Tech

FDA sets 18-month deadline for mobile, automation plans

It's part of an agencywide "sprint" called for by recently nominated Food and Drug Administration Commissioner Dr. Robert Califf.

By Whitney Blair Wyckoff

October 22, 2015

The Food and Drug Administration’s chief information officer is giving himself a year and a half to get new mobile devices to the agency’s inspectors and automate their antiquated paper-based report filing system.

In the next 18 months, CIO Todd Simpson told FedScoop, he plans to put “a fully backed solution in production” to advance mobility through a “choose your own device,” or CYOD, program, and digitize and automate field inspection documents. Simpson said he set the milestone after recently nominated FDA Commissioner Dr. Robert Califf called during his ongoing confirmation process for agency leaders to set goals as part of an agencywide “sprint.”

“I’ve committed to him that these are the things that, [when you get to be] commissioner, you can expect to see because they’re going to fundamentally change the FDA,” Simpson told FedScoop. “And that’s what he’s all about.”

But Simpson’s interest in making the agency more mobile isn’t new. Not long after Simpson joined FDA in May, he told FedScoop that mobility would be a priority. In July, he shadowed an FDA inspector who struggled to juggle all the notebooks and tools she needed to do her job.

As it stands, the inspection system is paper-based, he said: Inspectors take notes in a notebook, take pictures with a camera and then file a paper report. The inspected facilities are supposed to receive a copy of that report — they sometimes don’t — and they often stow it away in a file folder.

“We’re taking that paper process and burying it inside of a Web form,” he said. With this new system, if “I hit the submit button, it builds the report, it fires the report to the approved parities, the people that need it, it archives it, the whole system.”

For its CYOD program, the agency selects a handful of smartphone products from which employees may choose their government-issued device. So far, they’ve issued iPhones and plan to soon deploy Androids. As part of the sprint, Simpson also plans to focus on other topics like cloud services, precision medicine and digitizing the agency’s paper warehouses as well.