EHR (Electronic Health Record) systems are central to the European Health Data Space (EHDS), enabling secure and seamless cross-border health data exchange. Interoperability is key - healthcare providers can only collaborate effectively if their systems are compatible. To address this, new obligations are placed on manufacturers of EHR systems under the EHDS Regulation to enable interoperability. Ensuring that only interoperable systems are available on the market simplifies processes for healthcare providers, fostering smoother collaboration and improved patient care.
What is an Electronic Health Record (EHR)?
The EHDS Regulation describes an electronic health record (EHR) as a ‘collection of electronic health data related to a natural person and collected in the health system, processed for the purpose of the provision of healthcare’. An EHR typically includes a comprehensive range of medical information, such as a person’s medical history, diagnoses and treatment, medications, allergies, immunisations, radiology images and laboratory results, and other medical data.
What is an Electronic Health Record system (EHR system)?
The EHDS Regulation (Article 2(2)(k)) describes electronic health record system (EHR system) as ‘any system where the appliance or software allows to store, intermediate, export, import, convert, edit or view personal electronic health data that belongs to the priority categories of personal electronic health data (patient summaries, electronic prescriptions, electronic dispensations, medical imaging studies and related imaging reports, medical test results, discharge reports, systems that only processes other kinds of data, e.g. appointment booking systems, are not EHR systems.) and is intended by the manufacturer to be used by healthcare providers when providing patient care (e.g. systems used by clinicians for recording notes, test results etc., up to a patient management system) or by patients when accessing their electronic health data (e.g. an app that connects to the electronic health data access service for patient will count as an EHR system.).
Who is a manufacturer of an EHR system?
The EHDS Regulation does not explicitly define ‘manufacturer of an EHR system’. Instead, it refers to Regulation (EU) 2019/1020, where manufacturer is defined as ‘any natural or legal person who manufactures a product or has a product designed or manufactured, and markets that product under its name or trademark.’
What is the European electronic health record exchange format (EEHRxF)?
The European Electronic Health Record Exchange Format (EEHRxF) is a standardised, machine-readable format designed to facilitate the secure and interoperable exchange of electronic health data across the EU. It enables the seamless transmission of health data between different software applications, devices, and healthcare providers.
According to the EHDS Regulation, EEHRxF shall include:
- harmonised datasets that define data structures, such as fields and groups, for representing clinical content
- coding systems and values to ensure consistency in electronic health data
- technical interoperability specifications, including content representation, standards, and profiles.
The EEHRxF is a key component of the European Health Data Space, allowing citizens to easily access and share their health records, particularly when consulting specialists or receiving emergency treatment in another EU country. The European Commission’s Recommendation (C(2019)800) outlines the principles and technical specifications forming the foundation of this exchange format.
How will the new requirements for EHR systems under EHDS benefit manufacturers and healthcare providers?
Manufacturers
- easier market access across Member States: Harmonised requirements for interoperability and logging components make it easier for EHR manufacturers to sell their products in various EU countries
- lower switching costs leading to easier market entry: Increased interoperability reduces switching costs for healthcare providers, making exchanging EHR systems easier.
Healthcare providers (HCPs)
- increased interoperability: When procuring a new EHR system, HCPs will know it has harmonised logging and interoperability components supporting the exchange of data between systems – including MyHealth@EU
- enhanced patient care: Interoperability supports seamless healthcare provision across different providers
- CE-marking enables Health Care Providers to determine which systems can support the citizens' rights under EHDS, for example, by providing health data in an EEHRxF and ensuring log-data availability
- efficiency & cost savings: Reduces redundant testing, saving time and resources. Lower switching costs make vendor changes easier and minimize vendor lock-in effects
- procurement flexibility: Standardized systems allow HCPs to replace or upgrade EHR systems more easily, increasing vendor choices.
What parts of the EHR are harmonised under the EHDS? (Articles 26, 29, 36)
EHR systems must contain two harmonised components, starting in early 2029, early 2031 for 1st / 2nd group of priority categories:
- the interoperability component provides the capability to import/export data in EEHRxF
- the logging component provides the capability to generate access logs as per Art. 9.
Details specifications for the harmonised software components of EHR systems will be defined through implementing acts. Member States remain free to have requirements on other parts of EHR systems, provided they don’t interfere with the harmonised components.
Manufacturers will have to test harmonised components of products before placing them on the market and include test results in public technical documentation. To facilitate this, Member States will establish European digital testing environments, providing manufacturers with an automated means to verify that the harmonised software components of their EHR systems comply with the EHDS Regulation. (Article 40)
Which requirements apply to the manufacturers of EHR systems? (Article 30)
EHR systems shall be placed on the market or put into service only if they comply with the provisions in Chapter III of the EHDS Regulation.
The EHR manufacturers are to:
- ensure that the harmonised software components of their EHR systems and the EHR systems themselves, are in conformity with the essential requirements laid down in Annex II, and with common specifications in accordance with Article 36. Requirements under Annex II of the EHDS include:
- general requirements: manufacturers must ensure that their systems perform as intended and maintain patient safety during normal use. In addition, EHR systems must be designed for seamless supply, installation, and operation according to the manufacturer’s instructions, without compromising their characteristics or performance
- requirements for interoperability: any system designed to store, intermediate, or provide access to personal electronic health data must enable access and reception of such data in the EEHRxF. Further, they must not include features that restrict authorised access, sharing, use, or export of such data
- requirements for security and logging: EHR systems shall provide reliable mechanisms for the identification and authentication of health professionals. EHR systems shall include tools or mechanisms to review and analyse the log data, or it shall support the connection and use of external software for the same purposes.
- ensure that the harmonised software components of their EHR systems are not impeded or negatively adversely affected by other software components of the same EHR system;
- draw up the technical documentation of their EHR systems before placing them on the market, and subsequently keep it up to date; (Article 37)
- ensure that their EHR systems are accompanied, free of charge for the user, by the information sheet and clear and complete instructions for use; (Article 38)
- draw up the EU declaration of conformity (Article 39)
- CE marking (Article 41)
- indicate the manufacturer’s name, contact details, and a single contact point, in a user-friendly language.
- enter the required data, as defined by the Commission through delegated acts, into the EU database for registration of EHR systems, including the results of the assessment of harmonized software components of EHR systems, before placing an EHR system on the market or into service. (Article 49)
- take corrective action, recall or withdraw non-conforming EHR systems and notify national authorities about the action and timeline
- inform distributors, representatives, importers, and users of non-conformity, corrective actions, recalls, withdrawals, and mandatory preventive maintenance of EHR systems with its frequency
- provide market surveillance authorities with all the information and documentation necessary to demonstrate compliance with essential requirements listed in Annex II
- establish and maintain complaint channels and registers of complaints and non-conforming EHR systems, keeping distributors informed.
