6 September 2023, Brussels – A multi-stakeholder group consisting of 32 European patient organisations, medical associations, research organisations, data collaborations and industry associations met EU officials involved in the legislative negotiations for a Regulation on the European Health Data Space (EHDS) this morning. Attendees included: MEP Tomislav Sokol, Co-Rapporteur, as well as other EU Parliament officials and the representatives of several permanent representations that will hold upcoming Presidencies of the Council of the European Union.
The informal group of organisations have formed a partnership due to a shared concern that the European Commission’s proposal for the EHDS could lose some of its impact and potential value in the co-legislative negotiations. In October 2022, the group put forward recommendations calling for consistent legislation and successful implementation of the EHDS. In June 2023, the group issued a joint statement expressing support for the Commission’s original proposal that strikes a balance between the protection of personal data while allowing the secondary use of electronic health data to enable the creation of tangible benefits for patients in the EU.
In that joint statement, the group raised concerns about the risk that data bias would become systematic within the EHDS from its inception and thus undermine its principal value for secondary use purposes, if an opt-out or opt-in mechanism were added, and called for an impact assessment of those policy options. Should the legislative negotiations move towards adopting an opt-out mechanism, the statement outlined challenges and recommendations for implementing an effective opt-out mechanism.
Quotes by the multi-stakeholder group:
‘Effective health research requires analyses of large health datasets while ensuring strong safeguards for data protection. The Commission’s proposal strikes the right balance between data protection and facilitating data-driven advancements in medical research to bring value to patients and society.’
‘Data that is not representative of the entire population may undermine the data accuracy and data quality requirements of public health statistics and public health management. Data biases may also exacerbate inequity of access to healthcare.’