The European Parliament’s Committees on the Environment and on Civil Liberties have adopted their position, which substantially amends the proposal for the creation of a European Health Data Space (EHDS).
The report by Tomislav Sokol (EPP, Croatian) and Annalisa Tardino (ID, Italian) on this dossier was adopted with 95 votes in favour, 18 against and 10 abstentions.
Each country will set up national health data access services based on the MyHealth@EU platform (see EUROPE 13135/3). The EHDS will enable the sharing of aggregated health data, including pathogens, health claims and reimbursements, genetic data and public health registry information, for reasons of health-related public interest, including research, innovation, policy-making, education, patient safety or regulatory purposes.
At the same time, the rules prohibit certain uses: for example, advertising, decisions to exclude people from benefits or types of insurance, or sharing to third parties without permission.
Requests for access to secondary data will be processed under these rules by national bodies, which will ensure that data is only provided in an anonymised or, if necessary, pseudonymised format.
The MEPs want to: - make it mandatory for patients to give explicit authorisation for the secondary use of their health data; - give citizens the right to challenge a decision of a health data access body and allow non-profit organisations to lodge complaints on their behalf; - expand the list of cases where a secondary use would be banned (labour market, financial services); - ensure that all EU countries receive sufficient funding to provide protections for the secondary use of data, and protect data falling under intellectual property rights or constituting trade secrets.
The European Parliament plenary vote on this report will take place in December in Strasbourg.
Link to the compromise amendments: https://aeur.eu/f/9sh (Original version in French by Lionel Changeur)