COCIR welcomes the much-awaited European Commission’s proposal for the European Health Data Space (EHDS). This initiative in the context of the European Data Strategy is key for delivering modern, innovative, and patient-centric healthcare.
Despite the rapid rise of virtual care and increased data sharing in the wake of COVID-19, digital transformation of healthcare across the EU has been slow as barriers to adoption of digital health technology in hospitals and healthcare facilities remain. Access to data and data systems’ interoperability are the cornerstone of this digital transformation of healthcare in EU member states. The released proposal for the EHDS aims to address the barriers in a systemic manner. The proposed process of the single health data space creation on the EU level should lead to a fair, balanced, and efficient framework to support the ambitious goals of the EU Data Strategy for Healthcare.
COCIR has always been very supportive of the Commission’s goals and intentions for the EHDS. We advocate for a patient centric pursuit of clinical excellence and safety, clear governance mechanisms and secure processing environment allowing researchers and innovators to access relevant health data to develop products and services for better diagnosis, treatment, and well-being of individuals. The EHDS will make a significant contribution to the European innovation capacity in healthcare and support the Commission’s pursue of “modern, responsive and sustainable health systems”1 in the EU.
To ensure effective implementation of the proposed regulation, the following areas should be carefully assessed:
First, potential overlaps of the EHDS with the recently proposed Data Act and the existing medical device legislation should be addressed to ensure legal clarity and certainty for both manufacturers and the end users and to avoid unnecessary additional costs to develop and use digital products and services.
Second, the interplay between the GDPR and the EHDS will have to be clarified when it comes to processing of personal data and in particular personal health data.
Third, the proposed requirements for conformity assessment of EHR systems and products claiming interoperability with EHR systems should be carefully assessed regarding their practical implications for developers and added value for healthcare systems.
COCIR, along with its members, looks forward to working with the EU institutions during the legislative process. We are ready to share our technical expertise to support the best possible healthcare for EU citizens and promote the European Union’s competitiveness in the global health technologies market.
1. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52011XG0708(04)