Dive Brief:
- The FDA has announced plans to use EMRs to find risk factors associated with adverse events in drug use; the data would help the agency determine which drugs might require warnings about appropriate use.
- Right now, consumers and health providers to report drug side effects to the FDA voluntarily, but there are problems with this approach, in that some adverse side effects do not show up immediately, and that the forms' complexity leads to inaccurate or incomplete reports.
- To address these concerns, the FDA is seeking a partner to develop a database of de-identified EMR information which would allow the agency to assess risk factors such as health history, drug use, hospitalizations and demographics; the database will include electronic medical records of at least 10 million U.S. residents.
Dive Insight:
It's hard to argue that the FDA could stand to have more information on board about drug side effects and adverse events. And digging into EMRs may be the best way to gather such data quickly and effectively. But there is one hitch. When you're dealing with information as sensitive as medical records, there's always the worry that de-identified data will get re-identified, possibly on a catastrophic level. Let's see how the FDA handles objections in that arena.