The European Health Data Space (EHDS) regulation aims to provide a common framework across EU Member States for accessing and sharing health data such as electronic health records, patient registries, hospital discharge reports, and genomic data to support healthcare delivery, and to facilitate health research, policymaking, and legislation. For this endeavour to be truly successful, the EU must do more to promote digital health literacy and to put safeguards in place to protect its citizens’ health data, both against cybersecurity attacks and corporate interests.

In response to the proposal for this Regulation, EPHA has published a position paper putting forward nine key recommendations that would give ordinary citizens more control over their health data, as well as promote their rights.

The nine recommendations of this position paper are:

  1. Dedicate extra funding and take a proactive role in ensuring individuals living in the EU have sufficient digital skills and health literacy to truly empower them to make use of the European Health Data Space.
  2. Ensure proper representation of patients, healthcare professionals, and civil society groups representing them in the European Health Data Space Board (EHDS Board), as well as all other data governance authorities
  3. Allow individuals to opt-out of having electronic health records and continue providing paper alternatives.
  4. Give individuals control over which health information contained in their health records can be processed for primary and secondary use of electronic health data.
  5. Clarify and specify the consent model that will be implemented for the secondary use and processing of electronic health data.
  6. Exclude wellness apps and behavioral data from the scope of the legislation due to data quality and privacy concerns.
  7. Health data access bodies shall be obliged to provide specific information to individuals concerning the secondary use of their electronic health data.
  8. Health data access bodies should not automatically issue data permits when they fail to approve them within the two-month time frame.
  9. The use of health data for research and innovation made available by the EHDS should be disclosed and fully transparent.
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