DIGITALEUROPE’s Position Paper on the European Health Data Space proposal

Executive summary

DIGITALEUROPE welcomes the European Commission’s proposal for a Regulation on the European Health Data Space (EHDS), and strongly supports its objectives. The EHDS can create important harmonisation by establishing well-governed access to health data for the delivery of healthcare services, and by regulating a wide range of secondary use purposes to support better health outcomes. This could increase Europe’s capability and global competitiveness in health research and innovation, and strengthen its health systems and public health resilience.

In this paper, DIGITALEUROPE provides recommendations on possible improvements to the EHDS proposal, which correspond to challenges identified by a diverse set group of stakeholders, such as:

• The need for alignment with all relevant horizontal and sectoral European legislation, including the General Data Protection Regulation (GDPR), the Medical Devices Regulation (MDR), the AI Act and the Cyber Resilience Act. Confusion needs to be avoided with critical definitions enshrined in the GDPR, the Data Governance Act or (proposed in) the Data Act.
• The need to clarify the scope of the rights of natural persons in relation to the primary use of their electronic health data and the relation of these rights with corresponding rights under the GDPR and the Data Act.
• The need to set forth clearly the definition of an ‘electronic health record (EHR) (system)’ to avoid covering all products and services interacting with electronic health data at any point.
• The need to advance a digital single market for telemedicine services.
• The need to clarify the general conditions and the governance and mechanisms for secondary use of electronic health data.
• The need for alignment with the Trade Secrets Directive (TSD) and protection of trade secrets and intellectual property (IP) rights.
• The need to provide clarity and harmonised processes for health data access bodies by specifying requirements for data holders and data users. There is also a need to describe more clearly what is the criteria that may delay a data permit application or lead to refusal, and how specific minimum categories of electronic health data are intended to be included.
• The need to remove the proposed additional restrictions relating to international access to and transfers of non-personal data in the context of the EHDS.
• The need to avoid bottlenecks by permitting successful data sharing to continue through voluntary bilateral and multilateral agreements, which are not necessarily channelled through the EHDS.
• The need for the European Health Data Space Board to involve all stakeholders including industry representatives to leverage expertise.

The EHDS could enhance the quality of healthcare and medical innovation in Europe, and unleash much-needed investment, if policymakers can ensure regulatory alignment and consistency without eroding established legal rights and concepts. However, we caution that the EHDS by itself cannot address all data-related regulatory challenges in healthcare. The fragmentation across the EU in the interpretation and application of the GDPR, both for primary and secondary use of health data, continues to hamper research and innovation in Europe.