FDA Approval Process Could Benefit from Big Data, Social Media

Data aggregated from electronic health record (EHRs), social media platforms, and other sources could hasten the medical device development process and help regulators monitor safety, according to an assembly of bipartisan experts.

Earlier this week, speakers at the Bipartisan Policy Center’s “FDA: Advancing Medical Innovation” initiative lamented the lag time during the medical device discovery process, a process that hasn’t been updated since 1997, according to former United States Senator Bill Frist. This has led product developers to take development overseas where patients can be treated faster and with less red tape.

According to a Healthcare IT News report on the conference, speakers advocated for a Big Data approach to gathering data on medical devices and agreed to encourage Congress to take another look at the FDA’s approval practices.

Device makers “should be able to engage in sophisticated methods [or data collection and analysis] to understand patient preferences. But we’re not taking these well-established methods and plugging them into drug and device development,” noted Marc Boutin, CEO of the National Health Council. He also added that this approach to data has served electoral politics and consumer marketing well.

Patients with medical devices now have the ability to update physicians and researchers in real time by reporting feedback straight into their EHRs via patient portals. They are also likely to discuss their successes and problems with a device on social media platforms and other disease-specific web forums.

“Our inefficient, less-than-modern, drug discovery and device approval process drives up cost and delays treatment,” said Frist. “We must accelerate the process of getting safe and effective drug and medical devices to patients.”

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