Software Requirement Specification (SRS)
        • SRS-001: Generate Automatic PASI (APASI) severity analysis report for single zone
        • SRS-002: Generate Automatic SCORAD (ASCORAD) severity analysis report for single zone
        • SRS-003: Generate Automatic Urticaria Activity Score (AUAS) report for single zone
        • SRS-004: Generate Automatic GPPGA (AGPPGA) report for single zone
        • SRS-005: Generate Automatic IHS4 (AIHS4) report for single zone
        • SRS-006: Generate ALADIN Score report for single zone
        • SRS-007: Generate Automatic VASI (AVASI) report for single zone
        • SRS-008: Generate Automatic AWOSI report for single zone
        • SRS-009: Generate Automatic NSIL report for single zone
        • SRS-010: Generate Automatic SALT (ASALT) report for single zone
        • SRS-011: Generate Automatic EASI (AEASI) report for single zone
        • SRS-012: Orchestrate severity analysis workflow
        • SRS-013 Generate an aggregated ICD probability distribution from an image
        • SRS-014 Generate per-image ICD analysis with explainability heat map
        • SRS-015 Generate an unified report of ICD class distributions
        • SRS-016: Include model sensitivity in report
        • SRS-017: Include model specificity in report
        • SRS-018: Include entropy score in report
        • SRS-019: Include the indicator of the presence of a condition in the report
        • SRS-020: Include the indicator of the image presenting a pigmented lesion in the report
        • SRS-021: Include the indicator of malignancy in the report
        • SRS-022: Include the indicator of needing an urgent referral in the report
        • SRS-023: Include the indicator of needing a high priority referral in the report
        • SRS-024 The product checks the image quality with the Dermatological Image Quality Assessment (DIQA) algorithm
        • SRS-025 The product checks the image's clinical domain
        • SRS-026 The product classifies the image's modality
        • SRS-027 The product provides a final image validity summary
        • SRS-028: Orchestrate diagnosis support workflow
        • SRS-029: Compute 7-Point Checklist (7PC) Score
        • SRS-030: Compute Dermatology Life Quality Index (DLQI) Score
        • SRS-031: Compute PURE-4 Score
        • SRS-032: Compute Urticaria Control Test (UCT) Score
        • SRS-033: Calculate Global Acne Grading System (GAGS) Score
        • SRS-034: Calculate RESVECH Score
        • SRS-035: Calculate SCOVID Score
        • SRS-036: Calculate Physician's Global Assessment (PGA) Score
        • SRS-037: Generate Global Automatic VASI (AVASI) Score for Full Body
        • SRS-038: Secure Communication Protocol Enforcement
        • SRS-039: Network Service Exposure
        • SRS-040: URL-Based API Versioning
        • SRS-041: Concurrent API Version Support
        • SRS-042: JSON Data Interchange Format
        • SRS-044: Deterministic Response Schemas
        • SRS-045: Performance and Latency
        • SRS-046: Standard HTTP Status Code Usage
        • SRS-047: Endpoint Access Control
        • SRS-048: API Documentation Endpoint
        • SRS-049: High Availability and Load Balancing Support
        • SRS-051: API Rate Limiting
        • SRS-052: Request Body Size Limitation
        • SRS-053: Provision of Clinical Parameter Endpoints
        • SRS-054: API Health Check Endpoint
        • SRS-055: User Action Auditing
        • SRS-056: Authentication Event Auditing
        • SRS-057: Security Event Auditing
        • SRS-058: Consolidated Audit Record Content
        • SRS-059: Write-Once Audit Storage
        • SRS-060: Tamper-Evident Audit Records
        • SRS-061: Audit Tampering Detection and Logging
        • SRS-062: Secure Audit Trail Access Interface
        • SRS-063: Accurate Time Synchronization
        • SRS-064: Audit Trail Data Retention Policy
        • SRS-065: Audit System Failure Handling
        • SRS-066: System Information Endpoint Implementation
        • SRS-067: User Authentication Endpoint Implementation
        • SRS-068: Diagnostic Support Endpoint Implementation
        • SRS-069: Manual Severity Assessment Endpoint Implementation
        • SRS-070: Single-Zone Automatic Severity Assessment Endpoint Implementation
        • SRS-071: Full-Body Automatic Severity Assessment Endpoint Implementation
        • SRS-072: Device Information Endpoint Implementation
        • SRS-073: Generate FHIR DiagnosticReport Base Structure
        • SRS-074: Assign FHIR DiagnosticReport Identifier
        • SRS-075: Record Analysis Duration in FHIR Report
        • SRS-076: Encapsulate Proprietary Data
        • SRS-077: Map Aggregated Diagnostic Conclusions to FHIR
        • SRS-078: Embed Performance and Clinical Indicators in FHIR Report
        • SRS-079: Map Per-Image Analysis to FHIR
        • SRS-080: Embed Explainability Mechanisms in FHIR Report
        • SRS-081: Map Severity Assessment Scores to FHIR
        • SRS-082: Embed Detected Lesion Data in FHIR Report
        • SRS-083 Display the legal information about this medical device
        • SRS-084 Role-Based Access Control (RBAC) with Least Privilege Principle to restrict users to essential functions.
        • SRS-085 Conduct periodic access reviews to verify permissions align with job functions.
        • SRS-086 Enforce strong password policies (min. 12 characters, complexity rules, expiration policies).
        • SRS-087 Use hashed and salted passwords
        • SRS-088 Lock accounts after five failed attempts
        • SRS-089 Implement progressive delays between failed login attempts.
        • SRS-090 Generated JWTs must have an expiration date.
        • SRS-091 AES-256 encryption for data at rest
      • Product Requirement Specification (PRS)
      • R-TF-012-037 Labeling and IFU Requirements
      • deprecated
      • Usability engineering file
    • GSPR
    • Benefit-Risk Analysis and Risk Management
    • Product Verification and Validation
    • Design History File
    • Post-Market Surveillance
  • Legit.Health Plus Version 1.1.0.1
  • Licenses and accreditations
  • Applicable Standards and Regulations
  • Grants
  • Public tenders
  • Legit.Health Plus Version 1.1.0.0
  • Design and Manufacturing Information
  • Software Requirement Specification (SRS)
  • SRS-078: Embed Performance and Clinical Indicators in FHIR Report

SRS-078: Embed Performance and Clinical Indicators in FHIR Report

Identifier​

SRS-078

Software System​

  • Report Builder

Category​

  • Functional

Description​

The system shall embed overall analysis quality and clinical indicator metrics as custom objects within the DiagnosticReport.

  • The system shall create and populate the performanceIndicator object at the root level, containing metrics such as sensitivity, specificity, and entropy.
  • The system shall create and populate the clinicalIndicator object at the root level, containing metrics such as hasCondition, malignancy, and urgentReferral probabilities.

Derived from PRS​

  • PRS-5LJ: Support health data interoperability using the HL7 FHIR standard

Risks related to the SRS​

Risks that are caused by the requirement​

Risks to which the requirement is the solution (mitigation or control)​

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SRS-077: Map Aggregated Diagnostic Conclusions to FHIR
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SRS-079: Map Per-Image Analysis to FHIR
  • Identifier
  • Software System
  • Category
  • Description
  • Derived from PRS
  • Risks related to the SRS
    • Risks that are caused by the requirement
    • Risks to which the requirement is the solution (mitigation or control)
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.)