Ehealth: introduction

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1 Ronald Buyl (Vrije Universiteit Brussel) Ehealth: introduction Introduction...4 E-health Definitions Impact and importance of e-health Economical benefits Health care benefits E-health initiatives in Europe E-health initiatives in Belgium Electronic Health Records (EHR) Definition Aspects of EHRs Role of the patient in the EHR Core function of the EHR Standards for classification and nomenclatures Data integrity and security Interoperability...31

2 Introduction Within the context of this work the terms e-health (also ehealth or electronic health) and EHR (electronic health record) will be frequently used. For these concepts, many, sometimes confusing definitions exist. Obviously it is very important that the reader gets a clear understanding of what is meant by the concepts e-health and EHR within the scope of this work. In this first chapter the different aspects of the terms e-health and EHR are highlighted, thereby defining the environment and context in which this work has been performed. In a first part of this chapter, e-health is handled in detail. We will discuss the development of e-health definitions in detail and emphasize on the particularities of the different propositions. In a next part the impact, both economically and concerning the delivery of care will be dealt with. Additionally the current status of the work that is performed in Europe in this domain with a highlight on to the situation in Belgium is presented {see note 1 on literature search}. {note 1} The literature search for this part of the chapter was performed in different steps. First by a Medline (Pubmed) search, using the keywords: e-health (102), ehealth (74 hits), electronic health (320), with the following limits (abstract available, published the last 5 years, English, word in title). We emphasize that until today, no Medical Subject Heading (MeSH) taxonomy exists. These articles were checked manually. In a second step, the reference lists of important recent reviews were used to find other interesting articles. Finally, reports of European projects (via projects websites) as well as conference proceedings were used as valid information sources for information concerning e-health. In a second part of this chapter, the general concepts of the EHR are detailed. Again we will start by defining the concept and we will elaborate briefly on the EHR initiatives in Europe and Belgium. Special attention is given in this part to some crucial aspects, such as interoperability and codification standards {see note 2 on literature search}. {note 2} The literature search for this part of the chapter included again different levels. First a Medline (Pubmed) search was performed, using the following limits (abstract available, published the last 5 years, English). The Mesh keywords Medical Records (+1400) and "Medical Records Systems, Computerized" (+500) led to too many hits. These mesh keywords were combined in a second stage with Physicians, Family (Mesh) and Physical Therapy (Specialty). Further combinations with non mesh keywords (with additional limits such as title word ) were performed. Additionally, pertinent information was drawn from the reference lists, cited in the

3 review articles, found in the previous search as well as reports from different projects, via the projects websites. E-health 1.1. Definitions What is e-health? Many have already tried to answer this question. Gunther Eysenbach, editor of the Journal of medical internet research stated in his 2001 editorial titled What is e-health? : The term e-health was barely in use before 1999, but now this term seems to serve as a general "buzzword," used to characterize not only "Internet medicine", but also virtually everything related to computers and medicine [1]. The situation has only become more confusing since then. In 2005 a review was published by Pagliari and colleagues [2] that included 36 different definitions for the term e-health. The authors state that the term is not immediately discernable from that of the wider (medical) health informatics field. This is, amongst others (as stated earlier no correct keyword, such as Mesh), a very important reason for the confusion and lack of appreciation regarding the research domain. Therefore terms such as medical informatics, health informatics, telehealth and telecare are all domains that have a large overlap with what is generally considered as e-health. This characteristic of the e-health domain makes unambiguous and well structured (literature) searches extremely difficult. They usually result in too broad and unspecific conclusions. The list of Pagliari (2005) [2] was even extended by Oh et al. (2005). In their review article bearing again the same title What is ehealth? an exhaustive overview of all possible definitions used to describe the terms ehealth, e- health or electronic health is presented [3]. In total these authors came up with 51 unique definitions, but conclude that possibly more exist. The definitions range from very short: Internet technologies applied to health care industry [4], E-health is all that s digital or electronic in the health care industry [5] or even Internet related health care activities [6] to extremely large definitions as The most broad term is ehealth, with refers to the use of electronic technologies in health, health care and public health. (...) The various functions of ehealth [are]: (...) reference (electronic publishing, catalogues, databases); selfhelp/self-care (online health information, support groups, health risk assessment, personal health records), Plan/provider convenience services (online scheduling, test and lab results, benefit summaries), Consultation and referral (doctor-patient or doctor-doctor consultation via telemedicine systems, remote readings of digital image and pathology samples), E-health commerce (sales of health related product

4 and services) [and] Public health services (automated data collection, data warehouses, online access to population survey data and registries, advance detection and warning systems for public health threats). (...) This chapter uses the term ehealth to refer to the broadest possible range of interactive technologies applied to health and health care. [7]. Other definitions are very specific, and focus on a particular aspect (e.g. Economical): E-health the application of e-commerce to health care and pharmaceuticals or sub-domain of e-health (e.g. telehealth or telecare): Ehealth is the process of providing health care via electronic means, in particular over the Internet. It can include teaching, monitoring (e.g. physiologic data), and interaction with health care providers, as well as interaction with other patients afflicted with the same conditions [8]. In the context of this work, the goal is not to come up with yet another definition for the term e-health. Neither will we criticize or make remarks on one of the definitions used by other researchers or institutions, because they all contain valuable aspects of the large concept of e-health. We clearly want to emphasize the broad scope of the domain, and we realize that the content of the definitions is significantly biased by the stakeholders perspective on the field. Social insurance companies will have a totally different view of e-health than commercial software vendors. Hospitals will have a completely different vision on the concept than independent nursing practitioners. A summary-overview of the most important aspects of the numerous definitions discussed in the 2005 review of Oh et al. can be found in the next paragraph. Analysis of the definitions From the 51 unique definitions two universal themes health (49/51) and (46/51) can be identified. Six other less general aspects were used in different definitions: commerce, activities technology, stakeholders, outcomes, place, and perspectives. In 11 definitions, e- health was referred to in terms of commerce, suggesting that e-health is health care's component of business over the Internet, the application of e-commerce to health care and pharmaceuticals or as new business models using technology. Others associated e- health with activities such as managing, educating, arranging, connecting, obtaining, providing, redefining, supporting, using, assisting and accessing. The stakeholders most often mentioned were health care providers (physicians, health care providers, health care professionals, health workers, managers, and caregivers). The public is mentioned as public, patients, consumers, non-professionals, and citizens. Governments, employers, and payers are also listed as potentially benefiting from e-health. While most of the definitions concentrated on the process of care, about one quarter of them focused on the outcomes to be expected. These definitions mentioned improving and increasing the cost-effectiveness of

5 health care and making processes more efficient. Others suggested that e-health could solve problems related to access to care, cost, quality, and portability of health care services. While the actual word place was not used in any of the definitions, some authors referred to the concepts of distance, geography, and location. One definition describes the impact of e-health as local, regional, and worldwide. Another describes e-health as taking place both at the local site and at a distance. A third suggests that distance and place no longer remain barriers, as e-health is to provide and support health care wherever the participants are located. Finally, other definitions suggest that e-health represents a new perspective on health care. One author describes e-health as a state-of-mind, a way of thinking, an attitude, and a commitment for networked, global thinking. Another source describes e-health as a consumer-centered model of health where stakeholders collaborate (summarized from Oh, 2005 [3]) Because e-health is such a broad concept involving many aspects, some authors have tried to come up with a very global, all covering definition. From these efforts the following one (already dating back to 2001) from Eysenbach is still perceived as a very good overall statement of what is covered by the term e-health: e-health is an emerging field in the intersection of medical informatics, public health and business, referring to health services and information delivered or enhanced through the Internet and related technologies. In a broader sense, the term characterizes not only a technical development, but also a state-of-mind, a way of thinking, an attitude, and a commitment for networked, global thinking, to improve health care locally, regionally, and worldwide by using information and communication technology [1]. For us, academic researchers the content of e-health is also very well described in an article by Jones, R and colleagues, again titled What is ehealth? In this article, using, processing, sharing and controlling information (data) are considered the key aspects in e-health. All other aspects relate more to how the results of this research should be implemented and carried out or to how the improvement in health care can be measured [9]. The latter are more important to other stakeholders like end-users, commercial (software) companies, governmental organizations, social security. We emphasize that e-health and the e-health applications as described in this work are looked at from a researchers perspective, but with the contribution of as many stakeholders as possible. Although from an e-health-research perspective we are more interested in the flow and the management of the data, we realize that these latter aspects also deserve the necessary attention, because in the end it are the software vendors who will build the systems, the government who will certify and control the systems and the health care workers who will use the systems. All the stakeholders start to realize that an interdisciplinary

6 collaboration in e-health research with mutual awareness and respect for each others methods and contextual drivers will eventually result in better technologies [10]. This is particularly the case between the software developers and the health services and academic researchers. In our research we have always tried to incorporate the ideas and beliefs of the whole field, by means of user committees and focus groups. This did not always prove to be the most efficient and fastest way of working, but finally resulted in technologies where all stakeholders could agree upon and that are already used in the field Impact and importance of e-health. Is e-health worth it? Why bother to make the switch from paper-based to electronic communication and data storage to digital applications in health care? Are all initiatives in e-health research really necessary? Does e-health save money? Or even more importantly: does e-health save lives? The answer to these questions is not straightforward, but the different examples in this paragraph illustrate that e-health really is worthwhile if the technologies and methods are applied in a carefully planned way. E-health is, as discussed in detail in the previous paragraph, a very complex domain. It consists not only of different professional approaches, uses numerous technical building blocks, but also has to deal with the legal framework and the goodwill of the end-users. The complexity and wide variety of e-health applications makes it almost impossible to measure the impact of e-health on the modern health care systems, but in this paragraph we will try to give some answers, based on some real-life examples. Health care systems are a fundamental part of the social infrastructure of a country. For many years, information and communication technologies (ICT) have been expected to contribute to the development of our health care systems. Unfortunately, e-health or health information technologies have mostly realm for just a few enthusiasts. Recently however, the results of the European e-health IMPACT study have shown that - given the right approach, context and implementation process ICT based solutions can indeed improve the quality, accessibility and efficiency of health care. These benefits include both economical and health care-professional benefits on individual as well as societal level [11].

7 Especially the lack of reliable evidence of the economic impact of using ICT in delivering high quality health care has been a key barrier to the more widespread diffusion of e-health solutions. But particularly that impact, although potentially enormous, is very difficult to measure because evaluations often have only a single perspective (such as financial) or the view of only one stakeholder. Moreover, privacy issues and dependency on technology lead to conservative attitudes in favor of the paper-based handling of medical documents. The Aho report (January 2006 [12]) explicitly acknowledged the importance of ICT in tackling specific challenges within the health care sector, and thus identified e-health as an example of a key area where a market for innovation can operate and public policy can have a significant role. Consequently, the European Union (EU) commission proposed the Lead Market initiative on e-health aiming at the creation of markets with high economic and social value, in which European countries could develop a globally leading role. [13] The Lead Market initiative was about identifying example areas with the greatest potential to the European economy. It was not about artificially creating markets for research results, but creating an environment that enables industry and academic institutions to develop innovative products and services. For the EU commission the e-health market can be defined as comprising the following four inter-related major categories of applications: 1. Clinical information systems a. For health professionals within care institutions b. For primary care workers 2. Telemedicine and home care 3. Integrated regional/national health care networks 4. Secondary usage non-clinical systems a. Health education b. Systems for research and data collection c. Support systems

8 E-health is becoming a mainstream element of national health system priorities. This is shown by the fact that virtually all EU member states feature by now e-health strategies in dedicated documents or as a part of wider e-services. Most of these documents have been published since However, some countries such as Denmark, as will be discussed in the next paragraph already adopted initial e-health policies during the 1990 s Economical benefits The health sector in the European Union employs almost 10% of the total workforce and corresponds to almost 9% of the gross domestic product (GDP) (in 2006). Health spending is rising faster than the GDP and is estimated to reach 16% of the GDP by 2010 in OECD 1 countries. The e-health industry in the EU was estimated to be worth close to 21 billion in This figure covers the four previously mentioned areas in the e-health market, including ICT infrastructure belonging to the health delivery system. The major part (almost 80%) of this figure represents generic ICT infrastructure (networks, communication, hardware, software, ). So e-health cost a lot of money. But is there also a return of investment? All market players and observers agree the e-health in Europe is set for an explosive growth, driven by the need to face health related challenges [14]. One example that clearly illustrates the possible economical benefit from e-health is Medcom, the Danish Health Data Network [11]. In Europe this is one of the oldest health care networks, with a start already dating back to the early 1980 s. Medcom as it exists now is the results of different projects based on new information and communication technologies in health care, lead by the Danish centre for Health Telematics, that was founded in the 1990 s. The focus of the projects lies in the electronic data interchange (EDI) which is used for the messaging process of electronic data, including referrals, prescriptions, request reports, discharge letters, notifications and reimbursements. The economic results of the project are summarized and shown in Figure 1 below and they clearly demonstrate a financial benefit for the introduction of this e-health technology. Some more detailed results are: First year of annual net benefit, i.e. when annual benefits exceed annual costs: 1997, year 3 Estimated annual net benefit for the year 2008: approximately 80 million First year of cumulative net benefit: 1999, year 5 1 OECD: Organisation for Economic Co-operation and Development (30member countries worldwide)

9 Estimated cumulative benefit by 2008: approximately 1.4 billion Cumulative investment costs, including operating expenditure, by 2008: approximately 725 million Estimated productivity gain, measured in decrease in cost per message transaction: 97% Distribution of benefits to 2008: Citizens 2%; HPOs 98% Figure 1: Present Values (PV) of the estimated annual costs and benefits for Medcom, Danish Health Data Network , in 000s. (from e-health IMPACT study, The data after 2006 are estimated number based on the virtual health economy concept of the IMPACT study [11]) No overall figures are available of the possible economical benefit of e-health in Europe. Recent studies have shown that the benefits for health care delivery as discussed in the next part can have an indirect positive benefit on the financial picture of e-health. However sound management and well organized spending of the available resources is needed Health care benefits Many aspects of how e-health can contribute to the improvement of the health care process have been described in literature. Some examples that are often cited include the use of clinical decision support systems that will help the clinician in making the correct diagnosis and choosing the best therapy for the patient [15-18] and the use of telemonitoring and telecare systems, that provide clinical aid to patients living at a great distance from the regular point of care (hospital, GP, nursing office, ) [18-20]. But many more examples ranging from better record keeping with electronic health records [21-24] to electronic prescriptions of medication and care [25-27] are often mentioned.

10 To describe the impact of e-health on the citizens health, Eysenbach [1] identified 10 features, or the 10 e s, that collectively distinguish e-health programs and each can be looked at as a measure for their health care benefit: efficiency (reducing excess care and costs), enhancing quality (facilitating choice of high-quality providers), evidence-based (scientifically proven), empowerment (access to knowledge bases and electronic records), encouragement (shared decision making), education (access to training for providers and high-quality information for consumers), enabling (standardized information exchange), extending (global access), ethics (professional practice and privacy issues), and equity (must reduce digital divide). The EU IMPACT study (2006) [11] defines benefit categories along the lines of the following quality aspects: Informed patients and health care providers Sharing of information designed to streamline health care processes Timeliness (scheduling and providing health care at the right time) Safety Effectiveness Access Efficiency But the real question for health care benefits is: do these technologies actually improve the patients health-level? Are there lives being saved? Does e-health really have an impact on the patients health status? Example: A study from an e-prescription system from the North-Atlantic region in the US showed that in 2007, more than 525,000 prescriptions were written electronically. In addition, nearly 23,000 medication history requests were made, allowing the physician to review all of the patient s medications. Reviews of the complete medication history resulted in prescription changes due to allergy warnings (9 percent), drug-drug interaction warnings (34 percent), duplicate therapy warnings (36 percent), dose warnings (13 percent) and formulary non-compliance warnings (22 percent) [28]. This example not only shows economic benefits when using this e-health technology, but the results confirm that using an e-prescribing system clearly has a beneficial influence on the patients health status. Numerous allergic reactions and drug-drug interactions would not have been spotted without the e-prescribing technology.

11 Although this component of e-health, namely the real effect on the patients health status is very difficult to measure, it will become one of the key aspects in the acceptance and development of e-health systems in the near future. This is an aspect that not only addresses the patients directly but is also the primary concern for the health care providers. Therefore it will be necessary to strictly define the assessment rules and come up with an inimitable set of criteria on an international (European) level that will be used to evaluate the efficiency and effectiveness of the e-health systems regarding the patients health status E-health initiatives in Europe It would take a series of encyclopedia to describe all the recent e-health initiatives that have started in Europe. Over the past years, the number of e- health projects has increased rapidly. Web of Science 2 is currently reporting 20 journals in the field of Medical informatics. Moreover the online Journal of Medical Internet research, founded in 1999 has become the leading journal in the field in just 10 years time, mainly due to the increasing pressure to publish state of the art research in a very innovative field where technologies and applications change rapidly. E-health initiatives range from very small to very large, from local or regional to national or even international, although there are not yet many largescale national e-health procedures in routine operation. Most undertakings are at the stage of development, pilots or in larger test phase. Few initiatives already have gone through a fully functional roll-out. Only the three Scandinavian countries have already implemented fully operational national ICT infrastructures. Most EU countries have their e-health infrastructure in the process of development and schedule the implementation phase in the years to come. The EU ERA report provides a detailed report on the priorities and strategies of the European countries until 2007, and their plans for the future [14]. In Table 1 you find a summary-overview of the 32 European countries that were covered by this study. Six major e-health themes were selected: Infrastructure, electronic health records, interoperability, patients and health 2 Web of Science, more info on:

12 professional mobility, legal and regulatory framework and evaluation and impact analysis. Table 1: Overview of e-health initiatives in EU countries until (Summarized from ERA report EU Commission, i2010 countries are countries that are not EU-member states, but involved in the EU policy framework for the information society and media i2010) a. Infrastructure As a fully operational telecommunications infrastructure (preferably broad-band) is a prerequisite for regional or national e-health solutions, all EU countries have invested in such networks. Therefore all countries score a plus on this item. This however does not imply that all EU countries have dedicated network infrastructures connecting health service providers and other relevant stakeholders. In most case we are just talking about basic

13 infrastructure like broadband connections or basic technical or semantical interoperability 3. Scandinavian countries are amongst the most advanced here. Since 2002, for example, all hospitals and primary care centers in Sweden are connected via Sjunet [29]. It is a federated telecommunications network which also links together pharmacies and several other health care enterprises and regional administrations. Most EU countries are planning to extend their telecommunications infrastructure in near future. b. Electronic Health Records (EHR) Electronic health record is a rather fuzzy term, as will be discussed in detail further on in this chapter. EHRs can range from summarized to complete (well structured) health records. Most EU countries already have some form of long-term summarized records, accessible regionally or even nationally. The EHRs can be organized within a national health program, as in the MedCom health infrastructure in Denmark [30], can be hospital based [31-33, 43] or even managed by the primary care sector, as a collaboration between commercial software providers and national health institutes, as in Belgium [21, 22, 40, 42]. Next to the national initiatives also European projects exist that endorse the use of well organized EHRs. OpenEHR for instance is an organization that has as goal to come up with an economically viable construction of maintainable and adaptable health computing systems and patient-centric electronic health records. [34-35]. Another initiative, EuroRec is an independent not-for-profit organization, promoting the use of high quality Electronic Health Record systems (EHRs) in Europe. EuroRec is organized as a permanent network of National ProRec centers and provides services to industry (the medical software developers and vendors), health care providers (the buyers), policy makers and patients. 3 Semantical interoperability: is the ability of two or more computer systems to exchange information and have the meaning of that information automatically interpreted by the receiving system accurately enough to produce useful results, as defined by the end users of both systems. Will be explained in more detail in paragraph 2.2.5

14 c. Interoperability Data exchange and interoperability are concepts that are closely linked to the EHRs discussed in the previous paragraph. Despite this relationship, not many EU countries have put interoperability high on their agenda. This is surprising because interoperability is one of the key issues in the EU Action Plan. Only about a third of the member states mention interoperability in their action plan. A few, for example Denmark, with the MedCom initiative have already developed a platform based on technical standards and interoperability for e-messages, called the Danish Health Data Network [30]. Also on a transnational level initiatives have taken place. RIDE is a roadmap project, supported by the sixth framework of the EU commission, for research and development on interoperability of e-health systems leading to recommendations for actions and to preparatory actions at the European level, with Special Emphasis on Semantic Interoperability [36]. d. Patient and health professional mobility As with interoperability, patient and health professional mobility is not a key issue in most EU countries e-health policy, although it is a central point of e-health action plan of the EU. In most case mobility must be viewed in the context of electronic identity or health cards or web-based access to health information or other services. Slovenia s health policy explicitly states patient mobility as a priority topic. This country has also been dealing with the issue of an electronic health insurance card for many years now [37-39]. Besides this, in various European Union regions a wide variety of cross-border schemes allowing citizens to obtain health care in another EU member state have been developed. Moreover, in the early 2000 s public health insurance funds in Germany, the Netherlands and Belgium together with the hospitals of the touristic regions along the North Sea coast, introduced a service that supports immediate access to health care for traveling citizens, which instantaneously informs participating hospitals about the

15 insurance status of the patient. Moreover it guarantees reimbursement within a week thanks to electronic transfer of administrative data. [14]. e. Legal and regulatory framework Legal and regulatory frameworks are crucial building blocks for fully functional e-health infrastructures. Not only for health care providers but also for citizens are medical data very sensitive information that should be handled with care. Especially when the data are available via the network and possibly visible to and accessible by numerous persons. Citizens are very anxious to know what is happening with their health information. But many e-health applications such as EHRs, ehealth platforms, health grids involve new legal challenges [44]. Therefore in EU countries where legislation is already implemented or at least under serious discussion, the introduction of e-health systems will prove to progress more efficiently. Alongside legislation and general regulations on data protection, confidentiality and telecommunications, legislation on digital signature and medical device liability is widely spread. Several countries already have legislation in place for different aspects of e- health, like for example Belgium, with the new ehealth platform [45], or are on the verge of reviewing their existing legislation in respect to new developments in the e-health domain E-health initiatives in Belgium Belgium is a federal constitutional monarchy, where executive and legislative power is divided between the federal government, three regions (Flanders, Wallonia and Brussels) and three communities (Flemish-, Frenchand German speaking). Because the communities are responsible for personal matters, comprising health and welfare, Belgium s e-health policy is subject to several ministries. Due to that large number of participants, Belgium sees clear advantage and need for a concerted official e-health

16 roadmap, mainly supported by the Ministry of Health (FOD Volksgezondheid, Veiligheid van de Voedselketen en Leefmillieu 4 ). In Belgium the first e-health initiatives originated from this Ministry of Health (Dr. J.P. Dercq, Dr. M. Bangels, Director Dr. C. De Coster and colleagues). By law (Royal Decree of May 3 rd 1999) the Telematics commission was created to coordinate research and deployment actions in the e-health field. In 2008 major changes took place: the e-health Platform was created (law on e- Health, Aug. 2008) and the focus of initiatives shifted from the Ministry of Health to the social security administration (RIZIV / INAMI). Currently many regional and national e-health initiatives exist in Belgium. In the next part we will briefly summarize a few of the most important ones, emphasizing that this list is far from complete. a. Local and regional initiatives between hospitals Flow projects (Facilities, Legal implementation, Organizations, Wisdom): national health care network(s), built around the shared electronic health record between geographically spread hospitals. Pertinent health data are available via the sites selected by the mobile patients, who can freely decide where they get treatment in the health care system. Currently three major initiatives exist: Flow alpha: Réseau Santé Wallon, between several Walloon hospitals. [46] Flow beta: Abrumet (BHIP: Brussels Health Information Platform), between several hospitals in the Brussels region. [47] Flow gamma: GZO (Gents Ziekenhuis Overleg), between several hospitals in the region of Gent. [48] Besides these projects, more local projects attempt to connect physicians and other healthcare providers to large hospitals. For example in Leuven LISA (Leuvense Internet Samenwerking Artsen) [49]. 4 FOD Volksgezondheid, Veiligheid van de Voedselketen en leefmillieu: https://portal.health.fgov.be

17 b. Carenet My-Carenet [50] This project is putting in operation a safe electronic exchange of financial and administrative information between health care institutions and health care providers on one hand, and mutual health insurance institutions on the other hand. Carenet has the following three main goals: Improve the quality of the invoice data used in a third-party payer environment Decrease the administrative workload, by reducing the amount of manual and in particular repeated data input Cost savings on printing and sending. c. IBBT projects IBBT (Interdisciplinary Institute for Broadband Technology) is an independent research institute founded and funded by the Flemish government to stimulate ICT innovation. The IBBT team offers companies and organizations active support in research and development. It brings together companies, authorities, and non-profit organizations to join forces in the context of research projects. Both technical and non-technical issues are addressed within each of these projects. The mission of IBBT is the creation of highly competent human capital in different aspects of ICT through multidisciplinary demand-driven research. IBBT carries out this multi-disciplinary research for the Flemish business community and the Flemish government. This includes all technological, legal and social dimensions of the development and exploitation of broadband services. A few of the projects of the IBBT are: ehip (e-health Information Platforms 1 Sep Feb 2008) is a regional information platform for the health care sector. It offers authorized care personnel safe and reliable access to confidential clinical patient information. The system is always accessible at every workplace. E-HIP is designed to promote co-operation between the information islands of today. The final objective is an adequate health care, which is supported by an integrated regional IT infrastructure that is available to all care personnel, including family doctors, hospitals, specialists, health centers, etc. [51] Share4Health (1 May Apr 2010): The focus of this project is a common patient centric, community centric health care IT platform that is used by hospitals, general practitioners and pharmacists and that

18 addresses the needs of the next generation clinical applications, which focus on collaboration and decision support. Furthermore it relies on the advances and the innovations that come with Web2.0. [52] d. Kmehr (Kind messages for electronic health records) This project that already dates back to the early 2000 s defines an XML implementation for health related electronic messages. Kmehr-bis (Belgian Implemantation Standard) is currently considered as the standard for exchanging health related electronic messages, which are used in many of the above described e-health initiatives. Amongst these messages are discharge letters, medical prescriptions and lab-results. More detailed information on Kmehr can be found in the next chapters. [53] e. Recip-e [27] The Recip-e project involves the creation of an electronic prescription system for Belgium, corresponding to the theoretical model realized previously, fitting into the Belgian health system and aiming to obtain a consensus from all involved parties: physicians, pharmacists, authorities and the patients. The in depth analysis of the pilot study resulted in a detailed requirements set, specifying the implementation features and taking into account the features that will enable painless roll-out. A realistic estimation was already made of the efforts required and a clear pathway is drawn, to come to an operational system, from which all involved parties will benefit, especially the patient, who becomes more knowledgeable about the status of his prescriptions and who will get more protection against errors f. Belgian ehealth platform [54-55] Although all these regional or even national initiatives exist, there still remains a need for coordination of all these projects, without losing the original approach and dynamics of the individual programs. Therefore the ehealth platform 5 (formerly Be health) was created based on a shared basic vision and strategy concerning e-health between all the actors in the Belgian health care domain. Another important goal of e-health is to create of platform for technical and semantical interoperability, for quality and 5 ehealth platform: we will use BOLD formatting when referring to the Belgian ehealth platform. Normal formatting will be used when referring to the general e-health term.

19 security standards applicable in the whole country. In this model the ehealth platform has special attention to: the protection of the privacy of the patient the professional secrecy of the health care provider regulations about information security coherence of all the parts of the proposed model Some other crucial aspects of the ehealth platform model: no central repository for medical / personal health data secure data exchange between all health care providers if a patient wishes, partial redirection to the places where his /her heath data is available application of current legislation about e-health, and privacy of the patient respect and support for existing e-health initiatives the utilization of the ehealth platform is offered, not forced the ehealth platform is not performing any research regarding health care in its own right and does not have access to medical data, themselves Schematically, the use of the ehealth platform and its services is presented in figure 2. The model consists of three layers. Maybe the most important aspect of the ehealth platform is the provision of free basic ICT services (BS) that can support the local and regional e-health initiatives, which can be found in the middle layer. These basic services are made available to institutions that can use these services in order to generate added value services (AVS). The basic services are: portal-site environment (https://www.ehealth.fgov.be) integrated user / access management management of logins

20 personal electronic mailbox for every health care provider time stamping coding and anonymisation upkeeping of KMEHR, software certification o system for end-to-end encryption o coordination of electronic partial processes The top layer consists of the added value services. These added value services are put available for patients and / or health care workers. Examples of these added value services are as described above: My-Carenet, Flow projects, the site of the ministry of Health (FOD Volksgezond, veiligheid van de voedselketen en leefmillieu) and many others as will be described in next chapters. The bottom layer stands for validated authentic sources (VAS). These are basic database that are used by the ehealth platform. The manager of the database is responsible for the availability and the (organization of the) quality of the data that is provided. Examples of these databases are the registry of health care providers ( Kadaster van zorgverleners ) managed by the Ministry of Helath (FOD Volksgezond, veiligheid van de voedselketen en leefmillieu), that contains information on diploma and specialty of the health care providers, identified using his social security number (INSZ 6 ). Another database is managed by the RIZIV 7 and contains information about the recognition of the health care providers. The introduction of the ehealth platform has many advantages, not only for the government, but also for the health care providers as well as for the patients at large. Government: better policy support maximum spending of available budget on care thanks to more efficient handling of administrative formalities singe implementation of-re-usable (basic)services Health care provider: less administrative formalities, more time for care better professional support one affiliation to the electronic platform suffices for many applications support for local and regional cooperation Patient: 6 INSZ: Identificatie nummber voor sociale zekerheid. 7 RIZIV: Rijksinstituut voor Ziekte- en Invaliditeitsverzekering (http://www.riziv.fgov.be)

21 improved quality of the health care and security for the patient in some cases, faster delivery of care better transparency Figure 2: Schematical representation of the ehealth platform. AVS stands for Added Value Service, BS means Basic Service, and VAS is Validated Authentic Source (schematically from e-health presentation of F. Robben, 2008)

22 2. Electronic Health Records (EHR) 2.1. Definition Electronic health records are a major focus for current research in the field of health informatics and e-health [56, 57]. Most research has been performed on the possibilities of the current technologies and the underlying architecture. The EHR is considered to be one of the cornerstones of e-health as recently confirmed by CEN s focus group on E-health [58]. In 2006 the EU commission reports: achieving a European health record is not yet an overarching goal, but collaboration on developing individual countries' health records or basic patient summaries as a first step towards more comprehensive records appears to be an aim of increasing interest to many of the Member States [11]. This last example clearly demonstrates the need for well organized EHRs. But before one can dream of an EHR at a European level, we need to agree on what we define as an EHR. And EHR is a rather fuzzy term, as mentioned in the EU report. As with e-health there exists a wide variety of definitions [59-64]. The list is more exhaustive in comparison with the e-health definition, due to the different health care disciplines that all try to define their own EHR. Big differences exist between primary care and hospital settings or between family physicians and specialist. Also other health care providers as nurses, pharmacists, physiotherapists and paramedics use their own domain specific definition for the EHR. Despite this wide variety, some very general and standardized definitions are available, which was not the case for e-health. In 2004, the International Organization for Standardization (ISO) defined the electronic health record [65]. According to this definition, the EHR means a repository of patient data in digital form, stored and exchanged securely, and accessible by multiple authorized users. It contains retrospective, concurrent, and prospective information and its primary purpose is to support continuing, efficient and quality integrated health care. This definition, although not very detailed, is very clear and it describes and contains all the core concepts that are needed to build a well organized EHR. An adapted version of this definition is also being used by the openehr 8 project, an open standard specification that describes the management and storage, retrieval and exchange of health data in EHRs. 8 OpenEHRM : The openehr Foundation is a not-for-profit company. Its founding shareholders are University College London, UK and Ocean Informatics pty, Australia.

23 They define the EHR as repository of information regarding the health status of a subject of care in computer processable form, stored and transmitted securely, and accessible by multiple authorized users. It has a standardized or commonly agreed logical information model which is independent of EHR systems. Its primary purpose is the support of continuing, efficient and quality integrated health care and it contains information which is retrospective, concurrent, and prospective [34, 35]. Many more definitions exist, but in the scope of this work, we do not wish to give a large overview of all possibilities. For our research work, the definition of ISO, includes all the necessary elements that are needed in an EHR. We emphasize the fact that not only EHR is used as a term to describe the electronic storage of clinical (patient) data. According to the health care domain, different types of EHRs exist and they are defined using different concepts. ISO also gives a number of other terms that are frequently used in the relevant literature, to describe different types of EHRs. This is clearly illustrated in table 2, which contains the data from a review article from 2008 (from Häyrinen and colleagues [64]), concerning the definitions on EHRs As already mentioned above, some organizations deal with the topic of EHR. On an international level, the openehr-project [34, 35] is one example, another on a European level is Eurorec [66]. In Europe, 15 countries including Belgium (7 other applicant countries) each have their own ProReccentre, an initiative supported EU commission. These centers provide services to industry (the developers and vendors), health care providers (the buyers), policy makers and patients, mainly concerning EHRs. EuroRec is organized as a permanent network of National ProRec. The EUROREC Institute (EuroRec) is an independent not-for-profit organization, promoting in Europe the use of high quality Electronic Health Record systems (EHRs). One of its main ambitions is to support, as the European authorized certification body, EHRs certification developments, testing and assessment by defining functional and other criteria. The topic of certification and quality labeling will be further discussed in chapter 2.

24 Table 2: Overview of the types of definitions used for describing EHRs (from Häyrinen et al., 2008 [64]) 2.2. Aspects of EHRs When developing EHR systems many aspects have to be taken into account. What is the patients role in the EHR (1). What is the core function of the EHR (2). Which are the standards, codes, nomenclatures and vocabularies that are going to be used (3). What about data integrity and security (4). Are these EHRs interoperable with other systems and is data exchange possible (5) [64]. These aspects can be found in the definitions that are mentioned above and they are pertinent to our research that will be discussed in the next chapters Role of the patient in the EHR

25 The patient plays a central role in the EHR. Not only is he the subject of the EHR, but the patient can also play an active role in the management of the EHR. Should the patient be responsible or at least partially - for managing his own EHR? Nowadays, using secure web technologies, many options are available and the topic forms a very pertinent discussion. Many voices speak in favor, but equally as many are against [72-76]. It is not the goal within this work to further extend on this discussion, moreover that in Belgium the general practitioner (GP) is keeper of the medical record of the patient 9. The fact that the GP is the manager of the patients medical record, and therefore also the EHR, is a key concept of this work which will be elaborated in more detail in chapter 4, where interoperability between EHRs for GP and EHR for physiotherapists is discussed. Patient empowerment is ever increasing, the patient is considered more and more as a partner in the health care team. Further debate on the patients role in assigning authorization rights to parts of a shared patient record are going on, as this work is being published. Therefore it is impossible to go into detail, but this item also remains a key aspect for the future development of EHR systems. [73, 74] Core function of the EHR As already mentioned above, different types of EHRs exist depending on the speciality of the health care provider. Most EHRs include a part of administrative patient data such as names, addresses, gender etc. Besides this, the core functionality and structure of the EHR is often determined by the way the health care provider organizes his work. Early classifications for the structure of EHRs that are mentioned in literature are time-oriented problem-oriented and source-oriented EHRs. Nowadays EHRs combine all three elements. In the time-oriented electronic medical record, the data are presented in chronological order. In the problem-oriented medical record (POMR), notes are taken for each problem assigned to the patient, and each problem is described according to the subjective information, objective information, assessments and plan (SOAP). In the source-oriented record, the content of the record is arranged according to the method by which the information was obtained, such as notes of visits, X-ray reports and blood tests. Within each section, the data are reported in chronological order [75-76]. 9 The general medical record of the patient (in Dutch: Globaal medisch dossier ) is managed by the family physician in Belgium

26 Not only the way EHRs are structured is differentiated, also the content differs according to the health care domain and the scope of the EHR. It is clear that nurses are interested in keeping other health care data than physiotherapists, and hospitals store other data than GPs. Many initiatives to build a solid EHR exist. Unfortunately they are often organized using the point of view of a specific health care domain, without the broader vision of the whole sector. These structural disparities between EHRs for different health care providers, is an important issue when discussing the topic of interoperability. This topic will be further elaborated in chapter 4, regarding the exchange of data between electronic medical records and electronic physiotherapy records. These systems have a completely different approach for dealing with a health care problem. Another aspect when dealing with the content of the EHR is the concept of a minimal needed set of health care data. In different countries these minimalistic EHRs are already being put into practice, but they differ a lot in functionality. Some are stored within the hospital information systems, others like the Sumehr 10 in Belgium are kept by the GPs EHR. Other initiatives even want to store the data on the patients health insurance card [77] Even non-official projects exist, where commercial software companies encourage patients to store there minimal patient record on a memorystick or similar devices that they always carry with them. Next to the medical minimal datasets, there also exist minimal datasets used in the context of the management and financing of health care institutions (MKG, MPG) 11. Through the coding of diagnosis and treatment in the medical records (ICPC-coding, used in primary care and DHCP coding in hospitals {see 2.2.3}), unambiguous exchange of medical information is made possible. Coding systems enable the extraction of minimal datasets for epidemiologic studies and for management purposes. The minimal datasets in their own right fall outside the scope of our work, that is aiming at the clinical aspects of patient data. Of course the clinical datasets form the source from which minimal datasets are built Standards for classification and nomenclatures 10 Sumehr: Summarized electronic health record (https://portal.health.fgov.be/pls/portal/docs/page/internet_pg/homepage_menu/gezond HEIDZORG1_MENU/AUTOMATISERING1_MENU/HOPITAUX9_MENU/SUMEHRPHOTOSANTE1_ME NU/SUMEHRPHOTOSANTE1_DOCS/ SUMEHR.PDF) 11 MKG: Minimale klinische gegevens (minimal clinical patient data), MPG: minimale psychiatrische gegevens (minimal phychiatric patient data)

27 Standardization and coding of the data, forms a crucial aspect when one wants to store information in a digital format. To retrieve data efficiently and accurately, the health care provider needs to be able to rely not only on well structured data but preferably on carefully coded data. Many different standards and classification methods exist in health care. In this paragraph we will discuss the main standards and classifications for electronic health care data that are of interest for our research. We will only consider the standards for classification of health care data on the level of the disease or more in general the health care problem. In the paragraph on interoperability (2.2.5), standards for exchanging health care data will be discussed. These standards are interlinked, but have a different core concept. We briefly discuss the definitions for ICD9/10 (a), ICPC2 (b) and ICF (c) according to the WHO 12 in this paragraph, but elaborate on their particularities when they are used within chapters 3 and 4. The standards for classification depend mainly on the specification of the health care discipline. These differences were developed historically and have now grown into classifications that are more appropriate for a typical health care domain and are better suited to the needs of the health care providers working in that domain. To illustrate this, without detailing what the different classification codes are, the following example: A GP will try to code / classify a health care problem with a patient at the level of the disease. For instance a patient comes to the GP with an ankle sprain. This is classified at the level of the disease. The primary goal of the doctor is to cure this patient by eliminating the disease. The patient is usually considered as cured when he/she does not return to the doctors office for this health care problem. However for a physiotherapist, it is necessary that he is able to make statements not only on the status of the disease but also on the amount of pain, possibilities of daily life activities etc. This is needed for the therapy planning and measuring the progress of the patient. a. ICD 9/10 (International classification of diseases, v9 or v10) 13 The ICD is the international standard diagnostic classification for all general epidemiological, many health management purposes and clinical use. The ICD codes include the analysis of the general health situation of population groups and monitoring of the incidence and prevalence of diseases and other health problems in relation to other 12 WHO: World Health Organisation: more info on: 13 ICD9/10: more information on:

28 variables such as the characteristics and circumstances of the individuals affected, reimbursement, resource allocation, quality and guidelines. It is used to classify diseases and other health problems recorded on many types of health- and administrative records including death certificates and health records. In addition to enabling the storage and retrieval of diagnostic information for clinical, epidemiological and quality purposes, these records also provide the basis for the compilation of national mortality and morbidity statistics by WHO Member States. b. ICPC2 (International classification of primary care, second edition) 14 ICPC-2 classifies patient data and clinical activities in the domains of General/Family Practice and primary care, taking into account the frequency distribution of problems seen in these domains. It allows classification of the patient s reason for encounter (RFE), the problems/diagnosis managed, interventions, and the ordering of these data in an episode of care structure. It has a biaxial structure and consists of 17 chapters, each divided into 7 components dealing with symptoms and complaints (comp. 1), diagnostic, screening and preventive procedures (comp. 2), medication, treatment and procedures (comp. 3), test results (comp. 4), administrative (comp. 5), referrals and other reasons for encounter (comp. 6) and diseases (comp. 7). c. ICF (International classification of functioning, disability and health) 15 The International Classification of Functioning, Disability and Health, known more commonly as ICF, is a classification of health and healthrelated domains. These domains are classified from body, individual and societal perspectives by means of two lists: a list of body functions and structure, and a list of domains of activity and participation. Since an individual s functioning and disability occurs in a context, the ICF also includes a list of environmental as well as personalfactors [78, 79]. 14 ICPC2: more information on: 15 ICF: International Classification of Functioning, Disability and Health. More info on:

29 Data integrity and security When dealing with clinical data, data integrity and security aspects are very import. Examples are protecting the patients privacy [72-73], managing the authorization rules for accessing the EHRs [85], especially in a shared medical record situation. Other legal facets of the e-health systems need to be controlled very carefully to form a solid basis for a good EHR structure. For example, the patients rights to access his own EHR(s), and the list of accesses by other parties to his medical data, as recommended by the IMIA working group on security in health information of 2006 [87] These aspects however fall outside the scope of this work, because they need an in-depth understanding of the legal structures of the health caresystem. Although it will not be discussed in detail here, there is one aspect of this topic that was partially subject of this work: data encryption. It will be discussed further in chapter Interoperability Interoperability is currently a major issue when dealing with EHRs. Interoperability is the ability of different information technology systems and software applications to communicate, to exchange data accurately, effectively, and consistently, and to use the information that has been exchanged to good purpose. Making health care information systems interoperable will reduce cost of health care and will contribute to more effective and efficient patient care [80]. For many years EHRs have been developed in many sectors of the health care domain, but only few of them are ready to communicate with each other. Interoperability can be looked at in many ways and depends also on the data structure (see 2.2.2) that is used. Interoperability can be investigated at different levels, such as the interoperability of the messages exchanged between health care applications and interoperability of complete EHRs. Another aspect of

30 interoperability is the mutual exchange of patient identifiers, coding terms, clinical guidelines and health care business processes. Graphically the interoperability between two EHRs or in general health care applications can be represented as in figure 3. Figure 3: Standardized message exchange between two health care applications, e.g. EHRs (schematically from Dogac et al [80]). Typically, a messaging interface gathers data from the back-end application systems, encodes the data into a message, and transmits the data over a network such as a Value Added Network (VAN) to another application. On the receiver side, the received messages are decoded, processed and the data which have been received are fed into the receiver s back-end systems to be stored and processed Furthermore, all these categories can be investigated in two major layers: the syntactic interoperability layer and the semantic interoperability layer. Syntactic interoperability (which we term as messaging layer), involves the ability of two or more systems to exchange information. Syntactic interoperability involves several layers: network and transport layer (for example Internet), application protocol layer (such as HTTP(S)), messaging protocol and message format layer, and the sequencing of the messages. Syntactic interoperability guarantees the message to be delivered but does not guarantee that the content of the message will be machine processable at the receiving end. To guarantee message content interoperability, either the message content should conform to a single machine processable standard or semantic interoperability must be provided, such as the ones we discussed in paragraph Semantic interoperability is the ability for information shared by systems to be understood at the level of formally defined domain concepts. As with classification standards it is impossible to discuss all the available interoperability standards in this work. Moreover that not only international standards but also national or system specific standards exist. Therefore we will restrict ourselves to some global definitions of the different standards that are useful for our research, and we will provide an in depth discussion related to our research in the next chapters.

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