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Digital Doublespeak: The Language Barrier When Tech Companies Meet Regulators

 
• By Cole Werble

A US National Academies meeting on digital health technology showcased the communication gap between regulators and tech developers when it comes to important concepts like “digital biomarkers.”

Communication failure with geek due to language barrier and different way of thinking
Sponsors trying to incorporate digital devices into clinical trial programs should take care in how they describe their projects to FDA. • Source: Shutterstock

“Digital biomarker” is a marked term for the US Food and Drug Administration team in charge of drug development tools.

Regulators tend to react negatively to the oft-used-phrase because it appears to overstate the role of digital equipment in the collection of functional or physiological information to support new drug...

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