Regulatory Correspondence, published by Gravitate Health and HL7 Vulcan. This guide is not an authorized publication; it is the continuous build for version 0.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/cander2/rfi-ig/ and changes regularly. See the Directory of published versions

Request for Information

Core Resources

• Communication: RFI metadata (issuer, recipient, application).
• Questionnaire: Questions with rich text (Markdown) and images (Attachment).
• QuestionnaireResponse: Responses with text and images.
• Bundle: Packages RFI/response resources.

RFI Structure

• Bundle (type: collection):
  • Contains Communication, Questionnaire.
• Communication:
  • status: active (issued).
  • sender: Organization (e.g., FDA).
  • recipient: Organization/Practitioner (MAH).
  • topic: RegulatedAuthorization.
  • payload: References Questionnaire.
  • Extensions: rfi-due-date, rfi-priority.
• Questionnaire:
  • item.text: Markdown.
  • item.type: group (mixed content), display (text), attachment (images).
  • item.code: ValueSet-rfi-category-subcategory.
  • Extension: rfi-question-id.

Response Structure

• Bundle (type: collection):
  • Contains QuestionnaireResponse.
• QuestionnaireResponse:
  • questionnaire: Links to Questionnaire.
  • item.answer: valueString (Markdown), valueAttachment (images).