Market entry of digital health providers after the introduction of a new reimbursement pathway

Digital therapeutics are increasingly used to complement traditional health care. In a pioneering move, Germany became the first country to introduce a structured regulatory framework — known as the DiGA scheme — that enables developers of digital therapeutics to be reimbursed in the statutory health insurance system. Our study evaluates the impact of this novel regulation on the development and market entry of patient-centered digital health applications. Using a panel dataset of app availability by language and month from the Apple App Store, covering the period from January 2018 to September 2021, we compare trends in health app availability in German to those in other languages. Applying event study designs and a set of synthetic control methods, we find that the DiGA regulation likely stimulated the development of German-language digital therapeutics in the app market. While the number of apps increased, our results suggest that neither the diversity of health conditions targeted nor the number of high-quality apps expanded significantly. To the contrary, the increase was almost exclusively driven by apps that sell patient data for advertisement. This suggests that the initial enthusiasm surrounding the new reimbursement pathway did not translate into a broad increase in high quality apps with strong data privacy protections. Further research is needed to assess the longer-term effects on innovation and quality, especially as other countries begin to adopt regulatory frameworks inspired by the German model.