publication date: Sep. 20, 2019

Real-World Evidence

FDA begins technology overhaul in preparation for tsunami of data and real-world evidence

By Matthew Bin Han Ong

To keep up with an increasingly data-rich health ecosystem, FDA is implementing a multi-year strategic plan to modernize its technology infrastructure—boosting cloud capabilities and building sophisticated data analytics for using real-world evidence to support regulatory decisions.

The program, FDA’s Technology Modernization Action Plan, was announced Sept. 18. On the same day, at the 8th Annual Blueprint for Breakthrough Forum in Washington, D.C., Friends of Cancer Research and its partner health IT companies shared results from the second phase of a pilot study of real-world evidence.

The plan sets the stage for what the agency needs to do in the near future to take advantage of new and innovative technology, said Amy Abernethy, FDA principal deputy commissioner and acting chief information officer.

“How do we set ourselves up for our use of data going forward? And how, as FDA, do we point the way for the use of data across all of modern medicine?” Abernethy said at the forum. “What’s in the plan? The plan really is in three parts.”

The strategic plan is focused on:

Modernizing FDA’s technical infrastructure; 

Enhancing FDA’s capabilities to develop technology products to support its regulatory mission; and 

Communicating and collaborating with stakeholders to drive technological progress that is interoperable across the system and delivers value to consumers and patients. 

FDA’s plan—led by Abernethy, a medical oncologist who built her career by innovating and transforming cancer informatics—is particularly important for oncology.

“In diseases like cancer, you really have a choice, and so, … Continue reading FDA begins technology overhaul in preparation for tsunami of data and real-world evidence

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