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Harmonised software components of EHR systems
1. EHR systems shall include a European interoperability software component for EHR systems and a European logging software component for EHR systems (the ‘harmonised software components of EHR systems’), in accordance with the provisions laid down in this Chapter. 2. This Chapter shall not apply to general purpose software used in a healthcare environment.
Placing on the market and putting into service
1. EHR systems shall be placed on the market or put into service only if they comply with the provisions laid down in this Chapter. 2. EHR systems that are manufactured and used within health institutions established in the Union, as well as EHR systems offered as a service as defined in Article 1(1), point (b), of Directive (EU) 2015/1535 of the European Parliament and of the Council ( 33 ) to a natural or legal person established in the Union, shall be considered as having been put into service. 3. Member States shall not prohibit or restrict the placing on the market of EHR systems which comply with this Regulation, on account of considerations relating to aspects concerning the harmonised software components of EHR systems regulated by this Regulation.
Relation to Union law governing medical devices, in vitro diagnostic medical devices and AI systems
1. Manufacturers of medical devices or in vitro diagnostic medical devices, as defined in Article 2, point (1), of Regulation (EU) 2017/745 and Article 2, point (2), of Regulation (EU) 2017/746, respectively, that claim interoperability of those medical devices or in vitro diagnostic medical devices with the harmonised software components of EHR systems shall prove compliance with the essential requirements on the European interoperability software component for EHR systems and the European logging software component for EHR systems, laid down in Section 2 of Annex II to this Regulation. Article 36 of this Regulation shall apply to those medical devices and in vitro diagnostic medical devices. 2. Providers of AI systems considered to be high-risk in accordance with Article 6 of Regulation (EU) 2024/1689 (the ‘high-risk AI system’) and which do not fall within the scope of Regulation (EU) 2017/745 or (EU) 2017/746, that claim interoperability of those high-risk AI systems with the harmonised software components of EHR systems, shall prove compliance with the essential requirements on the European interoperability software component for EHR systems and the European logging software component for EHR systems, as laid down in Section 2 of Annex II to this Regulation. Article 36 of this Regulation shall apply to those high-risk AI systems.
Claims
In the information sheet, instructions for use or other information accompanying EHR systems, and in the advertising of EHR systems, it shall be prohibited to use text, names, trademarks, pictures and figurative or other signs that may mislead the professional user as defined in Article 3, point (8), of Regulation (EU) 2018/1807 of the European Parliament and of the Council ( 34 ) with regard to their intended purpose, interoperability and security by: (a) ascribing functions and properties to the EHR system which it does not have; (b) failing to inform the professional user of likely limitations related to interoperability or security features of the EHR system in relation to its intended purpose; (c) suggesting uses for the EHR system other than those stated to form part of the intended purpose in the technical documentation.
Procurement, reimbursement and financing
Member States may maintain or define specific rules for the procurement or financing of, or reimbursement for, EHR systems in the context of the organisation, delivery or financing of healthcare services, provided that such rules are compliant with Union law and do not affect the functioning or compliance of the harmonised software components of EHR systems.
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