Trends and Anticipated Developments

Digital health solutions are undeniably transforming European healthcare systems, but not as quickly as their developers would like. The diversity of healthcare system structures, financing models and regulations - as well as increasing scrutiny from payers, providers and physicians - means that companies seeking reimbursement from nationwide healthcare systems will need to invest significant time and effort to demonstrate the patient benefits and effectiveness of their digital treatments.

The COVID-19 pandemic has accelerated the development and adoption of some digital health solutions. More and more European countries are following Germany's lead and creating dedicated HTA processes for digital health solutions. Although there is trial reimbursement for digital health solutions for which full proof of benefit has not yet been established, rapid market introduction will not be possible on a regular basis. Early dialog with HTA authorities and careful and early trial planning is critical to successfully bring a digital health solution to European markets.