EU Parliament agrees position on digitalising health data

The European Parliament agreed on their position on digitalising EU health data on Wednesday (13 December), paving the way for the start of interinstitutional negotiations on Thursday.

By a large majority, the plenary adopted its report which will serve as Parliament’s negotiating mandate in talks with the Council on the final form of the European Health Data Space (EHDS) legislation. 

The EHDS proposal aims to optimise the potential of health data for patients and healthcare professionals as well as policymakers and researchers. 

The Health Committee (ENVI) and Civil Liberties, Justice and Home Affairs (LIBE) led on the Parliament’s text, with Croatian MEP Tomislav Sokol (EPP) and Italian MEP Annalisa Tardino (ID) as rapporteurs.

“Our text is a significant improvement on the Commission proposal,” Tardino told her colleagues at the plenary session on Tuesday, ahead of the vote.

Parliament’s position on the primary use of data

On the primary use of health data, which is data used by citizens and healthcare professionals at the national and EU levels, the Parliament expanded the proposal for the patients’ right to restrict access by including the possibility “to restrict access to anyone except the health professional who inserted the electronic health data”.

“For instance, if you have some kind of mental health condition, you will be able to restrict access to these parts of the data so that your mental health data is only seen by your psychiatrist and not other doctors that treat you,” Sokol explained after the vote.

When it comes to electronic health record (EHR) systems, the Parliament added several amendments stipulating that EHR systems should undergo a conformity assessment procedure before being placed on the market. For this, establishing notifying authorities and a conformity assessment body would be the responsibility of member states.

Parliament’s position on the secondary use of data

Secondary use of data regards that gathered by hospitals, universities, and research institutes which is catalogued and made available for health care, innovation, research, and policy-making after being anonymised or pseudonymised.

“For instance, a university researcher from Berlin will be able to access data sets on pancreatic cancer from Paris, from Rome, from Madrid and so on,” Sokol said, adding that the whole idea is to use data potential “much better”. 

This is especially important in the rare diseases field, where there is a lack of patients to complete clinical trials.

The Parliament, as expected, called for an opt-out option: “Natural persons shall have the right to opt-out of the processing of their electronic health data for secondary use,” the amendment on Article 33 said. This is not in line with the Commission’s proposal, which relied on the existing GDPR, which currently varies wildly in implementation across the EU. 

MEPs went even further in the case of certain sensitive data, such as genetic and genomic information, by introducing an explicit consent or opt-in system that means that every patient whose data is part of this will have to give consent each time this data is used.

Health Commissioner Stella Kyriakides, who was present in the debate on Tuesday, argued against the opt-out. “Having an opt-out can introduce bias into the data because in particular, minority groups could be negatively affected by this, and if they are not represented in the data set, as we all know from research, new treatments and or health applications on which they need, they will not have their data into this,” she said.

However, Sokol urged caution. “We are really striking the balance between the right of privacy and data protection on one side and the need to use data on the other,” he said, adding that this approach was supported by patient organisations.

The opt-out option is likely to be a point of contention in the upcoming trilogue negotiations, which are due to start on Thursday (14 December), as the Council set their position last week, on 6 December.

What to expect at the negotiations 

The Council, in its mandate, introduced the possibility for member states to impose additional limitations on the primary use of data in cross-border situations.

“This essentially means that some member states could adopt one set of rules for the exchange of data and primary use of data within the country, and impose limitations on the use of data when patients go abroad or when patients come from abroad,” Sokol said.

“This is contrary to the basic principles of the EU and the treaty,” he added.

The timeline is also in question, with the Council asking for five to seven years to register all the data into the electronic health records after implementation. With two years for implementation and an additional seven years, the EHDS would become fully operational nine years after the adoption of the regulation.

“This is definitely too much,” Sokol said.

Another concern is funding, with both Parliament and the Council aiming to increase centralised funding from the EU budget.

[Edited by Nathalie Weatherald]

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