The European Commission has published a
roadmap announcing a recommendation to establish an electronic health record
exchange format (EHRxF) before the end of the current legislative period.
The aim of the Recommendation is to help
Member States develop strategies and adapt their legal framework to promote the
secure exchange of electronic data between patient records. Furthermore, the
Recommendation is concerned about the adoption and further development of
common technical specifications for a European Electronic Health Record
exchange format. Finally, the Recommendation seeks to identify ways for the
Commission, Member States and other stakeholders to work together to continuously
improve standards and specifications to achieve interoperability.
Meanwhile, the eHealth Network, an
initiative of the European Commission’s Directorate-General for Health involving
all Member States and their respective ministries responsible for electronic
health services, is discussing this proposal. The main question is whether this
EU initiative can possibly interfere with the national implementation of
electronic health records and telematics infrastructures.
According to the roadmap, the Commission is
preparing a revision of Implementing Decision 2001/890/EU on the establishment,
the management and the functioning of the network of national authorities
responsible for eHealth. Among other things, the General Data Protection
Regulation (GDPR, EU/2016/679), which has since entered into force, should be
taken into account.
The initiative was announced both in the
Commission’s 2019 work programme and in the Commission Communication on the
digital transformation of health and care in the Digital Single Market.
The Commission’s roadmap from 22 Dec 2018: https://ec.europa.eu/info/law/better-regulation/initiatives/ares-2018-5986687
2019 Commission Work Programme: https://ec.europa.eu/info/publications/2019-commission-work-programme-key-documents_en
Communication on enabling the digital
transformation of health and care in the Digital Single Market; empowering
citizens and building a healthier society from 25 Apr 2018: https://ec.europa.eu/transparency/regdoc/rep/1/2018/DE/COM-2018-233-F1-DE-MAIN-PART-1.PDF