Relation extraction from biomedical text is important for clinical decision support applications. In post-marketing pharmacovigilance, for example, Adverse Drug Events (ADE) relate medical problems to the drugs that caused them and were the focus of ...
BACKGROUND: Vaccine safety surveillance is important because it is related to vaccine hesitancy, which affects vaccination rate. To increase confidence in vaccination, the active monitoring of vaccine adverse events is important. For effective active...
UNLABELLED: was to develop a methodology for conducting post-registration clinical monitoring of software as a medical device based on artificial intelligence technologies (SaMD-AI).
Adverse drug reactions are a common cause of morbidity in health care. The US Food and Drug Administration (FDA) evaluates individual case safety reports of adverse events (AEs) after submission to the FDA Adverse Event Reporting System as part of it...
INTRODUCTION: The accurate identification and timely updating of adverse reactions in drug labeling are crucial for patient safety and effective drug use. Postmarketing surveillance plays a pivotal role in identifying previously undetected adverse ev...
IMPORTANCE: The Sentinel System is a key component of the US Food and Drug Administration (FDA) postmarketing safety surveillance commitment and uses clinical health care data to conduct analyses to inform drug labeling and safety communications, FDA...
Technology and health care : official journal of the European Society for Engineering and Medicine
40105179
BackgroundHealthcare institutions throughout the world rely on medical devices to provide their services reliably and effectively. However, medical devices can, and do sometimes fail. These failures pose significant risk to patients.ObjectiveOne way ...
Technology and health care : official journal of the European Society for Engineering and Medicine
40105162
BackgroundAnalysis of data from incident registries such as MAUDE has identified the need to improve surveillance and maintenance strategies for infusion pumps to enhance patient and healthcare staff safety.ObjectiveThe ultimate goal is to enhance in...
European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences
39419129
The advent of artificial intelligence (AI) has catalyzed a profound transformation in the pharmaceutical industry, ushering in a paradigm shift across various domains, including drug discovery, formulation development, manufacturing, quality control,...
Journal of the American Medical Informatics Association : JAMIA
39471493
OBJECTIVES: Traditional methods for medical device post-market surveillance often fail to accurately account for operator learning effects, leading to biased assessments of device safety. These methods struggle with non-linearity, complex learning cu...