Shaping a patient-centred European health data environment

EPF responds to the consultations on the European Health Data Space and the Data Governance Act

There is an ongoing “data revolution” taking place at the EU-level. In healthcare, the proposed use and re-use of health data has the potential to improve the sustainability of Europe’s health systems  by increasing the quality, safety and patient-centredness of healthcare, improving access, decreasing costs, and transforming care into a more participatory process. Nevertheless, the road to fully exploit the potential benefits of data in health is only partially built, still extremely fragmented and undeveloped with and for patients. 

EPF aims to be strongly engaged in this debate, to ensure the benefits that health data can bring for European patients are exploited to the fullest, while ensuring adequate data protection, clear rights and fostering digital and data literacy levels. Hence, EPF has provided input to two European Commission public consultations: on Digital health data and services - the European health data space (EHDS); and on the Data sharing in the EU - (Data Governance Act).  

European Health Data Space (EHDS)

On the EHDS, EPF welcomes the European Commission’s plans  as a positive step towards a more harmonised, interoperable, safe, and trustworthy environment for health data. At the same time, to drive the creation of a patient-centred EHDS which is fit-for-purpose, EPF calls for:  

1) An improved and harmonised health data access and control (i.e., ensuring patient’s barrier-free access and control over their health data, all while ensuring data portability),  

2) A clear framework to improve transparency and trust in health data use and re-use,  

3) The build-up of best practices, synergies, and better investments (all based on the range of existing initiatives, projects, and collaborative platforms, and with the view to limit inequalities within and across Member States), and  

4) The use of the patients’ experience to address challenges and needs (i.e., incorporating the necessary mechanisms to guarantee meaningful involvement of patients’). 

Data Governance Act (DGA)

EPF also provided input on the upcoming proposal  for a regulation on European data governance (i.e., the Data Governance Act - DGA), which will serve as a horizontal framework for data governance across the different sectoral data spaces, including the Health Data Space.  In its response, EPF addresses set of elements included in the current version of the proposal that we believe require further attention, especially considering their potential impact on the field of health data. These are the following:  

1) Having a clear definition and concepts to improve understanding and trust in data sharing (e.g., “data-altruism” or “data intermediaries”),  

2) Increasing trust through labelling, clarity, and transparency (i.e. via mandatory notification requirements of data sharing service providers, and a register of recognised data altruism organisations),  

3) The European data altruism consent form  

4) The re-use and data sharing with third countries, and  

5)  The establishment of an inclusive European Data Innovation Board.  

As these topics further develop during 2021, the EPF will continue liaising with its Membership to further deepen its work on health data topics to make sure that European patients can make the most out of  the “data revolution” that we are witnessing in Europe.  

For more information, please contact our Policy Adviser Michele Calabro' at michele.calabro@eu-patient.eu