On the proposal for a regulation of the European Parliament and of the Council on the European Health Data Space
IMCO-PA-740773
Committee on the Internal Market and Consumer Protection · Rapporteur: Andrey Kovatchev
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The Internal Market and Consumer Protection Committee's draft opinion proposes amendments to the Commission's proposal for a regulation on the European Health Data Space. It focuses on the mandatory self-certification scheme for electronic health record (EHR) systems in Chapter III, clarifying definitions and the use of harmonised standards.¶¶ The amendments require the Commission and member states to set time-based targets for cross-border health data interoperability and infrastructure. They also clarify how the regulation interacts with other laws, such as the Medical Devices Regulation, the In-vitro Medical Device Regulation, the upcoming AI Act and the Data Act.¶¶¶ The draft opinion amends definitions for EHR, EHR systems, economic operators and general software, and sets rules for manufacturers, importers, distributors and other economic operators. It also adds provisions on common specifications, market surveillance, wellness application labels, advisory tasks of the EHDS Board and penalties.¶¶¶
Committee position. The rapporteur proposes amendments to clarify definitions, ensure the Commission uses harmonised standards for EHR system security and interoperability, reconcile the regulation with other sectoral legislation, and require time-based targets for cross-border health data interoperability.¶¶¶
Key points
- The opinion focuses on Chapter III, which sets up a mandatory self-certification scheme for EHR systems, with essential requirements on interoperability and security.¶
- It clarifies definitions related to EHR and EHR systems and adds new definitions to interpret Chapter III conditions clearly.¶
- It requires the Commission to base EU-wide standards for EHR systems on international and harmonised standards, consulting all relevant stakeholders.¶
- It defines how the European Health Data Space interacts with other sectoral legislation, especially when devices fall under more than one act.¶¶
- It requires the Commission and member states to set explicit time-based targets for implementing and progressing cross-border health data interoperability and infrastructure.¶¶¶
- It amends recitals to add time-based targets for health data interoperability and to correct wording on accessibility of electronic health data.¶
- It amends Article 2 to add definitions for 'professional user', 'putting into service', 'economic operator', 'EHR', 'EHR system' and 'general software'.¶¶¶
- It requires manufacturers of EHR systems that are also medical devices and claim interoperability to prove compliance with essential interoperability requirements and follow Article 23.¶
- It sets rules for placing EHR systems on the market, prohibits misleading information, and requires manufacturers to keep technical documentation and the EU declaration of conformity for 10 years.¶¶¶
- It extends manufacturer obligations to importers, distributors and other economic operators who modify EHR systems, and makes them responsible for malfunctions caused by their changes.¶¶¶
- It requires market surveillance authorities to notify and cooperate with data protection authorities, and sets rules for wellness application labels.¶¶¶
- It adds tasks for the EHDS Board to advise on cross-border health data interoperability for primary and secondary use, and sets criteria for penalties for infringements not covered by other regulations.¶¶¶
Who is affected
- Manufacturers of EHR systems, including those also qualifying as medical devices, must comply with interoperability requirements and documentation obligations.¶¶
- Importers, distributors and other economic operators who modify EHR systems may be considered manufacturers and bear responsibility for changes.¶¶¶
- The Commission and member states must set time-based targets for health data interoperability and develop MyHealth@EU.¶¶¶
- Market surveillance authorities must cooperate with data protection authorities and inform other member states of measures taken.¶
- EHR system providers and data holders may face penalties for infringements, with criteria for determining the amount.¶¶¶