EMSA at eHealth Workshop in Lisbon Revising Guidelines for Electronic Cross-Border Exchange of Health Data

Lisbon eHealth Workshop

Electronic Health, “using digital tools and services for health”, has the potential to meaningfully improve cross-border healthcare and therefore to save patients’ life. In the European Union, guidelines for electronic exchange of health data (electronic patients summaries, electronic prescriptions) have been developed under Article 14 of the Cross-Border Directive 2011/24/EU. First adopted in November 2013 and November 2014 by the eHealth Network, they are now under revision. Electronic cross-border exchange of health data is thought to finish piloting phases and start to go live in participating countries in 2017.

On June 26-27, 2016 in Lisbon, EMSA took part in a workshop revising these guidelines. It was a joint workshop of the Joint Action supporting the eHealth Network (JAseHN) and the renewed eHealth Stakeholder Group of the European Commission (that EMSA is an organisational member of for the duration 2016-2018).

Cross-Border Guidelines
It has been a challenge to set up a sustainable environment enabling cross-border exchange between 28+2 European countries that are each at different stages of development in the eHealth sector and have their own jurisdictional authority. The guidelines were primarily voluntary and ought not to require change within any Member State. They may become binding for Member States that wish to receive funding for cross-border services from the Connecting Europe Facility (CEF).

Electronic Prescriptions
Electronic prescribing is the “computer-based electronic generation, transmission and filling of a medical prescription”. It is already widely used in some EU Member States. In a cross-border setting, electronic prescriptions from country A will be transferred via National Contact Points to country B. In this process, it is necessary to identify the patient, obtain their consent to access data, and access valid prescriptions in a converted (translated) format. A challenge is the unique identification of medicinal products (because they may have multiple identifiers due to multiple ways of authorisation in the EU, generic and brand names) and substitution (due to differing availability). Standardised Medicinal Product IDs (MPIDs) and Pharmaceutical Product IDs (PhPID) are being developed.
A dispensation message must then be sent back to country A. The question arises who is to receive such a dispensation message, weighing in possible benefits (better compliance, monitoring, feedback for doctor), and concerns (data privacy, new recipients’ responsibilities).

Electronic Patient Summaries

Patient summaries are documents providing a set of health data. Electronic patient summaries that can be easily accessed and automatically translated are thought to provide benefits in the instance of unscheduled (emergency) care, when it may be difficult to communicate due to unconsciousness or language barriers in the cross-border setting. In the EU Member States, the development of electronic patient summaries is at various stages, and what data is recorded may also differ and is debatable. An important question is how patients will be granted access to their data, a right ensured by the General Data Protection Regulation EU 2016/679.

Throughout the workshop, EMSA was able to give input in the revision process. Following the workshop, the guidelines will be further reviewed and submitted for further consultation in the upcoming months. An EMSA Policy on electronic Health is currently being developed.

Further reading
EMSA Policy on Cross-Border Healthcare

EMSA at the first meeting of eHealth Stakeholder Group

2013 Guidelines on minimun/nonexhaustive patient summary dataset for electronic exchange in accordance with the Cross-Border Directive 2011/24/EU

2014 Guidelines on ePrescriptions dataset for electronic exchange under Cross-Border Directive 2011/24/EU

Contact: Stefan Hardt, EMSA Policy Making Officer 2015-2016: policy@emsa-europe.eu

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