Public Comments submitted to TEHDAS2 regarding Health Data Access Bodies for public consultation

The MRCT Center submitted comments emphasizing the importance of developing a clear, operational, and harmonized framework for international and third-country access to electronic health data under the European Health Data Space (EHDS). The MRCT Center noted that the draft guideline appropriately recognizes key challenges associated with international data access, including reciprocity requirements, governance responsibilities, cross-border data transfers, and the continuing applicability of GDPR. However, significant uncertainty remains regarding how reciprocity assessments will be conducted, how EHDS requirements interact with existing GDPR transfer mechanisms, and how Health Data Access Bodies (HDABs) will operationalize international access pathways in practice. The response highlighted concerns that inconsistent national implementation could create barriers to multinational research collaborations and limit the EHDS’s effectiveness. The MRCT Center recommended greater clarification regarding governance responsibilities, liability allocation, reciprocity assessments, and the relationship between EHDS requirements and GDPR Chapter V transfer mechanisms. Particular attention was devoted to the needs of multinational clinical research, including public-private research collaborations that routinely operate across jurisdictions. The Center also called for practical examples, decision-support tools, and standardized templates to support consistent implementation across Member States.

The MRCT Center submitted comments supporting the development of comprehensive guidance for the linkage of health datasets within the EHDS ecosystem. The MRCT Center noted that the draft guideline provides valuable technical guidance on privacy-preserving linkage methods and appropriately recognizes the importance of data quality, validation, and governance. However, the response identified several areas requiring further development, including the absence of common expectations regarding acceptable linkage quality, unresolved questions surrounding accountability for linkage decisions, and the lack of guidance for cross-border linkage activities. The Center highlighted concerns that inconsistent approaches to linkage quality assessment and governance could undermine comparability, reproducibility, and confidence in linked datasets across Member States. The MRCT Center recommended developing standardized frameworks for assessing and reporting linkage quality, conducting fitness-for-purpose evaluations, and increasing transparency regarding linkage methodologies and validation practices. The Center also called for stronger guidance on auditability, provenance, interoperability, metadata standards, and communicating linkage-related uncertainty to data users. The response emphasized the importance of balancing privacy protection with scientific utility while ensuring that linked health data can support robust research, regulatory decision-making, and public health objectives across the EHDS.

The MRCT Center submitted comments supporting the development of Citizen Information Points (CIPs) as an important mechanism to promote transparency and public trust within the EHDS framework. The MRCT Center emphasized that CIPs should be viewed as a core tool for public accountability and not as a regulatory compliance requirement. The response highlighted the need for greater attention to meaningful transparency, plain language communications, accessibility, user experience, and comprehension by the individual. The MRCT Center noted that the act of publishing information is insufficient unless that information is understandable, accessible, timely, and relevant to the individuals whose data are being used.

The MRCT Center also identified several areas requiring further development, including the relationship between the EHDS transparency obligations, GDPR requirements, and existing clinical trial transparency systems such as the Clinical Trials Information System (CTIS). Recommendations included the development of standardized templates, lifecycle-based transparency models, clearer definitions, stronger accessibility requirements, plain language communication standards, mechanisms for citizen engagement and feedback, and harmonized approaches for communicating public benefit. The Center emphasized the importance of ensuring that CIP implementation supports trust, accountability, and meaningful public understanding across the 27 Member States.

The MRCT Center submitted comments emphasizing the importance of developing a cogent and practical framework for handling, reporting, and disseminating research outcomes generated through the secondary use of health data under EHDS. The MRCT Center noted that the draft guidance appropriately addresses key transparency objectives but will require additional clarification on several foundational concepts: the distinction between outcomes, results, and outputs; the definition of clinically significant findings; and the allocation of responsibilities amongst secondary data users, HDABs, and health data holders. The response also emphasized the need for greater consistency between this guideline and the companion Citizen Information Point (CIP) guidance.

The MRCT Center highlighted areas that should be strengthened, including alignment with existing clinical research frameworks such as the EU Clinical Trials Regulation, Good Clinical Practice, and ICH E6(R3). Additional recommendations focused on establishing mechanisms to manage commercially sensitive information, clarifying reporting obligations for product and service development, addressing AI and machine learning outputs, strengthening governance around significant findings, and developing practical tools such as reporting templates and responsibility matrices. The Center underscored the need to balance transparency, research integrity, public trust, and legitimate commercial interests while ensuring that EHDA requirements can be implemented consistently across the multinational clinical research environments.