“The Food and Drug Administration (FDA) yesterday issued a Request for Quotation (RFQ) for a large-scale electronic health record (EHR) system. This RFQ is very important as the objective is to develop a platform to support a critical project by the FDA’s Division of Bioinformatics and Biostatistics (DBB) “to conduct research to assess the safety and surveillance of FDA regulated products through the FDA adverse event reporting systems…” The project requires “use of the large electronic medical record (EMR) system…” Adverse drug reactions are one of the leading causes of death in the US, thus finding which drugs cause negative interactions is of vital importance. The project is going to leverage the largest, most comprehensive, and clinically relevant medical records database, that of the US Department of Veterans Affairs (VA).”
“In other words, the FDA is going to be leveraging the extensive database created over decades by the VA through their treatment of Veterans to study adverse drug reactions…”
“That the FDA is singling out the VA and VistA as the kind of large-scale EHR for the project because of the quality and relevance of the data. FDA’s approach is part of the extraordinary shift in software strategy that has taken place at FDA over the past several years…”
“According to the FierceBiotech article “That same ethos, which began percolating through the government when open-source advocate Beth Noveck took up a position at the White House in 2009, is central to precisionFDA. People in positions to influence decisionmaking at the FDA have become increasingly convinced of the value of an open ethos…” Read the full blog here.
Source: FDA Issues RFQ for Large Scale EHR Study – To Leverage VA’s Open Source VistA EHR Database for Research – By Roger Maduro, May 2, 2018. Open Health News.
