Digitization of the healthcare system: the BfArM’s contribution to the development of potential

Abstract

Digitalization is a clear megatrend of our time, also in the health sector, which is currently experiencing enormous acceleration due to the COVID-19 pandemic in addition to paving the way due to changes in the legal framework. Looking to the future, this trend will contribute to further digitalization and the merging of individual digital products, including medicinal products and medical devices, into a digital ecosystem. This will be supported by ever-shorter development cycles and technological progress. Digitization will not only strengthen patient sovereignty, but also enable more patient-centered medicine; artificial intelligence will improve and accelerate diagnoses and will contribute to a better understanding of disease patterns and underlying mechanisms or causes. In order to continue to enable innovations in the future, to focus on emerging trends, and, above all, to further improve patient safety, the BfArM is contributing in many places to transforming the opportunities associated with digitalization into possibilities – without losing sight of the risks. The following is an overview of how, for example, the expansion of the Research Data Center, activities addressing interoperability, research projects using artificial intelligence, (inter-)national cooperation, the utilization and inclusion of “Real World Data” in our benefit/risk assessments, and the evaluation of digital health and digital care applications among other activities of the BfArM contribute to “digital readiness” in Germany and Europe.