Sprache ändern: English

European Health Data Space

On 4th May 2022, the EU Commission presented a draft law to create a “European Health Data Space” (EHDS). The proposal aims to connect patients‘ health data across Europe. For example, patients’ medical histories, test results or prescriptions are to be shared with hospitals and doctors treating a patient throughout the EU, unless the patient restricts access. Industry, research and authorities would also be given access to personal health data with only the name removed („pseudonomised“).

“Information revealing my physical and mental health is extremely sensitive. If I can’t rely on this information being treated confidentially by my attending physicians, then I may no longer seek treatment. This puts sick people and their family at risk.

Dr. Patrick Breyer, MEP

My main objectives:

The proposed EU-wide exchange of health data needs to meet the following requirements:

  • Only the attending physician should have access to their own health records in the absence of the patient’s free consent. This includes the fact that a person is being treated by a particular doctor in the first place. There are good reasons, for example, to obtain a second opinion without the doctors involved knowing about each other.
  • Without the free consent of the patient, treatment information may only be stored locally by the patient‘s trusted doctor and not automatically in centralised databases, where patients lose control over it. There is a risk that in the event of a loss of centrally stored data, the data of the entire population will suddenly be lost.
  • If there is ever to be access by industry, by research or even by politics, then only to anonymised and aggregated data. It is not enough to simply remove the names of the patients. After all, treatment histories are so unique making it is easy to reassign them to the person in question.

Timetable

  • 6 December: First Shadow’s meeting
  • 11 January 2023: Shadow’s meeting
  • Deadline for sending draft report (of ENVI and LIBE rapporteurs) to translation: 3 February 2023
  • ENVI/LIBE: Presentation of draft report in committee: 1 March 2023
  • Deadline for tabling amendments: 23 March 2023
  • Vote in ENVI/LIBE: 6 July 2023
  • Plenary vote: September 2023

The negotiators

LIBE (co-lead)

Rapporteur: Annalisa Tardino (ID)
Shadows: ZARZALEJOS Javier (EPP), Petar VITANOV (S&D), Lucia ĎURIŠ NICHOLSONOVÁ (Renew), Patrick BREYER (Greens/EFA), Beata KEMPA (ECR), Konstantinos ARVANITIS (GUE/NGL)

ENVI (co-lead)

Rapporteur: Tomislav SOKOL (EPP)

BUDG (opinion)

Rapporteur: tbc

IMCO (opinion)

Rapporteur: Andrey KOVATCHEV (EPP)

ITRE (opinion)

Rapporteur: Cristian-Silviu BUŞOI (EPP)

Documents

Legislative Observatory

Draft Regulation