FDA releases its Technology Modernization Action Plan

The Food and Drug Administration wants to close the gap between scientific and biomedical advances and the technologies required to translate those advances into new patient therapies.

To address the problem, the FDA has developed a Technology Modernization Action Plan (TMAP) that lays out the agency’s short-term actions (for 12 to 24 months) to modernize its use of information technology, including hardware, software, data and analytics.

“The TMAP provides a sturdy technological foundation for development of FDA’s ongoing strategy around data itself—a strategy for the stewardship, security, quality control, analysis and real-time use of data—that will accelerate the path to better therapeutic and diagnostic options for patients and clinical care providers, and better tools to enhance and promote public health,” states the plan.

The agency notes that rapidly evolving technologies “feature increased biological complexity, complex data and software technology, and personalization and precision of interventions,” and the FDA must be prepared for near-term modernization of its hardware and software.

“Foundational requirements for a modern FDA technology infrastructure include virtual data storage (the cloud), problem-specific software development (devops), and solutions for efficiently exchanging data,” according to the agency’s plan.

What the FDA requires is the infrastructure to “securely receive, store, exchange, link and analyze data; careful attention to data quality, integrity and security; analyses at scale, including real-time dashboards, blockchain, appropriate strategies for both structured and unstructured data, and artificial intelligence; and a learning culture that continuously builds on prior knowledge.”

The TMAP will “provide the operational experience needed to evaluate the resources needed to achieve future capabilities, including a modern data infrastructure for FDA and novel applications of artificial intelligence and other capabilities to FDA’s regulatory mission.”

The agency is starting to leverage real-world data gathered from electronic health records, lab tests, wearable devices, insurance claims and even social media to improve regulatory decisions regarding drugs and biologics.

“FDA needs to have a technical infrastructure that can accept, evaluate and analyze novel sources of data (e.g., real-world data) and apply that data to regulatory decision making,” according to the agency. “Building this infrastructure is a primary goal of the TMAP.”

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