As new health data is created every second in the EU through the digitalization and interconnectedness of the healthcare sector, it is crucial that the health industry and innovators in the EU can turn the continuously generated health data across Europe into knowledge for EU citizens and for the better prevention, diagnosis and treatment of diseases.
Health data reuse is estimated to be worth around EUR 25-30 billion annually and it is expected to reach around EUR 50 billion within 10 years1. However, the complexity and fragmentation of rules, standards and processes in the EU makes it difficult to easily access and share health data. This creates barriers to healthcare delivery and innovation, leaving patients unable to benefit from its potential. To tap into the potential and to solve the existing problems, the European Commission launched the proposal for a Regulation for the European Health Data Space (EHDS) in May 2022. The EHDS is the first sectoral data space and it builds on the Data Act and the Data Governance Act.
The proposal introduces, amongst others, a new regulatory framework under which the so-called “data holder” need to make a wide range of electronic health data available to “data user” for research and innovation purposes. The term data holder is defined widely and will include most hospitals, public health bodies as well as pharma and medtech companies. On the other hand, the data users can be public, not-for-profit or private care providers, organisations, associations or other entities that perform research relating to health. The electronic health data in question goes far beyond the concept of “health data” under the GDPR and will include, e.g., clinical trial data, data from medical devices and wellness applications and data on matters that effect one’s health, such as professional status, education and lifestyle.
The permit to use the anonymised health data in a closed, secure environment will be granted by the national health data access body if the purpose of use is one of the permitted ones listed in the draft regulation. From an industry point of view, the following purposes will likely be of use:
- development and innovation activities for products or services contributing to public health or social security, or ensuring high levels of quality and safety of health care, of medicinal products or of medical devices; and
- training, testing and evaluating of algorithms, including in medical devices, AI systems and digital health applications, contributing to the public health or social security, or ensuring high levels of quality and safety of health care, of medicinal products or of medical devices.
The EHDS will, in essence, mean that both public and private entities will be obliged to make data available for secondary use. Industry players will have access to and benefit from the greater availability of health data that they can use to, for instance, test and train their AI. This does, however, come with a flipside as organisations face being compelled to hand over potentially valuable datasets to competitors. The EHDS specifies that data containing trade secrets shall be made available, but confidentiality should be preserved. It is not clear what trade secrets mean in the context of digital health data or how the confidentiality will be ensured in practice.
The aim of the EHDS is to enable the EU to make full use of the potential offered by a safe and secure exchange, use and reuse of health data, without the existing obstacles2. Undoubtedly, action in the area of improving the exchange and use of electronic health data is necessary. At this point in time, the legislative work is still in progress and the final outcome is yet unclear. The Commission hopes that by the end of its current mandate on 31 October 2024, the legislative process will be completed, with the EHDS operational in 2025. However, the level of digitalization of healthcare in different EU member states is varied and the EHDS may take longer than expected to become operational.
1 Communication from the Commission to the European Parliament and the Council, A European Health Data Space: harnessing the power of health data for people, patients and innovation, COM(2022) 196, 26.2.2023
2 Communication from the Commission to the European Parliament and the Council, A European Health Data Space: harnessing the power of health data for people, patients and innovation, COM(2022) 196, 27.2.2023