Friday, September 30, 2022

FDA’s Technology and Data Modernization in Action in 2022


Modernization in Action 2022. Driving Data and Technology Modernization. Business Transformation. Upper left image of lab technician filling test tubes in lab. Lower left image of woman on exercise bike using fitness app. Lower right image of diverse group of people sitting at conference table.

By: Robert M. Califf, M.D., MACC, Commissioner of Meals and Medication, and Vid Desai, Chief Info Officer

Robert M. Califf M.D., MACC
Robert M. Califf, M.D., MACC

Know-how and information have disrupted our world in methods unimaginable solely 20 years in the past – together with how the world thinks about well being. The COVID-19 pandemic accelerated these modifications and underscored the significance of aligning know-how and information methods to drive constructive outcomes in our important work addressing public well being challenges. From how we combine new know-how into medical product utility opinions and meals security efforts, to facilitating the usage of information insights to assist deal with illness, know-how and information are ubiquitous within the work of the U.S. Meals and Drug Administration. 

In 2021, we started an agency-wide information modernization and enhanced applied sciences initiative. The trouble supplies a framework for us to take a collaborative, centralized strategy to modernizing our technical IT infrastructure and the way in which we handle information throughout the FDA.

As we mark the one-year anniversary of the company’s Data Modernization Action Plan (DMAP), and practically three years since launching the company’s Technology Modernization Action Plan (TMAP), we’re happy to supply an replace on our progress with “Modernization in Action.” The anniversary report supplies an in depth evaluate of our progress as we transfer nearer to the pace of trade in streamlining workflows, lowering the price of sustaining information and community safety, and bettering the timeliness of supply of companies. Some highlights from the report embody:

Driving Know-how Modernization

  • Infrastructure and Operations Modernization. The company’s abrupt and seamless shift to a teleworking mode amid an infinite surge of labor in the course of the pandemic to assist 25,000 customers demonstrated the steadiness of FDA’s IT atmosphere. From internet hosting greater than 429,000 digital conferences yearly, to managing greater than 2,400 purposes and databases, to managing a 457% enhance in cyber-attacks in comparison with pre-pandemic ranges, the FDA met these challenges because of modernization efforts mixed with the arduous work of the FDA workforce. Individuals are at this core of this work and efficient modernization requires investing in individuals and organizational tradition to work sustainability. The Workplace of Digital Transformation (ODT) established a staff centered on bettering IT expertise acquisition and strengthening an rising IT and information workforce. These actions have led to a 9.6% hiring enhance over the prior yr and a 17% enchancment in Federal Worker Viewpoint scores.  
  • Agile and Product Tradition. Along with offering us the power to pivot due to the pandemic, TMAP has confirmed an necessary framework for our common infrastructure work. By way of it, we’re positioned to implement Presidential EO 14028, Improving the Nation’s Cybersecurity, issued Might 2021, directing businesses to modernize their cybersecurity capabilities. We proceed to fulfill vital milestones in our transfer to the cloud, concurrent with Finish-of-Life (EOL) modernization initiatives leading to >15% discount of EOL units in CY2021. This work is coupled with the adoption of trade requirements and good practices like Improvement, Safety, and Operations (DevSecOps) and Info Know-how Infrastructure Library (ITIL) processes throughout all working areas. In the end, elevated automation, sharing, reuse and constant, repeatable processes are considerably bettering the agility and price effectiveness of IT actions. This work is supported by a strengthened strategic planning and funds course of, analytics, and enhanced governance – working collectively to prioritize targets and investments. 
  • Collaborations among the many FDA, different authorities businesses, and stakeholders – together with the info/know-how sector – has been the catalyst for more practical growth of scalable, technical instruments wanted for the longer term. The Visitor Collaboration Expertise permits the FDA employees to speak and collaborate with exterior entities. In partnership with the Reagan-Udall Basis, the FDA and the Pals of Most cancers Analysis launched the Proof Accelerator (EA) to advance the usage of Actual-World Knowledge (RWD) to tell the COVID-19 response. In collaboration, ODT and the FDA’s Workplace of Meals Coverage and Response hosted the FDA New Period of Smarter Meals Security Low- or No-Value Tech-Enabled Traceability Problem. 

Driving Knowledge Modernization

  • Driver tasks are initiatives with measurable worth that assist a number of stakeholders envision what is feasible, enable technical and information consultants to establish options, and develop foundational capabilities within the company. This technique was an intentional departure from amassing information first and, subsequently, defining the questions the info can reply. 
  • Knowledge practices assist simplify information acquisition and cut back cycle time, strengthen governance, and supply safety and scalability for enterprise use of knowledge. Our progress over the previous yr ensures the FDA has entry to high-quality, effectively ruled information to be used in public well being determination making. 
  • The DMAP features a sturdy concentrate on expertise and elastic expertise networks to drive innovation, efficiencies, and collaboration. We’ll proceed to construct on initiatives together with scalable coaching, an AI-supported FDA-Experience and Analysis Portal, and government-wide approaches to recruit and retain information scientists. 

Wanting Forward

Portrait of Vid Desai, FDA's Chief Technology Officer, wearing a dark suit, dark tie, white shirt, glasses, and smiling while looking at the camera
Vid Desai

Our journey ahead contains the upcoming Enterprise Knowledge Implementation Roadmap and the FDA AI technique, which is able to improve our skill to place our information to work. It’s crucial we create enterprise-wide processes to assist the individuals of the FDA and their work. This yr we are going to roll out our Enterprise Modernization Motion Plan – our plans to form the FDA’s future by delivering profitable cross-agency efforts that optimize shared enterprise processes, improve operational effectivity and use of our information, whereas strengthening the alignment between agency-wide strategic targets and investments. 

When the FDA applies extra superior applied sciences to its work, the company might help facilitate modern growth of FDA-regulated merchandise and new strategies of producing and analyzing information to guage whether or not these merchandise meet the FDA’s requirements that sufferers rely on. In the end, profitable modernization of knowledge and know-how ought to make the job of working on the FDA each extra productive and extra enjoyable. We all know that individuals who work on the FDA like to make a distinction, use the perfect science based mostly on proof and apply their expertise to evaluation of choices to make good choices. We intend for information and know-how modernization to assist a greater and extra satisfying approach of working on the FDA.

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