Brussels, 05/09/2024. From 4th to 5th of September 2024, a workshop on Information Points for Citizens under the European Health Data Space (EHDS) took place in Brussels, Belgium. The aim of the meeting, organised by BBMRI-ERIC, was to analyze how citizens are appropriately involved in the sharing of their health data for medical research. This workshop showcased existing national and European initiatives to inform the public about ongoing data-sharing activities. Best practices as well as communication failures were discussed with experts from all over Europe to foster the implementation of Art. 35 (e) of the future EHDS regulation.
There is a lot of experience available on national levels on success factors for communications on data sharing for secondary health data use like shared by Franz Leisch from PRAEVENIRE (Austria), Antti Piirainen from FINDATA (Finland), Yacine Daquin from the French Health Data Hub (HDH), Liis Leitsalu from the Estonian Biobank, Regina Becker from the 1+Million Genome Initiative and Rebecca Alvarado from the Health Data Lab (HDL).
Sophie Haderer and Wiebke Lesch, TMF and coordination office of the Medical Informatics Initiative (MII), presented the state of the art of the Transparency Portal of the MII and which communication strategies and measures have been used to involve different stakeholders in the initiative. The MII currently provides more than 10 million basic patient data sets, 800 million lab data sets and 80 million medication data sets from routine care in Germany that are available for secondary use in a GDPR-compliant way via broad consent. The Transparency Portal is a section of the German Portal for Medical Research Data – FDPG.
„Health Data is the fuel driving the research and innovation engine of health care“, stated Aneta Tyszkiewicz from the European Federation of Pharmaceutical Industries and Associations (EFPIA). Maintaining trust is critical for conducting scientific research.
"Trust enables data sharing and participation, especially for secondary use."
Mélodie Bernaux (EU Commission)
She adds that the four pillars of trust in the EHDS are Security (protecting health data from unauthorized access or misuse), Privacy (ensuring individual privacy through GDPR-compliant safeguards), Transparency (providing clear information on data use and accountability), and Ethical Safeguards (ensuring all secondary uses are ethical and respect human dignity).
The workshop showed the importance of clear, transparent communication to foster trust and involvement in health data use. It’s essential to know your stakeholders, understand what they expect, and be prepared for a potential crisis around health data sharing.
Furthermore, participants pointed out the importance of improving the understanding of how data can be translated into tangible benefits for citizens and society in an engaged, positive, informative way. Knowing your stakeholders and their needs is important as well as providing appropriate channels that create engagement. Patients and doctors, respectively data holders, should be involved at an early stage. With regard to the EHDS a harmonised approach of communication strategies and measures would be desirable.