European Commission (EC) action in this area focuses on policy support through facilitating voluntary coordination of authorities and other stakeholders to share data, fostering the further use of standards and the development of technical specifications for secure access and cross border exchange of health datasets in the EU.  The vision is that, by implementing such common standards and specifications, health care providers may address interoperability challenges both at national and international level. It should be however understood that European interoperability assets will need a certain amount of localization in the national contexts, an activity that is commonly taken forward by national health authorities working together with national stakeholders.

European co-operation on interoperability is exemplified through the common electronic Health Record Exchange Format, which targets pan European interoperability of Health Records for care purposes and at the same time supports the European strategy for data, underpinning the creation of the common European Health data space for scaling up secondary use of this data for research, innovation and regulatory compliance.

Electronic Health Record Exchange Format (EHRxF)

In an effort to support MS efforts to overcome interoperability challenges, the European Commission is promoting a stepwise approach for creating EU level interoperability of EHRs, building on the European Patient Summary and ePrescription information domains and creating a roadmap for extending to additional three domains:

• Patient Summary
• ePrescription/eDispensation
• Laboratory Results
• Medical Imaging and Reports
• Hospital Discharge reports

When implementing the European Patient Summary and ePrescription kernels in your Electronic Health Record systems:

• You can select and reference, in your procurement, amongst the 27 interoperability specifications published by the European Commission, in the framework of the Standardization Regulation;
• You can draw upon the general implementation framework provided through the eHealth Network Guidelines.  This ensures standards-based implementation and your project will deliver a solid baseline pan European interoperability for your health records;
• If your country joins the European cross border community, your organization will be able to share health data of foreign EU patients;
• If your country has agreements with countries outside the EU, your organization will be to leverage on the International Patient Summary, in order to share health data of non-EU patients;
• Given that other coding systems are gradually linked to terminologies and classifications used in the European Patient Summary and ePrescriptions, (such as unique identification of medicines and of medical devices) this basic kernel support integrated management within your organization; 
• Your data will be re-usable for research. You may become an active node in the common European Health Data Space and develop win-win business models as a data provider with your data re-use network.

Secure access to Electronic Health Records

Hospitals are organisations process health data, which is a special category of sensitive data requiring greater protection and as such they will have to review their compliance to the GDPR.  Hospital managers should take legal advice to ensure that they are adopting and complying with the most appropriate legal basis, and ICT security advice on how to safeguard the data being used for care purposes and for research.

Healthcare providers (HCPs) – hospitals and private clinics – are, in the meaning of the Directive on Security of Network and Information Systems (NIS Directive), “Operators of Essential Services (OES)”, i.e. operators considered ‘essential for the maintenance of critical societal and/or economic activities’. These operators should comply with several binding provisions defined nationally in accordance to measures defined in the Directive for a high common level of security for networks and information systems across the EU. Health care providers and other organizations managing healthcare data should take appropriate and proportionate technical and organisational security measures to manage risks posed to the security of their networks and information systems, that are proportionate to the identified risks. In this way, the compliance of OES with such measures, will significantly contribute to raising the level of security across the EU.  Read More.

Common Technical Specifications

The European Patient Summary and ePrescription cross border information services have been made possible through MS level implementations leveraging on common European technical specifications. Furthermore, the five priority information domains in the EHRxF are largely supported by the 27 IHE profiles, published by the European Commission. Data exchange at this level, when based on European technical specifications, will allow effective cross border exchange of health data within the organization, across organizations and will further support continuity of care for mobile citizens.

Common Semantic Specifications

Meaningful sharing of health information across health care providers, both internally within a country and across borders, can be achieved when information can travel though common standardised messages, using standardised formats. Modelling and coding standards are the pillars on which technical, syntactic and semantic interoperability rests. Thus, health information should flow for European citizens along their healthcare pathway, with minimal loss of meaning, or no loss at all.

At the European level, the Master Value Sets Catalogue (MVC) is a collection of terms, used in the context of exchanging data on patient summaries and ePrescriptions (parts describing the patient demographics or the clinical problems, for example), based on standardised code systems such as ICD-10, SNOMED CT, ATC Classification, EDQM Standard Terms, or UCUM. This catalogue was collaboratively created by multinational teams under the epSOS large scale pilot and is now maintained by the eHDSI community of semantic experts.  New information domains will need to be covered. A five-year strategy and a common semantic approach towards standardised exchange of health information in the European Union has been adopted by the Member States.   This strategy contains the shared view about semantic interoperability among EU Member States; it was elaborated by Member State and Commission semantic specialists and includes a structured governance scheme and a solid roadmap for implementation.  

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