FDA Digital Tech Rule Faces Health Privacy, Inequity Test

Christina Kuhn’s commentary was included in a Law360 article discussing the finalization of new FDA guidance for collecting "remote" health data in clinical investigations. The rule establishes guidelines for the remote collection of key biomarkers, such as blood pressure or heart rhythm, and providing clinical assessment.

Christina observed that companies developing digital health technologies might target "both traditional clinical use settings" and "clinical trial use as market opportunities.” She further explained that “companies anticipating that they will want to market their technologies for use in clinical trials will need to consider both medical device regulatory considerations as well as the additional considerations in the guidance.”

Christina added that for digital health technologies that are medical devices, companies might “consider whether the device specifications and performance data that support 510(k) clearance are also sufficient to address the considerations in the guidance. For digital technologies that are not regulated as medical devices, companies still will need to be able to demonstrate to clinical trial sponsors and FDA that the technology has been adequately validated and is fit-for-purpose for the clinical trial use.”

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