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EU: Parliament Committees adopt position on European Health Data Space

The European Parliament announced, on November 28, 2023, that the Committees on Environment, Public Health, and Food Safety and on Civil Liberties, Justice, and Home Affairs adopted their position on the Proposal for a Regulation on the European Health Data Space, released by the European Commission in 2022. The Committees adopted the report with 95 votes in favor, 18 against, and 10 abstentions.

Civil Liberties Committee co-rapporteur, Annalisa Tardino, stated: "This is a very important and technical proposal, with a huge impact on, and potential for, our citizens and patients. Our text managed to find the right balance between a patient's right to privacy and the enormous potential of digital health data, which is meant to improve healthcare quality and produce healthcare innovation."

Access rights

The Parliament noted that, on one hand, the proposal would give patients the right to access their personal health data across the EU's healthcare systems, and on the other hand, it would allow health professionals to access data on their patients. Access would include patient summaries, electronic prescriptions, medical imagery, and laboratory results. To this end, according to the Parliament, each Member State would establish national health data access services.

Data-sharing provisions and banned uses

In addition, the Proposal would make possible the sharing of aggregated health data for reasons of health-related public interest, including research. In their position, the Committees introduced a requirement for the explicit permission of patients in case of secondary use of certain sensitive health data, and an opt-out mechanism for other data. In addition, the Parliament outlined that the Committees seek to give citizens the right to challenge a decision of a health data access body and allow non-profit organizations to lodge complaints on their behalf.

Notably, the Committees also expanded the list of cases where a secondary use would be banned, for example in the labor market or for financial services.

Next steps

The position is expected to be voted on by the full house of the Parliament in December 2023.

You can read the press release here.

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