Digital Health Technologies for Remote Data Acquisition in Clinical Investigations

A digital health technology (DHT) is a system that uses computing platforms, connectivity, software, and/or sensors, for healthcare and related uses. This guidance provides recommendations for sponsors, investigators, and other interested parties on the use of DHTs for remote data acquisition from participants in clinical investigations evaluating medical products. There is a large spectrum of DHTs available for potential use in a clinical investigation, some of which meet the definition of a device under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and some of which do not. DHTs may take the form of hardware and/or software. In many instances, DHT software may run on general-purpose computing platforms (e.g., mobile, phone, tablet, or smart watch). A clinical investigation can use multiple DHTs to collect a range of information that may include clinical, physiological, psychological, behavioral, or functional data. This guidance outlines recommendations intended to facilitate the use of DHTs in a clinical investigation as appropriate for the evaluation of medical products. These recommendations address some of the information that should be contained in an investigational new drug application (IND) or an investigational device exemption (IDE) application for a clinical investigation in which the sponsor plans to use one or more DHTs or in a marketing application that includes such a clinical investigation.

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