AI Integration in EHR-Based Pharmacovigilance: A Comparative Study of Germany and Egypt

Introduction: Pharmacovigilance (PV) depends mainly on traditional reporting as a main source of data. This research will focus on another source, namely EHRs (electronic healthcare records). As we deal with big data from EHRs, AI (artificial intelligence) tools will be indispensable for the processing, and analysis of data and the early detection of ADRs (adverse drug reactions) from EHRs. In this research, we will explore the knowledge, attitudes and practices (KAPs) of the experts regarding the current application of AI in EHR-based PV, the potential benefits of implementing these technologies in PV, and the challenges toward their implementation in Germany and Egypt. Methodology: A semi-structured survey of 30 questions that targeted the attitudes, knowledge and experience from PV experts (172 responses) was conducted. Results: The results revealed that most PV companies in Egypt or Germany do not use EHRs as a main data source. This can be attributed to the lack of the application of EHRs in Germany and Egypt (e.g. EHRs in Germany is in a very early phase). Most of the PV organizations in both companies do not use AI as well in their PV activities. There is also a lack of proper adherence to data protection regulations in Egypt. However, the participants in both countries show a very positive attitude toward the adoption of AI and EHRs in the PV. Conclusion: AI technologies and EHRS in the domain of PV are very rarely applied either separately or collectively in both countries, there is also a lack of knowledge among PV specialists about Digital Health but there are positive attitudes toward its adoption.