Trilogue on the European Health Data Space begins
European Parliament and Council adopt their positions.
CC – 12/2023
The creation of a European Health Data
Space (EHDS) is clearing two important hurdles. In December, the European Parliament
and the Council adopted their respective positions on the Proposal
for a Regulation presented by the European Commission a year and a half
ago. This clears the way for the inter-institutional negotiations - the
trialogue. An initial meeting was held in December.
European Parliament
The report presented by rapporteurs
Tomislav Sokol (EPP, HR) and Annalisa Tardino (ID, IT) was adopted by a large majority of 516 votes in favour, 95 against and 20 abstentions. From
the outset, MEPs have focussed on cross-border data exchange in their
discussions on the EHDS. In addition to protection of privacy and data
security, the focus was also on the co-determination rights of patients. The
question of which health data should be recorded, used and passed on is
very sensitive and has been discussed for a long time. An amendment adopted in
plenary is now intended to make it clearer that Member States can grant natural
persons a right to object ("opt-out") to the recording of personal data,
and not just to the use thereof in an electronic health record (EHR). The
regulations on the opt-out procedure for the EHR planned in Germany with the
Digital Act (DigiG) therefore do not contradict the parliamentary position.
With regard to the further use of health data, the so-called secondary data
use, the European Parliament calls for an opt-out in principle, except for
particularly sensitive data categories, such as genomic and genetic data.
Council
After three Council presidencies and many
rounds of negotiations with compromise proposals, the Council adopted its general approach in November. The Member States advocated strengthening
their co-determination rights, particularly with regard to governance and the
definition of technical specifications. The Council also clarified the
co-determination rights of patients compared to the European Commission's
proposal. It should be left to the discretion of the Member States to define
opt-out regulations. Another specific change relates to the exchange format of
the EHR. The Council would like to distinguish between two profiles – a
national and a cross-border profile.
Finding a compromise
Even though time has elapsed since the
draft regulation was presented, the fact that the Council and the European
Parliament were able to agree on their respective positions is already a
success. Rapporteur Tomislav Sokol seemed confident that the European Council
and Parliament would be able to find a compromise. There is agreement that the
European Commission must provide significantly more funding for the EHDS.
According to Sokol, there will be agreement on the timing of the realisation
and entry into force of the EHDS. However, it is still to be discussed on how
the opt-out regulations for patients should be organised in specific terms.
It remains to be seen how realistic it is
that both institutions will be able to reach an agreement on such a technically
complex and sensitive dossier during the current legislative term of the European
Parliament. A possible trialogue result would have to be confirmed by the
European Parliament in April.
Background
In May 2022, the European Commission
presented a proposal for a regulation to create a European Health Data Space
(EHDS). Being the central digitisation project in the healthcare sector, it is
an ambitious, large-scale one. The aim of the proposed regulation is to make
electronic patient records available across borders for healthcare provision in
the EU (primary data utilisation). In addition, health data for research,
innovation and policy-making are to be brought together and made usable across
borders (secondary data utilisation). The German Social Insurance (DSV) had
taken a position on the project in a detailed opinion.