EPF Statement on EHDS
The patient community’s recommendations on the European Health Data Space
Following the consultation with our members, EPF releases its position statement on the Commission’s proposal for a European Health Data Space (EHDS), alongside 19 proposed amendments.
We believe that this initiative has the potential to establish an efficient framework for the exchange of and access to health data to support healthcare delivery and timely access to data, and to facilitate research, innovation and policy making. Harnessing the power of EU health data can help deliver better care and ultimately improve patients’ lives, but only if it is shaped with and for patients.
Our key recommendations put the patients at the very heart of this initiative. Trust, transparency, meaningful involvement of patients and their representatives, security and data protection are elements that will impact the success of the EHDS and we, therefore, invite the legislators to include them in the regulation from the outset. The recommendations call for:
- Patient organisations must be included in the governance and decision-making structures of the EHDS Board, national digital health authorities and health data access bodies.
- Patients should receive their data in a common MyHealth@EU format with option to include disease-specific data.
- Patients should have the right to opt out if they do not wish their health data to be processed for secondary use.
- Purposes for secondary use of health data should bring benefits to patients, and these purposes must be defined in partnership with them.
- At the request of individual patients or patient organisations, data access bodies should provide information about the use of health data, including who has been authorised to access data, for which purpose, and under which legal basis.
- Data users should report the results or findings of projects for which data were used within a maximum of 12 months and in lay language.
- Misuse of health data must be sanctioned with fines, which should be transparent, proportionate, effective, and harmonised between Member States.
- The Regulation should include provision on effective access to justice in cases of misuse of health data.
- The EU and Member States should invest sufficient resources in developing digital health literacy, digital skills, access to digital means and infrastructure to support the implementation of the EHDS.