The European Commission’s proposed European Health Data Space (EHDS) is set to transform health systems in the European Union (EU), offering a wide range of opportunities for research, innovation and policymaking. The EHDS is a health ecosystem comprising of two digital infrastructures: an EU-wide infrastructure to store, access and control patients’ health data to facilitate cross-border access to healthcare; and an infrastructure providing health data for research and development, policymaking, and regulatory activities. In the context of transatlantic relations – critical in light of the covid-19 pandemic – can the EHDS be leveraged to increase the competitiveness of the EU life sciences market while increasing EU-US cooperation?  

European stakeholders have emphasised that trust is a fundamental enabler for the EHDS’ success. If patients and healthcare professionals lack trust in the personal data protection and security of the EHDS infrastructures, as well as the anonymity of data for secondary use, it will significantly inhibit the use of the data space. The proposal currently encompasses access to health data for secondary use by third countries, including companies operating in third countries, on a case-by-case basis. However, the distrust of a number of Member States towards US attitudes to data protection could hinder access to this health data pool by the U.S. government and businesses.  

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U.S.-based businesses have already faced some issues entering the EU health data. Most notably, France is moving its Health Data Hub, on which the EHDS is mirrored, from Microsoft Azure to a national-based cloud stating that data may only be held in a trusted entity, away from the potential eyes of security agencies. These concerns regarding the safety and security of stored patient data have also been increasing amid cyber-attacks and data breaches at healthcare facilities, further limiting investment and market entry opportunities for U.S.-based businesses.  

However, if the EHDS is implemented in an effective harmonised manner, visibly improving care access and control over patient data, it could increase citizens’ trust in the data infrastructure proposed, simultaneously raising the quality and quantity of data for secondary use for research and innovation. This could then offer significant opportunities for EU- and US-based businesses – if the pool of secondary data will be accessible to third countries - in terms of research and innovation, increasing the competitiveness of the EU life sciences market. EU and US governments could also leverage the EHDS for their recently signed cooperation arrangement on preparedness and response to (emerging) public health emergencies. Thus, if the EHDS is a notable success for patients and businesses alike, it may help move the EU and US beyond data sharing issues and focus on mutual economic advantages and promoting public health.