A digital health entrepreneur’s best skill is the ability to solve problems; from HR to accounting, finance and strategy, to finding a cutting edge-solution for a pressing health challenge. However, an entrepreneur’s vision is often curtailed by the complexity of having to navigate European health policy – which can be highly fragmented and complex. More often than not, navigating these systems takes time and resources away from what would otherwise be spent on research and innovation.

This fragmentation of health policy at the EU level is particularly evident in the collection, access and sharing of health data. Digital health startups rely particularly on access to quality health data sets, the secondary use of health data for research and innovation, and the cross-border interoperability of health data and electronic health records to bring their initiatives to the market. The lack of common standards and diverging national regulations makes innovating in the health sector extremely complex. This, in turn, prevents digital health technologies and solutions from reaching their full potential. 

The European Commission’s development of the European Health Data Space (EHDS) is a key initiative to reduce regulatory fragmentation and introduce common standards to facilitate an environment that empowers startups and other digital health innovators to scale. For this reason, it is important that digital health startup entrepreneurs participate in the development of the EHDS and have a say in EU public consultations – this allows the EU Commission to know all the critical insights of what a startup needs. 

In consultation with our members, we provided feedback along three key takeaways that are important for startups in the development of the European Health Data Space:

• Establishing a clear, harmonised framework for secondary health data sharing and re-use in the EU. Enabling interoperability and standardised, high quality datasets at the EU level and beyond is fundamental in building global health databases and exchanging information between institutions and across borders.
• Developing an EU-level framework for the reimbursements and insurance coverage of digital health products and services. Wide scale access to digital health innovations will not be achieved until public systems embrace and integrate digital health products in their reimbursement schemes. 
• Enabling more innovation & investment in AI across Europe, which underpins the need for synchronised AI legislation that provides clear and efficient pathways for startups and other innovators to scale in the EU (considering the ‘high risk’ classification of AI in health).

Digital health entrepreneurs – this is your chance to participate in the making of legislation that will directly affect you. By providing feedback in this consultation, you can ensure that the EU Commission is hearing your needs! At Allied for Startups, we are ready to provide you with the expertise and knowledge to help you navigate this consultation. Don’t hesitate to reach out should you have any questions!

Read our position on the EHDS here and you can find the link to the public consultation here.

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