Abstract
The pandemic COVID-19 has shown us how important it is for medical teams to have access to all patient data, to be able to implement appropriate guidelines, and to adapt as easily as possible to new challenges. This paper explores the implementation of an open platform within Slovenia’s healthcare backbone and identifies requisite elements for bolstering a national healthcare ecosystem. A gap analysis between the Slovenian open platform and Apperta’s specifications has revealed discrepancies. Through addressing this gap and examining backbone challenges, a preliminary list of success factors has been identified. These insights not only inform the establishment of a resilient national healthcare ecosystem but also contribute to a broader comprehension and execution of digital transformation within healthcare systems.
Introduction
To establish sustainable eHealth services, fostering a collaborative ecosystem within the entire healthcare sector is of utmost importance. Such an ecosystem should provide sufficient value to all stakeholders. The objective should be supported by high-level architectures encompassing all technical aspects, including security, interoperability, and integration of enterprise information systems. Therefore, an ecosystem-driven design strategy is required in the early stages of technical development. 1 The complexity of the healthcare environment and data means that a new entrant is much less likely to succeed than in other sectors. Any new product must integrate and share data with the existing systems. In this case, the many non-standard interfaces and data formats, and the difficulty of obtaining information and cooperation from existing vendors, make this an often impossible task.
As can be seen in the literature, all current solutions that offer the electronic health record (EHR) system design and build a lag behind interoperability, a critical functionality that a healthcare EHR management system should provide. The new era of cross-border healthcare in the European Union is now regulated by EU directives that also address issues of privacy and confidentiality, personal data, and data protection, which are of great importance when considering the EHR. 2 eHealth and a patient-centered approach, mainly through the implementation of national and eventually pan-European systems, is demonstrated by the announced Horizon 2020 work program entitled Health, Demographic Change and Wellbeing. 3 EU countries have made individual efforts to update existing national eHealth systems or develop new ones. In 2012, an eHealth action plan was formulated to evaluate the progress of eHealth development and establish primary goals. Despite the prevailing economic crisis during that year, the telemedicine market witnessed a remarkable growth. However, the intricate nature of the European legal framework presented a substantial challenge. Many of the barriers that impeded the widespread adoption of eHealth at that time remain unaddressed. These encompass a lack of awareness and confidence in eHealth solutions among patients, citizens, and healthcare professionals, the absence of interoperability between different eHealth solutions, a scarcity of substantial evidence demonstrating the cost-effectiveness of eHealth tools and services on a large scale, inadequate and fragmented legal structures, including the absence of reimbursement mechanisms for eHealth services, and considerable initial expenses associated with establishing eHealth systems. 4
Estonia emerges as a pioneer in digitalizing the EHR for both patients and healthcare providers. In fact, Estonia was hailed as a leading country for eHealth innovation in Europe according to the 2019 Annual European eHealth Survey, conducted in collaboration between HIMSS (Healthcare Information and Management Systems Society) and McKinsey. 5 Other countries such as Austria, 6 Sweden 7 and Italy 8 have functioning eHealth systems at the regional level. However, because of the lag of standards across Europe, their diffusion is slow. 9
The purpose of this paper is to explore how an open platform has been implemented in the Slovenian healthcare system and what other elements of the backbone are needed to support a healthcare ecosystem. We identified a gap between the Slovenian implementation of an open platform and the open platform requirements defined by Apperta in 2017. 10 Apperta is considered to be the standard for measurement in the context of open platforms because it defines the minimum core open platform services that should be present in a healthcare system. When a country does not have an existing open platform, Apperta’s guidelines provide a framework for evaluating and establishing the essential components and functionalities required for an open platform in the healthcare domain. By addressing this gap, we identified success factors for building a national healthcare ecosystem that will also guide better understanding, planning, and execution of the overall digital transformation of our healthcare system.
Principles of an open platform
The vision of an open platform is to create an open ecosystem that drives competition at the application, service, and platform levels. 10 The idea is that the data is not vendor-locked. The hospital can choose a unique set of applications from different vendors, with each application meeting the hospital’s specific needs and all applications working together seamlessly. All patient data is open, meaning it can be shared in standardized formats. In addition, all applications, services, and platforms are interchangeable.
An open platform adheres to the following eight principles
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Open standards-based—The implementation should adhere to agile open standards, ensuring that any interested party can freely use these standards to construct an independent and compliant instance of the complete platform without any charges. Shared common information models—Information models provide an unambiguous description of a piece of information (content). Supporting application portability—Applications written for one platform implementation should be able to run on another independently developed platform with trivial or no changes. Federatable—It should be possible to connect any implementation of the open platform to all others that were independently developed, in a federated structure, to allow the sharing of appropriate information and workflows between them. Vendor and technology-neutral—The standards should not depend on particular technologies or require components from particular vendors. Supporting open data—Data should be made available as needed in an open, shareable, computable format in near real-time. Providing an open application programming interface (API)—The full specification of the APIs should be freely available. Operability—The platform should support the principles of software operability.
An essential component of an open platform is the provision of data repositories to store data about patients and service users who are the subjects of care, and for these to be held in an open shareable format. The repositories contain the patients’ own records and have been described as the EHR. Note that the platform can also provide federation services to enable applications to access the data or services held on other compliant platforms. Moreover, it can provide services to orchestrate the workflow between applications, or services for decision support when prescribing medications (e.g., is it safe to combine medication one and medication two if the patient has the following diagnoses and/or certain allergies?). An open platform provides infrastructure and services that are wholly based on openly published standards. Open standards are critical for achieving the central aim of an open platform which is portability for data and substitutability for applications so that neither gets locked into a particular vendor’s platform.
Making the metadata and content open and shareable facilitates interoperability, improves quality, and reduces duplication of effort. 10 There are two types of data: structured and unstructured. For structured data, openEHR standards should be used. OpenEHR is the only currently available open standard for the representation of fine-grained structured clinical content that is sufficiently mature and proven at scale. OpenEHR has been adopted as a standard for the representation of clinical content in the Norwegian hospital sector and as a national standard in India, Slovenia, and Brazil. 10 There has been a recent adoption of openEHR in the UK. HL7 1 standards deserve special mention due to their appealing nature to developers and the significant interest they have sparked within both global and local informatics communities. The HL7 standard plays a crucial role in achieving healthcare interoperability. With widespread adoption, it serves as a pivotal means for exchanging medical information among diverse information systems. 11 As a result, it stands as a cornerstone for implementing the EHR system. For unstructured data, Integrating the Healthcare Enterprise-Cross Enterprise Document Sharing (IHE-XDS) standard should be used. IHE-XDS is an open standard that provides a mechanism designed for the sharing of documents and images along with relevant metadata in a health and care environment. Although primarily used for documents and images, it can be used for managing any type of unstructured or semi-structured data. For instance, this combination has been used successfully at scale in both Moscow and Ljubljana.
Methods
This study adopts a case study research design to explore the implementation of an open platform in the Slovenian healthcare backbone and identify the necessary elements to support a national healthcare ecosystem. The case study approach allows for an in-depth examination of a specific healthcare system, taking into account its complexities and real-world context.
Data for this study was collected through multiple sources. First, a comprehensive literature review was conducted to understand the principles of an open platform and the requirements defined by Apperta. This review provided a framework for evaluating the Slovenian implementation.
Additionally, one interview was conducted with Samo Drnovšek, Head of Better Platform Pre-sales, who provided valuable information on the Slovenian ecosystem. The questionnaire that guided our nearly hour-long interview can be found in the Appendix. We also used information from the Better Platform website and podcast episode 40: “How strong is the digital health community?” 12 in the podcast Faces of Digital Health hosted by Tjaša Zajc, Business Development and Communication Management at Better. The episode includes an interview with Tina Vavpotič, a board member of the Healthday.si community. It is a community of healthcare stakeholders from Slovenia working toward an innovation-friendly ecosystem with the aim to support small and medium-sized enterprises in their digital transformation as well as enhance their role as agents of transformation of the whole Slovenian healthcare system.
The interpretation of the data revolves around the identified gap between the Slovenian implementation and the Apperta-defined open platform principles. The success factors for building a national healthcare backbone are discussed in light of the study’s objectives and the broader context of digital transformation in the healthcare sector.
A case study of the Slovenian healthcare backbone
To enhance the health of individuals and the community as a whole, it is crucial to foster collaboration within the entire local community. Thus, promoting the competencies and skills of all stakeholders who can play a role in creating a supportive environment to achieve health-related objectives becomes imperative. Local health communities, comprised of various healthcare providers, professionals, organizations, and engaged citizens, provide a platform for their population.
Slovenia launched the comprehensive, strategic National eHealth Project (NHP) in 2005, which was to be completed by 2015. After a promising start in 2006/2007, the project essentially came to a halt in 2008 due to the global financial and economic crisis. Due to the economic instability caused by the global financial crisis, stakeholders resorted to developing information systems and solutions individually, rather than continuing with the centralized project. This led to a lack of coordination of health information systems in the country and delays in the implementation of eHealth solutions. As a result, real progress has been observed mainly in 2015–2018, with the nationwide implementation of ePrescriptions, eReferrals and eAppointments on a national scale and unification of solutions by healthcare providers under a centralized system (hospitals are obliged to send data). By 2018, all services that were part of the NHP had been implemented.
The most important project was the Central Registry of Patient Data (CRPD). Its development proceeded in two phases. First, the CRPP was implemented as an IHE-based, cross-enterprise document-sharing solution with the ability to mobilize documents already created by legacy systems. Second, the backbone was upgraded with a clinical data repository to store national-level structured EHR records based on openEHR. This created the ability to share core clinical information such as basic data, referrals, prescriptions, medication lists, allergies and reactions, immunization records, and other related data with the backbone. The CRPD not only defines semantic and technical standards but also meets the highest standards for personal data protection and data security.
The eHealth system in Slovenia was designed at the national level as a horizontal, integral system covering the entire healthcare system in the country. The system integrates and connects all three levels of the healthcare system into an integrated platform, that is accessible and available to all patients and all service providers in the country. In practice, this means that regardless of the entry point, i.e., at the local community of the general practice center, specialty clinic, or hospital, citizens have access to the same set of integrated services and, through the zVem platform, to the same electronic medical documents. The most commonly used integrated services are eReferrals/eAppointments and the CRPD. When fully utilized, they provide critical documents and information to stakeholders in a patient pathway through the national healthcare system via zVem.
Today, the Slovenian open platform meets the minimum core open platform services defined by Apperta (Figure 1) in the following way:
Essential elements of an open platform defined by Apperta.
Authentication services
Authentication service runs in the security platform. The security platform is an application that provides unified management of users and their rights to work in different applications. It performs authentication and authorization and also supports the management of the rights of system users (applications).
Master patient index (demographic service)
Master Patient Index runs in the Registry of Patients and Geodetic Data (RPGD)—the central patient registry that contains the basic status and demographic data of patients. It represents the list of patients—persons with permanent or temporary residence in the Republic of Slovenia, whose health data are recorded in the CRPD.
Service dictionary (staff and services)
Service Dictionary is available on the eZDRAV website set up by the Ministry of Health. It is intended to share information such as public APIs, organizational procedures, or instructions for developers to deploy new applications over the backbone.
Clinical data repository based on openEHR
Patient data is stored in the structured and unstructured form. For structured data openEHR is used, for unstructured IHE-XDS. An example of a document with structured data is the patient summary, while an example of a document with unstructured data is a discharge letter (saved as a PDF).
Registry of vaccinated persons
The Slovenian open platform also has an Electronic Registry of Vaccinated Persons (eRVP), which stores surveillance and monitoring of vaccinations and adverse reactions.
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Information on all vaccinations (including COVID-19) provided to the eRVP is available to:
Patients in the patient summary, accessible through the zVem portal. Physicians involved in the patients’ care and selected physicians access the data for an individual patient as part of a specific treatment. Other healthcare professionals involved in the patients’ care through patient summary. ePrescription
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was introduced in 2016 on a national level and its use is mandatory for all health service providers in the country. All ePrescriptions are stored in the CRPD and in the last few years, more than 92% of all prescriptions issued were digital. Physicians only issue paper prescriptions as an exception and under special circumstances (home visits). The main objectives of the application were to increase the quality of services to the patient by reducing the error rate, to have a better overview of the prescribed medications, both individually and cumulatively, to simplify procedures, to reduce administrative costs, and more. All pharmacies in the country have access to the central database of ePrescriptions. eReferrals/eAppointment
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was launched in 2017 on a national level and is mandatory for all citizens in Slovenia equipped with the application that allows issuing electronic referrals. All eReferrals are collected in the CRPD in EHR and are accessible to health service providers. Healthcare service providers are required to update the central database on waiting times and available capacity daily. In this way, patients receive information about relevant healthcare providers, waiting times, and more through the zVem portal. They can select the hospital or clinic where they would like to be examined or treated and make an appointment via the eAppointment service. Documents
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is an application for accessing patient data. The advantage for the individual is that he/she can view all health documents concerning him/her and his/her children. The patient summary includes twelve sections such as allergies, vaccinations, surgical procedures, diagnoses, pregnancy, medical implants, disabilities, social history, prescribed medications, and more. Moreover, it is possible to obtain the EU Digital COVID Certificate.
When the open platform of the ecosystem was prepared, different vendors offered different healthcare applications. Today, the platform supports approximately 2600 healthcare providers, including hospitals, health centers and dental studios. There are 50 million records in the backbone (20 million unstructured and 30 million structured records). Ninety-five percent of the Slovenian population has at least one record stored in the backbone. Applications that process the patient data of the Slovenian population are collected on the zVem
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portal:
Discussion
To comprehensively assess the success factors within the ecosystem, we have integrated a success factor list from Apperta. This foundational list, when coupled with insights from subsequent interview and podcast discussion, provides a robust framework for understanding the challenges inherent in Slovenia's healthcare ecosystem (Figure 2). The following text elucidates the responses garnered from the interview, shedding light on the intricate issues identified within the system.
Healthcare ecosystem backbone success factor.
Inadequate integration with hospital information systems
At the moment, the weakest points in the system are the numerous internal hospital information systems, many of which are not yet fully integrated with the national interoperability backbone and therefore not yet sending all relevant medical documents to the CRPD. In addition, it takes time for physicians to get used to a new way of retrieving patient data from the computer. Previously, the patient had to carry their documents with them. The new way of retrieving documents is more bureaucratic for physicians, as certain authorization and authentication requirements must be met beforehand. In Slovenia, there is a law that states that patient data must be stored electronically. However, no one controls this and consequently, no fines are imposed for non-compliance. For instance, the national eHealth system of Estonia covers the entire country uniformly and registers the medical history of all citizens from birth to death. This comprehensive system enables seamless data exchange and interoperability across healthcare facilities. On the other hand, while Italy has made efforts to improve eHealth and digital health services, the integration of hospital information systems across the country has faced challenges. The lack of a fully integrated national system has led to variations in data exchange and interoperability.
Insufficient communication and consultation channels
Another weakness of the Slovenian healthcare system is communication and consultation between the patients and healthcare providers, especially the various specialists when patients need advice on non-urgent medical problems. There are several internet forums trying to fill the gap in some of the most common specialties, such as cardiology, urology, diabetes, and more. A systemic eSolution as part of the healthcare system would make consultation between patients and the appropriate medical advisor much easier, more efficient, and timelier. An innovative eConsultation solution using advanced AI solutions (i.e., managing digital consultations by cross-referencing similar health conditions registered in the system), available 24/7 through different communication channels including mobile apps, could significantly reduce the current extreme pressure on emergency medical centers in Slovenia. The core open platform services offered by the Slovenian system vary in maturity. The maturity of the service dictionary is very low. The Ministry of Health has established a website eZDRAV, which (among other things) serves to provide information for developers. Shared public APIs are one of the key enablers of an ecosystem. Registries connected to the backbone should, in theory, have publicly available APIs. However, at this time (December 2022), the list of public APIs that provide access to the backbone is missing or could not be found. We also could not find any organizational processes for: How can a vendor certify their application to show that it is compatible with the platform and can be offered in the platform market? How can it be demonstrated that the application has no security or privacy issues? Currently, user authentication resides within a domain of applications, posing challenges for public APIs. The existing APIs, limited to basic authentications (username and password), are not publicly accessible. It is essential to move the authentication and validation of end users to the domain of APIs, utilizing tokens for this purpose.
Effective implementation of eHealth services requires and triggers adaptation of internal processes and procedures, documents, workflows, and data flows. The digitization of the healthcare system in Slovenia has not been extensively utilized to drive significant reorganization of outdated organizational structures or the implementation of new innovative business models and processes throughout the entire healthcare system. A notable example is the absence of a demo environment for testing new applications. Although technically feasible for a new provider to offer a new application, the practical process of integrating it into the backbone proves highly complex due to non-public APIs and the lack of a system for positioning new applications in the backbone. In addition, there is a lack of a process for accrediting and certifying new applications so that they meet certain security standards. For example, Estonia’s government and health authorities actively engage with healthcare professionals, patient groups, and the general public through various channels, including social media, websites, and public events. Regular consultations with stakeholders help in understanding their needs and addressing any concerns related to eHealth adoption. 17 Italy has made efforts to improve communication and consultation channels for eHealth initiatives. Successes include the establishment of dedicated eHealth communication platforms and engagement with stakeholders, including patients. However, challenges persist, such as fragmentation due to the decentralized healthcare system, language barriers, awareness and education gaps, and addressing the digital division. 18
Centralized management
The ecosystem should be centrally managed, and currently, it is not. Solutions and projects are managed by the National Institute of Public Health and the Ministry of Health of Slovenia. As a result, information is scattered across multiple websites and sub-sites, with a confusing structure of implemented projects that delivered different types of outcomes/services (e.g., applications, documentation) to different beneficiaries. To date, there is little evidence that the government is monitoring and evaluating the impact of eHealth in a systematic or even improvisational manner. Regular monitoring, ex-ante and expost evaluation of eHealth programs and projects is the key instrument for the efficient and effective development of eHealth solutions and rational use of resources. The neighboring country, Italy, also has a decentralized healthcare system, and the management of eHealth initiatives is distributed among different regions and authorities. The country’s healthcare system operates at both national and regional levels, and each region has some degree of autonomy in managing its healthcare services, including eHealth initiatives. 18 A centralized management can be found in Estonia, which has led to the successful adoption of digital health solutions, streamlined healthcare processes, and improved patient outcomes. The country’s approach to eHealth has been recognized for its efficiency, security, and patient-centered focus. 17
Lack of strategic planning and evaluation
Slovenia needs to develop a new strategy for eHealth development. Actions in support of a new strategy should include preparation and adoption of the new mid-term strategic framework in the field of health informatics (i.e., eHealth services) and outline the main directions of development. Almost all activities have been carried out over the last few years in Slovenia to implement the most important eHealth services such as ePrescriptions, eReferrals/eAppointments, CRPD, were defined in the distant year 2005 when the national eHealth project was launched. Since then, there have been no updated or new strategic documents that would have adapted all planned activities to the current needs of the Slovenian healthcare system and new technological developments. The lack of clear strategic goals and coordination of activities at the national level led many healthcare providers, especially larger hospitals, to go their own way and develop their own solutions, which are now difficult to integrate, as their maintenance costs are very high and the further fate is unclear. To avoid these problems in the future, the government would need to create a regular strategy and action plans for a period of 3–5 years with concrete goals, expected results, milestones, indicators, reporting, and clear responsibilities. For example, to establish the groundwork for implementing the eHealth information strategy, the Ministry of Health of Italy has undertaken numerous initiatives that align with both the national framework represented by the new national health information system and the areas identified as priorities for intervention such as health services booking systems, online transmission of sickness certificates, ePrescription, and dematerialization. 19
Unclear financial plan and motivational factors
A solid financial plan with clearly defined sources of funding, monitoring, and auditing should also be established. Many service providers and especially IT solution developers are confused about how to allocate their resources and how to invest in this area, as there is no clear strategy or financial plan on how much money the government intends to invest in this area in the future. In addition, the government should place more emphasis on motivational factors for all stakeholders so that the adoption and use of eHealth services is a win-win solution for all stakeholders. Healthcare providers should have tangible benefits and financial incentives for the use of eHealth services, while patients should be rewarded with easier access, better quality of services, less paperwork, and better transparency of the entire system.
Conclusion
Realizing the vision of an open platform is not about creating a single, isolated instance of a platform. Instead, it involves building an ecosystem where multiple application providers compete for business. These ecosystems can benefit from new technologies for eHealth, enabling more efficient networking among all users and providers. It is essential to understand that information communication technology defines a new type of citizen who is well-informed and demands better products and services, while also being participative and constantly interacting, taking responsibility for their reality. These characteristics are evident in every aspect of their lives, including health. This new citizen necessitates a robust healthcare ecosystem.
Footnotes
List of abbreviations
Acknowledgments
We extend our sincere appreciation to the anonymous reviewers whose valuable insights and constructive feedback greatly enhanced the quality and rigor of this paper. Their meticulous review and thoughtful suggestions contributed significantly to shaping the final version of our work. We are grateful for their time, expertise, and dedication in reviewing our manuscript.
Contributorship
Explanations concerning contributorship are not applicable to this study since it was conducted by one author only.
Declaration of Conflicting Interests
The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Ethical approval
Verbal informed consent was obtained from the sole participant involved in the research. The participant was provided with a comprehensive explanation of the study’s objectives, procedures, confidentiality measures, and his rights as a participant. It was emphasized that participation was entirely voluntary, and he had the autonomy to decline participation or withdraw at any point without any adverse consequences.
Funding
The authors disclosed a receipt of the following financial support for the research, authorship, and/or publication of this article: This work was supported by the Slovenian Research and Innovation Agency, (grant number P2-0037).
Guarantor
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