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  1. MCM Regulatory Science

Adverse Events Monitoring and Analysis Pilot Program

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This project has been completed, and this page is no longer being updated. For new project updates, visit MCM Regulatory Science.

Employing existing electronic health record data during emergency situations will help FDA monitor, assess and communicate medical countermeasure-related risks in near real-time.

Performer: MITRE Corporation (Federally Funded Research and Development Center - FFRDC)

Project leaders: Juan Arroyo, Ph.D. and Heather Hawley

Contract value: $1,419,283

Project dates: September 2013 - March 2015


In the event of a public health emergency, such as an influenza pandemic or emerging infectious disease outbreak, the FDA may expedite the availability of medical countermeasures (MCMs) by using regulatory mechanisms like Emergency Use Authorizations.

Based on the circumstances of the emergency, public health officials may need to use medical projects that have not yet been approved by the FDA, or are not approved for the situation. Although all products are tested for safety in humans before authorization for use—even in emergencies—it is still possible that safety issues could arise when product use is expanded to a larger population.

It is critical to assess how countermeasures used during emergencies perform, to inform future emergency preparedness and response efforts, optimizing resilience and recovery.

Project Description

Electronic health records (EHRs) are a valuable source of information for public health officials. FDA is exploring using existing EHR data to evaluate how medical countermeasures perform during emergencies.

This pilot study will assess the feasibility of rapidly detecting, verifying and assessing adverse events, so FDA can conduct risk-benefit analyses during emergency situations, and communicate related risk.

Project Outcomes

This project includes:

  • Querying MCM use in broad populations, identifying key EHR data, and developing algorithms for evaluation (pilot study)
  • Implementing the pilot study, including detecting and verifying adverse events within multiple EHR systems to identify trends
  • Developing processes for near real-time analysis and reporting of adverse events to FDA

The Adverse Events Monitoring and Analysis pilot project will identify gaps in the processes, infrastructure and data availability within EHR systems. FDA will evaluate these gaps to inform a strategic action plan to enhance risk management and medical countermeasure data collection during a public health emergency—an important step to improve preparedness against emerging diseases and CBRNE threats.


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