Dive Brief:
- The FDA is offering $1 million in grant funding for mining electronic health record data for the purpose of postmarket drug-safety surveillance.
- The agency's Center for Drug Evaluation and Research will award the one-year grant to a bidder that can develop "new analytic methodologies" that will help identify pharmaceutical-related safety issues in the FDA's Mini-Sentinel Distributed Database. The database is a pilot program with access to 178 million medical records.
- A single recipient will be announced by July 15. Applications are due June 15.
Dive Insight:
The holy grail here is safety surveillance in real time—the kind of analytics that could have caught the recent CRE outbreaks tied to duodenoscopes, including one at a Seattle hospital that caused 35 patients to fall ill and 11 to die over a muti-year period.
The recipient will support the Innovations in Medical Evidence Development and Surveillance-Methods program, which according to the grant announcement, "aims to improve the tools for conducting post-marketing safety surveillance using automated healthcare data and to foster their adoption."