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FDA's Push for Big Data FDA's Push for Big Data

FDA's Push for Big Data

Sabermetrics is the empirical analysis of baseball, especially baseball statistics that measure in-game activity. Brad Pitt, playing Billy Beane in the 2011 blockbuster Moneyball, confirmed a proper breakdown of statistics creates a significant advantage for a baseball general manager. The use of baseball analytics like sabermetrics caused a monumental shift in talent evaluation. Now, general managers no longer rely as heavily on intuition or human experience, but rather objective data to find the right players. Similarly, the FDA is currently endeavoring to create a collaborative data-collection system that will hopefully revolutionize the medical device industry just as analytics transformed baseball.
Jeffrey Shuren, director of the FDA Center for Devices and Radiological Health (CDRH), emphasized FDA's progress building the foundation for its National Evaluation System for health Technology (NEST) in recent comments at the Food and Drug Law Institute's annual meeting. NEST is intended to aggregate and analyze "real-world" medical device data once a device is commercialized. FDA has stated that NEST is a critical piece of its evolution in the digital health space. The NEST program is intended to utilize new data models to align the interests of various parties including FDA, industry and healthcare providers for the purpose of driving quicker development and commercialization of life-saving medical devices. NEST was envisioned in 2012, but is just now to the point where applications for leadership positions are being reviewed by FDA. The leadership team will be comprised of representatives from FDA, industry, patient advocacy groups, and healthcare providers.
"Garbage in, garbage out" is a slang expression that means regardless of how well developed and precise a computer system is, the results will only be as accurate as the data being entered into the system. To that end, as FDA implements NEST, the agency will likely push for better data input related to medical devices from "real-world" sources. Healthcare providers, especially those in hospital settings, utilize medical devices frequently for numerous purposes and will be among those that FDA relies on to provide data for NEST to work effectively. 
Currently, hospitals have medical device reporting obligations that require them to report defects and adverse events associated with medical devices. Notwithstanding these obligations, FDA inspected seventeen hospitals in December of 2015 and found significant noncompliance with medical device reporting obligations in all seventeen hospitals. In light of the hospital's consistent failures and FDA's drive towards data aggregation with the NEST program, there may be increased pressure to expand medical device reporting obligations, increased inspections to ensure compliance, or, perhaps, even additional formal regulations related to reporting obligations. 
Recently, Shuren authored a blog post in which he stated, "as the nation's hubs for real-time health care data, hospitals are uniquely positioned to help identify new safety problems with devices as well as changes in the frequency of already known safety problems because they use these technologies in the real-world setting of clinical practice, outside of the more controlled setting of a clinical trial. FDA is looking to improve the way we work with hospitals to modernize and streamline data collection about medical devices." Suren acknowledged FDA, as a result of 1997 legislation, relies on a network of approximately 300 hospitals to provide "real-world" data (the Medical Product Safety Network), but states, "we will work with the hospital community on what role they should play in assuring the safe use of medical devices. This work will include how they can effectively participate in [NEST], and whether or not current reporting requirements should remain, be modified, or eliminated in light of more effective modem tools, such as software tools to conduct active surveillance of electronic health information that contains unique device identifiers."
Based on FDA's stated goal of implementing a robust data-collection system, it follows that FDA will expect hospitals to work with them to build the NEST infrastructure and may conduct more inspections to verify such compliance. It is unclear at this time what the FDA/hospital partnership will look like, but it is important that healthcare providers remain aware of this developing program and evaluate their internal procedures related to medical device reporting.
For more information, contact James Banister at or 317-236-5812. James is an associate at Ice Miller LLP. He offers clients detailed and practical guidance on how to avoid and resolve FDA regulatory challenges. He imparts to clients his knowledge of the law and a keen forward-looking sense of how the agency will view a matter, so the client can develop the most effective and persuasive approach in any given situation. James has experience representing clients on issues related to the development and marketing of medical devices and diagnostics.
This publication is intended for general information purposes only and does not and is not intended to constitute legal advice. The reader should consult with legal counsel to determine how laws or decisions discussed herein apply to the reader’s specific circumstances.
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