Structure of a CDA R2 Report injected into a PDF according to the HL7 Italia Guidelines

In the context of Italian healthcare interoperability, the clinical report must be represented in a structured and interoperable manner. For this purpose, the HL7 CDA Release 2 standard is used, adopted nationally in the specifications published by HL7 Italia.
In Italian implementations, especially for documents intended for the Electronic Health Record (EHR), it is common to use a PDF containing the readable human report, into which the CDA document structured in XML is injected. This approach allows you to combine:

1. readability for the doctor and patient
2. interoperability for healthcare information systems

The technical structure of this document is shown below.

Concept of CDA R2 with PDF representation

The CDA document is a structured XML file that represents a clinical document.
In the model adopted in Italy:

1. the PDF contains the readable report
2. the CDA XML contains the semantic structure of the document
3. the CDA is inserted as an attachment in the PDF

In practice, the document becomes a PDF with a structured payload.
This approach is envisaged in the guidelines for documents intended for the Electronic Health Record (EHR)