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.

March 20, 2023
Today, Regulation (EU) 2023/607 extending the transitional provisions for the placing on the market and putting into service of certain medical devices and in vitro diagnostic medical device...
January 31, 2023
Clinical trials: Ministry of Health signed off on decrees that (i) reorganize ethics committees and coordinate their activities, (ii) determine the single tariff for the authorization proced...
December 19, 2022
On 13 December 2022, EMA, European Commission and HMA jointly adopted a recommendation paper on the introduction of decentralised elements in the conduct of Clinical Trials in the EU/EEA
September 21, 2022
Payback for medical devices: Decree quantifying the exceeding of the expenditure ceiling for medical devices at national and regional level for the years 2015, 2016, 2017 and 2018 published ...
September 1, 2022
The 2021 annual law for market and competition addressing, as to the healthcare sector, reimbursement of drugs, intermediate distribution, patent linkage and institutional accreditation of p...
Search by...
Follow us on
Follow us on