Modernizing FDA’s Information Technology

By: Eric D. Perakslis, Ph.D.

As I look back at my first year as chief information officer and chief scientist (informatics) at FDA, I am gratified with all of the progress that has been made. But I am also eager to transform initial wins into consistent and sustained success.

My team at the Office of Information Management (OIM) manages and advances information technology at FDA. Our mission is to provide the organizational structure and services that allow the exchange of information, communication and knowledge that enhance and sustain FDA’s ability to protect and promote the public health.

Our vision is that FDA’s technology and knowledge capability is modern, secure, accessible, cost-effective, and exceeds customer and partner expectations.

Some of our early successes include important contributions to what we call the Innovation Pathways 2.0 initiative, which provides a rapid new way to submit breakthrough medical devices to FDA for approval. This in turn would get such products faster to the patients who need them.

OIM also completed 20 projects in very short time in support of the Food and Drug Administration Safety and Innovation Act (FDASIA), signed into law by President Obama in July 2012. Many of these projects strengthen the process of reviewing and approving important new medical products, while making that process more transparent to the tax-paying public.

In addition, this year we launched a new strategic effort to improve the overall “customer experience” with FDA’s information technology, customers in this case being FDA employees stationed all over the world. Our goal is to provide the technology to ensure that FDA employees can reliably perform their daily duties efficiently and timely regardless of location, whether they’re in an office or in the field, or at home working remotely.

And our improvements to the process of analyzing the health risks presented by medical products of all kinds have helped drive the modernization of the FDA inspection process. This helps ensure that the growing number of products we regulate have a higher level of safety and quality before they reach American consumers.

While these accomplishments are significant, there is still much to be done to modernize information technology at FDA.

The new FDA Information Management Strategic Plan sets the path forward. Its priorities include strengthening real-time connectivity and access to key data and information. This is essential for daily FDA operations and for our connections to the public we serve and to our many partners outside of the agency who depend on FDA for the execution of their own public health missions.

The Strategic Plan also focuses on the availability and usability of data essential to the speed and efficiency of decision-making at FDA. The intent of this goal is to facilitate a learning and knowledge network that will enable FDA to assess the potential risks of regulated products on a scale that routinely handles global sources and large volumes of data. 

Going forward, we will do our best ensure that FDA’s technological needs today and tomorrow are fully covered and in place. There is no more inspirational public health mission than that of the FDA. Every citizen of this great nation depends on us every day and we will never forget that. In many ways this Strategic Plan is as much about what we believe, and our commitment to our customers and mission, as it is about what we deliver.

Eric D. Perakslis, Ph.D., is FDA’s Chief Information Officer and Chief Scientist for Informatics