Pharmacovigilance and Regulatory Affairs

Adverse Event Reporting through Mobile Health Tools

Mobile health (mHealth) technologies are revolutionizing adverse event (AE) reporting by enabling real-time, patient-driven data submission. Apps, SMS services, and wearable devices offer convenient, accessible platforms for capturing and transmitting AE information, particularly in remote or underserved regions. This digital shift enhances the timeliness, granularity, and volume of safety data collected across the product lifecycle. Patient-reported outcomes captured via mobile tools often provide richer context than traditional channels, including symptom severity, treatment adherence, and quality of life. Integration with electronic health records and centralized safety databases enables seamless data flow and analysis. Mobile interfaces also allow healthcare professionals to report AEs efficiently at the point of care. Ensuring data accuracy, privacy, and regulatory compliance remains crucial. Systems must align with global standards such as GVP, HIPAA, and GDPR. Additionally, user-friendly design and patient education are key to encouraging adoption. As digital health becomes embedded in pharmacovigilance, mobile tools will play a central role in democratizing drug safety reporting and enhancing signal detection capabilities.