An open, component-based information infrastructure for integrated health information networks Manolis Tsiknakis a, , Dimitrios G. Katehakis a, Stelios C. Orphanoudakis a,b a Center for Medical Informatics and Health Telematics Applications (CMI-HTA), Institute of Computer Science (ICS), Foundation for Research and Technology-Hellas (FORTH), Science and Technology Park of Crete, Vassilika Vouton, P.O. Box 1385, GR 711 10 Heraklion, Crete, Greece b Department of Computer Science, University of Crete, Heraklion, Crete, Greece Abstract A fundamental requirement for achieving continuity of care is the seamless sharing of multimedia clinical information. Different technological approaches can be adopted for enabling the communication and sharing of health record segments. In the context of the emerging global information society, the creation of and access to the integrated electronic health record (I-EHR) of a citizen has been assigned high priority in many countries. This requirement is complementary to an overall requirement for the creation of a health information infrastructure (HII) to support the provision of a variety of health telematics and e-health services. In developing a regional or national HII, the components or building blocks that make up the overall information system ought to be defined and an appropriate component architecture specified. This paper discusses current international priorities and trends in developing the HII. It presents technological challenges and alternative approaches towards the creation of an I-EHR, being the aggregation of health data created during all interactions of an individual with the healthcare system. It also presents results from an ongoing Research and Development (R&D) effort towards the implementation of the HII in HYGEIAnet, the regional health information network of Crete, Greece, using a component-based software engineering approach. Critical design decisions and related trade-offs, involved in the process of component specification and development, are also discussed and the current state of development of an I-EHR service is presented. Finally, Human Computer Interaction (HCI) and security issues, which are important for the deployment and use of any I-EHR service, are considered. # 2002 Elsevier Science Ireland Ltd. All rights reserved. Keywords: Integrated electronic health record Message-based integration Federated architecture Healthcare information infrastructure Integrated regional health information networks Component architecture Component-based software engineering 1. Introduction The healthcare environment is currently changing with increased emphasis on preven- tion and early detection of disease, primary care, intermittent healthcare services provided Corresponding author E-mail addresses: tsiknaki@ics.forth.gr (M. Tsiknakis), katehaki@ics.forth.gr (D.G. Katehakis), orphanou@ics.forth.gr (S.C. Orphanoudakis). International Journal of Medical Informatics 68 (2002) 3 /26 www.elsevier.com/locate/ijmedinf 1386-5056/02/$ - see front matter # 2002 Elsevier Science Ireland Ltd. All rights reserved. PII: S 1 3 8 6 - 5 0 5 6 ( 0 2 ) 0 0 0 6 0 - 6

by medical centres of excellence, home care, and continuity of care. This requires the definition of wellness pathways and the provi- sion of personalized healthcare services based on best practices and evidence-based medi- cine. In such a dynamic environment, informa- tion and communication technologies (ICT) are taking on a leading role and are currently having a significant impact on the practice of healthcare at all levels. The catalyst for change in the health sector, based on the use of ICT, is the need for improved quality of healthcare services and the containment of related costs. Also, as citizens become better educated and informed, they will increasingly have higher expectations regarding access to care and the quality of healthcare services. Furthermore, the traditional healthcare delivery structures flatten. Instead of the three or four level hierarchy (primary, secondary, tertiary, and university hospital level care), only two are likely to exist in the future, i.e. centres of excellence specializing in technology-intensive procedures and primary care (front line) facilities. At the same time, part of the responsibility of care is shifting into the hands of the citizen, with emphasis on wellness or health maintenance. This change in healthcare service provision has been ongoing for several years and has undergone several paradigm shifts. One must also take notice of the fact that we are living in an increasingly mobile society. As a result, each citizen may have a number of encounters with the system of health at different times and with different healthcare facilities, over the course of a lifetime. Mil- lions of healthcare transactions take place in developed countries every day, involving lab tests, diagnostic imaging examinations, and hospital in-patient visits, while some tens of thousands of doctors are seeing 30 / 50 pa- tients a day, as reported in [1]. Other important trends in healthcare in- clude the movement towards shared or inte- grated care in which the single doctor-patient relationship is giving way to one in which an individual���s healthcare is the responsibility of a team of professionals across organizational boundaries within the healthcare system. This is being accompanied by a very significant growth in home care, which is becoming increasingly feasible even for seriously ill patients, through sophisticated telemedicine services facilitated by intelligent sensors, mon- itoring devices, hand-held technologies, the Internet and wireless broadband communica- tions. Within such an environment, the need for a single I-EHR for every citizen becomes the cornerstone for supporting continuity of care and the evolving, novel health telematics and e-health services of today. This paper begins with a brief overview of the expected benefits from the creation and use of the I-EHR, together with correspond- ing requirements, and a presentation of cer- tain international efforts towards its design and development. Then, it focuses on the definition of a scalable HII to provide support for efficient service development within the context of a corporate, regional, national, or trans-national health information network, and presents arguments regarding the need for defining an architectural framework and a component-based software engineering ap- proach for the gradual, evolutionary develop- ment of the HII. An on going effort towards the develop- ment of HYGEIAnet, the regional health information network on the island of Crete is also presented and related results are discussed. The fundamental software compo- nents of the corresponding HII are described, focusing on those components required for the creation of an I-EHR. The process, as well as critical design decisions of component identification, specification and development, M. Tsiknakis et al. / International Journal of Medical Informatics 68 (2002) 3 /26 4

receives particular emphasis. Finally, the cur- rent status of development of a federated I- EHR environment is presented and critical HCI and security issues are considered. 2. Integrated electronic health record A scalable I-EHR would provide the means to access all available clinical information, at a corporate, regional, national or even inter- national level, and to meet challenges posed by patient mobility and the fact that an individual���s health data may reside at many geographically dispersed information systems. An I-EHR is a collection of all of an individual���s lifetime health data in electronic form, generated during relevant interactions with the healthcare system. In addition to providing support for continuity of care, the I-EHR may prove to be a valuable tool in basic and clinical research, medical decision making, epidemiology, evidence-based medi- cine, and in formulating public health policy. 2.1. I-EHR service: expected benefits There are a number of envisaged benefits from the development and deployment of an I-EHR service, provided that the need for citizen consent, user authentication, and the required levels of security is properly ad- dressed. Envisaged benefits include the fol- lowing: . Vital health information would be available and accessible 24 hours a day, 7 days a week, regardless of where the person re- quiring care happens to be. . Since healthcare practitioners would be able to view a patient���s relevant medical history, they would be better positioned to offer more effective and efficient treatment, and could spend more quality time with the patient. Contrast this with the current situation, where medical practitioners have access, if at all, to a partial or inaccurate patient history and may recommend a course of treatment that could potentially be life-threatening. . Access to information on previous medical or lab examinations would reduce the number of redundant procedures and result in greater cost savings. Certain procedures may also pose a health risk to patients, if repeated unnecessarily, and ought to be avoided. . The information that an I-EHR would provide to researchers (with safeguards built in to protect the identity of patients and obtain their consent) would result in improved quality of care, based on an enhanced ability of health planners and administrators to develop relevant health- care policies for the future. Population health statistics, developed from the infor- mation contained in the I-EHR, can be instrumental in the formulation of such policies. . An I-EHR would greatly empower indivi- duals by giving them access to their own personal health records. It will enable them to make informed choices about options available to them and give them the oppor- tunity to exercise greater control over their own health. Anticipated benefits of the I-EHR, together with the related information technology (IT) supporting features, are listed in Table 1. 2.2. I-EHR service: features and technological challenges Any successful I-EHR realisation requires, from a technological point of view, the existence of certain supporting features. Those M. Tsiknakis et al. / International Journal of Medical Informatics 68 (2002) 3 /26 5