FDA Awards Sparksoft with a Prime Contract to Provide Future-State Reference Enterprise Architecture

Sparksoft Corporation, an industry leader of innovative Digital Health solutions, has been awarded a prime contract by the U.S. Food and Drug Administration (FDA) to Provide Future-State Reference Enterprise Architecture that will focus on security, lean-agile development, data governance, data quality, and powerful analytics to accelerate the path to better therapeutic and diagnostic options for people and animals, better secure the food supply chain, and provide state-of-the-art tools to enhance and promote public health. FDA’s Office of Information Management and Technology (OIMT) and Office of Digital Transformation (ODT) have established the Technology Modernization Action Plan (TMAP), Data Modernization Action Plan (DMAP), Enterprise Modernization Action Plan (EMAP), and Cybersecurity Modernization Action Plan (CMAP) over the course of five years. These plans are the reflection of a common IT strategy to fulfill the agency’s Prescription drug User Fee Act (PDUFA) and Fiscal Year 2023 Omnibus Bill commitments with a shared FDA vision for excellence.  Being the lead office for all agency field activities, Office of Regulatory Affairs (ORA) is uniquely positioned to commit to this vision and to implement the strategy. ORA inspects regulated products and manufacturers, conducts sample analysis of regulated products and reviews imported products offered for entry into the United States. ORA closely works with other FDA centers such as CDER, CFSAN, CDRH, as well as its state, local, tribal, territorial, and foreign counterparts. There are about 80 IT applications operational in ORA with every one demanding a share of development, modernization and enhancement (DME) and operations and maintenance (O&M) budget. Under this contract, Sparksoft will develop a future-state reference enterprise architecture blueprint to ensure long-term business success for ORA’s IT strategy to modernize its enterprise software applications to meet the following business objectives:

• Safeguard FDA digital assets and business processes by adhering to zero-trust principles
• Shorten development and release cycle and increase development productivity
• Achieve organizational adaptability, business agility and lean operation
• Ensure long-term ROI by pivoting to modern architecture principles and paradigms

“It is truly a privilege to be such a trusted partner to our HHS clients, who are dedicated public servants leading transformational missions. It is never easy to break into a new agency and I am very excited to establish Sparksoft’s roots at the FDA” said Sparksoft’s President Ms. Siva Sivaraman. Sparksoft’s CEO, Mr. Mike Finkel stated that “We are honored and humbled that the government continues to trust us with support on mission-critical public health programs that impact our families and communities. I am proud of Sparksoft’s success to continue the penetration into the life sciences, epidemiology, biostatistics, health informatics, clinical quality, and medical research market segments.”  Through our strategic partnership with Red Hat and deep healthcare domain expertise, this award further establishes Sparksoft as a preferred system integrator for the Federal Government and expands Sparksoft’s footprint across HHS driving innovation through best of breed technologies on agency-wide programs like Centers for Disease Control and Prevention (CDC) Immunization Gateway (IZGW); National Institutes of Health (NIH) Red Hat OpenShift Kubernetes Engine consulting services; Health Resources and Services Administration (HRSA) Customer Service & Program Operations Center (CSPOC) for National Practitioner Data Bank (NPDB); and Centers for Medicare & Medicaid Services (CMS) Marketplace Open Modernization and Optimization Technologies (MOMOT) to develop a cloud-agnostic, multi-tenant OpenShift Container Platform (OCP) and Trusted Software Supply Chain (TSSC), as well as delivering other CMS ecosystem innovations such as the Federal Data Services Hub (Hub) for Healthcare.gov Marketplace data exchanges between hundreds of partners and millions of users, providing highly secure and available access to over 50 integrated systems on Enterprise Portal Services (EPS), Medicare Payment Systems Modernization from legacy Mainframe and Cobol solution to a Microservices Architecture in the AWS Cloud on Medicare Integrated Systems Testing (MIST), the eligibility appeals case management system that processes up to 15000 monthly appeals on Eligibility Appeals Operations Support-Digital Services Support (EAOS-DSS). and the Advanced Provider Screening (APS) program that continuously screens over 4 million active Medicare and Medicaid providers and suppliers in all 50 states and 6 territories.

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