Interoperability Nuts and Bolts in the EU

This page summarises the nuts and bolts of interoperability. Go here to learn about examples in the EU.

Components and layers of interoperability

IT interoperability enables IT systems to share data as they provide services. On top of interoperability, semantic interoperability enables IT systems to automatically process the data that was shared. This then enables the IT systems to better support users, with automated functions like decision support, comfortable searching, and re-use of the data.

To achive this, a lot of aspects must be satisfied, ranging from legal and regulatory aspects, to organisational and then to procedural issues, and finally the semantic and technical details. In the European Union (EU) the New European Interoperability Framework (EIF) was established, to define and better understand all this these layers of interoperability. This was done with the goal to actually implement interoperable IT services in the public sector in the EU. See the image of the EIF Conceptual model, under "What has changed", and find more information on the EIF page.

Interoperability efforts in the EU

The EU has invested substantially into the common market. Doing so, the EU has emphasised the need to efficently implement coherent IT services, that make use of semantic interoperability in the best possible way.

ISA2

The ISA² Program - Interoperability solutions for public administrations, businesses and citizens - supports the development of digital solutions that enable public administrations, businesses and citizens in Europe to benefit from interoperable cross-border and cross-sector public services. Find the details about ISA2 on the ISA2 home page https://ec.europa.eu/isa2/home_en.

In the EU member states, a large number of solutions have already been deployed, that were supported by ISA2. Go here to learn more about these ISA2 solutions (https://ec.europa.eu/isa2/solutions_en).

Connecting Europe Facility (CEF)

The Connecting Europe Facility (CEF) is a key EU funding instrument to promote growth, jobs and competitiveness through targeted infrastructure investment at European level. Learn more on the CEF home page (https://ec.europa.eu/inea/en/connecting-europe-facility).

Within CEF, specific business domains of the European market implement interoperable  IT services. The current focus domains are Energy, Transport and Telecom.

In order to facilitate cooperation and re-use of existing components, CEF works to provide "CEF building blocks" and DEF Digital Service Infrastructures" to implementers of services in the member states.

eHealth DSI within CEF

Within CEF, work is ongoing to implement cross border data exchange to support patient care. Find an incredible amount of details at the eHealth DSI Operations Home space.

At this time the focus is on the European Patient Summary and ePresciption. These services are currently rolled out over Europe, see the eHDSI Deployment Plans. the goal is to provide these services all over Europe by the year 2020.

A large variety of international IT standards are used within the eHealth DSI. Go here for the specifications of the eHealth DSI to see exactly how.

Use of IT Standards for eHealth in the EU

In 2019 the EU published a Recommendation on a European Electronic Health Record exchange format. It is recommended to exchange Patient Summaries, ePrescription/eDispensation, Laboratory results, as wellas medical imaging data and reports. This recommendation builds on a series of activities in the EU and its member states. Further work is ongoing to provide more detailed guidance on how to implement coherent IT services for health and care to better support citicens in Europe, while maintaining the quality, to sustain health and care on the long term.

Information domains in healthcare in the EU: EHRs, Rare Diseases and Medical Registries as fields of action for Interoperability

Much effort is invested into interoperability in healthcare, across different fields of application. Find here some examples. Future efforts may target to further interconnect and harmonise the IT infrastructures that support the services mentioned here. Both users as well as manufacturers of IT systems in health will benefit from the improved data quality and quantity as well as from increased efficiency. No more need to re-enter data that was already entered into an IT system! (Also see the European legislation on open data and the re-use of public sector information, e.g. the Open Data Directive and the PSI directive)

eHealth DSI: Cross border information sharing for patient care

Within the "Connecting Europe Facility" (CEF) program, many different Digital Service Infrastructures (DSIs) are being developed and deployed, for different business domains of the public services in the EU. "The eHealth Digital Service Infrastructure (eHDSI or eHealth DSI) is the initial deployment and operation of services for cross-border health data exchange under the Connecting Europe Facility (CEF). eHDSI sets up and starts deploying the core and generic services, as defined in the CEF, for Patient Summary and ePrescription." Go here for the deployment plans.

IT services are currently being develoepd and deployed throughout Europe. Detailed specifications are available for the eHealth DSI.

European Reference Networks (ERNs) for patients with rare diseases

European Reference Networks (ERNs) for rare diseases "create a clear governance structure for knowledge sharing and care coordination across the EU. They are networks of centres of expertise, healthcare providers and laboratories that are organised across borders". rare diseases are a very important field, where interoperability can truly deliver. This is exactly what interoeprability must enable: Move data to places where it can be processed efficiently. From that, provide great benefits for citizens. Connect those who experience a situation with those who work to better understand and act in the situation.

Many organisations are involved in ERNs. They are running large IT infrastructures to enable sharing information within the ERNs.

  • The RareConnect network, for example, enables rare disease communities to connect and share information. RareConnect provides moderated online forums.
  • The European Patient Identity Management (EUPID) system was developed within the ENCCA project (European Network  for  Cancer  Research  in  Children and Adolescents). It enables to support secondary use of data while maintaining privacy.
  • EURORDIS is a non-governmental patient-driven alliance of patient organisations representing 864 rare disease patient organisations in 70 countries. EURORDIS runs a platform to support patients with rare diseases. This platform provides a significant amount of information and services.

Other IT services enable healthcare providers and patients to provide data from individual patients. This data generates valuable evidence, to expand the knowledge about specific diseases. This knowledge is then used to support and treat individual patients. In this way ERNs contribute substantially to collect all information that is available, to aggregate and review it as a first step. Further on, ERNs then make best possible use of the available evidence, in that they provide it to patients no matter where they are settled geographically.

Registers / Registries

Registers (also called Registries) for medicine evolved historically over many years. The "London Bills of Mortality" was initiated in the 16th century. It is often referred to as one of the origins of the International Classification of Diseases (ICD). ICD is today managed by the World Health Organisation (WHO), see the WHO History of the development of the ICD.

Today, in the EU and internationally numerous registers have emerged. The European Network of Cancer Registries (ENCR) is one example of a public service. It combines and orchastrates the efforts of local registers in the EU member states. The Network of Orthopaedic Registries of Europe (NORE) is an international registry network built up as a standing committee of EFORT and founded in 2015. NORE focuses on medical device surveillance and arthroplasty outcome in order to support improvements in patient care.

Other registers have emerged from research projects. These registers often encounter challenges as the research funds reach their limits, and it becomes difficult to sustain the effort. Overall hundreds of medical registers exist in the EU and worldwide.

Registers have gained in attention in the EU as a result of the changes in the Medical Device Regulation. Among the improvements that the regulators targeted, we find the strengthening of post-market surveillance requirements for medical device manufacturers. Medical registers may provide a valuable source of post market data that may be used to evaluate the performance of devices in the field. Many device manufacturers find it hard to build their own tools and infrastructures to collect post marketing data. In this way registers may serve as a means to support compliance to the MDR.

Automated versus manual data collection - Interoperability beween Registries and EHRs

One general challenge of medical registers is to support the medical staff to enter data at a sufficient level of quality, efficiently. Electronic Healthcare Records (EHRs) serve as the primary means for clinicians to record medical observations about their patients. In the best of worlds this information may be reused in medical registries. A 2014 report of the Agency for Healthcare Research and Quality (AHRQ) suggest that IT supported data collection and interoperability between EHRs) and medical registries is useful to improve quality: "Besides enabling health care information to be more readily available for registries and other evidence development purposes, bidirectionally interoperable EHRs may also serve an efferent role of delivering relevant information from a registry back to a clinician (e.g., information about natural history of disease, safety, effectiveness, and quality)." (Senior Editors: Richard E Gliklich, MD and Nancy A Dreyer, MPH, PhD. Editor: Editor: Michelle B Leavy, MPH.:Rockville (MD): Registries for Evaluating Patient Outcomes, 3rd edition - A User's Guide. Agency for Healthcare Research and Quality (US); 2014 Apr.Report No.: 13(14)-EHC111. The report also notes that the challenge still remains to implement this interoperability in practice.

Tools for IT interoperability in the EU: EIRA, CarTool, ...

The EU program ISA2 (https://ec.europa.eu/isa2/home_en) supports implementers of public services by providing tools and solutions. Within this effort one solution is the European Interoperability Reference Architecture (EIRA) and the Cartography tool (CarTool).

How to get started on EIRA and the CarTool

As a first step, download the CarTool, from the release page. Please consider the user guide. At first you download and install the Archi tool (https://www.archimatetool.com/), which is provided by The Open Group (http://www.opengroup.org/). You then need to install the plugin Archi plugin jar file that has been developed by the EU. You then have a working CarTool installation, which enables to review architectures.

The European Interoperability Reference Architecture (EIRA) is available on the from the EIRA Solution page in the Joinup platform. From there you get the EIRA „.archimate“ file, to be opened in CarTool.

How to review specific solution architectures

The EU Joinup platform (https://joinup.ec.europa.eu) enables to search for Solution Architecture Templates (SATs). To search, you might use https://joinup.ec.europa.eu/search?keys=SAT. A SAT comes in the form of an „archimate“ file (It also comes in other forms, but archimate is the modelling file format). Archimate files can be opened in the CarTool, and reviewed. For example the following SATs are available:

You download the x.archimate file you are interested in, and then open it in the CarTool.

Enjoy the beauty of views on solution architectures in the CarTool

Each Solution Architecture Template (SAT) provides views for different purposes:

  • Legal view, showing the laws, regulations etc. that apply for the service
  • Organisational view, showing the roles and actors who take part in and use a service
  • Semantic View, showing which specifications and standards apply for the data that is exchanged as part of a service
  • Technical View, in the form of application and infrastructure views, showing the software building blocks that are needed to provide a service
  • There may be other views for example „Motivation“, „Underlying Principles“, showing important principles that are good to understand in the context of a service

Review the SATs using the CarTool, to explore the full beauty of this. The views also provide references tot he many specific source documents to consider, e.g. EU regulations, technical specifications, standards. In this way they enable newcomers to enter a new field efficiently, and quickly orient within the specific environment of a service.