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Wave 3 - Package 2 - Operation Ready - Release  Details [W3-Pkg2-OR]



Last update:  Oct 14, 2019 15:16

Last update details: Test Framework 2.0.0.RC2 ( ) and OpenNCP 4.0.1 - Wave 3 HotFix released on  )

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The current release includes:

  • The missing artefacts for Wave 3 (artefacts included in the Wave 3 Package 1)
  • The release notes contain only the artefacts included in Pkg2 (in a normal release, all artefacts are included and the ones that not received any update, are described as such).


  • Taking in consideration the reduced number of artefacts (when compared to a normal release), we proposed a 2 week feedback cycle (from  to  )


Even if there was no official extension of the feedback cycle, the Solution Provider team considered all received feedback from the eHDSI stakeholders, including feedback coming after . All requests for feedback or clarifications will be addressed with the respective stakeholders in due time before the eHMSEG meeting.


  • After conclusion of feedback cycle (2 weeks) and consolidation period (1 week), the artefacts will be submitted  (by ) for eHMSEG adoption  .
    • All NCPeHs in routine operation must comply with these artefacts by July 2020.
    • The Frameworks (Operations, Test, Audit, Monitoring) are applicable immediate in the moment of adoption (e.g. Test Framework is applicable for October test event)



Wave 3 - Package 2 - Operation Ready Release


Operation Ready Release (OR)


  • Requirements Catalogues (V3.0.1)

  • Interoperability Specifications (V3.1.0)

  • CDA Implementation Guides (V3.0.0)
  • NCPeH Reference Implementation (4.0.1)
  • Audit Framework (2.0.0) - Audit Checklist (V2.0.0)

  • Test framework (V2.0.0)
  • Monitoring Framework (V2.1.0)

  • Operations Framework (V2.0.0.RC2)
  • Communication Services (2.0.0)
  • eHDSI Guidelines (CDA Display Tool 1.0.0)

3rd release cycle for eHDSI Artefacts

  • This is the 2nd package of Wave 3 artefacts.
  • This 2nd pkg complements the artefacts missing in the 1st package (adopted by eHMSEG on ).


RequirementsCatalogue (Normative)3.0.1
  • The GDPR impact analysis on eHDSI Central Services must be reviewed with the SANTE DPC and eHDSI Owner.

Interoperability Specifications
Specifications (Normative)


CDA Implementation Guides Specifications (Normative)3.0.0

The 3.0.0 contains all the functionality planned for Wave 3.

Next step is to include the release in the IHE Gazelle EVS client validator. Once we are confident and quality assurance has been applied on the release, we will release the official version to be used in the upcoming test events.

NCPeH TG Reference Implementation (a.k.a. OpenNCP)

Software (optional)

  • Open Source Reference Implementation
  • Deployed by each MS or participating nation


Audit Framework

  • Readiness Checklist
Framework (Normative)2.0.0

eHMSEG adoption expected at a later date, in written procedure.

  • Audit Checklist

    • Improve Readiness Criteria description and guidelines
    • Link between criteria and source Requirement
    • Provide rationale for risk assessment to each
  • Incorporation of Operational Audit provisions (agreed during 16 May eHMSEG)

Test Framework

Framework (Normative)2.0.0

Release Notes

  • Detailed change log available at: 
  • Issues addressed:
      • Production Environment findings lack of FOLLOW UP provisions 
      • Production environment testing lack of provisions for upgrade only situations
      • Insufficient number of partners and Selection of Test Partners
      • Production Environment access and Start Routine Operations
      • Exponential work load (NCPeHs and Test Monitors)
      • Complexity of UPGRADING test event and number of events
      • Lack of National Representative Test Data
      • Pre-Production not connected to National infrastructure & Production Env. not Mirroring Pre-Production & FAIL or PASS expectations
      • Test Findings lack of traceability
  • eHDSI Testing Platform (1.2.0) - to be updated to consider CP-023 (new HP roles)
  • Detailed test cases for each type of document (PS, eP and eD)
  • Review of the specific questions in the Evaluation Form (functional End-2-End testing) related to Patient Consent

Monitoring Framework

Framework (Normative)


Release Notes

  • Update of the Monitoring Framework
    • Renamed Chapter 4 to: ''Data Collection, Processing, Reporting and Publication''.
    • Added small clarifications to the NCPeH KPIs (AP5). For KPI-1.2, also replaced ''interactions'' with ''transactions''.
    • Added Country of affiliation to ''Country A'' and Country of treatment to ''Country B''.
    • Separated Chapter 4.2 (Processing of data) from 4.3 (Reporting).
    • Added info in Chapter 4.2 about the data templates to be provided as Annex 1 to the eHDSI Monitoring Framework.
  • Defined Annex: Template for raw data reporting (non-normative)

Operations Framework

Framework (Normative)2.0.0.RC2
Release Notes
  • eHDSI Knowledge Base
  • eHDSI Access Management
  • eHDSI GoLive Workflows - diagrams and explanations
    • eHDSI Global View
    • eHDSI Test Workflow
    • eHDSI Audit Workflow
  • Consultancy visit scope and procedure

eHMSEG adoption expected at a later date, in written procedure.

Proposal for:

  • [UPDATE] Risk Management (further details in methodology application within eHDSI)
  • [UPDATE] Event, Incident, Problem, Access, Configuration Management (further details in methodology application within eHDSI)
  • [NEW] Deployment Guidelines - new approach considering the existing documentation
  • [NEW] Availability Management (within Service Operations Functions)


Collaboration Services

Guidelines (optional)2.0.0
  • Editing area is currently not supported by the tool.
    • The editing workflow supporting tools is open for each NCPeH to choose the most convenient methodology (e.g. word documents, NCPeH internal wiki, sharepoint)
    • For the 2nd version of this tool, if agreement is made on a common EDIT AREA, there are several possibilities (already explored) on how to achieve it.
eHDSI GuidelinesGuidelines (optional)--

CDA Display Tool 1.0.0

  • Updates:
    • Incorporate W3 guidelines on the presentation of no information/known absence for the required sections.
    • Alerts section: info on displaying Severity information
    • Vaccinations section: info on displaying Administered information
[NEW] eHDSI Guidelines on the use of OIDs
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