European Parliament approves European exchange of patient files

The European Parliament has approved by a large majority (516 votes in favour, 95 against and 20 abstentions) the creation of a European Patient Data Exchange Agency. The new European Health Data Space (EHDS) enables exchange between doctors, hospitals and pharmacies throughout the EU, but requires residents to first approve this.

Because earlier this month the Ministers of Health Care agreed to the proposal of EU Commissioner Didier Reynders after months of official preparations and negotiations, final adoption is expected early next year and implementation from 2025. 

The Netherlands has also agreed to this because, according to outgoing Minister Ernst Kuipers, Dutch conditions have been more than sufficiently included in the final proposal. For example, EU countries that already have an (electronic) patient file exchange can continue to do so. 

The EU countries will also have the opportunity to give their residents the choice of whether their medical data may be exchanged between EU countries (opt-out). It will even be possible to include an opt-in arrangement for exchanging data for scientific DNA research. This data is therefore not shared as standard.

In order to quickly organize the introduction in the Netherlands, the HDAB-NL program was started this month. This must develop technical functionalities for the new European system. The Dutch Data Protection Authority is also involved to monitor privacy aspects.

Patient organizations in several EU countries and EU politicians have expressed concerns about the privacy implications. Dutch MEP Bert-Jan Ruissen (SGP) called the bill 'the prelude to a European health union. By collecting patient data at EU level, we are moving towards one insurance system. Brussels will soon prescribe to us which treatments we will still be reimbursed for.'

MEP Anja Haga is very concerned about the confidentiality of the medical data of millions of patients within the European Union: “It is not the intention that commercial companies have access to patient data if the patient does not give explicit consent.” Haga therefore wants medical data to only be shared if patients give explicit permission for this in advance.

According to Haga, it is unfortunate that large pharmaceutical companies can benefit from such a system: “The risk of a data breach is always present and is disproportionate to the possible benefit for the patient.” A few years ago, the Christian Union was very critical of the introduction of an electronic patient file in the Netherlands, because for a long time it was unclear who exactly could access that data.