German (DEU) electronic Product Information Leaflet (ePIL) Implementation Guide - Local Development build (v0.7.0) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions

eCAPI Output Delivery

This page documents the eCAPI (electronic Consumer API) output behavior and the differences to the eAAPI input profiles.

Output Document Depth

The eCAPI delivers ePIL documents in depth 2 or depth 3. The consumer cannot control or request a specific depth — the system delivers the document as it is stored. Consumers must be prepared to handle both variants.

Depth 2 — Chapters with content only:

QRD Root (200000029894)
├── Chapter 1 (title + text)
├── Chapter 2 (title + text)
├── Chapter 3 (title + text)
├── Chapter 4 (title + text)
├── Chapter 5 (title + text)
└── Chapter 6 (title + text)

Depth 3 — Chapters with subsections:

QRD Root (200000029894)
├── Chapter 1 (title + text)
│   └── Subsections...
├── Chapter 2 (title + text)
│   ├── Do not take/use X
│   ├── Warnings and precautions
│   ├── ...
│   └── X contains {excipient}
├── ...

A single document may contain a mix — some chapters at depth 2 (text only), others at depth 3 (with subsections). Consumers should not assume uniform depth across all chapters.

Depth Integrity Per Chapter

Each individual chapter is delivered as either depth 2 or depth 3 — never a mix of both. When a chapter is delivered at depth 2, its text element contains the complete content (all subsection content is merged into the chapter text). The content is not missing — it is simply not split into subsections. When a chapter is delivered at depth 3, the subsections carry the detailed content and the chapter's own text element alone does not contain the full content.

Relaxed Subsection Cardinality

In the eAAPI input profiles, certain subsections are mandatory (1..1) per the QRD template. In the eCAPI output profiles, all subsections are optional (0..1). The chapters themselves (1-6) remain required.

Change Detection (eCAPI only)

Change detection is exclusively available in eCAPI output documents and is not present in eAAPI input documents.

When a document replaces a previous version, the eCAPI output may include:

• DEU-ePIL-Section-Change extension (0..1) on sections at any level — valueBoolean = true indicates the section content has changed compared to the previous version
• relatesTo with type replaces — references the previous version with a publicationDate in YYYY-MM format

A bidirectional invariant ensures consistency: if any section has the change extension set to true, a relatesTo[replaces] entry must be present, and vice versa.

For details on change detection, see Chapter Change Marking.

Consumer Implementation Notes

• Always check whether subsections are present before rendering — do not assume depth 3
• Depth 2 chapters: The chapter's text element contains the complete content (subsection content is merged in). Render it directly — nothing is missing.
• Depth 3 chapters: The chapter's text element alone is not sufficient. Consumers must either:
  • Render all subsections individually (e.g., as collapsible sections), or
  • Aggregate subsection text into the parent chapter for a flat display
• A chapter is always entirely depth 2 or entirely depth 3 — subsection content is never partially in the chapter text and partially in subsections
• Change detection extensions are informational — consumers may use them to highlight updated content but are not required to do so
• The Localized Sections root section is optional and may or may not be present in the output