• INTERVIEW: Malcolm Harbour
Chairman of the Internal Market and Consumer Protection Committee (LINK)

• INTERVIEW: Elena Santiago
CEN-CENELEC Director General (LINK)

• Knut Blind: Interoperability within the Europe 2020 Flagship Initiative – the Innovation Union

www.talkstandards.com/interoperability-within-the-europe-2020-flagship-initiative-the-innovation-union
In the European Commission’s recently published communication on the Innovation Union, the need for “faster setting of interoperable standards” is highlighted. However, as Knut Blind commented, it remains rather unclear how this objective will be reached. While the EC acknowledges the need for more efficient coordination of research and standardization efforts, two other dimensions are missing which are also crucial for assuring interoperability. These are, demand-side considerations (including public sector procurement) and, most importantly, greater integration of international consortia.

• Helen Disney: Creating a Modern Framework
www.talkstandards.com/creating-a-modern-framework
While Interoperability is an essential component in ensuring that standards are utilized across the board, recently, we are witnessing a worrying trend in which policy-makers are afforded a greater degree of discretion concerning the desirable direction and forms in which standardization interoperability should take place. As opposed to this coercion and exclusion, Helen Disney emphasized the need to discuss and consider the most effective ways of securing and maintaining this objective. The real challenge is to create a modern framework that incentivizes and harnesses market forces towards greater interoperability, while also providing the necessary safeguards to deal with market failures when they occur.

• Ken Krechmer: Suggestions for the future of EU standardization
www.talkstandards.com/suggestions-for-the-future-of-eu-standardization
Ken Krechmer outlined five key points which need to be addressed within the European standardization framework. These include addressing the ambiguity within the EU literature, greater emphasis towards Government-led R&D, greater inclusion of stakeholders, avoiding confrontation with consortia, and a move away from “fixed standards”. Regarding the ambiguity of terms, Krechmer commented: “Open standards” is like “democratic government,” it is easy to say but very hard to achieve. The first step is a clear definition.

• James Bryce Clark: Interoperability within the Standards Marketplace
www.talkstandards.com/interoperability-within-the-standards-marketplace
While classical economic theory would say that the standards market is delivering exactly the amount of interoperability that its forces require at equilibrium, OASIS’ James Bryce Clack commented that even at its best, the standards “market” is an example of the imperfect markets spawned by the knowledge economy. Further exasperating this, the word “interoperability” is often thrown around, but it’s rarely quantified. Interoperability requires clear designation, clear criteria and clear proof.

• Ait Jaokar: Standards, Fora, Innovation and Geography
www.talkstandards.com/standards-fora-innovation-and-geography
There is an ongoing debate in the European commission regarding revision of the European Standardization System and the European Commission is currently working on a “Standardisation Package”. Ajit Jaokar outlined the vision as two over-arching goals; ensuring, through standards, European competitiveness at a global scale and Greater Integration on a European scale. Jaokar noted that European integration is a worthy goal, but asks whether we are mixing two goals: That of European integration and European competitiveness?

1. Help define the basic terms.
Without clear definitions, practice will be slipshod.
• What is a standard? It is not practical to transfer anything without a reference. Such ubiquity strongly suggests a “physical” law and mathematical form.
• What is an open standard? Most current descriptions are very biased.
• What is an open standardization process? Is it no IPR? Is RAND sufficient? Free standards documents? Fair representation of all stakeholders? World wide agreement?
“Open standards” is like “democratic government,” it is easy to say but very hard to achieve. First define it. (This task is underway in the EU, but deserves much higher visibility.) Then work to make it more likely.

2. Future proof systems:
There are systems being created now – Internet IPv6, smart grid, electronic health care records – that will have billions of instantiations, tens of thousands of implementations, their standards will change thousands of times and the systems will last for 100s of years. Current technology does not have ways to assure the absolute long term viability of such systems. Commercial organizations are not capable of addressing such problems. Government research and direction is needed.

3. Bring in absent stakeholders.
ICANN makes a much stronger attempt to engage a wider audience in the Internet than any SSO. More of these efforts are needed as more technology becomes basic to our lives.

Back EU standardization away where other mechanisms are possible:

4. Avoid competition with consortia.
If multiple consortia want to compete over similar technology, let evolution precede. Direct health and safety requirements should be the only standardization areas where government interest should be preemptive (and only with considerable caution).

5. Move away from fixed standardization.
Standardization is the selection part of an on-going evolutionary process. A standard is not a “best” solution, only a specific solution to be changed as needed by future events. Help focus EU standardization organizations on defining adaptable standards, which can change as necessary, where practical.

Of these five points, perhaps two are lightly noted in the EU documents.

Join the Forum discussion here: www.talkstandards.com/questions-for-event-reforming-eu-standardization/

This series is substantially drawn from an article I wrote for the Stanford Law and Policy Review (Volume 18, Issue 1 (2007)). As we move into a time of predictibly heightened interest in government intervention in IT standards and interoperability with the deployment of cloud technologies, I find it interesting to once again consider the arguments of this article.

The explosive growth of the role of IT in our society and as a component of our economy has dramatically elevated the importance of IT interoperability. Interoperability may be achieved in a number of ways, through intellectual property licensing and cross-licensing, relatively simple technical means (for instance, in information technologies and consumer electronics converters and translators are commonplace in both software and hardware), industry collaboration with companies working to facilitate interoperability among their products, through a company designing its product to interoperate with the products of other companies, and through consulting services that facilitate interoperability among otherwise non-interoperable technologies. And indeed, interoperability between modern technologies is often a far simpler task than during previous eras of technological evolution wherein inventors were limited by physical characteristics and mechanical interactions. Further to this point, in light of Web 2.0 technologies and cloud computing, interoperability and the use of widely accepted standards to achieve that interoperability are at the core of both innovation and implementation.

Since the early 1990’s, increased need for interoperability has in turn resulted in enormous demand for standards at a pace that challenges traditional standards-setting processes. Concurrently, government programs have transitioned from reliance on government-specific standards, such as U.S. Department of Defense MilSPEC/MilStandards in the U.S., to voluntary standards developed in the private sector, placing an additional burden on standards-setting forums. As a result of these factors, the information technologies industries are in an extremely competitive commercial environment, one that is also reliant on standards that facilitate interoperability among increasingly heterogeneous products and services. Approaches to enterprise architecture such as Service Oriented Architecture (SOA) and the latest IT trend, cloud computing, further emphasize the need for interoperability. The high demand for interoperability is in turn creating an environment wherein stakeholders are more likely to turn to government to intervene in the market to aid in achieving particular goals more rapidly than may occur in the natural course of market activity.

In some cases, the government is being asked by one business sector or another to play a role in, or even to take responsibility for, setting IT standards, the development of which were vexing the industry with conflicting interests, or identified by one proponent or another to need government assistance to accelerate the advancement of one technological solution, business model or corporate venture over another. Throughout this dynamic period, governments have been asked by stakeholders or have independently pursued mandating particular IT standards in several areas:

Copyright protection and digital rights management for copyrighted works. This has been a technical, legal and political issue for years. Examples include recent efforts to seek a government mandate, such as legislation in the U.S. which would precipitate a government mandate for digital rights management standard and efforts by both Congress and the Federal Communications Commission to establish a “broadcast flag” digital marker with specific technical standards for digital broadcast television.

Open Source Software. There is an ongoing debate as to whether governments should mandate standards that are implemented with open-source code software over proprietary software because, proponents of open source argue, open source software has characteristics that are better aligned with the needs of government and government adoption would accelerate broader market adoption of open source applications.

National security information sharing. Subsequent to the events of September 11, 2001, there has been heightened attention given to improving data interoperability to facilitate better information sharing between law enforcement, intelligence, immigration, and foreign service agencies, to better protect national security for countries around the globe.

Emergency communications interoperability. Also subsequent to the events of September 11th and several natural disasters, there has been greater interest in improving radio and data communications interoperability for fire, law enforcement, and other “first responders.”

Electronic medical records. Since the early 1990’s, research has shown that conversion from paper to interoperable electronic health care records and prescription systems, would save thousands of lives and billions of dollars annually. Over recent years governments have given significant attention to this problem.

Cloud Computing. With the advent of cloud computing, interoperability has once again come to the fore as central to the success of deployment of the latest technology. Cloud computing elevates the importance of interoperability throughout IT architecture.

The need for interoperability has never been greater, and global cooperation around interoperability is now more than ever critical to the evolution of the benefits of IT – but so to the industry has never been so focused on achieving interoperability. This series will explore the need for government mandates for interoperability standards, arguing that the occassions are rare that warrant government intervention into the marketplace for standards. To help policy makers, I’ll also set out an analytic framework for governments to consider questions of standards mandates when they arise.

Ajit Jaokar spoke of the possibility that eHealth will take off in emerging markets and what the implications thereof could be. As an illustration, Jaokar mentioned the M-Pesa mobile payment service which took off in Kenya, serving 6.5 million subscribers by May 2009; such a service is yet to be deployed in Western countries. Jaokar argued that emerging markets have a way of solving real life problems which is likely to mean that eHealth innovation will take place in emerging markets. Further, the lack of infrastructure might actually provide further incentives, as it did in the M-Pesa case. The implications of such a development for global standards are not clear but it is important to not only think of eHealth as a ‘Western’ concept.

Highlighting the fact that the healthcare of yesterday is changing, and a new healthcare experience is emerging, Helen Disney discussed the challenges facing us in ‘the post-bureaucratic age’. New technology can revolutionize the way in which governments and citizens interact and move towards a bottom-up approach; but this requires the development of standards to build trust in new systems. Interoperability is one of the main challenges we are facing as companies are set to compete on delivering eHealth services. More open, network systems will benefit patients but at the same time it will be less easy for governments to intervene, argued Disney. This will ultimately affect which standards are going to be widely used. Further, Disney raised the question whether some of the poorest patients, who lack internet access, face a risk of being left behind in the eHealth-age.

Keith W Boone provided valuable input on US eHealth policy. He expressed concerns over the shotgun approach taken by recent US initiatives and called for more coordination in standardization efforts. Further, Boone was critical to the fact that there is no US ‘national program’, rather conflicts within government and between SSOs are impeding developments. Governments can help by offering a consolidated voice, setting national goals and driving standardization efforts. Unified efforts across the ICT spectra is needed to look after national interests.

Denise Silber expressed her optimism over Health 2.0 services as a driver of eHealth innovation and development. She drew the attention to existing services; blogs, wikis, search engines etc, and pointed to the fact that these are available by computer or mobile phone and contributing to participatory medicine. Lack of standards is not the issue, Silber argues, web to web synchronization is already possible. Security should not be an impediment either, online banks have succeeded and so should healthcare. Rather, the obstacle lies in data not being electronically available or safely portable. Silber called on doctors and laboratories to digitize their information and leave the rest to participatory medicine.

Recognizing that seamless access to information is important in eHealth, and that standards are vital in achieving this, Jay Kesan expressed concern over the likeliness of governments’ early involvement in the standardization process, choosing winners (and losers) prematurely. The reason for this, he said, is because the governmental role in healthcare is not as challenged as that in other sectors. Kesan argued that it is the ICT private sector that are the domain specialists and that they must be allowed to work towards standardization, jointly developing standards within private SSOs. Thus, competition should be fostered among private firms developing downstream, innovative, proprietary technologies relying upon ICT standards. Learning from past behavior, Kesan also argued that US authorities are more likely to focus on spectrum management and setting power ratings to avoid interference, while letting different industry solutions and standards compete with each other, European authorities will be prone to mandate interoperability.

Also, prior to the forum Talkstandards conducted an exclusive interview with David Ingram, Founding Chairman of openEHR. Ingram spoke of the difficulties of gathering all challenges of eHealth under one common umbrella, and expressed concern over governments sometimes being excessively enthusiastic. It is vital that governments appreciate the scope of ICT standardization and development, as to handle the challenges properly. The approach to eHealth should be practical and empirical, Ingram said, and welcomed the fact that practical progress toward interoperability is actively sought. Although difficult barriers to eHealth implementation exist in Europe which might be hard to overcome, Ingram is optimistic with the direction developments are taking. Ultimately, Ingram said, implementation is the best way to achieve progress since it offers a sense of learning-by-doing.

The discussion around these topics is bound to continue. Please visit the Open Forum Event Page for further reading.

Part II: eHealth in an international perspective

(This is the second of three parts of the interview. Read Part I on The future of eHealth here, and Part III on Openness, implementation and governance here.)

Talkstandards [TS]: There is a significant difference between health care systems in the USA and Europe. How are these differences reflected in eHealth standardization in your opinion?

David Ingram [DI]: Without being too specific, I think it is important to recognize the cultural differences that separate the USA and Europe. Healthcare in Europe is sometimes characterized as “socialized medicine” in the American debate while the US healthcare system is sometimes giving negative vibes in Europe particularly when it comes to the lack of universal coverage.

However in terms of health informatics, innovative companies in health information technology emerged earlier in North America than in Europe and similarly, academic progress in the area was making progress earlier in the US. This is because the North American industry came to recognize the need to build bridges between different systems and applications at an early stage, thus working towards interoperable standards.

In Europe, an educational gap between clinical practice and science on the one hand and information technology on the other contributed to bringing the clinical challenge of information technology into focus later. Progress was sought through clinical practice rather than IT.

Some welfare states in Europe has a problem of scale; managing healthcare for a population of 5-10 million is easier than for a population of 50-60 million. Governments can and should make priorities for industry and the health care sector. New cooperation between industry and government is needed to handle the challenges at hand. This can also be vital in avoiding lock-in in outdated technologies, which is a dangerous trap in the fast moving IT sector. This is an important rationale for openEHR to be open; to maximize the possibility to detect and adapt to new and superior technology.

TS: Health care markets have historically been local and national. Is it possible that eHealth and ICT standards contribute to the longstanding European vision of a single market for healthcare services?

DI: The European single market is an important economic driver but considerable impediments exist, e.g. cultural, financial and political barriers, which mean that full integration will take time. I do believe that the goals are good, but it is key to have a bottom-up approach. Change needs to come from the grass root level. One particularly challenging task in this perspective is to reach harmonization of data.

In order to create a single healthcare service market, trust and understanding are vital elements. It is important not to generalize as patient preferences differ between areas of healthcare. For certain services familiarity is essential for assurance while in other areas patients are more open to evidence-based and innovative treatment.

Part I: The Future of eHealth

(This is the first of three parts of the interview. Read Part II on eHealth in an international perspective here, and Part III on Openness, implementation and governance here.)

TalkStandards (TS): There is currently a great deal of political hopes that eHealth can improve health care. Are these hopes realistic?

David Ingram (DI): The greatest challenge for eHealth today is trying to collect the disparity of ideas and efforts under one single umbrella to gain sufficient momentum and progress. Depending on the specific issue, hopes may or may not correspond with prospects. Generally, I am afraid that governments tend to be excessively enthusiastic about getting eHealth services up and running. Sometimes they do not fully realize the complexity of standardization processes of IT solutions.

Today, information technology is embedded in everything that we do. It has been a long learning process. Unfortunately ICT is sometimes taken for granted, and solutions are expected to come automatically. Therefore, governments run into trouble when trying to build a complex system. Technology is constantly evolving and we must learn how to best exploit these new technologies to manage information in order to reap the full benefits of eHealth.

TS: A distinguished feature of the openEHR is the way in which the patient is put at the center of development. What are the outlooks of creating a system where the patient fully controls his or her information?

DI: This is an interesting issue as we already see this sort of systems developing today. There are many long term treatments that need regular and careful monitoring. An example is system of 5000 patients with a coagulation deficiency who can regularly sample blood autonomously and upload the result to their medical institution for analysis.

However, it is important not to generalize when discussing this issue. There are territories where patients are reluctant to accept autonomous care, where they need the assurance of being under professional care and responsibility. In these cases they rather visit hospitals or a general practitioner in person. However, there can be different areas where patients could request autonomy and there is no certain rule that applies since patient preferences differ.

TS: What important trends do you see in the near future and what role is openEHR playing in this development?

DI: First and foremost, I welcome that the challenge of accomplishing practical progress toward interoperability is being addressed. Many different stakeholders – public as well as private – are involved in eHealth development and need to collaborate. We need to capture information as close to the physical encounter as possible and simplify it in order to facilitate sharing. This requires clear specifications which can serve to give us an overview of each patient’s information.

Another important trend is trying to understand and learn how genomics interact with treatment, especially for cancer patients. 30-40 years ago treatment policies mainly included “weed-killers”, which while targeting the malignant cancer cells, also caused much damage to healthy tissue. Today, with the use of IT systems, we can gather data which allows us to analyze which patient responds to what treatment. As a result disease profiling allows customized treatment, for instance oncology has moved towards a more efficient management of cancer. With the combination of making healthcare delivery better and managing individual data better in the long term, personalized treatment is now a reality.

In reality, openEHR is still a relatively small player. Our goal is to provide base standardization that can be adapted to a shared infrastructure as well as being adapted to local requirements, which often vary. Our approach is empirical and pragmatic, which in our opinion is the best way to contribute to the systemic landscape.

Biography David Ingram, Professor of Health Informatics, University College London

David Ingram is Director of the Centre for Health Informatics and Multiprofessional Education (CHIME) at University College London. After undergraduate Physics at Magdalen College Oxford, his career posts have been in industry, the National Health Service and University Medical Schools. CHIME is active in a wide range of international research programmes, and offers an extensive, multi-disciplinary educational programme, in quality, information and governance for health. The work of CHIME is founded on close working partnerships, with health service professionals, industry and community groups, and contributes to every-day services within the NHS and further afield.

David Ingram’s work in health informatics has covered contributions in the areas of mathematical modelling of biological and clinical systems, informatics in medical education, and formal methods for modelling health information requirements and architectures. Since 1990, he has been co-ordinating partner and partner in six major EU Health Informatics Framework Programme projects, focusing on health record architecture, implementation and standards, internationally. He is currently a principal investigator in the Medical Research Council e-Science Programme (Clinical e-Science Framework project, CLEF). He is active in research on representation of knowledge about inherited diseases. In 2003, CHIME was officially designated as a World Health Organisation Collaborating Centre, working on genetics knowledge management for patient advisory systems.

David Ingram’s professional activities include membership of the MRC Health and Bioinformatics Advisory Board, the national e-Science Advisory Board, the eScience Advisory Board of the Central Computing Laboratory for the Research Councils and the UK Council for Health Informatics Professions. He is the founder and chairman of the board of the openEHR Foundation, which is dedicated to sharing of standardised and open source software to support interoperable electronic health records. He is a Trustee of Starthere, an innovative charity which is establishing a national, highly accessible network of electronic signposts to local healthcare support services. He is international advisor to the EU project promoting health informatics in the accession states of the EU. He was elected Honorary Member of the Royal College of Physicians of London, in 1999, in recognition of his contributions to medical science.

A 2008 study by the Sectoral Business Watch (SeBW) provided an assessment of the situation of eHealth standardization and implementation. The report put specific focus on electronic health records (EHRs) since these are a prioritized area among policy makers.

The main issue reported by SeBW is the outspread use of conflicting standards and specifications across the EU. Further, due to incorrect implementation of technical specifications there are examples showing that different versions of the same standard may be in conflict. Interoperability is thereby rarely made possible.

The reason why this situation has emerged is due to four different types of barriers: Political- governmental support for the development of prominent eHealth standards is low; as is the incentives for electronic communication which otherwise could spur innovation. SDO- many different SDOs are developing eHealth standards and each wish to realize positive returns. Hence the incentives to agree on one common standard are low. Company- ICT firms selling middleware for interoperability are thought to prosper on the use of conflicting standards and manufacturers are unwilling to adopt the most common standards due to expensive pricing. ICT user- on the user side barriers to adoption of interoperable standards are mainly related to cost; cost for searching, conversion, upgrading etc.

In 2009 the European Commission EHR IMPACT report on socio-economic impacts from interoperable EHRs was released in late 2009. The results, based on a number of case-studies, show that in all cases socio-economic benefits exceed the costs, albeit after a period of some time.

The EHRI report calls on policy makers to provide a dynamic climate and incentives for the development and implementation of interoperable EHR systems. A second plea is made that policy makers are aware of the time frame necessary to start reaping the benefits, in order to allow investors and other stakeholders enough time to complete projects; the strategic goal should be better healthcare rather than more cash

Recent European developments include a collaboration between ISO, CEN and HL7 formed to reach a harmonized standardization of eHealth solutions in the EU. This could prove vital for the further implementation of EHRs since conflicting standards for the collection and classification of data are one of the main barriers. Other important collaboration projects include epSOS (Smart Open Services for European Patients) which aims at enabling EU citizens to seek medical care in other member states.

It is clear that much work remains to be done in the EU which will take time and therefore, it is important that actions are taken soon. Looking at the WoHIT agenda, many interesting questions are up for discussion; such as healthcare 2.0 services, eHealth user platforms etc. Let’s just hope that policy makers take heed to the EHRI report and listen to stakeholder voices from the different conferences. Because time is ticking; and for every tick, the reaping of eHealth benefits move further away.

In the US, recent eHealth developments are dominated by the HHS’s Interim Final Rule (IFR) for Initial Set of Standards, Implementation Specifications and Certification Criteria for EHR Technology which was published in December 2009. The IFR is a product of the HITECH Stimulus Act which entails qualified physicians getting reimbursed for the implementation of certified EHR systems, so-called “meaningful EHR use” defined in a Notice of Proposed Rule Making (NPRM).

The IFR proposes adoption of standards for Healthcare IT and essentially works as a guidebook for developers and vendors who want to be eligible for compliance with the “meaningful use” definition. Among the promoted standards are e.g. HL7, SNOMED CT and LOINC.

The standards adopted in the IFR cover four main areas: Vocabulary- promotes the creation of a common language and codes to be applied in clinical problems and procedures; Content Exchange- setting guidelines to be followed when sharing information; Transport- for systems and processes which will transport information between healthcare systems; Privacy and Security- authentication and transmission security for safe handling of patient information.

Reactions to the NPRM and IFR have been generally positive. For instance, David C Kibbe of the Health Care Blog expresses his belief that the suggested blueprints for EHR technology from the IFR are what will revolutionize the marketplace. Kibbe welcomes the fact that the IFR creates a new software core for “EHR technology”, a core founded on support and quality rather than charge maximization. Further, he welcomes the introduction of EHR Modules, which are thought to ensure a sort of plug-and-play implementation of components from different vendors.

All in all, the IFR offers manufacturers a certain degree of innovational freedom, even if some main boundaries are drawn. It should also be noted that the HHS recognizes the need for standardization to be iterative and open for adoption of new standards when the need of such arises.

Hopefully the NPRM and IFR can provide clear guidelines for the future development of eHealth standards and speed up the implementation of EHR technology. Economic incentives such as those specified in the HITECH Act are usually a way good way to set the most grinding wheels in motion. But this is an ongoing process and subsequent rules and guidelines in coming years will need to continue to actively support eHealth standardization and implementation.

The foundation is dedicated to the development of specifications, open source software and tools for the creation of adaptable health computing systems and patient-centric electronic health records. The focus in openEHR is not on how different systems exchange data with each other, but on architecture, reference models and especially archetype models for standardization of data, irrespective of the application of such data. The term openEHR is used both for the foundation and its published work. The first version, openEHR 1.0, was released in February 2006, and the latest version, openEHR 1.0.2 was published in December 2008. Being rather new, the openEHR open standard has not yet been widely implemented. Various evaluations of openEHR are however ongoing in regions within about ten countries.

OpenEHR was founded by University College London and Ocean Informatics Pty ltd from Australia and the board of the foundation is composed of four members from these two organizations. Membership in the foundation is open to anyone, and by now, openEHR has more than 700 members from more than 70 countries. Membership is free of charge although the foundation is actively searching for sponsors.

Standardization is considered necessary by openEHR, however the openEHR view is that traditional standards setting processes with committees doing the development work does not have a future. Instead, a development process aligned to the open source model is considered to be needed, with continual and open review where anyone can request changes. OpenEHR seeks to standardize through openness and accessibility; the tree key activities fof openEHR are said to be “implementation, implementation, implementation”. Therefore, the published work is released in official versions which the users continually review, but with defined rules for how changes in the specifications are to be made. OpenEHR can be considered to consist of three types of content: specification documents, archetypes and software. The latter two builds on the specifications. Thus a new version of openEHR implies revision of the set of specifications. All the specifications are developed and managed by a project group within the foundation. However, each specification typically is the work of a specific working group. Anyone in the foundation may suggest changes to a specification, and when such a proposal is made it is discussed and developed until a consensus has been reached among the members of the foundation. Any such changes are then reviewed and documented by the Architecture Review Board consisting of seven members before the revision of the specification is implemented by the project group.

All intellectual property rights (IPR) of the contributions to openEHR is owned by the foundation and all material is made publicly available for free under licenses where the only terms are that users may not use the material out of context or modify it in such a way that it may damage the openEHR foundation. The stance of the foundation on IPR is that all components and specifications have to be in open source format; otherwise complete interoperability among all the complex systems in the healthcare area will never be achieved.

OpenEHR continually cooperate with other organizations such as CEN and ISO. The openEHR specifications build upon various definitions and specifications in standards from CEN and ISO – while CEN in turn have adopted standards based on openEHR. A large international project of harmonization is also underway within ISO to develop specifications for how data following the openEHR standard should be exchanged in messages following the HL7 version 3 Standard. Other examples is the development of terminology within the International Health Terminology Standards Development Organization (IHTSDO) and the definition of technical binding approaches for SNOMED-CT and openEHR archetypes and templates within UK NHS Connecting for Health.

Key success factors

The free membership of openEHR creates incentives for wide participation, especially from motivated individuals.

The set leadership of the foundation, although somewhat undemocratic, provides a coherent leadership vision.

The open development of standards and specifications provides swift reactions to technological progress and ensures that standards will meet the market demands.

The focus on interoperability enhances the ability of openEHR to respond and adapt to technological developments.

[Comments welcome!]

Because of the economies of scale in information technology that could result from standardization, it is generally regarded as advantageous for the European Union and its Member States to develop a common strategy for eHealth standardization that could enable semantic interoperability. For European standards to be developed, close cooperation between governments is very important due to the deep public involvement in the health care sector.

In view of this fact, the European Commission has been working to raise efforts from the Member States to agree on priority standards and implement already existing, leading standards.

The situation for the European Union is somewhat different from that in the US. European healthcare systems differ between nation states and (potentially) across regions. Different standards and standardization approaches can be found between Member States and national support for standardization varies greatly making the issue of interoperability even more complex.

Initiatives from the European Commission kicked off when the Commission in 2004, launched an eHealth Action Plan stating that new standards are to be emphasized and priority are to be on standards for patient identifiers and EHR. Reports on eHealth interoperability from the European Commission (2006) and CEN/ISSS (2005), recommended that a common European initiative regarding the issue should be worked out because it is necessary to increase awareness among the Member States.

Accordingly, on the mandate of the European Commission, three European Standardization Organizations (ESOs): the European Committee for Standardization (CEN), the European Committee for Electrotechnical Standardization (CENELEC), and the European Committee for Standardization (ETSI) initiated in 2007 the ICT Standards Board to develop a coordinated work program for standardization in health information technology (e-health) with priority on EHR. In turn, three priority areas were identified regarding EHR, namely: patient and health practitioner identifiers; patient summary; and emergency data set. This is regarded to be an important initiative for harmonizing activities. Furthermore, CEN, the International Standardization Organization (ISO) formed together with Health Level 7 (HL7) in 2007, a collaboration initiative for standardization within eHealth.rnrnOther currently ongoing projects funded by the European Commission are “A Roadmap for Interoperability of eHealth Systems” (RIDE) which gives suggestions on what steps needs to be taken at the European level, and the “SemanticHealth” that supports research in health information technology on the European as well as the global level.

According to the Commission Recommendation on cross-border interoperability (2008) which is a follow-up on the Community eHealth Action Plan, the goal within standardization within eHealth is to have in place European eHealth interoperability by the end of 2015. According to the same paper, it is important that interoperable EHR systems can be interpreted in a user-friendly way so that the purpose for health professionals and patients is broadened.  In comparison to the US, the European Commission is trying to increase the efforts on settling on standards and thereby work towards interoperability, rather than, as is now done in the US, implement existing health information technology. Even though the Commission supports and encourages effort of that kind, the implementation of existing health ICT is more of a concern for national governments.

The approach taken by the US to implement prominent technologies can be a first important step toward standardization, but one of the main challenges will in either case be the necessary harmonization of conflicting standards.