The Potential Impact of Physiological Computer Models in Medicine: Regulation 
and Considerations for Ensuring Patient Safety

Richard A. Gray, PhD, Senior Research Biomedical Engineer
 Food and Drug Administration (FDA)
Wednesday, Mar 14, 2018, 12:00 pm to 1:00 pm EST 

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Computational modeling has the potential to accelerate the ongoing revolution 
in healthcare underway attributable to personalized medicine and information 

Some potentially clinically useful computer models are based on the underlying 
mechanisms of human physiology which have unique benefits, but also present 
unique challenges. The benefits are numerous and span the entire medical 
product life-cycle from design to clinical outcomes as well as regulatory 
evaluation. The challenges are also numerous and include establishing trust, 
obtaining useful data, incorporating patient variability (if necessary) as well 
as ensuring models are validated and their use doesn't endanger patients. 

This talk will begin with a brief overview of ongoing modeling efforts at the 
FDA, and then focus on a discussion of the factors and methodologies regarding 
the appropriate evaluation metrics for physiological computer models to be used 
clinically. Examples of verification, validation, and uncertainty 
quantification (VVUQ) for complex cardiac electrophysiological models will be 
presented as well as discussing methods for assessing credibility for specific 
contexts of use.

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