“eStandards: eHealth Standards and Profiles in Action for Europe and Beyond” is a proposed coordination and support action to strengthen the standards & interoperability pillar of DAE2020 , by alignment and wide adoption of standards in eHealth market for products and services, advance global competitiveness of the ehealth industry, and support seamless, trusted, and safer health care in our society.
Recognizing that this is a time for action, CEN/TC251, HL7, IHE, leading Standards and Profile Development Organizations (SDOs), join forces to create an active evidence-driven roadmap to drive eHealth interoperability in Europe and beyond. In their quest for alignment and consensus to advance timely informed care in quality and safety, SDOs have partnered with enablers and implementers (OFFIS, EuroRec, RAMIT, MEDIQ), end users (HOPE), Member States, Regions, and Competence Centers supporting large scale eHealth Deployments (Region of Lombardy (IT), NICTIZ (NL), SPMSS(PT)), and the industry (COCIR).
As a core group, partners are committed to activate their networks in Member States (MS) and internationally to influence the eHealth standards agenda in the use cases prioritized by the eHealth Network (eHN) , starting with EU patient summary guideline and ePrescription. The eStandards proposal has received support letters from International SDOs namely ISO/TC215, IHTSDO, GS1, and IEEE11073, the International Medical Informatics Association (IMIA), the European Federation of Medical Informatics (EFMI), the French Association of Hospital Pharmacists (PHAST), MS, and the eHN.
Think of a global eHealth ecosystem…
where interoperability assets fuel creativity, entrepreneurship, and innovation
where people receive timely safe and informed health care, anywhere around the globe
where eStandards nurture large-scale eHealth deployments and enable a trusted productive provider-vendor dialog on costs, plans, and expectations.
eStandards, the proposed Coordination and Support Action, launches towards this vision with 7 concrete, measurable, and ambitious, yet attainable objectives contributing to an active evidence-based roadmap for aligning SDOs with eHealth stakeholder expectations to step-up collaborative standardization efforts and increase Europe’s global influence and impact. But first, a few thoughts on why formal standardization…
Large scale deployment of eHealth services is an opportunity to increase quality of health care, while fostering effectiveness, efficiency, and sustainability of health systems. eStandards, eHealth specifications and their profiles  along with consolidated implementation guides allows the users to contain costs of deployment and enables the European industry to innovate and compete not only in the EU single market but also in the global marketplace for products and services. However, there are many disconnects and misconceptions between SDOs and eHealth stakeholders that undermines the sustainability and viability of large scale eHealth investment. It is a common saying that the good about standards is that “there are so many to choose from…” referring to the multiple competing and overlapping standards in existence today. The “not invented here” mentality have plagued for many years the technical specifications associated with national or regional strategies, leading to fragmentation and suboptimal eHealth services. On the other hand, the long consensus driven policies and mostly paper-based practices of SDOs are not fit for purpose in our digital reality. Does this mean that we can do without formal standards?
Not at all. EHealth stakeholders need to help SDOs serve their interoperability needs. The title of 2011 Memo “More and faster standards to advance Europe’s competitiveness”  inspires and motivates us.
The epSOS project (http://www.epsos.eu) was pivotal in changing the way we think about eHealth in Europe starting with cross-border patient summary and ePrescription services. The European eHealth Interoperability Framework study (eEIF) , which evaluated IHE and Continua in the context of 2012 EU Standardization Regulation , formulated the strategic vision that recognizes technical, organizational, semantic and legal interoperability (see figure 1) and in the absence of formal standards or profiles considered also epSOS specifications as the ‘standard’ for cross-border eHealth. Then, in November 2013, the eHealth Network endorsed the EU Patient Summary (PS) Guideline , elaborating on the epSOS Patient Summary Specifications. Several EU funded projects, in an open collaborative effort have built on the work of epSOS and now the EU PS Guideline. EXPAND (www.expandproject.eu) currently maintains and expands the interoperability assets of epSOS. However, with all EU funded projects being time bound activities, co-existence of competing/ overlapping standards is only part of the picture. There is need for stewardship of interoperability assets in collaboration with the stakeholder community to (re)set the bounds of formal standards. It is true that SDOs need to align, accelerate, and rethink their processes to be more time and cost-effective. eHealth stakeholders, government, professional associations, industry can help and should be part of the discussion. The case for an open inclusive dialogue on formal standards is compelling.
 Digital Agenda for Europe (DAE) aims to help Europe's citizens and businesses to get the most out of digital technologies.
 eHealth Network was established under article 14 of Directive 2011/24/EU on patients' rights in cross-border healthcare.
 For the sake of brevity, technical specifications for eHealth, namely, eHealth standards, profiles, and implementation guides are collectively called “eStandards” hence forth.
 More and faster standards to advance Europe’s competitiveness Commission Européenne - MEMO/11/369 01/06/2011 http://europa.eu/rapid/press-release_MEMO-11-369_en.htm?locale=fr
 eHealth Interoperability Framework: http://ec.europa.eu/digital-agenda/en/news/ehealth-interoperability-framework-study
 EU Regulation No 1025/2012 on European standardisation, Annex II, 2012: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2012:316:0012:0033:EN:PDF
 Guidelines on minimum/nonexhaustive patient summary dataset for electronic exchange in accordance with the cross-border directive 2011/24/EU http://ec.europa.eu/health/ehealth/docs/guidelines_patient_summary_en.pdf
Recognizing the lack of common clinical reference standards at the international level, the absence of consensus on a common clinical reference information model for eHealth deployment in Europe, and the right of Member States (MS) to adopt competing/overlapping standards, eStandards will employ ‘Global Vision and Local Insight’ to engage the eHealth stakeholders and build consensus as to the way forward.
Starting with the topics identified in the work program of the eHN, eStandards will join up SDOs and the broad eHealth stakeholder’s  community. In an open consensus-building dialog to take place both in the MS and EU level, we will build bridges of understanding and cooperation on the eStandards deployed within national programs, associating them with the EU PS Guideline. Then, through the implementation of actions in the EU/US MoU roadmap, MS considerations will be reflected in the global alignment of standards. The Trillium Bridge project (http://www.trilliumbridge.eu) building on the EU PS Guideline has made significant progress towards bridging with the HL7 CCDA/CCD  mentioned in the Meaningful Use regulation, initially focusing on Portugal, Italy and Spain. If this process is successful it will create a rippling effect for eStandards adoption and alignment, while tangibly demonstrating the value and impact of a formal standardization dialog that is broad and inclusive. Supporting activities to this objective will build on the approach of the Antilope project , which supplements conferences with regional workshops and webinars with standardized material and delivery methods. A distinctive element of the outreach will be the shift towards acknowledging the problem and offering exemplary guidelines that aim to set the tone of the discourse.
The outstanding partnership of eStandards is uniquely positioned to achieve this objective, driven by global vision and local insight, to build consensus, shared understanding, gradual alignment, iterative consolidation and meaningful convergence of eHealth standards. In eStandards, leading SDOs, CEN/TC251, HL7, and IHE partner drivers of innovation: EuroRec (EHR operability), OFFIS (early DICOM Implementation), and MEDIQ (Quality in interoperability- Antilope), Regions and Competence Centers supporting large scale eHealth deployment (NICTIZ, SPMSS, the region of Lombardy), providers represented by HOPE (European Association of Hospitals), and the industry represented by COCIR. Our coordination and support activities, will give the opportunity to national Standardization bodies in the MS with a mirror ISO/TC215 or CEN/TC251, HL7 Affiliates in the EU and worldwide, IHE-Europe local deployment committees, and ProRec centers to join up with eHealth stakeholders in their region, throughout Europe and around the world to take ownership of the problem and create the solution in a realistic roadmap with concrete deliverables.
The coverage stakeholder registry (D7.5, M6) directing outreach activities to all 28 MS, participation in the two eStandards conferences, and endorsement of deliverables will measure our near term success. Medium-term, MS engagement with national, EU, and global standardization activities, formation of local eHealth SDO collaboratives, public awareness with eHealth standards, and successful large-scale eHealth implementations aspire us to continue even after the end of the eStandards project.
 eHealth stakeholders group of European Umbrella organizations established by DG Connect in 2012: http://ec.europa.eu/digital-agenda/en/news/ehealth-stakeholder-group-members
 HL7 Implementation Guide for CDA® Release 2: IHE Health Story Consolidation, Release 1.1 - US Realm https://www.hl7.org/implement/standards/product_brief.cfm?product_id=258
The eStandards project will elaborate an evidence-driven Roadmap evaluating alternatives and supporting concrete measures on how advance steadily towards eHealth interoperability across borders, cultures, and health systems. For the concrete deliverables of the Roadmap, eStandards will engage in consensus building and seek the endorsement of the broad eHealth stakeholder community. Following an evidence-driven policy development approach building and extending the experience and results of community-funded EU projects, eStandards will launch a small number of studies that reflect different perspectives to interoperability to investigate measures, alternative scenarios and approaches to overcoming the barriers of conflicting standards and their frequently inconsistent implementations. eStandards will seek endorsement not only for the full Roadmap, but also for contributing guidelines and reports that present evidence and associated recommendations, addressing specific perspectives.
Figure 2 present the four different perspectives that will be taken into account as we collect evidence for the Roadmap: contributing to the eEIF strategy (WP2), guideline for competing standards in large scale eHealth Deployment (WP4), International cooperation for accelerated Standards development and Adoption (WP5), Socioeconomic aspects of standards-based interoperability (WP6). The Deming/Shewhart management practices  of continuous improvement will be used here to assure a continuous flow of evidence in the elaboration of the Roadmap that will happen in two circles. We expect that the interplay of these perspectives and their integration with the roadmap, will help break through the barriers of different standardization philosophies and academic debate, to focus on cooperative problem solving.
The premise is that multiple dialects of eStandards will continue to coexist in Europe and internationally, just as communities prefer to converse in their own language. A positive attitude towards co-existence that builds on shared values and embraces “eHealth interoperability” as a societal good, is the key. As we move forward with large scale implementation dominant patterns of use will emerge together with a pressing need for alignment “agree to disagree”. Possible alternative convergence or coexistence strategies to be considered are: simple mapping, model-based mapping, model-based convergence, controlled non-compliance, etc. Focusing on a realistic approach to semantic interoperability and incrementally tackling the clinical content problem, creating, quality assuring, and reusing interoperability assets, shared knowledge will be developed. In this way, we will nurture shared understanding and a culture of gradual alignment, iterative consolidation, and continuous quality assurance of interoperability assets will emerge.
The degree to which the Roadmap will integrate these different perspectives and the number of stakeholders including MS that will endorse the deliverables of the roadmap and engage in action, will be the measure of success for this key objective.
Several healthcare authorities have identified quality labelling and certification as an important means to stimulate or enforce the market to comply with national or regional functional and quality requirements as well as to enforce the use of selected standards. Achieving this objective would mean making contributions to the EIF through the roadmap that would help accelerate deployment and sustain cross-border eHealth services as well as shared infrastructure in the frame of the Connection Europe Facility (CEF). At the same time, resolving ambiguities and supporting incorporation of national needs, national, regional or project based deployments would use interoperability assets that accelerate their deployment.
The current eEIF identifies 10 high-level use cases that require interoperability of eHealth systems. The eEIF associates each use case with a number of standards and/or integration profiles. The eHealth Stakeholders Group analysed the European eHealth Interoperability Framework (EIF) Study, in its March 2014 report on “Perspectives and Recommendations on Interoperability”, led by Nicole Denjoy of COCIR, further analysed the topic and presented recommendations and 7 eEIF priority use cases for 2015 (Figure 3).
Firstly, as a concrete contribution to the eEIF, a Quality Management System (QMS) for Interoperability Testing based on the results of the HITCH and Antilope projects, will be refined and extended to address the semantic and technical layers (Figure 4). Introducing the QMS to the eEIF will open the way for developing certification and quality labelling for eHealth systems.
Secondly, building on the knowledge gained in the awareness campaign of Antilope, meetings with eHealth stakeholders will be directed toward reducing ambiguities and contributing to the alignment and consolidation of various content profiles, to accommodate the specific semantic interoperability needs of large scale eHealth implementations. Starting from the EU PS guideline, we intend to facilitate consolidation, bridging the gap between developments in MS, the EU, and internationally, starting with the US in the context of the EU/US MoU Roadmap and the feasibility study of Trillium Bridge. To that end, a guideline on how to use different standards and the experience of participating large scale implementations from WP4, will bring evidence-based contributions to the eEIF and the Roadmap. Finally, based on stakeholder input, five (5) additional use cases based on existing standards and profiles will be proposed, offering an opportunity to discuss and elaborate on clinical content and its possible presence in multiple forms. eStandards will contribute to the harmonization of content profiles for priority use cases such as patient summaries for unplanned care, discharge summaries and encounter reports, resolving ambiguities and addressing the specific needs of MS.
The CEN13606/CDA alignment will be part of the discussion on the different ways to express content profiles. In that spirit and in the context of the roadmap we will investigate mappings ISO/EN13606 archetypes, IHE content profiles, HL7 CDA templates, and FHIR resources in concrete and constrained case that ideally links to other PHC34-CSAs (SNOMED-CT, Prescriptions, and Business Models). A good candidate that would have natural extensions to the EU/US context, is likely to build on the work of the SALUS project  related to Individual Case Safety Reports (ICSRs) . The finding of this study will feed into a guideline on how to deal with clinical content within integration profiles providing insights on the co-existence of standards. The resulting deliverable (D3.4) will be presented to the SDOs for endorsement.
The success metrics for Objective #3 are the refinement of a QMS for the eEIF to serve for the certification of eHealth systems, the resolution of ambiguities in the current eEIF use cases based on input from at least 5 MS (Portugal, Italy, The Netherlands, Romania and Greece), and 5 new use cases based on existing standards and profiles that will be proposed. The quality and extend of contributions to the EIF and the number of MS that will endorse and commit to implement the use cases will be the ultimate measure of success.
 ISO/HL7 27953-1:2011 Health informatics -- Individual case safety reports (ICSRs) in pharmacovigilance -- Part 1: Framework for adverse event reporting and ISO/HL7 27953-2:2011 Health informatics -- Individual case safety reports (ICSRs) in pharmacovigilance -- Part 2: Human pharmaceutical reporting requirements for ICSR
The convergence to a fully harmonized set of eHealth interoperability standards at international or European level is certainly a long-term vision, but not the reality today. Different approaches in terms of technical solutions, standards and profiles used, terminologies adopted, etc., are not seen as the result of right or wrong choices, but rather as the natural consequence of the many factors influencing architectural decisions in eHealth deployment, including culture, domain, country, implementation timeline and the interoperability layers addressed. It seems unlikely that international consensus on a common reference information model for eHealth deployment can be reached in a reasonable timeframe and budget and we need eHealth interoperability now! It is furthermore important to point out that interoperability is the result of a progressive refinement process across different perspectives. To support large-scale eHealth deployment, eStandards needs to tackle the important question how coexistence between competing or overlapping standards and standard options can be achieved in practical terms that ensure sustainability.
This objective is about providing the actors involved at different levels (European, National, Regional) with a means for better estimating the feasibility and the costs (in term of what needs to be changed) of achieving practical interoperability for identified use cases, by supporting them in the design of a reasonable migration strategy, as a set of step-by-step transition architectures, from “competing” to hopefully “converged/harmonized” standards.
This approach takes into account the requirements of Large-scale deployment, the reality of co-existent standards and the actions we can take in the transitional face. A guideline will be prepared and presented to the stakeholders helping promote interoperability at all levels in the region. Furthermore, it analyses how such alternative choices, and means of achieving interoperability between regional or national implementations based on different choices, can be incorporated to the eEIF.
The evidence that will be used in our guidelines will come from several sources of intelligence gathering in 5 EU MS, namely Netherlands, Portugal, Romania, Greece and Italy (Lombardy)
In The Netherlands, the 8 University Medical Centers (UMCs) cooperate with the National Institute for IT in Healthcare (Nictiz), on the definition of the content of a patient summary to be used primarily for referrals of patients. This project is part of a larger program that strives for better and uniform definitions of clinical information across the country, to be implemented and used not just for the referral, but also for deriving quality indicators, epidemiology, etc. The Dutch work will be closely analyzed and compared with the EU PS Guideline and the HL7 CCDA/CCD under Meaningful Use stage 2 in the US to investigate the level of convergence and the potential for alignment.
In Portugal, SPMS drives the efforts for country wide deployment of Electronic Health Records with the Portuguese health data platform which provides four distinct portals: citizens, professionals, institutions, and internationals. The international portal was developed for epSOS and allows the Portuguese PS of 4 million people to be shared upon request by physicians abroad. Portuguese physicians can also access the PS of visitors from MS in cases of unplanned care. The ability to extend this service to visitors across the Atlantic is analyzed in Trillium Bridge. SPMS will contribute the Portuguese experience with the use of standards to integrate different EHR systems in a national data platform and offer services across borders.
In Italy, the experience of Lombardy on the adoption of the EHR system dates back to the last Millennium. At present, all 10 million citizens are provided with eHealth smart cards and access to the Regional EHR, while all public / private Hospitals and labs, and 97% of the physicians are connected to the Regional EHR system. Lombardy was a key partner in epSOS and now in eSENS. Lombardy will contribute evidence for the guidelines based on their long experience.
In Romania, the patient summary service will be provided by Romanian National Insurance House. As the service rolls out, evidence will be collected by HL7 Romania and contributed to the Guideline development process.
In Greece, the patient summary service is foreseen as an extension of the Greek ePrescription system where epSOS common components and assets will be integrated and extended. Evidence regarding the progress of the deployment and its ability to cope with different systems and standards will be contributed by HL7 Hellas. Beyond these concrete examples of MS/large scale eHealth deployments engaging with eStandards, we expect that our outreach and commitment to consensus will help engage more MS initiatives, increasing our body of evidence and potential impact. Linkage with Scandinavian initiatives is also foreseen through our strong ties with MedCom (through Antilope).
Large-scale pilots currently at advanced stage (Lombardy, Portugal), and emerging patient summary initiatives in The Netherlands, Romania and Greece will provide evidence and will evaluate the eStandards guideline on how to deal with the heterogeneity of standards in large scale deployment. The number of MS that will endorse this guideline and the larg