EHN feedback to the Commission Consultation on Digital health data and services – the European health data space

Click here for EHN’s feedback to the Commission’s consultation on its European Health Data Space (EHDS) legislative proposal.

EHN welcomes the EHDS proposal, one of the central building blocks for a strong European Health Union.

We welcome the aim to strengthen patient rights for primary use of electronic health data and the proposed provisions for the needed use of health data for research, innovation, policy-making and regulatory purposes (secondary use) for public interest.

EHN recommendations for the EU and Member States include:

• Align the different EU legal pieces (EHDS, GDPR, Data Governance Act, etc) to facilitate a more harmonised approach and less fragmentation at the national level.
• Define important concepts such as ‘innovation’ and ‘public interest’ together with people and patients.
• Create a secure and privacy-preserving system that delivers for people, patients, healthcare professionals, researchers and innovators.
• Create flexible systems that allow people to receive personalised information and communication on their health data and its uses.
• Clarify the roles and responsibilities of the different bodies for governance and coordination.
• Ensure meaningful public and patient involvement by putting in place governance mechanisms that give a place to people, including patients and their representatives to allow for secondary use of health data that supports the public interest, promotes the safe and ethical reuse of data, and is conducted in a transparent and inherently trust-building manner.
• Ensure that the FAIR principles are applied at the source.
• Ensure that structures put in place, such as digital health authorities, health data authorities and surveillance authorities, and infrastructure, such as registries, are also fair, i.e., transparent, equal, trustworthy and righteous.
• Apply good and validated practices as evidenced by independent research (scientific evidence-based policy making).
• Invest in increasing digital literacy and digital health literacy to ensure uptake and successful diffusion of digital health data systems without widening existing inequalities in health, and with a view to building up public trust in secondary use of health data.

EHN’s feedback paper elaborates further on EHN’s views and recommendations put forward.

EHN will closely monitor and engage in the development of the proposal through the European Parliament and Council of the European Union to ensure that the great potential the use of health data holds is harnessed for good and respects the rights of the people behind the data.