FDA creating mobile app for use during public health crises

February 25, 2012

Prompted by the 2009 H1N1 influenza outbreak, the U.S. Food and Drug Administration (FDA) plans to create a mobile app to help it gather information and send out alerts about adverse reactions to experimental medications prescribed during a public health crisis.

» FDA creating mobile app for use during public health crises

Prompted by the 2009 H1N1 influenza outbreak, the U.S. Food and Drug Administration (FDA) plans to create a mobile app to help it gather information and send out alerts about adverse reactions to experimental medications prescribed during a public health crisis.

While the FDA was responding to the H1N1 outbreak, it issued an emergency use authorization (EUA) for the investigational antiviral drug peramivir (BioCryst) intravenous in certain adult and pediatric patients with confirmed or suspected 2009 H1N1 influenza infection who were admitted to a hospital. The only way health workers could report adverse reactions to the drug (and receive the FDA's daily communications) was through the Medwatch system, which depends on desktop computer access.

Although the initial program the FDA seems to want to develop is limited to public health crises, it could conceivably someday be expanded to more general adverse event reporting by the public, according to Leskin.

"The FDA is recognizing the difficulties and inefficiencies in the current reporting system," she says. "These same issues are present in the nonemergency current adverse event reporting system. It is not a far leap to believe that if the app is seen as successful in 'crisis' situations, the FDA could expand it to all adverse event reporting."

» Doctors' views of HIT vary with age

Physicians worldwide older than 50 who do not actively use health information technology (HIT) fail to see the benefits as much as their younger colleagues, according to survey results from the consulting firm Accenture.

The company surveyed more than 3,700 doctors across eight countries. Most agreed that computerization provided better access to quality data for clinical research (70.9%), improved coordination of care (69.1%), and a reduction in medical errors (66%).

More than 72% of doctors younger than 50 said they believe that electronic health records (EHRs) and health information exchanges (HIEs) will improve care coordination across settings and service boundaries. Seventy-three percent believe those technologies will offer better access to quality data for clinical research. Among doctors older than 50, however, 65% and 68%, respectively, perceive the same benefits.

High percentages of physicians reported a negative effect, no effect, or an unknown effect of HIT on reducing unneeded procedures (43.6%), improving access to services (43%), or improving patient outcomes (39.2%).

U.S. physicians were critical of EHR systems and HIEs. The United States had the lowest number of doctors (45%) who think HIT will improve diagnostic decisions, compared with 61% globally. Just 45% believe that technology improves health outcomes for patients, compared with a survey average of 59%. Only 47% of U.S. doctors report that HIT has helped improve quality of treatment decisions-compared with 61% globally.