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USFDA Guidance: Digital Health Technologies for Remote Data Acquisition & Data Standards for Drug and Biological Product Submissions and Real-World Data

Earlier this week the the U.S. Food and Drug Administration (FDA) released multiple guidances that is related to Digital Technologies and Real World Data.

Digital health technology (DHT): A system that uses computing platforms, connectivity, software, and/or sensors for health care and related uses. They include technologies intended for use as a medical product, in a medical product, or as an adjunct to other medical products (devices, drugs, and biologics).

This guidance provides recommendations on how to use digital health technologies (DHTs) to collect data remotely from participants in clinical investigations that evaluate medical products. DHTs for remote data acquisition can include hardware and/or software to perform one or more functions for clinical investigations.

This guidance may improve the efficiency of clinical trials for sponsors, investigators, and other stakeholders and may increase the opportunities for individuals to participate in research and make participation more convenient.

This guidance provides considerations for sponsors who intend to design a new registry or use an existing registry to support regulatory decisions.

Registries generally include data elements that capture information about patient characteristics, treatments received, and health outcomes for patients enrolled in the registry. Registry data collected initially for one purpose (e.g., to obtain comprehensive clinical information on patients with a particular disease) may or may not be fit-for-use for another purpose (e.g., to examine a drug-outcome association in a subset of these patients).

RWD is data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources. Example: electronic health records (EHRs).

This guidance addresses considerations for the use of data standards currently supported by FDA in applicable drug submissions containing study data derived from RWD sources. Sponsors are advised to follow this guidance when submitting RWD as study data in applicable drug submissions. FDA is issuing this guidance as part of its RWE Program and as part of fulfilling the mandate under section 505F of the FD&C Act (21 U.S.C. 355g) that RWE be used for regulatory decision-making.


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