Challenges in implementing nationwide electronic health records: lessons learned and how should be implemented in Greece

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1 Challenges in implementing nationwide electronic health records: lessons learned and how should be implemented in Greece Leonidas L. Fragidis and Prodromos D. Chatzoglou Democritus University of Thrace, Department of Production and Management Engineering, Xanthi, Greece {lfrangid, Abstract. During the last decade, healthcare administrations in all developed countries have dedicated huge amounts of resources to the implementation of Electronic Health Records (EHR). This paper determines the challenges in implementing EHR and acknowledges effective implementation strategies ( topdown, bottom-up and middle-out ) used in different counties worldwide. The main challenges are communication, standardization, interoperability and funding. The adoption of EHR is associated to cost reduction in healthcare, but the use of EHR is also accompanied with different kind of problems, like technical, legal, privacy and security. Another major issue in EHR implementation is the quality of data stored. Despite the fact that EHR data quality is considered in the strict sense of data verification and validation, ensuring that EHR data are suitable for their intended use should also be taken into account. In Greece, although a number of EHR implementation attempts have been made, both in the private and public sector, they are for local use only. Implementing a national EHR is an entirely different issue from just expanding a clinical system across different organizations. It involves defining a policy and standards framework that can integrate public and private, local and central systems into a functional national information system. An implementation approach that could be followed in Greece is proposed, taking into consideration all the special characteristics of the Greek national health system. Keywords: hospital information systems, electronic health record, ehealth, EHR implementation 1 Introduction Nowadays, cost reduction in the healthcare sector is more important than ever. Along with the necessity of reducing cost, quality improvements of health services are also required. The development and the increasing use of Information and Communications Technology (ICT), such as the internet and mobile communication, allows physicians and patients to expect better electronic services (e-services) such as electronic access to their medical data. The medical data should be accessible to all doctors both in the public and private sector. Further, patients require better information concern- 221

2 ing their health records in order to be updated for the medical procedures used and the proposed recovery methods [1]. In the last decade the efforts for developing Electronic Health Record (EHR) systems has increased significantly. The different development approaches between countries and their experiences in the implementation phase of such Information Systems could be used as a reference point for other countries that would intend to follow. Many developed countries have developed and use EHR such as the United States of America, Australia [2], and Canada [3]. In Europe an increasing number of countries have started the development of EHR and those that leading the way are United Kingdom [8], Switzerland, Germany, Holland, Danish, Sweden, France and Austria. This paper presents and discusses the three main and different nationwide EHR implementation approaches, top-down, bottom-up and middle-out and their challenges [4]. As Morrison et al [5] reports, the representative countries of those three approaches are UK for top-down, USA for bottom-up and Australia for middleout. Taking into account the lessons learned from these three different implementation approaches and considering the specific financial crisis that Greece is facing, it is proposed that the middle-out implementation approach should be followed in order for a fully operational EHR to be in use within the next three to five years. 2 EHR Implementation Approaches It is widely accepted that the use of EHR decreases cost and, simultaneously, increases the quality of the health care during hospitalization [6]. The benefits of an EHR system in operation are safety, quality and efficiency of Healthcare [7]. On the other hand, a number of technical, organizational and social problems may arise in the implementation phase [8]. The priorities that each country poses for EHR implementation differs. Netherlands are focusing on unscheduled care [9], Denmark on primary care [10], and lots of countries, like UK, have as main concern the secondary care [11]. 2.1 Top Down Approach. Coiera categorization of EHR implementation approaches denotes the top-down approach as a Government-driven centralized national approach [4]. In order for a county to consider this approach, nation-scale management and governance structures should match. The National Program for IT (NPfIT) in UK, which was started in 2002, is the main representative of this approach. The aim was the development of a universal electronic health records and secure data exchange throughout National Health Service (NHS) in England by 2010 [12]. All local NHS should be adapted to the new system and no local choice could be followed. However, after eight years of significant governmental efforts and over of 6.2 billion spending, the results were 222

3 disappointing; major delays, repetitive changes of specifications, cost escalation, compatibility problems, and significant technical issues [13]. As a result, the UK nationwide EHR implementation approach was ruled out in September 2010 and the responsibility for EHRs was assigned to individual NHS Trusts for a more locally led plural system approach [14]. The approach of the new attempt is connect all rather than replace all, thus recognizing the significance of letting the local NHS authority to decide which EHR systems fulfills its requirements. Another important aspect of the centralized approach is that considering the financial pressures there was a minimization of the systems development. Thus, this approach suits with the UK current economic situation for efficiency savings [15]. 2.2 Bottom Up Approach The bottom-up approach is based on the initiative of the local healthcare organizations to implement EHR either by transforming the operational systems or develop new healthcare information systems in accordance with interoperability standards [4]. It is expected that a big number of different software applications still run locally, but the attention is given to data accessibility and integration issues in order for these systems to be able to communicate with each other and share information under specific standards. The United States decided (in 2003) that the U.S. residents should have an EHR system in ten years adopting the bottom-up implementation approach. As a first step, it was assigned to the Centers for Medicine and Medicaid Services to develop the standards [2]. Health Level Seven (HL7) Version 3 and Clinical Document Architecture (CDA) are used, which promote the interoperability of an EHR information system. The scope of the Federal government was to set a framework concerning policies, strategies and actions relating to data privacy and security, interoperability, adoption and collaborative governance [16]. In contrast to UK s approach, in USA there was a very strong government support focusing on the motivation of all stakeholders, even patients, in order to persuade them for the necessity of policy development at local and federal level. The Certification Commission for Health Information Technology (CCHIT) developed a set of certification criteria that each local EHR information system has to comply with, in order to ensure interoperability [17]. In 2009, the Office of the National Coordinator for Health Information Technology launched a certification test for EHR technology compliance and standards and assigned to CCHIT to be the certification body. The certification has transformed to standards with the Health Information Technology for Economic and Clinical Health Act (HITECH). These standards and specifications are known as the Meaningful Use Criteria. More than twothirds (71 percent) of the complete electronic health records of providers and hospitals that have successfully tested to federal meaningful use criteria and qualified for incentives through the American Recovery and Reinvestment Act (ARRA) are dually certified under both the ONC-ATCB and the CCHIT [18]. The big problem is that a lot of American hospitals and physicians cannot afford the costs of a certified EHR system as reported by the American Medical Association 223

4 (AMA) and American Hospital Association (AHA). Rational timelines are needed because insufficient lead time for implementation, product development and certification, increases implementation costs and brings at risk patient safety in hospitals [19]. Although AMA primary concern is the privacy of EHRs and local implementation costs, it seems that the cost can be covered by hospitals and large healthcare practices but for the majority of them (smaller in scale) could not deal with such cost. A progress report on Electronic Health Records in U.S. Hospitals published from Health Affairs in 2010, shows that only two per cent of USA hospitals reported that they have records that currently met the national Meaningful Use Criteria [20]. 2.3 Middle Out Approach The combination of the top-down and bottom-up approaches generates the middle-out approach. It brings together local based systems, which are financial supported by government, in order to ensure national interoperability according to defined standards. The only obligation that the local healthcare authorities have to meet is that the operable EHR systems should share their data under specific national standards. The country where the government aims at the development of a set of standards for Health sector and not at the development of a universal EHR information system is Australia [4]. In 2003, Australia started to implement the HealthConnect program in a national level. This national strategy for electronic health records changed in 2005, sharing the responsibility between HealthConnect Program Office and the National EHealth Transition Authority (NEHTA). The role of NEHTA's was "to develop better ways of electronically collecting and securely exchanging health information and to establish the fundamental standards necessary to progress ehealth" [21]. NEHTA approach complies with the middle-out approach where government invests to the development national standards that can be reconciled by the local EHR and the interoperability of clinical IT systems. Another big issue that NEHTA is also in charge with is the development of a security framework for the data that is stored and the way it will be accessed. The new program of the Australian government for the healthcare sector is the Internet-based Person-Controlled Electronic Health Records (P-CEHRs). The primary objective is P-CEHR to operate from 2012/13 and offer to its user s access to their medical information stored in different healthcare providers IT systems under secure access via a portal [22]. The P-CEHR users will be able to display a health summary, which will consist of users demographic details, medical conditions, prescribed medications and allergies. In the near future the intentions of the developers are to offer more services to users like referrals, test results and prescriptions. It is believed more healthcare providers will include to their implementation the adoption of P-CEHR [23]. 224

5 3 Lessons Learned The Implementation of EHR has progressed much more slowly worldwide than it was initially anticipated. Also, there are no significant benefits either to patients or to medical staff yet. A number of reasons prevents the completion of EHR development such as the continuously change of system characteristics, and politically driven contractual relationships among NHS healthcare providers. Stakeholders need to acknowledge the magnitude of the problems arising from the implementation of such a system and not to have unrealistic expectations concerning the functions of these systems. The improvement of data sharing and time consumption in the implementation process is the main benefits of regional implemented systems with similar functionalities to a national system. The initial efforts should focus on the designing technology that is fit for local use and satisfies users and organizational needs [24]. Although, large-scale interoperability is very important and necessary, it should be the second priority. The lessons learned from England s experience to implement a national-scale centrally procured EHR system are the following [24]: The initial focus should be on making the software usable. Expectations need to be realistic. Benefits may take a long time to realize, and systems may initially slow down work practices and impact adversely on organizational functioning. Implementing EHRs is an ongoing process and it should be expected to continue in line with changing local and national needs as well as political landscapes. Efforts should ideally begin with the user, before moving on to more general organizational and national requirements. A balance between customization and standardization is vital. Aligning efforts of various stakeholder groups is necessary for an integrated approach. Appropriate time and resources need to be allocated nationally to allow the process of local accommodation to occur. Centrally negotiated contracts may inhibit these desired developments. A very good example that can be followed is Switzerland s e-health architecture. Switzerland is a federal republic consisting of 26 cantons. Each canton is responsible for its own healthcare, welfare, law enforcement and public education issues. Building an e-health framework for Switzerland is like building e-health for Europe. Heterogeneity, with educational and cultural differences, several languages, numeral legal frameworks and political organizations, different cultures and understandings are the basic obstacles of implementing a new Health Information System [25]. In order to respect all those characteristics the adoption of the following pre-requisites has to be ensured: No central patient registry No central document registry Patient self-determination of which information is available to whom 225

6 Consent management Use of standards whether they exist Use of European standards whether they exist 4 EHR Implementation in Greece In 2001, a reform of the Greek National Healthcare System was introduced aiming to improve the performance and control of the healthcare in Greece [26]. Major interventions implementing ICT in public Health, Welfare and Social Insurance should have been completed under the CSF III ( ), but there are still in progress (such as EHR). Unfortunately, the development of an EHR system is still in the designing phase. Under the National Strategic Reference Framework (NSRF) ( ), there is a strategic plan for developing the EHR and defining conceptual and technological framework. This is illustrated in objective of the Operational Program "Administrative Reform , strengthening the administrative and organizational environment and institutional establishment of Electronic Health Records. In June 2006, the mapping of e-health applications was initiated by the Ministry of Health and Welfare for the quality and safety of the health care services. The aim was to create a National Health Information System (NHIS) [27]. The duration of the mapping process will be a decade and is divided into three phases: : During the first phase the goal is to strengthen the structures, standardization and communication : Pilot implementation of the health network at regional level : Implementation at the national level. A number of localized developments concerning EHR have been made in Greece in different regions and in different organizations. There was no actual plan to facilitate the collaboration of these systems. The interoperability and security of these systems is a big issue. The major EHR developments in Greece are the following: The Integrated Health Record of the Institute of Computer Technology and Research Foundation (ICSFORTH) in Crete EHR in Homeopathy EHR of the General Hospital of Naoussa EHR of the General Hospital of Piraeus "TZANEIO'' EHR of the Papageorgiou Hospital EHR of the Onasseio Hospital EHR in Military Hospitals 226

7 4.1 Proposed Implementation method Greece, facing the economic crisis, is in a stage of reforms in many areas, including the health care sector. The implementation method that has been followed from individual organization so far was the bottom-up approach. On the contrary, the government had initially adopted the top-down approach. Until now, there is no clear evidence that either of the above approaches can reach the ultimate goal of an interoperable EHR system. To this extend, it is proposed that the adoption of the middle-out approach should be followed in Greece in order to have an operable EHR within a short timeframe. This approach is compatible with the Greek reality as there are already several EHR systems that operate locally, developed by different vendors. The main goal of this approach is to make data accessible by all different systems. The initiation of this method should be based on a strategic plan which will revise the existing institutional framework, identify of key priorities, and defines the appropriate penalties to noncompliance stakeholders. Greek government should be involved only in setting the policies and standards and support convergence both in public and private sector. It is very crucial for the state to develop the regulatory framework needed to safeguard the interests of citizens. Finally, the technological infrastructure that exists in Greece nowadays allows the EHR implementation to become a reality. References 1. Katehakis, D. G., Tsiknakis, M., and Orphanoudakis S. C. (2002), Towards an Integrated Electronic Health Record - Current Status and Challenges, Business Briefing: Global Healthcare 2002, The Official Publication of the World Medical Association 2. Thompson T. G. and Brailer D. J., The Decade of Health Information Technology: Delivering Consumer-centric and Information-rich Health Care, Department of Health and Human Services, United States, Framework for Strategic Action, G. Sherman. (2001), Toward electronic health records, Office of Health and Information Highway Health Canada [Online], Available: 4. Coiera E. Building a National Health IT System from the middle out. J Am Med Inform Assoc 2009;16(3): pp Morrison Zoe, Robertson Ann, Cresswell Kathrin, Crowe Sarah, and Sheikh Aziz, Understanding Contrasting Approaches to Nationwide Implementations of Electronic Health Record Systems: England, the USA and Australia, Journal of Healthcare Engineering, Vol. 2, 2011, pp Chen, C., Garrido, T., Chock, D., Okawa, G. & Liang, L. (2009) The Kaiser Permanente Electronic Health Record: transforming and streamlining modalities of care. Health Affairs (Millwood), 28 (2), Majeed A, Car J, Sheikh A. Accuracy and completeness of electronic patient records in primary care.family Practice 2008; 25(4): pp

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