Skip to main content
QMSQMS
QMS
  • Welcome to your QMS
  • Quality Manual
  • Procedures
  • Records
  • TF_Legit.Health_Plus
    • Legit.Health Plus TF index
    • Legit.Health Plus STED
    • Legit.Health Plus description and specifications
    • R-TF-001-007 Declaration of conformity
    • GSPR
    • Clinical
    • Design and development
    • Design History File (DHF)
      • Version 1.0.0.0
        • Requirements
          • REQ_001 The user receives quantifiable data on the intensity of clinical signs
          • REQ_002 The user receives quantifiable data on the count of clinical signs
          • REQ_003 The user receives quantifiable data on the extent of clinical signs
          • REQ_004 The user receives an interpretative distribution representation of possible ICD categories represented in the pixels of the image
          • REQ_005 The user can send requests and get back the output of the device as a response in a secure, efficient and versatile manner
          • REQ_006 The data that users send and receive follows the FHIR healthcare interoperability standard
          • REQ_007 If something does not work, the API returns meaningful information about the error
          • REQ_008 Notify the user if the image does not represent a skin structure
          • REQ_009 Notify the user if the quality of the image is insufficient
          • REQ_010 The device detects if the image is of clinical or dermatoscopic modality
          • REQ_011 The user specifies the body site of the skin structure
          • REQ_012 Users can easily integrate the device into their system
          • REQ_013 The user receives the pixel coordinates of possible ICD categories
          • ignore-this
            • SWR-001- Users of the REST API can log in and receive an access token
            • SWR-002- The REST API enforces HTTPS for all communications to ensure data security
            • SWR-003- The REST API implements rate limiting to prevent abuse
            • SWR-004- The REST API verifies the access token for every request to secure endpoints
            • SWR-005- Data exchanged with clinical endpoints of the API adhere to the FHIR standard
            • SWR-006- The REST API only accepts and outputs images in Base64 format
            • SWR-007- The diagnosis support service accepts multiple images to deliver more accurate results
            • SWR-008- The user's password is stored in the database as a hashed password
            • SWR-009- New users of the device are only created by an internal user registration service
        • Test plans
        • Test runs
        • 🥣 SOUPs
    • IFU and label
    • Post-Market Surveillance
    • Quality control
    • Risk Management
  • Licenses and accreditations
  • External documentation
  • Procedures
  • Records
  • TF_Legit.Health_Plus
  • Design History File (DHF)
  • Version 1.0.0.0
  • Requirements
  • ignore-this
  • SWR-006- The REST API only accepts and outputs images in Base64 format

SWR-006- The REST API only accepts and outputs images in Base64 format

Internal IDSWR_006
TitleThe REST API only accepts and outputs images in Base64 format
CategoryINTERFACE
ImportanceHIGH
SystemREST API, Backend
Editor(s)Alejandro Carmena Magro , JD-017
SupervisorAlfonso Medela , JD-005
ApprovalPENDING
Created at21 Jun 2024

Description​

Base64 encoding converts binary image data into a text format that can be easily included in JSON payloads. The REST API endpoints must be designed to handle images only in Base64 encoded format. This approach makes sure that image data can be reliably transmitted over HTTP within JSON documents, facilitating integration and compatibility with different client systems and maintaining data integrity during transmission.

Rationale​

Encoding images in Base64 format is essential for smooth and consistent data exchange between the client and server over HTTP. This universally supported format ensures that binary image data can be safely included in JSON requests and responses, preventing data corruption. It simplifies the process of handling image data in web services and ensures compatibility with existing web standards.

Source​

This requirement arises solely from the system's need to ensure reliable and secure transmission of image data over the REST API.

Tested by software tests​

  • PLAN_011: Base64 encoded images are accepted and returned
  • PLAN_012: Non-Base64 encoded images are rejected

Activities generated​

  • Implement encoding and decoding functionalities in the server-side code.
  • Implement encoding and decoding functionalities in client applications within the medical device.
  • Update the API documentation to specify the requirement for Base64 encoded images.

Implements user needs​

This requirement ensures that users can reliably transmit image data for analysis and receive results without issues related to data corruption or incompatibility.

Causes failure modes​

  • Incorrectly encoded images leading to API errors.
  • Increased payload size due to Base64 encoding.
  • Misinterpretation of image data if encoding/decoding processes fail.

Implements risk control measures​

  • Binary image data is reliably transmitted within JSON payloads, reducing the risk of data corruption during transmission.
  • Standardizing on a universally supported encoding format guarantees compatibility with many client systems, reducing integration issues and the likelihood of interface errors.
  • Base64 encoding can provide an extra layer of protection for binary data, making it less vulnerable to easy interception or tampering during transmission.

Acceptance criteria​

  • The API clinical endpoints accept and correctly process Base64 encoded images in requests.
  • The API clinical endpoints return Base64 encoded images in responses.
  • No data corruption or errors occur during the transmission of Base64 encoded images.

Constraints​

No specific constraints apply for this requirement.

Dependencies​

This requirement depends on the availability of libraries or functions in the client and server environments to handle Base64 encoding and decoding.

Performance considerations​

Base64 encoding increases the size of the image data by approximately 33%. The larger data size from this encoding can affect API performance, especially with big images. To avoid any issues, it's important to use efficient handling and optimization strategies.

Additional notes​

Ensure that any documentation or training materials provided to users include clear instructions on how to encode/decode images in Base64 format.

Revision history​

Document versionDateAuthorDescription
Previous
SWR-005- Data exchanged with clinical endpoints of the API adhere to the FHIR standard
Next
SWR-007- The diagnosis support service accepts multiple images to deliver more accurate results
  • Description
  • Rationale
  • Source
  • Tested by software tests
  • Activities generated
  • Implements user needs
  • Causes failure modes
  • Implements risk control measures
  • Acceptance criteria
  • Constraints
  • Dependencies
  • Performance considerations
  • Additional notes
  • Revision history
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.)