What the German DiGA pathway means for digital diagnostics.

Germany was the first country to build a national route for prescribing and reimbursing digital health applications. Under the framework run by the Federal Institute for Drugs and Medical Devices (BfArM), an application that clears the evidence and safety bar can be listed and reimbursed by statutory insurers.

For a diagnostics platform, that bar is set by clinical evidence. It is the reason our 3.000-patient trial is designed against DiGA requirements from the first day of data collection, rather than retrofitted afterwards.

A listing is our objective, not a current status. The pathway is open, the requirements are public, and the work between here and there is the trial.