After several trilogues, on 13 March, the Council of the EU and the European Parliament finally reached a political agreement on the European Health Data Space (EHDS). The main point of contention was the extent to which patients would be able to opt out of the system’s secondary use of data, through which startups could use anonymised (or pseudonymised) data to innovate. While the European Parliament called for all patients to have that option, the Council advocated for Member States to be the ones deciding whether patients would have that possibility. As both positions would have created opt-outs with no privacy benefit, the startup ecosystem called for a solution that would not hinder innovation. 

Unfortunately, last week’s deal leans towards the Council’s position, which advocates for opt-outs. Consequently, the text is now set to empower Member States to decide whether patients can opt-out their data for secondary purposes, with the exception of public interest research, creating further fragmentation of the Digital Single Market and barriers for health innovators. At Allied for Startups, we have always advocated for the creation of a unified framework for health data across the EU that would have facilitated the access for digital health startups to a wide range of anonymised (or pseudonymised) data, crucial for the development of innovative health solutions. If startups are not able to access and use the data available, they will not have the space to enhance their platforms, personalise healthcare and improve patient outcomes.

The provision for an opt-out mechanism for secondary purposes poses a significant challenge for startups. This is particularly worrying for startups on two different fronts. Firstly, in countries with a high inclination toward opt-outs, startups will find it difficult to navigate the space. Secondly, this creates an extra barrier to research and develop solutions to rare diseases, as an opt-out will minimise the pool of data. This agreement on the EHDS is nonetheless a significant moment in revolutionising digital health in the EU and marks both opportunities and challenges for the startup ecosystem. Now more than ever, healthtech startups will be required to adapt to this new framework. 

Moving forward, the provisional agreement has to now be officially endorsed by the Council of the EU and European Parliament, to be wrapped up prior to the EU Elections. The European Parliament’s vote is scheduled to take place during their plenary session in April. This moment in time is valuable for startups to begin exploring partnerships in public interest research, while engaging within the new landscape and advocating for a balanced approach.