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eStandards Report Summary

Project ID: 643889
Funded under: H2020-EU.3.1.

Periodic Reporting for period 1 - eStandards (eHealth Standards and Profiles in Action for Europe and Beyond)

Reporting period: 2015-05-01 to 2016-04-30

Summary of the context and overall objectives of the project

"The eStandards Coordination and Support Action has been proposed by HL7, CEN/TC 251, & IHE, lead-ing Standards Organizations (SDOs), and is supported by the eHealth Network, ISO/TC 215, GS1, IHTSDO, IEEE11073, and IMIA to advance eHealth interoperability and global alignment of standards by:
• Joining up with Stakeholders in Europe and globally to build consensus on eHealth standards, accelerate knowledge-sharing, and promote wide adoption of standards;
• Delivering an evidence-based Roadmap for alignment, iterative consolidation, and broad ac-ceptance of eStandards that is endorsed by SDOs, the eHealth Network, the providers, and the Industry;
• Contributing to the eHealth Interoperability Framework use cases focusing on clinical content modelling for different paradigms and embed a Quality Management System for interoperabil-ity testing and certification of eHealth systems;
• Collecting evidence and provide guidance on the coexistence of competing or overlapping standards in large-scale eHealth deployment nationally and cross-border;
• Participating in EU/US MoU roadmap actions as the international patient summaries standard;
• Exploring socio-economic aspects of eHealth interoperability, revisiting the language for user-vendor interaction that embodies ‘co-making’ in trust, collaboration and long-term engage-ment;
• Aligning across PHC-34 to nurture innovation, sustainability and growth under CEF and beyond contributing to Key actions of the Digital Agenda 2020.

The concrete measurable objectives of the project supported by individual WPs are as follows:
• Objective #1: SDOs joining up with eHealth stakeholders to build consensus on eHealth stand-ards
• Objective #2: Roadmap for alignment, iterative consolidation, and broad adoption of eStand-ards
• Objective #3: Contribute to the eEIF by resolving ambiguities & embedding quality manage-ment
• Objective #4: Support Large-Scale eHealth Deployment: regional, national, and cross-border
• Objective #5: Support Global Cooperation (EU/US MoU) & wide adoption of eHealth standards
• Objective #6: Explore the socio-economic aspects of eHealth Standards
• Objective #7: Align across PHC-34 to deliver a EU value proposition for sustainability & growth

The project’s ambition is to strengthen Europe’s voice and impact, while reinforcing the bridges estab-lished with the EU Patient Summary guideline across the Atlantic in Trillium Bridge and among member states with epSOS, e-SENS, Antilope, and EXPAND. The eStandards Roadmap and associated evidence base, a white paper on the need for formal standards, and two guidelines addressing how to work with: (a) clinical content in profiles and (b) competing standards in large-scale eHealth deployments will be pragmatic steps toward alignment and convergence."

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

"The eStandards project objectives during the first year of the project were achieved, planned delivera-bles were submitted, and milestones reached. An agile project management approach facilitated coor-dination with the PHC34 projects, JAseHN and the eHealth Network, maximizing the value for money of the project funding. Figure 1, provides an overview of the activities in eStandards during the first year and the specific contribution of Work packages and associated deliverables to the first iteration of the eStandards roadmap for essential standards development: strategic options and policy instruments (D3.3). Two eStandards deliverables i.e. the case for formal standardization (D3.1) and recommended areas for essential standards development together with associated strategic options and policy in-struments (D3.3 executive summary) were delivered to the EHN, and reflect cooperative work with JAseHN in the context of the European Standards Platform. To maximize the impact of the project, the 1st eStandards conference moved from M3 to M11 and focused workshops in MedInfo2015 (the lead-ing bi-annual medical informatics event) and a roadmap writing workshop were introduced.

The following sections provide a summary of the progress achieved towards the project objectives, justifying the differences between work expected under Annex I and work actually performed, if any for each of the project WPs.

WP2: Quality in Interoperability – contribution to the EU eHealth In-teroperability Framework
Task T2.1 Extend the eEIF with 5 new use cases. Led by IHE, with contribution from HL7, EuroRec and MEDIQ.
Potential use cases were first collected from different sources such as PHC 34 European projects, stakeholder groups, Hope and other EU projects. The additional use cases proposed by eStandards have been selected based on the availability and readiness of standards and/or profiles that are already been used in operation. Other important criteria that have been selected in VALUeHEALTH were also considered for supporting our analysis such as the level of interest from stakeholders and the impact on the quality of patient’s life.
Finally all the selected use cases are documented by using the use case and realisation scenario tem-plates defined by the Antilope project, reviewed by the JASeHN project and endorsed by the 8th eHealth Network meeting in November 2015.
After reviewing and updating the templates, the additional Use Cases and realisation scenarios are described in order to facilitate their integration in the Antilope ReEIF:
Use cases:
• Integrated antenatal care
a. Immunization use case
• Realisation scenarios:
a. Neonatal care plan management at the local or regional scale
b. Mobile services to empower patient with heart failure
c. Exchange of Patient Summaries across Atlantic
d. Structured Report in radiology
e. Monitoring the radiation exposure
f. Immunization use case at the local or regional scale with a national immunization reg-ister
g. Healthcare Provider Directory
h. Workflow care plan management
In the case of realisation scenarios, a selection of standards and profiles are provided to be consistent with other realisation scenarios already available and addressing the same use cases.
To further improve access and readability by end-users which are interested to address requirements for Health Information Exchange (HIE) in their projects, these additional use cases selected in the eS-tandards project along with the ReEIF previously defined ones have been entered in a multi-criteria Use Cases Repository at .
Task 2.2. Study guidance for Clinical Content in a selected use cases. Led by EuroRec with contribution from HL7, CEN, MEDIQ and Lombardy.
The work in this task has been done by building on evidence based and emerging best practice for a generic guideline for how to develop the appropriate clinical content specifications for any example EIF use case. The work takes into consideration the breadth and level of granularity needed in specifying that content (the data items, value list etc.) that are needed to achieve the targeted benefits of the use case.
The guideline focuses on uniform and comprehensive approaches for specifying clinical content as a prerequisite for interoperability and aims to guide standards bodies and other specification develop-ment groups such as professional medical societies on how to develop new areas of clinical (EHR) con-tent. This includes guidance on how such professional bodies can examine the content within existing non-harmonised standards in order to agree on their common areas of clinical content.
The European Standard EN 13940 "Health Informatics - System of concepts to support continuity of care" (CONTsys), has been used to achieve a common understanding of eHealth concepts, regarding the specification of clinical content to be exchanged.
The work is on-going and will be finalised in Q3, 2016 by adding examples on how the specify clinical content on European, national and regional level linked to EIF use cases that include content of clinical importance.
Task 2.3 Introduce a Quality Management System for Interoperability Testing to the eEIF:
The work started already in May 2016 by discussing the existing Quality Management System for In-teroperability Testing:
• How can the work be included in the eEIF?
• How can task 2.2 be included in the QMS Interoperability Testing?
The discussion during years one has been fruitful and useful to understand how task 3 will present the outcome.
There are more standards for Quality Management Systems, which all are derived from ISO 9001:
• ISO 17025 General requirements for the competence of testing and calibration laboratories
• EN 15224 Quality Management System in Healthcare
What is specific and added to ISO 17025 and EN 15224 is currently discussed and analysed. The aim is to assess if we need a “new” standard for QMS for Interoperability Testing.

WP3: Develop Roadmap for Aligning of Standardization Activities
During the reporting period, the work in WP3 focused on three tasks: T3.1 “Establish the case for for-mal standardization”, T3.2 “Open and Maintain SDO policy dialog with the eHealth stakeholders”, and T3.3 “Draft Roadmap for essential eHealth Standards”.
Task 3.1 “Establish the case for formal standardization” (Task Lead: HL7, Contributors: NEN, IHE, Euro-Rec, MEDIQ, Lombardy, HOPE, COCIR, SPMS) focused on the development and consensus building process concerning Deliverable D3.1, a position paper that asserts the case for formal standardization to support large-scale deployment of eHealth from four distinct perspectives that entail a balance of roles with different interests, costs, and benefits. Each perspective reveals a compelling case for formal standardization that can be empowered by collaboration and coordination among standards develop-ment and profiling organizations and their constituencies at all levels. It is the resulting trusted dialogs that will lead to co-creation in interoperability and nurture large-scale eHealth deployment. The four perspectives are: Citizens (as consumers of health services), Workforce (in the delivery and administra-tion of health services), eHealth Market (where eHealth solutions and services are traded), and the Health System (where care is delivered and cost, quality, and access decisions are made). The report concludes with a number of implications at the policy level for both the direct users and stakeholders of standards, as well as the standards development and profiling organizations, highlighting the need for collaboration and coordination at all levels.
Task 3.2 “Open and Maintain SDO policy dialog with the eHealth stakeholders” (Task Lead: NEN; Con-tributors: HL7, IHE, OFFIS, Lombardy, Nictiz, HOPE, COCIR, SPMS) has the mission of initiating an SDO and eHealth Stakeholder policy dialog, mindful of competitiveness, innovation, and growth for essen-tial standards development, will be initiated. The goal is to foster this dialog on regional, national and cross-border levels. In the reporting period, the work in this task focused on Deliverable D3.2, a docu-ment that proposes standard instruments including process, metrics / indicators and tools to engage and gather evidence from eHealth stakeholders as to the role of standards and the future of standardi-zation. The outcome has informed the draft roadmap (D3.3) and will inform its further elaboration to produce the final roadmap (D3.5).
Task 3.3 “Draft Roadmap for essential eHealth Standards” (Task Lead: OFFIS, Strongly involved part-ners: NEN, HL7, IHE, EuroRec, Nictiz) focused on the development of the first version of the eStand-ards Roadmap (D3.3), a document that describes the actions to be taken jointly by standards develop-ment and profiling organisations (SDOs), policymakers in eHealth, and national competence centres that acting together will warrant high availability and use of general and personal health information at the point of care, at the fingertips of the individual citizen, as well as for biomedical, clinical, public health, and health policy research. Since a roadmap in the field of standardization is by definition the result of a consensus building process, a large number of authors – internal and external to the project – were involved in this activity; 31 authors are mentioned by name in the document.
Work in WP3 was organized via a dedicated mailing list and regular conference calls, of which 17 were performed during the reporting period. Furthermore, 9 dedicated conference calls of the “Roadmap Reading Group”, i. e. the core team working on the eStandards Roadmap, were also performed. Finally, a two-day “roadmap writing workshop” was performed with ca. 20 participants at the end of March 2016, and provided significant input to the roadmap. The draft roadmap and recommendations were presented and discussed with the audience during the eStandards Conference co-located with conhIT 2016 on 21 April 2016, and the results, as well as the results of a poll/questionnaire opened during this conference influenced the final version of the document.

WP4: Support Large-scale eHealth Deployment
Focus of the work in WP4 within the first 8 months of the project was Task 4.1, “Evidence Gathering on Solutions for Coexistence of Standards” (Task Lead: OFFIS, Contributors: HL7, NICTIZ, LOMBARDY, HOPE, SPMS). The objective of this task was to gather and compile evidence on existing approaches and solutions for achieving interoperability across eHealth networks despite different choices of stand-ards e. g. for representing medical information (syntax and semantics) and for access/transfer of in-formation. This evidence has been compiled as a collection of 19 case studies. For this purpose, an extensive template for case studies was developed to ensure a consistent presentation of all case stud-ies, and authors both within and beyond the project were identified who were able to contribute case studies about real-world eHealth deployment projects (national or cross-border) or research projects in this field that specifically addressed the issue of coexistence of competing or overlapping standards. In particular, case studies from Romania, Denmark, Netherlands, Italy, United Kingdom, Greece, Spain, and Portugal were included. Once the collection was complete, an overall analysis was performed and the relevant “lessons learned” were extracted from all case studies and documented in the Conclu-sions chapter of the case study collection (Deliverable D4.1).
Once Deliverable D4.1 was completed and submitted, work on Task 4.2 started, which has the mission of converting the “input”, i.e. experiences, tools and recommendations collected from the many case studies into a practical guideline (“cook book”) for large-scale eHealth deployment projects. This task is currently ongoing and planned to complete by the end of October 2016. At this time, an agreement has been achieved in WP4 about the structure and list of topics of Deliverable D4.2, in which the re-sults of this task will be documented, and authors/editors have been identified for most of the topics. The writing process is in progress.
Work in WP4 was organized via a dedicated mailing list and regular conference calls, of which 16 were performed during the reporting period.

WP5: Global Standards, international collaboration, EU/US MoU
The eStandards WP5 supports and promotes actions that depends on external entities and decisional processes, in consideration of this an agile and adaptive approach has been selected, in order to fine tune the design of the WP5’s action plan to a manageable scope that meets the project needs. In brief, goals (drivers) and course of actions (levers) described in the Description of Work (DOW) have been consolidated, and then refined and formalized, using as reference the Business Motivation Model. The strategies, and the related tactics (i.e. operative actions), deemed necessary for achieving the agreed goals, have been developed. Those actions have been therefore analyzed and prioritized for defining a baseline action plan that drove the activities accomplished during the first year. The action plan cov-ered both the tasks described in the Description of Action: T5.1: Promote Standardization actions for supporting existing eHealth initiatives (EU-US MoU); and T5.2: Contribute to International Standard for Patient Summaries; having both HL7 Foundation as task leader and NEN, IHE, EuroRec, Nictiz, SPMS as contributors.
The operative actions initiated during the first six months, that included also the methodology applied, have been reported in the deliverable 5.1. Those actions can be summarized into four main groups:
• Actions propaedeutic to the realization of an International Patient Summary, including the fol-low up the Trillium Bridge Policy Convergence Recommendations Short Term and the prelimi-nary insights on the design principles of the International Patient Summary (e.g. possible con-texts of creation and use, expected proprieties);
• Cooperation activities with other European projects and initiatives impacting on the Interna-tional Patient Summary; (e.g. ASSESS CT, EXPAND , OpenMedicine and JAseHN / eHealth Net-work – EU Guideline Revision).
• Report on activities done in (and with) the Standardization Bodies about the Patient Summary, including the JIC Standards Set initiative; the INTERPAS project; the Hl7 Europe project on ART DECOR.
• Networking and supporting activities related to the EU US MOU roadmap, including EU-US eHealth/ Health IT MoU Roadmap Stakeholder Input Sessions;
The initial results collected, considering the progress status of the interdependent processes, have been used to adaptively revise the baseline plan. The publication of the draft roadmap and related annex moved the focus on those actions rather than on the Trillium Bridge Policy Convergence Rec-ommendations Short Term. The “Public stakeholder consultation on next phase of EU-US cooperation in eHealth/Health IT” was promoted among stakeholders and used as reference for an internal discus-sion. Supporting activities for the eStandards deliverables D3.2 and D3.3 was realized about global standard and Patient Summaries. All those activities – together with those described in D5.2 - are re-ported in the in-progress deliverable D5.2.
Work in WP5 was organized via a dedicated mailing list and regular conference calls, of which 19 were performed during the reporting period. Materials used during the meetings are documented in the project WP5 TCONs folder.

WP6: Support Large-scale eHealth Deployment
During the first year of eStandards project the work that was carried out was:
The task T6.1: this task was led by HL7 with the contribution of MEDIQ, LOMBARDY, HOPE and COCIR. Focused on inventory of tools, dif
ferent actions were conducting in order to finalize this inventory:
• Analysis of existing methodology and tool inventory that were developed in HITCH project, An-tilope and HL7: main results of this analysis are the specification of the template that was used for describing and classifying tools;
• Presentation of tools by partners or invitees: HL7, IHE, IHTSDO, Results for Care,
• Analysis of open source tools linked to the procurement case starting with the analysis of the legislative framework, continuing with explanation on the role of the Multi Stakeholder Plat-form for ICT in order to identify international standards and profiles that can be used in the Eu-ropean market and finishing with references on European projects and other documentation.
Several webinars presenting tools have been organized and additional ones are planned for the second year. Finally, a draft tool repository was proposed which is available at
The task 6.2 was led by MEDIQ with HL7, IHE, LOMBARDY, HOPE and COCIR partners. The objectives of the tasks were:
• Exploring ways to educate various target audiences
• Acceptance of standards driven ehealth interoperability through Connectathons, projecta-thons and other testing events.
• Ways and language that appeals better to different groups of stakeholders when talking about standards and interoperability.
The task was organized into three subtasks for better answering the objectives.
For the first objective, the task leader collected from partners case studies on ICT strategies in differ-ent countries, SDOs and procurement languages. After collecting information, the language used for these various purposes were analysed by the partners.
For the second objective, the adoption of the standards was analysed by collecting indicators on the participation of vendors and other implementers to the IHE connectathons and projecthons over the last 15 years. The analysis showed a great progression of the Connectathon usage and the adoption of profiles and their underlying standards by vendors. Projectathon is now coming popular within pro-jects implementing profiles and standards. It demonstrates also the maturity of the testing process, test methods and tools. Additional data from HL7 testing events were provided.
For the last objective, recommendations were built on the lessons learned of the approach used in this task.
The work package tasks were coordinated by IHE by setting up every two weeks regular conference calls from June – except August- 2015 to May 2016 where partners brought their inputs or their ques-tions and the task leaders reviewed the progress of task in order to achieve the results in manageable way.

WP7 Global vision, Local Insight: Networking, Liaison, Stakeholder Engagement
T7.1 Project Visibility, Web, and Social Media Presence, and T7.2 Dissemination, Liaison, and Stakeholder Engagement
This task has been active from the beginning of the project starting with the development of the pro-ject website and a fact sheet that have been distributed at meetings in printed form and emailed wide-ly. During the course of this first year a further 10 newsletters or magazine articles have been pub-lished. A standard project overview presentation was created and used especially to explain the pro-ject to other projects in the PHC-34 cluster, and to JAseHN. Detailed presentations have been given at 17 conferences and workshops, progressively including information about the case for formal stand-ardisation, the new proposed use cases for interoperability, and most recently the recommendations within the first draft eStandards Roadmap.
A communications strategy has been developed with key messages that are important for each of sev-eral stakeholder groups, published as D7.2. This project has had high impact by reaching many differ-ent stakeholder audiences, inevitably with particular focus on standards development and profiling organisations, but also targeting European level decision-makers, health ministries and E health pro-grams. There has been good connectivity with health care provider organisations and healthcare pro-fessional organisations, and naturally also with the health informatics research community. These dissemination and promotion activities, along with some examples of the materials developed, are reported in deliverable D7.3.
The 1st eStandards conference, held in April 2016 in Berlin during the CONHIT conference, was well attended and a great success. It provided an important public forum to present the first draft recom-mendations for the eStandards Roadmap, for them to be discussed and refined following that feed-back.

T7.3: Endorsement of Key deliverables, Exploitation, and Sustainability
A distinctive feature of this project has been the importance of seeking endorsement of main project results from important stakeholder communities. A strategy for how this should be accomplished was developed early in the project and is reported in D7.5. This deliverable defines the major stakeholder categories and indicates why they are important, and presents (as a series of matrices) the most im-portant stakeholder groups from which endorsement will be sought, per key deliverable.
An important success for the first year has been the endorsement by the Joint Initiative Council of De-liverable 3.1: The case for formal standardization in large-scale eHealth deployment.
An extended executive summary has now been produced for deliverable 2.1: Extension of the eEIF: Five new Use Cases. As explained in deliverable 7.5, the extended executive summary is a simplified version of the full deliverable that is deliberately framed to be sufficient to communicate the important endorsable recommendations of the deliverable, without excessive detail. This is in the process of being communicated for endorsement to the bodies identified in the corresponding matrix in D7.5."

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

"WP2: Quality in Interoperability – contribution to the EU eHealth In-teroperability Framework
During the first year, this Work Package has completed the first planned deliverable:
• D2.1 Extension of the eEIF #1: 5 new use cases
WP2 delivered beyond what was foreseen in the Annex II of eStandards with the use case repository at .

WP3: Develop Roadmap for Aligning of Standardization Activities
WP3 has completed all three deliverables foreseen during the reporting period. Deliverable D3.1 “The case for formal standardization in large-scale eHealth deployment” has been widely circulated and has, in general, received very positive feedback, including an endorsement from the Joint Initiative Council on SDO Global Health Informatics Standardization (JIC). Deliverable D3.2 “Set of measures and tools for data gathering across the eStandards WPs and beyond” has informed the work on the eS-tandards Roadmap including the work in WP2, 4, 5 and 6 that contributed knowledge to this process. Finally, Deliverable D3.3 “Initial Draft Roadmap for Essential Standards Development” (115 pages, 12 figures, 3 tables) summarizes the results of the work on the eStandards Roadmap achieved so far, to be continued in Task 3.5, which will work on the second, final version of the roadmap. D3.1 (Case for formal standardization) and the executive summary of D3.3 including the recommended areas for essential standards development, the strategic options and policy instruments has been delivered to the eHN.
Several news articles linked to D3.1, D3.2, and D3.3 have been produced. A report based on D3.1 has been submitted and is to be presented in the conference IHIC2016 on June 14.

WP4: Support Large-scale eHealth Deployment
WP4 has completed Deliverable 4.1 “Solutions for a Coexistence of eHealth Standards”, the only deliv-erable of this WP in the reporting period. The document presents 19 case study and an analysis and conclusions drawn from the collection of case studies. It has 240 pages, 76 figures, 23 tables.
News articles and a scientific paper accepted at MIE2016 are based on D4.1.

WP5: Global Standards, international collaboration, EU/US MoU
WP5 has completed Deliverable 5.1 “First Activity Report relevant to Global Standards and the EU/US MoU”, the only deliverable of this WP in the reporting period.

WP6: Support Large-scale eHealth Deployment
WP6 has completed the two expected Deliverables
• D 6.1 Incentive, Tools, Open Source for adoption of eStandards
• D6.2: How to improve acceptance and recognition of the importance of standards by improv-ing the user/vendor dialog.

WP7 Global vision, Local Insight: Networking, Liaison, Stakeholder Engagement
• High profile dissemination materials, especially the web site, fact sheet and feature articles in newsletters.
• Strong engagement with multiple SDOs and profiling organisations, including obtaining their endorsement of the case for formal standardisation in large-scale eHealth deployment.
• 17 conference and workshop presentations, targeting multiple important stakeholder groups including European level decision-makers, health ministries, health care provider organisa-tions, healthcare professional and patient associations, and health insurers.
• Formal representation at important stakeholder for a such as the eHealth Stakeholder Group.
• Successful 1st eStandards conference.
• Visibility on the Web (project website, twitter, ...)
• Project flyers"

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