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Current eHDSI Change Management procedure and Change Proposal Form Template adopted by eHMSEG on the . New version of the template endorsed by eHOMB on .

Last update of this page:  Apr 25, 2019 15:29

Goal of the current page


The purpose of this page is to describe the Change Proposal (CP) Management procedure used within eHDSI in order to assess and approve the integration of the change requests which can impact the policy, technical and/or operational activities of eHDSI.

Procedure Scope


The CP Management procedure applies to changes requested to the normative eHDSI artefacts (Requirements, Specifications and/or Frameworks). 

  • These changes can be the consequence of new requirements, use of new building block, use of new technology etc.

The requested changes must be consolidated within a group of interest (Task Force, Cluster, Work group), before being submitted as a CP to the eHDSI Change Manager.

The CPs can have a policy, technical or operational impact on the eHDSI activities. The impact is analyzed during the assessments performed for each CP, by the eHDSI Owner and Co-owner, eHMSEG and eHDSI Solution Provider.


Functional Mailbox

Submit your Change Proposals for eHDSI at the following e-mail address:

SANTE-EHEALTH-DSI@ec.europa.eu

Current Procedure and CP Form Template

ProcedureCP Form Template

eHDSI Change Proposals Registry

Check the status of all the change proposals within eHDSI, by using the updated CP Registry:

view eHDSI Change Proposals Registry



Actors Description




ACTOR

DESCRIPTION[1]

1

Requester

The requester is the initiator of the change request, who submits the CP to the eHDSI Change Manager. The requester should be a member of the eHDSI Governance bodies, including Clusters and Task Force members. The requester shall only submit CPs which are consolidated by a group of interest (Task Force, Cluster, Work group).

Contact Point: the email address of the requester

2

eHDSI Change Manager

The eHDSI Change Manager is a person coming from the eHOMB who manages the CPs.

Contact Point: SANTE-EHEALTH-DSI@ec.europa.eu

3

eHDSI Solution Provider

The eHDSI Solution Provider is the European Commission, DG SANTE Unit A4. The eHDSI Solution Provider is responsible for building eHDSI specific software and services, providing core services. eHDSI Solution Provider advises and assists Member States on setting up their generic services.

Contact Point: SANTE-EHEALTH-DSI@ec.europa.eu

4

eHDSI Owner and

Co-owner

The eHDSI Owner and Co-owner ensure the liaison between the various Commission services and the eHealth Network.

Contact Point: SANTE-EHDSI-SECRETARIAT@ec.europa.eu

5

Stakeholders


The Stakeholders includes the eHMSEG, the Communities (e.g., OpenNCP Community) and SDO (Standards Development Organization like IHE, HL7, LOINC etc.). By their expertise in different domains, the stakeholders can provide advice.

Contact Point: eHMSEG (via eHMSEG Chairs), Semantic Community (SANTE-EHDSI-SEMANTIC@ec.europa.eu),
Technical Community (SANTE-EHDSI-TECHNICAL@ec.europa.eu), SDO (to be determined)

6

eHOMB


The eHealth Operational Management Board (eHOMB) is composed of: eHDSI Owner and Co-owner, eHDSI Solution Provider, Core Building Blocks Solution Provider and eHMSEG Chairs. Its main functions are: to oversee the provision of service, make tactical and operational decisions about the eHDSI, and coordinate with other DSIs; to oversee the building of core elements and maintain the close links to Countries and NCPeH. It reports to the eHealth Network and is assisted by the eHDSI Member State Expert Group.

Contact Point: via eHDSI Solution Provider (SANTE-EHEALTH-DSI@ec.europa.eu)

7

eHMSEG

The eHealth Member States Expert Group (eHMSEG) is a group representing the participating Member States. eHMSEG coordinates the technical and organisational implementation of the NCPeH to ensure that they are fully interoperable. It gives advice to the eHealth Network and eHOMB on core elements and provides a link to building of the national elements. It is composed of project managers responsible for implementing the NCPeH, nominated by the participating Member States.

In the context of the Change Management Procedure, it performs the legal, organizational, business/functional, semantic and technical Impact Assessment, at the National level of each participating Member State.

Contact Point: via eHMSEG Chairs

[1]Source: eHealth Network: Governance model for the eHDSI during the CEF funding - https://ec.europa.eu/cefdigital/wiki/x/z0QZAg



Workflow


The following picture illustrates the CP Management process applicable for all the change requests initiated by the eHDSI stakeholders.

eHDSI Change Management Workflow




Procedure Description



#

STEP

ACTOR

DESCRIPTION

STATUS

DURATION

1Prepare CP DraftRequester

The Requester prepares a draft CP and shares it for review and discussions with the relevant eHDSI work group/s (communities). The relevant eHDSI work groups are considered those who have the highest level of expertise on the topic of the draft CP. It is not necessary to involve all the eHDSI work groups, at this step.

  • The draft CP should be sent to the leader of the relevant eHDSI work group/s, in order to be added on the agenda of the next meeting/s of that work group.
  • The leader/s of the eHDSI work group/s should consolidate the input received at each group level and send it to the Requester.
  • The Requester will further consolidate the input received from each eHDSI work group leader.

This is a preliminary/preparatory step (before the CP is submitted), to ensure the completeness and accuracy of the content of the draft CP.

DraftAs long as the Requester decides
2

Generate CP

Requester

The Requester generates a new CP by filling in the CP Form template and sends it to the eHDSI Change Manager. Requester should provide an explanation and clarification of the CP and provide information on the implications and relation to other CPs, where applicable.

New

As long as the Requester needs to prepare it

3

Register CP

eHDSI Change Manager

The eHDSI Change Manager registers the CP, assigns it an identifier and makes it publicly available (registration in the CP Registry).

  • The Change Manager should make sure that the CP is granular enough to avoid partial decision voting further in the process. The Change Manager will be able to send the CP back to the Requester and recommend modifications, in order to make the CP more granular.

In Registration

1 week

4Distribute CP

eHDSI Change Manager,

eHMSEG Chairs

  • The eHDSI Change Manager sends the registered CP to the eHDSI Solution Provider, eHDSI Owner and eHMSEG Chairs.
  • The eHMSEG Chairs send the CP to eHMSEG (all Member States) for impact assessment and provide additional related information, where needed (e-mail, X-Border tcon).

If needed, the eHDSI Change Manager also organizes a monthly meeting opened to the eHDSI Stakeholder to present the progress in the CPs.

Under Distribution

2 days

(1 day for eHDSI Change Manager and 1 day for eHMSEG Chairs)

5

Assess CP Impact by eHDSI Solution Provider

eHDSI Solution Provider (SANTE A4)

The eHDSI Solution Provider (SANTE A4) assesses the impact of the CP, from Technical point of view. The impact assessment will indicate:

  • If additional advice is requested from different expert groups.
  • The position in favor, against or abstention regarding the CP implementation.
  • The recommended actions.

Technical impact of a CP refers to the following eHDSI changes:

  • Solution Requirements
  • Specifications
  • Frameworks

The eHDSI Solution Provider will participate to the monthly CPs Status Report meeting.

Under Assessment







2 weeks



6

Assess CP Impact by eHDSI Owner

eHDSI Owner (SANTE B3), by consulting eHDSI co-Owner and/or other DGs

The eHDSI Owner (SANTE B3) together with eHDSI co-Owner (CNECT H3) assess the impact of the CP, from Policy point of view. The impact assessment will indicate:

  • If additional advice is requested from different expert groups.
  • The position in favor, against or abstention regarding the CP implementation.
  • The recommended actions.

Policy impact of a CP refers to the following changes:

  • eHDSI Business requirements
  • eHealth Network Guidelines
  • Legislation - EU treaties, regulations, directives and/or decisions
  • Policy strategies

The eHDSI Owner will participate to the monthly CPs Status Report meeting.

Under Assessment

7

Assess CP Impact by eHMSEG

eHMSEG

Member States assess the impact of the CP at National level, from all points of view: legal, organizational, business/functional, semantic and technical where needed.

The impact assessment will indicate:

  • The position in favor, against or abstention regarding the CP implementation.
  • The recommended actions.

If needed, the Member States shall request to eHMSEG Chairs for extension of the impact assessment period.

All Member States shall submit their impact assessment to the eHDSI Change Manager, also in the case when they have no specific review remarks.

eHMSEG may participate in the monthly CPs Status Report meeting.

Under Assessment

8Merge InputseHDSI Change Manager

The eHDSI Change Manager merges the different inputs, before transmitting them to the eHOMB, the Requester and the Assessors.

If needed, the eHDSI Change Manager organizes consultations to allow the Assessors, the Stakeholders and the Requester to clarify the possible points that are still not clear.

In Consolidation

1 week

9

Prepare Consultations (if needed)

eHDSI Change Manager (eHOMB)

The eHDSI Change Manager receives the Impact Assessments and performs consultations of the stakeholders, if needed, to clarify the possible points that are not clear.

  • During this step, the CP content must not be changed. The purpose of the consultations is to bring clarifications to the content.
  • The stakeholders might change their positions if following the consultations, their opinion changed. If this is the case, the eHDSI Change Manager will update the merged inputs accordingly.

In Consultation

1 week

10Provide Clarifications (if needed)
RequesterThe Requester provides clarifications and additional information if assessors raise questions which cannot be answered by the eHDSI Change Manager.1 week
11

Provide Advice (if needed)

eHDSI Communities

Based on the comments of the Impact Assessments, the eHDSI Change Manager solicits the stakeholders to provide advice on the CP.

1 week

12

Share the outcome of the consultations with eHMSEG (if applicable)

eHDSI Change Manager

At the end of the consultations, the eHDSI Change Manager shares their result with the eHMSEG Chairs, who will further share them with eHMSEG.

For Information

2 days

(1 day for eHDSI Change Manager and 1 day for eHMSEG Chairs)

13

Decide on CP

eHOMB

The eHOMB shall be responsible for adopting decisions on the acceptance of a CP, on the basis of:

1) the eHMSEG position, presented/expressed by the eHMSEG Chair, adopted by simple majority of eHMSEG members in accordance with the eHMSEG rules of procedure; and of
2) the position of Commission’s services represented within eHOMB1, presented by the eHOMB Chair; the position of Commission services shall be exclusively based on the assessment of compliance of the change proposal with CEF funding rules and with other applicable EU rules, as well as on the assessment of its technical feasibility and viability; the Commission services shall not support any changes not complying with such rules and criteria.

The eHOMB shall adopt its decision by agreement of the eHOMB Chair and eHMSEG Chair.

Without prejudice to the Regulation (EU) No 283/20142, in case of disagreement between the eHMSEG Chair and the eHOMB Chair, they shall endeavour in good faith to find an agreement, failing which the proposal shall not be adopted.

1 These are: the Solution Provider (DG SANTE), the DSI Owner (DG SANTE) and Co-owner (DG CNECT), the Core Building Block Solution Provider in matters related to core building blocks (DG DIGIT).

2 REGULATION (EU) No 283/2014 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 11 March 2014 on guidelines for trans-European networks in the area of telecommunications infrastructure and repealing Decision No 1336/97/EC

For Approval

2 weeks

14

Publish CP

eHDSI Change Manager

The eHDSI Change Manager updates the status of the CP and publishes the final CP version.

For Publishing

1 week

15

Perform Changes

eHDSI Solution Provider (SANTE A4)

  • If the CP is accepted, the eHDSI Solution Provider performs the change of the normative eHDSI artefacts impacted by the CP. If eHOMB does not decide otherwise, the changes are only performed and applicable to the version of the artefacts for next waves (coming after the CP was approved).
  • If the CP is rejected, the CP is not integrated into the normative eHDSI artefacts and the procedure is closed.

Closed

--


 



TOTAL (Steps 3 - 15)

(default time)

Minimum: 7 weeks and 2 days;

Maximum: 10 weeks and 4 days.




Timescale


eHDSI Change Management Timeline




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