by Giedre Peseckyte
As the European Parliament debates how European health data space should be shaped, the co-rapporteur of the file has warned that the agreements regarding the secondary use of data were the hardest to reach.
Over a year has passed since the Commission proposed European health data space (EHDS), a new legislative proposal with ambitions to make a true revolution in health data and unleash its full potential for all stakeholders – from patients and healthcare professionals to policymakers and researchers.
Therefore the Parliament is running through more than a 100 page-document, aiming to empower EU citizens to better control their health data, unleash the market potential and set up the framework for data reuse while ensuring the protection of this highly sensitive data.
At the moment, according to the TEHDAS project which develops joint European principles for the secondary use of health data, member states vary widely in how they organise and manage health data, as well as in their preparedness to facilitate the secondary use of health data as part of the future EHDS.
To give an example, according to Florian Benthin, EY digital health leader for EU Institutions, one university hospital in Germany has several electronic medical records systems (EMRs).
Therefore, the EU seems to be going, as Andrea Renda, senior research fellow and head of a unit in the CEPS think tank, rightly put it, ”from zero to 100” when it comes to managing health data in the bloc.
The task is not easy for the parliamentarians and Croatian MEP Tomislav Sokol (EPP), the rapporteur of the file, was not hiding this on Thursday (29 June) during a discussion organised by the CEPS in Brussels.
“I am more confident about the trilogue,” he said explaining that “It will be harder to get the final agreement in the parliament than at the end with the Council”.
The issues with primary use
The proposal ticks two boxes – the primary and secondary use of data.
The primary use of data focuses on data use for citizens and healthcare professionals at the national and EU levels, and on fostering a genuine single market for electronic health record systems (EHRs), relevant medical devices, and high-risk AI systems.
Currently, the debate in Parliament is whether the EHRs should be evaluated externally or through self-certification by the providers or by the users themselves.
Another aspect under scrutiny is if a patient should be able to hide some of the data from health professionals, such as, for example, sexually transmitted diseases and if yes, whether healthcare professionals should see that some of the data was restricted, without specifying details.
According to Sokol, Parliament “resolved most of the topics about primary use” and when it comes to primary use, “we should have no major political issues”.
The secondary use of data, currently the main focus for parliamentarians, is a different story. It is there to provide a consistent, trustworthy and efficient data pool for research, innovation, policy-making, and regulatory activities.
“It’s much more complicated because it is not healthcare professionals using the data. It’s the universities, policymakers, of course, the industry and that’s always sensitive, as you can imagine,” Sokol said.
The crucial thing for Sokol here is to “strike a balance between the necessity to have representative data sets that can actually be useful on one side, and also protecting data and privacy patients”.
The burdensome question is who and to what extent should access the data pool.
“Of course, we agree that this should be research and innovation but what about policymakers and to what extent?” Sokol said.
Opt-In or Out?
While the Commission’s proposal does not include any say from patients on their data reuse, “this is something that will never go through” the Parliament, Sokol said.
Therefore rapporteurs of the file suggested the opt-out option, which means patients who don’t want their data to be used for secondary purposes could decide to stay out of the system.
This, however, does not include the opt-in option, which would be giving consent, as “we just wouldn’t have enough data, so this would become useless,” Sokol said, adding that the idea is to have large data sets that could enable boost research in, for example, rare disease field.
Sandra Gallina, the director-general of the Commission’s DG SANTE, asked in the opening speech at the European Health Summit on 8 June: “How can we treat these people that are not millions, very few, without thinking that we can share this thing [health data]?”
“The most important thing to bear in mind is that we need to have a sufficiently high level of ambition for secondary use,” she said.
Standing “wholeheartedly” by the Commission’s proposal, Gallina said that “we would not have opt-outs if it were for us”, adding that it is very costly for the member states.
“On the other hand, I understand that there is a clear need for patients to have the possibility to express what they want that data to be down to,” she said.
In the meantime, the European Parliament’s civil liberties committee (LIBE)’s members are more restrictive on data use than the members of the health committee (ENVI) which co-leads the file.
The other headaches
Touching on other parts of the proposal, there is a lot of reluctance in the parliament regarding access to health data from third countries and “the majority of political groups want this [access] to be very, very limited,” Sokol said.
The debate on intellectual property (IP) rights has not started yet as “we save the best for last”, Sokol said.
In the first draft report, the lawmakers proposed restrictions on using the data while clinical trials are still ongoing but other parts are still to be discussed, such as when a data set becomes intellectual property.
The discussions on the waiver of IP rights on COVID-19 vaccines and treatments in the COVI committee have already shown that the left groups are not the biggest fans of IP protection.
In the Council, as EURACTIV previously reported, the member states’ representatives suggested amending the final text to have a single, more detailed article dealing with intellectual property (IP) rights and trade secrets instead of having many provisions scattered in the text.
Reconciling the protection of trade secrets with fostering the circulation of data is also a central point in the discussions of the Data Act, a horizontal legislative proposal to regulate how data can be accessed, ported and shared.
The Data Act overlaps with EHDS, but also with the Data Governance Act, as well to some extent with the Digital Markets Act and other provisions that are yet to be finalised but are coming soon – for example, the Interoperable Europe Act Proposal, in turn having a potential influence on how EHDS will operate, according to CEPS Renda.
Reaching the deal with the Council
Despite the complexity, Sokol voiced hope that Parliament can finalise its work on the file by September and start the interinstitutional negotiations. He foresees two main issues in the talks with other EU institutions: funding and implementation timeline.
As Parliament is in favour of bigger funding from the EU budget to member states, there should be no clashes with the Council here.
When it comes to the timeline, the Commission aims to launch EHDS space in 2025, while the Council seems to be in favour of 10 years instead. According to Sokol, parliament will be settling on the middle ground “about three, four or five years.”
Contrary to HTA regulation where big member states, such as Germany, were more reluctant, they are now in favour, which gives hope for the Parliament.
“It’s important to have the big countries of the council pushing for the deal,” Sokol said, adding that this is what makes him think that reaching an agreement in the trilogue will be easier than finalising the parliament’s opinion.
*first published in: Euractiv.com
By: N. Peter Kramer
