The abundance and speed of software development have brought new challenges and opportunities to healthcare. It is hard to imagine modern healthcare without software in different forms — in digital devices as well as standalone software, known as Software as a Medical Device or SaMD.While the unique features of SaMD make it difficult to define such medical devices, to assess their safety as well as to set up the rules for reimbursement, these steps are necessary to give patients access to these modern technologies.In Europe, only a few countries are currently advanced in terms of setting up reimbursement policies for SaMD. Germany and Belgium are the pioneers in this space: Germany with its Digital Healthcare Act Fast Track platform, and Belgium with its mHealthBELGIUM platform. France and the UK are also among the leaders, with France having a PECAN fast-track market access pathway system similar to the German one, and the UK system being de-centralized, with local developed solutions for reimbursement. Other European countries are also taking steps towards reimbursement of digital healthcare and working to adopt innovations in the reimbursement domain developed by the leaders.