General

The API for adverse incident reporting consists of one endpoint for each reporting area and one endpoint for combined reporting. In combined reporting, one report may contain reporting for multiple report areas.

Each report contains a header part and a report part. The header contains generic information and is very similar between report areas. The report part is specific to each report area.

API payload data is on the JSON format and has the following structure:

• Header
  • ExternalCaseId (Unique report id in the client system)
  • Reporter (Information about the reporter)
  • Patient (Information about the patient, where applicable)
  • Incident (Information about the incident)
• Report
  • The report itself, with all details

Documentation

Detailed documentation for the different endpoints are mainly found in the Swagger generated documentation. Below is a list of endpoint documentation files.

• Serious incident
• Biovigilance
• Cosmetics
• Dietary supplements
• Drug side effects
• Medical equipment
• Adverse indicent (combined reporting)

Authentication

Clients must be authenticated by HelseId in order to call the API.

Authorization

Reporting may take place when the following criteria is met:

• The client id must be registered in the Melde system
• The access token must contain a valid scope, allowing access to the reporting service

Test client

A test client has been made to make it easier to get started developing API clients. Can be found on GitHub

You will need a JSON web key (JWK) to use the test client. Please contact the Melde team to obtain a key.