In the autumn of 2024, we undertook a legal challenge in the field of e-health. We conducted an extensive legal analysis to assess how Ukrainian legislation aligns with European Union law regarding e-health and health data. We conducted this study on behalf of the Estonian Centre for International Development in collaboration with the Ukrainian law firm AEQUO.

The completed analysis supports Ukraine’s incorporation into the European Union’s health data infrastructure, MyHealth@EU. This platform allows member states to exchange health data to provide healthcare services among themselves and with countries outside the European Union. “This approach to health data exchange helps lower healthcare costs and ensures individuals receive more effective treatment. Joining the infrastructure enables healthcare providers to access a patient’s medical history and test results from other countries,” explains our partner, Lise-Lotte Lääne. Moreover, the project helps Ukraine’s EU accession, as in order to join Ukraine would have to align its domestic laws with EU laws.

As part of the project, we reviewed the Ukrainian and European Union legal acts impacting health data exchange, including an examination of regulations, directives and recommendations, followed by a general and detailed analysis. The detailed analysis consisted of a norm-by-norm comparison of EU legal norms with Ukrainian legal provisions in order to identify compatibility or contradictions.

“Within the analysis, we also provided recommendations on necessary changes to Ukrainian law and outlined what their content should be. This helps promote the introduction of amendments into Ukrainian legislation,” says Lise-Lotte Lääne. Alongside other EU legal acts, the detailed analysis examined the compatibility of Ukrainian law with the EU Health Data Space Regulation, the General Data Protection Regulation, the Cybersecurity Directive 2, the Data Regulation, the Data Governance Regulation, and the Directive on Cross-Border Healthcare. Furthermore, the project explored alternatives to the MyHealth@EU infrastructure for health data exchange. In total, the analysis covered more than 40 EU legal acts.

Our services and client team

In addition to drafting the analysis, the project team participated in various activities organised as part of the preparation process, including focus interviews, meetings and a presentation event. As a result of the project, we completed a final analysis totalling over 500 pages.

The Sorainen team included partners Lise-Lotte Lääne and Mihkel Miidla, senior associate Cathriin Majas, and associates Jürgen Adamson and Kärt Saar.