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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 the European Health Data Space

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Committee on the Internal Market and Consumer Protection · Rapporteur: Andrey Kovatchev

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The Committee on the Internal Market and Consumer Protection gives its opinion on the proposed regulation on the European Health Data Space, focusing on Chapter III on EHR systems. It proposes amendments to clarify definitions of EHR, EHR systems and related terms, and to require the Commission to base EU-wide standards on international and harmonised standards with stakeholder participation. It seeks to define how the EHDS interacts with other sectoral legislation, including the Medical Devices Regulation, the In-vitro Medical Device Regulation, the AI Act and the Data Act. It asks the Commission and member states to set time-based targets for cross-border health data interoperability and infrastructure, and adds rules on cybersecurity, market surveillance, penalties and evaluation.

Committee position. The committee proposes amendments to the Commission's proposal to clarify definitions, base EU standards on international and harmonised standards, reconcile the EHDS with other sectoral legislation, and set time-based targets for interoperability.

Key points

  1. The opinion focuses on Chapter III, which sets up a mandatory self-certification scheme for EHR systems with essential requirements on interoperability and security.
  2. It clarifies definitions of EHR, EHR system, general software, wellness application, economic operator and professional user, and adds new definitions.
  3. It requires the Commission to take existing international standards and formats into account when setting the European electronic health record exchange format and common specifications.
  4. It requires the Commission and member states to agree time-based targets for health data interoperability and for implementing MyHealth@EU.
  5. It sets rules for software that is also a medical device or high-risk AI system, which must follow the conformity assessment of those acts and only the common specifications for EHR systems.
  6. It requires member states to give market surveillance authorities the human, technical and financial resources, equipment, IT tools, premises, infrastructure, knowledge and training to do their work.
  7. It adds manufacturer obligations on immediate corrective action, reporting to authorities, complaint channels, investigation of complaints and compensation for damage from defective EHR systems.
  8. It adds obligations for importers and distributors to inform authorities of risks, verify complaint channels, investigate complaints and cooperate on bringing systems into conformity, withdrawal or recall.
  9. It makes the once-only principle apply, so natural or legal persons provide data to public bodies or EHR providers only once under the primary or secondary use regime.
  10. It requires the Commission to issue guidance on prioritisation criteria for health data access bodies, avoiding fragmentation of the single market.
  11. It requires member states to run communication campaigns on infringements and the regulation's provisions, and to publish penalty decisions within one month.
  12. It sets evaluations after 5 and 7 years, with delegated acts on common indicators, and extends the transition period for certain data categories and EHR systems to 3 years.

Who is affected

  • Manufacturers of EHR systems, who face new obligations on documentation, corrective action, complaint handling and compensation.
  • Importers and distributors of EHR systems, who must inform authorities of risks, verify complaint channels and cooperate on conformity.
  • Health data access bodies, which may charge proportionate fees and must follow Commission guidance on prioritisation criteria.
  • Member states, which must resource market surveillance authorities, run communication campaigns and report on common indicators.
  • Natural persons, who gain rights to information on who accessed their data and to compensation for defective EHR systems.

Figures and deadlines

  • 100% of Union citizens having access to their electronic health records by 2030
  • 10 years after the last EHR system covered by the EU declaration of conformity has been placed on the market
  • no longer than 5 years after personal data in the internal register of complaints have been encoded
  • no longer than five years after personal data in the importer's internal register of complaints have been encoded
  • no later than 18 months after the completion of the electronic health data processing or after receiving the answer to the data request
  • no later than one month after the penalty is imposed
  • after 5 years from the entry into force of this Regulation, a targeted evaluation
  • after 7 years from the entry into force of this Regulation, an overall evaluation