What are the objectives of the Recommendation?
The Recommendation aims to allow EU citizens to access securely their health records across Member States more easily. In particular it aims at the creation of a European format that will allow electronic health records being shared in a secure manner at the same time as adhering to data protection rules.
Member States have already taken the first steps in making some parts of the health records interoperable, such as patient summaries and e-prescriptions. The Recommendation takes this action further and proposes that Member States extend this work into three new areas of the health record: laboratory tests, medical discharge reports and images, and imaging reports. Moreover, the text sets the basis for the necessary technical specifications that should be used in health record exchanges.
The initiative also aims to place the future development of the work into a clear framework by setting down principles for the exchange of health information across EU borders and a governance process involving the Commission, Member States and relevant stakeholders.
How will the Recommendation benefit to citizens, doctors and medical practitioners?
The possibility to exchange health records across borders will help citizens to have better health care as they move around the European Union. For example, it can provide important health history about an individual in the event of an accident, or other need for unplanned health care while abroad. Subsequently, once the citizen returns home the records of the treatment abroad can be integrated into the existing health record.
Furthermore, health systems will benefit significantly from exchanging health records, since this would enable access to a patient's recent laboratory or radiology tests. This will help a hospital in another Member State to avoid repeating such tests and thus save patients' time and reduce hospital costs. This could increase the efficiency and sustainability of healthcare systems.
Moreover, as electronic health records become more interoperable across borders, more health data will be available to support the integration of Artificial Intelligence (AI) systems that can assist medical decision making. This should have positive impact both on the quality of health care received and the efficiency of health care systems.
How can access to Electronic Health Record be helpful in real life situations?
Let's take a concrete example: Davide is a 59 -year old who has lived and worked abroad for the last 30 years. He suffers from a particular heart condition and would like his doctors in his native country to have access to his full medical records built-up abroad over the last 30 years. The new Recommendation will make this possible.
Another example would be of a citizen, who is seeking referral to a specialist medical centre in another Member State, such as for a rare condition or for treatment for an advanced cancer. The possibility to exchange his or her Electronic Health Record across-borders will be of great support.
How does the Recommendation make sure that health data are fully protected?
Security and privacy are essential to ensure trust and are at the core of this Recommendation. It encourages Member States to ensure that citizens are able to choose to whom they provide access to their electronic health data, and which health information details are shared.
Moreover, the exchange of Electronic Health Records (EHR) needs to be implemented in full compliance with the General Data Protection Regulation (GDPR). This is the framework for the protection of personal data and which sets out directly applicable rules for the processing of individuals' personal data, including health data.
Moreover, the Directive on security of network and information systems (the NIS Directive) sets out a range of measures for Member States to provide a level of security for network and information systems, including health information systems.
Access, security and trust in EHR systems should be also enhanced by the use of secure electronic identification and authentication means.
The Recommendation proposes that Member States create National Digital Health Networks in order to, inter alia, ensure that the security of national health systems is enhanced and to support the cross border secure exchange of health data.
Does the Recommendation cover the use of health data for research purposes?
The purpose of the Recommendation is to develop the systems that can support citizens and the health care they receive when travelling through the EU. By improving the interoperability of EHRs, it will also support health research (as well as diagnostics and prevention), by enabling the use of advanced technological solutions, such as Artificial Intelligence and high performance computing.
What else is the Commission doing in order to promote an exchange of Electronic Health Records across the EU?
There is ongoing work both within Member States and at European level in order to build infrastructures for health data exchange. There is considerable accumulated knowledge and experience to build upon in particular through the eHealth Digital Service Infrastructure (eHDSI) established under the CEF Programme. A number of Member States have agreed to exchange Patient Summaries and ePrescriptions between health professionals across borders. Some of them have already started these exchanges: at this moment, Finland has already made their ePrescriptions available abroad and Estonia has accepted ePrescriptions coming from another European country. Luxembourg will soon accept patient summaries from other European countries and the Czech Republic will made its patient summaries available abroad. The other countries will join these exchanges later.
ePrescription (and eDispensation) allows citizens in Europe to retrieve their medication in a pharmacy located in another European country, thanks to the online transfer of their electronic prescription from their country of affiliation to their country of travel. The country of residence is informed about the medicine the patient retrieves in the country of travel (eDispensation). The Patient Summary can provide information on important health related aspects such as allergies, current medication, previous illness, major surgeries in the past 6 months, implants, medical devices, pregnancy (if relevant), social history, physical findings, diagnostic tests etc. The digital Patient Summary is meant to provide doctors with essential information in their own language concerning the patient, when the patient comes from another EU country and there may be a linguistic barrier. However, it is not mandatory that all the above information exists, is known or can be translated.
These elements represent parts of electronic health records. These agreements provide a firm basis and will eventually enable citizens to access and exchange their full electronic health records throughout the European Union.
The Commission is also putting forward a new Implementing Decision on the management and functioning of the eHealth Network.
Will the specifications of the EU Electronic Health Records exchange format be further elaborated?
The specifications of the European Electronic Health Record exchange format should be regularly reviewed and updated in order to further define the granularity of the health data and respond to technological developments. Relevant stakeholders will be involved in revising and updating the specifications.
On which principles are the technical specifications established?
The specifications cover an initial set of healthcare information categories to which Member States should aim to provide cross border secure digital access.
The technical specifications have been established on the basis of the work of the e-Health Digital Service Infrastructure (eHDSI), and the process has been implemented by the European Commission together with Member States. Therefore, several services for cross-border health data exchange are currently been deployed under the Connecting Europe Facility (CEF) Programme. The eHDSI uses established industry specifications that have been adopted by the participating Member States.
The exchange format which is being proposed is designed in such a way that would allow flexibility both in terms of technological choices and in relation to individual Member State's readiness to engage. This flexibility is also required due to the dynamic nature of the technical specifications, and the fast pace of advancements in the area of digital technology.
What are the specifications for the Electronic Health Record exchange format?
The Recommendation comprises an initial set of two categories
- Health information domains to be exchanged, covering, inter alia, patient's summaries, ePrescriptions, laboratory results reports, medical imaging reports and images, Hospital discharge reports.
- Specifications for the exchange of data within these health information domains.
How will the implementation of the European Electronic Health Record exchange format be governed?
The exchange format is a baseline to be revised periodically through a joint coordination process with Member States and other relevant stakeholders. The aim is to ensure that the process remains up-to-date, sustainable and constantly develops in a way that addresses the needs of citizens, health systems and society more widely.
The process to further develop the European EHR exchange format should be steered through a joint coordination process. This should be based on a shared roadmap that identifies agreed priorities and tasks for further specifications to be considered in the years ahead.
In addition to implementing further improvements to the interoperability of EHR systems, the Joint Coordination Process should also monitor and assess progress and allow for horizon scanning with regard to technological and methodological innovations and their incorporation into EHR systems.
The eHealth Network, comprising e-health agencies in Member States and coordinating the exchange of patient summaries and e-prescriptions through the eHealth Digital Service Infrastructure, will have an essential role in taking the format forward by developing specific guidelines and monitoring its implementation.
 22 Member States: Austria, Belgium, Croatia, Cyprus, Czech Republic, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Slovenia, Spain and Sweden.