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OPINION (COM(2022)0197 – C90167/2022 – 2022/0140(COD))

On the proposal for a regulation of the European Parliament and of the Council on European Health Data Space

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Committee on Industry, Research and Energy · Rapporteur: CristianSilviu Buşoi

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The Committee on Industry, Research and Energy gives its opinion on the proposed regulation on the European Health Data Space (EHDS). It supports the initiative but proposes amendments to the text. The amendments add new recitals on aligning the EHDS with other Union programmes, cooperating on standards, complying with the Cyber Resilience Act, and studying the regulation's impact on research. They change definitions and rules on interoperability, cross-border identification, common specifications, and the categories of electronic health data available for secondary use. They add a right for natural persons to restrict access to their data for secondary use, ban the sale of data, and require stakeholder involvement in health data access bodies. They delete the article allowing direct access to data from a single data holder and give the EMA and ECDC rapid access to health data.

Committee position. The committee supports the EHDS initiative but proposes amendments to ensure prudent GDPR implementation, better treatment of regulatory authorities, interoperable standards, alignment with existing legislation, and new rights for natural persons.

Key points

  1. The Rapporteur supports the EHDS for better health outcomes, innovation and research, but says changes are needed for its success.
  2. The Rapporteur calls for prudent implementation of the GDPR to avoid unnecessary restrictions on health research and data sharing.
  3. The Rapporteur says the EMA and national medicines agencies should be treated differently from other data users, with better informed and faster regulatory decisions.
  4. The Rapporteur says interoperable and common rules and standards are essential, and the lack of standardisation is a major obstacle.
  5. The Rapporteur says the EHDS should build on the Data Governance Act and Data Act.
  6. New recitals state the EHDS is crucial for a European Health Union, should be aligned with other Union programmes, and should comply with the Cyber Resilience Act.
  7. A new recital requires the Commission to conduct a public study one year after entry into force on the regulation's impact on research, with recommendations.
  8. Amendments change the definition of interoperability and the European electronic health record exchange format, and add definitions of data sharing and pseudonymisation.
  9. Amendments change the categories of electronic health data for secondary use, deleting health-related administrative data and adding anonymised genetic data.
  10. A new article gives natural persons the right to restrict access by health data access bodies to all or part of their electronic health data.
  11. Amendments ban the sale of electronic health data and require stakeholder representatives in the governance of health data access bodies.
  12. Amendments delete the article allowing direct access to data from a single data holder and grant the EMA and ECDC rapid access to health data.

Who is affected

  • Patients and natural persons, who gain a right to restrict access to their electronic health data for secondary use.
  • Health data access bodies, which must involve stakeholders and publish biennial activity reports.
  • Data holders, including health providers and research entities, who must make data available for secondary use under amended rules.
  • The EMA and ECDC, which are granted rapid access to health data for evaluating medicines and assessing infectious disease threats.
  • The Commission, which must conduct a public study on the regulation's impact on research one year after entry into force.

Figures and deadlines

  • One year after entry into force, the Commission should conduct a public study on the regulation's impact on research.
  • A health data access body shall issue or refuse a data permit within 2 months, extendable by 2 additional months.
  • Data users shall make public the results of secondary use no later than 18 months after completion of processing.
  • The health data access body shall inform public sector bodies about data availability within 2 months, extendable by 2 additional months.
  • The health data access body shall make data available within 2 months after receiving them from data holders.