In May 2022, the European Commission put forward a proposal on the European Health Data Space, which aims to improve the use of health data for research, innovation and policymaking. At the same time, Europeans should have more control over the use of their own health data.
Benefits for citizens
EU citizens would be able to access their health data in electronic form immediately and without any costs. Health data, such as patient summaries, electronic prescriptions, laboratory results and discharge reports, would be available in a common European format that could be shared with health professionals within the patient’s country or cross-border.
In this way, people wouldn't have to worry about having access to health services when travelling within the EU.
Security and privacy issues
While researchers, industry and public institutions would be able to use some health data, the rules include strong data protection safeguards. No personal information will be shared. Patients would be able to add information, rectify wrong data, restrict access to others and obtain information on how their data are used and for which purposes.
Benefits for health professionals, researchers and industry
Since there will be a common European format, health professionals will have faster access to a patient’s health records, even if the patient is from another EU country. Better access and exchange of health data will result in faster and cheaper administrative procedures.
Researchers will have better, faster, cheaper and more effective access to health data of higher quality.
The common European format of electronic data will enable businesses to provide their services in other EU countries much more easily. The availability of data could stimulate the growth of the digital health industry by 20-30% on an annual basis.
EU countries' obligations
All countries should establish national health data access services, based on the MyHealth@EU platform, by the end of 2025 and appoint a digital health authority to safeguard people's rights.
Parliament’s position
Parliament adopted its position in December 2023. In addition to the existing proposal, MEPs call for the following:
- Certain sensitive health data should be used for research and development, policymaking, education, patient safety or regulatory purposes only if patients grant explicit permissions
- There should be an opt-out mechanism if people would like not to share other types of data
- The use of collected health data in areas such as recruitment or provision of financial services should be banned
Next steps
Parliament is now ready to start negotiations with the governments of EU countries on the final legislative text.
Ref.: 20231207STO15736
www.europarl.europa.eu