Pharmacovigilance data from digital health systems: Regulations, implications, and opportunities – A TransCelerate perspective

Digital health technologies (DHTs) represent a clear potential to advance the science of pharmacovigilance and promote patient safety. A project was created to assess the current landscape for use of DHTs and identify opportunities to use DHTs in fulfilling these objectives. TransCelerate Biopharma Inc, a non-profit launched in 2012 to accelerate and enhance research of human medicines, led an assessment of digital health in pharmacovigilance focused on the global regulatory landscape. This was achieved through first identifying and forming a glossary of applicable terminology and compiling an index of related regulations, guidelines, and source materials from global health authorities. Using this information, a regulatory landscape assessment was performed, and an industry survey designed.Both outputs indicated that the use of DHTs in pharmacovigilance applications in the pharmaceutical industry is in early development stages for both regulations and real-world utilization. This insight led TransCelerate to develop a tool that would enable a robust exploration of individual DHTs used in the post approval setting through the lens of pharmacovigilance professionals, through proposed considerations for enhancing product safety. This work is intended to positively support the industry in understanding the use and impact of DHTs on pharmacovigilance and readiness.There remains an opportunity to set forth guiding principles and a framework, in collaboration with regulators, healthcare professionals, systems, and patients for DHTs to advance the science of pharmacovigilance.