Posted by Michael Wonder on 09 Jan 2019
The future of FDA's electronic safety surveillance
9 January 2019 - The U.S. FDA is an information-driven agency that requires robust data to make regulatory decisions.
One of our key obligations is to analyse large quantities of data related to the safety and effectiveness of medical products; and turn these signals into information that can help patients and providers make more informed decisions. Maximising the benefits of today’s sophisticated arsenal of FDA-approved medical products requires an equally advanced set of tools for collecting this data, and evaluating it, as a way to monitor and inform about the safety of these new innovations.
One of the most important of those tools that we use to advance these efforts is large-scale electronic safety surveillance: the ability to access and analyse data across millions of patient experiences with the medical products they use – while protecting the privacy of individual health care records.
