FDA Partners With Captricity On Drug Safety Backlog


In June, the U.S. Food and Drug Administration (FDA) posted an alert noting that there was a backlog of paper reports submitted to FDA’s Adverse Event Reporting System (FAERS). FAERS is a new FDA database that contains reports from the public, health professionals, and industry on drug side effects and medication errors associated with marketed drugs. At the time, the agency said “unforeseen issues,” in data entry operations slowed down processing of these reports.

Reports can be submitted to the FAERS system by fax, by mail, or online, and come in a variety of formats. Some of them are handwritten, others are typed, and the submissions also come in varying levels of quality. FDA currently receives about 900,000 adverse event reports every year. For those reports submitted electronically, processing is straightforward. For those that come in over fax or by mail, processing takes a lot longer. These issues were exacerbated by the recent government shutdown and budget cuts.

FDA brought on additional data entry professionals in June to handle the backlog, and instituted a triage system – prioritizing entry of the most critical reports. Over the course of the year they also tested and partnered with Captricity, a data capture company that provides a SaaS solution to digitize handwritten documents. FDA’s Chief Health Informatics Officer, Taha Kass-Hout spoke of the partnership this morning at Amazon Web Services re:Invent in Las Vegas, Nevada.

Captricity is a SaaS solution that allows users to create user defined spreadsheets from handwritten items by scanning them in and essentially telling the spreadsheet what it should pull out of the document.  The resulting spreadsheet presents the same data as the document in a machine readable format. An API is also available for the data, making it of use to developers. The company offers the service in two models – a web-based self-service option or a full scale option that will sort and create spreadsheets from whatever is scanned in on its own. Captricity emerged from Code for America, and is also working with some state and local governments to digitize records.

“When we started working with FDA we were able to let them test the service and move into security review inside of a few weeks, which was a very rapid timeline for a federal project,” Kuang Chen, CEO and Founder of Captricity, tells CivSource. “Since then the FDA has reduced its backlog to zero.”

Captricity has already beat some of the obvious hurdles, it is HIPPA compliant and can thus deal with sensitive personal data. Through its work with FDA, and backing from the agency, they have achieved an authorization to operate (ATO) within the FDA based on FedRAMP moderate security protocols. Captricity’s user data is also stored on Amazon’s FedRAMP compliant clouds. Achieving that milestone, will be important for other civic startups looking to work with agencies on mission critical issues. “Everyone is crowding into FedRAMP compliance right now, I think what really helped us was having an agency sponsor,” Chen notes.

Beyond security, procurement was also a big challenge for the partnership. Like other SaaS offerings, Captricity offers tiered subscription models largely based on usage or projected usage. “There are a variety of procurement vehicles available to an agency like FDA, but really none of them are prepared to handle a SaaS subscription model. We had to work on crafting a pricing agreement that would fit into those procurement rules. We’re still working with procurement issues in order to offer pricing that makes sense, as well as getting on the GSA schedule. This wasn’t really something we’d ever planned for, but the opportunity set is significant enough that it made sense to start digging in,” Chen says, highlighting a common problem for civic startups new to the procurement machine.

Some agencies, and a few companies, are working on an app-store-like option for federal procurement that would be able to handle common SaaS subscription models, but that may take awhile to appear in the GSA schedule. In the interim, Captricity’s smallest tier is well within discretionary spend boundaries for agencies or departments that want to try a small internal pilot. Chen explains that offering this has been helpful with getting public sector clients into the service.

“We’ve had a lot of support from the FDA’s CHIO and CIO, which was helpful throughout the process, getting top level support is important,” he says. “We’re really excited to be working with FDA and we hope this can be a proof-of-concept for other agencies with similar backlogs.”