Since earlier this month the Health Ministers, after months of bureaucratic preparations and negotiations, agreed with the proposal from EU Commissioner Didier Reynders, final adoption is expected early next year with implementation from 2025 onwards.
The Netherlands also agreed because, according to outgoing Minister Ernst Kuipers, Dutch conditions have been sufficiently included in the final proposal. For example, EU countries that already exchange (electronic) patient records themselves can continue to do so.
EU countries will also have the option to give their residents the choice to opt-out of having their medical data exchanged between EU countries. For exchanging data for scientific DNA research, it will even be possible to introduce an opt-in scheme. This means such data will not be shared by default.
To ensure swift implementation in the Netherlands, the HDAB-NL program was launched this month. This program is tasked with developing the technical functionalities for the new European system. The Data Protection Authority is also involved to monitor privacy aspects.
Patient organizations in several EU countries and EU politicians have expressed concerns about privacy implications. Dutch MEP Bert-Jan Ruissen (SGP) described the proposal as 'the prelude to a European health union. With the collection of patient data at the EU level, we are heading toward a single insurance system. Brussels will eventually dictate which treatments will still be reimbursed.'
MEP Anja Haga has strong concerns about the confidentiality of the medical data of millions of patients within the European Union: “It is not the intention that commercial companies gain access to patient data unless the patient explicitly consents.” Haga therefore wants medical data to be shared only when patients give prior explicit permission.
According to Haga, it is problematic that large pharmaceutical companies could benefit from such a system: “The risk of a data breach is always present and does not outweigh the possible benefit for the patient.” The ChristenUnie was very critical some years ago regarding the introduction of an electronic patient record in the Netherlands because it was unclear for a long time who exactly could access that data.