Language: English

The MRCT Center submitted comments emphasizing the need for greater clarity, harmonization and operational guidance regarding data minimization, pseudonymisation, anonymisation, and synthetic data within the European Health Data Space (EHDS). The MRCT Center noted that while the draft appropriately adopts a risk-based approach, substantial ambiguity remains regarding key definitions, technical standards, governance expectations, and the respective roles of Health Data Access Bodies (HDABs), data holders, and data users. The response highlighted concerns that inconsistent implementation across 27 Member States could undermine both data utility and interoperability, particularly from the perspective of the multinational clinical research ecosystem and involved stakeholders. The MRCT Center recommended the development of standardized methodologies, templates, technical guidance, and risk assessment frameworks to support consistent implementation. Particular attention was devoted to the needs of clinical research, including genomic research, rare diseases, pediatric populations, and multinational clinical trials where aggressive de-identification may compromise scientific validity and data integrity. The MRCT Center also called for stronger guidance on pseudonymization practices, synthetic data validation, cross-border data use, governance and accountability frameworks, and alignment with GDPR, the AI Act, and other applicable European regulatory frameworks.

The MRCT Center submitted comments emphasizing that the proposed framework for notifying individuals of significant findings requires substantially greater conceptual, ethical, legal, and operational clarity before implementation. The MRCT Center identified the absence of a clear and actionable definition of “significant findings” as the most critical issue, noting the need to distinguish between clinically actionable findings, personally significant findings, unvalidated signals, and non-actionable findings derived from secondary-use research. The response highlighted concerns regarding standards of evidence, clinical validation requirements, responsibilities for notification, and the unique challenges posed by large-scale observational, genomic, and AI-enabled research.

The MRCT Center further stressed the need for stronger guidance on governance, accountability, data protection, cross-border implementation, and communication practices. Particular attention was paid to challenges involving data re-identification, interoperability, the right not to know, pediatric and other populations requiring additional supports, and multinational research programs. The Center recommended establishing minimum common European standards for validation communication, timelines, and oversight while developing clear responsibility frameworks for HDABs, data users, data holders, and other stakeholders involved in returning potentially significant findings to individuals.

The MRCT Center submitted comments emphasizing that implementing the EHDS opt-out framework requires substantially greater harmonization, clearer governance, and stronger technical guidance to avoid unintended consequences for research quality and data usability. The Center supported the guideline’s objective of empowering individuals to exercise meaningful choice regarding secondary use of their health data while noting that excessive variability in national implementation could result in significant data fragmentation, reducing the representativeness and utility of datasets available for research, innovation, and evidence generation. The response highlighted concerns regarding the allocation of responsibilities among Health Data Access Bodies (HDABs) and data holders, as well as unresolved questions surrounding interoperability, enforcement, legal accountability, and the relationship between EHDS opt-out provisions and existing GDPR requirements. The MRCT Center recommended developing common technical standards, governance frameworks, and implementation requirements to support consistent application across Member States. Particular attention was devoted to challenges involving multinational clinical research, cross-border data use, data protection, and the operational management of opt-out decisions throughout the data lifecycle. The Center also called for stronger guidance on citizen engagement, transparency, accessibility, authentication processes, and mechanisms for assessing the impact of opt-out practices on dataset representativeness and scientific validity. The response emphasized the need to balance individual autonomy, privacy protection, public trust, and research utility while ensuring that EHDS implementation remains feasible and interoperable across diverse healthcare and research environments.