New EU rules on health data spark concerns among MEPs

The European Health Data Space who is set to come into force could act as a potential game-changer for healthcare data, but trust, infrastructure investment, and training for healthcare professionals are key to its success. This was one of the main takeaways from a debate held in the European Parliament Committee on Health Matters soon after its constitutive meeting.

According to the European Court of Auditors, complexity and insufficient capacity in administration can pose hurdles for healthcare digitalization to achieve its overall effectiveness. While hearing from the committee members, the ECA auditor, Joëlle Elvinger, also mentioned the need for alignment in fund usage and better transparency as issues linked to optimizing the recent EU initiative in the field.

Speaking for the European Commission, the Deputy Head of the Unit for “Digital Health and European Reference Networks,” Martin Dorazil, acknowledged the recent ECA report’s positive evaluation and its remarks for improvement.

The EPP members repeatedly stressed their concerns about the lack of administrative capacity, especially related to access to funds, during the exchange. Croatian EPP member Tomislav Sokol clarified that the EHDS would allow patients to control their data, including opting out of sharing, and emphasized the need for investment in infrastructure, training, and trust-building.

Her compatriot from the S&D group, Romana Jerkovic, highlighted the importance of digital health literacy to prevent exacerbating inequalities, warning that a significant portion of the population lacks the necessary skills to benefit from digital health tools. Vlad Vasile Voiculescu, who is the coordinator of the Renew Group in the committee, questioned the disparities in healthcare digitalization across Member States, suggesting that institutional weaknesses may be a bigger factor than concerns about data protection.

The Patriots for Europe group joined the ECR group in raising concerns about the EHDS potentially compromising citizens’ privacy and criticized the overreach of EU-level health data management. Ignazio Marino, who serves as coordinator for the Greens/EFA group, also focused on the need for a balance between data sharing and privacy concerns.

Valentina Palmisano took the floor for The Left group and praised the potential of telemedicine to reduce barriers but noted its uneven implementation across Member States, calling for better coordination to ensure accessibility for all citizens.

The European Commission stated that the main added value of EHDS is that the regulation empowers patients while ensuring high-security standards. The recently published action plan on healthcare cybersecurity aims to demonstrate the EU’s commitment to protecting health data. The European Court of Auditors also stressed the advantage of the EHDS providing consistent rules across Member States to address cybersecurity concerns.