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Stakeholder Collaboration for the European Health Data Space (EHDS) Regulation

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A collective of prominent stakeholder organizations, representing patients, healthcare professionals, researchers, and industry players within the European Union (EU) and its Member States, is joining forces to shape the future of health data. These stakeholders, with their diverse expertise and perspectives, are rallying behind the refinement of the European Health Data Space (EHDS) Regulation. As Europe endeavors to establish a cohesive framework for healthcare data, its recommendations aim to address five pivotal challenges that will shape the EHDS’s impact and its ability to achieve its policy objectives.

A foundational challenge lies in establishing clear and coherent definitions within the EHDS framework. To ensure legal certainty, the EHDS must align its definitions with existing frameworks, such as the General Data Protection Regulation (GDPR). Key areas of focus include:

  • Defining ‘personal electronic health data’ in harmony with established GDPR definitions and authoritative interpretations.
  • Clarifying the scope of ‘electronic health data’ to encompass data types beyond ‘personal electronic health data,’ alleviates legal ambiguities.
  • Crafting a precise ‘data holder’ definition to identify those falling within its purview, promoting legislative consistency with other EU legal acts.

Ensuring Precision, Clarity, and Compliance for Secondary Health Data Use

The EHDS’s interaction with diverse legal frameworks raises complex questions. Clarity and coherence in its alignment with EU horizontal and sectoral legislation, international legal instruments, and voluntary contractual arrangements are imperative. Harmonizing the EHDS with the GDPR, Data Governance Act, Data Act, and other relevant legal acts is crucial to uphold legal certainty and consistency under EU law.

Unlocking the potential for secondary use of electronic health data necessitates a well-defined framework. Achieving this hinges on consistent terminology use to avoid uncertainty. Clarity regarding data categories, such as ‘data,’ ‘aggregated data,’ ‘electronic data,’ ‘health data,’ ‘healthcare-related data,’ ‘determinants of health,’ or ‘electronic health data,’ is essential. Ensuring that data types don’t overlap between categories with additional conditions for secondary use is equally critical. Scientific validation and compliance with existing legal safeguards must underpin the release of electronic health data for secondary purposes.

Health Data

Navigating International Health Data Transfer Challenges

The EHDS’s approach to data localization and international health data transfers warrants careful consideration. Imposing data localization requirements may inadvertently affect international health research and innovation collaborations, clinical trials, and digital health services. Any such requirement must come with clear technical specifications and align with GDPR Chapter V, enabling international data transfer in compliance. Avoiding fragmentation and inconsistency in data transfer regulations across the EU is essential to maintain data subject protection.

Engaging a diverse range of stakeholders is paramount for the EHDS’s responsible, trustworthy, and impactful implementation. The complexity of EHDS development necessitates the expertise and insights of stakeholders across the healthcare ecosystem, both at the EU and national levels. A multi-stakeholder governance approach, combining top-down and collaborative elements, could guide the EHDS Board’s functioning. This approach would foster cooperation, and information exchange among Member States, the Commission, the European Data Protection Board, and health technology assessment bodies. Steering subgroups, comprising representatives of patients, citizens, healthcare professionals, researchers, and industry actors, could further enhance the EHDS’s governance effectiveness.


Resource: EFPIA, December 04, 2023

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