I. Background
On 19.02.2020, the European Commission presented the European data strategy. Not least due to the experiences during the COVID-19 pandemic, the creation of a European Health Data Space was seen as a top priority. On 03.05.2022, the European Commission published its first framework for such a Union-wide, sector-specific data space with the proposal for a Regulation on the European Health Data Space (COM (2022) 197 final). The initiative was already adopted and approved by the EU Parliament on 24.04.2024.
With the publication of the EHDS Regulation in the Official Gazette of the EU the Commission has also published extensive FAQs (Frequently Asked Questions on the European Health Data Space).
II. Aim of the EHDS
The aim of the EHDS Regulation is to strengthen the interconnection of national healthcare systems through the secure and efficient exchange of health data for primary and secondary use:
- Chapter II of the EHDS Regulation on primary data use grants individuals access and control to their electronic health data
- Chapter III on EHR systems (electronic health record systems) is aimed at manufacturers and other economic operators providing EHR systems on the market and, as a CE legal act, sets out requirements for EHR systems in terms of interoperability and logging functions.
- Chapter IV on secondary data use creates obligations for holders of health data to make data available and specifies how users of health data can use this data. It provides the necessary infrastructure and Health Data Access Bodies (HDABs).
- Other chapters deal with governance, international aspects and other horizontal issues.
III. Primary use
Primary use is regulated in Chapter II of the EHDS Regulation (Art. 2 para. 2 lit. d) as “the processing of electronic health data for the provision of healthcare, in order to assess, maintain or restore the state of health of the natural person to whom those data relate, including the prescription, dispensation and provision of medicinal products and medical devices, as well as for relevant social, administrative or reimbursement services”.
EU citizens (natural persons) should have access to their electronic health data – especially across borders. Member States shall set up access services for this purpose (Art. 14 EHDS Regulation).
The most important innovation in this context is the right of patients to object (opt-out) to access to their health data both by healthcare professionals for primary use and by other authorized parties for secondary use. In Germany, such an opt-out is being implemented in the electronic patient record (ePA).
IV. Secondary use
According to Art. 2 para. 2 lit. e EHDS Regulation, secondary use means “the processing of electronic health data for the purposes set out in Chapter IV of this Regulation, other than the initial purposes for which they were collected or produced”. According to Art. 53 EHDS Regulation, this includes the following purposes:
- Public interest in the area of public health
- Policy-making and regulatory activities
- Development and innovation activities for products or services in the field of healthcare
- Educational or teaching activities in the health or care sector
- Scientific research
- Improvement of care, optimization of treatment and healthcare provision
This enables secondary use, in particular for commercial research, such as product development or data use for training AI-supported medical devices. The EHDS Regulation obliges health data bodies to provide certain minimum categories for the secondary use of data. Natural or legal persons can obtain access to health data (Art. 67 EHDS Regulation). An application must be submitted to an access point for this purpose. The request will be granted if the high legal requirements for data protection are met and the specified purposes are fulfilled (Art. 68 EHDS Regulation).
V. EHR systems
From a product law perspective, the conformity assessment and CE marking of so-called EHR systems (electronic health record systems) within the meaning of Art. 2 para. 2 lit. k) EHDS Regulation should be mentioned in particular.
The term EHR system (electronic health record system) means “any system whereby the software, or a combination of the hardware and the software of that system, allows personal electronic health data that belong to the priority categories of personal electronic health data established under this Regulation to be stored, intermediated, exported, imported, converted, edited or viewed, and intended by the manufacturer to be used by healthcare providers when providing patient care or by patients when accessing their electronic health data”.
In order to be made available on the market or put into service in the Union, EHR systems must contain two harmonized components:
- Interoperability component
- Logging component
In future, EHR systems will be subject to CE product law and the concept of economic operators in accordance with Art. 25 ff. EHDS Regulation, EHR systems will be subject to CE product law and the concept of economic operators. Art. 27 EHDS Regulation regulates the practically important interface to the Union harmonization legislations for medical devices, in-vitro diagnostics and high-risk AI systems within the meaning of the AI Regulation.
For wellness applications within the meaning of Art. 2 para. 2 lit. ab) EHDS Regulation, Art. 47 ff. EHDS Regulation now also provide for mandatory requirements for interoperability with EHR systems. Manufacturers of EHDS systems and wellness applications as well as other relevant economic operators should prepare for the upcoming product law requirements at an early stage. The overlaps and additional requirements for digitalized medical devices and IVDs are also evident.
VI. Date of application
The Regulation shall enter into force 20 days after its publication, i.e. on March 26.03.2025, and shall generally apply from 26.03.2027, in accordance with Art. 105 EHDS Regulation. In exceptional cases, transitional periods of four, six and ten years shall apply. For EHR systems in particular, graduated transitional provisions apply in accordance with Art. 105 para. 3 and 4 of the EHDS Regulation, which take effect from March 2029 and March 2031 respectively.
Do you have any questions about this news or would you like to discuss it with the author? Please contact: Prof. Dr. Boris Handorn and Anna Christ
