On 24 April 2024, the European Parliament voted to adopt a favourable position on the European Health Data Space (EHDS) proposal during their plenary session. The EHDS is a proposed regulatory framework which will reinforce and expand Europe’s health data ecosystem, with anticipated benefits for both patient care and secondary data use for research.
As currently envisioned, the EHDS will facilitate the secure sharing and access of health data across EU Member States (MS) by both patients and health professionals. Patients and their care providers will be able to access prescriptions, laboratory results, and more from any MS. The EHDS will also make it possible to share pseudonymised or anonymised data within Europe for secondary purposes, which is expected to support advances in research and policymaking.
Due to the highly sensitive nature of health data, the newly adopted text also provides for strong privacy safeguards to determine how and for what purposes data can be shared. For example, the legislation requires that patients have the ability to control in what contexts their data can be shared. Additionally, secondary use of data is only authorised for non-commercial purposes in service of the common good.
The EHDS’s potential to transform the European health data landscape has particular implications for the rare disease community, for whom data sharing is essential due to the sparse geographic distribution of patients and expertise. Following the plenary vote, EURORDIS published a press release emphasising the importance of the EHDS for people living with a rare disease, and lauded the text’s balance between data accessibility and patient privacy.
Following parliamentary approval, the next step towards implementation of the EHDS is approval from the Council of Europe. The act will enter into force twenty days after publication in the EU’s Official Journal, entering into force two years later. In the interim, national governments and EU institutions can take steps such as investing in digital and health literacy so that patients, caregivers, and health professionals are able to effectively use the tools which will soon be available to them.