H1N1 inspired FDA call for adverse reactions app

By Chris Gullo

iPhone_FDAThe US Food and Drug Administration (FDA) wants to develop a mobile app that helps it collect information and send out alerts about adverse reactions to experimental medications prescribed during public health crises. The agency realized the need for such an app during the 2009 H1N1 (swine flu) outbreak.

The need for the app became apparent while the FDA was handling 2009's H1N1 influenza outbreak. At the time, the FDA authorized the emergency use of an experimental drug called Peramivir. The only way health workers could report adverse reactions to the drug (and receive the FDA's daily communications) was through a delayed system that depended on desktop computer access. According to the agency, 10 percent of cases went unreported due to the system's inefficiency.

(During the H1N1 outbreak there were a handful of high-profile app launches. While hastily cobbled together, they did aim to keep providers and the general public informed about the much-hyped influenza.)

"FDA staff realized there were critical areas of the FDA’s implementation and communication process needing improvement in order to safely use investigational medications during national public health emergencies," the FDA wrote in the work order notice.

The FDA is seeking out an app development vendor for the project, according to a posting on a government work orders website. Applications are due by January 18th.

The selected vendor will have one year to create a working prototype of the app, which the FDA calls RAPID (Real-Time Application for Portable Interactive Devices). The prototype needs to work on  iPhone, Android, and BlackBerry smartphones, and tablet support (the FDA specifically mentioned iPads) is expected once the smartphone version is complete.

The purpose of the RAPID app, as described in the notice, is to "develop an efficient bidirectional communications system enabling FDA to fulfill its medical countermeasures (MCM) mission of providing emergency use of investigational medical products during emergent health situations using mobile devices, such as smart phones and tablets."

To that end, features of the app must include: the ability to record video and pictures of drug reactions and audio of a patient's medical history; support for viewing medical images (including X-ray and EKG); GPS functionality to track possible patterns in location for drug reactions; FDA communication to health workers through the app ("bidirectionally") to issue warnings or directions. Finally, the app must be capable of supporting 4 million of these drug reports yearly.

The FDA isn't the only government agency to create a mobile-based alert system. Last May, the FCC announced plans to launch an emergency alert system called Personalized Localized Alerting Network (PLAN), which sends alerts to only those mobile phone users in a certain designated area. Smartphones on the four major mobile carriers (Verizon Wireless, AT&T, Sprint and T-Mobile USA) will receive text messages and vibration alerts during emergency situations such as a natural disaster, AMBER alert, or terrorist attack.

You can read the RAPID app request for applications in the FedBizOpps notice here.

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