**2. Context of innovation within the PITES scenario**

#### **2.1. Evaluation of services based on telemedicine**

#### *2.1.1. Current context of the evaluation of e-services*

It is important to consider that innovation in telehealth does not only rest in technological advances. The system of innovation in this domain is very complex and interdependent. A fusion of technology with health care knowledge and the organization of health care systems is necessary together with measures to empower the users and a redefinition of the contact of

In this chapter, an experience is described in the conception, design, implementation and evaluation of a Platform of Innovation in Telehealth Systems (PITES) oriented at improving

The PITES platform is a stable and public innovation infrastructure. It is made up of a technological platform, services and tools, with its use directed at research groups, public or private entities and organizations, with the objective of offering support for the obtaining of evidence on new models for health care provision based on ICT (Telehealth) in scenarios

PITES is directed at broaching two main objectives: a) facilitating and accelerating the development of telehealth applications by making available technological infrastructures which in another way would not be tackled or would have to be designed and constructed from scratch by each project, and b) promote interoperability through the adoption of open standards for the communication of medical data and information (semantic interoperability). PITES stems from experience and lessons learned over 15 years in the design, implementation and use of telehealth applications in different environments and contexts of real application, supported by a large number of pilot projects and trials. PITES currently serves as an infra‐ structure for diverse projects in different locations in Spain. PITES also forms part of the Accion

The PITES platform supports research or innovation projects, not health care activities nor commercial services. The platform permits different telehealth projects to be implemented in a flexible and transparent manner using different local approximations and contexts of use for both professionals and patients. PITES incorporates the philosophy of separating the applica‐

As an R&D&I platform it has been conceived to be flexible, functionally transparent, secure and with the capacity to evolve and coexist with other platforms (for research or clinical use) by means of technical and semantic operability mechanisms based on standards. Technolog‐ ically, it is aligned with the current convergence framework for the provision of digital services

PITES follows an open innovation model promoted from the knowledge of the professional health users for the application of secure, accessible and interoperable telehealth environments using open standards. The PITES digital ecosystem gives each Project the freedom to design

The structure of the chapter is as follows: The two goals of the PITES innovation activi‐ ties are described in section 2. The obtaining of evidence (section 2.1) and the interoperabil‐ ity of the clinical information (section 2.2). As regards the obtaining of evidence, we begin

B3 of the European Innovation Partnership for Active and Healthy Ageing [4].

the professionals with the patients.

164 Telemedicine

related to chronic illness and dependency.

tions of the infrastructures that support them.

on IP networks using Web technologies and SOA.

and implement its protocols.

the health care of chronic, fragile and dependent patients.

One of the permanent challenges facing e-health, and therefore telemedicine and its effects is the obtaining of scientific, generalized and reliable evidence (transferable between different contexts) on it. There are numerous reasons for evaluation: promotional, pragmatic, ethical, medical-legal, even academic. The objective is to promote and legitimize practices of excel‐ lence, evaluate the policies, regulations and national legislations on e-health and value its impact in terms of efficiency and technical and clinical effectiveness, impact on the organiza‐ tion, health staff, costs, patient satisfaction and personal ethical health aspects, confidentiality and safety.

The recommendation for evaluation has been endorsed from multiple authorities and inter‐ national organizations such as the World Health Organization in its "eHealth Program for Health-Care Delivery" (eHCD) [5] and the "Global Observatory for eHealth" [6], which established that services based on e-health will be essential when they demonstrate that they are based on evidence, requiring well-defined agreed specifications and criteria for it, and validated by means of controlled experimental trials or by consensus widely accepted by experts. Also within the ambit of the European Union, by means of eEurope initiatives [7] or i2010 [8], the need to strengthen the aspects of demonstration and evaluation in projects has been made clear to allow the complete analysis of the results to be undertaken and make available the evidence of quality for the drawing up and dissemination of directives on good practices.

which have opened up new ways and action strategies related to evaluation, as well as

PITES: Telemedicine and e-Health Innovation Platform

http://dx.doi.org/10.5772/57021

167

In the health environment, an intervention is a deliberate action through which it is hoped to bring about an effect or change in any aspect of health which is the object of the aforementioned action. The intervention may be directed at individuals, collectives or at a population level; and the purpose may be a pathology, a behavior, etc. The concept of a "complex intervention" [17] arises from the evolution of the interventions that are extended or influenced by or immersed in organizational aspects, processes, and technological adoption. From the perspec‐ tive of complexity theory, a "complex intervention" is an intervention in which components that act independently and interdependently become involved, and are characterized by the difficulty in determining which participating agents are active elements in the intervention and how some are related to others and with the rest of the agents, and this represents a challenge as regards the definition, development, documentation, reproduction and evalua‐

It is evident that any intervention based on e-health services constitutes in itself a "complex intervention" [18]. Research into interventions has been a natural field of development of research into health services and its objective has been to gain knowledge into the impact of these interventions at a population level. Traditionally within the ambit of health, the clinicalepidemiology evaluation methodology most widely recognized and accepted as the "gold standard" in order to obtain evidence of the maximum quality is the Randomized Controlled Trial (RCT) [19]. By means of an RCT the validity and effectiveness of an intervention is determined quantitatively as are the possibilities of the transfer or generalization of the results

Historically, RCTs have been used in the evaluation of interventions in the context of acute illnesses, consequently, in short-term interventions and acute care hospital environments. It is a well-described fact that when this evaluation methodology is adopted in other context that imply periods of mid- to long-term intervention, such as, for example in the case of chronic illnesses, or complex environments such as e-health interventions (complex interventions), intrinsic practical limitations emerge [20]. These limitations have to be taken into account not only in the design of the studies and the evaluation of the results, but also the planning of the intervention itself [21], which has to adopt centered services design on the user [10], which also take into consideration the organization in which the new services are going to be implemented together with social aspects [22] and even the implementation process itself [23]. As a response to these challenges, and inspired in some cases in the industrial processes [24], the evaluation strategies that are shown to be potentially more efficient in the evaluation of ehealth services are those which combine longitudinal synergy [25], itinerary [26], progressive‐ ness [27], dissemination of the innovation [28], and a simultaneous consideration of the organizational aspects and human behavior from the perspective of complexity and complex adaptive systems [29]. Following these directives, "hybrid" evaluation models have been proposed that, setting out from an eclectic point of view, combine the characteristics of the

improving the quality and adoption of innovations.

tion of the intervention.

obtained.

*2.1.2. Complex interventions and hybrid evaluation methodologies*

Traditionally, the evaluation of e-health services has brought to light significant difficulties giving rise to uncertainties and thus resistance to its implementation by consultants and managers. The belief that the implementation of formal evaluation processes constitutes an obstacle for developers and the commercial and economic context is currently being dismissed. It has come to light through demonstration that the systems are effective, cost-effective safe, robust, accessible, and usable, as well as a source of benefits and knowledge, an aspect which is known in the technological sector as "evidence-based business" [9]. Nevertheless, it is evident that the organizations and health systems determine a priori numerous factors that, in evaluation interventions, condition the work frameworks and their implementation, and therefore the potential final results. In this sense, there still remain significant methodological challenges and practical implementations mainly related to two aspects: 1) the interdiscipli‐ nary nature of the field of e-health, and 2) the intrinsic complexity of the context in which the evaluations have to be carried out.

As regards the first aspect, it is an obvious fact that e-health constitutes a heterogeneous and interdisciplinary field of science with which two areas of research converge fundamentally (in turn, trans-disciplinary): the computer aspects of health (technological ambit) and research into health services (socio-health ambit). Traditionally, all of them use different languages, cultures, reasons and operating conditions which have generated divergent working templates [10]. These silos of parallel competencies are a cause of additional difficulties in the develop‐ ment of e-health. In the past decades efforts have been directed at achieving a mutual recog‐ nition between the respective disciplines and a search for synergies and single paradigms [11].

The second aspect refers to the intrinsic complexity of the context in which the evaluations have to be carried out. During the past two decades, the results achieved related to the dissemination of the innovation, knowledge and experience in the ambit of health have not all been as satisfactory as was hoped. The cause would have to be sought in some of the work strategies more orientated towards the resolution of complicated problems rather than a complex problem [12]. Starting from this idea, different authors have carried out an approxi‐ mation of the organizations and health practice from the perspective of complexity theory, contemplating them as adaptive complex systems [13, 14, 15, 16, 17]. Parallelisms related to questions such as changing behaviors, interrelated, yet not totally predicable, whose evolution and behavior patterns respond to the relationships between their components on the basis of non-explicit rules, the appearance of emerging behaviors, "attractor patterns", effects of selforganization, the influence of "shadow systems", etc. have come to light. By means of the aforementioned work, it has become possible to explain different aspects of behavior dynamics in relation to clinical care, education, leadership and management in health environments, which have opened up new ways and action strategies related to evaluation, as well as improving the quality and adoption of innovations.

#### *2.1.2. Complex interventions and hybrid evaluation methodologies*

validated by means of controlled experimental trials or by consensus widely accepted by experts. Also within the ambit of the European Union, by means of eEurope initiatives [7] or i2010 [8], the need to strengthen the aspects of demonstration and evaluation in projects has been made clear to allow the complete analysis of the results to be undertaken and make available the evidence of quality for the drawing up and dissemination of directives on good

Traditionally, the evaluation of e-health services has brought to light significant difficulties giving rise to uncertainties and thus resistance to its implementation by consultants and managers. The belief that the implementation of formal evaluation processes constitutes an obstacle for developers and the commercial and economic context is currently being dismissed. It has come to light through demonstration that the systems are effective, cost-effective safe, robust, accessible, and usable, as well as a source of benefits and knowledge, an aspect which is known in the technological sector as "evidence-based business" [9]. Nevertheless, it is evident that the organizations and health systems determine a priori numerous factors that, in evaluation interventions, condition the work frameworks and their implementation, and therefore the potential final results. In this sense, there still remain significant methodological challenges and practical implementations mainly related to two aspects: 1) the interdiscipli‐ nary nature of the field of e-health, and 2) the intrinsic complexity of the context in which the

As regards the first aspect, it is an obvious fact that e-health constitutes a heterogeneous and interdisciplinary field of science with which two areas of research converge fundamentally (in turn, trans-disciplinary): the computer aspects of health (technological ambit) and research into health services (socio-health ambit). Traditionally, all of them use different languages, cultures, reasons and operating conditions which have generated divergent working templates [10]. These silos of parallel competencies are a cause of additional difficulties in the develop‐ ment of e-health. In the past decades efforts have been directed at achieving a mutual recog‐ nition between the respective disciplines and a search for synergies and single paradigms [11].

The second aspect refers to the intrinsic complexity of the context in which the evaluations have to be carried out. During the past two decades, the results achieved related to the dissemination of the innovation, knowledge and experience in the ambit of health have not all been as satisfactory as was hoped. The cause would have to be sought in some of the work strategies more orientated towards the resolution of complicated problems rather than a complex problem [12]. Starting from this idea, different authors have carried out an approxi‐ mation of the organizations and health practice from the perspective of complexity theory, contemplating them as adaptive complex systems [13, 14, 15, 16, 17]. Parallelisms related to questions such as changing behaviors, interrelated, yet not totally predicable, whose evolution and behavior patterns respond to the relationships between their components on the basis of non-explicit rules, the appearance of emerging behaviors, "attractor patterns", effects of selforganization, the influence of "shadow systems", etc. have come to light. By means of the aforementioned work, it has become possible to explain different aspects of behavior dynamics in relation to clinical care, education, leadership and management in health environments,

practices.

166 Telemedicine

evaluations have to be carried out.

In the health environment, an intervention is a deliberate action through which it is hoped to bring about an effect or change in any aspect of health which is the object of the aforementioned action. The intervention may be directed at individuals, collectives or at a population level; and the purpose may be a pathology, a behavior, etc. The concept of a "complex intervention" [17] arises from the evolution of the interventions that are extended or influenced by or immersed in organizational aspects, processes, and technological adoption. From the perspec‐ tive of complexity theory, a "complex intervention" is an intervention in which components that act independently and interdependently become involved, and are characterized by the difficulty in determining which participating agents are active elements in the intervention and how some are related to others and with the rest of the agents, and this represents a challenge as regards the definition, development, documentation, reproduction and evalua‐ tion of the intervention.

It is evident that any intervention based on e-health services constitutes in itself a "complex intervention" [18]. Research into interventions has been a natural field of development of research into health services and its objective has been to gain knowledge into the impact of these interventions at a population level. Traditionally within the ambit of health, the clinicalepidemiology evaluation methodology most widely recognized and accepted as the "gold standard" in order to obtain evidence of the maximum quality is the Randomized Controlled Trial (RCT) [19]. By means of an RCT the validity and effectiveness of an intervention is determined quantitatively as are the possibilities of the transfer or generalization of the results obtained.

Historically, RCTs have been used in the evaluation of interventions in the context of acute illnesses, consequently, in short-term interventions and acute care hospital environments. It is a well-described fact that when this evaluation methodology is adopted in other context that imply periods of mid- to long-term intervention, such as, for example in the case of chronic illnesses, or complex environments such as e-health interventions (complex interventions), intrinsic practical limitations emerge [20]. These limitations have to be taken into account not only in the design of the studies and the evaluation of the results, but also the planning of the intervention itself [21], which has to adopt centered services design on the user [10], which also take into consideration the organization in which the new services are going to be implemented together with social aspects [22] and even the implementation process itself [23].

As a response to these challenges, and inspired in some cases in the industrial processes [24], the evaluation strategies that are shown to be potentially more efficient in the evaluation of ehealth services are those which combine longitudinal synergy [25], itinerary [26], progressive‐ ness [27], dissemination of the innovation [28], and a simultaneous consideration of the organizational aspects and human behavior from the perspective of complexity and complex adaptive systems [29]. Following these directives, "hybrid" evaluation models have been proposed that, setting out from an eclectic point of view, combine the characteristics of the traditional evaluation models (such as RCT) and the different perspectives of each of the "stakeholders" related to the process [10, 30-33].

phases. In this context, the risk is related to the resources invested in the evaluation: economic, infrastructures, human, etc. These progressive evaluation models establish decision-making elements between successive stages ("stakeholders") who, on the one hand, are recipients of the evaluation results of the previous phase. On the other hand, between its functions, it may be that which decides whether the evaluation progresses or not to the following phase, or if it is necessary to activate an iterative cycle with the objective of modifying some aspects of the

PITES: Telemedicine and e-Health Innovation Platform

http://dx.doi.org/10.5772/57021

169

In these methodologies an interdisciplinary vision of the process is combined assuming the diversity and complexity of the environment by means of aspects such as: 1) dealing with the evaluation process in successive phases by contemplating an ambit of differentiated evidence at each stage, 2) consider at each stage that the "stakeholders" are more suitable for deciding the continuation, closure or repetition (health and non-health professionals, patients, carers/ caretakers, evaluation agencies, health authorities, the research group) and 3) make it possible to gain progressive knowledge on the intervention which at the same time acts as a risk control mechanism which establishes a road map for the actors and agents involved, offering a clear

The proposal for "hybrid methodologies" assumes a significant advance in the evaluation of "complex e-health interventions" in the health context, conciliating holistic focuses with widely-accepted traditional validation procedures such as RCT. However, to date, the hybrid methodologies constitute general and not very specific proposals. In spite of setting out clear objectives in each of its phases, they are clearly non-specific in some relevant aspects lending it a generic character and therefore a non-direct application. The difficulties are aggravated even more by taking into account that the context in which the evaluations have to be carried out, there are some health systems unprepared for it, highlighting in the majority of cases, a lack of support and recourses necessariy to make the implementation of the interventions more

"Implementation" is understood as the full assimilation of a service by organizations for its routine use and sustained from the permanent recourses and infrastructures. The implemen‐ tation of e-health services, and in a wide sense the ICTs as a support to health attention, is in itself a complex process that has to be managed [34, 35], and which implies numerous determining factors in different ambits: organizational, technological, work and work flows and the individuals themselves. The implementation of e-services assumes the insertion of technology, reengineering of assistance processes, redistribution of resources, modification or addition of new roles, articulation of processes and collaboration models between different assistance levels, etc. Currently, the implementation of e-health services is still too slow and it is a fact that the said process is unsuccessful on a large number of occasions [36]: the lack of suitable infrastructures, the impossibility of finding financing, complications with the scala‐

In this sense the strategy of disseminating innovation and the management of change is relevant in organizations such as the "Breakthrough Series Learning Model" [28, 37], "Con‐

service and restart or resume the evaluation at a determined stage or point.

idea of where the project is and what is required at each stage.

*2.1.3. Implementation as an element of complexity in the evaluation*

bility and uncertainty of efficiency and sustainability.

visible when carrying out the evaluation.

The "hybrid models" have the capacity to tackle the evaluation as a successive process, in stages, to obtain the evidence in different ambits, by distinguishing at each phase which collectives have to be undoubtedly satisfied with the new resource, and for which ones is achieving the optimum result optional [25]. This division of the evaluation into consecutive stages or phases (see Figure 1) is a response to the complexity that is dealt with as a generation process and successive accumulation of knowledge of the interventions making each phase correspond to a different ambit of evidence. In general three generic phases are established: the first one related to the evaluation of the concept and the prototype of the service, the second one related to the evaluation of the results relative to the impact of the service in innovation in processes and health results in controlled environments, and a third pragmatic evaluation phase related to the long-term impact in production environments.

The progress of the evaluation is materialized by generating useful information, appropriate for each phase, and in this way reducing the profile of uncertainty or ambiguity in successive phases. It is, in short, a question of a gradual increase in knowledge on the intervention by predicting valuable information in advance which allows the risk to be reduced in successive phases. In this context, the risk is related to the resources invested in the evaluation: economic, infrastructures, human, etc. These progressive evaluation models establish decision-making elements between successive stages ("stakeholders") who, on the one hand, are recipients of the evaluation results of the previous phase. On the other hand, between its functions, it may be that which decides whether the evaluation progresses or not to the following phase, or if it is necessary to activate an iterative cycle with the objective of modifying some aspects of the service and restart or resume the evaluation at a determined stage or point.

In these methodologies an interdisciplinary vision of the process is combined assuming the diversity and complexity of the environment by means of aspects such as: 1) dealing with the evaluation process in successive phases by contemplating an ambit of differentiated evidence at each stage, 2) consider at each stage that the "stakeholders" are more suitable for deciding the continuation, closure or repetition (health and non-health professionals, patients, carers/ caretakers, evaluation agencies, health authorities, the research group) and 3) make it possible to gain progressive knowledge on the intervention which at the same time acts as a risk control mechanism which establishes a road map for the actors and agents involved, offering a clear idea of where the project is and what is required at each stage.

The proposal for "hybrid methodologies" assumes a significant advance in the evaluation of "complex e-health interventions" in the health context, conciliating holistic focuses with widely-accepted traditional validation procedures such as RCT. However, to date, the hybrid methodologies constitute general and not very specific proposals. In spite of setting out clear objectives in each of its phases, they are clearly non-specific in some relevant aspects lending it a generic character and therefore a non-direct application. The difficulties are aggravated even more by taking into account that the context in which the evaluations have to be carried out, there are some health systems unprepared for it, highlighting in the majority of cases, a lack of support and recourses necessariy to make the implementation of the interventions more visible when carrying out the evaluation.

#### *2.1.3. Implementation as an element of complexity in the evaluation*

traditional evaluation models (such as RCT) and the different perspectives of each of the

The "hybrid models" have the capacity to tackle the evaluation as a successive process, in stages, to obtain the evidence in different ambits, by distinguishing at each phase which collectives have to be undoubtedly satisfied with the new resource, and for which ones is achieving the optimum result optional [25]. This division of the evaluation into consecutive stages or phases (see Figure 1) is a response to the complexity that is dealt with as a generation process and successive accumulation of knowledge of the interventions making each phase correspond to a different ambit of evidence. In general three generic phases are established: the first one related to the evaluation of the concept and the prototype of the service, the second one related to the evaluation of the results relative to the impact of the service in innovation in processes and health results in controlled environments, and a third pragmatic evaluation

The progress of the evaluation is materialized by generating useful information, appropriate for each phase, and in this way reducing the profile of uncertainty or ambiguity in successive phases. It is, in short, a question of a gradual increase in knowledge on the intervention by predicting valuable information in advance which allows the risk to be reduced in successive

"stakeholders" related to the process [10, 30-33].

168 Telemedicine

**Figure 1.** Generic structure of the hybrid models.

phase related to the long-term impact in production environments.

"Implementation" is understood as the full assimilation of a service by organizations for its routine use and sustained from the permanent recourses and infrastructures. The implemen‐ tation of e-health services, and in a wide sense the ICTs as a support to health attention, is in itself a complex process that has to be managed [34, 35], and which implies numerous determining factors in different ambits: organizational, technological, work and work flows and the individuals themselves. The implementation of e-services assumes the insertion of technology, reengineering of assistance processes, redistribution of resources, modification or addition of new roles, articulation of processes and collaboration models between different assistance levels, etc. Currently, the implementation of e-health services is still too slow and it is a fact that the said process is unsuccessful on a large number of occasions [36]: the lack of suitable infrastructures, the impossibility of finding financing, complications with the scala‐ bility and uncertainty of efficiency and sustainability.

In this sense the strategy of disseminating innovation and the management of change is relevant in organizations such as the "Breakthrough Series Learning Model" [28, 37], "Con‐ tinuous Quality Improvement Model" [38], "Performance Improvement Model" [39], "De‐ ming Model" [26], among others. Equally the combination and putting into practice of "topdown" and "bottom-up" strategies with solid institutional support (political and organizational), leadership and participation of health and non-health professionals, the specification of clear programs for change and the maintenance of permanent "feedback" from all of the stakeholders.

What type of evidence on the intervention can be reached? Finally, what are the advantages of achieving a certain level of evidence on the intervention during the early stages of the

PITES: Telemedicine and e-Health Innovation Platform

http://dx.doi.org/10.5772/57021

171

The adoption of a strategy of "minimum implementation" during the initial phases of the

**•** It makes an initial distancing of the conditions of the local outline possible, facilitating the work of identifying the functional components of the intervention and in this way obtain

**•** Increase the possibility of success in multicentre interventions since a greater homogeneity in the interventions can be achieved without compromising either its internal or external

**•** It implies the professionals (health and non-health) before getting to full implementations, thus facilitating the "top-down", "bottom-up" and "peer-to-peer" dynamic during the

**•** It increases the confidence of the promoters and "stakeholders" to continue the evaluation of the intervention on making it possible to obtain early evidence. If the evidence obtained is negative, it permits: 1) to have the possibility and margin of maneuver to carry out rethinks of the intervention that will still be viable; 2) if it were inevitable, interrupt the progress of the evaluation of the intervention having been committed to up to the moment of minimum

**•** The putting into practice of a strategy of "minimum implementation" in the initial phases of the evaluation requires the resources and infrastructures required to make the deploy‐ ment of the intervention viable to be contributed to the organization externally for the aforementioned period of time. Under ideal conditions, it would only need the participation of the health and non-health professionals and as an organizational resource, facilitating externally all of the support necessary for the deployment of the experimental studies as

**•** A "minimum implementation" during the initial phases does not shorten the total evalua‐ tion period since the process does not conclude until a complete adaptation of the inter‐ vention at the local context is achieved. However, it does make the progressive obtaining of evidence on the intervention possible by maintaining of the resources committed in the initial phases since they are those that contribute the greatest uncertainty and risk and therefore those that have to be the most protected from the effects of additional complexity

**•** It reduces institutional resistance due to the lesser commitment to initial resources.

evaluation?

validity.

process

resources.

part of the methodological support

evaluation offers the following advantages:

greater general or transferable transparency evidence.

Finally, the following considerations have to be taken into account:

that contribute a more wide-ranging implementation process.

The PITES platform responds to the aspects below:

There is the opinion in which it is necessary to deal with implementation strategies that accompany design and development, in such a way that the new e-services are compatible with the infrastructures, purposes and local demands, and that the organization and the main "stakeholders" are involved in the local context and extended by adopting wide-ranging focuses so that the solutions are not extremely localized [35].

It seems evident then that implementation is probably the process that contributes the greatest complexity to the insertion of new e-services into the organizations, and therefore has a significant impact on the strategies for the search for evidence and evaluation on the said eservices. Nevertheless, the implementation forms part of the longitudinal evaluation process and therefore cannot be left out; the evaluation process cannot conclude until the e-service has been totally implemented into the organization and has had a mutual integration with the work flows, since there are extremes that cannot be determined without an adaptation being reached at a local context.

However, assuming the need to carry out an early implementation of the e-service into the health organization in order to be evaluated, it would have implications that might compro‐ mise the internal and external validity of the said evaluations, and even the feasibility itself of carrying it out. Among others, the most relevant implications are:


Therefore, it is relevant to develop proposals on how to make the need for the implementation and evaluation of an e-service in an organization compatible. In other words, within the framework of the "hybrid methodologies", search for evidence on an e-service at the same time by controlling the complexity that the implementation process introduces [40].

In this sense the following questions are posed: Is it possible to delay or at least contain within some essential minimums the implementation of the intervention in the health organization until the final stages of the evaluation? What type of resources or infrastructures is it necessary to authorize to make the deployment of these conditions viable? And under these conditions: What type of evidence on the intervention can be reached? Finally, what are the advantages of achieving a certain level of evidence on the intervention during the early stages of the evaluation?

tinuous Quality Improvement Model" [38], "Performance Improvement Model" [39], "De‐ ming Model" [26], among others. Equally the combination and putting into practice of "topdown" and "bottom-up" strategies with solid institutional support (political and organizational), leadership and participation of health and non-health professionals, the specification of clear programs for change and the maintenance of permanent "feedback" from

There is the opinion in which it is necessary to deal with implementation strategies that accompany design and development, in such a way that the new e-services are compatible with the infrastructures, purposes and local demands, and that the organization and the main "stakeholders" are involved in the local context and extended by adopting wide-ranging

It seems evident then that implementation is probably the process that contributes the greatest complexity to the insertion of new e-services into the organizations, and therefore has a significant impact on the strategies for the search for evidence and evaluation on the said eservices. Nevertheless, the implementation forms part of the longitudinal evaluation process and therefore cannot be left out; the evaluation process cannot conclude until the e-service has been totally implemented into the organization and has had a mutual integration with the work flows, since there are extremes that cannot be determined without an adaptation being

However, assuming the need to carry out an early implementation of the e-service into the health organization in order to be evaluated, it would have implications that might compro‐ mise the internal and external validity of the said evaluations, and even the feasibility itself of

**•** Carry out local adaptations of the intervention, which could compromise the capacity for

**•** Extend the envisaged period of time prior to the beginning of the evaluation, a fact that might compromise the committed administrative periods, especially in the context of

**•** Make public the high risk of not achieving homogeneous deployments in interventions which, in order to achieve a sufficient volume of users, require multicentre scenarios

Therefore, it is relevant to develop proposals on how to make the need for the implementation and evaluation of an e-service in an organization compatible. In other words, within the framework of the "hybrid methodologies", search for evidence on an e-service at the same

In this sense the following questions are posed: Is it possible to delay or at least contain within some essential minimums the implementation of the intervention in the health organization until the final stages of the evaluation? What type of resources or infrastructures is it necessary to authorize to make the deployment of these conditions viable? And under these conditions:

time by controlling the complexity that the implementation process introduces [40].

focuses so that the solutions are not extremely localized [35].

carrying it out. Among others, the most relevant implications are:

**•** To deal "suddenly" with the complexity of the implementation process

the generalization of the results obtained and therefore its transfer capacity

all of the stakeholders.

170 Telemedicine

reached at a local context.

research projects

The adoption of a strategy of "minimum implementation" during the initial phases of the evaluation offers the following advantages:


Finally, the following considerations have to be taken into account:


The PITES platform responds to the aspects below:


#### *2.1.4. Evaluation methodology of e-services in PITES*

Within the framework of the PITES platform the specification of an evaluation methodology has been carried out aligned with the hybrid methodologies for the search for evidence into the new assistance services based on telemedicine directed at chronic illness.

The PITES evaluation methodology is made up of four consecutive pages (Figure 2): pilot phase, exploratory trial phase, clinical trial phase, and the implementation phase. Responding to the classic sequence in hybrid models, an initial stage related to the evaluation of the concept and the configuration of the intervention prototype (pilot phase), followed by an intermediate step related to the evaluation of the results relative to the impact of the intervention in the innovation in health processes and results (exploratory trial and clinical trial phases), and a third pragmatic evaluation stage related to the long-term impact of the intervention in production environments (implementation phase).

working conditions, together with well-trained and motivated users. It is not a question of carrying out a comparison study since the focus continues to be on the technological system and its optimization; therefore throughout the development of this phase, proposals for improving the prototype are gathered and then sent to the laboratory. The technological prototype is developed externally to the health organization with the participation of health professionals among which include those belonging to the research group and the resources and infrastructures required are facilitated externally to the health organization by the

PITES: Telemedicine and e-Health Innovation Platform

http://dx.doi.org/10.5772/57021

173

To pass from phase 1 to phase 2 a positive evaluation of the results of phase 1 is necessary in relation to: the test of the concept, the technical viability, the acceptability of the health professionals, and the satisfaction of the users of the system. The decision is brought about within the ambit of the research group itself and is made effective by the promoting or

Once the technological prototype has been optimized, it is time to begin the evaluation of the intervention in the health aspect of clinical efficiency. For this and, in agreement with the requirement to maintain a controlled complexity by means of a "minimum implementation" in the health organization, it is necessary to establish the provision model by means of carrying out the intervention emphasizing the resources and infrastructures required that are going to be facilitated externally to the health organization by the PITES platform. To carry out this task the proposed procedure is the carrying out of one or more exploratory trials whose objective

PITES platform.

**Figure 2.** The PITES evaluation methodology.

financing entity.

**Exploratory trial phase**

By means of the support of infrastructures and resources that the PITES platform contributes, it is possible to carry out phases 1 to 3 (pilot, exploratory trial and clinical trial) under conditions of "minimum implementation".

The description of the phases is as follows:

#### **Pilot phase**

The objective of this phase is the evaluation of the technological prototype that is going to support the intervention as regards the quality and functioning of the prototype, usabili‐ ty, and satisfaction of the users of the prototype. Internally the process involves two consecutive tasks. Firstly, the design and development of the technological prototype under optimal laboratory conditions. This first task has the character of a concept trial, explorato‐ ry and iterative until the optimum prototype is configured. For this, it is necessary to carry out a study on the state of the art, available technologies, medical devices, communica‐ tions, etc. In second place, the carrying out of a feasibility study under controlled practi‐ cal conditions outside the laboratory. Few participants are required to carry out this initial field trial (It would be valid for the proposal of the basic model to not exceed 20 patients nor more than 5 health professionals), as is the availability of equipment under optimum

**Figure 2.** The PITES evaluation methodology.

**•** It proposes an evaluation strategy in interventions based on e-health based on the hybrid models that make the obtaining of evidence possible in the early stages implying some minimal institutional resources ("minimum implementation") in such a way that knowl‐ edge may be obtained, and at the same time, contain the complexity of the implementation

**•** It contributes a technological platform that, based on a generic conceptual model, makes possible the deployment of interventions become evaluated under conditions of "minimum implementation" during the initial phases, externally facilitating the resources and infra‐ structures necessary to the organizations, in such a way that for the health professionals, patients or other participating users, the intervention is perceived as an assistance service

Within the framework of the PITES platform the specification of an evaluation methodology has been carried out aligned with the hybrid methodologies for the search for evidence into

The PITES evaluation methodology is made up of four consecutive pages (Figure 2): pilot phase, exploratory trial phase, clinical trial phase, and the implementation phase. Responding to the classic sequence in hybrid models, an initial stage related to the evaluation of the concept and the configuration of the intervention prototype (pilot phase), followed by an intermediate step related to the evaluation of the results relative to the impact of the intervention in the innovation in health processes and results (exploratory trial and clinical trial phases), and a third pragmatic evaluation stage related to the long-term impact of the intervention in

By means of the support of infrastructures and resources that the PITES platform contributes, it is possible to carry out phases 1 to 3 (pilot, exploratory trial and clinical trial) under conditions

The objective of this phase is the evaluation of the technological prototype that is going to support the intervention as regards the quality and functioning of the prototype, usabili‐ ty, and satisfaction of the users of the prototype. Internally the process involves two consecutive tasks. Firstly, the design and development of the technological prototype under optimal laboratory conditions. This first task has the character of a concept trial, explorato‐ ry and iterative until the optimum prototype is configured. For this, it is necessary to carry out a study on the state of the art, available technologies, medical devices, communica‐ tions, etc. In second place, the carrying out of a feasibility study under controlled practi‐ cal conditions outside the laboratory. Few participants are required to carry out this initial field trial (It would be valid for the proposal of the basic model to not exceed 20 patients nor more than 5 health professionals), as is the availability of equipment under optimum

the new assistance services based on telemedicine directed at chronic illness.

process (section 2.1.4)

172 Telemedicine

integrated into the health context (section 3)

*2.1.4. Evaluation methodology of e-services in PITES*

production environments (implementation phase).

of "minimum implementation".

**Pilot phase**

The description of the phases is as follows:

working conditions, together with well-trained and motivated users. It is not a question of carrying out a comparison study since the focus continues to be on the technological system and its optimization; therefore throughout the development of this phase, proposals for improving the prototype are gathered and then sent to the laboratory. The technological prototype is developed externally to the health organization with the participation of health professionals among which include those belonging to the research group and the resources and infrastructures required are facilitated externally to the health organization by the PITES platform.

To pass from phase 1 to phase 2 a positive evaluation of the results of phase 1 is necessary in relation to: the test of the concept, the technical viability, the acceptability of the health professionals, and the satisfaction of the users of the system. The decision is brought about within the ambit of the research group itself and is made effective by the promoting or financing entity.

#### **Exploratory trial phase**

Once the technological prototype has been optimized, it is time to begin the evaluation of the intervention in the health aspect of clinical efficiency. For this and, in agreement with the requirement to maintain a controlled complexity by means of a "minimum implementation" in the health organization, it is necessary to establish the provision model by means of carrying out the intervention emphasizing the resources and infrastructures required that are going to be facilitated externally to the health organization by the PITES platform. To carry out this task the proposed procedure is the carrying out of one or more exploratory trials whose objective is to experiment with the intervention, varying the deferent components and alternatives, to observe the effect of the intervention in its entirety and its consistency in different contexts, viability, participant acceptability, etc. As a result, evidence has to be obtained on the most suitable parameterization of the clinical trial (the following phase), to specify the intervention and the optimum studies.

To pass from phase 2 to phase 3 a positive evaluation of the results of the experimental studies carried out in phase 2 is needed which guarantees the viability of carrying out the controlled randomized clinical trial in order to evaluate the intervention in terms of efficiency. The decision is made within the ambit of the research group itself and put into effect by the

PITES: Telemedicine and e-Health Innovation Platform

http://dx.doi.org/10.5772/57021

175

This phase is key to the evaluation of the efficiency of the complex interventions and consists of carrying out a controlled randomized trial with all of the rigor and power required, assuming the standard design aspects that require these types of trial: inclusion and exclusion criteria, sample size, criteria and duration of the intervention, randomization and informed consent of the participants, etc. From the knowledge accumulated in phase 2, definitive decisions must be taken on the nature of the intervention in order to standardize the inter‐ vention going to be evaluated and minimize the biases that limit not only the internal but also

During this phase, unlike the previous ones, it is absolutely prohibited to make modifications in the protocol of the intervention. The minimum sample size determines the statistical power of the clinical trial and there must be the possibility of carrying out a replication of the intervention in multiple centers (multicentre trial), maintain its uniformity of implementation to guarantee the internal and external validity of the study and the generalization of the results. The participation of multiple centers contributes an additional value as it makes possible the study in different contexts of established patterns and emerging self-organization behaviors

The support of the clinical trial and the corresponding interventions (resources, logistics, and infrastructures), are carried out externally to the health organizations involved and counting exclusively on the participation of health professionals belonging to the said organizations and contributing the resources and infrastructures required by the PITES platform. It is essential that the resources and infrastructures external to the health organization do not represent a direct object of evaluation in the clinical trial, and act exclusively as a support to the operational

To pass from phase 3 to phase 4 a positive evaluation of the efficiency of the intervention in the results of the trial, together with a decision from the health authority to adopt, is necessary (for example, an autonomous health service) with the support or endorsement of a Health Technology Evaluation Agency. Therefore, the ambit of the decision is outside the scope of the research group, although its continuity and participation in phase 4 may still be relevant.

Once the evidence on the efficiency of the health of the intervention is demanded, it is necessary to adapt it to the local contexts in order to deal with two objectives: the full implementation of the intervention in the health organization in its technologic and health ambits, in such a way that it constitutes a health procedure more as regards the provision of all of the resources and infrastructures required at the margin of the external supports, and from that, the carrying out of financial cost studies and long-term studies to determine the efficiency of the intervention.

shown by the health professionals that are of doubtable use in phase 4.

promoting or financing entity.

**Clinical trial phase**

the external validity.

deployment of the intervention.

**Implementation phase**

Aspects such as identifying the key processes and results of the intervention, identifying the mechanisms through which the intervention would lead to an improvement in the results, the identification of the application difficulties or implementation of the intervention, the estab‐ lishment of the collectives or groups on those that influence the intervention by optimizing its probability of response, the determination of the components and the intensity of the inter‐ vention in accordance with the available possibilities and resources, or the evaluation of the learning curve of the skills of the users are basic aspects to be determined in order to be able to guarantee the performance in the suitable intervention in the clinical trial phase. It is also not necessary to perform an analysis and modeling of the intervention that is required to be evaluated. If it is going to be compared with a practical standard, or an improved practice (for example, the same intervention with and without the support of telemedicine), it will also be necessary to model the comparison intervention which might be the same or even more complex. As well as the modeling process, if it is possible, it may be very interesting to carry out a simulation of the intervention by means of experimenting functional aspects of the scenario, the modeling of components, the statistical and mathematical model, etc.

As regards the methodology of the exploratory trial phase, the same degree of quality of evidence is not demanded as in a controlled randomized clinical trial; while it is inacceptable methodologically to modify an intervention during the course of the controlled randomized clinical trial, a study in this phase may be developed precisely to carry out trials on the variations in the intervention and clarify which are the most appropriate with views to the clinical trial. The criterion is to carry out one or more studies with a more adaptable develop‐ ment especially as regards the rigidity of the protocols and the inclusion of patients. The carrying out of quasi-experimental studies with sample sizes that do not exceed 100 patients and 10 health professionals may be suitable in this phase.

The availability of "Living Labs" as a community experimentation context may result in an appropriate option as it would carry out formal studies in social environments with a con‐ trolled complexity. If this is not possible, it would be advisable to carry out an analysis on the context in which the intervention is going to be evaluated since the degrees of complexity which show the different health problems are diverse and dependent on the context. It is recommended to consider aspects related to: the illness itself (risk factors, co-morbidity, prevalence, etc.), the patient (lifestyle, adherence to the treatment, symptoms, etc.), and the social context (social support, socio-economic level, cultural level, etc.).

The support of the exploratory trial and the corresponding interventions (resources, logistics, and infrastructures), is carried out externally of the health organizations involved and counting exclusively on the participation of health professionals belonging to the said organizations and contributing the resources and infrastructures required by the PITES platform.

To pass from phase 2 to phase 3 a positive evaluation of the results of the experimental studies carried out in phase 2 is needed which guarantees the viability of carrying out the controlled randomized clinical trial in order to evaluate the intervention in terms of efficiency. The decision is made within the ambit of the research group itself and put into effect by the promoting or financing entity.

#### **Clinical trial phase**

is to experiment with the intervention, varying the deferent components and alternatives, to observe the effect of the intervention in its entirety and its consistency in different contexts, viability, participant acceptability, etc. As a result, evidence has to be obtained on the most suitable parameterization of the clinical trial (the following phase), to specify the intervention

Aspects such as identifying the key processes and results of the intervention, identifying the mechanisms through which the intervention would lead to an improvement in the results, the identification of the application difficulties or implementation of the intervention, the estab‐ lishment of the collectives or groups on those that influence the intervention by optimizing its probability of response, the determination of the components and the intensity of the inter‐ vention in accordance with the available possibilities and resources, or the evaluation of the learning curve of the skills of the users are basic aspects to be determined in order to be able to guarantee the performance in the suitable intervention in the clinical trial phase. It is also not necessary to perform an analysis and modeling of the intervention that is required to be evaluated. If it is going to be compared with a practical standard, or an improved practice (for example, the same intervention with and without the support of telemedicine), it will also be necessary to model the comparison intervention which might be the same or even more complex. As well as the modeling process, if it is possible, it may be very interesting to carry out a simulation of the intervention by means of experimenting functional aspects of the

scenario, the modeling of components, the statistical and mathematical model, etc.

and 10 health professionals may be suitable in this phase.

social context (social support, socio-economic level, cultural level, etc.).

contributing the resources and infrastructures required by the PITES platform.

As regards the methodology of the exploratory trial phase, the same degree of quality of evidence is not demanded as in a controlled randomized clinical trial; while it is inacceptable methodologically to modify an intervention during the course of the controlled randomized clinical trial, a study in this phase may be developed precisely to carry out trials on the variations in the intervention and clarify which are the most appropriate with views to the clinical trial. The criterion is to carry out one or more studies with a more adaptable develop‐ ment especially as regards the rigidity of the protocols and the inclusion of patients. The carrying out of quasi-experimental studies with sample sizes that do not exceed 100 patients

The availability of "Living Labs" as a community experimentation context may result in an appropriate option as it would carry out formal studies in social environments with a con‐ trolled complexity. If this is not possible, it would be advisable to carry out an analysis on the context in which the intervention is going to be evaluated since the degrees of complexity which show the different health problems are diverse and dependent on the context. It is recommended to consider aspects related to: the illness itself (risk factors, co-morbidity, prevalence, etc.), the patient (lifestyle, adherence to the treatment, symptoms, etc.), and the

The support of the exploratory trial and the corresponding interventions (resources, logistics, and infrastructures), is carried out externally of the health organizations involved and counting exclusively on the participation of health professionals belonging to the said organizations and

and the optimum studies.

174 Telemedicine

This phase is key to the evaluation of the efficiency of the complex interventions and consists of carrying out a controlled randomized trial with all of the rigor and power required, assuming the standard design aspects that require these types of trial: inclusion and exclusion criteria, sample size, criteria and duration of the intervention, randomization and informed consent of the participants, etc. From the knowledge accumulated in phase 2, definitive decisions must be taken on the nature of the intervention in order to standardize the inter‐ vention going to be evaluated and minimize the biases that limit not only the internal but also the external validity.

During this phase, unlike the previous ones, it is absolutely prohibited to make modifications in the protocol of the intervention. The minimum sample size determines the statistical power of the clinical trial and there must be the possibility of carrying out a replication of the intervention in multiple centers (multicentre trial), maintain its uniformity of implementation to guarantee the internal and external validity of the study and the generalization of the results. The participation of multiple centers contributes an additional value as it makes possible the study in different contexts of established patterns and emerging self-organization behaviors shown by the health professionals that are of doubtable use in phase 4.

The support of the clinical trial and the corresponding interventions (resources, logistics, and infrastructures), are carried out externally to the health organizations involved and counting exclusively on the participation of health professionals belonging to the said organizations and contributing the resources and infrastructures required by the PITES platform. It is essential that the resources and infrastructures external to the health organization do not represent a direct object of evaluation in the clinical trial, and act exclusively as a support to the operational deployment of the intervention.

To pass from phase 3 to phase 4 a positive evaluation of the efficiency of the intervention in the results of the trial, together with a decision from the health authority to adopt, is necessary (for example, an autonomous health service) with the support or endorsement of a Health Technology Evaluation Agency. Therefore, the ambit of the decision is outside the scope of the research group, although its continuity and participation in phase 4 may still be relevant.

#### **Implementation phase**

Once the evidence on the efficiency of the health of the intervention is demanded, it is necessary to adapt it to the local contexts in order to deal with two objectives: the full implementation of the intervention in the health organization in its technologic and health ambits, in such a way that it constitutes a health procedure more as regards the provision of all of the resources and infrastructures required at the margin of the external supports, and from that, the carrying out of financial cost studies and long-term studies to determine the efficiency of the intervention. For this, it is necessary to count on a significant and essential institutional support that promotes and manages the change and the dissemination of the innovation to the health organizations participating in this phase, and preferably from legal and financial instruments that regulate the introduction of new technologies in the National Health System as a factor essential for the progression of the intervention as a routine health procedure.

But, what is interoperability? the ISO (specifically the Information Technology Vocabulary – Fundamental Terms, or ISO/IEC 2382-01) defines the interoperability as the "capacity to communicate, implement applications or transfer data between sever functional units without the user needing to know the particular characteristics of the said units". The definition is fairly clear, but perhaps insufficient. The first thing that has to be specified is that there are several types of interoperability: the classic technical, syntactical and semantic; the organizational has recently been merged, and there are authors that go further and even speak of political interoperability, whose existence depends rather on where the limit of the definition of the

PITES: Telemedicine and e-Health Innovation Platform

http://dx.doi.org/10.5772/57021

177

Technical Interoperability: this is the basis on which the connection between systems is supported. Technical interoperability defines the interfaces, both physical and logical, which allow the aforementioned functional definition to be able to exchange information. It is currently well advanced, since, it is not exclusive to the health scenario and its development has been necessary for many other fields. Regulations such as 802.3, 802.11, TCP/IP, HTTP, the Zigbee Bluetooth specification, the low levels of the ISO 11073, SOAP family, etc. are those that

Syntactical Interoperability: Syntactical interoperability deals with the formats of the ex‐ changed files or of the types of data used, making them able to make translations between formats depending on those used for each system involving the communication. The systems that only provide this type of interoperability act as mere messengers without intervening in the content of the information communicated without being able to react depending on it. This type of interoperability also has a high level of development, although in the health field some evolution is still necessary. Within the range of regulations on which they are based so as to achieve syntactical interoperability can be found XML, the specifications for types of data such as TS 14796 from CEN or the ISO 21090, the specifications of messages of versions 2.x of HL7 or the reference models of HL7 V3 or UNE-EN ISO 13606, although the latter are also the basis

Semantic Interoperability: according to the definition of the 251 Technical Committee of CEN, it is the state that exists between the two entities-applications when, with respect to a specific task, an application can accept data from the other and carry out this task satisfactorily without the need for the intervention of an external operator. That is, two systems will be semantically interoperable if the information circulates between them without the original meaning being altered and each of them understanding by itself what the other sends and is consequently able to act. It is that which it would permit, for example, that the dispersed information of a patient, generated in many different sources, in different places, systems and moments, may be shared. It also needs to be at the disposal of the professionals where they need it or can be used easily in secondary uses such as research or statistics. Contrary to what is frequently believed, the use of terminologies to encode the information is not sufficient to achieve semantic interoperability since clinical information consists of much more than just words. At the times of expressing the clinical information the vocabulary is necessary, as well as being able to express the context in which the information has been generated (who, when, with which objective, about whom, the level of viability, etc.) as well as being able to formalize that

organization is placed. Let us see what each of these "interoperabilities" are.

are used to achieve technical interoperability.

of the semantic interoperability, as can be seen below.

The total effect of knowledge that would contribute to carrying out the local implementation in different socio-health contexts from the participation of several organizations, would contribute to the convergence of the intervention towards the standardized health procedure. Taking the methods and other knowledge accumulated during the development of phases 2 and 3 as reference, it is necessary to carry out an analysis on the operative feasibility of the service that adapts the intervention in specific health contexts, together with a deployment project and all of them particularized for the conditions of each participating organization. In this process it would constitute a valuable contribution of the health professionals who would act as active agents of the health process in the previous phases due to their knowledge on the intervention and the health context, and as the promoters of complementary strategies for the dissemination of the innovation.

#### **2.2. Interoperability**

#### *2.2.1. Interoperability of the clinical information*

The interoperability of the clinical information is one of the requirements of the health continuity [41]. The current paradigms of the health put the patient at the centre of a process around which are located the organizations and professionals who provide them with their services independently of their geographical or temporary location. For this strategy to be effective it needs the information to flow between the different nodes in such a way that it is automatically interpretable by them. Thus the professionals will have all of the information that they require to carry out their work, avoiding problems of duplicating the test for the patient to increase his/her safety, statistical studies can be carried out more easily on having the normalized information available and are able to plan the action to be carried out auto‐ matically.

Also for a platform like the one presented here, or for any other medical telecare service, this question is essential, as one of the problems that usually comes up is that of its isolation as regards other information systems, since on being systems created specifically for carrying out the support work of the service, the possibility of communicating with others is not normally taken into account and the information generated in these services usually stays in their own storage systems, without reaching the patient's records unless a manual introduction of the required data is written [42]. The interoperability of these platforms, therefore, is a funda‐ mental requirement if it is required to integrate into the trends of the health continuity.

With these premises the PITES platform has been provided with an interoperability framework to facilitate the sharing of the information between the different nodes that are connected to the platform, as is its interconnection with other information systems such as the clinical records of the health organizations and for the use of the information for secondary uses.

But, what is interoperability? the ISO (specifically the Information Technology Vocabulary – Fundamental Terms, or ISO/IEC 2382-01) defines the interoperability as the "capacity to communicate, implement applications or transfer data between sever functional units without the user needing to know the particular characteristics of the said units". The definition is fairly clear, but perhaps insufficient. The first thing that has to be specified is that there are several types of interoperability: the classic technical, syntactical and semantic; the organizational has recently been merged, and there are authors that go further and even speak of political interoperability, whose existence depends rather on where the limit of the definition of the organization is placed. Let us see what each of these "interoperabilities" are.

For this, it is necessary to count on a significant and essential institutional support that promotes and manages the change and the dissemination of the innovation to the health organizations participating in this phase, and preferably from legal and financial instruments that regulate the introduction of new technologies in the National Health System as a factor

The total effect of knowledge that would contribute to carrying out the local implementation in different socio-health contexts from the participation of several organizations, would contribute to the convergence of the intervention towards the standardized health procedure. Taking the methods and other knowledge accumulated during the development of phases 2 and 3 as reference, it is necessary to carry out an analysis on the operative feasibility of the service that adapts the intervention in specific health contexts, together with a deployment project and all of them particularized for the conditions of each participating organization. In this process it would constitute a valuable contribution of the health professionals who would act as active agents of the health process in the previous phases due to their knowledge on the intervention and the health context, and as the promoters of complementary strategies for the

The interoperability of the clinical information is one of the requirements of the health continuity [41]. The current paradigms of the health put the patient at the centre of a process around which are located the organizations and professionals who provide them with their services independently of their geographical or temporary location. For this strategy to be effective it needs the information to flow between the different nodes in such a way that it is automatically interpretable by them. Thus the professionals will have all of the information that they require to carry out their work, avoiding problems of duplicating the test for the patient to increase his/her safety, statistical studies can be carried out more easily on having the normalized information available and are able to plan the action to be carried out auto‐

Also for a platform like the one presented here, or for any other medical telecare service, this question is essential, as one of the problems that usually comes up is that of its isolation as regards other information systems, since on being systems created specifically for carrying out the support work of the service, the possibility of communicating with others is not normally taken into account and the information generated in these services usually stays in their own storage systems, without reaching the patient's records unless a manual introduction of the required data is written [42]. The interoperability of these platforms, therefore, is a funda‐ mental requirement if it is required to integrate into the trends of the health continuity.

With these premises the PITES platform has been provided with an interoperability framework to facilitate the sharing of the information between the different nodes that are connected to the platform, as is its interconnection with other information systems such as the clinical records of the health organizations and for the use of the information for secondary uses.

essential for the progression of the intervention as a routine health procedure.

dissemination of the innovation.

*2.2.1. Interoperability of the clinical information*

**2.2. Interoperability**

176 Telemedicine

matically.

Technical Interoperability: this is the basis on which the connection between systems is supported. Technical interoperability defines the interfaces, both physical and logical, which allow the aforementioned functional definition to be able to exchange information. It is currently well advanced, since, it is not exclusive to the health scenario and its development has been necessary for many other fields. Regulations such as 802.3, 802.11, TCP/IP, HTTP, the Zigbee Bluetooth specification, the low levels of the ISO 11073, SOAP family, etc. are those that are used to achieve technical interoperability.

Syntactical Interoperability: Syntactical interoperability deals with the formats of the ex‐ changed files or of the types of data used, making them able to make translations between formats depending on those used for each system involving the communication. The systems that only provide this type of interoperability act as mere messengers without intervening in the content of the information communicated without being able to react depending on it. This type of interoperability also has a high level of development, although in the health field some evolution is still necessary. Within the range of regulations on which they are based so as to achieve syntactical interoperability can be found XML, the specifications for types of data such as TS 14796 from CEN or the ISO 21090, the specifications of messages of versions 2.x of HL7 or the reference models of HL7 V3 or UNE-EN ISO 13606, although the latter are also the basis of the semantic interoperability, as can be seen below.

Semantic Interoperability: according to the definition of the 251 Technical Committee of CEN, it is the state that exists between the two entities-applications when, with respect to a specific task, an application can accept data from the other and carry out this task satisfactorily without the need for the intervention of an external operator. That is, two systems will be semantically interoperable if the information circulates between them without the original meaning being altered and each of them understanding by itself what the other sends and is consequently able to act. It is that which it would permit, for example, that the dispersed information of a patient, generated in many different sources, in different places, systems and moments, may be shared. It also needs to be at the disposal of the professionals where they need it or can be used easily in secondary uses such as research or statistics. Contrary to what is frequently believed, the use of terminologies to encode the information is not sufficient to achieve semantic interoperability since clinical information consists of much more than just words. At the times of expressing the clinical information the vocabulary is necessary, as well as being able to express the context in which the information has been generated (who, when, with which objective, about whom, the level of viability, etc.) as well as being able to formalize that which must be gathered for each concept handled so that it makes sense (it must contain a summary of the records, a discharge report, the Barthel index, etc.). For the first necessity, the terminologies (SNOMED-CT, CIE-10, LOINC, etc.) can be used to express the context; (UNE-EN ISO 13606:1, RIM, CDA, etc.) reference models are used and there are mechanisms as archetypes to formalize and share the concepts (for example those defined in UNE-EN ISO 13606:2) or the detailed clinical models (DCM).

In such a scenario it would be very difficult to establish a rigid framework for the exchange of information to be set, for example, a series of predefined messages to which any user of the platform, present or future should attend, especially in the health field in which the complexity of the information dealt with is a determinant factor at the time of finding satisfactory

PITES: Telemedicine and e-Health Innovation Platform

http://dx.doi.org/10.5772/57021

179

In this sphere, current trends point to the use of strategies that permit the information to be separated (which is known from a certain entity and is not going to vary over time) from the knowledge (that which is valid for all of the entities of the domain but which is subject to variations as the research advances or new techniques are developed). These double-model strategies (information or reference model and knowledge model or archetypes) [43] allow, on the one hand, the variations systems in the knowledge to be protected and, on the other hand, separate the actions of the experts in the technical field (they develop the systems based on the reference model) of the domain experts (the health professionals that define the concepts to be used by means of archetypes). This is the strategy that, for example, the UNE-EN ISO 13606

Under these premises, the main requirement that the standardization framework must achieve is to provide interoperability to the information systems involved, independently of the moment in which the scenario is used, and with the best possible impact both in the configu‐ ration of its teams and in the way of working or organizing the information. In order to achieve it, the use of a series of international regulations has been opted for: ISO 21090 for the types of data, UNE-EN ISO 13606 for the transfer of the clinical information and the EN 13940 regulation

Syntactical interoperability strengthens the use of XML to encode the messages. This is done in accordance with the reference model of the UNE-EN ISO 13606 regulation using the type of information defined in ISO 21090. Given that the UNE-EN ISO 13606 regulation remains agnostic as regards the technology (and does not define what has to be used to carry out the final encoding), some common XML Schemas are used for the reference model created by Dr. Dipak Kalra's group (leader of the EHRCom task force that developed the regulation), which is being converted into the de facto regulation, as they are currently being used in a multitude

As regards the types of data specified by the ISO 21090 regulation [44], the XML Schema which proposes the regulation in its informative part is used. In this case, a reduction has been made in the types available to facilitate the implementation, always maintaining the compatibility with the regulation, as well as the possibility of easily adding the new types that are necessary.

Semantic interoperability is supported on two pillars: the use of terminologies together with the double reference model and archetypes of the UNE-EN ISO 13606 regulation [45, 46].

as a series of concepts to give support to the health continuity.

*2.2.2.1. Interoperability framework: syntactical interoperability*

*2.2.2.2. Interoperability framework: semantic interoperability*

of both national and international projects.

communications solutions, as is also the speed of changing the domain knowledge.

regulation implements.

Organizational Interoperability: summarizing considerably, it may be said that the organiza‐ tional interoperability is supported by business rules. In order for two organizations to be able to cooperate they must share a common context in their procedures and work flows. It will be difficult to interoperate, for example, if the definitions of the process, health plan or health order are different or incompatibles. The definitions of some of these concepts are currently imposed by the information systems that are used in the different organizations and that the providers have included in their developments without previously formalizing them. Other concepts are established by the health policies developed by the different administrations on which the organizations depend (that is the concept that some political interoperability authors use). There is still much more to be done in this field, although in the environment of stand‐ ardization there are works such as the EN 12967 HISA (Health Informatics - Service Architec‐ ture) regulation which, in its first part, deals with the business point of view, and mainly the UNE-EN ISO 13940 regulation (system of concepts to give support to the continuity of the health).

#### *2.2.2. Definition of the Interoperability Framework of the Platform*

The design of the interoperability layer of the PITES platform is dealt with by taking its objective into account (open platform to support e-health services) such as the special charac‐ teristics of the scenario in which its activity is developed, as well as the peculiarities in Spain, where the existence of autonomous regional governments (known as Comunidades Autóno‐ mas), with different languages and the health responsibilities transferred, conditions to a large extent the approach to be implemented:


In such a scenario it would be very difficult to establish a rigid framework for the exchange of information to be set, for example, a series of predefined messages to which any user of the platform, present or future should attend, especially in the health field in which the complexity of the information dealt with is a determinant factor at the time of finding satisfactory communications solutions, as is also the speed of changing the domain knowledge.

In this sphere, current trends point to the use of strategies that permit the information to be separated (which is known from a certain entity and is not going to vary over time) from the knowledge (that which is valid for all of the entities of the domain but which is subject to variations as the research advances or new techniques are developed). These double-model strategies (information or reference model and knowledge model or archetypes) [43] allow, on the one hand, the variations systems in the knowledge to be protected and, on the other hand, separate the actions of the experts in the technical field (they develop the systems based on the reference model) of the domain experts (the health professionals that define the concepts to be used by means of archetypes). This is the strategy that, for example, the UNE-EN ISO 13606 regulation implements.

Under these premises, the main requirement that the standardization framework must achieve is to provide interoperability to the information systems involved, independently of the moment in which the scenario is used, and with the best possible impact both in the configu‐ ration of its teams and in the way of working or organizing the information. In order to achieve it, the use of a series of international regulations has been opted for: ISO 21090 for the types of data, UNE-EN ISO 13606 for the transfer of the clinical information and the EN 13940 regulation as a series of concepts to give support to the health continuity.

#### *2.2.2.1. Interoperability framework: syntactical interoperability*

which must be gathered for each concept handled so that it makes sense (it must contain a summary of the records, a discharge report, the Barthel index, etc.). For the first necessity, the terminologies (SNOMED-CT, CIE-10, LOINC, etc.) can be used to express the context; (UNE-EN ISO 13606:1, RIM, CDA, etc.) reference models are used and there are mechanisms as archetypes to formalize and share the concepts (for example those defined in UNE-EN ISO

Organizational Interoperability: summarizing considerably, it may be said that the organiza‐ tional interoperability is supported by business rules. In order for two organizations to be able to cooperate they must share a common context in their procedures and work flows. It will be difficult to interoperate, for example, if the definitions of the process, health plan or health order are different or incompatibles. The definitions of some of these concepts are currently imposed by the information systems that are used in the different organizations and that the providers have included in their developments without previously formalizing them. Other concepts are established by the health policies developed by the different administrations on which the organizations depend (that is the concept that some political interoperability authors use). There is still much more to be done in this field, although in the environment of stand‐ ardization there are works such as the EN 12967 HISA (Health Informatics - Service Architec‐ ture) regulation which, in its first part, deals with the business point of view, and mainly the UNE-EN ISO 13940 regulation (system of concepts to give support to the continuity of the

The design of the interoperability layer of the PITES platform is dealt with by taking its objective into account (open platform to support e-health services) such as the special charac‐ teristics of the scenario in which its activity is developed, as well as the peculiarities in Spain, where the existence of autonomous regional governments (known as Comunidades Autóno‐ mas), with different languages and the health responsibilities transferred, conditions to a large

**•** PITES is an open platform to give support to a large variety of research groups belonging

**•** The organizations participating in PITES belong to different Comunidades Autónomas with

**•** The information systems of the different nodes may be manufactured differently and be

**•** The list of organizations participating in PITES is not closed, but it is envisaged that in future calls new nodes will be incorporated, a question that also forms part of the philosophy of the platform. That is, the solution that is adopted for the interoperability must be capable of incorporating new elements probably based on systems and models different from those

13606:2) or the detailed clinical models (DCM).

*2.2.2. Definition of the Interoperability Framework of the Platform*

the health powers transferred and with different languages.

extent the approach to be implemented:

to different organizations.

based on different models.

that currently exist.

health).

178 Telemedicine

Syntactical interoperability strengthens the use of XML to encode the messages. This is done in accordance with the reference model of the UNE-EN ISO 13606 regulation using the type of information defined in ISO 21090. Given that the UNE-EN ISO 13606 regulation remains agnostic as regards the technology (and does not define what has to be used to carry out the final encoding), some common XML Schemas are used for the reference model created by Dr. Dipak Kalra's group (leader of the EHRCom task force that developed the regulation), which is being converted into the de facto regulation, as they are currently being used in a multitude of both national and international projects.

As regards the types of data specified by the ISO 21090 regulation [44], the XML Schema which proposes the regulation in its informative part is used. In this case, a reduction has been made in the types available to facilitate the implementation, always maintaining the compatibility with the regulation, as well as the possibility of easily adding the new types that are necessary.

#### *2.2.2.2. Interoperability framework: semantic interoperability*

Semantic interoperability is supported on two pillars: the use of terminologies together with the double reference model and archetypes of the UNE-EN ISO 13606 regulation [45, 46].

#### *2.2.2.2.1. Use of terminologies*

The first basis for the semantic interoperability of the clinical information is the encoding of the terms used in the domain. For this it has become necessary to use the standardized terminologies. The proposed PITES interoperability framework, the use of SNOMED CT and its link with the archetypes defined as one of the means of supporting the semantic interoper‐ ability [47]. This is implemented by means of the creation of the corresponding subsets of terms. Equally, in those cases in which the use of SNOMED CT does not cover the terminological necessities, and given that the 13606 regulation does not impose any specific terminology, the terminologies suitable for each domain are used.

The reference model of the 13606 regulation organizes information in the following way (see Figure 3): the summary, which forms part of a message is the container of the information referring to a patient (the whole file or part of it) that is going to be transmitted. This infor‐ mation includes the demographic data (the identification of the people and entities are separated from the clinic in order to satisfy legal requirements), the access policies and the clinical information, which is organized thus: the summary contains a series of compositions (information on the subject gathered during the meeting, a report, etc.) which are adapted to be able to reconstruct the history of the data. The compositions store simple statements on observations, evaluations or instructions (entry), which may be grouped together in sections to represent the internal organization of the documents as their headings are made. Finally, the entries contain elements, in each of which a specific datum is stored. The elements may be grouped together in clusters to represent more complex structures of data, such as temporary series or tables. The regulation provides a way of additional organization high level which permits the compositions to be grouped together in folders, to be able to reproduce the organizational criteria of each centre (per episode, per service, per meeting, etc.). The clinical information is accompanied by another type of context information to complement its meaning or comply with the legal requirements. Thus any component can contain information on who completed it (audit\_info), it can be signed (attestation\_info) or be linked to other components (link), to express cause-effect relationships, problem-solución, etc. It also gathers information on the environment in which an activity is developed (clinical\_session), who participated in it (functional\_role) or if the information refers to the patient or another entity (related\_party).

PITES: Telemedicine and e-Health Innovation Platform

http://dx.doi.org/10.5772/57021

181

In order to achieve interoperability, a model such as this one has to be complemented in the knowledge domain with a formal model to transmit and share structures of predefined classes, agreed to by a community, corresponding to fragments of the registry created under specific clinical situations: the archetypes. An archetype is the definition of a hierarchical combination of components or the reference model, to which it restricts (given their names, types of possible data, default values, cardinality, etc.), to model clinical concepts of the knowledge domain. These structures, although sufficiently stable, can be modified or substituted by other through

The knowledge model (archetype model) implements the separation of information and knowledge and the strategy of the generation of systems to be changed. According to this new strategy, the technological professionals build the systems based only on the reference model. This provides protection against changes in the knowledge. If the domain concepts do not form part of the design of the systems, it will not be necessary to update these if those change. In the same way, the same system may be used by different organizations although they use different documents (that is, concepts of a different domain). On the other hand, the health professionals model the concepts of the domain using tools based on the knowledge model that will have generated the technologies for but without the need to have a profound knowledge of the technological artifacts on which they are based, being only concerned about correctly defining the concepts that they use. It is worth summarizing that these models (archetypes) can be created at any time, since the systems use them in real time to generate requests for data in accordance with them, they verify the validity of the requests received,

the evolution of clinical practice.

#### *2.2.2.2.2. Reference models and archetypes*

The reference model is in charge of representing the general characteristics of the components of the ECR, how they are organized, and the context information necessary to satisfy the requirements both ethical and legal of the register. The model defines the series of classes that make up the constituent blocks of the register, that is, gather its stable characteristics.

**Figure 3.** Simplified diagram of the UNE-EN ISO 13606 model reference (obtained from (2))

The reference model of the 13606 regulation organizes information in the following way (see Figure 3): the summary, which forms part of a message is the container of the information referring to a patient (the whole file or part of it) that is going to be transmitted. This infor‐ mation includes the demographic data (the identification of the people and entities are separated from the clinic in order to satisfy legal requirements), the access policies and the clinical information, which is organized thus: the summary contains a series of compositions (information on the subject gathered during the meeting, a report, etc.) which are adapted to be able to reconstruct the history of the data. The compositions store simple statements on observations, evaluations or instructions (entry), which may be grouped together in sections to represent the internal organization of the documents as their headings are made. Finally, the entries contain elements, in each of which a specific datum is stored. The elements may be grouped together in clusters to represent more complex structures of data, such as temporary series or tables. The regulation provides a way of additional organization high level which permits the compositions to be grouped together in folders, to be able to reproduce the organizational criteria of each centre (per episode, per service, per meeting, etc.). The clinical information is accompanied by another type of context information to complement its meaning or comply with the legal requirements. Thus any component can contain information on who completed it (audit\_info), it can be signed (attestation\_info) or be linked to other components (link), to express cause-effect relationships, problem-solución, etc. It also gathers information on the environment in which an activity is developed (clinical\_session), who participated in it (functional\_role) or if the information refers to the patient or another entity (related\_party).

*2.2.2.2.1. Use of terminologies*

180 Telemedicine

terminologies suitable for each domain are used.

*2.2.2.2.2. Reference models and archetypes*

The first basis for the semantic interoperability of the clinical information is the encoding of the terms used in the domain. For this it has become necessary to use the standardized terminologies. The proposed PITES interoperability framework, the use of SNOMED CT and its link with the archetypes defined as one of the means of supporting the semantic interoper‐ ability [47]. This is implemented by means of the creation of the corresponding subsets of terms. Equally, in those cases in which the use of SNOMED CT does not cover the terminological necessities, and given that the 13606 regulation does not impose any specific terminology, the

The reference model is in charge of representing the general characteristics of the components of the ECR, how they are organized, and the context information necessary to satisfy the requirements both ethical and legal of the register. The model defines the series of classes that

make up the constituent blocks of the register, that is, gather its stable characteristics.

**Figure 3.** Simplified diagram of the UNE-EN ISO 13606 model reference (obtained from (2))

In order to achieve interoperability, a model such as this one has to be complemented in the knowledge domain with a formal model to transmit and share structures of predefined classes, agreed to by a community, corresponding to fragments of the registry created under specific clinical situations: the archetypes. An archetype is the definition of a hierarchical combination of components or the reference model, to which it restricts (given their names, types of possible data, default values, cardinality, etc.), to model clinical concepts of the knowledge domain. These structures, although sufficiently stable, can be modified or substituted by other through the evolution of clinical practice.

The knowledge model (archetype model) implements the separation of information and knowledge and the strategy of the generation of systems to be changed. According to this new strategy, the technological professionals build the systems based only on the reference model. This provides protection against changes in the knowledge. If the domain concepts do not form part of the design of the systems, it will not be necessary to update these if those change. In the same way, the same system may be used by different organizations although they use different documents (that is, concepts of a different domain). On the other hand, the health professionals model the concepts of the domain using tools based on the knowledge model that will have generated the technologies for but without the need to have a profound knowledge of the technological artifacts on which they are based, being only concerned about correctly defining the concepts that they use. It is worth summarizing that these models (archetypes) can be created at any time, since the systems use them in real time to generate requests for data in accordance with them, they verify the validity of the requests received, interpret them automatically from the semantic point of view, build applications for entering data, etc.

The archetypes have to be completed with the terminologies. This process consists essentially of the association of an element of the archetype defined by the ADL language (Archetype Description Language) [48] to a SNOMED CT concept or to an expression following the

PITES: Telemedicine and e-Health Innovation Platform

http://dx.doi.org/10.5772/57021

183

Therefore, in accordance with the defined interoperability framework, the health professionals of the different nodes participating in the PITES platform generate the models (archetypes) of the concepts that handle in their domain and, from this moment on, the rest of the nodes are able to correctly interpret the messages that are transmitted. This process may be carried out

The interoperability of the health information is not only based on syntactical and semantic interoperability. In its COM(2008)3282 recommendation the European Commission recom‐ mends that the member states act on different planes, the organizational between themselves, to achieve trans-border interoperability of the health information in Europe [49]. Equally, in the final report of the Semantic Health project that proposes a road map to achieve the semantic interoperability in Europe. Organizational interoperability is cited as of the factors necessary

The scenario proposed by the PITES project, in which the participating nodes belong to different autonomous communities, with their powers transferred and, therefore, with the capacity to take their own decisions as regard health policy and how to implement the communications in their territory and using different languages, it becomes very similar to the general European scenario, therefore the organizational interoperability also becomes of great importance. This is why it is proposed to use the UN-EN ISO 13940 regulation [50]. The said regulation defines the types of concept and the descriptive associations, as regards the health processes with special consideration on the continuity of the care centered on the patient, and the shared care. Its objective is to carry out a description and formalization of the continuity of the care in the context of information systems, implying the definition of concepts and descriptive terms that contribute to establishing a common conceptual framework that overcomes national, cultural and professional barriers. That is why a set of concepts is designed to represent the phenomena of the attention process, related to the subject of attention. In this case, the focus is not on the subject in itself but on its condition or state. It applies a modeling technique of the processes in order to identify the objectives of the process, the sub-processes and the activities, also taking into account aspects on the resources, responsibilities and means for patient participation in his or her own care. In those points in which social health is

The regulation defines an attention organization as "an organization directly involved in the provision of care". Within an organization of this type, the provision of health services is modeled as a process of organization of the attention (Figure 5). This process will contain one or more attention processes. Similarly, it will also contain an administration process and probably a research process (aimed at improving medical knowledge) and a training process (with the object of improving the capacities of the health professionals by applying medical

at any time to adapt the concepts to the changes in the knowledge that come about.

grammatical regulations specified in the terminological standard.

*2.2.2.3. Interoperability framework: organizational interoperability*

necessary, there activities also appear as well as its work flow.

to achieve it (1).

By using this double model, it is not necessary to have a prior total agreement between the organizations participating in the communication, since they have the mechanism of the archetypes as a formalized way of sharing the concepts that are being used and that the receptor is capable of correctly interpreting, the information received automatically. In Figure 4 it can be seen how the communication process would be:


**Figure 4.** Communications model with archetypes

The archetypes have to be completed with the terminologies. This process consists essentially of the association of an element of the archetype defined by the ADL language (Archetype Description Language) [48] to a SNOMED CT concept or to an expression following the grammatical regulations specified in the terminological standard.

Therefore, in accordance with the defined interoperability framework, the health professionals of the different nodes participating in the PITES platform generate the models (archetypes) of the concepts that handle in their domain and, from this moment on, the rest of the nodes are able to correctly interpret the messages that are transmitted. This process may be carried out at any time to adapt the concepts to the changes in the knowledge that come about.

#### *2.2.2.3. Interoperability framework: organizational interoperability*

interpret them automatically from the semantic point of view, build applications for entering

By using this double model, it is not necessary to have a prior total agreement between the organizations participating in the communication, since they have the mechanism of the archetypes as a formalized way of sharing the concepts that are being used and that the receptor is capable of correctly interpreting, the information received automatically. In Figure 4 it can

**a.** When system A is going to send information to system D, it will turn to a repository of archetypes in order to obtain the model corresponding to the concepts that are wished to

**d.** will check according to which archetype has generated the information and will request it from the corresponding repository (or the organization that sent the information)

**f.** and with it, it correctly interprets the information received to incorporate it automatically

**b.** Using the corresponding archetype, system A will generate a message in real time.

be seen how the communication process would be:

**c.** The message is sent to system D, which...

**e.** System D obtains the requested archetype...

into its own storage system.

**Figure 4.** Communications model with archetypes

data, etc.

182 Telemedicine

be sent.

The interoperability of the health information is not only based on syntactical and semantic interoperability. In its COM(2008)3282 recommendation the European Commission recom‐ mends that the member states act on different planes, the organizational between themselves, to achieve trans-border interoperability of the health information in Europe [49]. Equally, in the final report of the Semantic Health project that proposes a road map to achieve the semantic interoperability in Europe. Organizational interoperability is cited as of the factors necessary to achieve it (1).

The scenario proposed by the PITES project, in which the participating nodes belong to different autonomous communities, with their powers transferred and, therefore, with the capacity to take their own decisions as regard health policy and how to implement the communications in their territory and using different languages, it becomes very similar to the general European scenario, therefore the organizational interoperability also becomes of great importance. This is why it is proposed to use the UN-EN ISO 13940 regulation [50]. The said regulation defines the types of concept and the descriptive associations, as regards the health processes with special consideration on the continuity of the care centered on the patient, and the shared care. Its objective is to carry out a description and formalization of the continuity of the care in the context of information systems, implying the definition of concepts and descriptive terms that contribute to establishing a common conceptual framework that overcomes national, cultural and professional barriers. That is why a set of concepts is designed to represent the phenomena of the attention process, related to the subject of attention. In this case, the focus is not on the subject in itself but on its condition or state. It applies a modeling technique of the processes in order to identify the objectives of the process, the sub-processes and the activities, also taking into account aspects on the resources, responsibilities and means for patient participation in his or her own care. In those points in which social health is necessary, there activities also appear as well as its work flow.

The regulation defines an attention organization as "an organization directly involved in the provision of care". Within an organization of this type, the provision of health services is modeled as a process of organization of the attention (Figure 5). This process will contain one or more attention processes. Similarly, it will also contain an administration process and probably a research process (aimed at improving medical knowledge) and a training process (with the object of improving the capacities of the health professionals by applying medical knowledge). The health care process constitutes the heart of the health care organizations and, at the same time, it is made up of a clinical process and a resources management process, which is in charge of the logistic of the activity. Finally, the clinical process contains a clinical management process, a documentation and communication process and management of the quality of attention process. The documentation process is essential in the entire clinical act. It is that which allows the activity to be registered and able to communicate its results to other activities, giving support to the health care continuity.

**INTEROPERABILITY ACTIONS REGULATIONS**

•Use of a series of types of data proposed by ISO 21090 •Messages in accordance with the 13606 XML Schema as defined by Dipak Kalra's group and that proposed by

•Generation of subsets of terms from SNOMED - CT •Use of other specific terminologies according to need

•Definition of a common conceptual framework based

•Definition of an inter-organizational processes based

•Definition of inter-organizational work flows based on

Within the ambit of new services based on telemedicine, the generic overall scenario constitutes

**•** Patients and citizens in different environments, With different health conditions and health care necessities, different degrees of dependence, age and family context, different skills and

**•** Health and non-health professionals and with different professional profiles, different skills,

**•** The world of medical devices, mainly for personal and domestic use, with an enormous diversity, a more and more extensive catalogue becoming even more essential so as to be able to put new health care models into practice, mainly for those whose self-treatment is

**•** Technological platforms of different types: health platforms, non-platforms, private monitoring platforms, research platforms, etc. These platforms make a ubiquitous access possible and provide personalized services in a complex environment in a solvent manner. **•** Some communications networks with a high level of capillarity which makes the Internet possible and with support by means of high-capacity, fixed wireless and digital networks

•Definition of the local concepts by means of archetypes in accordance with UNE-EN ISO 13606. •Linking of the terminologies and the subsets defined •XML

PITES: Telemedicine and e-Health Innovation Platform

ISO13606.1

•XML Schema UNE-EN

http://dx.doi.org/10.5772/57021

185

•XML Schema ISO 21090

•UNE-EN ISO 13606.1: Reference model •UNE-EN ISO 13606.2: Archetype model •SNOMED-CT \* Other terminologies

•UNE-EN 13940: System of •UNE-EN 13940: Processes

and work flows

•Encoding messages in XML

the computing part of ISO

with the archetypes

on UNE-EN ISO 13940

on UNE-EN ISO 13940

technological availability, different living and social habits, etc.

attitudes, and technological availability in their environments.

UNE-EN ISO 13940

**Table 1.** Specification of the PITES interoperability framework

a heterogeneous and diverse ecosystem (Figure 6):

**3. Description of the platform**

the main therapeutic option

Syntactical

Semantic

Organizational

**Figure 5.** Components of the organization of the attention process in accordance with EN 13940

#### *2.2.3. Summary: the PITES interoperability framework*

In summary, in the following Table 1 the interoperability model defined for the PITES project can be specifically seen


**Table 1.** Specification of the PITES interoperability framework
