Since July of 2016, Elaine Johanson has served as the Director of Health Informatics within the Office of the Chief Scientist at the Food and Drug Administration. In this position, she utilizes non-traditional mechanisms to share FDA data and to engage external experts in evolving areas of regulatory science. In addition, she facilitates agency-wide participation in international health data and terminology standards, leads the identification and curation of substance information and the exchange of product labeling information for FDA. Public facing examples of activities under Elaine Johanson’s leadership include:
OpenFDA - An FDA open data platform that has made it easier for researchers, scientists and developers to access publicly available FDA data related to drug adverse events, drug labeling, medical devices, and food recalls. To date, there have been more than 20 million API calls, more than 6,000 registered users, 21,000 connected systems, and dozens of new software applications devoted to making FDA data and analysis available to a wider audience.
PrecisionFDA - A collaboration space for genomics researchers around the world to work with FDA scientists to advance regulatory science through competition, sharing of tools, testing and comparision of tools, and expert dialogue. PrecisionFDA has over 3,000 members, and offers: (1) 42 terabytes of reference data, (2) an extensive library of NGS analysis tools and applications, (3) computational resources, (4) a discussion forum (5) expert blog posts, (6) app-a-thons, and (7) community challenges which promote crowd-sourced scientific innovation and advancement.
Healthy Citizen - A new exploratory initiative piloting in 2019 to provide cross-cutting FDA product information directly to healthcare providers and citizens by making tools available for use via healthcare portals. This project will enable the FDA to, (1) disseminate recall information, consumer complaints, and adverse event trends to the public in a consistent, targeted and timely manner, (2) collect and analyze de-identified citizen data related to usage of FDA-regulated products, and (3) send targeted invitations for relevant clinical and regulatory research and trials to citizens that fit the profile of the studies.
With thirty-three years' experience in information technology (IT) and health informatics, including fourteen years as a senior, strategic leader, Elaine Johanson has led an office of as many as 415 IT personnel, scientists and public health specialists. She has managed a portfolio of projects in excess of $400 million and has extensive knowledge of scientific computing, health informatics, genomics and next generation sequencing (NGS), cloud computing, crowd-sourcing, international data standard management, data harmonization, data analysis, strategic planning, software development, infrastructure operations, budget formulation and execution, human resources management, governance, project, risk, program and portfolio management. She has presented at and facilitated meetings with a wide range of internal and external stakeholders including, scientists, regulators, foreign dignitaries, congressional personnel, senior executives, and industry representatives.