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DRAFT 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

ITRE-PA-742310

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

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The Committee on Industry, Research and Energy's draft opinion on the proposed European Health Data Space (EHDS) regulation supports the initiative but proposes amendments to the Commission's text. The rapporteur wants prudent implementation of the General Data Protection Regulation (GDPR) to avoid unnecessary restrictions on health research and data sharing, and alignment with the Data Governance Act and Data Act. The amendments add interoperable and harmonized rules, standards and infrastructures, and clarify definitions for non-personal data, primary and secondary use, interoperability, and health data holders, recipients and users. They give health data holders the right to refuse access for legal, contractual, scientific integrity or intellectual property reasons, and exempt micro and small enterprises from making data available. They grant the European Medicines Agency (EMA) and the European Centre for Disease Prevention and Control (ECDC) rapid and unrestricted access to health data for evaluating the benefits and risks of medicinal products. They delete provisions on international transfer of non-personal data and on international access and transfer of personal electronic health data, saying these are already covered by the GDPR.

Committee position. The rapporteur supports many elements of the EHDS initiative but proposes amendments to ensure prudent implementation of the GDPR, alignment with the Data Governance Act and Data Act, and better access for regulatory authorities such as the EMA and ECDC.

Key points

  1. The rapporteur supports the EHDS for better health outcomes, innovation and research, but says changes are needed for it to succeed.
  2. The rapporteur calls for prudent implementation of the GDPR to avoid unnecessary restrictions on health research and data sharing, and for alignment with the Data Governance Act and Data Act.
  3. Amendment 1 adds that the regulation should also comply with the proposed Cyber Resilience Act (CRA) on security requirements.
  4. Amendment 2 says specifications should be commonly agreed and aligned with global standardisation and harmonisation activities and existing standards.
  5. Amendment 3 adds a recital that the regulation contributes to reducing inequalities in quality healthcare access, with no first and second-class citizens, and that barriers to reimbursement for telemedicine should be removed.
  6. Amendment 5 says EU funds must be distributed adequately among member states, taking into account different levels of health system digitalisation and the costs of making national data infrastructures interoperable.
  7. Amendments 6 to 18 change Article 1 and Article 2 to establish common and harmonized rules, interoperable infrastructures, and to clarify definitions of non-personal electronic health data, primary and secondary use, interoperability, and health data recipients, holders and users.
  8. Amendments 19 to 22 require the European electronic health record exchange format to be interoperable, including cross-border, and common specifications to take into account existing standardisation and harmonisation.
  9. Amendment 23 requires consultation with the Medical Devices Coordination Group or the European Artificial Intelligence Board before adopting common specifications affecting medical devices or high-risk AI systems.
  10. Amendments 24 to 33 give health data holders the right to refuse access for legal or contractual impediments, scientific integrity or protection of intellectual property rights or trade secrets, and exempt micro and small enterprises from making data available.
  11. Amendments 34 and 43 grant the EMA and ECDC rapid and unrestricted access to health data within the EHDS for evaluating the benefits and risks of medicinal products.
  12. Amendments 47 and 48 delete Article 62 and Article 63 on international transfer of non-personal data and international access and transfer of personal electronic health data, saying these are already covered by the GDPR.

Who is affected

  • Health data holders, including entities in the health or care sector and research bodies, gain the right to refuse access to their data in certain cases.
  • Micro and small enterprises are exempt from the requirement to make electronic health data available for secondary use.
  • The EMA and ECDC are granted rapid and unrestricted access to health data for evaluating medicinal products.
  • Member states must designate health data access bodies to fulfil tasks set out in Articles 37, 38 and 39.
  • Data users must not re-identify pseudonymised electronic health data provided to them.

Figures and deadlines

  • 2 months: period for health data access body to inform public sector bodies about data availability.
  • 2 additional months: possible extension of the period by the health data access body.
  • 2 months: period for health data access body to make data available to the data user after receiving them from data holders.