1. Implementing national EHR strategies in Europe: organisational, social and political issues
Laurence ESTERLE, MD,PhD
INSERM U 750
‘Medicine, Sciences, Health & Society’
Villejuif – France
It is a pleasure for me to have been invited by Pr de Moore to make a presentation at the eurorec meeting.
Presentation: my name is laurence Esterle, I am research director at Inserm in France and presently working at the Institute of Computer science of FORTH in Greece. But I am not a specialist of computer science, my fields of interest concern mainly the evaluation of public policies and the socio-organisational changes induced by the innovation.Then I am a social scientist.

2. Implementing national EHR strategies in Europe: organisational, social and political issues
1. New topics for Eurorec ?
2. Main issues and research topics
3. Next steps
Therefore, I would like to present you non technical issues but social, organisational and political issues of the national implementation of EHR (ilek’tronik helth). I mean implementation of EHR at a national scale for almost all the citizens.
First, I will try to convince you that Eurorec is concerned by these issues ,a s well as it is concerned by the technical ones. Then, I will present you, quite briefly, which are the main issues and the related research topics, and finally, I will indicate you what could be the next steps.

3. Implementing national EHR strategies in Europe: organisational, social and political issues
1. New topics for Eurorec ?
Then, why Eurorec could be concerned by the social issues of national EHR implementation ?

4. National EHR Implementation
A radical innovation facing:
Numerous technological issues
But also political, organisational and social issues
Possible failures because of non-technical issues
Social, cultural and organisational challenges at the core of EHR adoption
Failures due to limited knowledge or consideration for these issues
You know, better than me, that EHR development and implementation is still facing many numerous technological issues: (today and in the following days, there will be various discussions on technological issues such as interoperability and standardisation (stendedaï’zetion) of data, data privacy and safety …) These technical requisites are important but may be they are not the most difficult to address.
Why, Because EHR implementation is not simply a technical matter: It has political, organisational, social aspects (and I can add also economical, ethical, legal aspects as a part of the previous ones). Not only by the social scientists themselves, but also by the decision makers and the stakeholders consider that these aspects are very challenging for succeeding a sustainable (susteïneble) implementation of EHR. It is also obvious that many past (and also sometimes more recent) examples have proven that the limited knowledge of these issues or the lack of their consideration may lead (lid) to complete failures (‘feïleurz).

5. National EHR Implementation
A socio-technical innovation
Requires management of change at all levels & dimensions
It is the reason why social scientists describe EHR implementation as a socio-technological innovation. That means that this innovation has two components: social (in its broader sense) and technological ones. But these two components are fully (faulli) linked together and each of them has a major impact on the other one
Therefore, there is a great need for managing the changes taking into consideration both dimensions.

6. Organisational, social and political issues: New topics for Eurorec ?
European dimension
Many European countries already engaged
Lack of experience sharing and best practice exchanges
Eurorec scope and goals
Dissemination of information based on European experiences
Organisational, cultural and social issues
Complementary with existing projects :
Q-Req project
RIDE roadmap
So, what’s the links with Eurorec ? On one hand, the national HER implementation has an European dimension: many member states are already engaged in such a process or are on the verge of engaging in the process. At my knowledge, between the member states, there is not so much exchanges of experiences or of best practises related to the socio-organisational concerns. On the other hand, it is clearly expressed in the statutes that it is one of the major roles of Eurorec to foster international cooperation and dissemination of information regarding health records based on European experiences, and in the annex of the Eurorec articles the Organisational, cultural and social issues are mentioned in the tentative (‘tentative) list of working parties. Therefore, for me, as a quite external person, it is obvious that these topics fit within the goals of Eurorec, specially in their european dimensions.
Moreover, I can say that such topics are fully complementary with existing projects
With Q-Req :because the accommodation of quality labelling and certification must take into consideration at least the organisational and the social issues.
With RIDE : because the interoperability will lead to an harmonization and standardisation of the clinical procedures with the cultural components they include.

7. 2. Main issues and research topics
Implementing national EHR strategies in Europe: organisational, social and political issues
2. Main issues and research topics
Therefore,now I would like to review briefly what are the main political, organisational and social issues and I will indicate some research questions , considering the European level, I mean, the importance to compare the experiences and the practices in different European countries

8. National EHR implementation: Political issues
Strategy:
Political vision
Political decision
Management at the political level
Dynamic & very complex process
Introduction of a major innovation
Many actors involved
Many changes during the process
First, the political issue
We know that The decision of national HER adoption is highly political (1) and the national strategy usually starts with a political vision, then is supported by a political decision and is managed at the political level, even if its management is delegated to a special body,
IN fact the overall process is similar to the introduction of a major innovation at the national level (2) : it is a dynamic and very complex process including political decision, definition of the objectives, the conditions and the timing, including the negotiations for the technical object, the adjustments following the pilot (païlot) phase, and finally a phase of production and implementation. It involves many different actors : among them, decision makers, national authorities, engineers (endziniers) and industrialists, health professionals and citizens
Past experiences have shown that the political vision evolves progressively throughout the process for technical reasons, but not only . Hence the final implementation does not correspond to the starting vision. These changes must be managed at the political level.

9. National EHR implementation: Research topics on political issues
Governance of the system
Decision process
Institutional design
Actors involved
Funding mechanisms & financial models
Accompanying legal and regulatory measures
What could be interesting topics to be studied on the political aspects and at the European level ?
The overall governance of the system is one of them, with the analysis, the characterisation, and the comparison of the decisional process, of the institutional design (dizaïn) and of the actors involved in the process
Another important question is related to the funding mechanisms and we can anticipate that exist different financial models according to the national policies
And lastly, the implementation of accompanying (ekampeniing) legal and regulatory measures is an interesting topic to study and to compare from one country to another one.

10. National EHR implementation: Organisational issues
Impact on the National Healthcare system and its organisation
Changes in the healthcare practices
Changes in the role of the actors
Now, if we address the organisational aspects 1) It is well known that EHR implementation will impact on the national healthcare system. Even we can say that one objective of national EHR implementation is viewed as an essential leverage (‘li:veridz) to reform the national health system
2. It is also well known that EHR implementation will change the health practices, for example standardizing (stendedaïzing) the medical procedures, modifying (ma/odifaïing) the health care regulation, allowing more patient mobility,
3. And lastly, EHR implementation will change the respective role of the professionals, the distribution of the work, the flow of information

11. National EHR implementation: Research topics on organisational issues
Management of organisational change
Involvement and participation of users:
health professionals
citizens
Therefore at the European level, it would be important to analyse how these organisational changes are managed during the implementation process. One of the major issue being how and in which measure the users (the health professionals and the citizens who are the end users) are associated to the process; how they are involved in the decision process, how they participate to the different phases of the project, how they can influence the decisions

12. National EHR implementation: Social issues
Potential conflict with cultural or social values, eg:
Radical cultural change of healthcare tools
Change in respective roles of health professionals & patients
Empowerment of patients and citizens
Lastly, the social issues are not than less more important because EHR implementation could induce important conflicts with cultural or social values
For health professional, for example, EHR is almost diametrically opposed to the traditional medical record NOt only from a technical point of view but also from a cultural point of view…
EHR implementation will also place the patients in a field exclusively reserved until now to Health professionals, reducing the asymmetry of their respective role and allowing the patients to be more responsible, more informed and more concerned about their own health, what we called more empowered.

13. National EHR implementation: Research topics on social issues
Identification of controversies
User’s acceptance and/or resistance
Therefore, many questions could be developed from a research point of view, allowing, for examples to identify (aidentifaï) what we call the controversies, that means the conflicts that could occur at each moment of the innovation process. The knowledge of the controversies will allow to understand what must be done to raise (reiz) the users resistance, and finally how to facilitate the user’s acceptance

14. Implementation of national EHRs strategy: Organisational, social and political issues
3. Next steps
After this brief and quite incomplete presentation on the social issues, it is time to offer some ways for the future. What could be done ?

15. Next steps: National and European level
For decision makers:
Encouragement & funding of studies and projects on social aspects of EHR implementation
Experience sharing and benchmarking of best practices between Member states
For researchers
Development & reinforcement of a scientific community at the European level
Research projects and studies
Dissemination of expertise to decision makers
I will be brief on this very general slide which presents what could be done (and it is already done) at the national and European levels:
First by the decision makers, who can encourage and fund studies and research on the social aspects of EHR implementation, who can favour experience sharing and benchmarking of the best practices between the member states
And by researchers, who must develop and join their forces and competences at the European level, who must develop research project and who must disseminate their expertise to the decision makers and to the engineers (endziniers)

16. Next steps:Eurorec level
Consideration and prioritization of social aspects
Participation to research projects
e.g. EHR-IMPLEMENT
Establishment of a working group associating technical and social researchers
And I will end by allowing my self to make some suggestions for Eurorec. First, Eurorec could consider social issues (in the broadest sense) as a priority, besides the technical ones and engage some news actions.
For example, Eurorec may participate to research projects. This already started with the project EHR implement. This project associates seven partners including Eurorec and three Prorec and has been submitted to the last call of the work program of public health managed by the DG Health and consumer protection. This project has been positively evaluated and is now under negotiation with the EC.
If it works, what I hope, this would be the a very important involvement of Eurorec in the social field.
Beside, Eurorec could also put in place a working group associating social science researchers, but also technical researchers and stakeholders to define the research priorities, to elaborate a working program, to favour European cooperation…
Whatever the role of Eurorec, I hope important, , I will remain absolutely certain that there is an urgent need to strengthen (strenthen) the European competences, quite rare and sometimes not well known to deal with the social issues.

17. Conclusions
A real need exists for studying social, political and organisational aspects
This need should not be underestimated in National EHR implementation strategies
A lot can be learnt from social sciences
This will be my conclusion:

18. Thank you
“No success, no social acceptability without participation, without representation of actors, of innovators, of producers, of intermediaries, of political authorities and of end users”
Michel Callon
And before thanking you for your attention, I would like to remind the words of Michel Callon who is a very famous sociologist of innovation: there is