On December 13, 2023, the European Parliament adopted the proposal to create a European Health Data Space (EHDS) aimed at improving access to personal health data across EU states and bolstering secure data sharing for research. The proposal, adopted with 516 votes for, 95 against, and 20 abstentions, will serve as Parliament's negotiating mandate in talks with the European Council on the form of the final legislation.

The EHDS will enable EU citizens to access their health records, including prescriptions, medical imagery, and lab tests, across Member States. Furthermore, the EHDS will also facilitate the sharing of aggregated health data for research into areas like cancer and rare diseases while ensuring strict privacy safeguards.

Key features of the legislation include portability rights for healthcare data, national health data access points integrated into the MyHealth@EU platform, and stringent rules for electronic health records (EHR) system providers. The proposal also prohibits the use of health data for advertising or insurance assessments.

The Parliament has emphasized strong privacy measures, proposing an opt-out system for secondary data use and mandatory explicit consent for sensitive data like genetic information. Furthermore, the Parliament seeks to broaden the ban on secondary uses in sectors like labor and finance and ensure that shared data contributes to medical advancements without falling under intellectual property rights.

Notably, the Parliament explained that it is now ready to negotiate with the Member States, who adopted their position on December 6, 2023, on finalizing the law.

You can read the press release here and the proposal here.