U.S. Department of Health and Human Services (HHS)

The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices and by ensuring the safety of our nation’s food supply, cosmetics, and products that emit radiation. The Office of Information Management and Technology’s (OIMT) mission is to ensure the timely and effective delivery of high quality, innovative, and cost effective information technology support services across the FDA centers and offices. In recent decades, globalization and the explosion of digital information pertaining to regulated industries has challenged the FDA to more effectively manage and utilize information to meet its regulatory and scientific mission. More recently, trends toward cloud computing, mobility, open data, sophisticated informatics analysis and visualization have resulted in an increased urgency to change the FDA IT portfolio. The 2015 OIMT Information Technology Strategic Plan was established to provide effective enterprise architecture aligned with IT environments, defined interconnecting processes and workflows, standardization and cost effective measures driven to improve customer satisfaction, quality, security, and promote automated delivery of service.

Confronted by digital transformation, FDA leadership recognized the need to innovate more, manage uncertainty better and establish more agility. However, this has to be done while simultaneously running the business and meeting predefined performance goals, which is where the bimodal capabilities, flexible governance, and creative sourcing described in this document are critical. Maintaining outdated systems is both time-consuming and expensive. In addition, some of the legacy systems will soon become incompatible with newer versions of operating systems or hardware.

"FDA leadership recognized the need to innovate more, manage uncertainty better and establish more agility"

OIMT recognizes the need to innovate, better manage changes in business process and establish more agility while simultaneously running the business. In order to establish the framework, OIMT needs to adopt more appropriate governance and planning mechanisms. Some of our proposed steps toward a governance approach include:

• Develop IT systems (applications) catalog in an easy-to-access and searchable form (as planned for the ServiceNow implementation).

• Establish the necessary transformation of IT budget allocation: systems of innovation vs. legacy systems.

• Evolve existing IT governance arrangements to become bimodal-aware by establishing a single set of IT governance principles and roles that aligns priorities between both modes.

• Educate and build support for the single set of bimodal-aware IT governance principles and roles.

• Establish review boards to ensure conformance with priorities, and standards as well as drive process improvements.

• Preserve business knowledge within domains via a comprehensive knowledge management approach that encompasses people, processes, documentation, and tools.

• Establish solution architecture to support transition and integration.

• Transition towards controlled decentralized IT governance, striking balance between agility and minimized technology footprint.

• Establish accountability–closely define roles and responsibilities within the organization, so that everyone “owns a piece of the puzzle”.

Conventional sourcing approaches create long, complex contract negotiations, which are an obstacle to quick and agile delivery. IT sourcing will need to be centered on efficiency, predictability, and a step-by-step approach that will support core business needs and be agile and flexible enough to support fast-moving, innovative initiatives that are critical to digital business success.

Below are some steps forward for approaching acquisition:

• Consolidate technology vendor contracts in aligning with the technology standards to drive efficiencies.

• Set up BPAs by technology.

• Develop an IT procurement category plan to reduce cost, manage risk and improve productivity.

• Consolidate with FDA’s internal procurement office on software license purchases.

• Develop SOW templates that utilize technology and process standards for sourcing and procurement activities that can help agility from an execution perspective. The expectation is to achieve fast, incremental, sustainable delivery of functionality. Therefore it is important for contracts to include performance metrics, requirements for adherence to FDA and industry established standards, requirements for automated testing and continuous integration, and expectations for code refactoring.

• Utilize application modernization considerations as a part of annual budget planning efforts.

Application modernization is a savvy way to modernize legacy systems in a cost-effective, efficient manner. Enterprises must innovate with a range of technologies and transform the business. The digital economy demands communications through digital channels and integration of products and services internally as well as with customers and business partners. The reality of entering digital transformation and facing high levels of uncertainty requires bringing together capabilities inside and outside of IT.

Some of the capabilities we are developing include: implementing agile software development; developing a digital strategy exploiting the cloud; reducing custom development to the lowest point possible; and finally developing a microservice architecture. According to Gartner, agile software development is an essential capability for any bimodal organization. Use of modular architecture by depicting shared and business specific services via microservice patterns should be considered where practical to achieve flexible delivery of changes, scalability and cloud readiness and can help teams deliver change with more speed and agility. Microservice architecture is a method of developing software applications as a suite of independently deployable, small, modular services in which each service runs a unique process and communicates through a well-defined, lightweight mechanism to serve a business goal.

FDA technical professionals responsible for application architecture and development must drive a DevOps culture and changes in process, organization, and platform to deliver business benefits. Establishing a DevOps workflow pipeline along with revamped tools and policies surrounding it enables agile application delivery.

The FDA’s plan moving forward includes developing an application modernization roadmap for each application using application rationalization results and new application development standards. This work will be done in collaboration between Centers and OIMT. The goal is to maximize the use of automation for existing IT systems (applications) to reduce O&M. We plan to modernize by transitioning the existing viable IT systems (applications) to DevOps Pipeline. This is where we will develop new applications using microservices and decommission old applications.