Digital health meets Europe's universal healthcare systems

Germany's DiGA pathway (DVG law) is the fastest route: demonstrate positive care effects in a 12-month trial, gain BfArM listing, and all 73 million statutory-insured patients can receive it on prescription. France's PECAN pathway and Belgium's mHealth validation pyramid offer alternatives. Most other EU countries lack a formal digital therapeutics reimbursement route, so hospital procurement or private insurance are the primary channels.

Class I software provides information for diagnosis support but does not directly drive clinical decisions. Class IIa software influences diagnosis or therapy — e.g., an AI that flags potential malignancies on imaging. Class IIa requires Notified Body involvement, clinical evaluation, and a quality management system (ISO 13485). Most AI-powered diagnostics fall into Class IIa or higher.

Yes, but under strict conditions. The EHDS creates 'secure processing environments' where approved researchers and companies can access pseudonymised data for secondary use. You cannot extract raw data; models must be trained inside the environment. Data access bodies in each member state will grant permits based on purpose, security measures, and ethical review.

Not directly for the EIC Accelerator (requires EU/EEA establishment). However, US companies can participate in Horizon Europe collaborative projects as associated or third-country partners. The practical route is to incorporate an EU subsidiary — Ireland, the Netherlands, and Estonia are popular choices — and apply from that entity.