“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...
Digital Doublespeak: The Language Barrier When Tech Companies Meet Regulators
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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.”
Learn what's happening at the US FDA. On the go.
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