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U.S. Department of Health and Human Services

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FDA IM Strategic Plan - Goal #2

 

GOAL #2


Develop the Knowledge Architecture and Infrastructure that enables smooth FDA operations, efficient review processes, risk-based analytics, and secure and seamless collaboration with public and private partners
 

 

DESCRIPTION


The availability and usability of data is essential to the speed and efficiency of decision making at FDA.  Some data must be available real-time 24:7 and is required to be translatable from data to information and knowledge almost instantly, as in the cases of imports review and the evaluation of medical adverse events.  Other data-driven processes require deeper contemplation and multivariate analysis capability, such as the pre-market review of biopharmaceuticals.

OIM at FDA supports and enables the availability, usability, connectivity, inter-operability, security, analysis and visualization of the vast array of data types and processes that stream into, through and out of FDA on a daily basis.  The intent of this goal is to make data available and consumable within and across the FDA and to enable a learning and knowledge network that enables risk-based analytics on a scale that routinely handles global sources and volumes of data.  This goal is also intended to drive the global data-sharing, risk analytics, and reliance on third parties that is envisioned in FDA’s 2011 special report, Pathway to Global Product Safety and Quality.

 

OBJECTIVES


2.1   Enable Seamless Data Availability via End-to-End and Standards-Based Master Data Capability by 2015

The FDA must have well-defined processes for the development, adoption, harmonization, and implementation of data standards to enhance interoperability of information acquired from multiple sources, to align its systems to Health IT and other standards, and to interface with industry and other government agencies both at home and abroad.

2.2   Enable Enterprise Data Management by 2015

Enterprise Data Management provides a coordinated and comprehensive approach to ensuring data integrity and that FDA’s data and information are accessible and secure.

2.3   Enhance the Efficacy of FDA Programs via Integrative Informatics by 2014

The scientific computing technology and data infrastructure enable advanced analytics, integrative analysis, data aggregation and disambiguation and a wide range of advanced computational needs, while leveraging agency-wide foundational capabilities made of reusable components.

2.4   Establish Efficient and Effective Operational Governance by 2012

FDA and OIM operational and investment strategy governance provides a business-driven, business-oriented investment management framework integrating critical organizational disciplines to successfully improve and ensure cross-agency integration and alignment of IM investments (see the U.S. General Accounting Office (GAO) - defined IT Investment Management Capability Maturity Model).

2.5   Develop and Utilize Enterprise Architecture (EA) as an Enabling and Driving Force by 2013

FDA IM EA provides a business-driven framework that captures the current state, the desired end-state, and develops solutions and transition plans for FDA’s business architecture, data architecture, systems architecture, technical architecture, security architecture, and standards via utilization of the GAO-defined IT EA Management Maturity Framework.

2.6   Utilize Rigorous Information Security Practices to Drive Innovation and Collaborative Data Access by 2012

FDA IM provides a secure IM environment with multiple levels of firewall protection, accurate personal identity verification, up-to-date intrusion prevention, detection, and response systems, and effective user security awareness.  These essential principles will be the key enablers of technological innovation and worldwide collaboration.

 

MAJOR ACTIVITIES and TIMING


Activities

FY 2012

FY 2013

FY 2014

FY 2015

FY 2016

2.A    Define, advocate, and implement standards for information exchange consistent with Health IT

 

 

X

 

X

 

X

 

X

2.B    Implement harmonized controlled vocabularies through enterprise thesaurus management

 

 

 

 

X

 

X

2.C    Implement comprehensive Master Data Management for key FDA data elements

 

 

 

X

 

X

 

X

2.D   Utilize standardized enterprise information flow processes with modern data warehousing

 

 

 

 

X

 

X

2.E    Transform legacy data to standardized formats for harmonized data warehouses

 

 

 

 

 

X

2.F    Coordinate enterprise management and injection of data quality throughout the Data Life Cycle

 

 

 

 

 

X

2.G    Utilize structured data modeling and architecture methods to assure data quality and consistency

 

 

X

 

X

 

X

 

X

2.H    Provide efficient tools for search, retrieval, reporting, auditing, and utilization of data

 

 

X

 

X

 

X

 

X

2.I     Provide for fully electronic submissions and reviews with advanced analytics and tools

 

 

 

X

 

X

 

X

2.J     Provide efficient solutions for Comprehensive Product Life Cycle Management

 

 

 

 

X

 

X

2.K    Provide advanced document and knowledge management and collaboration environments

 

 

 

X

 

X

 

X

2.L    Provide infrastructure for scientific computing, scientific enclaves, and laboratory support

 

X

 

X

 

X

 

X

 

X

2.M   Establish shared investment management processes for Agency and OIM leadership 

 

 

X

 

X

 

X

 

X

2.N    Establish effective IT investment governance processes for operations and implementation

 

 

X

 

X

 

X

 

X

2.O    Establish EA framework that integrates business, data, and systems

 

 

 

X

 

X

 

X

2.P    Maintain a secure environment where security, privacy, and confidentiality are ensured

 

X

 

X

 

X

 

X

 

X

2.Q    Establish processes to identify and evaluate new technologies and innovative approaches

 

X

 

X

 

X

 

X

 

X

 

KEY PERFORMANCE INDICATORS


  • There is a collaboratively managed menu of effective analytical tools for all primary data types
  • The FDA Security Operations Center monitors and remediates billions of intrusion attempts against FDA IT Systems annually with no major information security breaches
  • 80% of systems delivery is based upon pre-designed architectural roadmaps
  • Strategic blend between center-specific and enterprise systems development is achieved
  • Risk-based analytics drive 10-15% of annual change in inspection prioritization
  • Data availability is greatly increased as measured by imports staff
  • Knowledge management layers exist in greater than 30% of software applications
  • At least one new major component of FDA strategic plan is data-enabled annually

 

PROGRESS TO DATE and SUCCESS STORIES


Personal Identity Verification Implementation

The Division of Technology assumed a leadership role in the HHS Personal Identity Verification (PIV) compliance effort [Homeland Security Presidential Directive (HSPD) -12] ensuring that FDA personnel had the ability to use PIV cards to access their computers and FDA facilities.  PIV cards are an alternative to users having multiple accounts and passwords and are a much safer way to secure sensitive data and systems.

Progress on Automated Risk Management

The Division of Technology completed a comprehensive Automated Risk Management  plan in support of Office of Management and Budget (OMB) Directive 10-15 and began the initial phases of implementation.  Automated Risk Management is a methodology for real-time risk management of IT systems and data.  Introduction of Automated Risk Management  at the FDA will greatly streamline the introduction of new IT systems and capabilities and will ensure that proper protections are applied as threats arise and diminish.

Recognition as an HHS-wide Information Security Center of Excellence

The FDA was recognized as an HHS-wide Information Security Center of Excellence in acknowledgement of the Division of Technology's leadership in Personal Identity Verification (HSPD-12), Automated Risk Management  (OMB 10-15), and compliance with the Federal Information Security Act of 2002

Scientific Enclave Delivery

The Division of Technology delivered the Scientific Enclave environment to facilitate scientific computing collaboration within the FDA, across HHS operating divisions, and with Industry and Academia while ensuring that the appropriate controls are in place to protect the sensitive and proprietary data of patients and sponsors.  The Scientific Enclave environment is designed for rapid implementation of collaboration environments where communities of scientists can come together to analyze large, integrated data sets and address important questions confronting clinical medicine.  This accomplishment has been publically acknowledged by the Secretary of HHS.

Progress on Enterprise Architecture

EA completed a draft functional model to align with the CIO’s Plan, Build, Run paradigm.   It depicts EA threaded throughout the paradigm; as a result we are now determining the appropriate staffing needs.  EA is working on options for the Architecture/Engineering Review Board which will play a pivotal role in the new governance model being established at the FDA.

Introduction of Six-sigma Process Improvement

EA continues to work with one of the CIO’s Senior Technical Advisors on process improvement.  The first processes work (using six sigma techniques) is data architecture and management.  We have the process flows developed, have met internally, and are starting to socialize the model across the Agency.  We are in the preliminary stages of starting the next process which is service architecture.  There are three other Green-belt projects underway within OIM

 


 

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