Trilogue on the three European Health Data Space proposals - challenges and opportunities

Determined to make this decade the ‘Digital Decade’ of Europe, one of the European Commission's key priorities is the European Health Data Space (EHDS). The Commission's objective is to promote the digital transformation of Europe's health sector and improve EU health systems for the benefit of patients, research and public health.

The idea of a common, Europe-wide network for sharing health data has the potential to promote high-quality health research datasets and innovation, and to contribute to better health services. The EHDS has the potential to achieve its objectives of providing a strong data base for research, innovation, improved patient safety and personalized medicine. However, the success of the EHDS is highly dependent on the outcome of the current trilogue negotiations between the European Commission, the Council of the European Union and the European Parliament on the three EHDS proposals presented.

This article, written in collaboration with EUCOPE (European Confederation of Pharmaceutical Entrepreneurs) which you can access here - focuses on three themes that are key elements for a successful and balanced use of (mainly personal) health data for secondary uses such as research and innovation. The three topics discussed in the article are:

• The requirements for ensuring sufficient and timely application of safeguards for intellectual property rights and the protection of trade secrets of data holders.
• The need for clear and transparent rules on the location of health data processing and international data transfers from and into the European Union.
• The impact of opt-out or opt-in rights for individuals with regard to the secondary use of their health data under the EHDS and ideas for balanced solutions.

Read the full article The European Health Data Space: Common statement on the Amendment proposals of the Council of the EU and the European Parliament here.

Next steps

Please contact the author or the Hogan Lovells attorneys with whom you regularly work for more information or if you have questions about the EHDS.

Authored by Dr. Karolin Hiller and Leander Vranken Digital Health Policy Officer, EUCOPE.