Increasing Accountability and Transparency for the FDA

  • Case Study
  • Application Design & Development
  • Health & Civilian

Background

The Food and Drug Administration (FDA)’s Office of Regulatory Affairs (ORA) executes FDA’s compliance and enforcement mission. In support of President Obama’s Memorandum on Transparency and Open Government, ORA sought to increase transparency around the activities it performs and associated data- enhancing the public’s understanding and awareness of FDA’s decisions, promoting accountability, and better protecting public health.

ORA needed a publicly accessible data dashboard that would make FOIA-approved health safety related information available to external stakeholders and the public. In addition to providing downloadable data, the website would need to offer drillable graphic visualizations that enabled real-time analysis of available datasets. Ultimately, the FDA hoped to:

  • Enhance its mission performance (e.g., by spotting key trends and exceptions that represent potential public health risks) and improve its data quality.
  • Promote transparency and accountability.
  • Strengthen collaborations with other public health agencies.
  • Establish more effective and consistent avenues to combine, analyze, and display large-pooled datasets.
  • Provide the public with user-friendly, digestible data, presented in a manner that allows for easy and effective use.
  • Make it easier for importers and manufacturers to meet supply-chain requirements under the Food Safety Modernization Act (FSMA).

Understanding the Need

ORA sought a cloud-based, easy-to-use, customizable, and visually accessible solution that could provide analysis, visualization, data compliance, and enforcement, as well as accountability for public data. This solution had to:

  • Complement the Open.FDA.gov site, which only provided downloading of data.
  • Aggregate and analyze data from 30+ applications covering data related to inspections, compliance actions, recalls, and imports.
  • Be accessible to over 6,000 employees at FDA headquarters, 20 district offices, more than 150 resident posts and border stations, 13 laboratories, and several international offices.
  • Address the needs of a wide range of users including the general public, FDA staff and other regulators, researchers, colleges/universities, importers and suppliers, pharmaceutical companies, and news organizations.

In addition to the right solution, ORA needed a contracting team with the right skills and delivery approach to successfully design, develop, implement, maintain, and enhance the selected dashboard and analytics solution.

5.7M
Records integrated from 12 distinct data sets and dashboards.
60%
Increase in system usage in six months.
2
FedHealthIT Innovation Awards

Our Solution

To create the optimal dashboard solution, GovCIO (formerly Salient CRGT) first conducted an in-depth analysis of COTS products best suited to meet FDA’s needs and selected Qlik. Core BI and analytics tools and technologies included Qlik Sense Dashboard, Qlik Sense Mashup, NodeJS, HTML, JQuery, Bootstrap, CSS, APIs, XML, JSON, CSV, and XLS.

Once we selected the product, we used our iterative, Agile delivery method to design, develop, test, integrate, and implement a secure, cost-effective, highly scalable cloud solution. Using an automated API for secure data exchange and interaction with external systems, our solution compiles data imports from multiple disparate systems, eliminating human error and allowing for future system growth. In addition, our team established an ETL pipeline to process data so it can be used not only within the dashboard, but also represented via Geographic Information System features. The team enhanced map capabilities by developing required geo-codes.

To create the data dashboard website, GovCIO used digital designs and a heavy emphasis on both UI/UX and mobile responsiveness to ensure proper rendering of visual elements. As part of the UI/UX work, we used Bootstrap to ensure no matter what platform and browser is used to access the data, the user experience is the same.

Our team initially deployed the dashboards and analytics solution within FDA hosted data centers. In 2020, we migrated the public-facing website to AWS GovCloud.

Applying Agile and ITIL best practices, our team continuously enhances this dashboard and analytics to improve usability, accessibility, navigation, search, and filtering with an increased emphasis on complete user experience from desktops to mobile devices. This includes:

  • Data modeling and integration for six distinct dashboards driven by 12 different data sets from distinct data sources with ~5.73M records.
  • Making dashboards more user-friendly and creating more informative data views.
  • Improving compliance of imported products.
  • Developing internal FDA websites that allow staff to search, visualize, and apply analytics to complex datasets.
  • O&M for all websites and environments.
  • Evaluating new capabilities and technologies.
  • Authoring and editing content within public-facing and internal websites.

Results

Since 2017, the FDA Data Dashboard has provided users with advanced, user-friendly analysis tools that easily transform abstract administrative data into approachable graphical forms to reveal trends and drill-down data into narrower segments. Emphasizing user experience, the site balances sophisticated functionality with simple navigation, intuitive search, and clear visualizations.

When initially launched, the dashboard included four main datasets. Soon after, in support of the Food and Safety Modernization Act, our team added FSMA Data Search module to provide a one-stop-shop tool for finding information about a given firm or supplier. Previously, users had to search multiple FDA applications to find all the information that are presented here. Between 2018 and today, we’ve added additional datasets; the dashboard currently comprises 12 total datasets.

GovCIO continues to consistently deliver and maintain this dashboard site, which has added business and safety value to the FDA, industry, and public. We have progressively expanded the public website to provide nine major data visualization subject areas, each of which provides multiple integrated and interactive visualizations that allow users to filter content such as FDA inspections, recalls, and imports.

Key positive outcomes GovCIO’s solution has delivered to the FDA include:

  • A single interface to access import food safety data- improving public access.
    • Our external dashboards feature interactive data visualizations that eliminate the need for external users to search multiple data sources by seamlessly integrating data dashboards.
  • A data dashboard site that compliments Open.FDA.gov and provides for visualization, data compliance, and enforcement, which increased system usage by over 60% in six months.
  • The creation of the Imports Entry Dashboard, which offers insight into FDA regulated products imported into the US.
  • Improved user experiences- our team gave dashboard users the ability to apply data filters, use maps, perform searches, use data tables, and exploit a “selection tool” to drill down from a chart and filter data beyond the dimensions presented in the user interface.
  • Optimized dashboard site responsiveness.
  • The use of routine health checks for database platforms and dashboards to ensure users continually have a responsive, available, and reliable method to search, filter, and report on compliance information.