Governing the European Health Data Space (EHDS): Ethical and Political Perspectives on the TEHDAS2 Second Public Consultation

This white paper consolidates comments submitted to the TEHDAS2 second public consultation on the TEHDAS2 guidelines (September 2025). TEHDAS2 guidelines provide practical guidance and operational interpretation of key provisions of the European Health Data Space (EHDS) Regulation, aimed at supporting consistent implementation across Member States while allowing for national flexibility.

TEHDAS2 guidance addresses core aspects of the secondary use framework of the EHDS, including fee structures, permitted and prohibited uses of health data, metadata cataloguing, data access application and request procedures, enforcement and sanctions, and individual opt-out mechanisms. Across the guidelines, foundational principles such as transparency, proportionality, non-discrimination, due process, competition neutrality, data minimization, and alignment with FAIR principles are emphasized. The guidelines also clarify procedural requirements, including compliance monitoring, verification and assessment workflows, coordination mechanisms, and transparency obligations at both national and EU levels.

While the TEHDAS2 guidelines offer valuable operational clarity, our analysis identifies several areas where further specification, harmonization, or clarification would strengthen implementation. These include, among others: the rationale and consistency of fee models and accounting standards; cross-border coordination and enforcement; alignment with GDPR requirements and AI governance; interpretation of allowed purposes and public interest; handling of intellectual property and trade secrets; metadata scalability and resource constraints; differentiation between data and dataset quality; and the practical implementation of opt-out mechanisms, particularly in relation to genetic data, vulnerable populations, and communication strategies.