On 19 November, founders of European digital health startups Ada, Brain+, Byteflies, Disior, Tired of Cancer and Biloba came to Brussels to talk directly to policymakers and regulators from the European Parliament and Commission. 

The aim was to discuss face-to-face some of the most crucial policy topics for startups – e.g. the impact of regulations on health innovation, barriers and enablers to disruption in healthcare, market access and financing, and furthering cooperation in the sector.

The startup founders not only discussed regulations with policymakers, but also had the opportunity to brainstorm on how to move forward with health and digital regulations with key EU healthcare stakeholders. These included the European Commission’s Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs; the Directorate-General for Health and Food Safety; MSD, Johnson & Johnson and Microsoft.     

What was discussed? The necessity for more transparency and guidance in health and digital regulations, particularly the GDPR and the MDR (Medical Device Regulation) was mentioned by each single founder, and noted by MEP Wölken, who hosted the discussion. The founders and other stakeholders voiced that more harmonisation of regulations (including reimbursement systems) at the EU level could help bridge regulatory differences as well as variations in the amount of investment going into regulatory guidance at the Member State level. Another prominent topic was the need to avoid too early and too complicated regulation, through more interaction between regulators and those affected by them – startups. More dialogue, the discussants argued, could not only lead to better thought through regulation, but more access to funding and partnerships.    

And the main takeaways? More cooperation and co-creation between startups and healthcare stakeholders means more European startup champions. 

The point of convergence was that digital health products as well as regulations should first and foremost empower patients, which startups work to realise by giving patients more governance over their own health data.

The overall conclusion was that digital health startups have a proven value in improving patients’ quality of life, but need a stronger and more unified voice to demonstrate their economic value and to push for fundamental improvements in regulation. This is the aim of Allied for Startups DTx – to be the bridge between startups, policymakers and stakeholders in the European healthcare ecosystem in order to lower regulatory barriers, enhance growth and support innovation for startups. This will lead to innovate solutions for creating the healthcare of the future in Europe.

* You can read an analysis of the regulations that matter for European digital health startups here.