15(1) Implementing Act

Implementing Act related to EHDS Article 15(1)

Subject of this implementing act are the technical specifications for the EEHRxF.

March 2027 is the deadline for the Commission to adopt this implementing act, providing detailed rules for the regulation operationalisation.

Discussion

• The technical specifications are very likely based on the FHIR Implementation Guides created by HL7 Europe.
• Versioning. It is desirable for the EHDS board to recommend the use of a new release every 18 months or 2 years.

  HL7 Europe has created FHIR R4 as well as FHIR R5 version of the FHIR Implementation Guides. This to ensure that even if the implementing act were to identify a fixed version of the FHIR implementation guides there'd at least be a R4 and a R5 version.

  Article 15(2) allows for separate implementing acts related to updates in coding systems.

HL7 Europe has defined FHIR Data models for each of the regulated EHDS Priority Categories. These are a mix of FHIR Documents (Patient Summary, Discharge Report), FHIR Resources (MedicationRequest/Dispense), or a mix (Lab/Imaging)

• Patient Summary a FHIR Document summarizing the patient's core clinical data (~IPS). HL7 Europe Patient Summary v0.0.1-ci
• Medications: MedicationRequest and MedicationDispense Resources. HL7 Europe Medication Prescription and Dispense v0.1.0-ballot
• Lab Results: A FHIR Document wrapped around DiagnosticReport, describing a laboratory or diagnostic test. HL7 Europe Laboratory Report v0.1.1
• Imaging Results: Both imaging result reports, and an 'imaging manifest' enabling access to diagnostic quality image retrieval. HL7 Europe Imaging Study Report v0.1.0-ballot
  1. Imaging Report: A FHIR Document wrapped around DiagnosticReport representing a radiology (or other imaging specialty) result report.
  2. Imaging Manifest: An index of imaging data in a PACS. DICOM KOS Document, ImagingStudy resource, or non-document FHIR Bundle [undecided]
• Discharge Report: A FHIR Document representing a Discharge Report, describing an encounter. HL7 Europe Hospital Discharge Report v0.1.0-ballot

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