Today in Strasbourg, during the ongoing plenary session of the European Parliament, a debate took place on the European Health Data Space (EHDS). ECR MEPs Joanna Kopcińska and Beata Kempa spoke during the debate.
Joanna Kopcińska said she had doubts as to whether the European Commission’s original proposal—which was very comprehensive and innovative—had a chance of success and whether it might interfere too much with patients’ privacy or with national healthcare systems. According to the MEP, however, the LIBE and ENVI committees succeeded in jointly developing a text that significantly improves the Commission’s proposal.
“I particularly appreciate the expansion of patient control over the storage and sharing of data,” she emphasized. Furthermore, as she noted, the Parliament’s text also strengthens the system of oversight and monitoring of the security of data collection, storage, and sharing at the level of national supervisory authorities. “In this way, we have managed to tighten the provisions of many articles of the regulation in line with the principle I have often emphasized: data processing security comes first,” she said.
Kopcińska also praised the sensible narrowing of the scope of secondary data use. In her view, the so-called “opt-out” option should help build citizens’ trust in the system.
The PiS MEP stated that during the upcoming trilogue negotiations, she will support solutions that maximize the security of data processing and minimize the purposes of such processing. “However, I believe that the Parliament’s position is a good response to most of these concerns, provides a basis for productive negotiations with the Council, and deserves support in tomorrow’s vote,” she noted.
Beata Kempa spoke about the enormous sums associated with patients’ medical information within the European Union’s single market, which was valued at 160 billion euros in 2020. “That is why it is so important to build a system for utilizing this data and—above all—security systems,” she emphasized. According to the MEP, the protection of sensitive data is key in this regulation. “We cannot allow patients to be deprived of the ability to access their data or voluntarily withdraw it while such an important regulation is being developed,” the MEP stated. As she noted, the final decision must always rest with the patient, who must be guaranteed the ability to act at any time. In the Polish politician’s view, the regulation addresses many very important issues, particularly regarding the further transfer and use of anonymized data. One of these, she said, is the results of medical tests and examinations and their use by companies. “It is very important that we were able to reach a compromise on this matter that is valuable to all parties,” she added.
The Regulation on the European Health Data Space establishes provisions aimed at increasing digital access to and control over the electronic health data of individuals and healthcare institutions at both the national and EU levels.
The two main pillars of the regulation are: primary use of data (the “patient-physician” environment) and secondary use of data (access to anonymized health data for purposes such as scientific research).
In the area of primary data use: patients’ electronic health records will be accessible through online access points established by Member States (in practice, these will be national online platforms connected to the cross-border MyHealth@EU platform). The responsibility for entering the relevant data rests with the attending physician (or the relevant institution). Patients will be able to review the entered data and share it with a healthcare provider of their choice. To this end, Member States will be required to make priority data categories (such as patient records, e-prescriptions, e-dispensing records, medical images and imaging reports, laboratory test results, and discharge summaries) in a common European electronic exchange format. Healthcare professionals will have access to electronic health records and should update the electronic health data of the patients they treat.
In the area of secondary use, Member States will upload health data collected through primary use to the dedicated HealthData@EU platform—making it available for research, innovation, public health, health policy development, regulatory activities, and personalized medicine. Member States are to establish an authority at the national level responsible for granting such access. Individuals and institutions wishing to access this database will have to apply for permission. Access to and processing of this data will be permitted only in closed, secure processing environments subject to clear cybersecurity standards. All such data will be available exclusively in anonymized form. If researchers, companies, or public institutions need access to personal electronic health data, they may access it only in pseudonymized form—that is, data containing information about diseases, symptoms, and medications, without revealing the identity of the individual to the user. Users are prohibited from attempting to re-identify data subjects.
The European Parliament adopted a draft of its report at the committee level on November 28 of this year, by a decisive majority of 95 votes in favor, 18 against, and 10 abstentions.
