What is the EHDS?
The European Health Data Space (EHDS) is a key component of the European Health Union and the first sectoral EU data space.
The EHDS is intended to give individuals more control over their health data, but also to facilitate cross-border data exchange “for the purpose of providing health services”. It also aims to create a single market for electronic health record systems and a secure environment for research, innovation and regulation. The regulatory basis of the EHDS is formed in particular by existing EU legal acts such as the GDPR, the Data Governance Act, the Data Act, the Network and Information Systems Directive, but also the MDR and IVDR. These overarching frameworks encompass regulations, including safety measures, that also apply to the health sector. However, given the particular sensitivity of health data, the EHDS is supplemented by additional, sector-specific provisions. After the EU Commission already published a proposal for a regulation on the European Health Data Space (EHDS Regulation) in May 2022, the two other EU legislative actors, the EU Parliament and the Council of the EU, have adopted the new regulation on the EHDS. The regulation will now be formally signed by the Council of the EU and the EU Parliament and will enter into force 20 days after its publication in the Official Journal of the EU.
Opportunities and risks of the EHDS for manufacturers of medical devices and IVDs
The EHDS addresses commercial enterprises with the following promise: “You will benefit from the greater availability of electronic health data, enabling the use of data for applied research and innovation”.
For the medical technology industry, it is crucial that the secondary use of health data also includes product developments that can potentially contribute to public health. Article 53(1)(a) of the EHDS Regulation in its current version makes it possible to do just that: The access points for health data grant […] access to data for secondary use when there is a public interest in the area of […] public health monitoring or activities to ensure high quality and safety standards of health care, including patient safety, as well as medicines or medical devices. In the field of scientific research that contributes to the assessment of health technologies or ensures a high level of quality and safety of healthcare, medicines or medical devices, secondary use is also envisaged for training, testing and evaluation of algorithms, including in medical devices, IVDs, AI systems and digital health applications. The use of data for new product developments and improvements is not limited to medical software and AI-based medical devices, but also includes analogue medical devices.
The fact that medical devices, IVDs and AI systems will receive further additional regulation with the EHDS, which must be harmonised with existing regulations, could have a disadvantageous effect. In addition, it must be ruled out that no information relating to trade secrets or intellectual property of companies is used for secondary data use.
Conclusion and recommendation for action
The EHDS promises an innovation boost for the healthcare industry, but it entails increased regulatory requirements. While manufacturers can benefit from simplified data access and secondary use of data on the one hand, there is a risk of a certain overregulation on the other, which could intensify competition due to open data, compromise intellectual property and thus possibly slow down investments in new medical technologies.
Companies should therefore proactively deal with the new requirements and include them in their compliance strategy at an early stage. Once again, the following applies: Compliance with the MDR or IVDR alone is not enough. Continuous analysis and observance of all legal framework conditions is essential to achieve 360° compliance.