February 4, 2019
  • Erica Benigni

The European Commission issues a recommendation on a European electronic health record exchange format

On February 6, 2019, the European Commission issued a Recommendation concerning the development of a European Electronic Health Record (EHR) exchange format (Recommendation no 243/2019), which can be found on the following website: https://bit.ly/2X2qhAq. The EHR consists of a digital collection of medical records or similar documentation.

The aim of this Recommendation is to enable EU citizens and healthcare providers to access EHR throughout the EU. Cross-border sharing of health data provides many benefits including the improvement of the quality of care provided to EU patients and the saving of resources for national health services. For example, access to the clinical data contained in the EHR, such as laboratory test results, will enable faster and more appropriate health care and will prevent the repetition of tests and therefore a considerable reduction in costs for health care facilities.

The Recommendation specifies the principles governing the access to and exchange of health records within the EU. It requires, inter alia, Member States to guarantee citizens the option to choose who is granted access to their health data and which information can be shared.

It is also essential that security and privacy of the health data contained in the EHRs are safeguarded. In this regard, the protection of health data shall be implemented in compliance with Regulation (EU) 2016/679. The Recommendation also encourages Member States to ensure that citizens and healthcare professionals have access to their electronic health data through secure electronic identification, as provided for by the Regulation (EU) 2014/910.

Furthermore, the Recommendation is aimed at identifying a set of common technical specifications for the cross-border exchange of data in certain health information domains. Within this framework, Member States should take appropriate measures to share specific health information domains such as the patient’s medical history, ePrescription/eDispensation, laboratory results and medical imaging and reports. These measures will be the foundation for the European electronic health record exchange format.

As such, it is necessary to enhance the interoperability and security of national health systems and records exchange among Member States. Therefore, the Recommendation suggests that Member States set up a national digital health network in collaboration with the competent national authorities.

In conclusion, the development of this European EHR exchange format should be designed and implemented with maximum collaboration from all Member States, the European Commission and any other relevant stakeholders through a joint coordination process.

< Back to blog
Welcome to the Portolano Cavallo Life Sciences blog focusing on legal development and key legal issues affecting the life sciences and healthcare industry.
Read more
Our highly-ranked team of professionals will provide news, insights and multidisciplinary commentary on the hottest and most recent regulatory, transactional and contentious aspects of the pharmaceutical, bio-tech, med-tech, food supplement and healthcare world with an eye on its digital transformation and technological developments.

This blog will be a place for focusing on digital health, telemedicine and artificial intelligence, as well as more traditional topics: from the protection of intellectual properties to performance of clinical trials, from the market access to advertising and competition issues, from internal and criminal investigations to M&A and venture capital transactions.

October 6, 2023
CBD products: the Administrative Court suspended until October 24 the recent Decree of the Italian Ministry of Health listing cannabidiol for oral use among narcotic drugs, due to the lack o...
October 4, 2023
The Guidelines for regulating contractual relations between universities and research institutes and private sponsors were adopted by the relevant Italian Ministries following the amendment ...
September 21, 2023
CBS products: from September 20th, compositions for oral administration of cannabidiol obtained from Cannabis sativa extracts shall be considered as narcotic drugs in Italy, as they have bee...
July 27, 2023
Payback on medical devices: Italian government announces extension of payment deadline to October 30, 2023
July 21, 2023
On July 21, 2023, the Italian Ministry of Health published new guidelines on health advertising of self-medication drugs (OTC) and non-prescription drugs (SOP), including advertising on new ...
Search by...
Follow us on
Follow us on