The European Parliament agreed on their place on digitalising EU well being knowledge on Wednesday (13 December), paving the best way for the beginning of interinstitutional negotiations on Thursday.
By a big majority, the plenary adopted its report which can function Parliament’s negotiating mandate in talks with the Council on the ultimate type of the European Well being Knowledge House (EHDS) laws.
The EHDS proposal goals to optimise the potential of well being knowledge for sufferers and healthcare professionals in addition to policymakers and researchers.
The Well being Committee (ENVI) and Civil Liberties, Justice and Residence Affairs (LIBE) led on the Parliament’s textual content, with Croatian MEP Tomislav Sokol (EPP) and Italian MEP Annalisa Tardino (ID) as rapporteurs.
“Our textual content is a major enchancment on the Fee proposal,” Tardino advised her colleagues on the plenary session on Tuesday, forward of the vote.
Parliament’s place on the first use of information
On the first use of well being knowledge, which is knowledge utilized by residents and healthcare professionals on the nationwide and EU ranges, the Parliament expanded the proposal for the sufferers’ proper to limit entry by together with the chance “to limit entry to anybody besides the well being skilled who inserted the digital well being knowledge”.
“As an illustration, you probably have some type of psychological well being situation, it is possible for you to to limit entry to those components of the information in order that your psychological well being knowledge is just seen by your psychiatrist and never different medical doctors that deal with you,” Sokol defined after the vote.
Relating to digital well being report (EHR) techniques, the Parliament added a number of amendments stipulating that EHR techniques ought to endure a conformity evaluation process earlier than being positioned available on the market. For this, establishing notifying authorities and a conformity evaluation physique could be the duty of member states.
Parliament’s place on the secondary use of information
Secondary use of information regards that gathered by hospitals, universities, and analysis institutes which is catalogued and made obtainable for well being care, innovation, analysis, and policy-making after being anonymised or pseudonymised.
“As an illustration, a college researcher from Berlin will be capable of entry knowledge units on pancreatic most cancers from Paris, from Rome, from Madrid and so forth,” Sokol mentioned, including that the entire concept is to make use of knowledge potential “significantly better”.
That is particularly vital within the uncommon illnesses discipline, the place there’s a lack of sufferers to finish scientific trials.
The Parliament, as anticipated, referred to as for an opt-out choice: “Pure individuals shall have the appropriate to opt-out of the processing of their digital well being knowledge for secondary use,” the modification on Article 33 mentioned. This isn’t consistent with the Fee’s proposal, which relied on the prevailing GDPR, which at present varies wildly in implementation throughout the EU.
MEPs went even additional within the case of sure delicate knowledge, equivalent to genetic and genomic info, by introducing an express consent or opt-in system that implies that each affected person whose knowledge is a part of this should give consent every time this knowledge is used.
Well being Commissioner Stella Kyriakides, who was current within the debate on Tuesday, argued towards the opt-out. “Having an opt-out can introduce bias into the information as a result of specifically, minority teams could possibly be negatively affected by this, and if they aren’t represented within the knowledge set, as everyone knows from analysis, new therapies and or well being purposes on which they want, they won’t have their knowledge into this,” she mentioned.
Nonetheless, Sokol urged warning. “We’re actually hanging the steadiness between the appropriate of privateness and knowledge safety on one aspect and the necessity to use knowledge on the opposite,” he mentioned, including that this strategy was supported by affected person organisations.
The opt-out choice is prone to be a degree of rivalry within the upcoming trilogue negotiations, that are as a consequence of begin on Thursday (14 December), because the Council set their place final week, on 6 December.
What to anticipate on the negotiations
The Council, in its mandate, launched the chance for member states to impose extra limitations on the first use of information in cross-border conditions.
“This primarily implies that some member states might undertake one algorithm for the change of information and first use of information inside the nation, and impose limitations on the usage of knowledge when sufferers go overseas or when sufferers come from overseas,” Sokol mentioned.
“That is opposite to the fundamental rules of the EU and the treaty,” he added.
The timeline can also be in query, with the Council asking for 5 to seven years to register all the information into the digital well being data after implementation. With two years for implementation and an extra seven years, the EHDS would grow to be totally operational 9 years after the adoption of the regulation.
“That is undoubtedly an excessive amount of,” Sokol mentioned.
One other concern is funding, with each Parliament and the Council aiming to extend centralised funding from the EU finances.
[Edited by Nathalie Weatherald]
Learn extra with Euractiv
