Evidence of positive care effects by digital health apps-methodological challenges and approaches

Abstract

Since 2020, digital health applications (DiGA) can be prescribed at the expense of the German statutory health insurance (SHI) system after undergoing an approval procedure by the Federal Institute for Drugs and Medical Devices (BfArM). DiGA can be approved provisionally for 1year (with the option of extension) or permanently. The latter is dependent on scientific evidence of apositive effect on care, which can be amedical benefit or apatient-relevant structural and procedural improvement in care. However, it is apparent that the investigation of DiGA in scientific studies is challenging, as they are often complex interventions whose success also includes user and prescriber factors. In addition, health services research data underpinning the benefits of DiGA are lacking to date. In the current article, methodological considerations for DiGA research are presented, and aselection of internal medicine DiGAs is used to critically discuss current research practice.